COMPENDIUM

2013
of selected publications
The 2013 Compendium of Selected Publications CD-ROM contains all Committee Opinions, Practice Bul-
letins, Policy Statements, Technology Assessments, and Patient Safety Checklists published by the American
College of Obstetricians and Gynecologists (the College) that are current as of December 31, 2012. The
information in these documents should not be viewed as establishing standards or dictating rigid rules.
The guidelines are general and intended to be adapted to many different situations, taking into account the
needs and resources particular to the locality, the institution, or the type of practice. Variations and innova-
tions that improve the quality of patient care are to be encouraged rather than restricted. The purpose of
these guidelines will be well served if they provide a firm basis on which local norms may be built.

Copyright 2013 by the American College of Obstetricians and Gynecologists. All rights reserved. No part
of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted,
in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to make photocopies should be directed
to the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923.

The American College of Obstetricians and Gynecologists

409 12th Street, SW
PO Box 96920
Washington, DA 20090-6920

ISBN: 978-1-934984-25-3

Publications can be ordered through the College Distribution Center by calling toll free 800-762-2264. To
receive order forms via facsimile, call 877-226-4329 and follow the audio instructions. Publications also can
be ordered from the College web site at www.acog.org.

The following resources from the College also contain College practice guidelines and should
be considered adjuncts to the documents in the Compendium of Selected Publications CD-ROM.

Guidelines for Perinatal Care, Seventh Edition

Guidelines for Women’s Health Care, Third Edition
Special Issues in Women’s Health
Guidelines for Adolescent Health Care, Second Edition

These documents are available online to members at www.acog.org

2013 COMPENDIUM OF SELECTED PUBLICATIONS i

 SEARCH

CONTENTS
Foreword........................................................................................................................................................................... xv

The Scope of Practice of Obstetrics and Gynecology.............................................................................. xvi

Code of Professional Ethics................................................................................................................................. xvii

COMMITTEE OPINIONS
Committee On Adolescent Health Care

349 Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign
(Joint with American Academy of Pediatrics).............................................................................................................2
355 Vaginal Agenesis: Diagnosis, Management, and Routine Care............................................................................8
415 Depot Medroxyprogesterone Acetate and Bone Effects (Joint with the Committee
on Gynecologic Practice)..........................................................................................................................................13
417 Addressing Health Risks of Noncoital Sexual Activity (Joint with the Committee
on Gynecologic Practice)..........................................................................................................................................17
448 Menstrual Manipulation for Adolescents With Disabilities.................................................................................20
451 Von Willebrand Disease in Women (Joint with Committee on Gynecologic Practice)............................................24
460 The Initial Reproductive Health Visit...................................................................................................................29
463 Cervical Cancer in Adolescents: Screening, Evaluation, and Management........................................................33
467 Human Papillomavirus Vaccination.....................................................................................................................37
506 Expedited Partner Therapy in the Management of Gonorrhea and Chlamydia
by Obstetrician–Gynecologists (Joint with the Committee on Gynecologic Practice)..............................................41
*539 Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine
Devices (Joint with the Long-Acting Reversible Contraception Working Group)......................................................47

Committee On American Indian/Alaska Native Women’s Health

*515 Health Care for Urban American Indian and Alaska Native Women (Joint with
the Committee on Health Care for Undeserved Women)..........................................................................................54

Committee On coding and nomenclature

205 Tubal Ligation with Cesarean Delivery................................................................................................................60
249 Coding Responsibility............................................................................................................................................61
250 Inappropriate Reimbursement Practices by Third-Party Payers.........................................................................62

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS ii

Committee On Ethics
297 Nonmedical Use of Obstetric Ultrasonography...................................................................................................67
321 Maternal Decision Making, Ethics, and the Law.................................................................................................69
347 Using Preimplantation Embryos for Research.....................................................................................................80
352 Innovative Practice: Ethical Guidelines................................................................................................................93
359 Commercial Enterprises in Medical Practice......................................................................................................100
360 Sex Selection........................................................................................................................................................103
362 Medical Futility....................................................................................................................................................107
363 Patient Testing: Ethical Issues in Selection and Counseling.............................................................................111
364 Patents, Medicine, and the Interests of Patients (Joint with Committee on Genetics).........................................114
365 Seeking and Giving Consultation.......................................................................................................................119
369 Multifetal Pregnancy Reduction..........................................................................................................................124
370 Institutional Responsibility to Provide Legal Representation...........................................................................129
371 Sterilization of Women, Including Those With Mental Disabilities..................................................................131
373 Sexual Misconduct...............................................................................................................................................135
374 Expert Testimony.................................................................................................................................................139
377 Research Involving Women................................................................................................................................141
385 The Limits of Conscientious Refusal in Reproductive Medicine.......................................................................147
389 Human Immunodeficiency Virus........................................................................................................................153
390 Ethical Decision Making in Obstetrics and Gynecology....................................................................................159
395 Surgery and Patient Choice.................................................................................................................................168
397 Surrogate Motherhood........................................................................................................................................173
403 End-of-Life Decision Making.............................................................................................................................179
409 Direct-to-Consumer Marketing of Genetic Testing (Joint with Committee on Genetics)....................................186
410 Ethical Issues in Genetic Testing (Joint with Committee on Genetics).................................................................188
422 At-Risk Drinking and Illicit Drug Use: Ethical Issues in Obstetric and Gynecologic Practice........................196
439 Informed Consent................................................................................................................................................208
456 Forming a Just Health Care System....................................................................................................................216
466 Ethical Considerations for Performing Gynecological Surgery in Low-Resource Settings
Abroad (Joint with Committee on Global Women’s Health)...................................................................................222
480 Empathy in Women’s Health Care.....................................................................................................................229

2013 COMPENDIUM OF SELECTED PUBLICATIONS iii

Committee On Ethics (continued)

500 Professional Responsibilities in Obstetric–Gynecologic Medical Education and Training..............................235

501 Maternal–Fetal Intervention and Fetal Care Centers (Joint with the American Academy
of Pediatrics Committee on Bioethics)....................................................................................................................240
510 Ethical Ways for Physicians to Market a Practice..............................................................................................246
*528 Adoption..............................................................................................................................................................249
*541 Professional Relationships With Industry..........................................................................................................254

Committee On Genetics

318 Screening for Tay–Sachs Disease........................................................................................................................262

324 Perinatal Risks Associated With Assisted Reproductive Technology (Joint with Committees on
Obstetric Practice and Gynecologic Practice)..........................................................................................................264
399 Umbilical Cord Blood Banking (Joint with Committee on Obstetric Practice)......................................................268
430 Preimplantation Genetic Screening for Aneuploidy..........................................................................................271
432 Spinal Muscular Atrophy.....................................................................................................................................273
442 Preconception and Prenatal Carrier Screening for Genetic Diseases in Individuals of
Eastern European Jewish Descent......................................................................................................................276
446 Array Comparative Genomic Hybridization in Prenatal Diagnosis..................................................................280
449 Maternal Phenylketonuria...................................................................................................................................283
469 Carrier Screening for Fragile X Syndrome..........................................................................................................285
478 Family History as a Risk Assessment Tool.........................................................................................................288
481 Newborn Screening.............................................................................................................................................292
486 Update on Carrier Screening for Cystic Fibrosis................................................................................................296
488 Pharmacogenetics................................................................................................................................................300
*527 Personalized Genomic Testing for Disease Risk................................................................................................ 302
1 Genetics and Molecular Diagnostic Testing.......................................................................................................304

Committee On Gynecologic practice

240 Statement on Surgical Assistants (Joint with the Committee on Obstetrics Practice)...........................................324
253 Nongynecologic Procedures................................................................................................................................325
278 Avoiding Inappropriate Clinical Decisions Based on False-Positive Human
Chorionic Gonadotropin Test Results................................................................................................................326

* Published in 2012
Technology Assessment

2013 COMPENDIUM OF SELECTED PUBLICATIONS iv

Committee On Gynecologic practice (continued)

313 The Importance of Preconception Care in the Continuum of Women’s Health Care.....................................329
323 Elective Coincidental Appendectomy.................................................................................................................331
324 Perinatal Risks Associated With Assisted Reproductive Technology (Joint with the
Committee on Obstetric Practice and Genetics)......................................................................................................333
336 Tamoxifen and Uterine Cancer...........................................................................................................................337
345 Vulvodynia (Joint with the American Society for Colposcopy and Cervical Pathology)..........................................341
372 The Role of Cystourethroscopy in the Generalist Obstetrician–Gynecologist Practice...................................345
375 Brand Versus Generic Oral Contraceptives........................................................................................................349
378 Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures..............................................................................351
388 Supracervical Hysterectomy................................................................................................................................353
396 Intraperitoneal Chemotherapy for Ovarian Cancer...........................................................................................356
408 Professional Liability and Gynecology-Only Practice (Joint with Committees on
Obstetric Practice and Professional Liability).........................................................................................................359
411 Routine Human Immunodeficiency Virus Screening.........................................................................................360
412 Aromatase Inhibitors in Gynecologic Practice...................................................................................................363
413 Age-Related Fertility Decline (Joint with American Society for Reproductive Medicine)......................................366
420 Hormone Therapy and Heart Disease................................................................................................................369
434 Induced Abortion and Breast Cancer Risk.........................................................................................................373
440 The Role of Transvaginal Ultrasonography in the Evaluation of Postmenopausal Bleeding...........................375
444 Choosing the Route of Hysterectomy for Benign Disease.................................................................................378
450 Increasing Use of Contraceptive Implants and Intrauterine Devices to Reduce
Unintended Pregnancy (Joint with the Long-Acting Reversible Contraception Working Group)...........................381
458 Use of Hysterosalpingography After Tubal Sterilization...................................................................................386
477 The Role of Obstetrician–Gynecologist in the Early Detection of Epithelial Ovarian
Cancer (Joint with the Society of Gynecologic Oncologists)....................................................................................389
482 Colonoscopy and Colorectal Cancer Screening Strategies................................................................................394
484 Performance Enhancing Anabolic Steroid Abuse in Women............................................................................400
489 Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus Infections in
Obstetrician–Gynecologists.................................................................................................................................403
505 Understanding and Using the U.S. Medical Eligibility Criteria for Contraceptive Use, 2010
(Joint with the Long-Acting Reversible Contraception Working Group)..................................................................408

2013 COMPENDIUM OF SELECTED PUBLICATIONS v

Committee On Gynecologic practice (continued)

509 Management of Vulvar Intraepithelial Neoplasia (Joint with the American Society for
Colposcopy and Cervical Pathology)......................................................................................................................415
513 Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse (Joint with the
American Urogynecologic Society)..........................................................................................................................418
*532 Compounded Bioidentical Menopausal Hormone Therapy (Joint with the
American Society for Reproductive Medicine Practice Committee)..........................................................................424
*534 Well-Woman Visit...............................................................................................................................................429
*537 Reprocessed Single-Use Devices........................................................................................................................433
*540 Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral
Contraceptive Pills...............................................................................................................................................436
*544 Over-the-Counter Access to Oral Contraceptives.............................................................................................440
6 Robot-Assisted Surgery.......................................................................................................................................445
7 Hysteroscopy........................................................................................................................................................448
* 8 Sonohysterography..............................................................................................................................................454

Committee On Health Care for Underserved Women

307 Partner Consent for Participation in Women’s Reproductive Health Research...............................................459

317 Racial and Ethnic Disparities in Women’s Health.............................................................................................462
361 Breastfeeding: Maternal and Infant Aspects (Joint with the Committee on Obstetric Practice)...........................466
416 The Uninsured.....................................................................................................................................................468
423 Motivational Interviewing: A Tool for Behavior Change...................................................................................472
424 Abortion Access and Training.............................................................................................................................476
425 Health Care for Undocumented Immigrants.....................................................................................................480
428 Legal Status: Health Impact for Lesbian Couples..............................................................................................484
429 Health Disparities for Rural Women..................................................................................................................488
437 Community Involvement and Volunteerism......................................................................................................492
454 Health Care for Homeless Women.....................................................................................................................494
457 Preparing for Disasters: Perspectives on Women..............................................................................................498
470 Challenges for Overweight and Obese Urban Women.....................................................................................502
471 Smoking Cessation During Pregnancy (Joint with the Committee on Obstetric Practice)....................................506
473 Substance Abuse Reporting and Pregnancy: The Role of the Obstetrician–Gynecologist..............................510

* Published in 2012
Technology Assessment

2013 COMPENDIUM OF SELECTED PUBLICATIONS vi

Committee On Health Care for Underserved Women (continued)

479 Methamphetamine Abuse in Women of Reproductive Age..............................................................................512

491 Health Literacy (Joint with the Committee on Patient Safety and Quality Improvement)......................................517
492 Effective Patient–Physician Communication (Joint with the Committee on Patient Safety
and Quality Improvement).....................................................................................................................................521
493 Cultural Sensitivity and Awareness in the Delivery of Health Care.................................................................525
496 At-Risk Drinking and Alcohol Dependence: Obstetric and Gynecologic Implications...................................529
498 Adult Manifestations of Childhood Sexual Abuse.............................................................................................535
499 Sexual Assault......................................................................................................................................................539
503 Tobacco Use and Women’s Health.....................................................................................................................543
507 Human Trafficking...............................................................................................................................................548
511 Health Care for Pregnant and Postpartum Incarcerated Women and Adolescent Females............................552
512 Health Care for Transgender Individuals...........................................................................................................557
*516 Health Care Systems for Underserved Women.................................................................................................562
*518 Intimate Partner Violence...................................................................................................................................566
*524 Opioid Abuse, Dependence, and Addiction in Pregnancy (Joint with the American
Society of Addiction Medicine)...............................................................................................................................572
*525 Health Care for Lesbians and Bisexual Women.................................................................................................579
*530 Access to Postpartum Sterilization.....................................................................................................................583
*535 Reproductive Health Care for Incarcerated Women and Adolescent Females.................................................587
* 536 Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome
and Women of Color...........................................................................................................................................592
*538 Nonmedical Use of Prescription Drugs..............................................................................................................597
*542 Access to Emergency Contraception...................................................................................................................603
*547 Health Care for Women in the Military and Women Veterans........................................................................607

Committee On International affairs

427 Misoprostol for Postabortion Care......................................................................................................................613

Committee On Obstetric practice

234 Scheduled Cesarean Delivery and the Prevention of Vertical Transmission

of HIV Infection...................................................................................................................................................618
260 Circumcision........................................................................................................................................................621

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS vii

Committee On Obstetric practice (continued)

267 Exercise During Pregnancy and the Postpartum Period....................................................................................623

268 Management of Asymptomatic Pregnant or Lactating Women Exposed to Anthrax......................................626
275 Obstetric Management of Patients with Spinal Cord Injuries..........................................................................629
295 Pain Relief During Labor (Joint with the American Society of Anesthesiologists).................................................632
299 Guidelines for Diagnostic Imaging During Pregnancy......................................................................................633
315 Obesity in Pregnancy..........................................................................................................................................638
326 Inappropriate Use of the Terms Fetal Distress and Birth Asphyxia..................................................................643
333 The Apgar Score (Joint with the American Academy of Pediatrics).......................................................................645
339 Analgesia and Cesarean Delivery Rates.............................................................................................................649
340 Mode of Term Singleton Breech Delivery..........................................................................................................651
346 Amnioinfusion Does Not Prevent Meconium Aspiration Syndrome................................................................654
348 Umbilical Cord Blood Gas and Acid-Base Analysis...........................................................................................657
376 Nalbuphine Hydrochloride Use for Intrapartum Analgesia..............................................................................661
379 Management of Delivery of a Newborn With Meconium-Stained Amniotic Fluid.........................................662
381 Subclinical Hypothyroidism in Pregnancy.........................................................................................................663
382 Fetal Monitoring Prior to Scheduled Cesarean Delivery...................................................................................665
404 Late-Preterm Infants...........................................................................................................................................666
418 Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations...................670
433 Optimal Goals for Anesthesia Care in Obstetrics (Joint with the American Society
of Anesthesiologists)...............................................................................................................................................674
435 Postpartum Screening for Abnormal Glucose Tolerance in Women Who Had
Gestational Diabetes Mellitus.............................................................................................................................677
441 Oral Intake During Labor....................................................................................................................................680
443 Air Travel During Pregnancy..............................................................................................................................681
453 Screening for Depression During and After Pregnancy....................................................................................683
455 Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection (Joint with
the Society for Maternal–Fetal Medicine)...............................................................................................................685
462 Moderate Caffeine Consumption During Pregnancy.........................................................................................688
465 Antimicrobial Prophylaxis for Cesarean Delivery: Timing of Administration..................................................690
468 Influenza Vaccination During Pregnancy...........................................................................................................692
474 Nonobstetric Surgery During Pregnancy............................................................................................................694

2013 COMPENDIUM OF SELECTED PUBLICATIONS viii

Committee On Obstetric practice (continued)

475 Antenatal Corticosteroid Therapy for Fetal Maturation....................................................................................696

476 Planned Home Birth............................................................................................................................................699
485 Prevention of Early-Onset Group B Streptococcal Disease in Newborns........................................................703
494 Sulfonamides, Nitrofurantoin, and Risk of Birth Defects..................................................................................712
495 Vitamin D: Screening and Supplementation During Pregnancy.......................................................................714
504 Screening and Diagnosis of Gestational Diabetes Mellitus...............................................................................716
514 Emergent Therapy for Acute-Onset, Severe Hypertension With Preeclampsia or Eclampsia.........................719
*521 Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination...........................723
*529 Placenta Accreta..................................................................................................................................................725
*533 Lead Screening During Pregnancy and Lactation.............................................................................................730
*543 Timing of Umbilical Cord Clamping After Birth................................................................................................735

Committee On patient safety and quality improvement

447 Patient Safety in Obstetrics and Gynecology.....................................................................................................741

459 The Obstetric–Gynecologic Hospitalist..............................................................................................................745
464 Patient Safety in the Surgical Environment.......................................................................................................748
472 Patient Safety and the Electronic Health Record...............................................................................................753
487 Preparing for Clinical Emergencies in Obstetrics and Gynecology...................................................................756
490 Partnering With Patients to Improve Safety......................................................................................................759
508 Disruptive Behavior.............................................................................................................................................762
*517 Communication Strategies for Patient Handoffs...............................................................................................765
*519 Fatigue and Patient Safety..................................................................................................................................769
*520 Disclosure and Discussion of Adverse Events (Joint with Committee on Professional Liability).........................772
*523 Re-entering the Practice of Obstetrics and Gynecology....................................................................................776
*526 Standardization of Practice to Improve Outcomes............................................................................................780
*531 Improving Medication Safety..............................................................................................................................782
*546 Tracking and Reminder Systems.........................................................................................................................787

Committee On professional liability

497 Coping With the Stress of Medical Professional Liability Litigation................................................................791

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS ix

 PATIENT SAFETY CHECKLISTS
2 Inpatient Induction of Labor...............................................................................................................................795
3 Scheduling Planned Cesarean Delivery..............................................................................................................797
4 Preoperative Planned Cesarean Delivery...........................................................................................................799
5 Scheduling Induction of Labor...........................................................................................................................801
* 6 Documenting Shoulder Dystocia........................................................................................................................803
* 7 Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection.....................................................805
* 8 Appropriateness of Trial of Labor After Previous Cesarean Delivery (Antepartum Period)............................807
* 9 Trial of Labor After Previous Cesarean Delivery (Intrapartum Admission).....................................................809

READING THE MEDICAL LITERATURE.................................................................................................................812

PRACTICE BULLETINS
THE Committee On PRACTICE BULLETINS — OBSTETRICS

4 Prevention of Rh D Alloimmunization...............................................................................................................821
6 Thrombocytopenia in Pregnancy........................................................................................................................829
9 Antepartum Fetal Surveillance............................................................................................................................840
12 Intrauterine Growth Restriction..........................................................................................................................851
13 External Cephalic Version...................................................................................................................................863
17 Operative Vaginal Delivery.................................................................................................................................870
20 Perinatal Viral and Parasitic Infections...............................................................................................................878
22 Fetal Macrosomia.................................................................................................................................................891
30 Gestational Diabetes...........................................................................................................................................902
33 Diagnosis and Management of Preeclampsia and Eclampsia...........................................................................916
36 Obstetric Analgesia and Anesthesia...................................................................................................................925
37 Thyroid Disease in Pregnancy.............................................................................................................................940
38 Perinatal Care at the Threshold of Viability.......................................................................................................950
40 Shoulder Dystocia................................................................................................................................................958
44 Neural Tube Defects............................................................................................................................................964
49 Dystocia and Augmentation of Labor.................................................................................................................975

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS x

 THE Committee On PRACTICE BULLETINS — OBSTETRICS (continued)

52 Nausea and Vomiting of Pregnancy...................................................................................................................985

56 Multiple Gestation: Complicated Twin, Triplet, and High-Order Multifetal Pregnancy
(Joint with the Society for Maternal–Fetal Medicine).............................................................................................998
60 Pregestational Diabetes Mellitus......................................................................................................................1013
71 Episiotomy......................................................................................................................................................... 1024
75 Management of Alloimmunization During Pregnancy.................................................................................... 1030
76 Postpartum Hemorrhage................................................................................................................................... 1038
77 Screening for Fetal Chromosomal Abnormalities (Joint with the Committee on Genetics and
the Society for Maternal–Fetal Medicine)............................................................................................................. 1047
78 Hemoglobinopathies in Pregnancy................................................................................................................... 1058
80 Premature Rupture of Membranes................................................................................................................... 1067
82 Management of Herpes in Pregnancy.............................................................................................................. 1080
86 Viral Hepatitis in Pregnancy............................................................................................................................. 1090
88 Invasive Prenatal Testing for Aneuploidy (Joint with Committee on Genetics)..................................................1105
90 Asthma in Pregnancy........................................................................................................................................ 1114
92 Use of Psychiatric Medications During Pregnancy and Lactation.................................................................. 1122
95 Anemia in Pregnancy........................................................................................................................................ 1142
100 Critical Care in Pregnancy................................................................................................................................. 1149
101 Ultrasonography in Pregnancy.......................................................................................................................... 1157
102 Management of Stillbirth.................................................................................................................................. 1168
105 Bariatric Surgery and Pregnancy....................................................................................................................... 1182
106 Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and
General Management Principles....................................................................................................................... 1191
107 Induction of Labor............................................................................................................................................. 1202
115 Vaginal Birth After Previous Cesarean Delivery.............................................................................................. 1214
116 Management of Intrapartum Fetal Heart Rate Tracings.................................................................................. 1228
120 Use of Prophylactic Antibiotics in Labor and Delivery.................................................................................... 1236
123 Thromboembolism in Pregnancy...................................................................................................................... 1248
124 Inherited Thrombophilias in Pregnancy........................................................................................................... 1260
*125 Chronic Hypertension in Pregnancy................................................................................................................. 1271
*127 Management of Preterm Labor......................................................................................................................... 1283

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS xi

THE Committee On PRACTICE BULLETINS — OBSTETRICS (continued)

*130 Prediction and Prevention of Preterm Birth..................................................................................................... 1293

*132 Antiphospholipid Syndrome............................................................................................................................. 1304
251 Obstetric Aspects of Trauma Management...................................................................................................... 1313

THE Committee On PRACTICE BULLETINS — Gynecology

14 Management of Anovulatory Bleeding............................................................................................................. 1321
28 Use of Botanicals for Management of Menopausal Symptoms....................................................................... 1329
39 Selective Estrogen Receptor Modulators.......................................................................................................... 1340
46 Benefits and Risks of Sterilization.................................................................................................................... 1350
51 Chronic Pelvic Pain........................................................................................................................................... 1362
53 Diagnosis and Treatment of Gestational Trophoblastic Disease (Joint with Society
of Gynecologic Oncologists).................................................................................................................................. 1379
57 Gynecologic Herpes Simplex Virus Infections................................................................................................. 1392
63 Urinary Incontinence in Women......................................................................................................................1399
65 Management of Endometrial Cancer (Joint with Society of Gynecologic Oncologists).......................................1412
67 Medical Management of Abortion.................................................................................................................... 1425
72 Vaginitis............................................................................................................................................................. 1437
73 Use of Hormonal Contraception in Women With Coexisting Medical Conditions.......................................1449
81 Endometrial Ablation........................................................................................................................................ 1469
83 Management of Adnexal Masses...................................................................................................................... 1485
84 Prevention of Deep Vein Thrombosis and Pulmonary Embolism................................................................... 1499
85 Pelvic Organ Prolapse....................................................................................................................................... 1511
89 Elective and Risk-Reducing Salpingo-oophorectomy...................................................................................... 1524
91 Treatment of Urinary Tract Infections in Nonpregnant Women..................................................................... 1535
93 Diagnosis and Management of Vulvar Skin Disorders.................................................................................... 1545
94 Medical Management of Ectopic Pregnancy.................................................................................................... 1556
96 Alternatives to Hysterectomy in the Management of Leiomyomas................................................................1563
99 Management of Abnormal Cervical Cytology and Histology.......................................................................... 1577
103 Hereditary Breast and Ovarian Cancer Syndrome (Joint with the Committee on Genetics
and the Society of Gynecologic Oncologists)......................................................................................................... 1603
104 Antibiotic Prophylaxis for Gynecologic Procedures ........................................................................................ 1613

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS xii

THE Committee On PRACTICE BULLETINS — Gynecology (continued)

108 Polycystic Ovary Syndrome............................................................................................................................... 1623

110 Noncontraceptive Uses of Hormonal Contraceptives...................................................................................... 1637
112 Emergency Contraception................................................................................................................................. 1650
114 Management of Endometriosis......................................................................................................................... 1660
117 Gynecologic Care for Women With Human Immunodeficiency Virus...........................................................1674
119 Female Sexual Dysfunction............................................................................................................................... 1692
121 Long-Acting Reversible Contraception: Implants and Intrauterine Devices..................................................1704
122 Breast Cancer Screening.................................................................................................................................... 1717
*126 Management of Gynecologic Issues in Women With Breast Cancer.............................................................. 1728
*128 Diagnosis of Abnormal Uterine Bleeding in Reproductive-Aged Women.....................................................1745
*129 Osteoporosis...................................................................................................................................................... 1756
*131 Screening for Cervical Cancer........................................................................................................................... 1773

POLICY STATEMENTS
AAFP—ACOG Joint Statement on Cooperative Practice and Hospital Privileges
(July 1980, Revised and Retitled March 1998)........................................................................................................ 1792
Abortion Policy (January 1993, Reaffirmed July 2011).....................................................................................................1794
Access to Women’s Health Care (July 1988, Reaffirmed July 2009)................................................................................ 1797
Certification and Procedural Credentialing (February 2008, Revised and Approved July 2012)....................................1798
Cervical Cancer Prevention in Low-Resource Settings (March 2004, Reaffirmed July 2011).........................................1799
Joint Statement of ACOG/AAP on Human Immunodeficiency Virus Screening
(May 1999, Reaffirmed July 2011)............................................................................................................................ 1801
Joint Statement of Practice Relations Between Obstetrician–Gynecologists
and Certified Nurse-Midwives/Certified Midwives (February 2011)..................................................................... 1803
Midwifery Education and Certification (February 2006, Reaffirmed July 2011).............................................................. 1805
The Role of the Obstetrician–Gynecologist in Cosmetic Procedures (November 2008,
Reaffirmed July 2012)............................................................................................................................................... 1806
Tobacco Marketing Aimed at Women and Adolescents (July 1990, Revised
and Approved July 2009).......................................................................................................................................... 1807
Global Women’s Health and Rights (July 2012)............................................................................................................... 1809

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS xiii

A PPENDIX
Contents From Other College Resources.............................................................................................................. 1811
*Committee Opinion Lists of Titles........................................................................................................................ 1815
*Practice Bulletin Lists of Titles............................................................................................................................... 1824

*Published in 2012

2013 COMPENDIUM OF SELECTED PUBLICATIONS xiv

FOREWORD
The 2013 Compendium of Selected Publications CD-ROM is a compilation of all Committee Opinions, Practice Bulletins,
Policy Statements, Technology Assessments, and Patient Safety Checklists current as of December 31, 2012:
• Committee Opinions: Brief focused documents that address clinical issues of an urgent or emergent nature
or nonclinical topics, such as policy, economics, and social issues that relate to obstetrics and gynecology.
They are consensus statements that may or may not be based on scientific evidence.
• Practice Bulletins: Evidence-based guidelines developed to indicate a preferred method of diagnosis and
management of a condition. The evidence is graded, and peer-reviewed research determines the recom-
mendations in the document.
• Policy Statements: Position papers on key issues approved by the Executive Board
• Technology Assessments in Obstetrics and Gynecology: Documents that describe specific
technologies and their application
• Patient Safety Checklists: Documents designed to help facilitate standardization and a culture of safety
These series are developed by committees of experts and reviewed by leaders in the specialty and the American
College of Obstetricians and Gynecologists (the College). Each document is reviewed periodically and either reaffirmed,
replaced, or withdrawn to ensure its continued appropriateness to practice. The contribution of the many groups and
individuals who participated in the process is gratefully acknowledged.
Each section of the Compendium is devoted to a particular series and includes those documents considered
current at the time of publication. A comprehensive table of contents has been added for ease of use with titles listed
numerically by committee. Those published within 2012 are indicated with an asterisk. Also provided are current Committee
Opinion and Practice Bulletin lists of titles, grouped by committee in order of publication.
As the practice of medicine evolves, so do College documents. As a part of the continuing process of review
and revision, many documents initially published as a separate installment of a series evolve to become a part of a broader
effort to educate and inform our Fellows. Books such as Guidelines for Perinatal Care or Guidelines for Women’s Health
Care carry equal weight as practice guidelines and should be considered adjuncts to the documents in the series. For ease of
reference, the contents of these volumes are included in the appendix.
Throughout the year, new Committee Opinions and Practice Bulletins will be published in the College’s official journal,
Obstetrics & Gynecology. Single copies can be obtained from the Resource Center (202-863-2518), and the series are avail-
able for sale as a subscription (call 800-762-2264 to order). These documents also are available to members on our web site:
www.acog.org. To verify the status of documents, contact the Resource Center or check our web site.
We are making every effort to provide health professionals with current, quality information on the practice of obstetrics
and gynecology. The 2013 Compendium of Selected Publications CD-ROM represents another way to disseminate material
designed to promote women’s health.
Additional copies of the 2013 Compendium of Selected Publications CD-ROM can be purchased from the College
Distribution Center (Compendium CD-ROM [product number AA470]: $150, $65 for members). Please call 800-762-2264
or order online at sales.acog.org.

—Hal C. Lawrence III, MD, Executive Vice President

2013 COMPENDIUM OF SELECTED PUBLICATIONS xv

The Scope of Practice of
Obstetrics and Gynecology
Obstetrics and gynecology is a discipline dedicated to the broad, integrated medical and surgical care of
women’s health throughout their lifespan. The combined discipline of obstetrics and gynecology requires
extensive study and understanding of reproductive physiology, including the physiologic, social, cultural,
environmental and genetic factors that influence disease in women. This study and understanding of the
reproductive physiology of women gives obstetricians and gynecologists a unique perspective in address-
ing gender-specific health care issues.

Preventive counseling and health education are essential and integral parts of the practice of obstetricians
and gynecologists as they advance the individual and community-based health of women of all ages.

Obstetricians and gynecologists may choose a scope of practice ranging from primary ambulatory health
care to concentration in a focused area of specialization.

Approved by the Executive Board

February 6, 2005

2013 COMPENDIUM OF SELECTED PUBLICATIONS xvi

 Code of   Professional Ethics
of the Amer­ic­ an College of
Obstetricians and Gy­ne­col­o­gists
Obstetrician–gynecologists, as members of the medical profession, have ethical responsibili-
ties not only to patients, but also to society, to other health professionals and to themselves.
The following ethical foundations for professional activities in the field of obstetrics and gyne-
cology are the supporting structures for the Code of Conduct. The Code implements many of
these foundations in the form of rules of ethical conduct. Certain documents of the American
College of Obstetricians and Gynecologists also provide additional ethical rules, including
documents addressing the following issues: seeking and giving consultation, informed con-
sent, sexual misconduct, patient testing, human immunodeficiency virus, relationships with
industry, commercial enterprises in medical practice, and expert testimony. Noncompliance
with the Code, including the above-referenced documents, may affect an individual’s initial
or continuing Fellowship in the American College of Obstetricians and Gynecologists. These
documents may be revised or replaced periodically, and Fellows should be knowledgeable
about current information.
Ethical Foundations
I. The patient–physician relationship: The welfare of the patient (beneficence) is central 
to all considerations in the patient–physician relationship. Included in this relation-
ship is the obligation of physicians to respect the rights of patients, colleagues, and
other health professionals. The respect for the right of individual patients to make their
own choices about their health care (autonomy) is fundamental. The principle of justice
requires strict avoidance of discrimination on the basis of race, color, religion, national
origin, sexual orientation, perceived gender, and any basis that would constitute illegal
discrimination (justice).
II. Physician conduct and practice: The obstetrician–gynecologist must deal honestly
with patients and colleagues (veracity). This includes not misrepresenting himself or
herself through any form of communication in an untruthful, misleading, or decep-
tive manner. Furthermore, maintenance of medical competence through study,
application, and enhancement of medical knowledge and skills is an obligation of 
practicing physicians. Any behavior that diminishes a physician’s capability to 
practice, such as substance abuse, must be immediately addressed and rehabilitative
services instituted. The physician should modify his or her practice until the dimin-
ished capacity has been restored to an acceptable standard to avoid harm to patients
409 12th Street, SW (nonmaleficence). All physicians are obligated to respond to evidence of questionable
PO Box 96920 conduct or unethical behavior by other physicians through appropriate procedures
Washington, DC 20090-6920 established by the relevant organization.

2013 COMPENDIUM OF SELECTED PUBLICATIONS xvii

 III. Avoiding conflicts of interest: Potential conflicts of interest are inherent in the practice of medicine. Physicians are expect-
ed to recognize such situations and deal with them through public disclosure. Conflicts of interest should be resolved
in accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions. The
physician should be an advocate for the patient through public disclosure of conflicts of interest raised by health payer
policies or hospital policies.
IV. Professional relations: The obstetrician–gynecologist should respect and cooperate with other physicians, nurses, and
health care professionals.
V. Societal responsibilities: The obstetrician–gynecologist has a continuing responsibility to society as a whole and should
support and participate in activities that enhance the community. As a member of society, the obstetrician–gynecolo-
gist should respect the laws of that society. As professionals and members of medical societies, physicians are required
to uphold the dignity and honor of the profession.

Code of Conduct
I. Patient–Physician Relationship
1. The patient–physician relationship is the central focus of all ethical concerns, and the welfare of the patient must
form the basis of all medical judgments.
2. The obstetrician–gynecologist should serve as the patient’s advocate and exercise all reasonable means to ensure
that the most appropriate care is provided to the patient.
3. The patient–physician relationship has an ethical basis and is built on confiden­tiality, trust, and honesty. If no
patient–physician relationship exists, a physician may refuse to provide care, except in emergencies. Once the
patient–physician relationship exists, the obstetrician–gynecologist must adhere to all applicable legal or contrac-
tual constraints in dissolving the patient–physician relationship.
4. Sexual misconduct on the part of the obstetrician–gynecologist is an abuse of professional power and a violation of
patient trust. Sexual contact or a romantic relationship between a physician and a current patient is always unethi-
cal.
5. The obstetrician–gynecologist has an obligation to obtain the informed consent of each patient.
In obtaining informed consent for any course of medical or surgical treatment, the obstetrician– 
gynecologist must present to the patient, or to the person legally responsible for the patient, pertinent medical facts
and recommendations consistent with good medical practice. Such information should be presented in reasonably
understandable terms and include alternative modes of treatment and the objectives, risks, benefits, possible com-
plications, and anticipated results of such treatment.
6. It is unethical to prescribe, provide, or seek compensation for therapies that are of no benefit to the patient.
7. The obstetrician–gynecologist must respect the rights and privacy of patients, colleagues, and others and safeguard
patient information and confidences within the limits of the law. If during the process of providing information for
consent it is known that results of a particular test or other information must be given to governmental authorities
or other third parties, that must be explained to the patient.
8. The obstetrician–gynecologist must not discriminate against patients on the basis of race, color, religion, national
origin, sexual orientation, perceived gender, and any basis that would constitute illegal discrimination.

2013 COMPENDIUM OF SELECTED PUBLICATIONS xviii

II. Physician Conduct and Practice
1. The obstetrician–gynecologist should recognize the boundaries of his or her particular competencies and expertise
and must provide only those services and use only those techniques for which he or she is qualified by education,
training, and experience.
2. The obstetrician–gynecologist should participate in continuing medical education activities to maintain current
scientific and professional knowledge relevant to the medical services he or she renders. The obstetrician–gynecolo-
gist should provide medical care involving new therapies or techniques only after undertaking appropriate training
and study.
3. In emerging areas of medical treatment where recognized medical guidelines do not exist, the obstetrician–gyne-
cologist should exercise careful judgment and take appropriate precautions to protect patient welfare.
4. The obstetrician–gynecologist must not publicize or represent himself or herself in any untruthful, misleading, or
deceptive manner to patients, colleagues, other health care professionals, or the public.
5. The obstetrician–gynecologist who has reason to believe that he or she is infected with the human immunodefi-
ciency virus (HIV) or other serious infectious agents that might be communicated to patients should voluntarily
be tested for the protection of his or her patients. In making decisions about patient-care activities, a physician
infected with such an agent should adhere to the fundamental professional obligation to avoid harm to patients.
6. The obstetrician–gynecologist should not practice medicine while impaired by alcohol, drugs, or physical or mental
disability. The obstetrician–gynecologist who experiences substance abuse problems or who is physically or emo-
tionally impaired should seek appropriate assistance to address these problems and must limit his or her practice
until the impairment no longer affects the quality of patient care.

III. Conflicts of Interest

1. Potential conflicts of interest are inherent in the practice of medicine. Conflicts of interest should be resolved in
accordance with the best interest of the patient, respecting a woman’s autonomy to make health care decisions.
If there is an actual or potential conflict of interest that could be reasonably construed to affect significantly the
patient’s care, the physician must disclose the conflict to the patient. The physician should seek consultation with
colleagues or an institutional ethics committee to determine whether there is an actual or potential conflict of interest
and how to address it.
2. Commercial promotions of medical products and services may generate bias unrelated to product merit, creating or
appearing to create inappropriate undue influence. The obstetrician–gynecologist should be aware of this potential
conflict of interest and offer medical advice that is as accurate, balanced, complete, and devoid of bias as possible.
3. The obstetrician–gynecologist should prescribe drugs, devices, and other treatments solely on the basis of medical
considerations and patient needs, regardless of any direct or indirect interests in or benefit from a pharmaceutical
firm or other supplier.
4. When the obstetrician–gynecologist receives anything of substantial value, including royalties, from companies
in the health care industry, such as a manufacturer of pharmaceuticals and medical devices, this fact should be
disclosed to patients and colleagues when material.
5. Financial and administrative constraints may create disincentives to treatment otherwise recommended by the
obstetrician–gynecologist. Any pertinent constraints should be disclosed to the patient.

2013 COMPENDIUM OF SELECTED PUBLICATIONS xix

IV. Professional Relations
1. The obstetrician–gynecologist’s relationships with other physicians, nurses, and health care professionals should
reflect fairness, honesty, and integrity, sharing a mutual respect and concern for the patient.
2. The obstetrician–gynecologist should consult, refer, or cooperate with other physicians, health care professionals,
and institutions to the extent necessary to serve the best interests of their patients.

V. Societal Responsibilities
1. The obstetrician–gynecologist should support and participate in those health care programs, practices, and
activities that contribute positively, in a meaningful and cost-effective way, to the welfare of individual patients, the
health care system, or the public good.
2. The obstetrician–gynecologist should respect all laws, uphold the dignity and honor of the profession, and accept
the profession’s self-imposed discipline. The professional competence and conduct of obstetrician–gynecologists
are best examined by professional associations, hospital peer-review committees, and state medical and licensing
boards. These groups deserve the full participation and cooperation of the obstetrician–gynecologist.
3. The obstetrician–gynecologist should strive to address through the appropriate procedures the status of those physi-
cians who demonstrate questionable competence, impairment, or unethical or illegal behavior. In addition, the obste-
trician–gynecologist should cooperate with appropriate authorities to prevent the continuation of such behavior.
4. The obstetrician–gynecologist must not knowingly offer testimony that is false. The obstetrician–gynecologist must
testify only on matters about which he or she has knowledge and experience. The obstetrician–gynecologist must
not knowingly misrepresent his or her credentials.
5. The obstetrician–gynecologist testifying as an expert witness must have knowledge and experience about the
range of the standard of care and the available scientific evidence for the condition in question during the relevant 
time and must respond accurately to questions about the range of the standard of care and the available scientific
evidence.
6. Before offering testimony, the obstetrician–gynecologist must thoroughly review the medical facts of the case and
all available relevant information.
7. The obstetrician–gynecologist serving as an expert witness must accept neither disproportionate compensation nor
compensation that is contingent upon the outcome of the litigation.

Copyright July 2011 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. This document provides rules for ethical conduct for obstetricians and gynecologists.

2013 COMPENDIUM OF SELECTED PUBLICATIONS xx

COMMITTEE OPINIONS
Committee on Adolescent Health Care

2013 COMPENDIUM OF SELECTED PUBLICATIONS 1

 ACOG Committee
Opinion
Committee on
Adolescent Health Care
American Academy
of Pediatrics
DEDICATED TO THE HEALTH OF ALL CHILDREN ΤΜ

Committee on Adolescence Number 349, November 2006

Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject to
change. The in­for­ma­tion should not
be con­strued as dic­tat­ing an ex­clu­sive
course of treat­ment or pro­ce­dure to
be followed.
The committees would like to thank
Lesley Breech, MD; Angela Diaz,
MD; S. Paige Hertwick, MD; Paula
Adams Hillard, MD; and Marc
Laufer, MD, for their assistance in
the development of this document.
Copyright © November 2006
by the American Academy of
Pediatrics and the American College
of Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, posted
on the Internet, or transmitted, in any
form or by any means, electronic,
mechanical, photocopying, recording,
or otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to make
pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Menstruation in girls and adolescents:
using the menstrual cycle as a vital
sign. ACOG Committee Opinion No.
349. American Academy of Pediatrics;
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:1323–8.
Menstruation in Girls and
Adolescents: Using the Menstrual
Cycle as a Vital Sign
ABSTRACT: Young patients and their parents often are unsure about what
represents normal menstrual patterns, and clinicians also may be unsure
about normal ranges for menstrual cycle length and amount and duration
of flow through adolescence. It is important to be able to educate young
patients and their parents regarding what to expect of a first period and
about the range for normal cycle length of subsequent menses. It is equally
important for clinicians to have an understanding of bleeding patterns in
girls and adolescents, the ability to differentiate between normal and abnor-
mal menstruation, and the skill to know how to evaluate young patients’
conditions appropriately. Using the menstrual cycle as an additional vital
sign adds a powerful tool to the assessment of normal development and the
exclusion of serious pathologic conditions.
Young patients and their parents frequently have difficulty assessing what
constitutes normal menstrual cycles or patterns of bleeding. Girls may be
unfamiliar with what is normal and may not inform their parents about men-
strual irregularities or missed menses. Additionally, girls often are reluctant
to discuss this very private topic with a parent, although they may confide in
another trusted adult. Some girls will seek medical attention for cycle varia-
tions that actually fall within the normal range. Others are unaware that their
bleeding patterns are abnormal and may be attributable to significant under-
lying medical issues with the potential for long-term health consequences.
Clinicians also may be unsure about normal ranges for menstrual cycle
length and for amount and duration of flow through adolescence. Clinicians
who are confident in their understanding of early menstrual bleeding pat-
terns may convey information to their patients more frequently and with
less prompting; girls who have been educated about menarche and early
menstrual patterns will experience less anxiety when they occur (1). By
including an evaluation of the menstrual cycle as an additional vital sign,
clinicians reinforce its importance in assessing overall health status for both
patients and parents. Just as abnormal blood pressure, heart rate, or respira-
tory rate may be key to the diagnosis of potentially serious health condi-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 2

 tions, identification of abnormal menstrual patterns
through adolescence may permit early identification
of potential health concerns for adulthood.
Normal Menstrual Cycles
Menarche
From the early 1800s to the mid-1950s, menarche
occurred at increasingly younger ages in the United
States, but there has been no further decline in the
past 40–50 years. This finding also has been seen in
international studies of other developed urban popu-
lations (2). The U.S. National Health and Nutrition
Examination Surveys have found no significant
change in the median age at menarche over the
past 30 years except among the non-Hispanic black
population, which has a 5.5-month earlier age at
menarche than it did 30 years ago (3). Age at men-
arche varies internationally and especially in less
developed countries; in Haiti, for example, the mean
age at menarche is 15.37 years (4, 5). This knowl-
edge may be especially pertinent for practitioners
with a large number of immigrant families in their
patient population. Although onset of puberty and
menarche typically occur at a later age in females
from less well-developed nations, two large stud-
ies have confirmed that a higher gain in body mass
index (BMI) during childhood is related to an earlier
onset of puberty (6, 7). This earlier onset of puberty
may result from attainment of a minimal requisite
body mass at a younger age. Other possible explana-
tions for the perceived trend in timing and progres-
sion of puberty are environmental factors, including
socio­economic conditions, nutrition, and access to
preventive health care (8).
Despite variations worldwide and within the U.S.
population, median age at menarche has remained
relatively stable, between 12 and 13 years, across
well-nourished populations in developed countries.
The median age of females when they have their first
period or menarche is 12.43 years (see the box) (3).
Only 10% of females are menstruating at age 11.11
years; 90% are menstruating by age 13.75 years. The
median age at which black females begin to menstru-
ate is earlier (12.06 years) than the median age for
Hispanic females (12.25 years) and non-Hispanic
white females (12.55 years) (3). Although black
girls start to mature earlier than non-Hispanic white
and Hispanic girls, U.S. females complete second-
ary sexual development at approximately the same
ages (9). Menarche typically occurs within 2–3 years
COMMITTEE OPINIONS
Normal Menstrual Cycles in Young Females
Menarche (median age): 12.43 years
Mean cycle interval: 32.2 days in first gynecologic
year
Menstrual cycle interval: typically 21–45 days
Menstrual flow length: 7 days or less
Menstrual product use: three to six pads or tampons
per day
after thelarche (breast budding), at Tanner stage IV
breast development, and is rare before Tanner stage
III development (10). Menarche correlates with age
at onset of puberty and breast development. In girls
with early onset of breast development, the inter-
val to menarche is longer (3 years or more) than
in girls with later onset (11–13). By age 15 years,
98% of females will have had menarche (3, 14).
Traditionally, primary amenorrhea has been defined
as no menarche by age 16 years; however, many
diagnosable and treatable disorders can and should
be detected earlier, using the statistically derived
guideline of age 14–15 years (3, 14). Thus, an evalu-
ation for primary amenorrhea should be considered
for any adolescent who has not reached menarche by
15 years or has not done so within 3 years of thelar-
che. Accordingly, lack of breast development by age
13 years also should be evaluated (15).
Cycle Length and Ovulation
Menstrual cycles often are irregular through ado-
lescence, particularly the interval from the first to
the second cycle. According to the World Health
Organi­zation’s international and multicenter study of
3,073 girls, the median length of the first cycle after
menarche was 34 days, with 38% of cycle lengths
exceeding 40 days. Variability was wide: 10% of
females had more than 60 days between their first
and second menses, and 7% had a first-cycle length
of 20 days (16). Most females bleed for 2–7 days
during their first menses (17–19). Early menstrual
life is characterized by anovulatory cycles (20, 21),
but the frequency of ovulation is related to both time
since menarche and age at menarche (21–23). Early
menarche is associated with early onset of ovulatory
cycles. When age at menarche is younger than 12
years, 50% of cycles are ovulatory in the first gyne-
cologic year (year after menarche).
By contrast, it may take 8–12 years after men-
arche until females with later-onset menarche are
2013 COMPENDIUM OF SELECTED PUBLICATIONS 3
 fully ovulatory (23). Despite variability, most nor-
mal cycles range from 21 to 45 days, even in the first
gynecologic year (16–18), although short cycles of
fewer than 20 days and long cycles of more than
45 days may occur. Because long cycles most often
occur in the first 3 years postmenarche, that overall
trend is toward shorter and more regular cycles with
increasing age. By the third year after menarche,
60–80% of menstrual cycles are 21–34 days long,
as is typical of adults (16, 18, 24). An individual’s
normal cycle length is established around the sixth
gynecologic year, at a chronologic age of approxi-
mately 19 or 20 years (16, 18).
Two large studies, one cataloging 275,947
cycles in 2,702 females and another reporting on
31,645 cycles in 656 females, support the observa-
tion that menstrual cycles in girls and adolescents
typically range from 21 to approximately 45 days,
even in the first gynecologic year (25, 26). In the
first gynecologic year, the fifth percentile for cycle
length is 23 days and the 95th percentile is 90 days.
By the fourth gynecologic year, fewer females are
having cycles that exceed 45 days, but anovulation
is still significant for some, with the 95th percentile
for cycle length at 50 days. By the seventh gyneco-
logic year, cycles are shorter and less variable, with
the fifth percentile for cycle length at 27 days and
the 95th percentile at only 38 days. Thus, during the
early years after menarche, cycles may be somewhat
long because of anovulation, but 90% of cycles will
be within the range of 21–45 days (16).
Abnormal Menstrual Cycles
Prolonged Interval
A number of medical conditions can cause irregular
or missed menses. Although secondary amenorrhea
has been defined as the absence of menses for 6
months, it is statistically uncommon for girls and
adolescents to remain amenorrheic for more than
3 months or 90 days—the 95th percentile for cycle
length. Thus, it is valuable to begin evaluation of
secondary amenorrhea after the absence of menses
for 90 days. Therefore, girls and adolescents with
chaotically irregular cycles with more than 3 months
between periods should be evaluated, not reassured
that it is “normal” to have irregular periods in the
first gynecologic years.
Irregular menses may be associated with many
conditions, including pregnancy, endocrine disorders,
and acquired medical conditions because all of these
COMMITTEE OPINIONS
conditions are associated with derangement of hypo-
thalamic–pituitary endocrine function (see the box).
Commonly, polycystic ovary syndrome (PCOS)
causes prolonged intervals between menstrual periods,
especially in patients with signs of androgen excess.
The pathogenesis of PCOS is unclear; many experts
believe that PCOS results from primary function-
al intraovarian overproduction of androgen. Others
believe that excessive luteinizing hormone secretion
from the pituitary gland, which stimulates a second-
ary ovarian androgen excess, has a role in causing
the disorder. Still others hypothesize that PCOS may
be related to hyperinsulinism. Whatever its origins,
PCOS accounts for 90% of hyperandrogenism among
females and, by definition, is characterized by amen-
orrhea and oligomenorrhea. Before the diagnosis is
confirmed, hyperprolactinemia, adrenal and ovarian
tumors, and drug effects (such as those caused by
danazol and several psychotropic medications) must
be ruled out. Additionally, although uncommon in
the general population, congenital adrenal hyperplasia
should be ruled out by a negative 17α-hydroxypro­
gesterone test result (serum concentrations of less
than 1,000 ng/dL) (27). Treatment of PCOS should
target menstrual irregularities, hirsutism if present,
obesity, or insulin resistance.
Menstrual irregularities can be caused by distur-
bance of the central gonadotropin-releasing hormone
pulse generator as well as by significant weight loss,
strenuous exercise, substantial changes in sleeping
or eating habits, and severe stressors. Menstrual dis-
turbances also occur with chronic diseases, such as
poorly controlled diabetes mellitus; with genetic and
Causes of Menstrual Irregularity
Pregnancy
Endocrine causes
Poorly controlled diabetes mellitus
Polycystic ovary syndrome
Cushing’s disease
Thyroid dysfunction
Premature ovarian failure
Late-onset congenital adrenal hyperplasia
Acquired conditions
Stress-related hypothalamic dysfunction
Medications
Exercise-induced amenorrhea
Eating disorders (both anorexia and bulimia)
Tumors
Ovarian tumors
Adrenal tumors
Prolactinomas
2013 COMPENDIUM OF SELECTED PUBLICATIONS 4
 congenital conditions, such as Turner’s syndrome;
and with other forms of gonadal dysgenesis. The
diagnosis of pregnancy always should be excluded,
even if the history suggests the patient has not been
sexually active.
Excessive Menstrual Flow
A female’s first period usually is reported to be of
medium flow, and the need for menstrual hygiene
products is not typically excessive. Although experts
typically report that the mean blood loss per men-
strual period is 30 mL per cycle and that chronic loss
of more than 80 mL is associated with anemia, this
has limited clinical utility because most females are
unable to measure their blood loss. However, a recent
study in adult women confirms that the perception
of heavy menstrual flow is correlated with a higher
objective volume of blood loss (28).
Attempts to measure menstrual blood loss on
the basis of the number of pads or tampons used per
day or the frequency of pad changes are subject to
variables such as the individual’s fastidiousness, her
familiarity or comfort with menstrual hygiene prod-
ucts, and even variation among types and brands
of pads or tampons (29). Most report changing a
pad approximately three to six times a day, although
external constraints such as school rules and lim-
ited time between classes may make menstrual
hygiene more problematic for adolescents than
for adults. Menstrual flow requiring changes of
menstrual products every 1–2 hours is considered
excessive, particularly when associated with flow
that lasts more than 7 days at a time. This type of
acute menorrhagia, although most often associated
with anovulation, also has been associated with the
diagnosis of hematologic problems, including von
Willebrand’s disease and other bleeding disorders,
or other serious problems, including hepatic failure
and malignancy (30–33).
The prevalence of von Willebrand’s disease is
1% in the general population. Von Willebrand’s
disease is the most common medical disorder asso-
ciated with menorrhagia at menarche (34). As
many as one in six girls presenting to an emergency
department with acute menorrhagia may have von
Willebrand’s disease (30). Therefore, hematologic
disorders should be considered in patients present-
ing with menorrhagia—especially those presenting
acutely at menarche. Hormonal treatment, in the
form of estrogen therapy, may affect hematologic
COMMITTEE OPINIONS
factors and mask the diagnosis. Blood collection to
screen for hematologic disorders should be obtained
before initiating treatment. Evaluating the patient
may include referral to a hematologist or a special-
ized hemo­ philia treatment center for appropriate
screening.
Anticipatory Guidance
Because development of secondary sex characteris-
tics begins at ages as young as 8 years, primary care
clinicians should include pubertal development in
their anticipatory guidance to children and parents
from this age on. Clinicians should take an ongoing
history and perform a complete annual examination,
including the inspection of the external genitalia. It
is important to educate children and parents about
the usual progression of puberty. This includes the
likelihood that a child’s initial breast growth may be
unilateral and slightly tender. Breast development
will likely then become bilateral, but some asym-
metry is normal. Young females and their parents
should understand that the progression of puberty
also includes the development of pubic hair, which
will increase in amount over time and become
thicker and curlier. Additionally, clinicians should
convey that females will likely begin to menstruate
approximately 2–2.5 years after breast development
begins, keeping in mind that recent studies have
suggested that the onset of both breast develop-
ment and menarche may occur slightly earlier for
black girls than for white girls (35). Young females
should understand that menstruation is a normal part
of development and should be instructed on use of
feminine products and on what is considered normal
menstrual flow. Ideally, both parents and clinicians
can participate in this educational process.
Evaluation
Once young females begin menstruating, evaluation
of the menstrual cycle should be included with an
assessment of other vital signs. By including this
information with the other vital signs, clinicians
emphasize the important role of menstrual patterns
in reflecting overall health status. Clinicians should
ask at every visit for the first date of the patient’s
last menstrual period. Clinicians should convey that
the menstrual cycle is from the first day of a period
to the first day of the next period and may vary in
length.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 5
 Both the American Academy of Pediatrics
and the American College of Obstetricians and
Gynecol­ogists recommend preventive health visits
during adolescence to begin a dialogue and establish
an environment where a patient can feel good about
taking responsibility for her own reproductive health
and feel confident that her concerns will be addressed
in a confidential setting (36, 37). These visits are also
an opportunity to provide guidance to young females
and their parents on adolescent physical development
based on data that define normal pubertal develop-
ment, menarche, and menstrual cyclicity (38). Even
during visits with adult patients who interact with
adolescents or have children, education about appro-
priate expectations and normal patterns for the men-
strual cycle may be helpful guidance in the decision
to consider evaluation.
Asking the patient to begin to chart her menses
may be beneficial, especially if the bleeding history
is too vague or considered to be inaccurate. Although
uncommon, abnormalities do occur. Confirming
normal internal and external genital anatomy with a
pelvic examination or ultrasonography can rule out
significant abnormalities. Therefore, one might con-
sider the menstrual cycle as a type of vital sign and an
indicator of other possible medical problems. Using
menarche or the menstrual cycle as a sensitive vital
sign adds a powerful tool to the assessment of normal
hormonal development and the exclusion of serious
abnormalities, such as anorexia nervosa, inflamma-
tory bowel disease, and many other chronic illnesses.
Menstrual conditions that suggest the need for further
evaluation are listed in the box.
Because menarche is such an important mile-
stone in physical development, it is important to
be able to educate young females and their parents
regarding what to expect of a first period and about
the range for normal cycle length of subsequent
menses. Girls who have been educated about early
menstrual patterns will experience less anxiety as
development progresses (1). It is equally important
for clinicians to have an understanding of bleeding
patterns of young females, the ability to differenti-
ate between normal and abnormal menstruation, and
the skill to know how to evaluate the young female
patient appropriately.
References
1. Frank D, Williams T. Attitudes about menstruation
among fifth-, sixth-, and seventh-grade pre- and post-
menarcheal girls. J Sch Nurs 1999;15:25–31.
COMMITTEE OPINIONS
Menstrual Conditions That
May Require Evaluation
Menstrual periods that:
• Have not started within 3 years of thelarche
• Have not started by 13 years of age with no signs of
pubertal development
• Have not started by 14 years of age with signs of
hirsutism
• Have not started by 14 years of age with a history
or examination suggestive of excessive exercise or
eating disorder
• Have not started by 14 years of age with concerns
about genital outflow tract obstruction or anomaly
• Have not started by 15 years of age
• Are regular, occurring monthly, and then become
markedly irregular
• Occur more frequently than every 21 days or less fre-
quently than every 45 days
• Occur 90 days apart even for one cycle
• Last more than 7 days
• Require frequent pad or tampon changes (soaking
more than one every 1–2 hours)
2. Wyshak G, Frisch RE. Evidence for a secular trend in age
of menarche. N Engl J Med 1982;306:1033–5.
3. Chumlea WE, Schubert CM, Roche AF, Kulin HE, Lee
PA, Himes JH, et al. Age at menarche and racial compari-
sons in US girls. Pediatrics 2003;111:110–3.
4. Thomas F, Renaud F, Benefice E, de Meeus T, Guegan
JF. International variability of ages at menarche and
meno­pause: patterns and main determinants. Hum Biol
2001; 73:271–90.
5. Barnes-Josiah D, Augustin A. Secular trend in the age at
menarche in Haiti. Am J Hum Biol 1997;7:357–62.
6. He Q, Karlberg J. BMI in childhood and its association
with height gain, timing of puberty and final height.
Pediatr Res 2001;49:244–51.
7. Wang Y. Is obesity associated with early sexual matura-
tion? A comparison of the association in American boys
versus girls. Pediatrics 2002;110:903–10.
8. Apter D, Hermanson E. Update on female pubertal devel-
opment. Curr Opin Obstet Gynecol 2002;14:475–81.
9. Sun SS, Schubert CM, Chumlea WC, Roche AF, Kulin
HE, Lee PA, et al. National estimates of the timing of
sexual maturation and racial differences among US chil-
dren. Pediatrics 2002;110:911–9.
10. Marshall WA, Tanner JM. Variations in pattern of puber-
tal changes in girls. Arch Dis Child 1969;44:291–303.
11. Marti-Henneberg C, Vizmanos B. The duration of puberty
in girls is related to the timing of its onset. J Pediatr
1997;131:618–21.
12. Llop-Vinolas D, Vizmanos B, Closa Monasterolo R,
Escribano Subias J, Fernandez-Ballart JD, Marti-Henne­
berg C. Onset of puberty at eight years of age in girls
determines a specific tempo of puberty but does not affect
adult height. Acta Paediatr 2004;93:874–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 6
 13. Largo RH, Prader A. Pubertal development in Swiss girls.
Helv Paediatr Acta 1983;38:229–43.
14. National Center for Health Statistics. Age at menarche:
United States. Rockville (MD): NCHS; 1973. Available
at: http://www.cdc.gov/nchs/data/series/sr_11/sr11_133.
pdf. Retrieved June 26, 2006.
15. Reindollar RH, Byrd JR, McDonough PG. Delayed
sexual development: a study of 252 patients. Am J Obstet
Gynecol 1981;140:371–80.
16. World Health Organization multicenter study on men­
strual and ovulatory patterns in adolescent girls. II.
Longitudinal study of menstrual patterns in the early
postmenarcheal period, duration of bleeding episodes and
menstrual cycles. World Health Organization Task Force
on Adolescent Reproductive Health. J Adolesc Health
Care 1986;7:236–44.
17. Flug D, Largo RH, Prader A. Menstrual patterns in ado-
lescent Swiss girls: a longitudinal study. Ann Hum Biol
1984;11:495–508.
18. Widholm O, Kantero RL. A statistical analysis of the
menstrual patterns of 8,000 Finnish girls and their moth-
ers. Acta Obstet Gynecol Scand Suppl 1971;14:(suppl
14):1–36.
19. Zacharias L, Rand WM, Wurtman RJ. A prospective
study of sexual development and growth in American
girls: the statistics of menarche. Obstet Gynecol Surv
1976;31: 325–37.
20. Venturoli S, Porcu E, Fabbri R, Magrini O, Paradisi R,
Pallotti G, et al. Postmenarchal evolution of endocrine
pattern and ovarian aspects in adolescents with menstrual
irregularities. Fertil Steril 1987;48:78–85.
21. Venturoli S, Porcu E, Fabbri R, Magrini O, Grammi L,
Paradisi R, et al. Longitudinal evaluation of the different
gonadotropin pulsatile patterns in anovulatory cycles of
young girls. J Clin Endocrinol Metab 1992;74:836–41.
22. Apter D, Vihko R. Early menarche, a risk factor for breast
cancer, indicates early onset of ovulatory cycles. J Clin
Endocrinol Metab 1983;57:82–6.
23. Vihko R, Apter D. Endocrine characteristics of adolescent
menstrual cycles: impact of early menarche. J Steroid
Biochem 1984;20:231–6.
24. Hickey M, Balen A. Menstrual disorders in adolescence:
investigation and management. Hum Reprod Update
2003;9:493–504.
COMMITTEE OPINIONS
25. Treloar AE, Boynton RE, Behn BG, Brown BW. Variation
of the human menstrual cycle through reproductive life.
Int J Fertil 1967;12:77–126.
26. Vollman RF. The menstrual cycle. Major Probl Obstet
Gynecol 1977;7:1–193.
27. Cowan JT, Graham MG. Polycystic ovary syndrome:
more than a reproductive disorder. Patient Care 2003;37:
23–33.
28. Warner PE, Critchley HO, Lumsden MA, Campbell-
Brown M, Douglas A, Murray GD. Menorrhagia I: mea-
sured blood loss, clinical features, and outcome in women
with heavy periods: a survey with follow-up data. Am J
Obstet Gynecol 2004;190:1216–23.
29. Grimes DA. Estimating vaginal blood loss. J Reprod Med
1979;22:190–2.
30. Claessens E, Cowell CA. Acute adolescent menorrhagia.
Am J Obstet Gynecol 1981;139:277–80.
31. Bevan JA, Maloney KW, Hillery CA, Gill JC, Mont­
gomery RR, Scott JP. Bleeding disorders: a common
cause of menorrhagia in adolescents. J Pediatr 2001;138:
856–61.
32. Ellis MH, Beyth Y. Abnormal vaginal bleeding in adoles-
cence as the presenting symptom of a bleeding diathesis.
J Pediatr Adolesc Gynecol 1999;12:127–31.
33. Duflos-Cohade C, Amandruz M, Thibaud E. Pubertal
metrorrhagia. J Pediatr Adolesc Gynecol 1996;9:16–20.
34. Castaman G, Federici AB, Rodeghiero F, Mannucci PM.
Von Willebrand’s disease in the year 2003: towards com-
plete identification of gene defects for correct diagnosis
and treatment. Haematologica 2003;88:94–108.
35. Herman-Giddens ME, Slora EJ, Wasserman RC, Bour­
dony CJ, Bhapkar MV, Koch GG, et al. Secondary sexual
characteristics and menses in young girls seen in office
practice: a study from the Pediatric Research in Office
Settings Network. Pediatrics 1997;99:505–12.
36. American Academy of Pediatrics. Guidelines for health
supervision III. Elk Grove Village (IL): AAP; 2002.
37. American College of Obstetricians and Gynecologists.
Health care for adolescents. Washington, DC: ACOG;
2003.
38. Adams Hillard PJ. Menstruation in young girls: a clinical
perspective. Obstet Gynecol 2002;99:655–62.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 7
 ACOG
Committee on
Adolescent Health Care
Reaffirmed 2009
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
The Committee would like to
thank Marc R. Laufer, MD, for
his assistance in the development
of this document.
Copyright © December 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or trans-
mitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or oth-
erwise, without prior written per-
mission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
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(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Vaginal agenesis: diagnosis, man-
agement, and routine care. ACOG
Committee Opinion No. 355.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:1605–9.
COMMITTEE OPINIONS
Committee
Opinion
Number 355, December 2006 (Replaces No. 274, July 2002)
Vaginal Agenesis: Diagnosis,
Management, and Routine Care
ABSTRACT: Vaginal agenesis occurs in 1 of every 4,000–10,000 females.
The most common cause of vaginal agenesis is congenital absence of the
uterus and vagina, which also is referred to as müllerian aplasia, müllerian
agenesis, or Mayer–Rokitansky–Küster–Hauser syndrome. The condition
usually can be successfully managed nonsurgically with the use of suc-
cessive dilators if it is correctly diagnosed and the patient is sufficiently
motivated. Besides correct diagnosis, effective management also includes
evaluation for associated congenital renal or other anomalies and careful
psychologic preparation of the patient before any treatment or intervention.
If surgery is preferred, a number of approaches are available; the most
common is the Abbe–McIndoe operation. Women who have a history of
müllerian agenesis and have created a functional vagina require routine
gynecologic care and can be considered in a similar category to that of
women without a cervix and thus annual cytologic screening for cancer may
be considered unnecessary in this population.
Vaginal agenesis is an uncommon, but not rare, condition. Given an inci-
dence ranging from 1 per 4,000 to 1 per 10,000 females (1), vaginal agenesis
is a condition that general gynecologists will encounter once or twice during
their professional careers. The most common cause of vaginal agenesis is
congenital absence of the uterus and vagina, which also is referred to as mül-
lerian aplasia, müllerian agenesis, or Mayer–Rokitansky–Küster–Hauser
syndrome. The term müllerian aplasia will be used to describe this con-
genital reproductive anomaly throughout this document. Müllerian aplasia is
caused by embryologic growth failure of the müllerian duct, with resultant
anomalies in the müllerian structures. With absence of the vagina, there is
variation on the presence or absence of the uterus. A single midline uterus
can be present or uterine horns (with or without an endometrial cavity) can
exist. The ovaries, given their separate embryologic source, are normal in
structure and function.
To manage vaginal agenesis effectively, correct diagnosis of the under-
lying condition is important. Evaluation for associated congenital, renal,
or other anomalies also is essential. Both diagnosis and evaluation usually
can be completed without surgery. Patient counseling should be provided
2013 COMPENDIUM OF SELECTED PUBLICATIONS 8
 before any treatment or intervention. Nonsurgical
creation of the neovagina should be the first-line
approach.
Differential Diagnosis
Patients with müllerian aplasia have a normal
46,XX karyotype, normal female phenotype, and
normal ovarian hormonal and oocyte function.
Puberty and development of secondary sexual char-
acteristics progress normally except that menarche
does not occur. Therefore, patients with müllerian
aplasia typically present in adolescence with prima-
ry amenorrhea. The practitioner should remember
that it is usually 2–3 years from the onset of breast
development until the first period. If menarche
has not occurred within 3 years of the onset of
breast development, further evaluation is indicated.
Müllerian aplasia is the second most common cause
of primary amenorrhea, with gonadal dysgenesis
being the most common cause (2).
On physical examination, patients with mül-
lerian aplasia have normal breast development,
normal secondary sexual body proportions, body
hair, and hymenal tissue. A vagina is absent unless it
has been created by sexual encounters. Differential
diagnosis of vaginal agenesis includes congenital
absence of the vagina (with or without uterine struc-
tures), androgen insensitivity (absence or alteration
of androgen-receptor function), 17 α-hydroxylase
deficiency, a low transverse vaginal septum, and
imperforate hymen.
In cases of androgen insensitivity, the gonads
are testes, producing normal androgens in karyo-
typic 46,XY individuals. The lack of androgen
tissue receptors results in sparse or no pubic and
axillary hair. Patients with androgen insensitivity
typically have normal breast development because
of peripheral conversion of circulating androgens to
estrogens. They may have a small lower vagina, or a
normal length vagina can occur; however, no uterus
or cervix is present. In pubertal females, the dif-
ferential diagnosis between androgen insensitivity
and müllerian aplasia is easily made by assessing
serum testosterone levels. A testosterone level in
the pubertal male range confirms the diagnosis of
androgen insensitivity.
In postpubertal patients, the presence of func-
tioning ovarian tissue seen on pelvic ultrasound
examinations may serve as a secondary confirma-
tion of the diagnosis of müllerian aplasia, excluding
COMMITTEE OPINIONS
the diagnosis of androgen insensitivity. Chromo-
somal studies, although more costly than a serum
testosterone level assessment, provide the diagnos-
tic tool to differentiate between müllerian aplasia
in genetic females and disorders of testosterone
synthesis in genetic males. Chromosomal analysis
also is helpful in prepubertal children who do not
yet have postpubertal sex steroid production.
In cases of 17 α-hydroxylase deficiency, 46XY
individuals will have complete male pseudoher-
maphroditism with female external genitalia, a blind
short vaginal pouch, no uterus or fallopian tubes,
and intraabdominal testes. Affected males are usu-
ally raised as girls, with the underlying disorder
being recognized when the patient is evaluated for
lack of pubertal development (3, 4).
The differential diagnosis of vaginal agenesis
also includes imperforate hymen and low transverse
vaginal septum. Patients with these latter condi-
tions will have a normal cervix and uterus, both of
which may be palpable on rectal examination. In
contrast to most patients with müllerian aplasia, the
patient with an imperforate hymen will not have the
typical fringe of hymenal tissue. The patient with a
low transverse vaginal septum will have a normal
hymen, like the patient with müllerian aplasia.
Conventional ultrasonography, three-dimensional
ultrasonography, and magnetic resonance imaging
can be used to better define the müllerian structures
and are helpful in definitively defining anatomy.
Correct diagnosis of the underlying condition
affecting the genital anatomy is crucial before any
surgical intervention. If the patient undergoes an
operation because of an incorrect diagnosis (eg,
an incorrect preoperative diagnosis of an imperfo-
rate hymen in cases of vaginal agenesis), it can be
extremely difficult to correct the anomaly because
of scar tissue.
Evaluation of the Patient With
Müllerian Aplasia
Most patients with müllerian aplasia have small
rudimentary müllerian bulbs without any endome-
trial activity. In 2–7% of patients with mülle-
rian aplasia, active endometrium is found in these
uterine structures (1). These patients will present
with cyclic or chronic abdominal pain. Magnetic
resonance imaging has been suggested to assess the
reproductive anatomy, although it is rarely needed
in the initial evaluation unless ultrasound evalu-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 9
 ation for the presence of functional endometrium
in a müllerian structure is equivocal (5). Although
laparoscopy is not necessary to diagnose müllerian
aplasia, it may be useful in the evaluation of patients
with cyclic abdominal pain to exclude the possibil-
ity of endometrial activity in müllerian structures
(6). When obstructed hemi-uteri are identified (uter-
ine horns with the presence of active endometrium
without associated cervix and upper vagina), then
removal of the unilateral or bilateral obstructed uter-
ine structures should be performed. The removal
of the obstructed uterine structures can be accom-
plished laparoscopically (7, 8).
Patients with müllerian aplasia often have
concomitant congenital malformations, especially
of the abdominal wall, urinary tract, and skeleton.
Inguinal hernias occur at an increased incidence in
patients with müllerian aplasia. Ultrasonography
can be used to screen for the more common find-
ings of renal agenesis or a pelvic kidney. This
evaluation can be performed during the study of
ovarian and müllerian structures. The implications
of ureteral duplication in the case of later abdomi-
nal or pelvic surgery can be discussed, or intra-
venous pyelography can be used to exclude this
possibility. Scoliosis is the most common skeletal
abnormality associated with müllerian aplasia. It
also should be noted that there is an increased, but
small, rate of hearing impairment in patients with
müllerian aplasia.
After the diagnosis of müllerian aplasia, the
adolescent should be offered counseling to empha-
size that a normal sex life will be possible after a
neovagina has been created. Ultimately, however,
infertility may be a more difficult aspect of this
disorder for the patient to accept. Future fertility
options should be addressed with adolescents and
their parent(s) or guardian(s). Discussion of assisted
reproductive techniques and use of a gestational
carrier (surrogate) is appropriate. Specifically, it is
important to explain that eggs can be harvested from
patients with müllerian aplasia and used in assisted
reproductive technology; daughters of women with
Mayer–Rokitansky–Küster–Hauser syndrome con-
ceived by assisted reproductive technology have
been shown to have normal reproductive tracts (9).
This information allows teens to understand their
reproductive potential for becoming a biologic par-
ent and may help them accept the diagnosis and its
implications. Referral to a mental health profes-
sional is very worthwhile for some patients. The
COMMITTEE OPINIONS
best predictor of good emotional outcome after
diagnosis and vaginoplasty is a good relationship
between the patient and her parents or guardians
and the ability to share feelings with family and
friends (7). Contact with a support group or young
women with the same diagnosis may be helpful (6)
(see Resources).
Patients should be given a brief, written medical
summary of their condition, including a summary of
concomitant malformations. This information may
be useful if the patient requires urgent medical care
or emergency surgery from a health care provider
unfamiliar with müllerian aplasia.
Nonsurgical Creation of a Neovagina
Timing for nonsurgical or surgical creation of a
neovagina is elective; however, it is best planned
when the patient is emotionally mature. Nonsurgical
creation of the vagina is the appropriate first-line
approach in most patients because it is the least
morbid procedure. In a recently reported series of
patients with müllerian aplasia, more than 90%
were able to achieve anatomic and functional suc-
cess by vaginal dilation (10).
Patients are asked to manually place successive
dilators on the perineal dimple for 30 minutes to 2
hours per day. Another option of sitting on a bicycle
seat stool provides the perineal pressure and allows
the patient to participate in simultaneous productive
activities, such as doing homework or practicing a
musical instrument (11). Many young women find
that sitting on the bicycle seat stool is too uncom-
fortable or awkward, thus they may have better
success using dilators while reclining on a bed after
a relaxing bath. Use of dilators in the management
of vaginal agenesis is appropriate and successful
in most patients. Mature, highly motivated patients
who wish to avoid surgery and are aware that it will
take several months to achieve their goal are likely
to be successful (11, 12). Because the nonoperative
approach is noninvasive and usually successful, it is
strongly recommended as first-line therapy.
Clinicians often use “buddies,” other patients
with vaginal agenesis who have successfully di-
lated, as support to the young woman attempting
dilation. Young married patients make excellent
buddies. If fertility issues are a major concern to
the patient or her family, it may be helpful to find
a buddy who has used assisted reproductive tech-
niques to become a mother.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 10
 Surgical Creation of a Neovagina
Surgery becomes an option for patients who are
unsuccessful with dilators or patients who prefer
surgery after a thorough discussion with the patient
and her parent(s) or guardian(s) of the risks and
benefits of the procedure and the available non-
surgical alternatives. It should be stressed to the
young woman that a surgical vaginoplasty is not a
“quick fix” and that she will still need to use vaginal
dilators postoperatively to maintain her surgically
created vagina. The aim of surgery is the creation
of a vaginal canal in the correct axis of adequate
size and secretory capacity to allow intercourse to
occur without the need for continued postoperative
dilation. The timing of the surgery depends on the
patient and the type or procedure planned. Surgeries
often are performed in late adolescence (ages 17–21
years) when the patient is more mature and better
able to adhere to postoperative dilation or instruc-
tions. Surgery usually is scheduled during summer
vacation to allow for an adequate recovery time
without missing school and to reduce questions
from peers (6, 13).
A number of operations are appropriate for the
correction of vaginal agenesis. The approach usually
is based on the experience of the operating surgeon.
Pediatric surgeons are more likely to use bowel seg-
ments for the creation of a neovagina; gynecologists
are more likely to use a perineal approach. Whatever
technique is chosen, the surgeon must be experi-
enced with the procedure because the initial surgery
is more likely to succeed than follow-up procedures.
Reoperation in these cases increases the chance of
operative injury to surrounding tissues and the pos-
sibility of a poor functional outcome. At present,
there is no consensus in the literature regarding the
best option for surgical correction (14).
The most common surgical procedure used
by U.S. gynecologists to create a neovagina is the
Abbe–McIndoe operation. This involves the dis-
section of a space between the rectum and bladder,
placement of a mold covered with a split-thickness
skin graft into the space, and the diligent use of
vaginal dilation postoperatively. Postoperative dila-
tion must be continued to prevent significant skin
graft contracture. This surgery is inappropriate if
the patient rejects the nonsurgical technique because
she has concerns about or objections to dilation. If
postoperative dilation is not done, the patient will
have a nonfunctional vagina. The dilators are used
COMMITTEE OPINIONS
long-term on a less frequent basis until the woman
is having vaginal intercourse because at that time
the penis will act as a dilator to maintain the length
of the vagina.
Other procedures for the creation of the neo-
vagina are the Vecchietti procedure and laparo-
scopic modifications of operations previously
performed by laparotomy. The Vecchietti procedure
involves the creation of a neovagina via dilation
with a traction device attached to the abdomen,
sutures placed subperitoneally via laparotomy, and
a plastic “olive” placed on the vaginal dimple. In
the laparoscopic modification, traction sutures are
placed laparoscopically. The two techniques are
comparable in terms of producing a functional
neovagina (15). Davydov developed a three-stage
operation involving dissection of the rectovesical
space with abdominal mobilization of the perito-
neum, with creation of the vaginal fornices and
attachment of the peritoneum to the introitus. The
newer adaptation involves dissection of the recto-
vaginal space, with mobilization of the peritoneum
from below and laparoscopic assistance from above.
This is followed by closure of the abdominal end of
the neovagina with a laparoscopically placed purs-
estring suture (8, 16, 17).
General Gynecologic Care
Women who have a history of müllerian agenesis
and have created a functional vagina do require
routine gynecologic care. Annual pelvic examina-
tions should be performed to examine for vaginal
stricture or stenosis. Women with müllerian agen-
esis should be aware that the neovagina has the
same risk as a native vagina for sexually transmit-
ted diseases and thus they should be appropriately
screened. In addition, vaginal speculum examina-
tion and inspection should be performed to look
for possible malignancies (in cases of skin graft or
bowel vaginas), colitis or ulceration (in cases of
bowel vaginas), or other problems. No data exists
regarding the need or lack of need for routine Pap
testing in women with a neovagina. It is reasonable
to consider these women in the same category as
women without a cervix because of hysterectomy
for the treatment of benign disease. Thus, annual
cytologic screening for cancer can be considered
unnecessary, although no data are available to sup-
port or oppose this concept.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 11
 Conclusion
The most important steps in the effective manage-
ment of müllerian aplasia are correct diagnosis of
the underlying condition; evaluation for associated
congenital, renal, or other anomalies; and prepara-
tion of the patient before any treatment or interven-
tion. If any of these are neglected, the success of the
intervention will be compromised.
Laparoscopy is seldom required to make the
diagnosis but may be appropriate in the patient
presenting with pelvic pain. Nonsurgical creation
of the neovagina should be the first-line approach.
In cases in which surgical intervention is required,
referrals to centers with expertise in this area should
be considered. Few surgeons have extensive expe-
rience in construction of the neovagina, and the
initial surgery has the greatest chance for success.
In addition, experts at these centers may be more
successful in promoting the nonsurgical approach,
given their experience.
References
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tions. Am J Obstet Gynecol 1981;141:910–20.
2. Reindollar RH, Byrd JR, McDonough PG. Delayed sex-
ual development: a study of 252 patients. Am J Obstet
Gynecol 1981;140:371–80.
3. New MI. Male pseudohermaphroditism due to 17 alpha-
hydroxylase deficiency. J Clin Invest 1970;49:1930–41.
4. Nieman LK, Kovacs WJ. Uncommon causes of congeni-
tal adrenal hyperplasia. In: Rose BD, editor. UpToDate.
Waltham (MA); 2006.
5. Fedele L, Dorta M, Brioschi D, Giudici MN, Candiani
GB. Magnetic resonance imaging in Mayer-Rokitansky-
Kuster-Hauser syndrome. Obstet Gynecol 1990;76: 593–
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6. Laufer MR, Goldstein DP, Hendren WH. Structural
abnormalities of the female reproductive tract. In: Emans
SJ, Laufer MR, Goldstein DP, editors. Pediatric and ado-
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Williams & Wilkins; 2005. p. 334–416.
7. Poland ML, Evans TN. Psychologic aspects of vaginal
agenesis. J Reprod Med 1985;30:340–4.
8. Adamyan LV. Laparoscopic management of vaginal
aplasia with or without functional noncommunicating
rudimentary uterus. In: Arregui ME, Fitzgibbons RJ Jr,
Katkhouda N, McKernan JB, Reich H, editors. Principles
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New York (NY): Springer–Verlag; 1995. p. 646–51.
COMMITTEE OPINIONS
9. Petrozza JC, Gray MR, Davis AJ, Reindollar RH.
Congenital absence of the uterus and vagina is not com-
monly transmitted as a dominant genetic trait: outcomes
of surrogate pregnancies. Fertil Steril 1997;67:387–9.
10. Roberts CP, Haber MJ, Rock JA. Vaginal creation
for müllerian agenesis. Am J Obstet Gynecol 2001;
185:1349–52; discussion 1352–3.
11. Williams JK, Lake M, Ingram JM. The bicycle seat stool
in the treatment of vaginal agenesis and stenosis. J Obstet
Gynecol Neonatal Nurs 1985;14:147–50.
12. Rock JA, Breech LL. Surgery for anomalies of the
Müllerian ducts. In: Rock JA, Jones HW 3rd, editors. Te
Linde’s operative gynecology. 9th ed. Philadelphia (PA):
Lippincott Williams & Wilkins; 2003. p. 705–52.
13. Templeman CL, Lam AM, Hertweck SP. Surgical man-
agement of vaginal agenesis. Obstet Gynecol Surv
1999;54:583–91.
14. Laufer MR. Congenital absence of the vagina: in search
of the perfect solution. When, and by what technique,
should a vagina be created? Curr Opin Obstet Gynecol
2002;14:441–4.
15. Borruto F, Chasen ST, Chervenak FA, Fedele L. The
Vecchietti procedure for surgical treatment of vaginal
agenesis: comparison of laparoscopy and laparotomy. Int
J Gynaecol Obstet 1999;64:153–8.
16. Davydov SN, Zhvitiashvili OD. Formation of vagina
(colpopoiesis) from peritoneum of Douglas pouch. Acta
Chir Plast 1974;16:35–41.
17. Adamyan LV. Therapeutic and endoscopic perspectives.
In: Nichols DH, Clarke-Pearson DL, editors. Gyneco-
logic, obstetric, and related surgery. 2nd ed. St. Louis
(MO): Mosby; 2000. p. 1209–17.
Resources
MRKH.org, Inc.
PO Box 301494
Jamaica Plain, MA 02130
Web: www.mrkh.org
The Center for Young Women’s Health
Children’s Hospital Boston
333 Longwood Avenue, 5th Floor
Boston, MA 02115
(617) 730-0192
Web:www.youngwomenshealth.org
A guide to vaginal agenesis in teens. Available at www.
youngwomenshealth.org/vaginalagenesis.html
MRKH (Mayer Rokitansky Kuster Hauser Syndrome) and
vaginal agenesis: a guide for parents and guardians. Available
at www.youngwomenshealth.org/mrkh_parent.html
2013 COMPENDIUM OF SELECTED PUBLICATIONS 12
 ACOG COMMITTEE OPINION
Number 415 • September 2008

Depot Medroxyprogesterone Acetate and

Bone Effects
Committee on ABSTRACT: Although depot medroxyprogesterone acetate (DMPA) is associated
Adolescent Health with bone mineral density (BMD) loss during use, current evidence suggests that partial
Care or full recovery of BMD occurs at the spine and at least partial recovery occurs at the hip
Committee on after discontinuation of DMPA. Given the efficacy of DMPA, particularly for populations
Gynecologic such as adolescents for whom contraceptive adherence can be challenging or for those
Practice who feel they could not comply with a daily contraceptive method or a method that must
This document reflects be used with each act of intercourse, the possible adverse effects of DMPA must be bal-
emerging clinical and sci- anced against the significant personal and public health impact of unintended pregnancy.
entific advances as of the
date issued and is subject Concerns regarding the effect of DMPA on BMD should neither prevent practitioners
to change. The information from prescribing DMPA nor limit its use to 2 consecutive years. Practitioners should not
should not be construed
as dictating an exclusive perform BMD monitoring solely in response to DMPA use because any observed short-
course of treatment or term loss in BMD associated with DMPA use may be recovered and is unlikely to place a
procedure to be followed.
woman at risk of fracture during use or in later years.

Depot medroxyprogesterone acetate (DMPA) at the hip after discontinuation of DMPA.

is a highly effective, long-acting contracep-
tive injection used by more than two mil-
lion women annually in the United States,
including approximately 400,000 adolescents
(1). Convenient dose administration and
privacy are appealing to adolescents, and the
expanded use of DMPA has been credited
for at least part of the decrease in adolescent
pregnancy rates over the past decade (2,
3). Depot medroxyprogesterone acetate pre-
vents pregnancy by inhibiting the secretion of
pituitary gonadotropins resulting in anovu-
lation, amenorrhea, and a decreased produc-
tion of serum estrogen. Hypoestrogenism is
associated with a decrease in bone mineral
density (BMD). In older women, low BMD
consistent with osteopenia or osteoporosis is
associated with an increased risk of fracture.
No studies have been conducted to exam-
ine the association between BMD and frac-
tures in low-risk young women, including
those using DMPA or those experiencing the
The American College physiologic hypoestrogenism of lactation.
of Obstetricians Although DMPA is associated with BMD
and Gynecologists loss during use, current evidence suggests
Women’s Health Care that partial or full recovery of BMD occurs at
Physicians the spine and at least partial recovery occurs
Given the efficacy of DMPA, particularly for
populations such as adolescents for whom
contraceptive adherence can be challenging or
for those who feel they could not comply with
a daily contraceptive method or a method that
must be used with each act of intercourse, the
possible adverse effects of DMPA must be bal-
anced against the significant personal and pub-
lic health impact of unintended pregnancy.
Bone Mineral Density
A number of studies demonstrate the effect
of DMPA on BMD. Cross-sectional and
longitudinal studies using dual-energy X-ray
absorptiometry (DXA) technology among
current users of DMPA (ages 18–54 years)
demonstrate that DMPA use results in lower
BMD compared with nonusers regardless of
the anatomic site measured (4–10). Longi-
tudinal studies report BMD losses at the hip
and spine of 0.5–3.5% after 1 year of DMPA
use (5, 11) and a 5.7–7.5% loss in BMD after
2 years of use (8, 10).
Although few studies have examined
long-term use of DMPA, it appears that the
greatest BMD loss is experienced during
the first few years of use (7, 10, 11). In one

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 13

 3-year longitudinal study, mean change in BMD at each
6-month interval decreased as the number of cumulative
months of DMPA use increased (7). Those using DMPA
for 12 months or less lost BMD at a faster rate than
those using DMPA for 13 months or more (7). Another
recent longitudinal study with a 4-year follow-up period
demonstrated that almost 75% of the BMD lost at the
hip and 90% lost at the spine occurred during the first
24 months of use (9). Women who continued DMPA
use beyond 24 months still lost additional bone, but the
magnitude of loss was smaller with each subsequent year
of use (9).
A recent prospective study of BMD monitored
DMPA users and nonhormonal contraceptive users
20–25 years of age for up to 5 years of use and for up to 2
years after discontinuation. Despite BMD loss during use,
total hip BMD among DMPA users had returned almost
to baseline levels at 2 years after discontinuation (from
-5.16% after 240 weeks of use to -0.2% at 96 weeks after
discontinuation), and BMD values in the lumbar spine
showed partial recovery (from -5.38% after 240 weeks of
use to -1.19% at 96 weeks after discontinuation) (12). As
in prior studies, the rate of BMD loss was greater in the
first year of treatment than in subsequent years.
Bone loss during the reproductive years is not unique
to DMPA use. Studies of adult women show a decrease
in BMD of 2–8% during pregnancy and 3–5% during
breastfeeding (13, 14). These losses are temporary; 6–12
months after birth or cessation of breast-feeding BMD
values increase to near preconception values in most
women (11). Similarly, studies suggest that at least some
of the bone loss experienced as a result of DMPA use is
recovered after discontinuation. However, studies differ
in their assessment of the speed and completeness of this
recovery (7, 9, 10, 12, 15–17). Furthermore, the degree of
recovery appears to differ by site. A 3-year longitudinal
study of 18–39-year-old DMPA users noted that women
experienced steady gains in BMD after discontinuation,
regardless of duration of DMPA use (7). Lumbar spine
BMD of DMPA users was similar to that of nonusers by
30 months after discontinuation (7). Increases in BMD
at the hip among those discontinuing use of DMPA also
were noted, but the gain in BMD at this location was
lower than that of nonusers 30 months after discon-
tinuation. Similarly, a 4-year study of first-time users of
DMPA 18–35 years of age demonstrated that the length
of time required for BMD values to return to baseline
levels depended on the site measured and the duration
of DMPA use. Complete recovery occurred at the spine
within 27–30 months among those using DMPA up to
24 months. Recovery at the hip was slower; among those
women who used DMPA for 24 months or less, a return
to baseline values was not observed by 30 months after
discontinuation (9).
Bone mineral density normally increases during the
teenaged years. Therefore, a decrease or stabilization in
BMD during this period may be cause for concern. In a
COMMITTEE OPINIONS
study of DMPA users aged 12–21 years, BMD decreased
an average of 3.1% (18). In contrast, adolescents who
were not using hormonal contraception gained BMD
at an average rate of 9.5% over 2 years (18). Among
new DMPA users aged 14–18 years, a decrease of 5% at
the spine occurred after 24 months compared with an
increase of 2.3% in nonusers (16). The decrease in BMD
observed in these studies may be mitigated by the short-
term or intermittent nature of DMPA use in many adoles-
cents because the discontinuation rate is 50% in the first
year (19). Furthermore, increases in BMD of 1–4% at the
hip and spine 12 months after discontinuation of DMPA
have been shown in adolescents aged 14–18 years (16).
At least two cross-sectional studies provide reas-
suring data that BMD in former adult DMPA users is
similar to that of never users (20, 21). A World Health
Organization study observed this lack of difference in
BMD in an international population of former DMPA
users and nonusers (20). Another study of postmeno-
pausal women in New Zealand indicated similar BMD in
former adult DMPA users compared with that of never
users (21).
Fracture Risk
Although many studies have examined the intermediate
outcome of decreased BMD related to DMPA, few inves-
tigations have examined the outcome of critical impor-
tance to women’s health—that of fracture risk. Two studies
have examined DMPA use and fracture, both in high-risk
populations. A prospective, short-term study of female
military recruits found that, in white women only, history
of DMPA use was one of several factors associated with
an increased risk of stress fractures of the calcaneus (22).
This study was limited to women at high risk of fractures
and is not applicable to the general population. Another
recent study of developmentally delayed women suggests
an increased risk of fractures in those with a history of
DMPA use. This study is limited by its cross-sectional
design and its use of retrospective data (23).
There are no reported studies in which the risk of
osteoporosis or fractures has been examined in a low-
risk population of prior DMPA users. A recent Cochrane
review reveals that not a single randomized controlled
trial of DMPA and fracture risk has been performed (24).
The “Black Box” Warning
Concerns over the effect of DMPA use on BMD caused
the U.S. Food and Drug Administration to issue a “black
box” warning in November 2004. This warning stated
that prolonged use of DMPA may result in significant
loss of BMD, that the loss is greater the longer the drug
is used, and that the loss may not be completely revers-
ible after discontinuation. The warning cautions that use
of DMPA beyond 2 years should be considered only if
other contraceptive methods are inadequate. In a letter
to physicians, a manufacturer of DMPA suggested DXA
monitoring after 2 years of use.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 14
 The U.S. Food and Drug Administration warning
is based on intermediate effects on BMD, which may or
may not be relevant to increased fracture risk. Because the
evidence suggests that the rate of BMD loss may slow with
longer term DMPA use, the rationale for restriction to
2 years of use or DXA monitoring is unclear. Practitioners
should not perform BMD monitoring solely in response
to DMPA use because any observed short-term losses in
BMD may be recovered and are unlikely to place women
at risk of fracture during DMPA use or in later years.
Risks of Bone Loss Versus the
Benefits of Contraception
Most women and adolescents use DMPA to avoid preg-
nancy. The failure rate in typical users is 2–3% for DMPA
(25). As a result, DMPA is widely used by women for
whom successful use of a daily or partner-dependent
contraceptive method is difficult. Increased use of DMPA
in the past 15 years has been paralleled by a decrease in
the adolescent pregnancy rate (2, 3). Although there are
many factors contributing to the decrease in adolescent
pregnancies, DMPA has likely played a role. It is impor-
tant to weigh the theoretical risk of future fracture from
decreased BMD in DMPA users against the very real risk
of pregnancy if contraceptive choices are limited (26). For
example, an adolescent who is at high risk for pregnancy
may be best served by the use of DMPA as a contraceptive
option; both pregnancy and DMPA are associated with
loss of BMD. The risk–benefit ratio might differ for a
noncontraceptive indication such as dysmenorrhea (23).
Counseling
Women initiating DMPA should be thoroughly coun-
seled about the benefits and the potential risks of DMPA.
Daily exercise and age-appropriate calcium and vitamin
D intake should be encouraged. No studies have shown
that these measures will offset loss of BMD during
DMPA use, but these recommendations can benefit gen-
eral health, and most adolescents do not ingest sufficient
dietary calcium. Although studies of adolescents and adult
women demonstrate that low-dose estrogen supplemen-
tation limits BMD loss in DMPA users (27, 28), estrogen
supplementation during DMPA use is not currently rec-
ommended. Most importantly, clinicians should provide
counseling regarding the side effects of DMPA, including
irregular bleeding, in order to attempt to reduce the high
rates of discontinuation of this method.
Conclusion
Depot medroxyprogesterone acetate is a safe and effective
means of long-term contraception, which has likely con-
tributed to a decrease in adolescent pregnancy rates over
the past decade. Concerns regarding the effect of DMPA
on BMD should neither prevent practitioners from pre-
scribing DMPA nor limit its use to 2 consecutive years.
Appropriate counseling with a discussion of current
medical evidence should occur before the initiation of
this medication and during prolonged use. Practitioners
COMMITTEE OPINIONS
should not perform BMD monitoring solely in response
to DMPA use because any observed short-term loss in
BMD associated with DMPA use may be recovered and is
unlikely to place a woman at risk of fracture during use or
in later years. Effective long-term contraceptive methods
that have no effect on BMD and have high continuation
rates, such as contraceptive implants and intrauterine
devices, should also be considered as first-line methods
for adolescents.
References
1. Mosher WD, Martinez GM, Chandra A, Abma JC, Willson
SJ. Use of contraception and use of family planning ser-
vices in the United States: 1982-2002. Adv Data 2004;(350):
1–36.
2. Santelli JS, Abma J, Ventura S, Lindberg L, Morrow B,
Anderson JE, et al. Can changes in sexual behaviors among
high school students explain the decline in teen pregnancy
rates in the 1990s? J Adolesc Health 2004;35:80–90.
3. Santelli JS, Lindberg LD, Finer LB, Singh S. Explaining
recent declines in adolescent pregnancy in the United
States: the contribution of abstinence and improved con-
traceptive use. Am J Public Health 2007;97:150–6.
4. Cundy T, Cornish J, Roberts H, Elder H, Reid IR. Spinal
bone density in women using depot medroxyprogesterone
contraception. Obstet Gynecol 1998;92:569–73.
5. Berenson AB, Radecki CM, Grady JJ, Rickert VI, Thomas A.
A prospective, controlled study of the effects of hormonal
contraception on bone mineral density. Obstet Gynecol
2001;98:576–82.
6. Wanichsetakul P, Kamudhamas A, Watanaruangkovit P,
Siripakarn Y, Visutakul P. Bone mineral density at various
anatomic bone sites in women receiving combined oral
contraceptives and depot-medroxyprogesterone acetate for
contraception. Contraception 2002;65:407–10.
7. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM.
Injectable hormone contraception and bone density: results
from a prospective study [published erratum appears in
Epidemiology 2002;13:749]. Epidemiology 2002;13:581–7.
8. Berenson AB, Breitkopf CR, Grady JJ, Rickert VI, Thomas
A. Effects of hormonal contraception on bone mineral den-
sity after 24 months of use. Obstet Gynecol 2004;103:899–
906.
9. Clark MK, Sowers M, Levy B, Nichols S. Bone mineral den-
sity loss and recovery during 48 months in first-time users
of depot medroxyprogesterone acetate. Fertil Steril 2006;
86:1466–74.
10. Clark MK, Sowers MR, Nichols S, Levy B. Bone mineral
density changes over two years in first-time users of depot
medroxyprogesterone acetate. Fertil Steril 2004;82:1580–6.
11. Ulrich CM, Georgiou CC, Snow-Harter CM, Gillis DE.
Bone mineral density in mother-daughter pairs: relations to
lifetime exercise, lifetime milk consumption, and calcium
supplements. Am J Clin Nutr 1996;63:72–9.
12. Kaunitz AM, Miller PD, Rice VM, Ross D, McClung MR.
Bone mineral density in women aged 25-35 years receiving
depot medroxyprogesterone acetate: recovery following
discontinuation. Contraception 2006;74:90–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 15
 13. Karlsson C, Obrant KJ, Karlsson M. Pregnancy and lacta-
tion confer reversible bone loss in humans. Osteoporos Int
2001;12:828–34.
14. Sowers M, Corton G, Shapiro B, Jannausch ML, Crutchfield
M, Smith ML, et al. Changes in bone density with lactation.
JAMA 1993;269:3130–5.
15. Cundy T, Cornish J, Evans MC, Roberts H, Reid IR.
Recovery of bone density in women who stop using
medroxyprogesterone acetate. BMJ 1994;308:247–8.
16. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott
SM. Change in bone mineral density among adolescent
women using and discontinuing depot medroxyprogester-
one acetate contraception. Arch Pediatr Adolesc Med 2005;
159:139–44.
17. Johnson CC, Burkman RT, Gold MA, Brown RT, Harel Z,
Bruner A, et al. Longitudinal study of depot medroxypro-
gesterone acetate (Depo-Provera) effects on bone health in
adolescents: study design, population characteristics and
baseline bone mineral density. Contraception 2008;77:
239–48.
18. Cromer BA, Stager M, Bonny A, Lazebnik R, Rome E,
Ziegler J, et al. Depot medroxyprogesterone acetate, oral
contraceptives and bone mineral density in a cohort of
adolescent girls. J Adolesc Health 2004;35:434–41.
19. Zibners A, Cromer BA, Hayes J. Comparison of continua-
tion rates for hormonal contraception among adolescents.
J Pediatr Adolesc Gynecol 1999;12:90–4.
20. Petitti DB, Piaggio G, Mehta S, Cravioto MC, Meirik O.
Steroid hormone contraception and bone mineral density:
a cross-sectional study in an international population. The
WHO Study of Hormonal Contraception and Bone Health.
Obstet Gynecol 2000;95:736–44.
21. Orr-Walker BJ, Evans MC, Ames RW, Clearwater JM,
Cundy T, Reid IR. The effect of past use of the injectable
contraceptive depot medroxyprogesterone acetate on bone
mineral density in normal post-menopausal women. Clin
Endocrinol 1998;49:615–8.
22. Lappe JM, Stegman MR, Recker RR. The impact of life-
style factors on stress fractures in female Army recruits.
Osteoporos Int 2001;12:35–42.
COMMITTEE OPINIONS
23. Watson KC, Lentz MJ, Cain KC. Associations between
fracture incidence and use of depot medroxyprogesterone
acetate and anti-epileptic drugs in women with develop-
mental disabilities. Womens Health Issues 2006;16:346–52.
24. Lopez LM, Grimes DA, Schulz KF, Curtis KM. Steroidal
contraceptives: effect on bone fractures in women.
Cochrane Database of Systematic Reviews 2006, Issue 4.
Art. No.: CD006033. DOI: 10.1002/14651858.CD006033
25. Trussell J. Contraceptive failure in the United States.
Contraception 2004;70:89–96.
26. Cromer BA, Scholes D, Berenson A, Cundy T, Clark MK,
Kaunitz AM, et al. Depot medroxyprogesterone acetate
and bone mineral density in adolescents—the Black Box
Warning: a Position Paper of the Society for Adolescent
Medicine. Society for Adolescent Medicine. J Adolesc
Health 2006;39:296–301.
27. Cundy T, Ames R, Horne A, Clearwater J, Roberts H,
Gamble G, et al. A randomized controlled trial of estrogen
replacement therapy in long-term users of depot medroxy-
progesterone acetate. J Clin Endocrinol Metab 2003;88:
78–81.
28. Cromer BA, Lazebnik R, Rome E, Stager M, Bonny A,
Ziegler J, et al. Double-blinded randomized controlled trial
of estrogen supplementation in adolescent girls who receive
depot medroxyprogesterone acetate for contraception. Am
J Obstet Gynecol 2005;192:42–7.
Copyright © September 2008 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Depot medroxyprogesterone acetate and bone effects. ACOG
Committee Opinion No. 415. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2008;112:727–30.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 16
 ACOG COMMITTEE OPINION
Number 417 • September 2008

Addressing Health Risks of Noncoital

Sexual Activity
Committee on ABSTRACT: Noncoital sexual behaviors, which include mutual masturbation, oral
Adolescent Health sex, and anal sex, are common expressions of human sexuality. Couples may engage in
Care noncoital sexual activity instead of penile–vaginal intercourse hoping to reduce the risk of
Committee on sexually transmitted diseases and unintended pregnancy. Although these behaviors carry
Gynecologic Practice little or no risk of pregnancy, women engaging in noncoital behaviors may be at risk of
This document reflects acquiring sexually transmitted diseases. Practitioners can assist by assessing patient risk
emerging clinical and sci- and providing risk reduction counseling for those participating in noncoital sexual activities.
entific advances as of the
date issued and is subject
to change. The information
should not be construed Noncoital sexual activities are common before initiation of coitus is rare, and the
as dictating an exclusive
course of treatment or in both adults and adolescents. The 2002 prevalence of anal sex increases slowly after
procedure to be followed. National Survey of Family Growth found initiation of coitus.
that 88% of females and 90% of males aged When engaging in oral sex, most indi-
25–44 years, and 55% of males and 54% of viduals, including adolescents, are unlikely
females aged 15–19 years, have had oral sex to use barrier protection for a variety of rea-
with an opposite-sex partner (1). Anal sex sons, including a greater perceived safety of
is less common than oral or vaginal sex and noncoital sexual activity compared with vag-
is commonly initiated at a later age; 35% of inal sex (3, 4). In the 2002 National Survey
females and 40% of males aged 25–44 years of Family Growth, only 11% of females and
and 11% of male and female adolescents 15% of males aged 15–17 years who had ever
aged 15–19 years reported anal sex with engaged in oral sex reported using a condom
an opposite-sex partner (1). Comparison the most recent time that they had engaged
of data on oral sex from the 2002 National in oral sex (5).
Survey of Family Growth with data from Some sexually transmitted diseases
three national surveys from the early and (STDs) may be transmitted during nonco-
mid 1990s (the 1991 National Survey of ital sexual activity. Infections can be spread
Men, the 1992 National Health and Social through saliva, blood, vaginal secretions,
Life Survey, and the 1995 National Survey semen, and fecal material. Preexisting infec-
of Adolescent Men) provides no evidence tions, open sores, abrasions, or any compro-
for a recent increase in oral sex prevalence mise of the epithelial tissue can increase the
among adolescents and young adults despite risk of transmission. Transmission of STDs
concerns expressed in the popular media (1). is organism specific, with certain infections
Noncoital behaviors commonly co- commonly infecting the oral or rectal cavity,
occur with coital behaviors. Both oral sex and many rarely doing so or causing infec-
and anal sex are much more common tion without sequelae.
among adolescents who have already had
vaginal intercourse as compared with those Human Immunodeficiency
who have not (2). Likewise, the prevalence Virus
The American College of oral sex among adolescents jumps dra- Human immunodeficiency virus (HIV)
of Obstetricians matically in the first 6 months after initia- transmission is highly correlated with the
and Gynecologists tion of vaginal intercourse, suggesting that HIV viral load of the infected partner. In
Women’s Health Care both are often initiated at the same time and addition, the risk of acquiring HIV varies
Physicians with the same partner. Initiation of anal sex dramatically according to the specific sexual

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 17

 behavior, especially whether it is insertive or receptive.
The U.S. Centers for Disease Control and Prevention
(CDC) estimates a 100-fold increase in risk from the safest
to the least safe behavior (Table 1). Human immunodefi-
ciency virus is most readily transmitted through anal sex.
Receptive anal sex with a partner who is infected with HIV
is the sexual behavior associated with the greatest risk of
HIV transmission. Condom use reduces HIV transmis-
sion by approximately 80% in HIV-serodiscordant cou-
ples (6). Although saliva appears to have components that
inactivate HIV, there are case reports of HIV acquisition
in men who engaged only in oral sex with other men (7).
Herpes Simplex Virus
Herpes infection is commonly transmitted through kiss-
ing and via oral, vaginal, and anal sex. Typically, herpes
simplex virus type 1 (HSV-1) is associated with oral
lesions, whereas herpes simplex virus type 2 (HSV-2) is
associated with genital lesions. However, both HSV-1
and HSV-2 are capable of infecting oral, anal, and genital
sites. A study of university students seeking treatment
for herpes found the percentage of HSV-1 genital herpes
infections increased from 31% in 1993 to 78% in 2001
(8). Therefore, older studies that based their results
solely on the presence of HSV-2 have underestimated the
prevalence of genital herpes infections (9, 10).
Human Papillomavirus
Human papillomavirus (HPV) is a very common sexu-
ally transmitted virus that causes anogenital and oral
cancers as well as the benign genital warts. There are more
than 100 strains of HPV, 40 of which selectively infect
the anogenital and oral areas. More than 90% of the
HPV infections resolve spontaneously without sequelae;
however, persistent infection in the anogenital area or
oral cavity may cause cancer. Although the most efficient
means of transmission appear to be penile–vaginal sex
or penile–anal sex, oral transmission appears to occur
as well. However, data currently suggest that transmis-
Table 1. Risk of Human Immunodeficiency Virus
Transmission According to Sexual Behavior
Sex Act Relative Risk*
Insertive fellatio 1
Receptive fellatio 2
Insertive vaginal sex 10
Insertive anal sex 13
Receptive vaginal sex 20
Receptive anal sex 100
*Refers to relative risk of acquiring human immunodeficiency virus (HIV) infection
among persons without HIV infection.
Varghese B, Maher JE, Peterman TA, Branson BM, Steketee RW. Reducing the
risk of sexual HIV transmission: quantifying the per-act risk for HIV on the basis of
choice of partner, sex act, and condom use. Sex Transm Dis 2002;29:38–43.
COMMITTEE OPINIONS
sion is less efficient to the oral cavity than to the genital
area. The digital spread of HPV is theoretically possible
because genital HPV DNA has been detected on the hand.
However, because this is only detection of DNA, it is not
proved that this DNA is infectious.
Hepatitis Viruses
Hepatitis B virus can be found in semen, saliva, and
feces and is commonly spread through sexual contact.
Hepatitis A is transmitted from fecal contamination of the
oral cavity, thus explaining the higher incidence of infec-
tion in homosexual men who engage in oral–anal contact.
Sexual transmission of hepatitis C is uncommon but has
been associated with both preexisting hepatitis B and HIV
infection and with oral–genital contact (7).
Nonviral Sexually Transmitted
Diseases
A substantial number of recent primary and secondary
cases of syphilis reported in Chicago were attributable to
oral sex, with 86 of 627 (13.7%) individuals with syphilis
reporting oral sex as the only sexual exposure that could
account for their infection (11).
Most gonorrheal infections are sexually transmitted
and involve the urethra, cervix, rectum, or mouth (12).
Disseminated disease after oral–genital contact has been
documented. Although only 10% of isolated pharyngeal
gonorrheal infections are symptomatic, pharyngitis, with
or without fever or lymphadenopathy, should raise sus-
picion for gonorrheal infection when all other etiologies
have been ruled out.
Chlamydia has been isolated from throat cultures in
both men and women. In women, pharyngeal infection
is associated with performing oral sex on men (12, 13).
Chancroid, shigellosis, salmonellosis, and other enteric
infections have been linked to oral–genital or oral–anal
sex in a few case reports but appear to be relatively
uncommon. The role of noncoital sexual activity in the
transmission of other nonviral infections, such as vulvo-
vaginal candidiasis, bacterial vaginosis, and trichomonia-
sis remains unclear (12).
Patient Counseling
Noncoital sexual activity is not necessarily “safe sex.”
Because people define sexuality in a variety of ways, it is
important that practitioners ask direct questions regard-
ing sexual activity, including questions about oral or anal
sex and mutual masturbation, and questions about sex-
ual partners, including whether the patient has sex with
men, women, or both men and women.
A positive response to these questions indicates the
need for counseling regarding infection prevention strate-
gies specific to noncoital sexual activity. To individual-
ize counseling, the clinician must consider the woman’s
infection risk from partner factors (number of sexual part-
ners and her partners’ sexual behaviors, particularly mul-
tiple sexual partnerships) and the community prevalence
2013 COMPENDIUM OF SELECTED PUBLICATIONS 18
 of STDs. Because most women who engage in noncoital
sexual activity also are engaging in penile–vaginal inter-
course, the clinician needs to consider whether noncoital
behaviors add any additional risks to those already posed
by sexual intercourse. When a young person engages in
only oral or anal sex, the likelihood of encountering a part-
ner infected with an STD should be considered. Correct
and consistent condom use should be encouraged, espe-
cially for anal sex and vaginal sex. Practitioners also should
consider the patient’s history of STDs and patterns of bar-
rier method use with each partner. In brief, practitioners
need to consider the totality of the patient’s STD risk.
Counseling should focus on reducing STD risk factors
such as multiple partners. This may be more effective than
discouraging oral or anal sex. Risk-reduction strategies
may include engaging in safer behaviors (eg, oral sex often
is safer than vaginal intercourse, anal sex often is riskier
than penile–vaginal sex), abstinence, mutual monogamy,
limiting the number of partners, STD testing before engag-
ing in sexual activity with a new partner, and correct and
consistent use of condoms, particularly for vaginal and
anal sex. Sex toys should be cleaned between uses. Couples
counseling may be helpful for STD-serodiscordant couples.
Routine screening for chlamydia is recommended
annually for all sexually active women aged 25 years or
younger, and routine screening for gonorrhea is recom-
mended for all sexually active adolescents. Although
the 2006 CDC STD Treatment Guidelines recommend
behavioral screening for anal and oral sex, they do not
make specific recommendations for routine oral or anal
STD laboratory screening (14). Selected laboratory test-
ing for oral and anal STDs should be based on clinical
symptoms and behavioral risks.
Lesbians and bisexual women should be screened
for STDs based on the same risk factors as other women.
Because most lesbians have been sexually active with men at
some point in their lives and because some STDs also can be
transmitted by sexual activity exclusively among lesbians, it
should not be assumed that STD screening is unnecessary.
Conclusion
Great efforts are needed to educate health care practitio-
ners and the public regarding the potential health risks
of noncoital sexual activities and the importance of risk
reduction and barrier methods of protection. Practitioners
can assist by assessing patient risk and providing risk
reduction counseling for those participating in noncoital
sexual activities. Ultimately, additional research is needed
to determine the full impact of noncoital sexual activity
on the health of patients.
References
1. Mosher WD, Chandra A, Jones J. Sexual behavior and
selected health measures: men and women 15–44 years of
age, United States, 2002. Adv Data 2005;(362):1–55.
COMMITTEE OPINIONS
2. Lindberg LD, Jones R, Santelli JS. Non-coital sexual activi-
ties among adolescents. J Adolesc Health 2008;42(suppl 1):
44–5.
3. Prinstein MJ, Meade CS, Cohen GL. Adolescent oral sex,
peer popularity, and perceptions of best friends’ sexual
behavior. J Pediatr Psychol 2003;28:243–9.
4. Halpern-Felsher BL, Cornell JL, Kropp RY, Tschann JM.
Oral versus vaginal sex among adolescents: perceptions,
attitudes, and behavior. Pediatrics 2005;115:845–51.
5. Terry-Humen E, Manlove J, Cottingham S. Trends and
recent estimates: sexual activity among U.S. teens. Child
Trends Research Brief No. 2006–08. Washington, DC: Child
Trends; 2006. Available at: http://childtrends.org/files/
sexualactivityrb.pdf. Retrieved April 23, 2008.
6. Weller SC, Davis-Beaty K. Condom effectiveness in reduc-
ing heterosexual HIV transmission. Cochrane Database
of Systematic Reviews 2002, Issue 1. Art. No.: CD003255.
DOI: 10.1002/14651858.CD003255.
7. Edwards S, Carne C. Oral sex and the transmission of viral
STIs. Sex Transm Infect 1998;74:6–10.
8. Roberts CM, Pfister JR, Spear SJ. Increasing proportion of
herpes simplex virus type 1 as a cause of genital herpes infec-
tion in college students. Sex Transm Dis 2003;30:797–800.
9. Cherpes TL, Meyn LA, Hillier SL. Cunnilingus and vaginal
intercourse are risk factors for herpes simplex virus type 1
acquisition in women. Sex Transm Dis 2005;32:84–9.
10. Lafferty WE, Downey L, Celum C, Wald A. Herpes simplex
virus type 1 as a cause of genital herpes: impact on surveil-
lance and prevention. J Infect Dis 2000;181:1454–7.
11. Centers for Disease Control and Prevention (CDC).
Transmission of primary and secondary syphilis by oral
sex—Chicago, Illinois, 1998-2002. MMWR Morb Mortal
Wkly Rep 2004;53:966–8.
12. Edwards S, Carne C. Oral sex and transmission of non-viral
STIs. Sex Transm Infect 1998;74:95–100.
13. Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn
TS, Terho P, et al. Chlamydia trachomatis in the pharynx
and rectum of heterosexual patients at risk for genital infec-
tion. Ann Intern Med 1985;102:757–62.
14. Workowski KA, Berman SM. Sexually transmitted diseases
treatment guidelines, 2006. Centers for Disease Control and
Prevention [published erratum appears in: MMWR Morb
Mortal Wkly Rep 2006;55:997]. MMWR Recomm Rep
2006;55:1–94.
Copyright © September 2008 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Addressing health risks of noncoital sexual activity. ACOG Committee
Opinion No. 417. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2008;112:735–7.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 19
 ACOG COMMITTEE OPINION
Number 448 • December 2009

Menstrual Manipulation for Adolescents

Committee on
Adolescent Health
Care
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
With Disabilities
ABSTRACT: Defining the reasons for intervention and the precise goal of treatment
are the most critical issues regarding use of interventions to alter menstrual flow in ado-
lescents with disabilities. Reasons for intervention may relate to abnormal uterine bleed-
ing, hygiene, mood issues, fear of pregnancy, and acute onset of other medical
conditions. Goals of treatment may include a decrease in the amount of bleeding, peri-
odic amenorrhea, or treatment of symptoms, such as mood issues or dysmenorrhea.
First-line treatment options should be safe, minimally invasive, and nonpermanent.
Endometrial ablation has not been studied in adolescents, has not been studied long-
term, is considered irreversible and, therefore, is not recommended in teenagers.

Reaffirmed 2012

For an adolescent with either physical or to a family member or personal assistant.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
developmental disabilities, menstruation can
provide significant challenges for the patient
and her caregivers. The hygiene component
of often irregular early bleeding episodes and
the behavioral concerns that accompany
menstrual periods especially in developmen-
tally delayed teenagers may cause significant
problems. In addition, concerns regarding
sexuality and vulnerability to abuse and preg-
nancy contribute to the worries of many par-
ents. Requests for amenorrhea or menstrual
manipulation will be presented to obstetri-
cian–gynecologists, who then need to offer
information and counseling in this area. This
committee opinion focuses on the concerns,
assessment, and methods used for menstrual
manipulation in adolescents with disabilities.
Communication and Special
Considerations for History
Taking
Optimal gynecologic health care of adoles-
cents with disabilities is comprehensive;
maintains confidentiality, if possible; does
not treat the patient as infantile, affirms the
patient’s dignity; maximizes the patient’s
interests; and avoids harm. When possible,
the patient should have the opportunity to be
interviewed in private (1). Communication
should be directed to the teenager and not
Having knowledge of the teenager’s mode of
communication and provider patience in the
process are critical.
Knowledge of puberty, menstruation,
sexual activity, safety, and the ability to con-
sent to any sexual act should be assessed.
Adolescents with disabilities often are thought
to be asexual, but they are as likely as other
teenagers without disabilities to be sexually
active, and are at greater risk for forced sex-
ual encounters (2). When knowledge deficits
are present, developmentally appropriate edu-
cation on hygiene, contraception, sexually
transmitted infections, and abuse prevention
measures should be provided. Most adoles-
cents who are able to use the toilet without
assistance can learn to use pads or tampons
or both appropriately.
When the obstetrician–gynecologist
receives a request for amenorrhea or men-
strual manipulation, it is important to assess
the reason(s) for the request, especially if the
request does not directly come from the
patient. If the patient herself requests to have
her menstrual periods eliminated, her rea-
sons can be discussed directly with her. If her
caregiver requests this for the teenager, espe-
cially if the teenager has a significant devel-
opmental delay, the issues become more
complex. Before determining the next steps,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 20

 the health care provider needs to ascertain whether the
request is based on convenience for the family or care-
givers, vulnerability for abuse and pregnancy, or menses
that truly affect the patient’s quality of life. If the adoles-
cent with disabilities cannot participate in her usual activ-
ities during her menses, this may be due to inadequate
help with her hygiene needs, behavioral issues during
menses, or dysmenorrhea.
Menstrual Concerns
Although all teenagers may have irregular cycles during
the first 2–5 years after menarche (3), adolescents with dis-
abilities may have additional reasons to experience men-
strual irregularities, including thyroid disease in teenagers
with trisomy 21, high prolactin levels due to mood stabi-
lizing medication, and polycystic ovary syndrome in
teenagers with seizure disorders (10–20%) (4, 5).
Examination
With the new guidelines regarding cervical cytology
screening (6), a pelvic examination is rarely needed in a
teenager who is not sexually active and is only recom-
mended for specific indications, including abnormal
bleeding, vaginal discharge, suspicion of a vaginal foreign
object, or abuse evaluations, which may require an exam-
ination under anesthesia. Sexually transmitted infection
screening can be done by urine and blood testing. The
evaluation for abnormal bleeding is the same for adoles-
cents with disabilities as for other adolescents.
Treatment Options
If after an evaluation, the teenager, her family and health
care provider have decided that menstrual intervention is
warranted, the least invasive, reversible, and least harmful
intervention should be used. It is important to assess if pre-
dictable but potentially longer bleeding is easier to manage
than sporadic, irregular bleeding and counsel that total
amenorrhea is difficult to obtain. The following options are
available.
Nonsteroidal Antiinflammatory Drugs
Antiprostaglandin drugs in adequate dosages decrease
ovulatory bleeding by approximately 30–40% with less
reduction in anovulatory cycles. Although this will not
stop menses, it may help with pain and bleeding (7).
Estrogen-Containing Methods
Combined Oral Contraceptives
Combined oral contraceptives (OCs) used cyclically
result in less menstrual blood loss in patients. Combined
OCs can be used continuously or for an extended period
to attempt to reduce the total days of menstrual flow.
This, however, increases the incidence of unscheduled
bleeding, especially early in use, but amenorrhea rates
may increase to 50%. There are only sparse data on how
to manage the unscheduled bleeding; however, one study
suggests that use of norethindrone acetate resulted in
2 ACOG Committee Opinion No. 448
COMMITTEE OPINIONS
more amenorrhea than levonorgestrel (8). There is a
chewable combined OC available to use with G-tubes or
patients who are unable to swallow pills.
Contraceptive Patch
Pharmacologic data indicate that estrogen exposure is
higher with use of the contraceptive patch than with oral
contraceptives or the vaginal ring. It is unclear how this
may affect the risk of deep vein thrombosis (DVT) (9,
10). Caution, therefore, is recommended for use of the
patch in nonmobile women (see following discussion of
DVT). In teenagers with developmental disabilities,
unscheduled removal of the patch may occur. Placement
of the patch on the buttocks or shoulder, where the indi-
vidual cannot reach it, may remedy this problem.
Contraceptive Ring
Contraceptive rings often are difficult for adolescents
with mobility issues or functional hand limitations to
insert. There are clear intimacy issues with using care-
givers to assist with inserting a ring, although some
women may feel comfortable with partner help. The ring
can be used for 3 weeks, with an interval free week, but
rings used for 4 weeks continuously lead to lighter bleed-
ing and more days of amenorrhea (11).
Estrogen Use and Risk of Deep Vein Thrombosis
Immobility is not listed as a contraindication to estrogen-
containing contraceptives by the World Health Organ-
ization and the American College of Obstetricians and
Gynecologists (12). However, there are minimal data on
the risk of DVT in women who take contraceptives with
or without exogenous estrogen and who use wheelchairs.
Clinicians, therefore, will want to assess patients for
hypercoagulability by obtaining a careful family history
(13) and encourage exercise of extremities in patients
who are physically able. Because there is a possible con-
cern about clotting risk with patches and combined OCs
with third-generation progestins (14), they may not be
the first choice for women who are immobile.
Progestin-Only Methods
Oral Medications
Cyclic progestins reduce blood loss in women with
anovulation, but do not work in this capacity for women
who are ovulatory (15). While taking the progestin only
“minipill,” patients will have ovulatory cycles approxi-
mately 40% of the time, short irregular cycles 40% of
time, or lack of cycles from amenorrhea to irregular
bleeding 20% of the time (16). Oral progestins in higher
doses than the progestin-only birth control pills can be
used daily to achieve amenorrhea. Occasional depressed
mood has been noted by clinicians, although, there is not
substantial data to support this.
Implants
Progestin contraceptive subdermal implants have an inci-
dence of unscheduled bleeding of up to 40% in the first
2013 COMPENDIUM OF SELECTED PUBLICATIONS 21
 months after insertion (17) and need significant patient
cooperation or sedation for insertion.
Intramuscular Depot Medroxyprogesterone Acetate
Use of depot medroxyprogesterone acetate (DMPA)
results in relatively high rates of amenorrhea by the
fourth dose (approximately as high as 90% per 90-day
cycle in some studies) and has traditionally been used
extensively to suppress menses (18). There are two main
areas of concern for adolescents with disabilities.
1. Bone density: Although a decrease in bone density has
been described with DMPA use in teenagers, there is
evidence showing recovery of bone after DMPA is dis-
continued (19). However, in teenagers where the sup-
pression may need to be long term or when the risk for
very low bone density may be increased because of
immobility or being under weight or both, DMPA use
may be less advisable. Supplementation with calcium
and vitamin D should be considered. Several studies of
adolescents and women demonstrate that low-dose
estrogen supplementation limits bone mineral density
loss in DMPA users; however, estrogen supplementa-
tion during DMPA use is not currently recommended
(19).
2. Weight gain: Weight gain is variable but appears to be
particularly problematic for overweight patients
(20). For adolescents with disabilities who may be
dependent on their own strength or the help of care-
givers for transfers in and out of chairs and beds, a
relatively small weight gain may affect their inde-
pendence and should be closely monitored.
Progesterone-Releasing Intrauterine Contraception
The levonorgestrel intrauterine device (IUD) is utilized
outside of its contraceptive labeling as a method of men-
strual suppression (21). Irregular bleeding is common
initially, but amenorrhea rates increase over time and
overall blood loss is significantly decreased. One meta-
analysis of levonorgestrel IUD use in the general popula-
tion indicates a 70–80% reduction of blood loss (22).
Ovulation is variable so amelioration of ovulatory symp-
tomatology will vary. Current data on the levonorgestrel
IUD is not specific to adolescents with disabilities. In ado-
lescents with disabilities, IUD insertion may need to be
done under anesthesia because of a higher likelihood of
nulligravid status (23), unpredictable cooperation, a nar-
row vagina, a small uterus, and significant contractures.
Special Consideration: Antiepileptic Drugs and
Hormone Use
Even though estrogen is a proconvulsant, combined OCs
have not been associated with an increase in seizures.
Irregular bleeding is common and contraceptive effec-
tiveness may be affected by enzyme inducing antiepileptic
drugs (24). Progestins increase seizure threshold and can
play an important role for women with epilepsy (25).
ACOG Committee Opinion No. 448
COMMITTEE OPINIONS
Estrogen or progesterone content may need to be
increased or DMPA may be used in 10-week intervals to
decrease irregular bleeding (26).
Surgical Methods
Endometrial Ablation
Endometrial ablation aims to treat heavy bleeding by
selectively destroying the endometrial lining while leaving
the uterus intact. It is generally recommended with con-
comitant contraception or sterilization, only if reproduc-
tion is no longer desired. The use of endometrial ablation
in adolescents with disabilities is not recommended
because of the following issues:
• There is no real long-term outcome data (for exam-
ple, 20–40 years) or data on adolescents.
• Guardians and patients who request endometrial
ablation in adolescents with disabilities do so in the
hope to obtain amenorrhea, which occurs in approx-
imately 13–47% of adults at 12 months (27).
• Women younger than 45 years experience a signifi-
cantly higher failure rate of the procedure than older
women (28).
• Although ablation is not considered sterilization by
many, the destruction of the endometrium will ren-
der the patient subfertile, if not infertile. In the event
that pregnancy ensues after an ablation, complica-
tions are likely (29).
• Consent requirements for sterilization in adolescents
with disabilities who cannot give their own consent,
either because of age or developmental delay, should
apply to this procedure as well (1). Although there
are laws in some states protecting minors from steril-
ization procedures, it is unclear if these laws apply to
ablation.
Hysterectomy
Occasionally, a family may request a hysterectomy for
definitive amenorrhea in adolescents with disabilities.
Issues with hysterectomy in this situation include that this
method is always irreversible and has the highest poten-
tial for morbidity and mortality. In situations when
guardians request hysterectomy, it is critical to define
what benefits they desire. Hysterectomy is seen by some as
ideal for pregnancy prevention, and menstrual control
may be a secondary goal. It is critical for guardians to
understand that a hysterectomy will not protect the child
from the hazards of sexual abuse or sexually transmitted
infections. Only very rarely should a hysterectomy be con-
sidered for adolescents with disabilities, just as for
teenagers without disabilities, such as when they are done
for extreme situations like cancer. Abnormal bleeding is
almost always managed medically for a teenager without
disabilities. The same should be true for adolescents with
disabilities. Laws regarding minor sterilization, hysterec-
tomy, and consent issues vary from state to state.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 22
 Guidelines are available from the American College of
Obstetricians and Gynecologists regarding consent (1).
References
1. Sterilization of women, including those with mental dis-
abilities. ACOG Committee Opinion No. 371. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:217–20.
2. Cheng MM, Udry JR. Sexual behaviors of physically dis-
abled adolescents in the United States. J Adolesc Health
2002;31:48–58.
3. Menstruation in girls and adolescents: using the menstrual
cycle as a vital sign. ACOG Committee Opinion No. 349.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:1323–8.
4. Prasher VP. Down syndrome and thyroid disorders: a review.
Downs Syndr Res Pract 1999;6:25–42.
5. Herzog AG, Schachter SC. Valproate and the polycystic
ovarian syndrome: final thoughts. Epilepsia 2001;42:311–5.
6. Cervical cytology screening. ACOG Practice Bulletin No.
109. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2009;114:1409–20.
7. Bonnar J, Sheppard BL. Treatment of menorrhagia during
menstruation: randomised controlled trial of ethamsylate,
mefenamic acid, and tranexamic acid. BMJ 1996;313:
579–82.
8. Edelman AB, Koontz SL, Nichols MD, Jensen JT. Continuous
oral contraceptives: are bleeding patterns dependent on the
hormones given? Obstet Gynecol 2006; 107:657–65.
9. Use of hormonal contraception in women with coexisting
medical conditions. ACOG Practice Bulletin No. 73.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:1453–72.
10. Phelps JY, Kelver ME. Confronting the legal risks of pre-
scribing the contraceptive patch with ongoing litigation.
Obstet Gynecol 2009;113:712–6.
11. Sulak PJ, Smith V, Coffee A, Witt I, Kuehl AL, Kuehl TJ.
Frequency and management of breakthrough bleeding with
continuous use of the transvaginal contraceptive ring: a
randomized controlled trial. Obstet Gynecol 2008;112:
563–71.
12. World Health Organization. Medical eligibility criteria for
contraceptive use. 3rd ed. Geneva: WHO; 2004.
13. Savelli SL, Kerlin BA, Springer MA, Monda KL, Thornton
JD, Blanchong CA. Recommendations for screening for
thrombophilic tendencies in teenage females prior to con-
traceptive initiation. J Pediatr Adolesc Gynecol 2006;19:3
13–6.
14. Girolami A, Spiezia L, Rossi F, Zanon E. Oral contraceptives
and venous thromboembolism: which are the safest prepara-
tions available? Clin Appl Thromb Hemost 2002;8: 157–62.
15. Lethaby A, Irvine GA, Cameron IT. Cyclical progestogens
for heavy menstrual bleeding. Cochrane Database of
Systematic Reviews 2008, Issue 1. Art. No.: CD001016. DOI:
10.1002/14651858.CD001016.pub
16. Broome M, Fotherby K. Clinical experience with the
progestogen-only pill. Contraception 1990;42:489–95.
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COMMITTEE OPINIONS
17. Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A,
Schmidt J, et al. Safety and efficacy of Implanon, a single-
rod implantable contraceptive containing etonogestrel.
Implanon US Study Group. Contraception 2005;71:319–26.
18. Speroff L, Fritz MA. Long-acting methods of contraception.
In: Clinical gynecologic endocrinology and infertility. 7th
ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2005.
p. 949–69.
19. Depot Medroxyprogesterone Acetate and Bone Effects.
ACOG Committee Opinion No.415. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2008;
112:727–30.
20. Bonny AE, Ziegler J, Harvey R, Debanne SM, Secic M,
Cromer BA. Weight gain in obese and nonobese adolescent
girls initiating depot medroxyprogesterone, oral contracep-
tive pills, or no hormonal contraceptive method. Arch
Pediatr Adolesc Med 2006;160:40–5.
21. Noncontraceptive uses of the levonorgestrel intrauterine
system. ACOG Committee Opinion No. 337. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2006;107:1479–82.
22. Mansour D. Modern management of abnormal uterine
bleeding: the levonorgestrel intra-uterine system. Best Pract
Res Clin Obstet Gynaecol 2007;21:1007–21.
23. Suhonen S, Haukkamaa M, Jakobsson T, Rauramo I. Clinical
performance of a levonorgestrel-releasing intrauterine sys-
tem and oral contraceptives in young nulliparous women:
a comparative study. Contraception 2004;69:407–12.
24. Foldvary-Schaefer N, Falcone T. Catamenial epilepsy:
pathophysiology, diagnosis, and management. Neurology
2003;61:S2–15.
25. Foldvary-Schaefer N, Harden C, Herzog A, Falcone T.
Hormones and seizures. Cleve Clin J Med 2004;71 Suppl
2:S11–8.
26. Quint EH. Menstrual issues in adolescents with physical
and developmental disabilities. Ann N Y Acad Sci 2008;
1135:230–6.
27. Endometrial ablation. ACOG Practice Bulletin No. 81.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2007;109:1233–48.
28. El-Nashar SA, Hopkins MR, Creedon DJ, St Sauver JL,
Weaver AL, McGree ME, et al. Prediction of treatment out-
comes after global endometrial ablation. Obstet Gynecol
2009;113:97–106.
29. Hare AA, Olah KS. Pregnancy following endometrial abla-
tion: a review article. J Obstet Gynaecol 2005;25:108–14.
Copyright December 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permis-
sion from the publisher. Requests for authorization to make photo-
copies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Menstrual manipulation for adolescents with disabilities. ACOG
Committee Opinion No. 448. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2009;114:1428–31.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 23
 ACOG COMMITTEE OPINION
Number 451 • December 2009

Von Willebrand Disease in Women

Committee on ABSTRACT: Approximately 3 million women in the United States have inherited
Adolescent Health bleeding disorders. The prevalence of bleeding disorders is particularly high among
Care women with menorrhagia. Von Willebrand disease is the most common inherited bleed-
Committee on ing disorder. Once a diagnosis is made, collaboration with a hematologist is helpful
Gynecologic for long-term management. Women with von Willebrand disease may be at increased
Practice risk for gynecologic and obstetric complications. Many treatments are available for the
This document reflects control of menorrhagia in women with von Willebrand disease, but the first-line therapy
emerging clinical and sci- remains combined hormonal contraception.
entific advances as of the
date issued and is subject
to change. The information
should not be construed Background disorder is menorrhagia, but additional
as dictating an exclusive
Approximately 3 million women in the symptoms or signs also may be present (7,
course of treatment or
procedure to be followed. United States have inherited bleeding disor- 8). Other presenting symptoms may include
ders (1). Von Willebrand disease is the most epistaxis, bleeding after dental extraction,
common inherited bleeding disorder, with a bleeding from minor cuts or abrasions, post-
prevalence of 0.6–1.3% (2, 3). Among women operative bleeding, gingival bleeding, easy
with menorrhagia, the prevalence is greater, bruising, postpartum hemorrhage, joint
and ranges from 5% to 15%. In particular, bleeding, and gastrointestinal bleeding (7,
von Willebrand disease appears to be more 9). Among women with a diagnosis of von
prevalent among Caucasians with menor- Willebrand disease, 48% reported easy bruis-
rhagia (4). One study suggests that 15.9% of ing, 44% reported epistaxis, 51% reported
Caucasians were found to have von Wille- gingival bleeding, and 84% presented with
brand disease, compared with 1.3% of African menorrhagia (8, 10). In one cross-sectional
Americans (5). study, women with von Willebrand disease
Von Willebrand disease is an autoso- were also more likely than controls to report
mally inherited congenital bleeding disor- other gynecologic conditions, including ovar-
der involving a qualitative or quantitative ian cysts (52%), endometriosis (30%), leio-
deficiency of von Willebrand factor (vWF). myomas (32%), endometrial hyperplasia
Dominant and recessive patterns of transmis- (10%), polyps (8%), and hysterectomy (26%)
sion exist. Von Willebrand factor is a protein in addition to menorrhagia (8).
that is critical for proper platelet adhesion Up to 20% of women presenting with
and protects against coagulant factor deg- menorrhagia at any time in life will have
radation. There are three main types of von an underlying bleeding disorder (2, 4, 5).
Willebrand disease. Type 1 (deficiency of The onset of heavy menses at menarche is
vWF), the most common, usually is mild; often the first sign of von Willebrand dis-
type 2 (abnormal vWF) is less common; type ease. Among a cohort of 38 women with
3 (complete absence of vWF) and pseudo von type 1 von Willebrand disease, retrospective
Willebrand forms are rare, and the presenta- analysis of bleeding symptoms revealed that
tion signs and symptoms are variable (6). menorrhagia at menarche was the most com-
mon initial bleeding symptom, occurring in
The American College Presenting Symptoms and 53% of women (11). The American College of
of Obstetricians Signs Obstetricians and Gynecologists recommends
and Gynecologists The most commonly reported symptom that an initial reproductive health visit occur
Women’s Health Care among women with a diagnosis of von between the ages of 13 years and 15 years.
Physicians Willebrand disease or suspected bleeding This gives many clinicians an opportunity

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 24

 to inquire about menstrual history early in reproductive
life (12). This also provides an opportunity to discuss
the use of a menstrual calendar to aid in patient recall,
which allows for clinicians to better differentiate menor-
rhagia from irregular, anovulatory bleeding. Anovulatory
bleeding is more common during early adolescence and
generally does not raise suspicion of a bleeding disorder
(13, 14). Other screening tools for identifying women
with menorrhagia who should be evaluated for a bleeding
disorder include the pictorial bleeding assessment chart.
This tool is useful for women to specifically record the
number of pads or tampons used during their menstrual
periods as well as noting how many times they may have
passed clots or had flooding accidents. This tool has been
validated in adult women and demonstrates greater than
80% sensitivity and specificity for scores greater than
100 (15). When the pictorial bleeding assessment chart
tool is combined with a set of eight questions that focus
on bleeding history, the sensitivity increases to 95% for
diagnosis of any underlying bleeding disorder and 92%
for von Willebrand disease; specificity is 72% and 8%,
respectively (16).
A recent study also highlights the varied presenta-
tion of menorrhagia among women with von Willebrand
disease of different age groups (5). One-hundred fifteen
women of all ages with diagnoses of menorrhagia were
evaluated for bleeding conditions. Nearly 50% of these
women were ultimately determined to have platelet
dysfunction, von Willebrand disease, or coagulation fac-
tor abnormalities. Importantly, bleeding disorders were
found to be just as prevalent in adolescents as they were
in adult women (5). The evaluation and management of
women presenting with abnormal uterine bleeding have
been addressed in other College publications as well (14).
Nonetheless, inherited and acquired disorders of coagu-
lation and hemostasis should be considered in the dif-
ferential diagnosis of menorrhagia and abnormal uterine
bleeding regardless of age.
Diagnosis
The first step in the evaluation of women with suspected
bleeding disorders involves careful history and physi-
cal examination (9, 17). Directed questions are useful
in assessing risk for inherited bleeding conditions (see
Box 1) (9, 17). If red flags exist, then health care provid-
ers should follow the National Heart, Lung, and Blood
Institute guidelines (9, 17). Family history of menor-
rhagia or other bleeding problems is helpful in assessing
the need for further evaluation, even in the absence of a
known bleeding disorder diagnosis. In one study of 580
women with menorrhagia, 33.9% of women had a family
history significant for excessive bleeding, but less than 1%
reported knowing of a specific or known or diagnosed
bleeding condition within their families (5). Other impor-
tant initial questions include personal history of bleeding
problems, liver or kidney disorders, family history of
COMMITTEE OPINIONS
Box 1. Bleeding Disorder Red Flags
• Patient has a relative with an inherited bleeding condi-
tion
• Prolonged bleeding, lasting more than 15 minutes, from
small injuries or wounds
• Heavy prolonged and recurrent bleeding following
surgical procedures
• Bruising with minimal or no trauma with palpable lump
under the bruise
• Spontaneous nosebleeds
• Prolonged bleeding following dental procedures
• Blood in the stool or bleeding ulcer that required
urgent medical attention for cessation
• History of anemia requiring blood transfusion
• Heavy menses resulting in anemia or low iron stores
• Passing clots more than 1 inch diameter with menses
or soaking more than one pad or tampon hourly
• Heavy bleeding during or following childbirth
Adapted from the National Heart, Lung, and Blood Institute,
The Diagnosis, Evaluation, and Management of von Willebrand
Disease. NIH Pub. No. 08-5832. December, 2007.
hysterectomy at an early age, history of postpartum
hemorrhage, or use of anticoagulants. Positive responses
to initial questions should be followed by more probing
questions and physical examination. Physical examina-
tion findings suggestive of a bleeding disorder include
petechiae, ecchymoses, skin pallor, or swollen joints,
although absence of these signs does not exclude the pos-
sibility of an underlying bleeding condition (7, 18, 19).
In patients with a positive screening history, labora-
tory testing is indicated (see Fig. 1) (9, 17). Initial tests
should include complete blood count with platelets, pro-
thrombin time, and partial thromboplastin time (fibrino-
gen or thrombin time are optional); bleeding time is
neither sensitive nor specific, and is not indicated.
Depending on the results of initial tests, or if a patient’s
history is suggestive of an underlying bleeding condition,
specific tests for von Willebrand disease, including von
Willebrand-Ristocetin cofactor activity, von Willebrand
factor antigen, and factor VIII may be indicated (see
Fig. 1) (9, 17, 19–21). These test results may be affected
by several variables such as age, race, family history, blood
type, stress, concurrent heavy bleeding, inflammation,
exogenous or endogenous hormones, pregnancy, time
of the menstrual cycle, sample processing, and quality
of the laboratory (9, 17, 19–29). Because existing labora-
tory assays have limitations and no single diagnostic test
reliably identifies the condition, this testing can be done
in conjunction with a hematologist if necessary (9, 17).
Furthermore, although certain types of von Willebrand
disease may be easily distinguished from other bleeding
2013 COMPENDIUM OF SELECTED PUBLICATIONS 25
 Positive initial screen by history
and physical examination

Initial hemostasis tests

• CBC and platelet count
• PT and PTT
• Fibrinogen or TT (optional)
If bleeding history is strong, consider
performing initial von Willebrand
disease assays in conjunction with
hematologist

Other cause identified, eg, decreased Isolated prolonged PTT that

platelets, isolated abnormal PT, low corrects on 1:1 mixing study, or no
fibrinogen, and abnormal TT abnormalities

Referral to hematologist for other Referral to hematologist for initial

appropriate evaluation von Willebrand disease assays
• vWF:Ag
• vWF:RCo
• FVIII
Abbreviations: CBC, complete blood count; FVIII, factor VIII activ-
ity; PT, prothrombin time; PTT, partial thromboplastin time; TT,
thrombin time; vWF:Ag, von Willebrand factor antigen; vWF:RCo, von
Willebrand factor ristocetin cofactor activity.

Fig. 1. Laboratory tests for suspected bleeding disorders *Adapted from the National Heart, Lung, and Blood Institute,
The Diagnosis, Evaluation, and Management of von Willebrand Disease. NIH Pub. No. 08-5832. December, 2007.

conditions on the basis of laboratory testing, not all types
are as straightforward to diagnose. Genetic tests may be
necessary for confirmation of certain von Willebrand
disease types (9, 17).
Management
Once a diagnosis has been established, a variety of treat-
ments exist. Treatments include ways to increase endog-
enous plasma concentration of vWF, replace vWF, or
promote hemostasis without affecting vWF. With mild
von Willebrand disease and menorrhagia, combination
hormonal contraceptives are first-line treatments. In
a study involving women with a diagnosis of von
Willebrand disease, 88% reported improvement in men-
orrhagia with oral contraceptives alone (7, 18). In addi-
tion, the levonorgestrel-releasing intrauterine device has
been proved effective for the reduction of menorrhagia
symptoms in adult women with bleeding disorders (30).
Intrauterine devices containing levonorgestrel have been
used in the adolescent population as well, especially
in cases of traditional hormonal management failure.
Although other contraceptives such as the contraceptive
patch and contraceptive ring have not yet been studied in
this population, theoretically, they would exhibit similar
control of menstrual bleeding. Extended cycle combined
hormonal contraceptives or depot medroxyprogesterone
acetate are other options for consideration to help control
heavy menses, although patients should still be warned
about breakthrough spotting (14).
Newer hemostatic agents include antifibrinolytics,
such as ε-aminocaproic acid and tranexamic acid (31).
These are agents that inhibit the conversion of plasmino-
gen to plasmin, inhibiting fibrinolysis, and thereby help
stabilize clots. These agents also may be used alone or in
conjunction with hormones to control menstrual bleed-
ing, especially in the event a definitive diagnosis of von
Willebrand disease has not yet been established. Because
tranexamic acid is not yet approved for treatment of
menorrhagia, this medication should be used with the
guidance of a hematologist (9, 17, 31).
Therapies generally prescribed in conjunction with a
hematologist once a diagnosis of von Willebrand disease-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 26

 has been established include desmopressin acetate and
Recombinant Factor 8 and vWF complex infusion (9,
17). Desmopressin acetate is a synthetic derivative of the
anti-diuretic hormone vasopressin and works by stimu-
lating the release of vWF from endothelial cells (21).
Recombinant factor VIII and vWF complex infusion are a
plasma-derived concentrate used to replace vWF and fac-
tor VIII. Patients also should be reminded that products
that prevent platelet adhesion, such as aspirin or non-
steroidal antiinflammatory drugs, should be avoided
once von Willebrand disease is diagnosed (9, 17).
Special Considerations
Gynecologic concerns in women with von Willebrand
disease include ruptured ovarian cysts, menstrual bleed-
ing, endometriosis, and leiomyomas. Patients with heavy
menstrual bleeding or hemorrhagic ovarian cysts may be
easily managed with the introduction of a combined con-
traceptive regimen, by preventing both heavy menstrual
bleeding or the development of hemorrhagic cysts (10).
For the acute presentation of a ruptured ovarian cyst,
patients with von Willebrand disease may require surgical
intervention for hemostasis. In the presence of menor-
rhagia, patients with von Willebrand disease may require
hormonal treatment (oral or intravenous) in addition
to a hemostatic agent or desmopressin acetate and vWF
replacement (9, 10, 17).
Obstetric concerns include postpartum hemorrhage,
mode of delivery, operative delivery techniques, sponta-
neous abortion, and epidural management. Many experts
have advocated that women with von Willebrand disease
may have a vaginal delivery safely, with cesarean delivery
reserved as indicated (9, 17). Because von Willebrand dis-
ease is an inherited condition, traumatic vaginal delivery,
such as what may occur with the use of vacuum or rota-
tional forceps, should be avoided because of the poten-
tial risk of traumatic injury to an infant with a possible
hereditary bleeding disorder (32). If surgery is planned,
it is important to coordinate care with a hematologist
because vWF replacement may be necessary. The same
considerations apply to epidural placement because this
may be dependent on severity of disease; therefore, con-
sultation with a hematologist is important. The rate of
spontaneous abortion is similar to that of the general
population. However, because patients may be at risk
for hemorrhage at the time of spontaneous incomplete
abortion, the use of vWF and factor VIII to control bleed-
ing may be required (32). Furthermore, in a recent large
epidemiologic study, the risk of postpartum hemorrhage
for women with von Willebrand disease was 50% higher
than for women without a bleeding disorder (29). Von
Willebrand factor and factor VIII concentrates may be
required to control bleeding in this situation as well (9).
Once estrogen levels begin to decrease in the postpartum
period, some individuals with bleeding conditions may
present with delayed hemorrhage. Throughout pregnan-
cy, at the time of delivery, and in the event of postpartum
COMMITTEE OPINIONS
hemorrhage, vWF and factor VIII levels are important to
assess because some women may require replacement of
vWF and factor VIII for safe range maintenance (10, 32).
Any surgical procedure in a woman with von
Willebrand disease requires consultation with a hema-
tologist because of the potential risk of hemorrhage.
Preprocedure vWF, vWF activity, and factor VIII levels
may be important in determining the need for and timing
of infusion treatment preoperatively and postoperatively
(21).
It is particularly important to diagnose bleeding
disorders early in children and adolescents because acci-
dental trauma is the most common source of morbidity
and mortality in this age group. Early warning signs and
family history are critical for the acute treatment in these
situations. Ensuring that families have adequate access to
care and encouraging use of medical alert bracelets are
important (9, 32).
Conclusion
Von Willebrand disease is a common cause of menorrhagia
and other bleeding problems. Obstetrician–gynecologists
should keep von Willebrand disease and other bleeding
disorders in mind when evaluating patients with menor-
rhagia, especially at menarche. Once a diagnosis is made,
collaboration with a hematologist is helpful for the long-
term management of women with bleeding disorders
such as von Willebrand disease. Von Willebrand disease
affects the reproductive system as well as other body
systems, so patients may need access to other health care
providers in addition to gynecologists. Many resources
exist for patients and health care providers through the
National Heart, Lung, and Blood Institute, National
Hemophilia Foundation’s Project Red Flag, and the
American Society for Hematology (9, 33).
References
1. National Women’s Health Information Center. Bleeding
disorders: frequently asked questions. Washington, DC:
NWHIC; 2009. Available at: http://www.womenshealth.
gov/FAQ/bleeding-disorders.cfm. Retrieved August 14,
2009.
2. James AH. More than menorrhagia: a review of the obstet-
ric and gynaecological manifestations of bleeding disorders.
Haemophilia 2005;11:295–307.
3. James AH. Von Willebrand disease. Obstet Gynecol Surv
2006;61:136–45.
4. Shankar M, Lee CA, Sabin CA, Economides DL, Kadir RA.
von Willebrand disease in women with menorrhagia: a
systematic review. BJOG 2004;111:734–40.
5. Dilley A, Drews C, Miller C, Lally C, Austin H, Ramaswamy
D, et al. von Willebrand disease and other inherited bleed-
ing disorders in women with diagnosed menorrhagia.
Obstet Gynecol 2001;97:630–6.
6. Pruthi RK. A practical approach to genetic testing for von
Willebrand disease. Mayo Clin Proc 2006;81:679–91.
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 7. Valente MJ, Abramson N. Easy bruisability. South Med J
2006;99:366–70.
8. Kirtava A, Crudder S, Dilley A, Lally C, Evatt B. Trends
in clinical management of women with von Willebrand
disease: a survey of 75 women enrolled in haemophilia
treatment centres in the United States. Haemophilia 2004;
10:158–61.
9. National Heart, Lung, and Blood Institute. The diagnosis,
evaluation, and management of von Willebrand disease.
NIH Publication No. 08-5832. Bethesda (MD): NHLBI;
2007. Available at: http://www.nhlbi.nih.gov/guidelines/
vwd/ vwd.pdf. Retrieved August 14, 2009.
10. James AH, Kouides PA, Abdul-Kadir R, Edlund M, Federici
AB, Halimeh S, et al. Von Willebrand disease and other
bleeding disorders in women: consensus on diagnosis and
management from an international expert panel. Am J
Obstet Gynecol 2009;201:12.e1–12.e8.
11. Ragni MV, Bontempo FA, Hassett AC. von Willebrand dis-
ease and bleeding in women. Haemophilia 1999;5:313–7.
12.W1 The initial reproductive health visit. ACOG Committee
Opinion No. 335. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2006;107:1215–9.
13. Philipp CS, Faiz A, Dowling N, Dilley A, Michaels LA,
Ayers C, et al. Age and the prevalence of bleeding disorders
in women with menorrhagia. Obstet Gynecol 2005;105:61–
6.
14. American College of Obstetricians and Gynecologists.
Management of anovulatory bleeding. ACOG Practice
Bulletin 14. Washington, DC: ACOG; 2000.
15. Lee CA. Women and inherited bleeding disorders: men-
strual issues. Semin Hematol 1999;36:21–7.
16. Philipp CS, Faiz A, Dowling NF, Beckman M, Owens S,
Ayers C, et al. Development of a screening tool for identi-
fying women with menorrhagia for hemostatic evaluation.
Am J Obstet Gynecol 2008;198:163.e1–163.e8.
17. James AH, Manco-Johnson MJ, Yawn BP, Dietrich JE,
Nichols WL. Von Willebrand disease: key points from the
2008 National Heart, Lung, and Blood Institute guidelines.
Obstet Gynecol 2009;114:674–8.
18. Kirtava A, Drews C, Lally C, Dilley A, Evatt B. Medical,
reproductive and psychosocial experiences of women
diagnosed with von Willebrand’s disease receiving care
in haemo-philia treatment centres: a case-control study.
Haemophilia 2003;9:292–7.
19. Kouides PA. Current understanding of von Willebrand’s
disease in women - some answers, more questions. Haemo-
philia 2006;12(suppl 3):143–51.
20. Jennings I, Kitchen S, Woods TA, Preston FE. Laboratory
performance of haemophilia centres in developing coun-
tries: 3 years’ experience of the World Federation of Hemo-
philia External Quality Assessment Scheme. Haemophilia
1998;4:739–46.
21. Foster PA. The reproductive health of women with von
Willebrand Disease unresponsive to DDAVP: results of an
international survey. On behalf of the Subcommittee on
von Willebrand Factor of the Scientific and Standardization
Committee of the ISTH. Thromb Haemost 1995;74: 784–
90.
COMMITTEE OPINIONS
22. Miller CH, Dilley AB, Drews C, Richardson L, Evatt B.
Changes in von Willebrand factor and factor VIII levels
during the menstrual cycle. Thromb Haemost 2002;87:
1082–3.
23. Miller CH, Haff E, Platt SJ, Rawlins P, Drews CD, Dilley
AB, et al. Measurement of von Willebrand factor activ-
ity: relative effects of ABO blood type and race. J Thromb
Haemost 2003;1:2191–7.
24. Miller CH, Dilley A, Richardson L, Hooper WC, Evatt
BL. Population differences in von Willebrand factor levels
affect the diagnosis of von Willebrand disease in African-
American women. Am J Hematol 2001;67:125–9.
25. Keightley AM, Lam YM, Brady JN, Cameron CL, Lillicrap
D. Variation at the von Willebrand factor (vWF) gene locus
is associated with plasma vWF:Ag levels: identification of
three novel single nucleotide polymorphisms in the vWF
gene promoter. Blood 1999;93:4277–83.
26. Gralnick HR, McKeown LP, Wilson OM, Williams SB, Elin
RJ. von Willebrand factor release induced by endotoxin. J
Lab Clin Med 1989;113:118–22.
27. Conlan MG, Folsom AR, Finch A, Davis CE, Sorlie P,
Marcucci G, et al. Associations of factor VIII and von
Willebrand factor with age, race, sex, and risk factors for
atherosclerosis. The Atherosclerosis Risk in Communities
(ARIC) Study. Thromb Haemost 1993;70:380–5.
28. Ruggeri ZM, Ware J. von Willebrand factor. FASEB J 1993;
7:308–16.
29. James AH, Jamison MG. Bleeding events and other com-
plications during pregnancy and childbirth in women with
von Willebrand disease. J Thromb Haemost 2007;5:1165–9.
30. Kingman CE, Kadir RA, Lee CA, Economides DL. The use
of levonorgestrel-releasing intrauterine system for treat-
ment of menorrhagia in women with inherited bleeding
disorders. BJOG 2004;111:1425–8.
31. Fraser IS, Porte RJ, Kouides PA, Lukes AS. A benefit-risk
review of systemic haemostatic agents: part 2: in excessive
or heavy menstrual bleeding. Drug Saf 2008;31:275–82.
32. Demers C, Derzko C, David M, Douglas J. Gynaecological
and obstetric management of women with inherited bleed-
ing disorders. Society of Obstetricians and Gynecologists of
Canada. J Obstet Gynaecol Can 2005;27:707–32.
33. National Hemophilia Foundation. von Willebrand disease.
Available at: http://www.hemophilia.org/NHFWeb/MainPgs/
MainNHF.aspx?menuid=182&contentid=47&rptname=
bleeding. Retrieved August 14, 2009.
Copyright December 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Von Willebrand disease in women. ACOG Committee Opinion No.
451. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;114:1439–43.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 28
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 460 • July 2010

Committee on Adolescent Health Care

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

The Initial Reproductive Health Visit

ABSTRACT: The American College of Obstetricians and Gynecologists recommends that the first dedicated
reproductive health visit take place between the ages of 13 years and 15 years. This visit will provide health guid-
ance, screening, and preventive health care services and offers an excellent opportunity to begin a physician–
patient relationship. This visit does not generally include an internal pelvic examination.

Timing and Scope of Initial Visit
The first visit to the obstetrician–gynecologist for screen-
ing and the provision of reproductive preventive health
care services and guidance should take place between the
ages of 13 years and 15 years (1, 2). From a developmental
standpoint, patients of this age may manifest characteris-
tics of early, middle, or late adolescence. An attempt to
determine the patient’s developmental stage is helpful
during the interview and evaluation. It is important to
recognize that growth in one developmental area (eg,
cognitive, physical, or psychosocial) may or may not cor-
respond with the patient’s chronological age.
The scope of the initial reproductive health visit
will depend on the individual’s need, medical history,
physical and emotional development, and the level of
care she is receiving from other health care providers. An
age-appropriate discussion of topics, including pubertal
development, normal menses, timing of routine gyne-
cologic visits, healthy eating habits, sexually transmitted
infections (STIs), pregnancy prevention, sexual orienta-
tion and gender identity, substance use and abuse, and
acquaintance rape prevention is important. Depending
on training and experience, not all primary health care
providers who otherwise care for adolescents, includ-
ing pediatricians, family medicine physicians, adolescent
medicine specialists, and clinical nurse practitioners,
choose to provide reproductive care (3). It is important
to assess the level of reproductive care previously received
by the patient and work as a team with the other health
care provider(s) to ensure the provision of comprehen-
sive reproductive health care. One way to assess whether
an adolescent is getting appropriate care from another
health care provider would be to ask the parent if the
primary health care provider allows time for the adoles-
cent to speak with him or her alone. The obstetrician–
gynecologist can then supplement the care provided by a
primary health care provider, if necessary. If the obstetri-
cian–gynecologist is unable to provide appropriate and
adequate care, then he or she should refer the patient to
another reproductive health care provider.
Creating an Adolescent-Friendly
Environment
If feasible, the obstetrician–gynecologist may strive to
concentrate adolescent visits on a dedicated office day
or time. Many adolescents prefer before or after school
appointments. It should be noted that a reception area full
of obstetric patients often intimidates nonpregnant ado-
lescents. It may be helpful to include age-appropriate and
culturally inclusive reading materials and audiovisual aids
in the reception area and examination rooms. Having one
or two rooms where adolescents are seen and examined
allows for the removal or deemphasizing of materials and
equipment that may make adolescents uncomfortable.
The use of visual materials, such as models, diagrams, and
charts is strongly encouraged for teaching about anatomy
and physiology of the reproductive tract. (For more
suggestions about creating an adolescent-friendly office
environment, see “Preparing Your Office for Adolescent
Health Care” in the American College of Obstetricians
and Gynecologists’ (the College) publication Tool Kit for
Teen Care, Second Edition.)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 29

 Confidentiality
It is helpful to discuss issues of confidentiality with both
the adolescent and her parent* (4). Lack of confidential-
ity often is a barrier to the delivery of health care services,
especially reproductive health care, for adolescents (5).
To overcome this obstacle, health care providers should
initiate a discussion of this topic at the initial visit and
advise the adolescent and her parent of relevant state and
local statutes. The importance of open communication
between the health care provider, patient, and parent
should be emphasized. Parents and adolescents should
be informed of any legal restrictions on the confidential
nature of the physician–patient relationship. For exam-
ple, the health care provider should explain that if the
patient discloses any evidence or risk of bodily harm to
herself or others, confidentiality would be breached (6).
Furthermore, state laws mandate the reporting of physi-
cal or sexual abuse of minors. Health care providers and
office staff should be familiar with state and local statutes
regarding the rights of minors to consent to health care
services and the federal and state laws that affect con-
fidentiality. (For a listing of state laws that is updated
monthly, go to www.guttmacher.org/statecenter/spibs/
index.html and consult with your state medical society.)
The Initial Visit
The primary goal of the initial reproductive health visit is
to provide preventive health care services, including edu-
cational information and guidance, rather than problem-
focused care. The visit also allows patients and parents the
chance to visit the office, meet the health care provider,
alleviate fears, and develop trust. After greeting the ado-
lescent and parent, a thorough explanation of the scope
of the visit and confidentiality issues should be provided.
A model office visit would include 1) an initial consulta-
tion with both the patient and parent together, 2) a dis-
cussion with the parent alone, if desired, 3) a confidential
visit between the health care provider and patient, and
4) a concluding consultation with the patient and par-
ent again. Please note the patient has the right to decide
if she does not want the parent’s presence at any point
during the visit. (For more information please refer to
“Confidentiality in Adolescent Health Care” and “ACOG
Adolescent Visit Record” in Tool Kit for Teen Care.)
During the initial consultation with the patient and
parent, the health care provider should inform them that
the visit does not require an internal pelvic examination,
unless indicated, and that the College recommends the
first Pap test at age 21 years (7). Many adolescents and
their parents are unaware of the difference between a Pap
test and a pelvic examination. This presents an opportu-
nity for the clinician to dispel any confusion and clarify
any questions (8). A review of the patient’s medical his-
tory, family history, and immunization status should
*Use of the word “parent” throughout the document also means
“guardian.”
COMMITTEE OPINIONS
be assessed, and appropriate vaccinations should be
provided at this time. The family history should include
family history of venous thromboembolism; cardiovas-
cular disease; familial gynecologic conditions such as
endometriosis or leiomyomas; breast, colon, ovarian, or
uterine cancer; or polycystic ovary disease. In addition,
conversations regarding normal pubertal development
and menstruation are important, along with an assess-
ment for dysmenorrhea, and discussion about nonsteroi-
dal antiinflammatory drugs as effective treatment options
for menstrual cramps. Because menarche and subsequent
menses are physiologically and emotionally important
milestones in an adolescent’s development, it is beneficial
to educate patients and their parents regarding expec-
tations for both menarche, if it has not yet occurred,
and normal menstrual variation. Discussions regarding
appropriate menstrual flow, menstrual hygiene, and
duration and frequency of bleeding can help the adoles-
cent assess if her menstrual cycle is normal (9).
Adolescents with developmental delays and their
caregivers may especially benefit from an initial repro-
ductive health visit with an obstetrician–gynecologist.
Depending on the degree of developmental delay, the
patient and caregivers may need an in-depth discussion
of menstruation, fertility, hygiene, options for menstrual
manipulation (10), and contraception.
After the initial consultation with both the patient
and parent, it can be helpful to speak briefly with the
parent alone to identify any concerns about the patient,
to assess awareness of any risk-taking behaviors, observa-
tions about other behaviors (eg, lack of exercise or disor-
dered eating), and to provide anticipatory guidance. The
confidential nature of the physician–patient relationship
should be reiterated to the parent and the patient. The
consultation with the parent should be done before
the confidential visit with the patient. This will reassure
the adolescent and emphasize to the parent that the infor-
mation the adolescent provides will not be shared with
the parent unless required by law.
During the confidential visit with the patient, the
health care provider should include a discussion of con-
traception and STIs because some adolescents are and
some will become sexually active. Forty-seven percent of
females aged 15–19 years have engaged in intercourse,
which increases with age from 14% of 15-year-olds to
75% of 19-year-olds (11). Many adolescents are at risk
of engaging in unhealthy and risky behaviors, such as
tobacco, alcohol, and other substance use, and these
issues should be identified and addressed. According to
the 2007 Youth Risk Behavior Surveillance Report, female
students in grades 9–12 indicated that in the past 30 days
they had at least one drink of alcohol (43%); had five or
more drinks in a row on at least 1 day (24%); drove when
drinking alcohol (8%); and rode with a driver who had
been drinking alcohol (30%)(12, 13). Screening for eat-
ing disorders and other weight issues; anxiety; depression;
and physical, sexual, and emotional abuse is important.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 30
 Screening for many of the previously mentioned issues
can be facilitated by use of a questionnaire as an alterna-
tive to direct interviewing. (See the “ACOG Adolescent
Visit Record and ACOG Adolescent Visit and Parent
Questionnaires” in Tool Kit for Teen Care. For more
information on these topics, refer to the “Primary and
Preventive Health Care for Female Adolescents” chapter
in Tool Kit for Teen Care.)
Examination
The patient should be provided with a description of
the examination process and asked if she would like her
parent present. An internal pelvic examination gener-
ally is unnecessary during the initial reproductive health
visit. A general physical examination, including a visual
breast examination and external genital examination,
may be done because it allows assessment of second-
ary sexual development, reassurance, and education. A
teaching external-only genital examination can provide
an opportunity to familiarize adolescents with normal
anatomy, assess adequacy of hygiene, and allow the health
care provider an opportunity to visualize the perineum
for anomalies. If the patient has had sexual intercourse,
annual screening for chlamydia, gonorrhea, and human
immunodeficiency virus (HIV) is recommended (1).
Chlamydia and gonorrhea screening can be performed
with a vaginal swab specimen that is obtained by either
the patient or health care provider. Such screening also
can be done with urine testing using nucleic acid ampli-
fication techniques (14). Urine testing is often more
acceptable to the patient.
Pelvic examinations are recommended for symp-
tomatic patients. Because the College currently recom-
mends that females have their first Pap test at age 21
years (7), some adolescents may visit the gynecologist
several times before a speculum examination is indi-
cated. Such visits allow the development of a comfortable
physician–patient relationship, in addition to adequate
patient preparation before the first pelvic examina-
tion is performed. A developmentally appropriate pelvic
examination may be performed if issues or problems are
discovered in the medical history (eg, pubertal aberrancy,
abnormal bleeding or discharge, or abdominal or pelvic
pain). If a speculum or bimanual examination is neces-
sary, a thorough explanation and patient assent should
always precede the procedure. It is helpful to provide the
adolescent with written information regarding the first
complete pelvic examination if it is to occur. (Refer to
the College’s Patient Education Pamphlet, “Your First
Gynecologic Visit,” http://www.acog.org/publications/
patient_education/bp150.cfm). When choosing a specu-
lum for the examination, the patient’s age, developmental
status, hymenal opening, and sexual experience should
influence the decision. Typically, a Pederson or Huffman
speculum should be used.
On completion of the physical examination, con-
sultation with the patient should address physical find-
ings, diagnosis, and treatment options, if needed. Once
COMMITTEE OPINIONS
a mutually agreed-on treatment plan is established, the
adolescent is encouraged to include her parent in treat-
ment planning. It is helpful to assess specifically what
information can be shared with the parent. At the con-
clusion of the visit, the patient, her parent, and the health
care provider should meet again. During this meeting,
findings and recommendations are discussed, if appro-
priate. Any remaining concerns also can be addressed
and the parent can be offered guidance on adolescent
development.
Current Procedural Terminology
Coding†
To decrease or avoid claim delays and denials, the health
care provider’s office will be well served by develop-
ing resources for accurate coding and billing to be used
for the initial reproductive health visit. These resources
should contain the “covered benefits” of the office’s most
frequently billed third-party payers. It also should include
the copayment amounts for the different beneficiaries.
Preventive Medicine Services
Code 99384 is used for the initial comprehensive pre-
ventive medicine evaluation and management of a new
patient aged 12–17 years. It covers the history; examina-
tion; counseling, anticipatory guidance, and risk factor
reduction interventions; and the ordering of appropriate
immunization(s) and laboratory or diagnostic proce-
dures. It is important to note that laboratory services,
radiologic services, immunizations, and other procedures
and screening tests identified with their own codes are
separately reported.
Code 99394 is used for a preventive visit of an estab-
lished patient aged 12–17 years. Annual gynecologic visits
also may be included in this category. Different payers
may vary in their definition of an annual gynecologic visit;
however, a pelvic examination, a breast examination, and a
Pap test are included in this nomenclature. It is important
to note, however, that a Pap test will likely not be a part of
many visits for patients younger than 21 years. The length
of time is not reported for these visits. It is important to
remember that evaluation and management (E/M) guide-
lines do not apply to preventive services codes.
Preventive medicine services provided to asymptom-
atic patients may be used only once a year by any health
care provider. This is problematic because some health
care providers offer the full range of care from general
preventive care to reproductive health care, but many
times no one clinician provides all the recommended
care an adolescent needs. Therefore, “well-child” care
may require two visits, a general preventive visit and a
†
Current Procedural Terminology (CPT) is copyright 2009 American
Medical Association. All rights reserved. No fee schedules, basic units,
relative values, or related listings are included in CPT. The AMA
assumes no liability for the data contained herein. Applicable FARS/
DFARS restrictions apply to government use. CPT® is a trademark of
the American Medical Association.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 31
 dedicated reproductive health visit. Both are critical and
each of these visits should be covered.
Individual Counseling in Preventive Medicine
Codes 99401–99404 are used for individual counseling in
preventive medicine or risk factor reduction or both for
individuals without a specific illness to promote health
and prevent illness or injury or both. These codes are
time based and range from 15 minutes to 60 minutes.
When the preventive counseling service is distinct from
a problem-oriented E/M service, both services can be
reported at the same time.
Preventive Services and a Problem-Oriented
Visit
When preventive and problem-oriented care is provided
in the same visit, two separate codes are necessary: 1) The
preventive medicine code and 2) The code for added level
of E/M service with modifier 25 (Significant, Separately
Identifiable Evaluation and Management Service by the
Same Physician on the Same Day of the Procedure or
Other Service). It is important to check with insurers to
assess coverage for both preventive and problem-oriented
codes because some insurers will not accept both during
the same encounter. (For more information, refer to
“Coding Information” in Tool Kit for Teen Care.)
Conclusion
The initial reproductive visit provides an excellent
opportunity for the obstetrician–gynecologist to start a
physician–patient relationship, build trust, and counsel
patients and parents regarding healthy behaviors while
dispelling myths and fears. It also will assist an adoles-
cent in negotiating entry into the health care system
when she has a specific reproductive health care need.
Health care for the adolescent should include review
of normal puberty and menstruation, diet and exer-
cise, healthy sexual decision making, the development
of healthy and safe relationships, immunizations, STI
screening, and STI and pregnancy risk reduction and
prevention. Preventive counseling also is beneficial for
parents or other supportive adults and can include dis-
cussions regarding physical, sexual, and emotional devel-
opment; signs and symptoms of common conditions
affecting adolescents; and encouragement of lifelong
healthy behaviors. The initial reproductive health visit
does not include an internal pelvic examination unless
indicated by the medical history.
References
1. American College of Obstetricians and Gynecologists.
Primary and preventive health care for female adolescents.
In: Tool kit for teen care. 2nd ed. Washington (DC):
ACOG; 2009.
2. Sanfilippo JS, Davis A, Hertweck SP. Obstetrician gyne-
cologists can and should provide adolescent health care.
ACOG Clin Rev 2003;8(7):1,15–6.
3. Akinbami LJ, Gandhi H, Cheng TL. Availability of ado-
lescent health services and confidentiality in primary care
practices. Pediatrics 2003;111:394–401.
COMMITTEE OPINIONS
4. American College of Obstetricians and Gynecologists.
Confidentiality in adolescent health care. In: Tool kit for
teen care. 2nd ed. Washington, DC: ACOG; 2009.
5. McKee MD, Fletcher J, Schechter CB. Predictors of timely
initiation of gynecologic care among urban adolescent girls.
J Adolesc Health 2006;39:183–91.
6. Center for Adolescent Health and the Law. Policy compen-
dium on confidential health services for adolescents. 2nd ed.
Chapel Hill (NC): CAHL; 2005.
7. Cervical cytology screening. ACOG Practice Bulletin No.
109. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2009;114:1409–20.
8. Blake DR, Weber BM, Fletcher KE. Adolescent and young
adult women’s misunderstanding of the term Pap smear.
Arch Pediatr Adolesc Med 2004;158:966–70.
9. Menstruation in girls and adolescents: using the men-
strual cycle as a vital sign. ACOG Committee Opinion No.
349. American Academy of Pediatrics; American College
of Obstetricians and Gynecologists. Obstet Gynecol 2006;
108:1323–8.
10. Menstrual manipulation for adolescents with disabilities.
ACOG Committee Opinion No. 448. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2009:
114:1428–31.
11. Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J.
Fertility, family planning, and reproductive health of U.S.
women: data from the 2002 National Survey of Family
Growth. Vital Health Stat 23 2005;(25):1–160.
12. Eaton DK, Kann L, Kinchen S, Shanklin S, Ross J, Hawkins J,
et al. Youth risk behavior surveillance--United States, 2007.
Centers for Disease Control and Prevention (CDC).
MMWR Surveill Summ 2008;57(SS-4):1–131.
13. Alcohol use among high school students - Georgia, 2007.
Centers for Disease Control and Prevention (CDC).
MMWR Morb Mortal Wkly Rep 2009;58:885–90.
14. Association of Public Health Laboratories. Laboratory
diagnostic testing for Chlamydia trachomatis and Neisseria
gonorrhoeae. Silver Spring (MD): APHL; 2009. Available
at: http://www.aphl.org/aphlprograms/infectious/std/
Documents/CTGCLabGuidelinesMeetingReport.pdf.
Retrieved March 29, 2010.
Copyright July 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
The initial reproductive health visit. Committee Opinion No. 460.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2010;116:240–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 32
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 463 • August 2010

Committee on Adolescent Health Care

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Cervical Cancer in Adolescents: Screening, Evaluation,

and Management
ABSTRACT: Based on several recent studies, new guidelines for initiation of cervical cancer screening have
been developed. Evidence shows that screening before the age of 21 years does not change the rate of cervical
cancer in that age group or in older women. Cervical cancer, in general, is extremely rare in those younger than
21 years. Consequently, cervical cancer screening should begin at age 21 years. If cytology is performed before
age 21 years, it is important to recognize that the management of cervical cytologic abnormalities in adolescents
differs from that of the adult population. The publication of the American Society of Colposcopy and Cervical
Pathology 2006 consensus guidelines has led to major changes in the management of cervical disease in adoles-
cents, which emphasize minimal to no intervention. These guidelines advise against human papillomavirus testing
and recommend observation for the management of cervical intraepithelial neoplasia 1 in adolescents. In addition,
observation is preferred for the management of cervical intraepithelial neoplasia 2. The guidelines were estab-
lished to minimize the potential negative effect that screening can cause, unnecessary referrals for colposcopy,
and the negative effect that treatment can have on future pregnancy outcomes.

Natural History of Human confusion and nonadherence to the guidelines. Con-

Papillomavirus Infection
Human papillomavirus (HPV) is the most common sexu-
ally acquired infection in the world. Numerous natural
history studies (1, 2) have demonstrated that as many as
50% of sexually active young women in the United States
will have positive test results for HPV within 36 months
of the onset of sexual activity. Recurrent infections also
are common. Consequently, prevalence data indicate that
up to 57% of sexually active female adolescents in the
United States at any one point in time are infected with
HPV (3). In adolescent patients with an intact immune
system, 90% of cases of HPV infection will resolve within
24 months (4).
Cervical Cancer Screening
In the past, the American Cancer Society, the American
College of Obstetricians and Gynecologists, and the
American Society of Colposcopy and Cervical Pathology
(ASCCP) recommended the initiation of cervical cytol-
ogy screening in an adolescent based on time since
onset of vaginal intercourse. However, there was much
sequently, many adolescents were being screened inap-
propriately. In light of recent evidence that screening
in adolescents does not appear to change the rate of
cervical cancer in these groups (5), the American College
of Obstetricians and Gynecologists now recommends
that cervical cytology screening begin at age 21 years,
regardless of the age of onset of sexual activity. The few
rare cases of cervical cancer in this population do not
appear to have been preventable by screening.
With the new screening recommendations, cervical
cytology will not be obtained in most women younger
than 21 years. An adolescent with a history of normal
cytologic screening in the past should not be rescreened
until age 21 years. If an adolescent has had a Pap test
result of atypical squamous cells of undetermined signifi-
cance (ASC-US) or low-grade squamous intraepithelial
lesions (LSIL), or cervical intraepithelial neoplasia (CIN)
1 histology in the past, but has had two subsequent nor-
mal Pap test results, rescreening can be delayed until
age 21 years. For adolescents with high-grade squamous
intraepithelial lesions (HSIL); atypical squamous cells,
cannot exclude HSIL (ASC-H); or CIN 2 or more severe,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 33

 the current management guidelines detailed in this
Committee Opinion should be followed. Once regression
is established based on current criteria, rescreening can be
delayed until 21 years of age. Annual cytologic screening
also can be considered.
It is recommended that adolescents with human
immunodeficiency virus (HIV) have cervical cytology
screening twice in the first year after diagnosis and annu-
ally thereafter (6). Guidelines for treatment of cervical
cytologic abnormalities in individuals with HIV infection
can be obtained at http://www.cdc.gov/mmwr/preview/
mmwrhtml/rr5804a1.htm. Sexually active immunocom-
promised adolescents, including those who have received
an organ transplant or those with long-term steroid use,
should undergo screening after the onset of sexual activity
and not wait until 21 years of age. This screening should
include Pap tests at 6-month intervals during the first
year of screening and then annual Pap tests thereafter.
Human Papillomavirus Testing
Human papillomavirus testing is not recommended at
any time in adolescents. Because of the high prevalence of
HPV infection in adolescents, there is little utility in HPV
testing in this population. There are no clinical situations,
screening, triage, or follow-up that require HPV testing in
this population. If conducted, a positive test result should
not influence management. There is no role for HPV test-
ing in the patient before HPV vaccination.
Management of Cervical Cytologic
Abnormalities
Although nonadherence to screening guidelines can
occur, the low rates of progression of cervical cytologic
abnormalities and the slow rates at which progression
typically occurs if the abnormality does not regress, indi-
cate that conservative observational management should
be the mainstay of care in adolescents with abnormal
cytology results. The following guidelines are for man-
agement of cytologic and histologic abnormalities. These
guidelines also address the situation in which screening
or treatment or both took place before the release of the
new cervical cytology screening guidelines in 2009.
Atypical Squamous Cells of Undetermined
Significance, Low Grade Squamous
Intraepithelial Lesions, and Cervical
Intraepithelial Neoplasia 1
The ASCCP 2006 consensus guidelines for the man-
agement of ASC-US, LSIL, and CIN 1 in adolescents
recommend repeat cytology at 12-month intervals for a
period of 2 years (7–9). This recommendation is based
on natural history studies of ASC-US, LSIL, and CIN 1
that demonstrate a high rate of resolution of the disease
within 2–3 years (1, 10). Clinicians should perform col-
poscopy only for a cytologic diagnosis of HSIL at any visit
or after the persistence of ASC-US or LSIL for a period
COMMITTEE OPINIONS
of 2 years. The management of a patient with persistent
CIN 1 (greater than 24 months) should be individual-
ized. Strong consideration should be given to continued
monitoring of these adolescent patients because of the
frequency of newly acquired HPV infections.
Atypical Squamous Cells, Cannot Exclude High-
Grade Squamous Intraepithelial Lesions
Atypical squamous cells, cannot exclude HSIL represents
a small proportion of cervical cytology results. Multiple
studies have demonstrated that women who receive an
ASC-H diagnosis frequently have an ongoing HPV infec-
tion (approximately 80%), and are at an increased risk of
CIN 2,3 in a 2-year period (11). Because there are limited
data, ASC-H in adolescents is managed with colposcopic
evaluation. In women where no CIN 2,3 is identified
histologically, the subsequent management approach is cyto-
logic evaluation at 6-month intervals. If any abnor-
mality is found (greater than or equal to atypical
squamous cells), the patient should undergo a repeat col-
poscopy. When the patient has two consecutive normal
Pap test results, screening can be reinitiated at age 21 years.
High-Grade Squamous Intraepithelial Lesions
The adolescent with HSIL requires a colposcopic evalu-
ation with endocervical assessment. Use of the “see
and treat” loop electrosurgical excision procedure for
patients with HSIL who are younger than 21 years is con-
sidered unacceptable. If on biopsy no CIN 2,3 is found,
observation with colposcopy and cytology at 6-month
intervals is recommended for up to 2 years provided the
result of the endocervical sampling is negative. If HSIL
or high-grade colposcopic lesions persist at 1 year, repeat
biopsy and thorough examination of the vagina is rec-
ommended. A diagnostic excisional procedure is recom-
mended if HSIL persists at 24 months as confirmed by
either cytology or colposcopy results and if the examina-
tion of the vagina does not explain the abnormality. The
rationale for less intervention in adolescents is the high
rate of resolution of CIN 2 in this population and the
increased relative risk of preterm labor and premature
rupture of membranes in women after undergoing a
loop electrosurgical excision procedure (12, 13).
Atypical Glandular Cells
The prevalence of atypical glandular cells (AGC) in the
adolescent population is very low, and most of these
abnormalities will arise from the squamous component
of the cervix (14). Because this diagnosis is rare and can
have significant clinical implications, a physician with
expertise in managing cervical dysplasia should man-
age cases of AGC in the adolescent. The adolescent with
AGC should undergo a colposcopy and endocervical
sampling. Endometrial sampling would not be used in
most adolescents unless they are morbidly obese, they
have abnormal uterine bleeding or oligomenorrhea, or
there is a suspicion of endometrial cancer.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 34
 Cervical Intraepithelial Neoplasia 2,3
Cervical intraepithelial neoplasia 2 is a significant abnor-
mality that has classically required therapy. A variety of
studies, including the ASCUS-LSIL Triage Study trial,
have demonstrated that this lesion may have a significant
rate of resolution (up to 40%) in adults (15). This rate
of resolution is suspected to be higher in adolescents.
The management approach of CIN 2,3 in adolescents
and young women is observation with colposcopy and
cytology at 6-month intervals for up to 24 months or
treatment with either ablation or with excision of the
transformation zone, provided that the colposcopy result
is satisfactory (7, 9). When the colposcopy result is unsat-
isfactory, treatment is recommended. When CIN 2 is
specified on cervical biopsy, observation is preferred, but
treatment is acceptable. During the observation period,
if the colposcopic appearance of the lesions worsens, or
if the high-grade cytology or colposcopy result persists
for 1 year, a repeat biopsy is warranted. Treatment is
recommended for the patient with persistent CIN 2,3 as
confirmed by histology results for a 24-month period.
If CIN 1 is found, continued observation is an option.
In the ASCCP 2006 consensus guidelines, the definition
of young women was left deliberately vague, but among
the factors that should be taken into consideration in
applying this definition are the number of years since
first intercourse and the woman’s parity and desire for
future fertility.
Cervical intraepithelial neoplasia 3 is a significant
cervical abnormality. Cervical cancer is very rare in the
adolescent population and the natural history of CIN 3
in this population has not been examined. Therapy is
recommended for all women with CIN 3. Randomized
prospective clinical trials have demonstrated that cryo-
therapy, laser therapy, and the loop electrosurgical exci-
sion procedure are equally effective interventions for the
treatment of CIN 3 (16). In one of the largest follow-up
studies of women having undergone outpatient abla-
tive therapy of CIN, four cases of microinvasive cervical
cancer and five cases of frankly invasive cancer were
subsequently diagnosed among 3,738 adult women (17).
Because of these considerations, some authors have rec-
ommended that excision be used for the management of
biopsy-confirmed CIN 3, especially for large lesions that
are at increased risk of having microinvasive or occult
invasive carcinoma. The type of intervention should be
based on the geometry of the cervical lesion as well as
the clinical recommendations of the health care provider.
Consent
Minors undergoing a colposcopic examination may find
it helpful to have parental involvement for the proce-
dure. However, colposcopic examinations are considered
evaluation for sexually transmitted infections (STIs), and
minors generally are allowed to consent for diagnosis and
treatment of STIs. State laws should be addressed when
making a decision about obtaining parental consent (18).
COMMITTEE OPINIONS
Consent for the examination should be obtained from the
minor or parent or both, if needed. Colposcopy is likely
to generate a bill, which can compromise confidential-
ity. This issue should be discussed with the adolescent
and parental involvement should be encouraged, even if
parental consent is not legally required.
Pregnancy and Screening for Sexually
Transmitted Infections
Having a non-HIV STI diagnosis is not an indication
for earlier cervical cancer screening. Because of high
rates of STIs in adolescents, screening and treatment
for Chlamydia trachomatis and Neisseria gonorrhoeae
before any cervical treatment, if appropriate, is strongly
recommended (19). Pregnancy in adolescents does not
alter screening guidelines. The management of cervical
cytologic abnormalities in pregnant women is discussed
in Practice Bulletin No. 99 (20).
References
1. Moscicki AB, Hills N, Shiboski S, Powell K, Jay N, Hanson E,
et al. Risks for incident human papillomavirus infection
and low-grade squamous intraepithelial lesion develop-
ment in young females. JAMA 2001;285:2995–3002.
2. Winer RL, Lee SK, Hughes JP, Adam DE, Kiviat NB,
Koutsky LA. Genital human papillomavirus infection:
incidence and risk factors in a cohort of female university
students [published erratum appears in Am J Epidemiol
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3. Moscicki AB, Ellenberg JH, Vermund SH, Holland CA,
Darragh T, Crowley-Nowick PA, et al. Prevalence of and
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of infection with human immunodeficiency virus. Arch
Pediatr Adolesc Med 2000;154:127–34.
4. Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5:
Updating the natural history of HPV and anogenital cancer.
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5. Barnholtz-Sloan J, Patel N, Rollison D, Kortepeter K,
MacKinnon J, Giuliano A. Incidence trends of invasive
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6. Kaplan JE, Benson C, Holmes KH, Brooks JT, Pau A, Masur H.
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and Prevention (CDC); National Institutes of Health; HIV
Medicine Association of the Infectious Diseases Society
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CE1–4.
7. Wright TC Jr, Massad LS, Dunton CJ, Spitzer M, Wilkinson EJ,
Solomon D. 2006 Consensus Guidelines for the Management
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Genit Tract Dis 2007;11:201–22.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 35
 8. American Society for Colposcopy and Cervical Pathology.
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ASCCP; 2007. Available at: http://www.asccp.org/pdfs/con-
sensus/algorithms_cyto_07.pdf. Retrieved April 13, 2010.
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Management of women with a histological diagnosis of
cervical intraepithelial neoplasia grade 1 (CIN 1) preceded
by ASC-US, ASC-H or LSIL cytology. Hagerstown (MD):
ASCCP; 2007. Available at: http://www.asccp.org/pdfs/con-
sensus/algorithms_hist_07.pdf. Retrieved April 13, 2010.
10. Moscicki AB, Shiboski S, Hills NK, Powell KJ, Jay N,
Hanson EN, et al. Regression of low-grade squamous
intra-epithelial lesions in young women. Lancet 2004;364:
1678–83.
11. Sherman ME, Castle PE, Solomon D. Cervical cytology of
atypical squamous cells-cannot exclude high-grade squa-
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histologic outcomes. Cancer 2006;108:298–305.
12. Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J,
McCowan L. Treatment for cervical intraepithelial neopla-
sia and risk of preterm delivery. JAMA 2004;291:2100–6.
13. Nohr B, Tabor A, Frederiksen K, Kjaer SK. Loop electro-
surgical excision of the cervix and the subsequent risk of
preterm delivery. Acta Obstet Gynecol Scand 2007;86:
596–603.
14. Raab SS. Can glandular lesions be diagnosed in pap smear
cytology? Diagn Cytopathol 2000;23:127–33.
15. Walker JL, Wang SS, Schiffman M, Solomon D. Predicting
absolute risk of CIN3 during post-colposcopic follow-up:
results from the ASCUS-LSIL Triage Study (ALTS). ASCUS
LSIL Triage Study Group. Am J Obstet Gynecol 2006;195:
341–8.
16. Kyrgiou M, Tsoumpou I, Vrekoussis T, Martin-Hirsch P,
Arbyn M, Prendiville W, et al. The up-to-date evidence on
colposcopy practice and treatment of cervical intraepithe-
lial neoplasia: the Cochrane colposcopy & cervical cytopa-
thology collaborative group (C5 group) approach. Cancer
Treat Rev 2006;32:516–23.
17. Pearson SE, Whittaker J, Ireland D, Monaghan JM. Inva-
sive cancer of the cervix after laser treatment. Br J Obstet
Gynaecol 1989;96:486–8.
18. English A, Kenney KE. State minor consent laws: a sum-
mary. 2nd ed. Chapel Hill (NC): Center for Adolescent
Health and the Law; 2003.
19. Harel Z, Riggs S. On the need to screen for Chlamydia and
gonorrhea infections prior to colposcopy in adolescents. J
Adolesc Health 1997;21:87–90.
20. Management of abnormal cervical cytology and histol-
ogy. ACOG Practice Bulletin No. 99. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2008;
112:1419–44.

Copyright August 2010 by the American College of Obstetricians and

Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Cervical cancer in adolescents: screening, evaluation, and manage-
ment. Committee Opinion No. 463. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2010;116:469–72.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 36

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 467 • September 2010 (Replaces No. 344, September 2006)

Committee on Adolescent Health Care

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Human Papillomavirus Vaccination

ABSTRACT: The U.S. Food and Drug Administration has approved both a bivalent and quadrivalent human
papillomavirus (HPV) vaccine. The Advisory Committee on Immunization Practices has recommended that HPV
vaccination routinely be given to girls when they are 11 years or 12 years old. The vaccine can be given to indi-
viduals as young as 9 years; catch-up vaccination is recommended in females aged 13 years through 26 years.
The American College of Obstetricians and Gynecologists endorses these recommendations. Although obstetri-
cian–gynecologists are not likely to care for many girls in the initial vaccination target group, they are critical to the
catch-up vaccination period. Both HPV vaccines are most effective if given before any exposure to HPV infection
(ie, before sexual activity). However, sexually active girls and women can receive some benefit from the vaccina-
tion because exposure to all HPV types prevented by the vaccines is unlikely in females aged 13 years through
26 years. Vaccination with either HPV vaccine is not recommended for pregnant women. It can be provided to
women who are breastfeeding. The need for booster vaccination has not been established but appears unneces-
sary. Health care providers are encouraged to discuss with their patients the benefits and limitations of the HPV
vaccine and the need for routine cervical cytology screening for those aged 21 years and older.

The relationship between infection with human papil-
lomavirus (HPV) and both cervical cancer and genital
warts has been recognized for many years (1). More than
100 genotypes of HPV have been discovered to date with
approximately 30 found in the genital mucosa. However,
only 15 have been shown to be associated with cervical
cancer. Approximately 70% of all cases of cervical cancer
are associated with HPV genotypes 16 and 18, and 90% of
cases of genital warts are associated with HPV genotypes
6 and 11 (2). Although the implementation of cervical
cytology screening programs and treatment of precancer-
ous lesions has led to a decrease in deaths from cervi-
cal cancer in the United States, such deaths still occur.
Approximately one half of all cases of cervical cancer
are found in women who have never had a Pap test, and
another 10% have not had one within the past 5 years (3).
Both ongoing cervical cytology screening and HPV vac-
cination are needed to help eliminate these deaths.
The U.S. Food and Drug Administration (FDA) has
licensed two vaccines shown to be effective at prevent-
ing HPV infection. The quadrivalent HPV vaccine offers
protection against cervical cancer, cervical dysplasias,
vulvar or vaginal dysplasias, and genital warts associated
with HPV genotypes 6, 11, 16, and 18 (4). The FDA has
approved administration of this three-dose vaccine to
females aged 9 years through 26 years. The bivalent HPV
vaccine recently obtained FDA approval for protection
against cervical cancer and cervical dysplasia in females
aged 10 years through 25 years. Results of studies of this
bivalent vaccine indicate that it offers protection similar
to the quadrivalent vaccine against HPV infections caused
by genotypes 16 and 18 (5).
Studies of the quadrivalent HPV vaccine have shown
that in participants naive to the vaccine genotypes who
followed protocol, the vaccine was close to being 100%
effective in preventing cervical intraepithelial neopla-
sia (CIN) 2, CIN 3, and condylomatous vulvar disease
related to the HPV genotypes covered by the vaccine (4).
For a woman with HPV infection, there is no evidence
of protection from disease caused by the HPV genotypes
with which she is infected. There is, however, evidence
of protection from disease caused by the remaining HPV
vaccine genotypes (6). Results of the clinical trials of the
bivalent vaccine demonstrate similar protection against
CIN 2 and CIN 3 in women who are naive to the vaccine’s
genotypes (7). The bivalent vaccine does not protect
against lower genital tract condyloma caused by low-risk
HPV types 6 and 11.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 37

 To be maximally effective against all HPV geno-
types included in either vaccine, vaccination should be
given before the onset of sexual activity. If the vaccine is
given after the onset of sexual activity, patients may have
already been infected with HPV. The need for booster
doses remains to be demonstrated but is unlikely (7). To
date, protection has been shown to last at least 5 years for
the quadrivalent vaccine (4) and more than 6 years for the
bivalent vaccine (7).
Recommendations
Vaccination of Girls, Adolescents, and Young
Women
The Advisory Committee on Immunization Practices
has recommended the initial HPV vaccination target
of females aged 11 years or 12 years. Depending on the
circumstances, the vaccine can be given to individuals
as young as age 9 years and catch-up is recommended in
females aged 13 years through 26 years (2). The American
College of Obstetricians and Gynecologists (the College)
endorses these recommendations. Obstetrician–gyne-
cologists are encouraged to discuss HPV and the potential
benefit of the HPV vaccine and to offer vaccination to
those females aged 13 years through 26 years who have
not already received it or completed the series (see box).
During a health care visit with a girl or woman in the
age range for vaccination, a health care provider should
assess the patient’s HPV vaccine status and document this
information in the patient’s record.
Human Papillomavirus Testing
Testing for HPV DNA is currently not recommended for
adolescents or adults before vaccination. Serologic assays
for HPV are unreliable and currently not commercially
available. If the patient is tested and the results are posi-
tive, vaccination is still recommended because the chance
that all vaccine preventable types are present is low.
Vaccination of Sexually Active Adolescents and
Young Women
Sexually active adolescents and young women can receive
either the quadrivalent or bivalent HPV vaccine. These
patients should be counseled that the vaccine may be less
effective in individuals who have been exposed to HPV
before vaccination than in individuals who were HPV
naive at the time of vaccination (4, 5). The need for ongo-
ing cervical cytology screening should be emphasized in
all women aged 21 years and older, even those vaccinated
before the onset of sexual activity.
Vaccination of Adolescents and Young
Women With Previous Cervical Intraepithelial
Neoplasia or Genital Warts
The HPV vaccines can be given to patients with previous
CIN or genital warts, but health care providers need to
emphasize that the benefits may be limited, and cervi-
COMMITTEE OPINIONS
cal cytology screening and corresponding management
based on the College recommendations must continue.
Vaccination Is Not Treatment
The HPV vaccines are not intended to treat patients with a
positive DNA test result, cervical cytologic abnormalities,
or genital warts. Patients with these conditions should
undergo the appropriate evaluation and treatment (8, 9).
Vaccination of Pregnant and Lactating Women
Both the quadrivalent and bivalent HPV vaccines have
been classified by the FDA as pregnancy category B.
Although HPV vaccination in pregnancy is not recom-
mended, routine pregnancy testing before vaccination
is not recommended. In clinical studies, the proportion
of pregnancies with adverse outcomes was comparable
in women who received the HPV vaccine and in women
who received a placebo (10, 11). However, it is wise to
remind patients to use contraception during the period
of time when they are receiving the vaccination series.
The manufacturer’s pregnancy registry (see box) should
be contacted if pregnancy is detected during the vac-
cination schedule. Completion of the series should be
delayed until pregnancy is completed. Lactating women
can receive either HPV vaccine because inactivated vac-
cines, such as these vaccines, do not affect the safety of
breastfeeding for mothers or infants (12).
Vaccination of Immunosuppressed Patients
The presence of immunosuppression, like that experi-
enced in patients with HIV infection or organ transplan-
tation, is not a contraindication to HPV vaccination.
However, the immune response may be less robust in the
immunocompromised patient.
Vaccination of Women Older Than
26 Years and Males
Research regarding vaccination of women older than 26
years is currently under way. Data available are insuf-
ficient to make recommendations for these women. The
FDA has approved the quadrivalent vaccine for boys and
men aged 9 years through 26 years for the prevention of
genital warts.
Educational Efforts
It is important for health care providers to provide
patient education about HPV-related disease and be pre-
pared to respond to questions from patients regarding the
HPV vaccine, its benefits, and its limitations as discussed
earlier. Studies have shown that physicians’ recommen-
dations play a crucial role in the acceptance of the vaccine
by patients (13).
Consent for Human Papillomavirus Vaccination
In all states, minors are allowed to consent for diag-
nosis and treatment of sexually transmitted infections.
However, many of the laws that authorize them to pro-
vide such consent may only permit it after they have
2013 COMPENDIUM OF SELECTED PUBLICATIONS 38
 Key Information Regarding the Bivalent and
Quadrivalent Human Papillomavirus Vaccines*
Dosage Precautions
Administered intramuscularly as three separate 0.5-mL As with any vaccine, vaccination may not protect all vac-
doses based on the following schedule: cine recipients. Neither vaccine is intended to be used
1. First dose: at elected date for treatment of active disease (ie, genital warts, cervical
2. Second dose: 1–2 months after the first dose cancer, cervical intraepithelial neoplasia, vulvar intraepithe-
3. Third dose: 6 months after the first dose lial neoplasia, or vaginal intraepithelial neoplasia). Human
papillomavirus vaccines can be administered simultaneously
Minimum interval between first and second dose is 4 weeks, or at any time before or after a different inactivated or live
between second and third dose is 12 weeks, and between first vaccine administration. Because vaccinated individuals may
and third dose is 24 weeks. If vaccine schedule is interrupted, develop syncope, sometimes resulting in falling with injury,
the series does not need to be restarted, regardless of the
health care providers should consider observing patients for
length of time between doses. Whenever possible, the same
15 minutes after vaccine administration.
vaccine product should be used for all doses in the series.
Recommended Age Storage
• Target population: females aged 11 years or 12 years Both formulations should be refrigerated at 2–8°C (36–46°F),
(can be started as early as age 9 years) should not be frozen, and should be protected from light.

• Catch-up vaccination: females aged 13 years through 26
years
Contraindications
Individuals who develop symptoms indicative of hypersensi-
tivity to the active substances or to any of the components of
either vaccine after receiving a dose of vaccine should not
receive further doses of the product. Safety and effective-
ness of the two formulations have not been established in
pregnant women. The manufacturers maintain pregnancy
registries to monitor fetal outcomes of pregnant women
exposed to the vaccine. Any exposure to it during pregnancy
can be reported by calling 800-986-8999 for the quadrivalent
vaccine and 888-452-9622 for the bivalent vaccine.
Vaccine Adverse Event Reporting
To report an adverse event associated with administration,
go to http://vaers.hhs.gov.
Advisory Committee on Immunization Practices
Recommendations
For current recommendations by the Advisory Committee on
Immunization Practices, go to http://www.cdc.gov/vaccines/
recs/acip/default.htm.
Current Procedural Terminology Code†
The American Medical Association has established a Current
Procedural Terminology code of 90649 for quadrivalent HPV
vaccination and 90650 for bivalent HPV vaccine.

*Note that the U. S. Food and Drug Administration labeling for the bivalent vaccine indicates it is for use in females aged 10 years through
25 years. In addition, the U. S. Food and Drug Administration approved dosage intervals for the quadrivalent and bivalent vaccines to be
0 months, 2 months, and 6 months and 0 months, 1 month, and 6 months, respectively.
†
Current Procedural Terminology (CPT) copyright 2009 American Medical Association. All rights reserved. CPT is a registered trademark of
the American Medical Association.

reached a specific age. Furthermore, these laws do not
mention vaccinations (14). Clinicians should be familiar
with state and local statutes regarding the rights of minors
to health care services and the federal and state laws that
affect confidentiality.
References
1. Human papillomavirus. ACOG Practice Bulletin No. 61.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;105:905–18.
2. FDA licensure of bivalent human papillomavirus vaccine
(HPV2, Cervarix) for use in females and updated HPV vac-
cination recommendations from the Advisory Committee
on Immunization Practices (ACIP). Centers for Disease
Control and Prevention. MMWR Morb Mortal Wkly Rep
2010;59:626–9.
3. Cervical Cancer. NIH Consens Statement 1996 April 1-3;
14(1):1–38. Available at http://consensus.nih.gov/1996/199
6CervicalCancer102html.htm. Retrieved May 10, 2010.
4. Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez–
Avila M, Wheeler CM, et al. Impact of human papillomavirus
(HPV)-6/11/16/18 vaccine on all HPV-associated genital dis-
eases in young women. J Natl Cancer Inst 2010;102:325–39.
5. Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN,
Apter D, et al. Efficacy of human papillomavirus (HPV)-
16/18 AS04-adjuvanted vaccine against cervical infection
and precancer caused by oncogenic HPV types (PATRICIA):
final analysis of a double-blind, randomised study in young
women. HPV PATRICIA Study Group. Lancet 2009;374:
301–14.
6. Prophylactic efficacy of a quadrivalent human papilloma-
virus (HPV) vaccine in women with virological evidence
of HPV infection. FUTURE II Study Group. J Infect Dis
2007;196:1438–46.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 39

 7. GlaxoSmithKline Vaccine HPV‑007 Study Group,
Romanowski B, de Borba PC, Naud PS, Roteli‑Martins CM,
et al. Sustained efficacy and immunogenicity of the human
papillomavirus (HPV)‑16/18 AS04‑adjuvanted vaccine:
analysis of a randomised placebo‑controlled trial up to 6.4
years. Lancet 2009;374:1975–85.
8. Cervical cancer in adolescents: screening, evaluation, and
management. Committee Opinion No. 463. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2010:116:469–72.
9. Management of abnormal cervical cytology and histol-
ogy. ACOG Practice Bulletin No. 99. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2008;
112:1419–44.
10. Merck & Co., Inc. Gardasil: highlights of prescribing infor-
mation. Whitehouse Station (NJ): Merck; 2009. Available
at: http://www.merck.com/product/usa/pi_circulars/g/
gardasil/gardasil_pi.pdf. Retrieved May 5, 2010.
11. GlaxoSmithKline. Cervarix: highlights of prescribing infor-
mation. Research Triangle Park (NC): GSK; 2009. Avail-
able at: http://us.gsk.com/products/assets/us_cervarix.pdf.
Retrieved May 10, 2010.
12. Atkinson WL, Pickering LK, Schwartz B, Weniger BG,
Iskander JK, Watson JC. General recommendations on
immunization. Recommendations of the Advisory Com-
mittee on Immunization Practices (ACIP) and the American
Academy of Family Physicians (AAFP). Centers for Disease
Control and Prevention. MMWR Recomm Rep 2002;
51(RR-2):1–35.
13. Zimet GD, Mays RM, Winston Y, Kee R, Dickes J, Su L.
Acceptability of human papillomavirus immunization.
J Womens Health Gend Based Med 2000;9:47–50.
14. English A, Kenney KE. State minor consent laws: a sum-
mary. 2nd ed. Chapel Hill (NC): Center for Adolescent
Health and the Law; 2003.
Resources
College Resources
American College of Obstetricians and Gynecologists. Cómo
prevenir las enfermedades de transmisión sexual [Spanish].
ACOG Patient Education Pamphlet SP009. Washington, DC:
ACOG; 2008.
American College of Obstetricians and Gynecologists. How to
prevent sexually transmitted diseases. ACOG Patient Educa-
tion Pamphlet AP009. Washington, DC: ACOG; 2008.
American College of Obstetricians and Gynecologists. Human
papillomavirus. In: Tool kit for teen care. 2nd ed. Washington,
DC: ACOG; 2009.
American College of Obstetricians and Gynecologists. Human
papillomavirus infection. ACOG Patient Education Pamphlet
AP073. Washington, DC: ACOG; 2006.
American College of Obstetricians and Gynecologists. Infección
por el papilomavirus humano [Spanish]. ACOG Patient Educa-
tion Pamphlet SP073. Washington, DC: ACOG; 2006.
Cervical cytology screening. ACOG Practice Bulletin No. 109.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;114:1409–20.
COMMITTEE OPINIONS
Human papillomavirus. ACOG Practice Bulletin No. 61.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;105:905–18.
Other Resources
The following list of organizations with information about
HPV infection or HPV vaccination is for information purposes
only. Referral to these sources and web sites does not imply the
endorsement of the College. This list is not meant to be compre-
hensive. The exclusion of a source or web site does not reflect
the quality of that source or web site. Please note that web sites
are subject to change without notice. Furthermore, the College
does not endorse any commercial products that may be adver-
tised or available from these organizations or on these web sites.
American Cancer Society
(800) ACS-2345
http://www.cancer.org
The American Social Health Association
(919) 361-8400
(919) 361-8488 (Sexually Transmitted Infection Resource
Center Hotline)
http://www.ashastd.org
http://www.iwannaknow.org
American Society for Colposcopy and Cervical Pathology
(301) 733-3640
(800) 787-7227
http://www.asccp.org
Center for Young Women’s Health
(617) 355-2994
http://www.youngwomenshealth.org
Centers for Disease Control and Prevention
(800) 232-4636
http://www.cdc.gov
Planned Parenthood
(800) 230-PLAN
http://www.plannedparenthood.org
Society for Adolescent Health and Medicine
(847) 753-5226
http://www.adolescenthealth.org
U.S. Food and Drug Administration
(888) 463-6332
http://www.fda.gov
Copyright September 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Human papillomavirus vaccination. Committee Opinion No. 467.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2010;116:800–3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 40
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 506 • September 2011
Committee on Adolescent Health Care
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Expedited Partner Therapy in the Management of

Gonorrhea and Chlamydia by Obstetrician–Gynecologists
ABSTRACT: Expedited partner therapy is the clinical practice of treating the sex partners of patients, in
whom sexually transmitted infections are diagnosed, by providing prescriptions or medications to the patient to
take to his or her partner(s) without the health care provider first examining the partner(s). The American College
of Obstetricians and Gynecologists supports expedited partner therapy in the management of gonorrhea and chla-
mydial infections when the partner is unlikely or unable to otherwise receive in-person evaluation and appropriate
treatment. The legality of expedited partner therapy is ambiguous in some states and overt legal impediments
exist in others; analysis suggests that the practice is permissible in 27 states. Clinicians practicing in states where
expedited partner therapy is legal should use it for eligible patients. In states, territories, and other jurisdictions
where expedited partner therapy is not legal or the legal status of expedited partner therapy is unclear or ambigu-
ous, clinicians are encouraged to advocate for its legality and implementation and work with their health depart-
ments to develop protocols for the use of expedited partner therapy. All health care providers should advocate for
greater availability of sexually transmitted infection services.

Background Evidence indicates that expedited partner therapy

Sexually transmitted infections (STIs) disproportionately
affect women and create a preventable threat to their fer-
tility. In the United States, adolescent girls and young
women aged 15–24 years consistently have the highest
number of cases of gonorrhea and chlamydial infections
(1). One of the contributing factors to these high rates is
reinfection from an untreated sexual partner. Studies in
adolescent girls and young women have demonstrated
rates of reinfection of 14–26% within 12 months of an
initial chlamydial infection (2–6). Increased risk of rein-
fection was associated with a younger age at the time of
infection and an untreated partner. Expedited partner
therapy has been advocated as one approach to address
this issue. This practice involves treating the sex partners
of patients, in whom STIs are diagnosed, by providing
prescriptions or medications to the patient to take to his
or her partner(s) without the health care provider first
examining the partner(s) ie, patient-delivered partner
therapy (7, 8).
can decrease reinfection rates compared with standard
partner referrals for examination and treatment (7, 9).
This approach is associated with desirable clinical and
behavioral outcomes when used to treat gonorrhea,
chlamydial infection, or both in heterosexual men and
women. To date, there is insufficient evidence about
the effectiveness of expedited partner therapy for same-
sex partners or for the treatment of trichomoniasis or
syphilis (7).
Consistent with the endorsement of other organiza-
tions such as the American Medical Association (AMA)
(10), Society for Adolescent Health and Medicine (11),
American Academy of Pediatrics (11), and American
Bar Association (ABA) (12), the American College of
Obstetricians and Gynecologists (the College) supports
the implementation of expedited partner therapy as out-
lined in the Centers for Disease Control and Prevention
(CDC) recommendations (7). Expedited partner therapy
should be used for the treatment of gonorrhea and chla-
mydial infections in heterosexual partners when they are

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 41

 unlikely or unable to otherwise receive in-person evalua-
tion and appropriate treatment.
Barriers to Routine Use of Expedited
Partner Therapy
Despite the effectiveness of expedited partner therapy,
numerous legal, medical, practical, and administra-
tive barriers hinder its routine use by obstetrician–
gynecologists. Analysis suggests that as of November 2,
2010, expedited partner therapy is permitted in 27 states
and one city, potentially permitted in 15 states, and
prohibited in 8 states (13, 14) (See Table 1). The CDC
maintains a web site (http://www.cdc.gov/std/EPT) with
information about the legal status of expedited partner
therapy in all 50 states and other jurisdictions (14).
Different legal provisions in the states—statutes, regula-
tions, judicial decisions, and administrative opinions—
affect the use of expedited partner therapy by clinicians.
In many states, legal provisions are ambiguous. In some
states, regulations by medical or pharmacy boards pro-
hibit health care providers from prescribing medicine
and pharmacists from dispensing medicine to patients
that the clinician has not evaluated. In other states, medi-
cal licensing laws may be a barrier to expedited partner
therapy. A statute that expressly permits expedited part-
ner therapy is preferable in all jurisdictions. Obstetrician–

Table 1. Legal Status of Expedited Partner Therapy in All 50 states and Other Jurisdictions*†
Expedited Partner Therapy Expedited Partner Therapy Expedited Partner Therapy
is Permissible is Potentially Allowable† is Prohibited

Alaska Alabama Arkansas

Arizona Connecticut Florida
California Delaware Kentucky
Colorado District of Columbia Michigan
Illinois Georgia Ohio
Iowa Hawaii Oklahoma
Louisiana Idaho South Carolina
Maine Indiana West Virginia
Minnesota Kansas
Mississippi Maryland‡
Missouri Massachusetts
Nevada Montana
New Hampshire Nebraska
New Mexico New Jersey
New York Puerto Rico
North Carolina South Dakota
North Dakota Virginia
Oregon
Pennsylvania
Rhode Island
Tennessee
Texas
Utah
Vermont
Washington
Wisconsin
Wyoming

*The information presented here is not legal advice, nor is it a comprehensive analysis of all the legal provisions that could impli-
cate the legality of expedited partner therapy in a given jurisdiction. It represents information from the Centers for Disease Control
and Prevention web site as of June 23, 2011. For updates, go to http://www.cdc.gov/std/EPT/legal.
†
No information is currently available about the legal status of expedited partner therapy in American Samoa, Guam,
Commonwealth of the Northern Mariana Islands, Republic of Palau, Marshall Islands, Federal States of Micronesia, or Virgin Islands.
Exception: Expedited partner therapy is permissible in Baltimore, Maryland.
‡

2 Committee Opinion No. 506

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 42

 gynecologists should rely on state or local legal counsel to
determine whether they are allowed to practice expedited
partner therapy in their locales.
In addition to legal barriers, reluctance to implement
expedited partner therapy is related to concerns that by
providing treatment without prior examination of the
partner, the opportunity to detect human immunodefi-
ciency virus (HIV) or other sexually transmitted coinfec-
tions may be missed, as well as concerns about adverse
effects of antibiotics in expedited partner therapy recipi-
ents (7). The CDC and several state health departments
have issued guidelines for practicing expedited partner
therapy (7, 15–20). These guidelines and endorsements
from professional organizations such as the College,
AMA, Society for Adolescent Health and Medicine, ABA,
and the American Academy of Pediatrics are important
elements in establishing a standard of care, which is the
primary medical–legal standard for appropriate practice.
Ideally, the partners of patients in whom gonorrhea, chla-
mydial infection, or both are diagnosed should receive a
complete in-person clinical evaluation before prescribing
antibiotics for treatment of those infections. If the part-
ner is unlikely or unable to otherwise receive in-person
evaluation and expedited partner therapy is provided, the
partner should be encouraged to seek medical evaluation,
which can help prevent underdiagnosis, undertreatment,
and subsequent development of STI sequelae (7).
Some obstetrician–gynecologists may be concerned
about medical–legal ramifications in the event of adverse
outcomes in the recipients of expedited partner therapy.
Evidence suggests that the benefits of expedited partner
therapy in preventing gonorrhea and chlamydial reinfec-
tions in individuals whose partners are otherwise unable
or unlikely to seek care outweigh the risks that may
include adverse effects of antibiotics, development of
antibiotic resistance due to poor treatment adherence, or
missed care opportunities (7). The risk of serious adverse
reactions after recommended antibiotic treatment of
gonorrhea or chlamydial infection is relatively low (8,
21–23), and can be further minimized by accompanying
expedited partner therapy with clear written instruc-
tions and printed information on contraindications and
sources of care in case of adverse reactions (7). The
instructions should explain the need for the medication,
how to take the medication, and encourage the partner to
seek clinical evaluation as soon as possible. In expedited
partner therapy programs that monitor adverse events,
no drug-related adverse events or lawsuits arising from
expedited partner therapy have been documented (11).
State immunity can protect physicians using this therapy.
Laws permitting expedited partner therapy passed from
2008 to 2010 in some states (Illinois, Maine, Missouri,
New York, Rhode Island, Utah, and Wisconsin) protect
clinicians from civil liability.
Other challenges of expedited partner therapy
implementation may include the lack of billing codes
for reimbursement for the health care provider’s time;
Committee Opinion No. 506
COMMITTEE OPINIONS
documentation issues for dispensing treatment for non-
index patients; concerns regarding patient confidential-
ity; and compliance with reporting requirements (7,
11). These practical and administrative barriers can be
addressed by the development of model protocols, rec-
ommendations, hospital procedures, and algorithms.
Additional barriers to using expedited partner ther-
apy with minors involve consent to treatment issues for
the male partner if also a minor. Although all 50 states
and the District of Columbia allow minors to consent
to STI testing and treatment, 11 states require a minor
to be of a certain age before being allowed to consent
(24). Other barriers may include the legal requirement
for reporting sexual activity or statutory rape. Every state
has laws that specify when sexual activity with a minor is
illegal. Most states use age parameters in defining whether
sexual intercourse with a minor is illegal under the state’s
criminal code; these laws often are referred to as statutory
rape laws. The state child abuse reporting laws vary widely
in terms of whether or not they require reporting sexual
activity of a minor—or statutory rape—as child abuse
(25). Cases in which the health care provider is required
to obtain the name and age of a partner in order to pre-
scribe or dispense expedited partner therapy may result
in the need for mandatory reporting of sexual activity, if
statutory rape is identified. This could have the unintended
consequence of reducing the likelihood an adolescent will
gain access to care and receive appropriate treatment.
Clinicians must be compliant with the reporting require-
ments of their states, which could involve balancing the
protection of adolescents from predatory sexual behavior
against issues of STI reduction and access to care (11).
Expedited partner therapy is not intended for cases of
suspected child abuse, sexual assault or abuse, or in situa-
tions where there is a question of the patient’s safety.
Implementation
In jurisdictions where expedited partner therapy is legally
permitted, the American College of Obstetricians and
Gynecologists recommends the following principles of
expedited partner therapy implementation in an obstet-
rics and gynecology practice:
• Heterosexual partners of female patients in the
previous 2 months (or, if no partners in that time
frame, the last partner) who are unable or unlikely to
personally access medical services should be offered
expedited partner therapy. Providing guidance on
how the patient can inform her partner(s) about the
infection can be helpful.
• Centers for Disease Control and Prevention treat-
ment guidelines (8), local and state guidelines, or
both should be used when choosing which medica-
tions are permissible and recommended for use.
• Expedited partner therapy should be accompanied
by counseling of the index patient. She should be
provided with written treatment instructions to give
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 43
 to her partner. The specific language for the instruc- legally permitted or the legal status of expedited partner
tions may be regulated by statute. The instructions therapy is ambiguous, the College encourages members
should explain the need for the medication, how to to advocate for legalization and work with their health
take the medication, and encourage the partner to departments to develop protocols for the use of expedited
seek clinical evaluation as soon as possible. When partner therapy. This involves active collaboration with
feasible and legally permissible, health care providers stakeholders (other health care providers, the state STI
may attempt to contact the partner(s) of the index director, pharmacy and medical boards, and state medi-
patient to discuss the diagnosis, prescription of expe- cal societies). An opinion or other ruling from the state
dited partner therapy, and any symptoms of STIs. medical and pharmacy boards indicating that expedited
• Depending on state laws and regulations, the health partner therapy is not unprofessional conduct may be
care provider can give medication to index patients easier to accomplish than passing a new statute. However,
to take to their partners or the health care provider a discrete statute expressly permitting expedited partner
can write a prescription for the partner. therapy is the strongest legal authority.
• Partners receiving expedited partner therapy should There is also a need to evaluate the process and out-
be encouraged to seek additional medical evaluation comes of expedited partner therapy implementation and
as soon as possible to discuss screening for other STIs disseminate best practices. The health care providers who
and HIV infection. practice expedited partner therapy and researchers are
encouraged to document their findings and report imple-
• Patients should be instructed to abstain from sexual mentation of their programs at conferences, scientific
intercourse until they and their sexual partner(s) have meetings, and in peer-reviewed publications. Physicians
completed treatment. Abstinence should be contin- reporting their experiences to the members of their local
ued until 7 days after a single-dose regimen or after and regional organizations and other health care provider
completion of a 7-day regimen. groups, as well as sharing model protocols, may help to
• A mechanism should be in place for patients to expand implementation of expedited partner therapy
report adverse events. among health care providers. In addition to advocating
for expedited partner therapy in states, territories, and
Documentation other jurisdictions where it is not yet legally permitted or
In most states, health care providers are legally required the legal status is ambiguous, health care providers also
to maintain medical records for all patients for whom should advocate for greater availability of STI services
they prescribe medication (11). Protocols for expedited to ensure that appropriate treatment is available to the
partner therapy documentation vary by state and may partners of their patients.
establish a medical record process for physicians to docu-
ment treatment of partners who have never been exam- Conclusions
ined in their offices. Some of the examples of expedited The American College of Obstetricians and Gynecologists
partner therapy documentation from published proto- supports the use of expedited partner therapy in accor-
cols from selected states include the following: dance with CDC guidelines as a method for preventing
• Documenting in the index patient’s chart the num- reinfection of patients with gonorrhea and chlamydia
ber of partners provided expedited partner therapy, when their partners are unable or unwilling to otherwise
the medication prescribed and dosage, and any seek medical care. Members practicing in states where
known medication allergies that apply to the partner expedited partner therapy is legal should use expedited
(15, 16, 18, 20). partner therapy for eligible patients and encourage all
partners treated with expedited partner therapy to seek
• Not creating a separate medical record for the clinical evaluation as soon as possible. Clinicians prac-
partner nor listing the partner’s name in the index
ticing in states, territories, or other jurisdictions where
patient’s chart (15, 18, 20).
expedited partner therapy is not legal or where the legal
• Reporting partners as part of the mandated STI status of expedited partner therapy is ambiguous, should
reporting systems rather than naming partners in advocate for laws permitting expedited partner therapy
the index patients’ medical record, thereby putting and work with their health departments to develop pro-
potential contact tracing in the arena of the public tocols for the use of expedited partner therapy. All health
health system (15, 18). care providers should advocate for greater availability of
STI services.
Advocacy
Both the AMA House of Delegates (26) and the ABA References
House of Delegates (12) have passed resolutions urging 1. Centers for Disease Control and Prevention. Sexually trans-
the removal of legal barriers to implementing expe- mitted disease surveillance 2009. Atlanta (GA): CDC; 2010.
dited partner therapy nationally. In states, territories, Available at: http://www.cdc.gov/std/stats09/surv2009-
and jurisdictions where expedited partner therapy is not Complete.pdf. Retrieved April 28, 2011.

4 Committee Opinion No. 506

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 44

 2. Gaydos CA, Wright C, Wood BJ, Waterfield G, Hobson S,
Quinn TC. Chlamydia trachomatis reinfection rates among
female adolescents seeking rescreening in school-based
health centers. Sex Transm Dis 2008;35:233–7.
3. Whittington WL, Kent C, Kissinger P, Oh MK, Fortenberry JD,
Hillis SE, et al. Determinants of persistent and recur-
rent Chlamydia trachomatis infection in young women:
results of a multicenter cohort study. Sex Transm Dis
2001;28:117–23.
4. Burstein GR, Snyder MH, Conley D, Boekeloo BO, Quinn TC,
Zenilman JM. Adolescent chlamydia testing practices and
diagnosed infections in a large managed care organization.
Sex Transm Dis 2001;28:477–83.
5. Orr DP, Langefeld CD, Katz BP, Caine VA. Behavioral
intervention to increase condom use among high-risk
female adolescents. J Pediatr 1996;128:288–95.
6. Burstein GR, Zenilman JM, Gaydos CA, Diener-West M,
Howell MR, Brathwaite W, et al. Predictors of repeat
Chlamydia trachomatis infections diagnosed by DNA
amplification testing among inner city females. Sex Transm
Infect 2001;77:26–32.
7. Centers for Disease Control and Prevention. Expedited
partner therapy in the management of sexually transmitted
diseases: review and guidance. Atlanta (GA): CDC; 2006.
Available at: http://www.cdc.gov/std/treatment/eptfinal
report2006.pdf. Retrieved April 28, 2011.
8. Workowski KA, Berman S. Sexually transmitted diseases
treatment guidelines, 2010. Centers for Disease Control and
Prevention (CDC) [published erratum appears in MMWR
Morb Mortal Wkly Rep 2011;60:18]. MMWR Recomm
Rep 2010(RR-12);59:1–110. Available at: http://www.
cdc.gov/std/treatment/2010/default.htm. Retrieved May 10,
2011.
9. Trelle S, Shang A, Nartey L, Cassell JA, Low N. Improved
effectiveness of partner notification for patients with
sexually transmitted infections: systematic review. BMJ
2007;334:354.
10. American Medical Association. Expedited partner therapy
(patient-delivered partner therapy): an update. Report 7 of
the Council on Science and Public Health (A-06). Chicago
(IL): AMA; 2006. Available at: http://www.ama-assn.org/
ama/no-index/about-ama/16410.page. Retrieved April 28,
2011.
11. Burstein GR, Eliscu A, Ford K, Hogben M, Chaffee T,
Straub D, et al. Expedited partner therapy for adolescents
diagnosed with chlamydia or gonorrhea: a position paper
of the Society for Adolescent Medicine. J Adolesc Health
2009;45:303–9.
12. American Bar Association. Recommendation No. 116A.
Adopted by the House of Delegates August 11-12, 2008.
Chicago (IL): ABA; 2008. Available at: http://www2.ameri
canbar.org/sdl/Documents/2008_AM_116A.pdf. Retrieved
May 10, 2011.
13. Hodge JG Jr, Pulver A, Hogben M, Bhattacharya D, Brown
EF. Expedited partner therapy for sexually transmitted
diseases: assessing the legal environment. Am J Public
Health 2008;98:238–43.
14. Centers for Disease Control and Prevention. Legal sta-
tus of expedited partner therapy (EPT). Available at:
Committee Opinion No. 506
COMMITTEE OPINIONS
http://www.cdc.gov/std/EPT/legal/default.htm. Retrieved
May 10, 2011.
15. New Mexico Department of Health. New Mexico Depart-
ment of Health guidelines for expedited partner treatment
(EPT) of sexually transmitted diseases (STDs). Santa Fe
(NM): NMDOH; 2008. Available at: http://www.health.
state.nm.us/pdf/EPT%20Guidelinesfinal.pdf. Retrieved
May 10, 2011.
16. Washington State Department of Health. Background
and recommendations for incorporating patient delivered
partner therapy (PDPT) by health care providers. Olympia
(WA): DOH; 2004. Available at: http://www.doh.wa.gov/
cfh/std/docs/DOHPDPT04.pdf. Retrieved May 10, 2011.
17. California Department of Public Health, Sexually
Transmitted Diseases (STD) Control Branch. Patient-
delivered partner therapy for Chlamydia trachomatis and
Neisseria gonorrhoeae: guidance for medical providers in
California. Sacramento (CA): CDPH; 2007. Available at:
http://www.cdph.ca.gov/healthinfo/discond/documents/
chlamydia-pdpt-guidelines-ptnr-info.pdf. Retrieved May
10, 2011.
18. Minnesota Department of Health. Expedited partner ther-
apy (EPT) for Chlamydia trachomatis and Neisseria gonor-
rhoeae: guidance for medical providers in Minnesota. St.
Paul (MN): MDH; 2008. Available at: http://www.health.
state.mn.us/divs/idepc/dtopics/stds/ept/EPTGuidance.pdf.
Retrieved May 10, 2011.
19. Illinois Department of Public Health, Sexually Transmitted
Diseases Section. Expedited partner therapy for Chlamydia
trachomatis and Neisseria gonorrhoeae: guidance for health
care professionals in Illinois. Springfield (IL): IDPH; 2010.
Available at: http://www.idph.state.il.us/health/std/Illinois_
EPT_Guidelines172010.pdf. Retrieved May 10, 2011.
20. Texas Department of State Health Services. Guidance for
patient-delivered partner therapy. Austin (TX): TDSHS;
2010. Available at: http://www.dshs.state.tx.us/hivstd/ept/
default.shtm. Retrieved May 10, 2011.
21. Centers for Disease Control and Prevention. Updated
recommended treatment regimens for gonococcal infec-
tions and associated conditions - United States, April
2007. Atlanta (GA): CDC; 2007. Available at: http://www.
cdc.gov/std/treatment/2006/GonUpdateApril2007.pdf.
Retrieved May 10, 2011.
22. Geisler WM. Management of uncomplicated Chlamydia
trachomatis infections in adolescents and adults: evidence
reviewed for the 2006 Centers for Disease Control and
Prevention sexually transmitted diseases treatment guide-
lines. Clin Infect Dis 2007;44(suppl 3):S77–83.
23. Newman LM, Moran JS, Workowski KA. Update on the
management of gonorrhea in adults in the United States.
Clin Infect Dis 2007;44(suppl 3):S84–101.
24. Guttmacher Institute. Minors’ access to STI services. State
policies in brief. New York (NY): GI; 201. Available at:
http://www.guttmacher.org/statecenter/spibs/spib_MASS.
pdf. Retrieved May 25, 2011.
25. Protecting adolescents: ensuring access to care and report-
ing sexual activity and abuse. Position paper of the American
Academy of Family Physicians, the American Academy of
Pediatrics, the American College of Obstetricians and
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 45
 Gynecologists, and the Society for Adolescent Medicine.
J Adolesc Health 2004;35:420–3.
26. American Medical Association. 928. Expedited partner
therapy. In: Proceedings of the 2007 Interim Meeting of the
AMA-HOD. Chicago (IL): AMA; 2007. Available at: http://
www.ama-assn.org/resources/doc/hod/i07resolutions.pdf.
Retrieved May 10, 2011.
6 Committee Opinion No. 506
COMMITTEE OPINIONS
Copyright September 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Expedited partner therapy in the management of gonorrhea
and chlamydia by obstetrician–gynecologists. Committee Opinion
No. 506. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;118:761–6.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 46
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

CommiTTee opinion
Number 539 • October 2012 (Replaces Committee Opinion No. 392, December 2007)
Committee on Adolescent Health Care
Long-Acting Reversible Contraception Working Group
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Adolescents and Long-Acting Reversible

Contraception: Implants and Intrauterine Devices
ABSTRACT: Long-acting reversible contraception (LARC)—intrauterine devices and the contraceptive
implant—are safe and appropriate contraceptive methods for most women and adolescents. The LARC methods
are top-tier contraceptives based on effectiveness, with pregnancy rates of less than 1% per year for perfect
use and typical use. These contraceptives have the highest rates of satisfaction and continuation of all reversible
contraceptives. Adolescents are at high risk of unintended pregnancy and may benefit from increased access to
LARC methods.

Sexual Behavior and Contraceptive depot medroxyprogesterone acetate (DMPA) injections,

Use Among American Adolescents
In the United States, 42% of adolescents aged 15–19 years
have had sexual intercourse (1). Although almost all sexu-
ally active adolescents report having used some method
of contraception during their lifetimes, they rarely select
the most effective methods. Adolescents most commonly
use contraceptive methods with relatively high typical use
failure rates such as condoms, withdrawal, or oral contra-
ceptive (OC) pills (1). Nonuse, inconsistent use, and use
of methods with high typical use failure rates are reflected
in the high rate of unintended adolescent pregnancies
in the United States. Eighty-two percent of adolescent
pregnancies are unplanned, accounting for one fifth of all
unintended pregnancies in the United States, a statistic
that indicates an unmet need for acceptable, reliable, and
effective contraceptive methods for adolescents (2).
Long-acting reversible contraception (LARC) meth-
ods are increasing in popularity with use increasing from
2.4% of all U.S. women using contraception in 2002 to
8.5% in 2009 (3). Approximately 4.5% of women aged
15–19 years who are currently using a method of con-
traception use LARC, with most using an IUD (3). The
etonogestrel single-rod contraceptive implant, approved
by the U.S. Food and Drug Administration in 2006, is
used by less than 1% of U.S. women using contraception
and 0.5% of those aged 15–19 years (4).
Short-acting contraceptive methods, including con-
doms, OCs, the contraceptive patch, the vaginal ring, and
are mainstays of adolescent contraceptive choices, but
these contraceptives have lower continuation rates and
higher pregnancy rates than LARC methods (5, 6). Of
1,387 females aged 15–24 years who initiated short-acting
hormonal methods, only 11% using the contraceptive
patch, 16% receiving DMPA injections, and approxi-
mately 30% using the vaginal ring and OCs were still
using the same method after 12 months (6). In a study
of 4,167 females aged 14–45 years that compared con-
tinuation rates for LARC and short-acting contraceptive
methods, the continuation rate for LARC was 86% at 12
months compared with 55% for short-acting contracep-
tive methods (7). In this study, continuation rates for the
levonorgestrel intrauterine system and the contraceptive
implant in women younger than 20 years were similar
to rates for older women at 85% and 80%, respectively,
at 1 year. Copper IUD continuation rates were slightly
lower for adolescents than for older women, but were still
72% at 1 year. In the same study population, unintended
pregnancy rates for short-acting contraceptives were 22
times higher than unintended pregnancy rates for LARC.
Women younger than 21 years using short-acting con-
traceptives had a risk of unintended pregnancy that was
two times the risk among older women using short-acting
contraceptives, but the risk was the same if they were
using LARC (8). Poor continuation coupled with higher
failure rates decrease the efficacy of short-acting contra-
ception in young women.

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COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 47
 Barriers to wide use of LARC methods by adolescents
include a lack of familiarity with or misperceptions about
the methods, the high cost, the lack of access, and health
care providers’ concerns about the safety of LARC use in
adolescents (9–11). A large study that removed cost and
other common barriers to LARC methods, and included
counseling on the full range of birth control options,
found that more than two thirds of females aged 14–20
years chose LARC methods (12).
Counseling, Consent, Confidentiality,
and Cost
Increasing adolescent access to LARC is a clinical and pub-
lic health opportunity for obstetrician–gynecologists.
With top-tier effectiveness, high rates of satisfaction and
continuation, and no need for daily adherence, LARC
methods should be first-line recommendations for all
women and adolescents (13). As with all nonbarrier meth-
ods, to decrease the risk of sexually transmitted infections
(STIs), including human immunodeficiency virus (HIV),
health care providers should advise sexually active ado-
lescents to consistently use condoms along with LARC
methods.
Like all women seeking reproductive health services,
adolescents have the right to decline the use of LARC as
well as the right to discontinue LARC without barriers.
Coercive insertion of long-acting contraception was used
in the past as a means of fertility control in marginalized
women (14). In the absence of contraindications, patient
choice should be the principal factor in prescribing one
method of contraception over another, and adolescents
have the right to decline any method of contraception.
Confidentiality is of particular importance to adoles-
cents. In many states, adolescents have the right to receive
confidential contraceptive services without parental con-
sent, and health care providers should be familiar with
laws concerning provision of contraception to minors
in their own states. Information regarding these laws
can be found at: http://www.guttmacher.org/statecenter/
adolescents.html.
High up-front costs for LARC methods can be a
deterrent to use. Adolescents who have insurance cover-
age through their parents may not want to use the benefit
because of confidentiality concerns; others may be unin-
sured or have insurance that excludes coverage for LARC
methods. In all of these cases, referral to a publicly funded
clinic may be appropriate. Proposed health care reform
provisions to cover all FDA-approved contraceptive
methods, including LARC methods, without copayments
or deductibles for these preventive health services, may
ease this burden.
Guidance for Adolescent Health
Care Providers to Address Common
Misconceptions
Health care providers’ concerns about LARC use by ado-
lescents are a barrier to access. Health care provider train-
COMMITTEE OPINIONS
ing and continuing education programs should address
common misconceptions and review the key evidence
and benefits of adolescent LARC use.
Intrauterine Devices
Intrauterine devices are safe to use among adolescents.
Current evidence demonstrates the safety of modern
IUDs. Although few studies have focused exclusively
on adolescents who use currently available IUDs, good
evidence suggests that the relative risk of pelvic inflam-
matory disease (PID) is increased only in the first 20
days after IUD insertion and then returns to baseline,
while the absolute risk remains small (15–17). Bacterial
contamination associated with the insertion process is
the likely cause of infection, not the IUD itself. The risk
of PID with IUD placement is 0–2% when no cervical
infection is present and 0–5% when insertion occurs with
an undetected infection (17). Women with positive chla-
mydia cultures after IUD insertion are unlikely to develop
PID, even with retention of the IUD, if the infection is
promptly treated (18, 19). The levonorgestrel intrauter-
ine system may lower the risk of PID by thickening cervi-
cal mucus and thinning the endometrium (20–22).
Intrauterine devices do not increase an adolescent’s risk of
infertility.
Infertility is not more likely after discontinuation of IUD
use than after discontinuation of other reversible meth-
ods of contraception (16). In a large case–control study
that examined determinants of tubal infertility, the pres-
ence of chlamydial antibodies, not previous IUD use, was
associated with infertility (23). Baseline fecundity returns
rapidly after IUD removal (24).
Intrauterine devices may be inserted without technical
difficulty in most adolescents and nulliparous women.
Little evidence suggests that IUD insertion is techni-
cally more difficult in adolescents compared with older
women. More than one half of young nulliparous women
report discomfort with IUD insertion (21). Anticipatory
guidance regarding pain and provision of analgesia dur-
ing IUD insertion should be individualized and may
include supportive care, nonsteroidal antiinflammatory
drugs (NSAIDs), narcotics, anxiolytics, or paracervical
blocks. The most effective method of pain control has
not yet been established (25). Use of buccal or vaginal
misoprostol 2–3 hours before IUD insertion to soften a
nulliparous cervix does not appear to reduce insertion
pain, and adverse effects are common (26–28).
Adolescents should be routinely screened for STIs (eg, gonor-
rhea and chlamydia) at the time of IUD insertion.
Women aged 15–19 years have the second highest rates of
chlamydia and the highest rates of gonorrhea of any age
group (29). Thus, all adolescents should be screened for
STIs at the time of or before IUD insertion. It is reason-
able to screen for STIs and place the IUD on the same day
(and administer treatment if the test results are positive)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 48
 or when the test results are available. If an STI is diag-
nosed after the IUD is in place, it may be treated without
removing the IUD (30–32). Routine antibiotic prophy-
laxis is not recommended before IUD insertion (33).
Intrauterine device expulsion is uncommon in adolescents.
Intrauterine device expulsion rates range from 3% to
5% for all IUD users and from 5% to 22% in adoles-
cents (34, 35). Young age, previous IUD expulsion, and
nulliparity may slightly increase the risk of expulsion,
but research on current IUDs is limited (34–36). Prior
expulsion should not be considered a contraindication
for another IUD provided that appropriate counseling
is given (36).
Intrauterine devices cause changes in bleeding patterns.
Adolescents using either copper IUDs or the levonor-
gestrel intrauterine system can expect changes in their
menstrual bleeding especially in the first months of use.
The copper IUD may cause heavier menses that can be
treated with NSAIDs. Women using the levonorgestrel
intrauterine system will have a decrease in bleeding over
time that will lead to light bleeding, spotting, or amenor-
rhea. Health care providers should counsel adolescents so
they understand that these changes are expected.
The Contraceptive Implant
The contraceptive implant causes changes in bleeding
patterns.
Adolescents who use the contraceptive implant can expect
changes in menstrual bleeding patterns throughout the
duration of use. In an analysis of 11 clinical trials, includ-
ing 942 etonogestrel implant users of all ages, the most
common bleeding pattern was infrequent bleeding in
33.3% of 90-day cycles, followed by amenorrhea in 21.4%
of cycles. Prolonged bleeding occurred in 16.9% of cycles
and frequent bleeding occurred in 6.1% of cycles (37).
A change in bleeding pattern is the most common rea-
son for implant discontinuation. Anticipatory guidance
regarding bleeding patterns may improve satisfaction and
continuation. The bleeding pattern women experience in
the first 3 months is broadly predictive of future bleeding
patterns (38).
Common strategies for treating problematic bleed-
ing include the use of short courses of combined OCs or
NSAIDs; however, there are no published placebo con-
trolled trials to support the use of these treatments (39).
Limited clinical trial data suggest that, compared with
placebo, mefenamic acid, mifepristone in combination
with ethinyl estradiol or doxycycline, and doxycycline
alone decrease the length of bleeding episodes in implant
users (40–42). More research is needed to determine
whether these or other interventions affect long-term
continuation or acceptability of the implant.
The contraceptive implant has secondary health benefits.
High rates of infrequent bleeding or amenorrhea lead to
higher hemoglobin levels in etonogestrel implant users
COMMITTEE OPINIONS
(43). Other noncontraceptive benefits of the contracep-
tive implant include reductions in dysmenorrhea and
pelvic pain (44, 45). A prospective study of etonogestrel
implant users showed no difference in the change in bone
mineral density compared with copper IUD users after
2 years of use (46).
The contraceptive implant has minimal or no effect on
weight.
Currently, no prospective studies of weight in etonogestrel
implant users have been published. A small percentage of
women (2.3%) in the clinical trials for the etonogestrel
implant discontinued use because of reported weight gain;
however, actual weight gain was not documented (37).
In contrast, DMPA injections are associated with weight
gain, with overweight adolescents more susceptible to
weight gain than normal weight adolescents (47).
Postpartum and Postabortal Long-
Acting Reversible Contraception
Initiation
Postpartum Long-Acting Reversible
Contraception
Adolescent mothers are at high risk of rapid repeat preg-
nancy; 20% give birth again within 2 years (48). Insertion
of an IUD or implant immediately postpartum ensures
reliable contraception for adolescents when they are
highly motivated to prevent pregnancy and are already
in the health care system. The benefits of postpartum
IUD insertion outweigh the risks, although recommen-
dations vary depending on the type of device and timing
of postpartum insertion (see Table 1) (31). Although the
risk of expulsion is higher for immediate insertion
compared with delayed insertion, if a delayed insertion
presents a significant barrier, immediate insertion should
be offered (49). Of adolescents in the postpartum period
who received care from a clinic that prioritizes contracep-
tive use, the implant was more likely to be placed before
resumption of sexual activity than the IUD, thus reducing
repeat pregnancy (50).
Postabortal Long-Acting Reversible
Contraception
Almost one half of all abortions performed in the United
States are repeat abortions (51). Inserting an IUD or
implant immediately after abortion significantly reduces
the risk of repeat abortion (52). As is the case with older
women, the benefits of providing LARC to adolescents
after a spontaneous or induced abortion outweigh the
risks (see Table 1). The implant is safe to place after any
abortion, including second-trimester or septic abortion
(31). Intrauterine devices are safe to place after a first-
trimester or second-trimester abortion; however, the
adolescent should be counseled about the possibility of
IUD expulsion. Data on postabortal etonogestrel implant
2013 COMPENDIUM OF SELECTED PUBLICATIONS 49
 Table 1. U.S. Medical Eligibility Criteria for Contraceptive Use
Copper LNG-
Condition Implant IUD IUD Clarification/Evidence/Comments

Age
Menarche to younger than 18 y 1
Menarche to younger than 20 y 1 2 2 Comment: Concern exists about the risk for expulsion from nulliparity
and for STIs from sexual behavior in younger age groups.
Postpartum
Less than 10 min after delivery 1 2 Evidence: Immediate postpartum insertion of a copper IUD, particularly
of the placenta when insertion occurs immediately after delivery of the placenta,
is associated with lower expulsion rates. Immediate insertion may
happen after vaginal or cesarean birth.
10 min after delivery of the 2 2 2
placenta to less than 4 wk
Less than 4 wk and not 1 2 2
breastfeeding
Less than 4 wk and breastfeeding 2 2 2
4 wk or later and breastfeeding 1 1 1
or not breastfeeding
Puerperal sepsis 4 4 Comment: Insertion of an IUD might substantially worsen the condition.
Postabortion Evidence: Risk for complications from immediate insertion versus
delayed insertion of an IUD after abortion did not differ. Expulsion
was greater when an IUD was inserted after a second-trimester
abortion than when inserted after a first-trimester abortion. Safety
and expulsion for postabortion insertion of an LNG-IUD did not differ
from that of a copper IUD.
First trimester 1 1 1 Clarification: IUDs can be inserted immediately after first-
trimester spontaneous or induced abortion.
Second trimester 1 2 2
Immediately after septic abortion 1 4 4 Comment: Insertion of an IUD might substantially worsen the condition.
1 = A condition for which there is no restriction for the use of the contraceptive method.
2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.
3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.
4 = A condition that represents an unacceptable health risk if the contraceptive method is used.
Abbreviations: IUD, intrauterine device; LNG-IUD, levonorgestrel-releasing intrauterine device.
Modified from U S. Medical Eligibility Criteria for Contraceptive Use, 2010. Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep 2010;59(RR-4):1–86.

safety and repeat abortion are lacking but can be extrapo-
lated from data on IUDs and previous experience with a
six-rod implant system that is no longer marketed in the
United States that shows these methods were easy and
safe to use and highly effective (53, 54).
Conclusion
When choosing contraceptive methods, adolescents
should be encouraged to consider LARC methods.
Intrauterine devices and the contraceptive implant are
the best reversible methods for preventing unintended
pregnancy, rapid repeat pregnancy, and abortion in
young women. Counseling about LARC methods should
occur at all health care provider visits with sexually
active adolescents, including preventive health, abortion,
prenatal, and postpartum visits. Complications of IUDs
and the contraceptive implant are rare and differ little
between adolescents and older women. Health care pro-
viders should consider LARC methods for adolescents
and help make these methods accessible to them.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 50

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2013 COMPENDIUM OF SELECTED PUBLICATIONS 52
COMMITTEE OPINIONS
Committee on American Indian/
Alaska Native Women’s Health

2013 COMPENDIUM OF SELECTED PUBLICATIONS 53

 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 515 • January 2012
Committee on American Indian/Alaska Native Women’s Health
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Health Care for Urban American Indian and Alaska

Native Women
ABSTRACT: Sixty percent of American Indian and Alaska Native women live in metropolitan areas. Most are
not eligible for health care provided by the federal Indian Health Service (IHS). The IHS partly funds 34 Urban Indian
Health Organizations, which vary in size and services. Some are small informational and referral sites that are lim-
ited even in the scope of outpatient services provided. Compared with other urban populations, urban American
Indian and Alaska Native women have higher rates of teenaged pregnancy, late or no prenatal care, and alcohol and
tobacco use in pregnancy. Their infants have higher rates of preterm birth, mortality, and sudden infant death syn-
drome than infants in the general population. Barriers to care experienced by American Indian and Alaska Native
women should be addressed. The American College of Obstetricians and Gynecologists encourages Fellows to
be aware of the risk profile of their urban American Indian and Alaska Native patients and understand that they
often are not eligible for IHS coverage and may need assistance in gaining access to other forms of coverage.
The American College of Obstetricians and Gynecologists also recommends that Fellows encourage their federal
legislators to support adequate funding for the Indian Health Care Improvement Act, permanently authorized as
part of the Patient Protection and Affordable Care Act.

Of the more than 4.3 million individuals who identified
themselves as either partly or solely American Indian or
Alaska Native in the 2000 U.S. Census, 61% do not live
on reservations or Native lands (1). Forty-three percent
do not reside in geographic areas where the federal Indian
Health Service (IHS) provides care (eg, reservations and
adjacent counties) (2). The number of American Indian
and Alaska Native women who live in metropolitan
areas is increasing (3–5). American Indian and Alaska
Native women lag behind the majority population in
many health indicators, and it is important for obstetri-
cian–gynecologists to be aware of their unique social and
economic needs. The American College of Obstetricians
and Gynecologists’ Committee on American Indian/
Alaska Native Women’s Health includes Urban Indian
Health Organizations in its annual site visits and program
reviews to address issues faced by American Indian and
Alaska Native women, provide guidance, and advocate
for improvements in health care for these women and
children.
Although many who self-identify as solely American
Indian or Alaska Native live in rural western states, most
live in metropolitan areas (6). According to the 2000 U.S.
Census, more than 87,000 individuals who identify as
American Indian or Alaska Native alone or in combina-
tion with another race live in New York City, 53,000 live
in Los Angeles, 35,000 live in Phoenix, and 20,600 live in
Chicago (1). Many American Indian and Alaska Native
women live in cities because of educational and employ-
ment opportunities or for access to services other than
health care; others were forced to relocate because of past
government policies. Many of these women have lived in
cities for generations and move back and forth between
cities and reservations in order to take advantage of IHS
or tribal health care on or near their reservations. The
IHS only pays for required services outside of a benefi-
ciary’s home service area if she has been away from that
service area for a period that does not exceed 180 days.
This requirement contributes to mobility between cities
and reservations that may be long distances apart.
Eligibility for services provided by the IHS requires
enrollment in a federally recognized Indian tribe. Al-
though the federal government recognizes 565 tribes, only
approximately 100 tribes are recognized by states and

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 54

 other tribes have no governmental recognition (4). Com-
pared with those living in rural reservation areas who
may share common tribal origins, American Indian and
Alaska Native populations living in cities tend to be het-
erogeneous. There is no standard definition of an urban
American Indian or Alaska Native. Individuals may self-
identify as an urban American Indian or Alaska Native
based on ancestry, shared culture, appearance, or partici-
pation in events organized by a local American Indian or
Alaska Native community (1).
Health Status
More than 20% of urban American Indian and Alaska
Native women live in families with incomes below the
federal poverty line compared with 12–13% of the gen-
eral population in metropolitan areas (1, 3). Compared
with the general urban population, American Indian and
Alaska Native women have higher unemployment rates;
are more likely to live in dwellings that lack plumbing,
kitchen facilities, or telephone service; have lower educa-
tion levels; and have a higher percentage of children in
single-parent households (1, 3).
Information on the health status of urban American
Indian and Alaska Native women is difficult to obtain
because these women represent a diverse and hetero-
geneous group. Many published studies are small and
clinic-based and do not represent the larger population of
urban American Indian and Alaska Native women.
In one study of birth outcomes, findings included
higher rates of prematurity but lower rates of low birth
weight infants in urban American Indian and Alaska
Native women compared with those in the general popu-
lation living in the same areas. American Indian and
Alaska Native women in this study were nearly twice as
likely to have late or no prenatal care as the general popu-
lation of women nationwide. Rates of smoking during
pregnancy were greater as well, although less than in all
pregnant American Indian and Alaska Native women.
Alcohol use in pregnancy was significantly greater among
urban American Indian and Alaska Native women than all
American Indian and Alaska Native women nationwide
and greater than all pregnant American Indian and Alaska
Native women (3). The number of births to teenagers
younger than 18 years was significantly greater among
American Indian and Alaska Native women than the gen-
eral population, but unlike nonurban American Indian
and Alaska Native women, did not decrease over time in
the urban American Indian and Alaska Native women
population (3).
National studies have shown that 37% of urban
American Indian and Alaska Native women are over-
weight and 20% are obese (7); in some urban areas, up to
66% are overweight (8). These rates are higher than those
seen in the general urban population (9). These trends
extend to American Indian and Alaska Native children. A
study from an American Indian and Alaska Native clinic
in Oklahoma City reported that 60% of urban American
COMMITTEE OPINIONS
Indian and Alaska Native children were overweight or
obese by age 12 years (10). American Indian and Alaska
Native women are at increased risk of type II diabetes,
although the differential rates for urban American Indian
and Alaska Native women compared with American
Indian and Alaska Native women who live on reserva-
tions have not been determined.
A Centers for Disease Control and Prevention study
of cervical cancer incidence between 1998 and 2001 found
the lowest rates among American Indian and Alaska
Native women compared with other ethnic groups. Urban
American Indian and Alaska Native women had lower
rates than American Indian and Alaska Native women
living in rural or suburban areas (11). However, the
authors noted that American Indian and Alaska Native
women in whom cervical cancer was diagnosed were
more likely than women of all other ethnic groups except
African Americans to have late-stage cervical cancer
diagnosed. This statistic was not stratified by urban or
nonurban residence (11). Data from 2002 to 2007 show
that almost three times as many American Indian and
Alaska Native women living in areas served by Urban
Indian Health Organizations reported never having had
a Pap test (14%) compared with white women (5%) (12).
Breast cancer is diagnosed at a later stage in Ameri-
can Indian and Alaska Native women than in non-
Hispanic white populations. In addition, the 5-year
survival rate of American Indian and Alaska Native
women following a diagnosis of breast cancer was 78.3%
compared with 89.9% for white women (12).
Health Care Coverage for Urban
American Indian and Alaska Native
Women
Most American Indian and Alaska Native women living
on or near a reservation are eligible for services pro-
vided by and within the IHS or a tribal facility. If services,
especially for emergent conditions, are not available at
the IHS or tribal facility, the patient may be referred to
non-IHS or non-tribal physicians or facilities. If she is
eligible and funding permits, Contract Health Services
may pay for health care from her home area. Indian
Health Service care is limited to “persons of Indian descent
belonging to the Indian community served by the facilities
and programs” (13). Tribal facilities determine eligibility
based on a number of factors such as tribal membership,
enrollment, residence on tribal lands, and other pertinent
factors. Contract Health Services are more restrictive
because the person must be eligible for care and live in
a contract care service delivery area, typically defined as
residing on or near a reservation. Approximately 1.9 mil-
lion American Indian and Alaska Native women living
on or near reservations receive care in those facilities and
through Contract Health Services. Except in certain cities,
approximately 2.5 million American Indian and Alaska
Native women who live in urban areas are rarely eligible
2013 COMPENDIUM OF SELECTED PUBLICATIONS 55
 for direct or contract health care services (13). Exceptions
include Phoenix, Albuquerque, Anchorage, and Tulsa,
which all have IHS facilities where American Indian and
Alaska Native women can receive direct care, but use of
contract care funding is restricted. Although the system
of direct and contract care for women on or near reser-
vations is suboptimal, it is superior to the patchwork of
services available to American Indian and Alaska Native
women who live in urban areas.
The Urban Indian Health Program
In 1976, Title V of the Indian Health Care Improvement
Act authorized the creation of the Urban Indian Health
Program. Currently, 34 Urban Indian Health Programs
offer services that range from primary outpatient medical
and dental care to information and referral services only
(14). Of the 20 cities in the United States with the largest
American Indian and Alaska Native populations, 10 have
centers that only provide outpatient care. Another six,
including Los Angeles and New York, have urban centers
that provide only informational and referral services. It
is estimated that approximately 25% of urban American
Indian and Alaska Native individuals live in a county with
an urban program.
Urban Indian Health Program centers differ in many
ways from IHS or tribal facilities. Only 1% of the annual
IHS budget is allocated to urban American Indian and
Alaska Native health programs. Urban programs must
supplement their budgets with revenues from Medicaid
and Medicare, private insurance, local and state support,
grants, and cooperative agreements. Services are available
to patients using a sliding scale, whereas services at IHS
sites are provided at no cost to patients. Urban Indian
Health Programs also help a larger proportion of non-
Indians than IHS or tribal facilities because they are in
urban areas and get most of their funding from sources
outside of the government. With the outside funding,
they cannot limit their services to American Indian and
Alaska Native individuals only.
Issues confronting urban Indian clinics nationwide
include lack of electronic medical records, which limits
the collection and reporting of critical statistics and com-
munication with referral facilities. There is also a critical
lack of space, and the clinics are subject to inconsistent
funding sources. In addition, unlike most IHS and tribal
facilities where services such as radiology and a phar-
macy are available on-site or by way of contract health
funds, patients must obtain these services in the com-
munity often at their own expense. This frequently results
in fragmentation of care or patients not receiving those
services.
The Role of Other Coverage for Urban
American Indian and Alaska Native
Women
It is important to note that American Indian and Alaska
Native women may be deterred from seeking care that
COMMITTEE OPINIONS
they may be entitled to because of the lack of cultural
understanding in and established relationships with public
and private health care environments. Nonetheless, other
coverage is available to some and should be made more
inviting to American Indian and Alaska Native women.
American Indian and Alaska Native women are eli-
gible for standard public assistance programs such as
Medicaid and the Children’s Health Insurance Program
if they meet eligibility requirements. Most state Medicaid
programs currently exclude childless adults and set eli-
gibility requirements such that individuals with children
must be below the poverty line to be eligible. Under the
Patient Protection and Affordable Care Act, Medicaid
coverage is expanded to nearly all individuals younger
than 65 years with incomes up to 133% of the federal
poverty line. All states participating in Medicaid must
cover these individuals by January 2014. In addition, the
Patient Protection and Affordable Care Act prohibits
cost sharing for American Indians below 300% of the
federal poverty line enrolled in any qualified health insur-
ance plan in the individual market through an Exchange.
The Patient Protection and Affordable Care Act creates
Exchanges through which individuals can purchase health
insurance coverage. It also adds facilities operated by IHS
and Indian, Tribal, and Urban Indian facilities to the
list of agencies that can serve as an express lane agency.
These agencies ensure that those eligible for Medicaid or
the Children’s Health Insurance Program have a fast and
simplified process for having their eligibility determined
or redetermined (15).
American Indian and Alaska Native individuals
younger than 65 years are more dependent on public
assistance programs than the general population. Overall,
28% of individuals younger than 65 years depend on
Medicaid for coverage compared with 12% of non-
Hispanic white individuals (16). Although approximately
one third of American Indian and Alaska Native indi-
viduals younger than 65 years live below the poverty line,
the highest percentage of any group and twice that of
the general population, approximately one half of those
below the poverty line are enrolled in Medicaid. Many
eligible American Indian and Alaska Native women resist
enrolling in Medicaid because of a lack of information
about the programs, the invasive and cumbersome appli-
cation process, and negative attitudes they may encounter
from workers who feel they should not use such services
because they may have access to care through IHS. In
addition, the belief that IHS is responsible for providing
care may keep some eligible American Indian and Alaska
Native women from enrolling in Medicaid.
American Indian and Alaska Native individuals
younger than 65 years are much less likely to have private
insurance than other groups. Overall, 41% of American
Indian and Alaska Native individuals younger than 65
years have private insurance coverage compared with 76%
of non-Hispanic white individuals younger than 65 years
(16). Approximately one fifth of American Indian and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 56
 Alaska Native individuals younger than 65 years live in a
household with no employed member of the family and
are thus excluded from employer-based policies.
Recommendations to Improve Care
for Urban American Indian and Alaska
Native Women
The Indian Health Service is chronically underfunded
and only meets approximately 50% of need. The agency
expends approximately $2,741 per user compared with
a national average of $6,909 per user (17). Because the
budget is calculated using the population that lives on
or near reservations, funds for urban American Indian
and Alaska Native women are minimal. Only approxi-
mately 1% ($43 million in fiscal year 2010) of the IHS
budget ($4.05 billion) is dedicated to the Urban Indian
Health Program (18). Increasing funding for health care
for urban American Indian and Alaska Native women
is critical to improving the health of this population.
Recent passage of the Patient Protection and Affordable
Care Act included provisions of the Indian Health Care
Improvement Act, which should provide consistent and
increased funding for American Indian and Alaska Native
individuals’ health care. This act provides a statutory basis
for the provision of appropriate health care to American
Indian and Alaska Native individuals, which had been
provided with discretionary funding each budget year.
Urban American Indian and Alaska Native women
are an “invisible” population for whom data about demo-
graphics, health care needs, and health issues are difficult
to obtain (5). Systems must be put in place to collect accu-
rate epidemiologic information. Such data are essential to
design and implement programs to eliminate the health
inequities for this population. The Patient Protection and
Affordable Care Act begins to address this by making data
analyses of federally or publicly conducted or supported
health care programs or activities available to IHS and
epidemiology centers funded under the Indian Health
Care Improvement Act (15).
Barriers to public assistance programs should be elim-
inated for American Indian and Alaska Native women.
The American College of Obstetricians and Gynecologists
recommends that Fellows do the following:
• Be aware of the increased risk profile of their Amer-
ican Indian and Alaska Native patients.
• Recognize that American Indian and Alaska Native Retrieved September 22, 2011.
women living in urban areas often are not eligible for
health care from the IHS.
• Be aware that many American Indian and Alaska Behavioral Risk Factor Surveillance System. Seattle (WA):
Native women may not be eligible for, or may not
apply for, health care safety net programs. Safety net
programs provide health care for people regardless of
their ability to pay. Physicians caring for American
Indian and Alaska Native women should educate
their patients about such programs and provide
4 Committee Opinion No. 515
COMMITTEE OPINIONS
information about and, where possible, assistance
with enrollment.
• Recognize that American Indian and Alaska Native
women’s health care may be highly fragmented, geo-
graphically and otherwise.
• Encourage legislators to support adequate funding
for the Indian Health Care Improvement Act, per-
manently authorized as part of the Patient Protection
and Affordable Care Act.
References
1. National Urban Indian Family Coalition. Urban Indian
America: the status of American Indian and Alaska Native
children and families today. A report to the Annie E. Casey
Foundation by the National Urban Indian Family Coali-
tion. Seattle (WA): NUIFC; 2008. Available at: http://www.
aecf.org/~/media/Pubs/Topics/Special%20Interest%20
Areas/SW%20border%20and%20American%20
Indian%20Families/UrbanIndianAmericaTheStatusof
AmericanIndianan/Urban%2020Indian%2020America.pdf.
Retrieved September 22, 2011.
2. Indian Health Service. Trends in Indian health. 2002–2003 ed.
Rockville, MD: IHS; 2009. Available at: http://www.ihs.
gov/nonmedicalprograms/ihs_stats/files/Trends_02-03_
Entire%20Book%20(508).pdf. Retrieved September 22,
2011.
3. Castor ML, Smyser MS, Taualii MM, Park AN, Lawson SA,
Forquera RA. A nationwide population-based study iden-
tifying health disparities between American Indians/Alaska
Natives and the general populations living in select urban
counties. Am J Public Health 2006;96:1478–84.
4. Office of Minority Health. American Indian/Alaska Native
profile. Rockville (MD): OMH; 2011. Available at: http://
minorityhealth.hhs.gov/templates/browse.aspx?lvl=
2&lvlID=52. Retrieved September 22, 2011.
5. Urban Indian Health Commission. Invisible tribes: urban
Indians and their health in a changing world. Seattle
(WA): UIHC; 2007. Available at: http://www.uihi.net/
Public/UIHC%20Publications/UIHC_Report_FINAL.pdf.
Retrieved September 22, 2011.
6. Census Bureau. M0203. Percent of the total population
who are American Indian and Alaska Native alone: 2008.
Washington, DC: Census Bureau; 2008. Available at:
http://factfinder.census.gov/servlet/ThematicMapFrame
setServlet?_bm=y&-geo_id=01000US&-tm_name=
ACS_2008_3YR_G00_M00629&-ds_name=ACS_
2008_3YR_G00_&-_MapEvent=displayBy&-_dBy=040.
7. Urban Indian Health Institute. Reported health and health-
influencing behaviors among urban American Indians
and Alaska Natives: an analysis of data collected by the
UIHI; 2008. Available at: http://www.uihi.org/wp-content/
uploads/2009/01/health_health-influencing_behaviors_
among_urban_indiansupdate-121020081.pdf. Retrieved
September 22, 2011.
8. Sherwood NE, Harnack L, Story M. Weight-loss practices,
nutrition beliefs, and weight-loss program preferences of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 57
 urban American Indian women. J Am Diet Assoc 2000;
100:442–6.
9. Challenges for overweight and obese urban women. Com-
mittee Opinion No. 470. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2010;116: 1011–4.
10. Stern NG, Barrett JR, Lawler FH. Childhood obesity onset
in an urban American Indian health clinic. J Okla State Med
Assoc 2007;100:462–5.
11. Benard VB, Coughlin SS, Thompson T, Richardson LC.
Cervical cancer incidence in the United States by area of
residence, 1998–2001. Obstet Gynecol 2007;110:681–6.
12. Urban Indian Health Institute. Breast and cervical cancer
facts. The WEAVING Project. Seattle (WA): UIHI; 2009.
Available at: http://www.theweavingproject.org/BCCFacts-
64.html. Retrieved September 22, 2011.
13. Henry J. Kaiser Family Foundation. Urban Indian health.
Menlo Park (CA): KFF; 2001. Available at: http://www.kff.
org/minorityhealth/loader.cfm?url=/commonspot/secu
rity/getfile.cfm&PageID=13909. Retrieved September 22,
2011.
14. Indian Health Service. Urban Indian health program. IHS
Fact Sheet. Rockville (MD): IHS; 2011. Available at: http://
www.ihs.gov/PublicAffairs/IHSBrochure/UrbnInds.asp.
Retrieved September 22, 2011.
15. Indian Health Service. Patient Protection and Affordable
Care Act (Affordable Care Act) summary of Indian health
provisions. Rockville (MD): IHS; 2010. Available at: http://
www.ihs.gov/PublicAffairs/DirCorner/docs/Affordable_
Committee Opinion No. 515
COMMITTEE OPINIONS
Care_Act_Provisions_Summary.pdf. Retrieved October 13,
2011.
16. Henry J. Kaiser Family Foundation. A profile of American
Indians and Alaska Natives and their health coverage.
Race, Ethnicity and Health Care Issue Brief. Menlo Park
(CA): KFF; 2009. Available at: http://www.kff.org/minori-
tyhealth/upload/7977.pdf. Retrieved September 22, 2011.
17. Indian Health Service. IHS year 2011 profile. IHS Fact
Sheet. Rockville (MD): IHS; 2011. Available at: http://www.
ihs.gov/PublicAffairs/IHSBrochure/Profile2011.asp.
Retrieved September 22, 2011.
18. Indian Health Service. Indian Health Service FY 2010 bud-
get. IHS Fact Sheet. Rockville (MD): IHS; 2010. Available at:
http://www.ihs.gov/PublicAffairs/IHSBrochure/Budget10.
asp. Retrieved September 22, 2011.
Copyright January 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care for urban American Indian and Alaska Native women.
Committee Opinion No. 515. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2012;119:201–5.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 58
COMMITTEE OPINIONS
Committee on Coding and Nomemclature

2013 COMPENDIUM OF SELECTED PUBLICATIONS 59

 ACOG Committee
Committee
on Coding and
Nomenclature
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be fol-
lowed. Requests for au­tho­ri­za­
tion to make pho­to­copies should
be di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
Copyright © August 1998
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
COMMITTEE OPINIONS
Opinion
Number 205, August 1998
Tubal Ligation with Cesarean
Delivery
Tubal ligation at the time of cesarean delivery requires significant additional
physician work even though the technical work of the procedure is brief.
Informed consent by the patient requires considerably more counseling by
the physician regarding potential risks and benefits of this procedure than
is necessary with alternative means of sterilization and contraception. Also,
many states require completion of special informed consent documents in
addition to the customary consent forms required by hospitals. These forms
must be completed before scheduling the procedure.
Patients have the right to change their minds. Thus, it is important to
reconfirm the patient’s decision shortly before the operation.
Tubal ligation with cesarean delivery involves removal of a segment of
fallopian tube, which is sent for histologic confirmation. With most cesarean
deliveries, tissue is not evaluated by a pathologist. Accordingly, it is im­por­
tant for the surgeon to verify the pathology report, which adds an additional
component to post-service work.
The risk of professional liability for operative complications is increased
with this procedure. This risk is low, but real. Furthermore, sterilization fail-
ure occurs in about 1 in 100 cases even though the operation was per­­­­­­­­­formed
properly. This failure also carries a liability risk.
Because tubal ligation is a discrete extra service, it should be coded
accordingly: 59510 or 59618—routine obstetric care including antepartum
care, ce­sar­e­an delivery, and postpartum care—and 58611—ligation or tran-
section of fallopian tube(s) done at the time of cesarean delivery or intra-
abdominal surgery.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 60
 ACOG Committee
Opinion
Committee on
Coding and
Nomenclature
Reaffirmed 2005

Number 249, January 2001

Coding Responsibility
Physicians are responsible for accurately coding the services they provide
to their patients. Likewise, insurers are obligated to process all legiti­mate
insurance claims for covered services accurately and in a timely man­
ner. It is inappropriate for physicians to code or for insurers to process
claims incorrectly in order to enhance or reduce reimbursement. When
either party engages in such a practice intentionally and repetitively, it
should be considered dishonest and may be subject to civil and criminal
penalties.

Copyright © January 2001

by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 61

 ACOG
Committee on
Coding and
Nomenclature
Copyright © January 2001
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
COMMITTEE OPINIONS
Committee
Opinion
Number 250, January 2001
Inappropriate Reimbursement
Practices by Third-Party Payers
The American College of Obstetricians and Gynecologists (ACOG)
Committee on Coding and Nomenclature believes that physicians must
code accurately the services they provide and the diagnoses that justify
those services for purposes of appropriate payment. This requirement is
consistent with the rules established by the American Medical Association
(AMA) Current Procedural Terminology Editorial Panel and published as
the Current Procedural Terminology (CPT) and with those established
by the International Classification of Diseases, Ninth Revision, Clinical
Modification (ICD-9-CM), which are published in the American Hospital
Association’s ICD-9-CM Coding Clinic. In fairness, payers should be equally
obligated to pay physicians based on the CPT standards and accept for pro-
cessing all ICD-9-CM codes recorded on the claim. Currently, no such obli-
gation for payers exists.
Inappropriate Billing Denials
Five frequently encountered billing situations account for most payers’ inap-
propriate first-time total or partial denials of correctly coded services. Each of
these situations can inappropriately deny payment to physicians for medically
indicated and correctly coded services because of payers’ payment policies.
1. Inappropriately bundling correctly coded multiple surgical procedures—
Current Procedural Terminology clearly describes surgical procedures
that may be performed to treat various conditions. Each CPT code
describes a specific procedure that was valued under the Resource Based
Relative Value Scale (RBRVS) on the basis of a description of the work
it entails. Many patients, especially those with complex clinical situations,
need more than one surgical procedure to be performed at an operative ses-
sion. For instance, a patient may require a vaginal hysterectomy because of
severe irregular bleeding, but also might require repair of a symptomatic
cystocele and rectocele. Because no single CPT code describes this combi-
nation of procedures, the physician should apply multiple CPT codes with
appropriate modifiers to the secondary procedures as mandated by CPT
2013 COMPENDIUM OF SELECTED PUBLICATIONS 62
 rules. Furthermore, the physician should expect
reimbursement for all of the provided services
defined by the CPT codes.
Despite the accuracy of the above statement
regarding reimbursement for multiple procedures,
payers often cite the efforts of Medicare to reduce
payments for inappropriately unbundled CPT
codes by physicians as justification for denial of
physician claims for appropriately coded services.
Indeed, the Health Care Financing Administration
has established the Correct Coding Initiative (CCI),
a process for bundling together many services that
should not be paid separately. The process con-
tinues to undergo refinement with input from the
AMA and medical specialty societies.
Unfortunately, some commercial software
products that do not adhere to either CPT or CCI
guidelines are being used by third-party payers to
identify CPT codes for services that will not be
reimbursed when coded together. For example,
some of these products incorrectly bundle anterior
and posterior colporrhaphy with enterocele repair
into the code for vaginal hysterectomy, presum-
ably because all of these procedures are performed
through a vaginal approach. The AMA Correct
Coding and Policy Committee, with input from
ACOG staff, has identified many instances of
inappropriate denial of reimbursement with some
of these commercial bundling products. Physi­
cians should appeal such denials (see the box) and
cite the content of this document in requesting
appropriate payment for these services.
2. Ignoring modifiers that explain qualifying circum-
stances—Current Procedural Terminology modi-
fiers provide a coding shorthand that helps explain
situations for which either increased or reduced
payment is justified. There is, at present, no insur-
ance industry standard for recognizing modifiers.
The American College of Obstetricians and
Gynecologists believes that third-party payers
should follow existing CPT guidelines and coding
options, including recognition of all CPT modi-
fiers, to ensure that all circumstances concerning
the service performed are recognized. Payers who
ignore correctly applied CPT modifiers inappro-
priately underreimburse physicians for the ser-
vices provided.
3. 
Denying payment for diagnostic and therapeu-
tic procedures performed on the same day of
service—In certain clinical situations, a diag-
nostic surgical procedure is performed to deter-
mine whether a therapeutic surgical procedure is
COMMITTEE OPINIONS
Seven Steps for Appealing Denied Claims
Take these steps when appealing inappropriate reim-
bursement practices by third-party payers:
1. Keep in mind that this is a negotiation process
that will succeed only if the insurer is con-
vinced that a charge is fair for the patient and
the physician. It is important to use accepted
coding standards when attempting to show
that an insurer’s policy is wrong. Polite but
direct communication is more likely to achieve
desired results than confrontation.
2. Have your staff contact the claims department
of the insurer and discuss the reason for denial
with the claims processor. These discus-
sions should be based on clinical facts that
rely on the Current Procedural Terminology
(CPT) code definition of the service and the
standard of care implied by the CPT code as
it was valued under the Medicare Resource
Based Relative Value Scale (RBRVS) system.
Document all communication with the insurer
(date, person from office making the call, per-
son spoken with, results).
3. If staff is unsuccessful, contact the medical
director of the payer yourself. Maintain open
lines of communication with the medical direc-
tor to discuss inappropriate payment policies
and accepted coding standards.
4. Involve the state medical society in disputes
with insurers. Many state societies will become
very involved when patterns of abuse emerge.
5. Contact the American College of Obstetricians
and Gynecologists (ACOG) for assistance in
dealing with inappropriately denied medically
indicated services that are covered by the
patient’s insurance policy and clearly were cor-
rectly reported. Contact ACOG’s Department of
Health Economics by fax or mail after down-
loading a complaint form from ACOG’s web
site (www.acog.org), or call (202) 863-2447
for assistance.
6. Send a copy of any correspondence between
the practice and the payer dealing with unre-
solved problems to the insurance commis-
sioner or equivalent regulatory authority in
your state.
7. Involve your patient when inappropriate billing
problems cannot be resolved in other ways.
Physicians are not responsible for the insur-
ance plan selected by the patient. Many third-
party payers will revise their payment policies
when they receive a complaint from the patient
or patient’s employer or union.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 63
 required. When this occurs, it often is appropriate
for the two procedures to be done at one time
rather than at two distinct times. For example, if
a diagnostic laparoscopy for a suspected benign
condition reveals cancer, the physician may decide
to perform a laparotomy to remove the cancer at
the same operative session. In such a situation,
many payers deny payment for the diagnostic
laparoscopy even though performance of both the
diagnostic and therapeutic procedures at the same
time is medically indicated and requires additional
physician work above that of the therapeutic pro-
cedure alone. In accordance with CPT guidelines,
both procedures should be coded and the physician
should be paid for both when the procedures have
been documented appropriately and coded correct-
ly. In the example, proper coding for the diagnos-
tic service in addition to a therapeutic procedure
would at the present time require the use of modi-
fier –59 to identify the diagnostic procedure as
distinct. In addition, however, the diagnostic pro-
cedure must be justified with a specific ICD-9-CM
diagnostic code, which may or may not be the
same as the ICD-9-CM code for the therapeutic
procedure.
The practice by payers of bundling diagnostic
and therapeutic procedures to reduce physicians’
payment is inappropriate. Physicians have a legal
obligation to code correctly. Insurers are equally
obligated not to alter coding by physicians that is
in accordance with approved CPT guidelines.
4. 
Precertifying consultations at a predetermined
level—Some payers require precertification of
a consultation and typically authorize a prede-
termined level of service based on the diagnos-
tic information provided by the physician who
requested the consultation. By contrast, the CPT
guidelines state that the correct level of consulta-
tion is determined by the extent of the history,
physical examination, and complexity of the medi-
cal decision-making process for each patient. This
definition of services was used by Medicare under
RBRVS to assign the relative value for physician
consultation. Each patient who requires a con-
sultation does so with a medical history typically
including co-morbidities that can dramatically
alter the physician work required to provide this
service. Often such co-morbidities will necessitate
a more thorough history and physical examination
and involve more complex medical decision mak-
ing than required in their absence. For example, a
request for a consultation to assess fetal well-being
COMMITTEE OPINIONS
in an otherwise healthy patient who has had an
uneventful pregnancy will not resemble a consul-
tation for this same problem when the patient has
preexisting complications of pregnancy, such as
cardiac disease, uncontrolled diabetes mellitus, or
a history of poor obstetric outcomes.
Because it is not possible to determine prospec-
tively the level of service that will be required to
evaluate and recommend treatment based on the
uniqueness of each patient’s problems, payers
should precertify for an unspecified level of con-
sultation that is paid at the appropriate level once
the service has been provided.
5. Denying diagnostic tests or studies performed at
the same encounter as a distinct evaluation and
management service—The CPT manual states:
The actual performance and/or interpreta-
tion of diagnostic tests/studies ordered dur-
ing a patient encounter are not included in
the levels of [evaluation and management
(E/M)] services. Physician performance of
diagnostic tests/studies for which specific
CPT codes are available may be reported
separately, in addition to the appropriate
E/M code.
With this statement, CPT has clarified that diag-
nostic tests and studies, including colposcopies,
biopsies, diagnostic ultrasound examinations, and
cystometrics, are ordered on the basis of clinical
criteria for each patient and not as a routine ser-
vice. This definition means that tests performed at
the time of an outpatient or other E/M encounter
are not to be paid as part of the E/M service, but
rather are to be paid separately. The E/M codes in
CPT were valued under the Medicare RBRVS fee
schedule on the basis of the CPT guidelines; these
values do not include any diagnostic tests or studies.
The payer may deny reimbursement of diagnos-
tic tests or studies at the time of an E/M encounter
because the payer’s payment policies might have
been formulated with a lack of understanding of
CPT coding standards that separate physician work
included with the E/M service from the diagnostic
test or study. This lack of understanding may lead
the payer to inappropriately include all services
provided to the patient at the E/M encounter as part
of that service. The payer also may deny payment
because the physician failed to add a modifier –25
to the billed E/M code to by-pass the payer’s estab-
lished coding edits to ensure appropriate payment
for both services.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 64
 Possible Remedies
The physician should ensure that his or her billing
staff are knowledgeable about:
• What is normally included and what is excluded
from the service being billed (This information is
provided in the most current edition of ACOG’s
OB-GYN Coding Manual: Components of Correct
Procedural Coding.*)
• How to link each service billed with one or more
specific ICD-9-CM diagnostic codes that spe-
cifically justifies the reason for the service (This
information is available in the most current edition
of ACOG’s ICD-9-CM: Diagnostic Coding in
Obstetrics and Gynecology.*)
* These resources are available from the American College of
Obstetricians and Gynecologists.
COMMITTEE OPINIONS
• The correct application of CPT modifiers, when
indicated (This information may be found in the
appendixes of the current AMA CPT manual and
in the current edition of ACOG’s CPT Coding in
Obstetrics and Gynecology.*)
• Billing rules established by individual payers
The billing office should communicate clearly
the indication for performing all coded services on
the same date of service by reporting the most spe-
cific ICD-9-CM diagnostic codes. In some encoun-
ters, the justification for all services rendered may
be documented by a single ICD-9-CM code. When a
patient has multiple complaints or problems, multiple
ICD-9-CM codes should be used.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 65
COMMITTEE OPINIONS
Committee on Ethics

2013 COMPENDIUM OF SELECTED PUBLICATIONS 66

 ACOG
Committee on
Ethics
Reaffirmed 2012
Copyright © August 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Nonmedical use of obstetric ultra-
sonography. ACOG Committee
Opinion No. 297. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:423–4.
COMMITTEE OPINIONS
Committee
Opinion
Number 297, August 2004
Nonmedical Use of Obstetric
Ultrasonography
ABSTRACT: The American College of Obstetricians and Gynecologists
(ACOG) has endorsed the “Prudent Use” statement from the American
Institute of Ultrasound in Medicine (AIUM) discouraging the use of obstetric
ultrasonography for nonmedical purposes (eg, solely to create keepsake pho-
tographs or videos). The ACOG Committee on Ethics provides reasons in
addition to those offered by AIUM for discouraging this practice.
The American College of Obstetricians and Gynecologists (ACOG) has
endorsed the following statement from the American Institute of Ultrasound
in Medicine (AIUM) discouraging the use of obstetric ultrasonography for non-
medical purposes (eg, solely to create keepsake photographs or videos) (1):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM
strongly discourages the non-medical use of ultrasound for psychosocial or enter-
tainment purposes. The use of either two-dimensional (2D) or three-dimensional
(3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the
fetal gender without a medical indication is inappropriate and contrary to responsi-
ble medical practice. Although there are no confirmed biological effects on patients
caused by exposures from present diagnostic ultrasound instruments, the possibili-
ty exists that such biological effects may be identified in the future. Thus ultrasound
should be used in a prudent manner to provide medical benefit to the patient.
In addition to the concerns noted by AIUM, the ACOG Committee on Ethics
believes that nonmedical use of ultrasonography should be discouraged for
the following reasons:
• Nonmedical ultrasonography may falsely reassure women. Even though
centers that perform nonmedical ultrasonography and create keepsake
photographs and videos of the fetus may offer disclaimers about the
limitations of their product, customers may interpret an aesthetically
pleasing image or entertaining video as evidence of fetal health and
appropriate development. Ultrasonography performed for psychosocial
or entertainment purposes may be limited by the extent and duration of
the examination, the training of those acquiring the images, and the qual-
ity control in place at the ultrasound facility. Women may incorrectly
believe that the limited scan is, in fact, diagnostic.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 67
 • Abnormalities may be detected in settings that
are not prepared to discuss and provide follow-
up for concerning findings. Without the ready
availability of appropriate prenatal health care
professionals, customers at sites for nonmedical
ultrasonography may be left without necessary
support, information, and follow-up for con-
cerning findings. For example, customers may
interpret a minor finding (eg, an echogenic
intracardiac focus) as a major abnormality,
resulting in unnecessary anxiety and concern.
Conversely, in the event of concerning findings
COMMITTEE OPINIONS
(eg, oligohydramnios), women may not receive
appropriate follow-up. Obstetric ultrasonogra-
phy is most appropriately obtained as part of an
integrated system for delivering prenatal care.
Reference
1. American Institute of Ultrasound in Medicine. Prudent use.
AIUM Official Statements. Laurel (MD): AIUM; 1999.
Available at http://www.aium.org/provider/statements/
_statementSelected.asp?statement=2. Retrieved May 19, 2004.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 68
 ACOG
Committee on
Ethics
Copyright © November 2005
by the American College of
Obstetricians and Gynecologists.
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publication may be reproduced,
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Maternal decision making, ethics,
and the law. ACOG Committee
Opinion No. 321. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:1127–37.
COMMITTEE OPINIONS
Committee
Opinion
Number 321, November 2005
Maternal Decision Making, Ethics,
and the Law
ABSTRACT: Recent legal actions and policies aimed at protecting the fetus
as an entity separate from the woman have challenged the rights of pregnant
women to make decisions about medical interventions and have criminal-
ized maternal behavior that is believed to be associated with fetal harm or
adverse perinatal outcomes. This opinion summarizes recent, notable legal
cases; reviews the underlying, established ethical principles relevant to the
highlighted issues; and considers six objections to punitive and coercive
legal approaches to maternal decision making. These approaches 1) fail to
recognize that pregnant women are entitled to informed consent and bodily
integ­rity, 2) fail to recognize that medical knowledge and predictions of
outcomes in obstetrics have limitations, 3) treat addiction and psychiatric
illness as if they were moral failings, 4) threaten to dissuade women from
prenatal care, 5) unjustly single out the most vulnerable women, and 6) cre-
ate the potential for criminalization of otherwise legal maternal behavior.
Efforts to use the legal system to protect the fetus by constraining pregnant
women’s decision making or punishing them erode a woman’s basic rights
to privacy and bodily integrity and are not justified. Physicians and policy
makers should promote the health of women and their fetuses through advo-
cacy of healthy behavior; referral for substance abuse treatment and mental
health services when indicated; and development of safe, available, and
efficacious services for women and families.
Ethical issues that arise in the care of pregnant women are challenging to
physicians, politicians, lawyers, and ethicists alike. One of the fundamental
goals of medicine and society is to optimize the outcome of pregnancy.
Recently, some apparent attempts to foster this goal have been characterized
by legal action and policies aimed at specifically protecting the fetus as an
entity separate from the woman. These actions and policies have challenged
the rights of pregnant women to make decisions about medical interventions
and have criminalized maternal behavior that is believed to be associated
with fetal harm or adverse perinatal outcomes.
Practitioners who care for pregnant women face particularly difficult
dilemmas when their patients reject medical recommendations, use illegal
2013 COMPENDIUM OF SELECTED PUBLICATIONS 69
 drugs, or engage in a range of other behaviors that
have the potential to cause fetal harm. In such situa-
tions, physicians, hospital representatives, and oth-
ers have at times resorted to legal actions to impose
their views about what these pregnant patients
ought to do or to effect particular interventions or
outcomes. Appellate courts have held, however,
that a pregnant woman’s decisions regarding medi-
cal treatment should take precedence regardless
of the presumed fetal consequences of those deci-
sions. In one notable 1990 decision, a District of
Columbia appellate court vacated a lower court’s
decision to compel cesarean delivery in a criti-
cally ill woman at 26 weeks of gestation against
her wishes, stating in its opinion that “in virtually
all cases the question of what is to be done is to be
decided by the patient—the pregnant woman—on
behalf of herself and the fetus” (1). Furthermore,
the court stated that it could think of no “extremely
rare and truly exceptional” case in which the state
might have an interest sufficiently compelling to
override a pregnant patient’s wishes (2). Amid
often vigorous debate, most ethicists also agree that
a pregnant woman’s informed refusal of medical
intervention ought to prevail as long as she has the
ability to make medical decisions (3, 4).
Recent legislation, criminal prosecutions, and
legal cases much discussed in both courtrooms and
newsrooms have challenged these precedents, rais-
ing the question of whether there are circumstances
in which a woman who has become pregnant may
have her rights to bodily integrity and informed
consent overridden to protect her fetus. In Utah, a
woman who had used cocaine was charged with
homicide for refusing cesarean delivery of a fetus
that was ultimately stillborn. In Pennsylvania, physi-
cians obtained a court order for cesarean delivery in
a patient with suspected fetal macrosomia. Across
the country, pregnant women have been arrested
and prosecuted for being pregnant and using drugs
or alcohol. These cases and the publicity they have
engendered suggest that it is time to revisit the ethi-
cal issues involved.
The ethics of caring for pregnant women and
an approach to decision making in the context of
the maternal–fetal relationship have been discussed
in previous statements by the American College of
Obstetricians and Gynecologists (ACOG) Commit-
tee on Ethics. After briefly reiterating those discus-
sions, this opinion will summarize recent, notable
cases; review the underlying, established ethical
COMMITTEE OPINIONS
principles relevant to the highlighted issues; con­
sider objections to punitive and coercive legal
approaches to maternal decision making; and sum-
marize recommendations for attending to future
ethical matters that may arise.
Recent Cases
In March 2004, a 28-year-old woman was charged
with first-degree murder for refusing to undergo an
immediate cesarean delivery because of concerns
about fetal well-being and later giving birth to a girl
who tested positive for cocaine and a stillborn boy.
According to press reports, the woman was men­tally
ill and intermittently homeless and had been brought
to Utah by a Florida adoption agency to give birth
to the infants and give them up. She ultimately pled
guilty to two counts of child endangerment.
In January 2004, a woman who previously had
given birth vaginally to six infants, some of whom
weighed close to 12 pounds, refused a cesarean
delivery that was recommended because of presumed
macrosomia. A Pennsylvania hospital obtained a
court order to perform the cesarean delivery and gain
custody of the fetus before and after delivery, but
the woman and her husband fled to another hospital,
where she reportedly had an uncomplicated vaginal
delivery of a healthy 11-pound infant.
In September 2003, a 22-year-old woman was
prosecuted after her son tested positive for alcohol
when he was born in Glens Falls, New York. A few
days after the birth, the woman was arrested and
charged with two counts of child endangerment for
“knowingly feeding her blood,” containing alcohol, to
her fetus via the umbilical cord. Several months later,
her lawyers successfully appealed her conviction.
In May 1999, a 22-year-old woman who was
homeless regularly used cocaine while pregnant and
gave birth to a stillborn infant in South Carolina.
She became the first woman in the United States to
be tried and convicted of homicide by child abuse
based on her behavior during pregnancy and was
given a 12-year prison sentence. The conviction
was upheld in the South Carolina Supreme Court,
and the U.S. Supreme Court recently refused to hear
her appeal. At a postconviction relief hearing, expert
testimony supported arguments that the woman had
had inadequate representation, but the court held
that there was no ineffective assistance of counsel
and that she is not entitled to a new trial. This deci-
sion is being appealed.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 70
 Ethical Considerations
Framing Ethics in Perinatal Medicine
It is likely that the interventions described in the
preceding cases were motivated by a shared con-
cept—that a fetus can and should be treated as
separable and legally, philosophically, and practi-
cally independent from the pregnant woman within
whom it resides. This common method of framing
ethical issues in perinatal medicine is not surprising
given a number of developments in the past several
decades. First, since the 1970s, the development of
techniques for imaging, testing, and treating fetuses
has led to the widespread endorsement of the notion
that fetuses are independent patients, treatable
apart from the pregnant women upon whom their
existence depends (5). Similarly, some bioethi-
cal models now assert that physicians have moral
obligations to fetal “patients” that are separate from
their obligations to pregnant women (6). Finally, a
number of civil laws, discussed later in this section,
aim to create fetal rights separate from a pregnant
woman’s rights.
Although frameworks that treat the woman and
fetus as separable and independent are meant to sim-
plify and clarify complex issues that arise in obstet-
rics, many writers have noted that such frameworks
tend to distort, rather than illuminate, ethical and
policy debates (7). In particular, these approaches
have been criticized for their tendency to empha-
size the divergent rather than shared interests of the
pregnant woman and fetus. This emphasis results in
a view of the maternal–fetal relationship as paradig-
matically adversarial, when in fact in the vast major-
ity of cases, the interests of the pregnant woman and
fetus actually converge.
In addition, these approaches tend to ignore
the moral relevance of relationships, including the
physically and emotionally intimate relationship
between the woman and her fetus, as well as the
relationships of the pregnant woman within her
broader social and cultural networks. The cultural
and policy context, for example, suggests a pre-
dominantly child-centered approach to maternal
and child health, which has influenced current per-
spectives on the fetus. The prototype for the federal
Maternal and Child Health Bureau dates back to
1912, when the first organization was called into
existence by reformers such as Florence Kelley,
who stated that “the U.S. should have a bureau to
look after the child crop,” and Julia Lathrop, who
COMMITTEE OPINIONS
said that “the final purpose of the Bureau is to serve
all children, to try to work out standards of care and
protection which shall give to every child his fair
chance in the world.” The current home page of the
Maternal and Child Health Bureau web site cites as
its “vision” an equally child-centered goal (8).
At times, in the current clinical and policy
contexts, when the woman and fetus are treated as
separate individuals, the woman and her medical
interests, health needs, and rights as moral agent,
patient, and research subject fade from view. Con­
sider, first, women’s medical interests as patients.
Researchers performing “fetal surgery”—novel
interventions to correct fetal anatomic abnormali-
ties—have been criticized recently not only for
their tendency to exaggerate claims of success with
regard to fetal and neonatal health, but also for their
failure to assess the impact of surgery on pregnant
women, who also undertake the risks of the major
surgical procedures (9). As a result, several cen-
ters performing these techniques now use the term
“ma­ ter­
nal–fetal surgery” to explicitly recognize
the fact that a woman’s bodily integrity and health
are at stake whenever interventions directed at her
fetus are performed. Furthermore, a study spon-
sored by the National Institute of Child Health and
Human Development comparing maternal–fetal
surgery with postnatal repair of myelomeningocele
(the Management of Myelomeningocele Study) is
now assessing maternal as well as fetal outcomes,
including measurement of reproductive and health
outcomes, depression testing, and economic and
family health outcomes in women who participate
in the clinical trial.
Similarly, new civil laws that aim to treat
the fetus as separate and independent have been
criticized for their failure both to address the health
needs of the woman within whose body the fetus
resides and to recognize the converging interests of
the woman and fetus. In November 2002, a revision
of the state child health insurance program (sCHIP)
that expanded coverage to “individual(s) under the
age of 19 including the period from conception until
birth” was signed into law. The program does not
cover pregnant women older than 18 years except
when medical interventions could directly affect
the well-being of their fetuses. For example, under
sCHIP, intrapartum anesthesia is covered, accord-
ing to the U.S. Department of Health and Human
Services, only because “if a woman’s pain during
a labor and delivery is not reduced or properly
2013 COMPENDIUM OF SELECTED PUBLICATIONS 71
 relieved, adverse and sometimes disastrous effects
can occur for the unborn child” (10).
Furthermore, for beneficiaries of sCHIP, many
significant women’s health issues, even those that
are precipitated by pregnancy (eg, molar gestation,
postpartum depression, or traumatic injury from
intimate partner violence not impacting the fetus),
are not covered as a part of routine antenatal care
(11). This approach has been criticized not only for
its failure to address the health needs of women,
but also for its failure to achieve the narrow goal
of improving child health because it ignores the
fact that maternal and neonatal interests converge.
For instance, postpartum depression is associated
with adverse effects in infants, including impaired
maternal–infant interaction, delayed cognitive
and emotional development, increased anxiety,
and de­creased self-esteem (12, 13). Thus, the law
ignores the fact that a critical component of ensuring
the health of newborns is the provision of compre-
hensive care for their mothers.
Likewise, in April 2004, the Unborn Victims
of Violence Act was signed into law, creating a
separate federal offense if, during the commission
of certain federal crimes, an individual causes the
death of, or bodily injury to, a fetus at any stage of
pregnancy. The law, however, does not categorize
the death of or injury to a pregnant woman as a sepa-
rate federal offense, or create sentence enhancement
for those who assault or murder a woman while
pregnant. The statute’s sponsors explicitly rejected
proposals that had virtually identical criminal pen-
alties but recognized the pregnant woman as the
victim, despite the fact that murder is responsible
for more pregnancy-associated deaths in the United
States than any other cause, including hemorrhage
and thromboembolic events (14, 15).
Beyond its impact on maternal and child health,
a failure to recognize the interconnectedness of the
pregnant woman and fetus has important ethical and
legal implications. Because an intervention on a
fetus must be performed through the body of a preg-
nant woman, an assertion of fetal rights must be rec-
onciled with the ethical and legal obligations toward
pregnant women as women, persons in their own
right. Discussions about rights of the unborn often
have failed to address these obligations. Regardless
of what is believed about fetal personhood, claims
about fetal rights require an assessment of the rights
of pregnant women, whose personhood within the
legal and moral community is indisputable.
COMMITTEE OPINIONS
Furthermore, many writers have noted a moral
injury that arises from abstracting the fetus from
the pregnant woman, in its failing to recognize the
preg­nant woman herself as a patient, person, and
rights-bearer. This approach disregards a funda-
mental moral principle that persons never be treated
solely as means to an end, but as ends in themselves.
Within the rhetoric of conflict and fetal rights, the
pregnant woman has at times been reduced to a ves-
sel—even a “fortress” holding the fetus “prisoner”
(16). As George Annas aptly described, “Before
birth, we can obtain access to the fetus only through
its mother, and in the absence of her informed con-
sent, can do so only by treating her as a fetal contain-
er, a nonperson without rights to bodily integrity” (3).
Some writers have argued that at the heart of
the distorting influence of the “two-patient” model
of the maternal–fetal dyad is the fact that, according
to traditional theories that undergird medical ethics,
the very notion of a person or a patient is someone
who is physically separate from others. Pregnancy,
however, is marked by a “particular and particularly
thoroughgoing kind of intertwinement” (17). Thus,
the pregnant woman and fetus fit awkwardly at best
into what the term “patient” is understood to mean.
They are neither physically separate, as persons
are understood to be, nor indistinguishably fused.
A framework that instead defines the professional
ethical obligations with a deep sensitivity to rela-
tionships of interdependency may help to avoid the
distorting influence of the two-patient model as
traditionally understood (18). Although this opinion
does not specifically articulate a novel comprehen-
sive conceptual model for perinatal ethics, in the dis-
cussion that follows, the Committee on Ethics takes
as morally central the essential connection between
the pregnant woman and fetus.
Ethics Committee Opinions and the Maternal–
Fetal Relationship
In the context of a framework that recognizes the
interconnectedness of the pregnant woman and fetus
and emphasizes their shared interests, certain opin-
ions previously published by the ACOG Committee
on Ethics are particularly relevant. These include:
• “Informed Consent” (19)
• “Patient Choice in the Maternal–Fetal Relation-
ship” (20)
• “At-Risk Drinking and Illicit Drug Use: Ethical
Issues in Obstetric and Gynecologic Practice”
(21)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 72
 One fundamental ethical obligation of health
care professionals is to respect patients’ autonomous
decision making and to adhere to the requirement
for informed consent for medical intervention. In
January 2004, the Committee on Ethics published a
revised edition of “Informed Consent” in which the
following points are defended:
• “Requiring informed consent is an expression
of respect for the patient as a person; it particu-
larly respects a patient’s moral right to bodily
integrity, to self-determination regarding sex-
uality and reproductive capacities, and to the
support of the patient’s freedom within caring
relationships.”
• “The ethical requirement for informed consent
need not conflict with physicians’ overall ethi-
cal obligation to a principle of beneficence; that
is, every effort should be made to incorporate a
commitment to informed consent within a com-
mitment to provide medical benefit to patients
and thus respect them as whole and embodied
persons.”
Pregnancy does not obviate or limit the require-
ment to obtain informed consent. Intervention on
behalf of the fetus must be undertaken through the
body and within the context of the life of the preg-
nant woman, and therefore her consent for medical
treatment is required, regardless of the treatment
indication. However, pregnancy presents a special
set of issues. The issues associated with informed
refusal of care by pregnant women are addressed
in the January 2004 opinion “Patient Choice in the
Maternal–Fetal Relationship” (20). This opinion
states that in cases of maternal refusal of treatment
for the sake of the fetus, “court-ordered intervention
against the wishes of a pregnant woman is rarely if
ever acceptable.” The document presents a review
of general ethical considerations applicable to preg-
nant women who do not follow the advice of their
physicians or do not seem to make decisions in the
best interest of their fetuses. Although the possibil-
ity of a justifiable court-ordered intervention is not
completely ruled out, the document presents several
recommendations that strongly discourage coercive
measures:
• “The obstetrician’s response to a patient’s
unwillingness to cooperate with medical advice
should be to convey clearly the reasons for
the recommendations to the pregnant woman,
COMMITTEE OPINIONS
examine the barriers to change along with her,
and encourage the development of health-pro-
moting behavior.”
• “[Even if] a woman’s autonomous decision
[seems] not to promote beneficence-based obli-
gations (of the woman or the physician) to the
fetus, .the obstetrician must respect the patient’s
autonomy, continue to care for the pregnant
woman, and not intervene against the patient’s
wishes, regardless of the consequences.”
• “The obstetrician must keep in mind that medi-
cal knowledge has limitations and medical
judgment is fallible” and should therefore take
great care “to present a balanced evaluation of
expected outcomes for both [the woman and the
fetus].”
• “Obstetricians should consider the social and
cultural context in which these decisions are
made and question whether their ethical judg-
ments reinforce gender, class, or racial inequal-
ity.”
In addition to revisiting questions of how prac-
titioners should address refusal of treatment in the
clinic and delivery room, the four cases outlined
previously illustrate punitive and coercive policies
aimed at pregnant women who engage in behav-
iors that may adversely affect fetal well-being. The
2004 opinion “At-Risk Drinking and Illicit Drug
Use: Ethical Issues in Obstetric and Gynecologic
Practice” (21) specifically addresses addiction and
the prosecution of women who use drugs and alco-
hol during pregnancy and recommends strongly
against punitive policies:
• “Addiction is not primarily a moral weakness,
as it has been viewed in the past, but a ‘brain
disease’ that should be included in a review of
systems just like any other biologic disease pro-
cess.”
• “Recommended screening .connected with legal-
ly mandated testing or reporting endanger[s] the
relationship of trust between physician and
patient, place[s] the obstetrician in an adver-
sarial relationship with the patient, and possibly
conflict[s] with the therapeutic obligation.”
• Punitive policies “are unjust in that they indict
the woman for failing to seek treatment that
actually may not be available to her” and in that
they “are not applied evenly across sex, race,
and socioeconomic status.”
2013 COMPENDIUM OF SELECTED PUBLICATIONS 73
 • Physicians must make a substantial effort to
“treat the patient with a substance abuse prob-
lem with dignity and respect in order to form a
therapeutic alliance.”
Finally, recent legal decisions affirm that physi-
cians have neither an obligation nor a right to per-
form prenatal testing for alcohol or drug use without
a pregnant woman’s consent (22, 23). This includes
consent to testing of the woman that could lead to
any form of reporting, both to legal authorities for
purposes of criminal prosecution and to civil child
welfare authorities.
Against Coercive and Punitive Legal Approaches
to the Maternal–Fetal Relationship
This section addresses specifically the ethical issues
associated with the cases outlined previously and
delineates six reasons why restricting patients’ lib-
erty and punishing pregnant women for their actions
during pregnancy that may affect their fetuses is
neither wise nor justifiable. Each raises important
objections to punishing pregnant women for actions
during pregnancy; together they provide an over-
whelming rationale for avoiding such approaches.
1. Coercive and punitive legal approaches to preg-
nant women who refuse medical advice fail to
recognize that all competent adults are entitled to
informed consent and bodily integrity.
A fundamental tenet of contemporary medical eth-
ics is the requirement for informed consent, includ-
ing the right of competent adults to refuse medical
intervention. The Committee on Ethics affirms that
informed consent for medical treatment is an ethi-
cal requirement and is an expression of respect for
the patient as a person with a moral right to bodily
integrity (19).
The crucial difference between pregnant and
nonpregnant individuals, though, is that a fetus is
involved whose health interests could arguably be
served by overriding the pregnant woman’s wishes.
However, in the United States, even in the case of
two completely separate individuals, constitutional
law and common law have historically recognized
the rights of all adults, pregnant or not, to informed
consent and bodily integrity, regardless of the
impact of that person’s decision on others. For
instance, in 1978, a man suffering from aplastic
anemia sought a court order to force his cousin,
who was the only compatible donor available, to
COMMITTEE OPINIONS
submit to bone marrow harvest. The court declined,
explaining in its opinion:
For our law to compel the Defendant to submit to an
intrusion of his body would change every concept
and principle upon which our society is founded.
To do so would defeat the sanctity of the individual
and would impose a rule which would know no lim-
its. . . . For a society that respects the rights of one
individual, to sink its teeth into the jugular vein or
neck of its members and suck from it sustenance for
another member, is revolting to our hard-wrought
concepts of jurisprudence. Forcible extraction of
living body tissues causes revulsion to the judicial
mind. Such would raise the specter of the swastika
and the Inquisition, reminiscent of the horrors this
portends. (24)
Justice requires that a pregnant woman, like
any other individual, retain the basic right to refuse
medical intervention, even if the intervention is in
the best interest of her fetus. This principle was
challenged unsuccessfully in June 1987 with the
case of a 27-year-old woman who was at 25 weeks
of gestation when she became critically ill with
cancer. Against the wishes of the woman, her fam-
ily, and her physicians, the hospital obtained a court
order for a cesarean delivery, claiming independent
rights of the fetus. Both mother and infant died
shortly after the cesarean delivery was performed.
Three years later, the District of Columbia Court of
Appeals vacated the court-ordered cesarean deliv-
ery and held that the woman had the right to make
health care decisions for herself and her fetus, argu-
ing that the lower court had “erred in subordinating
her right to bodily integrity in favor of the state’s
interest in potential life” (1).
2. Court-ordered interventions in cases of informed
refusal, as well as punishment of pregnant women
for their behavior that may put a fetus at risk,
neglect the fact that medical knowledge and pre-
dictions of outcomes in obstetrics have limitations.
Beyond its importance as a means to protect the
right of individuals to bodily integrity, the doctrine
of informed consent recognizes the right of indi-
viduals to weigh risks and benefits for themselves.
Women almost always are best situated to understand
the importance of risks and benefits in the context
of their own values, circumstances, and concerns.
Furthermore, medical judgment in obstetrics itself
has limitations in its ability to predict outcomes. In
this document, the Committee on Ethics has argued
that overriding a woman’s autonomous choice,
whatever its potential consequences, is neither ethi-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 74
 cally nor legally justified, given her fundamental
rights to bodily integrity. Even those who challenge
these fundamental rights in favor of protecting the
fetus, however, must recognize and communicate
that medical judgments in obstetrics are fallible (25).
And fallibility—present to various degrees in all
medical encounters—is sufficiently high in obstet-
ric decision making to warrant wariness in impos-
ing legal coercion. Levels of certainty underlying
medical recommendations to pregnant women are
unlikely to be adequate to justify legal coercion and
the tremendous impact on the lives and civil liber-
ties of pregnant women that such intervention would
entail (26). Some have argued that court-ordered
intervention might plausibly be justified only when
certainty is especially robust and the stakes are
especially high. However, in many cases of court-
ordered obstetric intervention, the latter criterion has
been met but not the former. Furthermore, evidence-
based medicine has revealed limitations in the abil-
ity to concretely describe the relationship of maternal
behavior to perinatal outcome. Criminalizing women
in the face of such scientific and clinical uncertainty
is morally dubious. Not only do these approaches fail
to take into account the standards of evidence-based
medical practice, but they are also unjust, and their
application is likely to be informed by bias and opin-
ion rather than objective assessment of risk.
Consider, first, the limitations of medical judg-
ment in predicting birth outcomes based on mode
of childbirth. A study of court-ordered obstetric
interventions suggested that in almost one third of
cases in which court orders were sought, the medical
judgment was incorrect in retrospect (27). One clear
example of the challenges of predicting outcome is
in the management of risk associated with shoulder
dystocia in the setting of fetal macrosomia—which
is, and should be, of great concern for all practitio-
ners. When making recommendations to patients,
however, practitioners have an ethical obligation to
recognize and communicate that accurate diagno-
sis of macrosomia is imprecise (20). Furthermore,
although macrosomia increases the risk of shoulder
dystocia, it is certainly not absolutely predictive;
in fact, most cases of shoulder dystocia occur
unpredictably among infants of normal birthweight.
Given this uncertainty, ACOG makes recommenda-
tions about when cesarean delivery may be con-
sidered, not about when it is absolutely indicated.
Because of the inability to determine with certainty
when a situation is harmful to the fetus or preg-
COMMITTEE OPINIONS
nant woman and the inability to guarantee that the
pregnant woman will not be harmed by the medical
intervention, great care should be exercised to pres-
ent a balanced evaluation of expected outcomes for
both parties (20). The decision about weighing risks
and benefits in the setting of uncertainty should
remain the pregnant woman’s to make in the setting
of supportive, informative medical care.
Medical judgment also has limitations in that
the relationship of maternal behavior to pregnancy
outcome is poorly understood and may be exag-
gerated in realms often mistaken to be of moral
rather than medical concern, such as drug use. For
instance, recent child development research has not
found the effects of prenatal cocaine exposure that
earlier uncontrolled studies reported (28). It is now
understood that poverty and its concomitants—poor
nutrition and inadequate health care—can account
for many of the effects popularly attributed to
cocaine. Before these data emerged, the criminal
justice approach to drug addiction during pregnancy
was fueled to a great degree by what is now under-
stood to be the distorting image of the “crack baby.”
Such an image served as a “convenient symbol
for an aggressive war on drug users [that] makes
it easier to advocate a simplistic punitive response
than to address the complex causes of drug use”
(29). The findings questioning the impact of cocaine
on perinatal outcome are among many consider-
ations that bring sharply into question any possible
justification for a criminal justice approach, rather
than a public health approach, to drug use during
pregnancy. Given the incomplete understanding of
factors underlying perinatal outcomes in general and
the contribution of individual behavioral and socio-
economic factors in particular, to identify homeless
and addicted women as personally, morally, and
legally culpable for perinatal outcomes is inaccu-
rate, misleading, and unjust.
3. Coercive and punitive policies treat medical
problems such as addiction and psychiatric ill-
ness as if they were moral failings.
Regardless of the strength of the link between an
individual’s behaviors and pregnancy outcome,
punitive policies directed at women who use drugs
are not justified, because these policies are, in effect,
punishing women for having a medical problem.
Although once considered a sign of moral weakness,
addiction is now, according to evidence-based medi-
cine, considered a disease—a compulsive disorder
2013 COMPENDIUM OF SELECTED PUBLICATIONS 75
 requiring medical attention (30). Pregnancy should
not change how clinicians understand the medical
nature of addictive behavior. In fact, studies over-
whelmingly show that pregnant drug users are very
concerned about the consequences of their drug use
for their fetuses and are particularly eager to obtain
treatment once they find out they are pregnant (31,
32). Despite evidence-based medical recommenda-
tions that support treatment approaches to drug use
and addiction (21), appropriate treatment is particu-
larly difficult to obtain for pregnant and parenting
women and the incarcerated (29). Thus, a disease
process exacerbated by social circumstance—not
personal, legal, or moral culpability—is at the heart
of substance abuse and pregnancy. Punitive poli-
cies unfairly make pregnant women scapegoats for
medical problems whose cause is often beyond their
control.
In most states, governmental responses to preg-
nant women who use drugs have upheld medical
characterizations of addiction. Consistent with long-
standing U.S. Supreme Court decisions recognizing
that addiction is an illness and that criminalizing it
violates the Constitution’s Eighth Amendment prohi-
bitions against cruel and unusual punishment, no state
has adopted a law that specifically creates unique
criminal penalties for pregnant women who use drugs
(33). However, in South Carolina, using drugs or
being addicted to drugs was effectively criminalized
when the state supreme court inter­preted the word
“child” in the state’s criminal child endangerment
statute to include viable fetuses, making the child
endangerment statute applicable to pregnant women
whose actions risk harm to a viable fetus (23). In all
states, women retain their Fourth Amendment free-
dom from unreasonable searches, so that pregnant
women may not be subject to nonconsensual drug
testing for the purpose of criminal prosecution.
Partly on the basis of the understanding of addic-
tion as a compulsive disorder requiring medical atten-
tion, medical professionals, U.S. state laws, and the
vast majority of courts do not support unique criminal
penalties for pregnant women who use drugs.
4. Coercive and punitive policies are potentially
counterproductive in that they are likely to dis-
courage prenatal care and successful treatment,
adversely affect infant mortality rates, and under-
mine the physician–patient relationship.
Even if the aforementioned ethical concerns could
be addressed, punitive policies would not be justi-
COMMITTEE OPINIONS
fiable on utilitarian grounds, because they would
likely result in more harm than good for maternal
and child health, broadly construed. Various studies
have suggested that attempts to criminalize pregnant
women’s behavior discourage women from seeking
prenatal care (34, 35). Furthermore, an increased
infant mortality rate was observed in South Carolina
in the years following the Whitner v State decision
(36), in which the state supreme court concluded
that anything a pregnant woman does that might
endanger a viable fetus (including, but not limited
to, drug use) could result in either charges of child
abuse and a jail sentence of up to 10 years or homi-
cide and a 20-year sentence if a stillbirth coincides
with a positive drug test (23). As documented pre-
viously (21), threats and incarceration have been
ineffective in reducing the incidence of alcohol and
drug abuse among pregnant women, and removing
children from the home of an addicted mother may
subject them to worse risks in the foster care system.
In fact, women who have custody of their children
complete substance abuse treatment at a higher rate
(37–39).
These data suggest that punishment of preg-
nant women might not result in women receiving
the desired message about the dangers of prenatal
substance abuse; such measures might instead send
an unintended message about the dangers of pre-
natal care. Ultimately, fear surrounding prenatal
care would likely undermine, rather than enhance,
maternal and child health. Likewise, court-ordered
interventions and other coercive measures may
result in fear about whether one’s wishes in the
delivery room will be respected and ultimately
could discourage pregnant patients from seeking
care. Encouraging prenatal care and treatment in a
supportive environment will advance maternal and
child health most effectively.
5. Coercive and punitive policies directed toward
pregnant women unjustly single out the most vul-
nerable women.
Evidence suggests that punitive and coercive poli-
cies not only are ethically problematic in and of
themselves, but also unfairly burden the most vul-
nerable women. In cases of court-ordered cesarean
deliveries, for instance, the vast majority of court
orders have been obtained against poor women of
color (27, 40).
Similarly, decisions about detection and man-
agement of substance abuse in pregnancy are fraught
2013 COMPENDIUM OF SELECTED PUBLICATIONS 76
 with bias, unfairly burdening the most vulnerable
despite the fact that addiction occurs consistently
across race and socioeconomic status (41). In the
landmark case of Ferguson v City of Charleston,
which involved selective screening and arrest of
pregnant women who tested positive for drugs, 29 of
30 women arrested were African American. Studies
suggest that affluent women are less likely to be
tested for use of illicit drugs than poor women of
color, perhaps because of stereotyped but demon-
strably inaccurate assumptions about drug use.
One study found that despite similar rates of
substance abuse across racial and socioeconomic
status, African–American women were 10 times
more likely than white women to be reported to
public health authorities for substance abuse dur-
ing pregnancy (42). These data suggest that, as
implemented, many punitive policies centered on
maternal behaviors, including substance use, are
deeply unjust in that they reinforce social and racial
inequality.
6. Coercive and punitive policies create the poten-
tial for criminalization of many types of otherwise
legal maternal behavior.
In addition to raising concerns about race and socio-
economic status, punitive and coercive policies
may have even broader implications for justice for
women. Because many maternal behaviors are asso-
ciated with adverse pregnancy outcome, these poli-
cies could result in a society in which simply being
a woman of reproductive potential could put an indi-
vidual at risk for criminal prosecution. For instance,
poorly controlled diabetes is associated with numer-
ous congenital malformations and an excessive rate
of fetal death. Periconceptional folic acid deficiency
is associated with an increased risk of neural tube
defects. Obesity has been associated in recent stud-
ies with adverse pregnancy outcomes, including
preeclampsia, shoulder dystocia, and antepartum
stillbirth (43, 44). Prenatal exposure to certain
medications that may be essential to maintaining a
pregnant woman’s health status is associated with
congenital abnormalities. If states were to consis-
tently adopt policies of punishing women whose
behavior (ranging from substance abuse to poor
nutrition to informed decisions about prescription
drugs) has the potential to lead to adverse perinatal
outcomes, at what point would they draw the line?
Punitive policies, therefore, threaten the privacy and
autonomy not only of all pregnant women, but also
of all women of reproductive potential.
COMMITTEE OPINIONS
Recommendations
In light of these six considerations, the Committee
on Ethics strongly opposes the criminal prosecution
of pregnant women whose activities may appear to
cause harm to their fetuses. Efforts to use the legal
system specifically to protect the fetus by constrain-
ing women’s decision making or punishing them for
their behavior erode a woman’s basic rights to pri­
vacy and bodily integrity and are neither legally nor
morally justified. The ACOG Committee on Ethics
therefore makes the following recommendations:
• In caring for pregnant women, practitioners
should recognize that in the majority of cases,
the interests of the pregnant woman and her
fetus converge rather than diverge. Promoting
pregnant women’s health through advocacy of
healthy behavior, referral for substance abuse
treatment and mental health services when nec-
essary, and maintenance of a good physician–
patient relationship is always in the best interest
of both the woman and her fetus.
• Pregnant women’s autonomous decisions
should be respected. Concerns about the impact
of maternal decisions on fetal well-being should
be discussed in the context of medical evidence
and understood within the context of each
woman’s broad social network, cultural beliefs,
and values. In the absence of extraordinary
circumstances, circumstances that, in fact, the
Committee on Ethics cannot currently imagine,
judicial authority should not be used to imple-
ment treatment regimens aimed at protecting
the fetus, for such actions violate the pregnant
woman’s autonomy.
• Pregnant women should not be punished for
adverse perinatal outcomes. The relation-
ship between maternal behavior and perinatal
outcome is not fully understood, and puni-
tive approaches threaten to dissuade pregnant
women from seeking health care and ultimately
undermine the health of pregnant women and
their fetuses.
• Policy makers, legislators, and physicians
should work together to find constructive and
evidence-based ways to address the needs of
women with alcohol and other substance abuse
problems. This should include the development
of safe, available, and efficacious services for
women and families.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 77
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21. At-risk drinking and illicit drug use: ethical issues in
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COMMITTEE OPINIONS
22. Ferguson v. City of Charleston, 532 U.S. 67 (2001).
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U.S. General Accounting Office; 1990.
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publications/data/kc2004_e.pdf. Retrieved June 17, 2005.
37. Haller DL, Knisely JS, Elswick RK Jr, Dawson KS,
Schnoll SH. Perinatal substance abusers: factors influenc-
ing treatment retention. J Subst Abuse Treat 1997;14:
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38. Hohman MM, Shillington AM, Baxter HG. A comparison
of pregnant women presenting for alcohol and other drug
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Characterizing pregnant drug-dependent women in treat-
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27–34.
40. Nelson LJ, Marshall MF. Ethical and legal analyses
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 42. Chasnoff IJ, Landress HJ, Barrett ME. The prevalence of
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N Engl J Med 1990;322:1202–6.
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COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 79

 ACOG
Committee on
Ethics
Reaffirmed 2008
Copyright © November 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or trans-
mitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or
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permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
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ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Using preimplantation embryos
for research. ACOG Committee
Opinion No. 347. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:1305–17.
COMMITTEE OPINIONS
Committee
Opinion
Number 347, November 2006
Using Preimplantation Embryos
for Research*
ABSTRACT: Human embryonic stem cell research promises an increased
understanding of the molecular process underlying cell differentiation.
Transplantation of embryonic stem cells or their derivatives may, in the
future, offer therapies for human diseases. In this Committee Opinion, the
American College of Obstetricians and Gynecologists (ACOG) Committee
on Ethics presents an ethical framework for examining issues surrounding
research using preimplantation embryos and proposes ethical guidelines for
such research. The Committee acknowledges the diversity of opinions among
ACOG members and affirms that no physician who finds embryo research
morally objectionable should be required or expected to participate in such
research. The Committee supports embryo research within 14 days after
evidence of fertilization but limits it according to ethical guidelines. The
Committee recommends that cryopreserved embryos be the preferred source
for research but believes that the promise of somatic cell nuclear transfer is
such that research in this area is justified. The Committee opposes reproduc-
tive cloning. Intended parents for whom embryos are created should give
informed consent for the disposition of any excess embryos. The donors of
gametes or somatic cells used in the creation of such tissue should give con-
sent for donation of embryos for research. Abandoned embryos should not
be accepted for research. Potential research projects should be described
to potential donors as much as possible. Donation of embryos for stem cell
research requires specific consent. The Committee believes that compensa-
tion for egg donors for research is acceptable, consistent with American
Society for Reproductive Medicine guidelines.
The human embryo† has long attracted the interest of researchers. Initially,
scientists studying embryos hoped to better understand human pregnancy
and embryonic development. Later, with the emergence of assisted repro-
ductive technologies such as in vitro fertilization (IVF), embryo research
focused on optimizing pregnancy rates and outcomes. Most recently,
research has targeted the stem cells derived from embryos because stem cell
*Update of “Preembryo Research” in Ethics in Obstetrics and Gynecology,
Second Edition, 2004
†
Terms defined in the glossary appear in bold type.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 80
 research promises an increased understanding of the
molecular process underlying cell differentiation
(the process of acquiring characteristics of specific
tissues and organs). Transplantation of embryonic
stem cells or their derivatives may, in the future,
offer therapies for human diseases. These possi-
bilities, coupled with the demonstration in 1998 that
stem cells could be isolated from either the inner
cell mass of blastocysts or fetal germ cell tissue,
have sparked public debate on the ethical foundation
of stem cell work specifically and embryo research
in general. The urgency of these questions makes
it timely both to review the moral issues raised by
human embryo research and to consider appropriate
guidelines for the ethical conduct of these endeavors.
The Committee on Ethics acknowledges the
diversity of opinions regarding these topics among
members of the American College of Obstetricians
and Gynecologists (ACOG), a diversity mirroring
that in society at large. These diverse positions
range from complete rejection of all human embryo
research to approval of the deliberate creation of
human embryos for research. Even among those
who accept embryo research on ethical grounds,
there is disagreement about the conditions under
which it may ethically be conducted.
The purpose of this Committee Opinion is to
present a relevant ethical framework within which to
view contemporary embryo research and to propose
ethical guidelines for such research. The opinion
focuses specifically on issues relating to research
using preimplantation embryos. The Committee
recognizes that the science of this field, especially
the science of stem cell research and therapy, is
changing rapidly and anticipates that future changes
will require revisiting past issues and either modi-
fying previous guidelines or creating new ones in
order to address formerly unimagined possibilities.
Historical Perspective: Policies and
Regulation
Oversight and regulation of research involving
human reproduction, especially that involving fertil-
ized eggs and embryos, have a long and contentious
history linked both to the politics of abortion and to
the introduction of IVF into clinical practice (Fig. 1).
Certainly, clinical progress with assisted reproduc-
tive technologies requires research, yet performing
such research raises important questions about how
the needed tissues should be obtained and treated.
COMMITTEE OPINIONS
Several events and issues, including the U.S.
Supreme Court’s decision on abortion in Roe v.
Wade and revelations of abuses in human subjects
research, led Congress in 1974 to establish the
National Commission for the Protection of Human
Subjects. On the basis of guidelines proposed by the
National Commission in 1975, the then Department
of Health, Education, and Welfare issued regulations
for federal funding of research involving human
fetuses. These regulations defined the fetus as the
product of conception from the time of implanta-
tion on (1). The regulations also recommended the
appointment of an ethical advisory board to examine
unresolved questions. The Ethics Advisory Board
(EAB) was appointed in 1978, shortly before the
first birth from IVF, with a mandate to review both
IVF research and research using embryos resulting
from IVF.
In its 1979 report, the EAB stated, “The human
embryo is entitled to profound respect; but this
respect does not necessarily encompass the full
legal and moral rights attributed to persons” (2). The
EAB statement supported the ethical acceptability of
research to study and develop the safety and efficacy
of IVF and embryo transfer techniques used for the
treatment of infertility. The EAB also accepted the
use of gametes of informed, married, and consent-
ing donors in such research, provided that develop-
ing embryos were not sustained longer than 14 days
in vitro, a limit chosen in part because the primitive
streak is formed at this juncture. In its statement, the
EAB did not distinguish between “excess” embryos
from IVF therapy and embryos “created solely for
research.” In fact, the EAB implied that research
may require the creation of embryos that, because
of concerns for safety, would never be intended for
transfer.
Because of public and political opposition to
embryo research, however, EAB guidelines were
never implemented, and the board’s charter was
allowed to expire in 1980, effectively imposing a
moratorium on federal funding of IVF and embryo
research because existing legislation required the
oversight of an ethical advisory board as a prereq-
uisite. Thus, any embryo research conducted in
the United States at that time had to use private or
university funding and often was undertaken in the
context of infertility treatment. Recognizing the
ethical and regulatory challenges associated with
the conduct of research outside of federal oversight,
the Ethics Committee of the American Fertility
2013 COMPENDIUM OF SELECTED PUBLICATIONS 81
 Stem cell research
National Bioethics funding bill passes
Advisory U.S. House of
Dickey Commission
Amendment Representatives
supports federal and U.S. Senate,
prohibits fed- funding for stem
eral funding for vetoed by
Ethics Advisory cell research President Bush.

COMMITTEE OPINIONS
any research in involving embryos
Board charter
which an embryo remaining after
expires, effectively
is destroyed or infertility treatment.
imposing a
harmed.
moratorium on Referendum in
U.S. Congress federal funding California approves
of IVF and American Fertility Clinton administration state funding for
establishes American Fertility
embryo research. Society publishes determines that the stem cell research
the National Society publishes
ethical guide- Dickey Amendment and establishes the
Commission ethical guide-
Louise Brown, lines for embryo does not prohibit California Institute
for the lines for embryo
the first IVF research. federal funding for Regenerative
Protection research.
baby, is born for research on Medicine.
of Human
in England. established human
Subjects.
stem cell lines.

74 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 000 001 002 003 004 005 006
19 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2

President
National American Fertility Human Embryo George W. Bush
Commission Society publishes Research Panel restricts federal
recommends ethical guide- is appointed and funding for
that an ethical lines for embryo approves embryo embryonic stem
advisory board be research. research for cell research to
appointed for in specific purposes. stem cell lines
vitro fertilization existing as of
(IVF) research. August 9, 2001.
Ethics Advisory Congress revokes Stem cells
Board report the requirement isolated Bill to expand
supports the of Ethics Advisory from human federal fund-
ethical Board approval embryonic ing for stem cell
acceptability and permits the and fetal research passes
of research on National Institutes tissues. in U.S. House of
IVF. of Health to fund Representatives, is
such research. under consideration
in U.S. Senate.

Fig. 1. Embryo research timeline. The American Fertility Society became the American Society for Reproductive Medicine in 1995.

2013 COMPENDIUM OF SELECTED PUBLICATIONS

82
 Society (now American Society for Reproductive
Medicine [ASRM]) issued specific guidelines for
conducting such work (3–5). The ASRM commit-
tee endorsed embryo research but, echoing earlier
guidelines, recommended that human embryos not
be maintained for research beyond the 14th day
after fertilization (3, 4). The same group noted that
because of the “high moral value” accorded to pre-
implantation embryos, research using these tissues
required “strong justification,” but later the group
also recognized that some “studies may require the
production of human [preimplantation embryos] as
an integral part of the analysis” (5). In the face of
ongoing debate at a federal level, privately funded
research in the United States has been influenced by
these ASRM recommendations.
Federal funding of embryo research was further
limited in 1995 with passage of the Dickey Amend­
ment, in which Congress prohibited the use of any
federal funds for “creation of a human embryo(s)
for research purposes or research in which a human
embryo(s) are destroyed, discarded, or knowingly
subjected to risk of injury or death for research pur-
poses” (6). A similar Dickey Amendment has been
attached to the appropriations bill for the Depart­
ment of Health and Human Services in every year
since. Thus, by the mid-1990s, although the pursuit
of embryo research was not prohibited by the federal
government, the ban on federal funding limited its
conduct.
The isolation of stem cells from embryonic and
fetal tissues in 1998 engendered debate about how
existing regulations and guidelines should guide
research with such cells. In 1999, the general counsel
of the Department of Health and Human Services
during the Clinton administration argued that the
literal language of the Dickey Amendment permitted
funding of embryonic stem cell research as long as the
stem cell line had been derived through research that
was not federally funded. Under this interpretation,
the use of embryonic stem cells would not constitute
research “in which an embryo was destroyed, discard-
ed, or subjected to risk of injury.” That same year, the
National Bioethics Advisory Commission, a group
charged with identifying “broad principles to gov-
ern the ethical conduct of research,” recommended
federal support for stem cell research using embryos
remaining after infertility treatments, but opposed
creation of embryos specifically for research (7).
In contrast to these recommendations, in August
2001, the Bush administration announced what re-
COMMITTEE OPINIONS
mains the current federal funding policy for embry-
onic stem cell research (8). This policy permits
federal funding only for work using stem cell lines
in existence on August 9, 2001; derived from excess
embryos created solely for reproductive purposes;
and made available with the informed consent of
the donors. Although critics note several important
limitations that these regulations place on U.S.
researchers (see “Are There Alternatives to Using
Preimplantation Embryos for Research?”), the regu-
lations remain active and unchanged as of late 2006.
However, funding of stem cell research using fetal
tissues (eg, obtained from abortus materials) is
still permitted—although perhaps less frequently
performed—under the Fetal Tissue Transplantation
Research Act (9) and guidelines established during
the Clinton administration.
Current Clinical Practices
Practices and policies for the care of patients are
likely to inform attitudes and future guidelines
regarding the use of embryos for research. Before
addressing specific questions on stem cell and
other embryo research, established clinical practices
involving gametes and embryos are noted briefly. A
complete review of each area and its moral founda-
tion is, however, beyond the scope of this Commit­
tee Opinion.
In Vitro Fertilization
Current IVF techniques often result in the creation
of more embryos than can be transferred safely to a
woman’s uterus for implantation. Practitioners and
patients should anticipate this possibility by having
patients prospectively consider the matter and detail
their wishes regarding such excess embryos. Many
have advocated, for example, “prefreeze agree-
ments” in which patients indicate their wishes for
disposition of frozen embryos in the event of life-
changing circumstances such as death or divorce.
Advance discussions and agreements do not, how-
ever, preclude the need to continue discussion at
the time final decisions regarding frozen embryos
are made, for researchers have demonstrated the
difficulties couples have processing this counseling
at the time of creating embryos for reproductive
purpose (10). The ASRM and individual states rec-
ognize the right of appropriate individuals to make
such decisions regarding embryos. Such options
include extended freezing, destruction of embryos
2013 COMPENDIUM OF SELECTED PUBLICATIONS 83
 either by failing to transfer or freeze or later thaw-
ing without transfer, and donation for attempted
implantation by another individual or couple. The
ACOG Committee on Ethics recognizes all of these
options as reasonable and appropriate and in so
doing accepts that it is the individual or couple who
created the embryos, either with their own or donor
gametes, who are entitled to make these decisions.
This current Committee Opinion outlines ethical
considerations related to the option of using preim-
plantation embryos for research.
Gamete Donation
Both egg and sperm may be donated either anony-
mously or by directed donation to specific individu-
als or couples. Donated gametes are widely used for
infertility treatment, and sperm and egg obtained in
excess of what is needed for such treatments have,
with appropriate consent, later been used for research.
Gametes also have been donated for research pur-
poses only, separate from any plans for infertility
treatment and therapy, and the Committee on Ethics
supports such donation. In the past, research using
gametes has included studies designed to optimize
IVF techniques and work examining gamete cryo-
preservation. The donation of oocytes for research
purposes is controversial, however, and has raised
what ASRM terms “special concern” (5) because of
the risk, pain, and side effects involved in the process
of egg donation and because of concerns about pos-
sible exploitation of donors.
Embryo Research: Ethical Questions
What Is the Moral Status of the Embryo?
In debates about the ethics of embryo research, the
central ethical question historically has focused
on the embryo’s “moral status” and whether the
embryo is deserving of the same rights and protec-
tions as a child or adult person. This Committee
Opinion is based on the view that although the
preimplantation embryo merits respect, its moral
status is not equivalent to that of a human being.
Scientific information alone will never resolve ques-
tions about the embryo’s moral status. However,
several distinguishing features of preimplantation
embryos inform the evaluation of the moral status
of the embryo and, hence, the ethical arguments
concerning embryo research. Figure 2 outlines the
development of pregnancy from gamete to fetus, a
COMMITTEE OPINIONS
path that highlights the distinguishing characteristics
of pre­im­plantation embryos:
1. Early embryonic cells are undifferentiated. Until
the blastocyst stage, each cell is totipotent, hav-
ing the capacity to differentiate into any of the
cell or tissue types of the fetus or to form pla-
cental and other extra-embryonic tissues. Each
of the cells of the inner cell mass of the blasto-
cyst is pluripotent, with the capacity to become
any of the cell or tissue types of the fetus, but at
this stage, these cells form a collection of undif-
ferentiated cells rather than a unified organism.
2. Embryos at early stages lack individuation. This
is evidenced by research demonstrating that, up
to at least the 8-cell stage, one or more blasto-
meres can be removed from the embryo (eg, as
for preimplantation genetic diagnosis [PGD])
and the remaining blastomeres can still produce
a complete human being. Also, from the initial
stages of cell division until the formation of
the primitive streak, the embryo is capable of
dividing into more than one entity (ie, twin-
ning). Only after this period has differentiation
of embryonic cells advanced to the point that
separation can no longer result in two or more
individuals (11–13).
3. The formation of the primitive streak at day
14 marks the beginning of the differentiation
of cells into the various tissues and organs of
the human body. Before the appearance of the
primitive streak, the cells of the embryo are
undif­ferentiated and pluripotent. Recognizing
this biologic landmark, many, now including
the ACOG Committee on Ethics, have recom-
mended limiting embryo research to the first 14
days after fertilization.
4. If the preimplantation embryo is left or main-
tained outside the uterus, it cannot develop into
a human being. Continuing potential for life
exists if, but only if, the embryo is transferred
to the uterus for implantation (this potential will
have important implications for the conduct of
research and therapy involving embryos). If
never implanted, development ceases. In the
United Kingdom, regulations focus on implan-
tation as a key to distinguishing moral status of
in vitro and cloned embryos from that of an in
vivo pregnancy (14). In the United States, fed-
eral regulations on fetal research apply from the
time of implantation on (1).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 84
 Developmental Stage
Requisite or Resultant Developmental
Day Process* Cells/Structures Mor­phol­o­gy

0 Oocyte Single germ cell

Sperm Single germ cell

1 Fertilization begins

Fertilization complete Zygote 1 cell (male and

(syngamy) after 24 hours female pronuclei)

2 Cell division begins Embryo 2 cells (nu­clei)

     Blastomeres (totipotential)

Genomic expression 4–8 cells

begins

     Morula 8–16 cells

(compacted)

     Blastocyst Multicellular

(inner cell mass
and trophectoderm)

5 Implantation begins† 
or
after
7 Differentiation begins
or
after
Cell division ends‡

8–9 Implantation complete§ Embryonic disc

or
after
14–16 Embryogenesis begins; Primitive streak
differentiation has passed
point of twinning

*Both in vivo and in vitro except as noted.

†
In vivo—organizational structure as a blas­to­cyst is requisite to beginning of implantation and per­sists after implantation (which may be
com­plete as ear­ly as 8–9 days after fer­til­i­za­tion) until ap­pear­ance of the primitive streak.
‡
Cell division may end at any time in vivo or in vitro; it has not persisted in vitro beyond 6–9 days.
§
In vivo.

Fig. 2. Early in vivo and in vitro human development process.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 85

 Why Pursue Embryo Research?
Most contemporary discussions about embryo
research center entirely on the question of the
embryo’s intrinsic moral status—whether or not the
embryo meets specific criteria for moral personhood.
Based on the understanding of the degree to which an
embryo does or does not meet such criteria, these dis-
cussions have taken a stand about the permissibility
of options for embryo disposition. Bioethicist Patricia
King has noted that human embryo research policy
should do more than reflect mere abstract assertions
about the moral status of human embryos. Rather,
the moral underpinnings of human embryo research
should be derived from a range of values, including
the facilitation of human procreation, the advance-
ment of applied scientific knowledge, the reduction
of human suffering, and the protection of vulnerable
persons from coercion and exploitation (15).
There can be no compelling argument for
embryo research without the promise of benefit.
Potential benefits of embryo research include an
improved understanding of fertilization, implanta-
tion, and early pregnancy biology and, with this
understanding, possibly fewer undesired outcomes,
such as miscarriage. For infertile couples, embryo
research offers the possibility of more effective
therapies: research efforts helped optimize condi-
tions for intracytoplasmic sperm injection, embryo
culture, and cryopreservation, for example. For
others at risk for heritable genetic disease who feel
pregnancy termination is undesirable or inappropri-
ate, embryo research has led to the possibility of
early, accurate genetic diagnosis: PGD provides
diagnostic results at a point before implantation, so
pregnancy termination can be avoided. In addition
to these benefits of embryo research in general,
stem cell research promises additional potential
benefits, for such work may lead both to a better
understanding of the processes leading to tissue
differentiation and function and to possible thera-
pies by creating lines that can replace diseased or
nonfunctioning tissues. Those who donate gametes
or embryos for research are offered the rewards
of potentially extending scientific knowledge and,
apart from any current or future hope of improv-
ing their own health, the opportunity to help oth-
ers with this knowledge. Indeed, in considering
the fate of excess embryos for which destruction
is planned, some have argued that donation for
research accords the embryo more respect than
destruction alone (16, 17).
COMMITTEE OPINIONS
Are There Alternatives to Using Preimplantation
Embryos for Research?
As with all human research, research on embryos
and embryonic stem cells should be engaged in
only when alternative means of developing knowl-
edge are inadequate. Whenever possible, animal
models or cell and tissue culture systems should be
used to advance the understanding of human biol-
ogy. However, direct extrapolation of results from
in vitro animal embryo studies to humans can be
misleading. Unfertilized oocytes also do not offer
the same opportunities for investigating growth pro-
cesses that embryos do.
Some have argued that obtaining or using
embryonic stem cells is unnecessary because stem
cells have been or can be isolated from umbilical
cord blood or adult tissues, such as brain and skin.
Yet such adult stem cells, in contrast to embryonic
stem cells, have already progressed along the path of
differentiation and lack the plasticity of embryonic
stem cells. It is unlikely that once differentiated,
these cells can be induced to form the range of
tissues that can, by contrast, be produced by less-
differentiated embryonic stem cells (18, 19).
Umbilical cord blood stem cells have been
shown in some studies to transdifferentiate to a
limited extent into nonhematopoietic cells, includ-
ing those of the brain, heart, liver, pancreas, bone,
and cartilage, in experimental culture and animal
systems (20, 21). Some have speculated that, on
the basis of these observations, cord blood might
serve as a source of cells to facilitate tissue repair
and regeneration in the distant future. Research is
needed to clarify the role, if any, of cord blood in
this field of regenerative medicine.
For those with ethical objections, recent activity
in stem cell research has led to a vigorous search
for alternative sources of stem cells that might
obviate the need to use or destroy fresh or fro-
zen embryos (22). Suggested techniques include 1)
extrac­tion of cells from embryos already dead, 2)
nonharmful biopsy of a single blastomere from a
living embryo, 3) extraction of cells from artifi-
cially created nonembryonic but embryolike cellular
systems (engineered to lack the essential elements
of embryogenesis but still capable of some cell
division and growth), and 4) dedifferentiation of
somatic cells back to pluripotency. The Committee
on Ethics recognizes that such techniques, if ulti-
mately proved to be productive, would avoid some
but not all of the arguments and objections that
2013 COMPENDIUM OF SELECTED PUBLICATIONS 86
 have been raised to embryo and stem cell research.
The Committee believes, however, that until such
hypothetical alternatives become realities for human
tissues, their possibility should not stand as a bar-
rier to pursuing available methods of demonstrated
efficacy. Indeed, technical barriers to these proposed
alternatives are not trivial, and the possibility of
reprogramming adult stem cells to achieve the same
potential as embryonic stem cells has been termed
by experts as “exceedingly rare” (23). It also is not
clear that all these suggestions are free from ethical
concerns or objections (eg, distinguishing when an
embryo is “dead”).
In considering embryonic stem cell research, it
is also important to indicate why progress requires
isolation of lines different from those already estab-
lished. Federal regulations prohibit funding for
investigations of the many new embryonic stem
cell lines created since August 2001, some of which
have been used by both international and U.S.
researchers to advance the field. Yet, advocates of
stem cell research note that in contrast to several of
these newer lines, all lines on the National Institutes
of Health (NIH) registry were cultured in contact
with mouse cells and bovine serum, which limits
potential therapeutic applications. Furthermore, the
U.S. federal guidelines prohibit federal funding
of somatic cell nuclear transfer techniques (also
known as SCNT techniques) and research, which
may offer unique opportunities for human therapy
by creating cells tailored to an individual’s genotype
and thus, in theory, requiring less need for immuno-
suppression if therapeutics can one day be created
from such individualized cell lines.
Are There Arguments Against Embryo Research?
Balanced against any potential benefits of embryo
research are known and potential risks. Embryo
research usually will involve destruction of embryos
and, as a result, most human embryo research will
not benefit the embryo that is used—enhancing
neither its developmental potential nor its chance of
survival. It is this potential harm that has led national
ethics advisory committees and commissions to eval-
uate the moral status of the embryo and has sharply
separated the two sides of the embryo research and
stem cell debate. Yet, as detailed previously, this
document views destruction of in vitro embryos as
different from destruction of a human being.
Short of destruction, the manipulation of embry-
os that are intended for transfer to the uterus (as with
COMMITTEE OPINIONS
embryo biopsy for PGD) raises concern for potential
manipulation-related damage in ongoing pregnan-
cies. Some embryo research can be validated scien-
tifically and be beneficial clinically only if there is
a subsequent transfer of the embryo to a woman’s
uterus in an attempt to achieve pregnancy, yet until
such transfer is accomplished, it remains unknown
whether research interventions will enhance or
reduce the prospects for healthy life.
Women and couples who either participate in
research or donate gametes or embryos for research
also may be at risk. If a couple decides to donate
“excess” embryos for research, such as stem cell
extraction, they may be at risk for psychologic
harms such as uncertainty, stress, and anxiety. These
potential hazards are not exclusively related to the
option of donation of embryos for research purposes
and may accompany all decisions regarding the dis-
position of frozen embryos. When research requires
hormonal stimulation and retrieval of oocytes sepa-
rate from plans for pregnancy (ie, tissues obtained or
created for research alone), the oocyte donor faces
risks similar to those involved in oocyte donation for
reproductive purposes. It is essential to ensure that a
woman’s or couple’s choice is free of coercion and
possible exploitation and that the woman or couple
gives informed consent.
Recognizing such risks, some have expressed
concern regarding the potential to exploit women
as oocyte donors. In part to answer such concerns,
some guidelines such as those proposed by the
National Academy of Sciences recommend no
compensation for oocyte donation for research other
than for out-of-pocket expenses (24). Such restric-
tions, however, seem inappropriate to the ACOG
Committee on Ethics and are inconsistent with pol­
icy and practice concerning compensation both to
oocyte donors for reproductive purposes and women
participating in other types of research protocols.
Compensation for oocyte donation for reproductive
purposes is supported by ASRM (25) and is cus-
tomary in the United States, and there is no strong
argument for distinguishing this practice from dona-
tion in the research context. The risks to the woman
and the need to protect against potential abuses are
similar in the two situations. Payment to an oocyte
donor should be understood to be compensation for
the woman’s time, effort, risk, and discomfort and
not as payment for the eggs that may be recovered.
The level of compensation should be consistent with
ASRM guidelines intended to preclude payment
2013 COMPENDIUM OF SELECTED PUBLICATIONS 87
 levels that might be construed as exerting undue
influence on the donor (25). In providing advice to
those seeking oocyte donors, ASRM guidelines also
highlight the importance of protecting vulnerable
populations and providing compensation commen-
surate with the time and effort involved.
Who Should Give Permission for Embryos to Be
Used for Research?
Individuals will differ in their beliefs about morality
of and appropriate limits for embryo research. This
is true for individuals or couples creating embryos
as part of infertility treatment and later making
decisions regarding frozen embryos, as well as for
gamete donors, who may in some cases be different
from the individuals for whom the embryos were
created (26, 27). In considering the question of who
should give consent for research using preimplanta-
tion embryos, it is important to recognize that such
research may occur long after gametes have been
donated and embryos created, and in addition, the
details of future research questions and protocols
are unlikely to be known at the time of donation.
In many cases, of course, those supplying the egg
and sperm will be the same as those for whom the
embryo is created, and these circumstances pres-
ent the easiest conditions for obtaining appropriate,
informed consent for research. In such cases, cou-
ples may indicate at the time the embryos are frozen
that they would be willing to consider future dona-
tion for research, but specific permission needs to
be obtained at the later time when custody is trans-
ferred to the research team. If details of the research
protocol are known at the time embryos are frozen,
couples should be so informed. Alternatively, some
couples will be willing to donate unused embryos to
an appropriate party (eg, those operating the labora-
tory or storage facility) for use in future research
projects as yet unformulated at the time of donation.
If such work includes projects in stem cell research,
this should be specifically discussed and the details
of stem cell research (eg, creation of immortal cell
lines) described insofar as they are known at the
time of donation. If both members of the couple
have not previously given consent at the time cus-
tody is transferred, embryos should not be used for
research.
If gamete donors are different from those for
whom embryos were created, research should pro-
ceed only if gamete donors have been made aware
of the option of embryo research and have given
COMMITTEE OPINIONS
their consent to such research. Given the emotions
and discussion surrounding stem cell research,
potential research projects should be described as
much as possible. However, gamete donors need to
recognize that the details of future research projects
are unlikely to be available at the time of gamete
donation, and therefore donors need to be comfort-
able consenting to research that is described only in
general terms (28). Abandoned embryos, as defined
by the ASRM Ethics Committee (29, 30), should not
be accepted for research.
When embryo research is conducted in antici-
pation of transfer (for example, PGD research), the
intended parents and, if different, the gamete donors
must be provided with adequate information regard-
ing the nature of the research, the risks to the embryo,
and the chances for a successful pregnancy resulting
in the birth of a healthy child, and they must provide
their informed consent (31). If research is to be done
on an embryo that is to be transferred eventually
to a third party (a gestational carrier’s uterus), this
individual also should give informed consent for the
research.
Finally, choices should be made in circum-
stances free of financial or other coercion. Full
information should, therefore, include assurance that
consent to donation of embryos for research is not a
condition for receiving services and that fee scales
are not contingent on consent to research. Moreover,
donors of embryos should understand that they will
receive no compensation for their donation of excess
embryos. The consent process also should cover any
possible identifiers that will be maintained with the
tissue to link it back to the donors, access to current
and future health information from donors, willing-
ness of donors to be contacted in the future, owner-
ship, patent rights, and commercial uses of stem cell
lines that may be developed from the embryo. All
providing consent also should understand that they
may withdraw their consent up to the time that the
donated tissues actually are used in research.
In the scenarios of adults donating gametes
for the creation of embryos solely for research and
adults donating somatic cells for somatic cell nucle-
ar transfer, special considerations must be taken
into account. The information provided to donors
for embryonic stem cell research must acknowledge
that the process of obtaining the embryonic stem
cell line from the inner cell mass of the blastocyst
will result in the destruction of the embryo and also
should indicate that the derived stem cell lines may
2013 COMPENDIUM OF SELECTED PUBLICATIONS 88
 be propagated indefinitely. The consent process also
should cover the same elements as consent obtained
when unused embryos are donated for research. A
woman wishing to donate oocytes for research must
be informed of possible risks to her in the process
of controlled ovarian hyperstimulation and retriev-
ing oocytes, and egg donor programs should set up
medical and psychologic screening procedures in
order to safeguard potential donors.
May Embryos Be Created for Research?
Many cryopreserved embryos exist in the United
States. When such embryos are appropriate to the
questions under investigation and appropriate con-
sent can be obtained, the ACOG Committee on
Ethics recommends that these embryos be the pre-
ferred resource for research. Not all frozen embryos
are available or appropriate for research, however,
and frozen embryos may not meet all criteria neces­
sary for some therapeutic applications (32). Investi­
gations of specific genetic defects, for example,
may require specific tissues not available in already
frozen embryos, and any future therapies using stem
cells (eg, somatic cell nuclear transfer) by design
may require that embryos and the derived embry­
onic stem cells have a genetic profile identical to
the intended recipient. The Committee on Ethics
believes that the promise of somatic cell nuclear
transfer as a technique to create important and
unique stem cell lines is such that research in this
area is justified, a finding consistent with the prac-
tices of the United Kingdom’s Human Fertilisation
and Embryology Authority (33). Furthermore, the
Committee on Ethics can imagine a future day
when the creation of tissues via somatic cell nuclear
transfer to be used in the isolation of human stem
cell lines for therapeutic purposes will be possible
and needed; if so, the Committee on Ethics would
consider this process to be ethically appropriate.
Although there are no physical differences
between “excess” embryos from an IVF therapy and
“created-for-research” embryos, the moral distinc-
tion that many make seems to rest on the intent of
the creation of the embryo, whether for procreation
or research, and the special respect given to human
embryos. An embryo originally created for procre-
ation may be seen to be created for its own sake,
as an “end in itself,” whereas an embryo created
for research may appear to be a “mere means” to
the ends of others. For some, the respect given to
the human embryo differentiates the embryo from
COMMITTEE OPINIONS
mere human tissues or cells and necessitates greater
obligation to justify valid scientific inquiry. Others
judge that the potential benefits of research for soci-
etal health outweigh any limitations conferred by
the respect due to human embryos, whether they are
“excess” embryos or “created for research.”
There is a precedent for creation of embryos for
research purposes. The early work in human IVF
by Edwards and colleagues consisted of fertilizing
human oocytes for research in order to study the
normality of the zygotes thus created before transfer
to a woman was even considered (34). In 1994, the
NIH Human Embryo Research Panel approved the
creation of IVF embryos for research when the very
nature of the research itself required the fertilization
of oocytes and when a research project deemed to
be exceptionally important required a particular type
of embryo for its validity. Currently, there is little
need for the creation of embryos by fertilization for
research purposes, but in the future the supply of
available tissues, research questions, or therapeutic
paradigms may change. If a compelling need arises,
the question of creating embryos by fertilization for
use in research will need to be addressed carefully.
Does Experimental or Other Use of Stem Cells
Lend Support to Reproductive Cloning?
In the processes involved, associated risks, and
intended outcomes, work involving stem cells and
cloning for biomedical research with the intent of
developing future therapies (eg, somatic cell nuclear
transfer) may clearly be distinguished from repro-
ductive cloning. The former areas of research and
practice involve the isolation and manipulation of
cells from embryos that are not allowed to progress
past the 14-day stage and are not transferred to the
uterus. Because reproductive cloning is designed
to produce a human being, it raises a distinct set
of issues and concerns, and these are not the focus
of this Committee Opinion. The support expressed
in this Committee Opinion for embryo research
and cloning for research purposes does not imply
endorsement of reproductive cloning, which the
Committee on Ethics opposes.
Guidelines
The Committee on Ethics takes the position that
human embryo research can be justified under
certain conditions. This position is based on an
interpretation of the moral status of the embryo as a
2013 COMPENDIUM OF SELECTED PUBLICATIONS 89
 living entity with a human genetic code, deserv-
ing of some form of respect in itself and not solely
for its usefulness in research. But this position also
recognizes the value of the embryo as relative, in
the sense that it does not require the degree of pro-
tection and absolute respect that is accorded human
persons. In other words, the embryo is human—not
simply like other human tissue (for it is genetically
unique and has human potential)—but it also is not
a human person.
Risks of harm to the embryo in research can
be justified, but not without limits. Embryos, for
example, should not be subjected to trivial or poorly
designed research programs; if the embryos are des-
ignated for transfer to a woman’s uterus, the goals
of successful pregnancy should be given priority;
and the real and symbolic values of the embryo
should not be negated or trivialized. The Committee
on Ethics recommends the following guidelines for
clinical and laboratory research involving human
embryos.
1. Research will be conducted only by scientifi­
cally qualified individuals and in settings that
include appropriate and adequate resources and
protections. The design of the research and each
of its procedures should be clearly formulated
in a research protocol that is submitted to a
specially appointed independent committee for
evaluation, guidance, and approval.
2. The question to be explored must be scientifical-
ly valid; must take into account scientific work
to date, including animal studies; and cannot be
answered through research on animal embryos
or on unfertilized gametes.
3. The information sought should offer potential
scientific and clinical benefit in areas such as
embryonic development, human reproduction,
chromosomal and genetic conditions, or, for
embryonic stem cell lines, potential disease
therapies.
4. The research will be conducted using embryos
at the earliest possible developmental stage of
the embryo, not to exceed 14 days after evi-
dence of fertilization in any case.
5. Any embryo that has undergone research will
be transferred to a uterus only if the original
research was undertaken to prepare the embryo
for selection or placement or to improve its
chances for implantation and only if specific
consent for transfer is obtained.
COMMITTEE OPINIONS
6. Intended parents for whom embryos are created
(embryo donors) should be provided with the
opportunity to provide informed consent as to
the disposition of any excess embryos, whether
for eventual destruction, donation for attempted
implantation by another individual or couple, or
scientific research. This presupposes an explicit
policy on the part of the researchers and their
sponsoring institutions that facilitates commu-
nication of options and provides for informed
donor choice. If gamete donors differ from the
embryo donors, then embryos may be donated
for research only if the gamete donors also have
given explicit consent for donation for research.
7. Those donating “excess” frozen embryos for
embryonic stem cell research must be adequate-
ly informed of the goals, anticipated benefits,
and potential hazards of the particular research.
Each potential donor is informed that she or
he is at liberty to decline participation in the
research and, until such a point when the tissues
are used or cell lines created, to withdraw con-
sent for research.
8. Other information must be included in informed
consent for donation of embryos for stem cell
research:
• Acknowledgment that removal of the inner
cell mass will destroy the embryo
• Statement that stem cell lines may con-
tinue indefinitely and be shared with other
researchers
• Discussion of potential ownership, patent,
and commercial uses of stem cell lines that
may be developed from the embryo
• Information regarding whether any identi-
fiers will be preserved in the stem cell lines
derived
9. For research or therapy involving somatic
cell nuclear transfer, oocyte donors and somatic
cell donors must give informed consent for use
of their eggs or somatic cells. In the rare cir-
cumstances in which IVF embryos are created
for research, the gamete donors should provide
informed consent for fertilization for research
purposes. In both cases, informed consent
should include points in guideline 8 and clearly
describe the researchers’ intention to deliber­
ately create a human embryo for research.
10. Special care must be taken to ensure that poten-
tial donors of oocytes for research understand
2013 COMPENDIUM OF SELECTED PUBLICATIONS 90
 the procedure and its risks. To safeguard donors
as much as possible, medical and psychologic
screening should be required. Although com-
pensation for egg donors for research is accept-
able, as it is for donors for infertility treatment,
such compensation should be understood to be
compensation for the woman’s time, effort, risk,
and discomfort and not as payment for the eggs
that may be recovered. The level of compensa-
tion should be consistent with ASRM guidelines
to minimize the possibility of exploitation of
egg donors.
11. Techniques and research designed to clone
human beings raise a different set of ethical
concerns. The Committee on Ethics opposes
reproductive cloning.
Conclusion
The Committee on Ethics has offered a position that
supports embryo research but limits it according to
ethical guidelines. This position advocates treatment
of the embryo with respect but not the same level of
respect that is given to human persons. It is a posi-
tion that will not be acceptable to those who believe
that full rights should be extended to early-stage
embryos. In arriving at its position, the Committee
on Ethics considered scientific and clinical informa-
tion relevant to ethical analysis, although it recog-
nizes that such consideration necessarily involves
both scientific and ethical interpretation of what
cannot be simply incontrovertible “facts.”
The Committee on Ethics once again acknowl-
edges that no single position can encompass the vari-
ety of opinions within the membership of ACOG,
and it affirms that no physician should be required
or expected to participate in embryo research if he
or she finds it morally objectionable. Nonetheless, it
is important to public discourse and to the practice
of responsible medicine that physicians become
aware of the medical and ethical issues involved in
the complex areas of embryo research. To advance
this discourse, it is helpful for physicians to reflect
on and share the basis of their own views and to rec-
ognize and explore the ethical perspectives of their
patients and colleagues.
References
1. Definitions. 45 CFR § 46.202 (2005).
2. U.S. Department of Health, Education, and Welfare.
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COMMITTEE OPINIONS
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3. Ethical considerations of the new reproductive technolo-
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in human stem cell research. Rockville (MD): NBAC;
1999.
8. Radio address by the President to the nation. Available
at: http://www.whitehouse.gov/news/releases/2001/08/
print/20010811-1.html. Retrieved March 9, 2006.
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10. Lyerly AD, Steinhauser K, Namey E, Tulsky JA, Cook-
Deegan R, Sugarman J, et al. Factors that affect infertil­ity
patients’ decisions about frozen embryos. Fertil Steril
2006;85:1623–30.
11. McCormick RA. Who or what is the preembryo? Kennedy
Inst Ethics J 1991;1:1–15.
12. Grobstein C. Becoming an individual. In: Science and the
unborn. New York (NY): Basic Books; 1988. p. 21–39.
13. Ford NM. When did I begin? Conception of the human
individual in history, philosophy, and science. New York
(NY): Cambridge University Press; 1988.
14. Report from the Select Committee on Stem Cell
Research. House of Lords HL 2002;83(i). Available
at: http://www.publications.parliament.uk/pa/ld200102/
ldselect/ldstem/83/8301.htm. Retrieved June 28, 2006.
15. King PA. Embryo research: the challenge for public pol­
icy. J Med Philos 1997;22:441–55.
16. Kukla H. Embryonic stem cell research: an ethical justi-
fication. Georgetown Law J 2002;90:503–43.
17. Green RM. Benefiting from ‘evil’: an incipient problem
in human stem cell research. Bioethics 2002;16:544–56.
18. Wilcox AJ, Weinberg CR, O’Connor JF, Baird DD,
Schlatterer JP, Canfield RE, et al. Incidence of early loss
of pregnancy. N Engl J Med 1988;319:189–94.
19. Weissman IL. Stem cells—scientific, medical, and politi-
cal issues. N Engl J Med 2002;346:1576–9.
20. Porada GA, Porada C, Zanjani ED. The fetal sheep: a
unique model system for assessing the full differentiative
potential of human stem cells. Yonsei Med J 2004;45:
7–14.
21. Kogler G, Sensken S, Airey JA, Trapp T, Muschen M,
Feldhahn N, et al. A new human somatic stem cell from
placental cord blood with intrinsic pluripotent differentia-
tion potential. J Exp Med 2004;200:123–35.
22. The President’s Council on Bioethics. Alternative sourc-
es of human pluripotent stem cells. A white paper of
the President’s Council on Bioethics. Washington, DC:
The President’s Council on Bioethics; 2005. Available
at: http://www.bioethics.gov/reports/white_paper/
alternative_sources_white_paper.pdf. Retrieved June 28,
2006.
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 23. Wagers AJ, Weissman IL. Plasticity of adult stem cells.
Cell 2004;116:639–48.
24. National Research Council; Institute of Medicine.
Recruiting donors and banking hES cells. In: Guidelines
for human embryonic stem cell research. Washington,
DC: The Institute; 2005. p. 81–96.
25. Financial incentives for oocyte donors. The Ethics
Committee of the American Society for Reproductive
Medicine. Fertil Steril 2000;74:216–20.
26. Kalfoglou AL, Geller G. A follow-up study with oocyte
donors exploring their experiences, knowledge, and atti-
tudes about the use of their oocytes and the outcome of
the donation. Fertil Steril 2000;74:660–7.
27. Klock SC, Sheinin S, Kazer RR. The disposition of
unused frozen embryos. N Engl J Med 2001;345:69–70.
28. Lo B, Chou V, Cedars MI, Gates E, Taylor RN, Wagner
RM, et al. Informed consent in human oocyte, embryo,
and embryonic stem cell research. Fertil Steril 2004;82:
559–63.
29. Donating spare embryos for embryonic stem-cell research.
Ethics Committee of the American Society for Reproductive
Medicine. Fertil Steril 2004;82(suppl 1): S224–7.
Glossary
*Blastocyst: A preimplantation embryo of approximately
150 cells. The blastocyst consists of a sphere made up of an
outer layer of cells (the trophectoderm), a fluid-filled cavity
(the blastocoel), and a cluster of cells on the interior (the
inner cell mass).
Blastomere: The cells derived from the first and subsequent
cell divisions of the zygote.
*Embryo: In humans, the developing organism from the
time of fertilization until the end of the eighth week of gesta-
tion, when it becomes known as a fetus. Other ACOG guide-
lines address research involving postimplantation embryos
and fetuses (ie, research during pregnancy). (American
College of Obstetricians and Gynecologists. Research
involving women. In: Ethics in obstetrics and gynecology.
2nd ed. Washington, DC: ACOG; 2004. p. 86–91.)
*Embryonic stem cells: Primitive (undifferentiated) cells
from the embryo that have the potential to become a wide
variety of specialized cell types.
Fertilization: The process whereby male and female gam-
etes unite.
Gametes: Mature reproductive cells, usually having half the
adult chromosome number (ie, sperm or ovum).
Implantation: Attachment of the blastocyst to the endome-
trial lining of the uterus and subsequent embedding in the
endometrium. Implantation begins approximately 5–7 days
after fertilization and may be complete as early as 8–9 days
after fertilization.
*Inner cell mass: The cluster of cells inside the blastocyst.
These cells give rise to the embryonic disk of the later
embryo and, ultimately, the fetus.
COMMITTEE OPINIONS
30. Ethics Committee of the American Society for Repro-
ductive Medicine. Disposition of abandoned embryos.
Fertil Steril 2004;82(suppl 1):S253.
31. Wolf SM, Kahn JP. Bioethics matures: the field faces the
future. Hastings Cent Rep 2005;35(4):22–4.
32. Hoffman DI, Zellman GL, Fair CC, Mayer JF, Zeitz JG,
Gibbons WE, et al. Cryopreserved embryos in the United
States and their availability for research. Society for
Assisted Reproduction Technology (SART) and RAND.
Fertil Steril 2003;79:1063–9.
33. Human Fertilisation & Embryology Authority. HFEA
grants the first therapeutic cloning licence for research.
Press release. London: HFEA; 2004. Available at: http://
www.hfea.gov.uk/PressOffice/Archive/109223388.
Retrieved June 28, 2006.
34. Edwards RG, Steptoe PC. A matter of life: the story of a
medical breakthrough. London: Hutchinson; 1980.
Oocyte: An immature female reproductive cell, one that
has not completed the maturing process to form an ovum
(gamete).
Pluripotent: Able to differentiate into multiple cell and tis-
sue types.
Preimplantation embryo: In humans, the developing
organism from the time of fertilization until implantation in
the uterus or other tissue (eg, ectopic pregnancy).
Primitive streak: The initial band of cells from which many
tissue systems, including the neural system of the embryo,
begin to develop, located at the caudal end of the embryonic
disc. The primitive streak is present approximately 15 days
after fertilization and marks the axis along which the spinal
cord develops.
Somatic cell nuclear transfer: The transfer of a cell nucleus
from a somatic cell into an egg from which the nucleus has
been removed.
Stem cells: Undifferentiated multipotent precursor cells that
are capable of perpetuating themselves indefinitely and of
differentiating into specialized types of cells.
Totipotent: Able to differentiate into every cell and tissue
type; the capacity of a cell or group of cells to produce all of
the products of conception: the extra-embryonic membrane
and tissue, the embryo, and, subsequently, the fetus.
Zygote: The single cell formed by the union of the male and
female haploid gametes at syngamy.
*Definitions marked with an asterisk are adapted from the National
Institutes of Health glossary, available at: http://stemcells.nih.gov.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 92
 ACOG
Committee on
Ethics
Reaffirmed 2012
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Innovative practice: ethical guidelines.
ACOG Committee Opinion No. 352.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:1589–95.
COMMITTEE OPINIONS
Committee
Opinion
Number 352, December 2006
Innovative Practice: Ethical
Guidelines
ABSTRACT: Innovations in medical practice are critical to the advancement
of medicine. Good clinicians constantly adapt and modify their clinical
approaches in ways they believe will benefit patients. Innovative practice
frequently is approached very differently from formal research, which is gov-
erned by distinct ethical and regulatory frameworks. Although opinions
differ on the distinction between research and innovative practice, the pro-
duction of generalizable knowledge is one defining characteristic of
research. Physicians considering innovative practice must disclose to
patients the purpose, benefits, and risks of the proposed treatment, including
risks not quantified but plausible. They should attempt an innovative proce-
dure only when familiar with and skilled in its basic components. A clinician
should share results, positive or negative, with colleagues and, when feasi-
ble, teach successful techniques and procedures to other physicians.
Practitioners should be wary of adopting innovative procedures or diagnos-
tic tests on the basis of promotions and marketing when the value of the
procedures or tests has not been proved. A practitioner should move an inno-
vative practice into formal research if the innovation represents a significant
departure from standard practice, if the innovation carries unknown or
potentially significant risks, or if the practitioner’s goal is to use data from
the innovation to produce generalizable knowledge. If there is any question
whether innovative practices should be formalized as research, clinicians
should seek advice from the relevant institutional review board.
Overview
In 21st-century medicine, the pace at which innovations are introduced into
clinical practice continues to increase. Many innovations differ considerably
from previous practices and may or may not have been subjected to formal
research protocols. In this context, the boundary between innovative practice
and medical research becomes blurred, making it difficult for physicians to
distinguish between them and to recognize the ethical issues that are
involved.
When innovative practices are introduced, they may become widely
accepted based on anecdotal reports of success. As a result, formal research
2013 COMPENDIUM OF SELECTED PUBLICATIONS 93
 may never be done that might show 1) that the inno-
vative practice carries higher risk than other treat-
ments or 2) that it is no more effective than standard
treatment. An inappropriate introduction of an inno-
vative practice, circumventing the formal study of
the new technique, leaves patients and practitioners
without the necessary data for appropriately assess-
ing an innovation’s risks and benefits, as well as its
long-term effects on health.
In this Committee Opinion, the Committee on
Ethics will review efforts to distinguish innovative
practice from research, identify ethical concerns
raised by innovative practice, and note current obsta-
cles to the conduct of formal research. Recommen-
dations will focus on two questions: 1) When does
the clinician have an obligation to subject an inno-
vative practice to formal research? 2) In situations
where innovative practice is not regulated as
research, what special ethical obligations might the
clinician have—to patients, to the community of
medical professionals, and to society at large?
Distinguishing Innovative Practice From
Research
In clinical practice, physicians aim to benefit their
patients by providing the best possible procedures
and treatments. The desire to improve currently
available practices has given an important impetus to
the development of new medical knowledge. The
notion of what is best or most appropriate evolves
with time, ongoing research, and changing individ-
ual and societal values. Good clinicians constantly
adapt and modify their clinical approaches in ways
they believe will benefit patients. The introduction of
such innovative interventions is guided primarily by
the judgment of the individual physician, although
professional organizations often advise and monitor.
Formal research, however, is highly regulated in
the United States. Research protocols involving
human participants must be described in detail and
submitted to an institutional review board (IRB) for
approval. Federal regulations mandate that IRBs
approve research protocols in order to ensure ade-
quate disclosure to potential participants, informed
consent from participants, appropriate risk–benefit
ratio, protection of participants’ privacy, and free-
dom of participants to withdraw from the study at
any time.
Innovative practice has elements in common
with research including, for example, the desire to
2 ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
learn and to improve treatment. Yet, innovation in
practice frequently is approached very differently
from formal research, which is governed by distinct
ethical and regulatory frameworks. The federal
research regulations as expressed in the “Common
Rule” draw a sharp distinction between research, which
is regulated, and innovation, which is not, stressing the
production of generalizable knowledge––knowledge
that can be applied beyond the particular individuals
studied––as the defining characteristic of research
(1). However, the distinction is somewhat artificial
and is not always clearly delineated.
An innovative practice may later become the
subject of a formal research protocol, with the
results of this research then applied to guide evi-
dence-based practice. In some cases, however, inno-
vative practice that appears to be safe and effective
may become accepted practice, even if it has never
been subjected to formal research and an evidence
base has never been developed to support efficacy
and safety. When this happens, patients and practi-
tioners are left without the data they need to make
adequately informed decisions.
Background: History and Evolution of
Terminology
It often is difficult to draw a clear line between inno-
vative practice and research. The history of research
regulation illuminates the effort to clarify the dis-
tinction.
The National Commission for the Protection of
Human Subjects, established by federal statute in
1975, developed the Belmont Report in 1978 to
identify the basic ethical principles governing
human research (2). In defining research, the
National Commission first distinguished it from
“the practice of accepted therapy.” However, exam-
ples proposed to the National Commission led it to
recognize that much practice is experimental (a term
the American College of Obstetricians and
Gynecologists’ Committee on Ethics interprets as
congruent with the term innovative), even though it
is not formalized as research. Should all such exper-
imental practice be treated as research and governed
by the ethical and regulatory guidelines for
research? The National Commission decided
against taking this position and adopted a narrower
definition of research, concluding that research
occurs when the clinician or investigator intends the
work to result in generalizable knowledge (2).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 94
 According to the National Commission,
“‘Research’ designates an activity designed to test a
hypothesis, permit conclusions to be drawn, and
thereby to contribute to generalizable knowledge”
rather than being “designed solely to enhance the
well-being of an individual patient or client” (2).
The fact that activities designed to enhance patient
well-being may depart significantly from standard
or accepted practice does not of itself make them
research. However, the National Commission
strongly urged that “radically new procedures” be
tested by formal research at an early stage and that
medical practice committees insist that new tech-
niques and treatments be submitted to formal
hypothesis testing. The National Commission did
not, however, define “radically new,” leaving its
definition to the judgment of practitioners.
Federal research regulations in effect since 1981
incorporate these concepts to a limited degree, defin-
ing research as follows: “Research means a system-
atic investigation, including research development,
testing and evaluation, designed to develop or con-
tribute to generalizable knowledge” (3). The pream-
ble to the regulations as finalized in 1981 explicitly
states that the definition is restricted to “generaliz-
able knowledge” because the regulations were not
intended to encompass “innovative therapy” (4).
In March 2003, the Lasker Foundation, a chari-
table trust established to promote advances in medi-
cine, sponsored the invitational “Lasker Forum on
Ethical Challenges in Biomedical Research and
Practice.” The forum focused on the intersection of
research and practice and questioned the artificial
separation between “what is called research and
therefore requires more regulatory oversight, and
what is called ‘care’ and requires little or none” (5).
The report on the Lasker Forum proposed that clini-
cal innovation involving a significant departure from
standard of care imposes particular moral duties on
the practitioner. In the view expressed at the forum,
a practitioner who attempts through innovation to
benefit an individual patient also is morally obligat-
ed to facilitate the development of knowledge useful
to other physicians and patients, thus suggesting an
obligation to conduct research on the innovative
practice.
The Lasker Forum report proposed criteria for
identifying the ethical threshold that mandates mov-
ing from innovative practice to formal research. In
this view, the most important criterion is the degree
of departure from standard practice, followed by the
ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
potential for harm to the patient from the innovative
practice. Other criteria proposed for consideration
are the goal of the clinician investigator, the avail-
ability of organizational structures supportive of
research, and the presence of commercial interests
or conflict of interest (5). These considerations will
be discussed more fully after examination of specif-
ic ethical concerns related to the introduction of
innovative practices.
Ethical Concerns Regarding Innovative
Practice
A variety of problems may arise when innovative
practices are inappropriately introduced apart from
formal research protocols. These problems often have
ethical implications related to patient safety, patient
autonomy, and the patient’s right to effective therapy:
• Premature adoption of innovative practices
without adequate supporting evidence may pro-
mote wide acceptance of therapies that are
ineffective. Examples of procedures that have
been proved ineffective include:
––Bed rest or home uterine activity monitoring
for prevention of prematurity (6, 7)
––Bone marrow transplant for breast cancer (8)
––Diethylstilbestrol or paternal antigen sensiti-
zation for the prevention of recurrent miscar-
riage
From an ethical perspective, recommending
procedures that are not effective for the intend-
ed purpose is misleading to patients, incurs
increased unnecessary costs both financial and
personal, and violates the patient’s autonomy-
based right to consent to therapy after accurate
disclosure. In addition, an unproven innovative
treatment may carry additional risks or morbid-
ity in comparison with standard treatment, as in
the case of bone marrow transplant for breast
cancer.
• Premature adoption of innovative practices
without formal scientific testing may compro-
mise the ability to determine effectiveness,
weigh risk against benefit, compare the practice
with other procedures, or develop alternative
approaches. When results of an innovative prac-
tice are publicized without adequate testing, it
may become increasingly difficult to recruit par-
ticipants for a clinical trial, particularly one that
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 95
 involves randomization. Such may have been
the case when techniques for maternal–fetal sur-
gery, electronic fetal monitoring, and laparo-
scopic hysterectomy were first introduced as
innovative and only later systematically studied.
When innovative practices are widely adopted
without formal research testing, an incremental
risk over standard practice may not be recog-
nized, and relative effectiveness, safety, and
risk–benefit ratio may never be determined.
Such a situation may make it difficult or impos-
sible for physicians to know if they are fulfilling
their obligation to provide safe and efficacious
treatment to patients (9).
• Long-term safety concerns may result when
innovative practices are widely adopted as stan-
dard practice without adequate scientific testing.
Examples in which careful, continued study
after a technique’s introduction demonstrated
small but potentially important risks include:
––Limb reductions associated with early chori-
onic villus sampling (10, 11)
––Sex chromosome abnormalities associated
with intracytoplasmic sperm injection used in
assisted reproductive technology (ART) (12,
13)
Although innovations in obstetrics and ART
offer important benefits to prospective parents,
they also may carry long-term risks that are not
recognized unless formal research is carried out.
Because of their eagerness to become parents,
infertile couples may be willing to overlook risks
involved in the use of ART. It is the responsibil-
ity of practitioners to carry out the studies that
are needed to ensure that patients are offered
effective and safe procedures. Appropriately,
many ART centers and practitioners have partic-
ipated in the ongoing registries and collabora-
tions needed for this research.
Research Barriers to Be Overcome
Medicine cannot advance without innovation.
Recent examples of highly valuable innovations
include new efficient laparoscopic components that
may improve visualization and new laparoscopic
procedures, such as laparoscopic retroperitoneal
lymph node dissection, that may speed or otherwise
facilitate closed surgical procedures. This could
4 ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
reduce the need for open procedures that may be
associated with longer or more complicated post-
operative recovery. At times, it may be appropriate to
introduce an innovative technique apart from a for-
mal research protocol. However, both the National
Commission for the Protection of Human Subjects
and the National Bioethics Advisory Commission
stipulate that innovations in clinical practice should
be studied under a research protocol as soon as it is
appropriate to study them systematically (2, 14).
A number of barriers to the conduct of formal
research exist, with some of them specific to partic-
ular subspecialties:
1. Lack of supportive structures. In many clinical
situations, the structures to facilitate research,
such as administrative support and an IRB, may
be lacking. Even if a particular innovation is ripe
for formalization as research, research may be
difficult to accomplish without the necessary
supportive structures. Bureaucratic obstacles
may be cited as an excuse for not conducting
research; however, such obstacles do not pro-
vide valid reasons for failure to conduct appro-
priate research under ethical guidelines. Rather,
clinicians ought to advocate changes in policy
and collaborative efforts that will provide neces-
sary support for research.
2. Absence of financial reimbursement. In addition
to the lack of supportive structures, financial
pressures may inhibit the pursuit of appropriate
research. Insurance coverage may be available
for treatment that is described as innovative
therapy, but not for formal research. This reim-
bursement situation played a role in the promo-
tion of the untested procedure of bone marrow
transplant for breast cancer, for example (15).
3. Lack of oversight for surgical innovation and
research. The absence of regulations that specif-
ically govern surgical innovation and research
has frequently been noted. Proposals have been
suggested to ensure oversight of surgical inno-
vation when formal research is not planned, for
example, submission of a written plan to the
department head for referral to an ad hoc com-
mittee. This committee would provide peer
review of “medical and scientific plausibility,
the adequacy of patient safeguards, and the
legitimacy of [the] clinical rationale” (16).
4. Prohibition of federal funding for ART and
embryo research. Because of the statutory pro-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 96
 hibition of federal funding for in vitro fertiliza-
tion and early embryo research, most research on
ART is privately funded and is conducted within
the practice of clinical infertility treatment.
Hence, it may be difficult to obtain funding for
some types of research on ART, particularly
basic research.
Clinical Decisions on Moving From
Innovation to Research
The field of medicine could neither progress nor be
practiced without innovative therapy. Given the
importance of formal research for evidence-based
medicine, however, the medical community must
determine when an innovative practice should be
subjected to formal research. If there is any question
whether an innovation should be formalized as
research, it is advisable that the protocol be submit-
ted to an IRB for review. From an ethical standpoint,
the following considerations offer guidance and cri-
teria to the clinician for a decision to move from
innovation to formal research (5):
• The degree of departure from standard practice.
As recommended by the Lasker Forum, if inno-
vation constitutes a significant departure from
standard practice, the innovative procedure
should quickly be subjected to a formal research
protocol. Significant departure from standard
practice occurs, for example, in most mater-
nal–fetal surgery and many new ART tech-
niques. However, minor modifications, such as a
change in a step during surgery, a different kind
of suture, or a new instrument similar to an old
one, clearly do not require formalization as
research.
• The potential for harm to the patient. When an
innovation carries risks that are unknown or that
may be significant in proportion to expected
benefits, its safety should be assessed through a
formal research protocol with the oversight of
an IRB, one of whose primary purposes is to
protect the welfare of participants. In addition,
formal research is essential in order to identify
long-term risks that may affect the safety of
large numbers of patients in the future.
• The intent of the physician. The original intent
in an innovation may be solely the welfare of the
individual patient. If the physician intends, how-
ever, to eventually use results of a trial of the
ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
innovation to produce generalizable knowledge,
the trial should be formalized in a research pro-
tocol. Valid generalizable knowledge ordinarily
requires randomized clinical trials rather than
reliance on case series and unplanned observa-
tions (17).
Special Ethical Requirements for
Innovative Practice
Duties to Patients
When patients become participants in a formal
research project, they become protected by the fed-
eral regulations for research involving human partic-
ipants. Even when a particular project does not
strictly fall under federal regulations because it does
not involve federal funding or oversight by the U.S.
Food and Drug Administration, most institutions
still comply with federal standards. Also, reputable
journals require compliance with ethical guidelines
as a condition for publication. Access to results of
clinical trials, even trials with negative outcomes, is
protected by the clinical trials registration process
(18–20). Many journals now require evidence that
trials were previously registered before accepting
reports for consideration for publication.
The same protections do not hold for a patient
who is offered innovative therapy. Although the
intent of such innovation is to provide the most ben-
eficial treatment possible for the patient, the patient
may not realize that a therapy is new or experimen-
tal. The practitioner has the obligation to disclose
information that would be material to the patient’s
decision, and in many cases, a patient would want to
know that a proposed therapy is innovative. As with
all therapies, the practitioner has the obligation to
disclose the purpose, benefits, and risks of the pro-
posed innovative treatment, including not quantified
but plausible risks. In addition, the practitioner has a
particular obligation to protect the patient from
potential harms that are not proportionate to expect-
ed benefits, a role that the IRB assumes with respect
to formal research protocols. To minimize risk,
physicians also need to consider their own knowl-
edge and skill levels and should attempt an innova-
tive procedure only when familiar with and skilled
in its basic components.
Patient protection requires transparent commu-
nication. In the words of the Lasker Forum report,
“Where innovation is clearly present, the require-
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 97
 ments for disclosure are likely to become more
pressing” (5). It may be important to the patient to
know how often this procedure has been done, what
this particular physician’s experience with the proce-
dure is, and what is known and unknown about pos-
sible adverse events and long-term sequelae. Care
should be taken that a patient is not unduly influ-
enced to consent to an innovative procedure solely
out of deference to her physician. When the advan-
tages and disadvantages of a truly new approach are
explained to the patient, the assistance of an experi-
enced third-party communicator, such as a patient
representative or social worker, may be helpful (5).
Particular care is needed when discussing proposed
treatments with vulnerable or possibly desperate
patients because they may be eager to pursue inno-
vative but unproven procedures or treatments.
Duties to the Profession and to Society
Innovative practice, unlike research, is not directed
specifically toward the production of generalized
knowledge. Yet, it is expected that innovation would
lead to the improvement of practice in general, not
just the practice of an individual physician. This
expectation imposes two duties on the physician: 1)
to structure the process of innovation so as to learn
from it, even if it is not as successful as hoped, and
2) to share what is learned with the medical com-
munity as a whole and, where appropriate, with
society. A clinician should share results, positive or
negative, with colleagues and, when feasible, coop-
erate in teaching successful techniques and proce-
dures to other physicians.
Current focus on clinical trials, especially ran-
domized clinical trials, suggests that they ordinarily
provide the best opportunity for unbiased learning
within the practice of medicine. Consequently, inno-
vative practice should move toward clinical trials
whenever possible in order to provide evidence-
based knowledge to the medical community for the
welfare of patients.
Practitioners need to be careful not to adopt
innovative procedures or diagnostic tests on the
basis of promotional and marketing campaigns
when the value of such procedures and tests has not
yet been proved. For example, serum-based screen-
ing tests for ovarian cancer have been promoted
even though more research is needed to determine
whether they are effective (21, 22). Similar cautions
apply to off-label and unproven uses of pharmaceu-
ticals that may be suggested to physicians. In all
6 ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
cases, physicians should rely on documented evi-
dence to guide clinical practice.
Summary
The introduction of innovative practices and tech-
niques is essential to medical progress. Ordinarily,
however, innovations should be subjected to system-
atic formal research as soon as feasible:
• In the absence of formal research, innovative
practices may become widely accepted without
adequate data for assessing risks and benefits.
• Without an adequate evidence base, practition-
ers cannot determine whether an innovative
technique is the most safe and effective method
for treating a patient.
• Without adequate data on the risks and benefits
of new treatments, patients are unable to provide
a true informed consent.
A practitioner should move an innovative prac-
tice into formal research when one of these criteria
is satisfied:
• The innovation represents a significant depar-
ture from standard practice.
• The innovation carries risks that are unknown or
that may be significant in proportion to expect-
ed benefits.
• The introduction of the innovation is expected
to result in generalizable knowledge, which de-
pends on results of formal clinical trials.
References
1. Protection of human subjects. 45 CFR § 46 (2005).
2. National Commission for the Protection of Human
Subjects. Belmont report: ethical principles and guide-
lines for the protection of human subjects of research. Fed
Regist 1979;44:23192–7.
3. Definitions. 45 CFR § 46.102 (2005).
4. Final regulations amending basic HHS policy for the
protection of human research subjects. U.S. Department
of Health and Human Services. Fed Regist 1981;46:
8366–91.
5. Lasker Foundation. The Lasker Forum on Ethical
Challenges in Biomedical Research and Practice, May
14–16, 2003. New York (NY): Lasker Foundation; 2003.
Available at: http://www.laskerfoundation.org/ethics/ethics_
report.html. Retrieved June 28, 2006.
6. Sosa C, Althabe F, Belizán J, Bergel E. Bed rest in single-
ton pregnancies for preventing preterm birth. Cochrane
Database of Systematic Reviews 2004, Issue 1. Art. No.:
CD003581. DOI: 10.1002/14651858.CD003581.pub2.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 98
 7. Assessment of risk factors for preterm birth. ACOG
Practice Bulletin No. 31. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2001;98:709–16.
8. Farquhar C, Marjoribanks J, Basser R, Lethaby A. High
dose chemotherapy and autologous bone marrow or stem
cell transplantation versus conventional chemotherapy for
women with early poor prognosis breast cancer. Cochrane
Database of Systematic Reviews 2005, Issue 3. Art. No.:
CD003139. DOI: 10.1002/14651858.CD003139.pub2.
9. Mayer M. When clinical trials are compromised: a per-
spective from a patient advocate. PLoS Med 2005;
2(11):e358. Available at: http://medicine.plosjournals.
org/archive/1549-1676/2/11/pdf/10.1371_journal.pmed.
0020358-L.pdf. Retrieved June 28, 2006.
10. World Health Organization Regional Office for Europe
(WHO/EURO). Risk evaluation of chorionic villus sam-
pling (CVS): report on a meeting. Copenhagen: WHO/
EURO; 1992. (WHO/EURO document EUR/ICP/MCH
123).
11. Kuliev AM, Modell B, Jackson L, Simpson JL, Brambati
B, Froster U, et al. Risk evaluation of CVS. Prenat Diagn
1993;13:197–209.
12. Rimm AA, Katayama AC, Diaz M, Katayama KP. A meta-
analysis of controlled studies comparing major malforma-
tion rates in IVF and ICSI infants with naturally conceived
children. J Assisted Reprod Genet 2004;21:437–43.
13. Perinatal risks associated with assisted reproductive tech-
nology. ACOG Committee Opinion No. 324. American
College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;106:1143–6.
ACOG Committee Opinion No. 352
COMMITTEE OPINIONS
14. National Bioethics Advisory Commission. Ethical and
policy issues in research involving human participants:
report and recommendations of the National Bioethics
Advisory Commission. Bethesda (MD): NBAC; 2001.
15. Mello MM, Brennan TA. The controversy over high-dose
chemotherapy with autologous bone marrow transplant
for breast cancer. Health Aff (Millwood) 2001;20:101–17.
16. Jones JW, McCullough LB, Richman BW. The ethics of
innovative surgical approaches for well-established proce-
dures. J Vasc Surg 2004;40:199–201.
17. Horton R. Surgical research or comic opera: questions,
but few answers [letter]. Lancet 1996;347:984–5.
18. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Horton R,
Kotzin S, et al. Clinical trial registration: a statement from
the International Committee of Medical Journal Editors.
International Committee of Medical Journal Editors [edi-
torial]. Lancet 2004;364:911–2.
19. Mayor S. Drug companies agree to make clinical trial
results public [news]. BMJ 2005;330:109.
20. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Hoey J,
Horton R, et al. Is this clinical trial fully registered? A
statement from the International Committee of Medical
Journal Editors. Ann Intern Med 2005;143:146–8.
21. American College of Obstetricians and Gynecologists,
Committee on Gynecologic Practice. Position regarding
OvaCheckTM, February 25, 2005.
22. Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro
VA, Steinberg SM, et al. Use of proteomic patterns in
serum to identify ovarian cancer. Lancet 2002;359:572–7.
7
2013 COMPENDIUM OF SELECTED PUBLICATIONS 99
 ACOG COMMITTEE OPINION
Number 359 • January 2007

Commercial Enterprises in Medical Practice*

Committee on Ethics ABSTRACT: Increasing numbers of physicians sell and promote both medical and
nonmedical products as part of their practices. Physicians always have rendered advice
Reaffirmed 2011
and treatment for a fee, and this practice is appropriate. It is unethical under most cir-
cumstances, however, for physicians to sell or promote medical or nonmedical products
or services for their financial benefit. The following activities are considered unethical:
sale of prescription drugs to be used at home, sale or promotion of nonprescription
medicine, sale or promotion of presumptively therapeutic agents that generally are not
accepted as part of standard medical practice, sale or promotion of non–health-related
items, recruitment of patients or other health care professionals into multilevel market-
ing arrangements, and sale or promotion of any product in whose sale the physician has
a significant financial interest. It is ethical and appropriate, however, to sell products to
patients as follows: sale of devices or drugs that require professional administration in
the office setting; sale of therapeutic agents, when no other facilities can provide them at
reasonable convenience and at reasonable cost; sale of products that clearly are external
to the patient–physician relationship, when such a sale would be considered appropriate
in an external relationship; and sale of low-cost products for the benefit of community
organizations. A rationale is provided for both the prohibited activities and exceptions.

Increasing financial pressures and the per-
vasiveness of entrepreneurial values in our
society have led to an increase in the scope
of activities for which physicians have sought
reimbursement. As a result, increasing num-
bers of physicians sell and promote both
medical and nonmedical products as part of
their practices.
Physicians always have rendered advice
and treatment for a fee, and this practice
is appropriate; however, the sale and pro-
motion of products for financial benefit is
qualitatively different from these traditional
activities. It is unethical under most circum-
stances for physicians to sell or promote
medical or nonmedical products or services
for their financial benefit. In this Committee
The American College Opinion, the American College of Obste­
of Obstetricians
and Gynecologists *Update of “Commercial Enterprises in Medical
Women’s Health Care Practice,” in Ethics in Obstetrics and Gynecology, Second
Physicians Edition, 2004.
tricians and Gynecologists’ Committee on
Ethics examines the following issues:
• The scope of the inappropriate activities
• The reasons for their unacceptability
• The limited circumstances under which
they may be acceptable
Recommendations
Sale or promotion of products by physicians
to their patients is unethical, with some
exceptions, in either clinical sites or other
places. This is true whether the sale is con-
ducted in person, by telephone, or by written
solicitation. The following activities are con-
sidered unethical, subject to the exceptions
outlined later in the discussion:
• Sale of prescription drugs to be used at
home (For example, some commercial
drug repackagers prepare these medi-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 100

 cines in standard doses and provide them to physi-
cians, who then resell them to patients [1].)
• Sale or promotion of nonprescription medicine
• Sale or promotion of presumptively therapeutic agents
that generally are not accepted as part of standard
medical practice
• Sale or promotion of non–health-related items, such
as household supplies (2)
• Recruitment of patients or other health care pro-
fessionals into multilevel marketing arrangements
(These are enterprises in which individuals recruit
other individuals to sell products and receive a com-
mission on sales by their recruits. These recruits, in
turn, can recruit a third generation of marketers,
whose commissions are shared with participants of
earlier generations.)
• Sale or promotion of any product in whose sale the
physician has a significant financial interest, even if
the sale would otherwise be appropriate (Such finan-
cial interest includes, among other things, sale for a
direct profit or sale of a product when the physician
holds a substantial equity interest in the product’s
manufacturer or wholesaler [3].)
Exceptions
It is ethical and appropriate for physicians to sell products
to patients in the following circumstances:
• Sale of devices or drugs that require professional
administration in the office setting (Under these
circumstances, the charge for the product should not
exceed the costs, which may include both the direct
cost of the product and the overhead incurred in
obtaining, storing, and administering it.)
• Sale of therapeutic agents, when no other facilities
can provide them at reasonable convenience and at
reasonable cost (This circumstance might occur in a
thinly populated area or in a locality in which certain
forms of reproductive control are unpopular. If phy-
sicians sell such products, the price charged should
not exceed the cost of the product, including both
direct and overhead costs.)
• Sale of products that clearly are external to the
patient–physician relationship, when such a sale
ordinarily would be considered appropriate in the
context of an external relationship (An example of
such a transaction is a brokered house sale at a fair
market price.)
• Sale of low-cost products for the benefit of commu-
nity organizations (An example of such a product
is Girl Scout cookies. These products must be sold
without pressure, and the physician must not derive
a profit from such sales.)
COMMITTEE OPINIONS
Rationale
There have been arguments given to support the sale in
physicians’ offices of drugs and other products related to
the treatment of patients (1). One is convenience—a busy
patient need not go to a pharmacy. Another, although
not borne out by empirical studies, is that increasing the
number of dispensers of drugs reduces the cost of drugs
(1). Finally, it is possible that adherence to treatment
is improved if the patient purchases the drug from the
physician.
Under most circumstances, however, the sale of
products by physicians violates several generally accepted
principles of medical ethics. First, and most important,
the practice of physician sales to patients creates a poten-
tial conflict of interest with the physician’s fiduciary
responsibility to provide “a right and good healing action
taken in the interests of a particular patient” (4). This
principle of fidelity is defined as the obligation of physi-
cians to put the interests of patients above their own.
Physicians must not engage in actions that violate
or call into question their fiduciary relationship with
patients. The term conflict of interest refers to circumstanc-
es in which this commitment to the fiduciary relationship
is compromised. Conflict of interest contains two ele-
ments: “1) an individual with an obligation, fiduciary or
otherwise, and 2) the presence of conflicting interests that
may undermine fulfillment of the obligation” (5).
The American Medical Association and other profes-
sional societies have long opposed practices that result in
conflicts of interest. The association’s Council on Ethical
and Judicial Affairs (CEJA) states that “as professionals,
physicians are expected to devote their energy, attention
and loyalty fully to the service of their patients” (6). Many
statements issued by CEJA and other American Medical
Association bodies have condemned various practices
resulting in conflict of interest. These related improper
commercial practices include fee splitting (payment by or
to a physician solely for the referral of a patient), physi-
cian self-referral, physician ownership of pharmacies, and
selling medical products (7). They have condemned phy-
sician ownership of stock in laboratories that pay physi-
cians in proportion to the amount of work they refer
and have disapproved of rebates from optical or medical
instrumentation companies (5, 8).
Referral by physicians to health care facilities, such as
laboratories, in which they do not engage in professional
activities but in which they have a financial interest is
called self-referral. This practice is analogous to product
sales in that physicians are deriving a profit from goods
(eg, laboratory tests or drugs) that they did not produce.
Both of these practices create a clear conflict of interest
because referring physicians accept money from vendors
to direct patients to use their products or services instead
of alternative products or services (including the option
of no treatment at all). The conflict, therefore, is between
2013 COMPENDIUM OF SELECTED PUBLICATIONS 101
 the financial advantage that accrues from physicians’
sales or referrals and physicians’ obligation to arrange the
best possible ancillary and consultative services for their
patients. For example, CEJA states that self-referral to
outside facilities is ethical only “if there is a demonstrated
need in the community for the facility and alternative
financing is not available” (6). In these circumstances, the
practice is considered ethical only if referring physicians
meet certain requirements designed to ensure that they
receive no more financial consideration than would an
ordinary investor and that certain safeguards are taken to
avoid exploitation of patients.
Several other cardinal principles are violated by the
practice of sales by physicians. The principle of truthful-
ness is violated if a conflict of interest related to the sale
exists and is not communicated to the patient.
The principle of nonmaleficence is violated when
there is a potential for injury to patients, which could
occur in several ways. Physicians may be tempted to sell
to patients items that they do not need. Even if its use
is appropriate, the product in question may not be the
most suitable for given patients. For example, joint ven-
tures in radiation oncology (ie, those in which referring
physicians had a financial interest) were found to provide
more frequent and more intense use of radiation therapy
than did freestanding facilities, without increased benefit
(9).
Another principle that may be violated by this
practice is that of respect for autonomy. A patient might
prefer comparing various alternatives when purchasing
products. If the product is offered by the physician on
whom she depends for advice and treatment, she could
feel constrained to accept the physician’s product. She
may feel coercion to comply with treatments with which
she does not agree. If the product is not health related,
patients might feel constrained to purchase goods they
do not want (8).
Finally, this practice violates the principles of profes-
sionalism and professional solidarity by weakening public
trust in the profession. As CEJA has stated, “The medical
profession’s ability to preserve autonomy and the nature
of the physician–patient relationship during periods of
transformation have succeeded in large part due to the
profession’s lack of tolerance for ‘commercialism’ in
medicine” (6).
Conclusion
The sale or promotion of products by physicians to their
patients rarely is ethical. Exceptions have been described
COMMITTEE OPINIONS
in this Committee Opinion. Practitioners of obstet-
rics and gynecology should not engage in commercial
arrangements that result in real, apparent, or potential
conflicts of interest.
References
1. James DN. Selling drugs in the physician’s office: a prob-
lem of medical ethics. Bus Prof Ethics J 1992;11:73–88.
2. Rice B. What’s a doctor doing selling Amway? Med Econ
1997;74(13):79–82, 85–6, 88.
3. Responsibility of applicants for promoting objectivity in
research for which PHS funding is sought. 42 C.F.R. §50
Subpart F (2005).
4. Pellegrino ED, Thomasma DC. A philosophical recon-
struction of medical morality. In: A philosophical basis
of medical practice: toward a philosophy and ethic of the
healing professions. New York (NY): Oxford University
Press; 1981. p. 192–220.
5. Rodwin MA. The organized American medical pro­fession’s
response to financial conflicts of interest: 1890–1992.
Milbank Q 1992;70:703–41.
6. Conflicts of interest. Physician ownership of medical
facilities. Council on Ethical and Judicial Affairs, American
Medical Association. JAMA 1992;267:2366–9.
7. American Medical Association. Sale of health-related
products from physicians’ offices. In: Code of medical eth-
ics of the American Medical Association: current opinions
with annotations. Chicago (IL): AMA; 2006. p. 225–6.
8. Sale of non-health-related goods from physicians’ offices.
Council on Ethical and Judicial Affairs, American Medical
Association. JAMA 1998;280:563.
9. Mitchell JM, Sunshine JH. Consequences of physicians’
ownership of health care facilities––joint ventures in radia-
tion therapy. N Engl J Med 1992;327:1497–501.
Copyright © January 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permis-
sion from the publisher. Requests for authorization to make photocop-
ies should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400
Commercial enterprises in medical practice. ACOG Committee Opinion
No. 359. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:243–5.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 102
 ACOG COMMITTEE OPINION
Number 360 • February 2007

Sex Selection*
Committee on Ethics ABSTRACT: In this Committee Opinion, the American College of Obstetricians and
Gynecologists’ Committee on Ethics presents various ethical considerations and argu-
Reaffirmed 2011
ments relevant to both prefertilization and postfertilization techniques for sex selection.
The principal medical indication for sex selection is known or suspected risk of sex-linked
genetic disorders. Other reasons sex selection is requested are personal, social, or cul-
tural in nature. The Commit­tee on Ethics supports the practice of offering patients pro-
cedures for the purpose of preventing serious sex-linked genetic diseases. However, the
committee opposes meeting requests for sex selection for personal and family reasons,
including family balancing, because of the concern that such requests may ultimately
support sexist practices. Because a patient is entitled to obtain personal medical informa-
tion, including information about the sex of her fetus, it will sometimes be impossible for
health care professionals to avoid unwitting participation in sex selection.

Sex selection is the practice of using medi-
cal techniques to choose the sex of offspring.
Patients may request sex selection for a num-
ber of reasons. Medical indications include the
prevention of sex-linked genetic disorders. In
addition, there are a variety of social, econom-
ic, cultural, and personal reasons for select-
ing the sex of children. In cultures in which
males are more highly valued than females,
sex selection has been practiced to ensure that
offspring will be male. A couple who has one
or more children of one sex may request sex
selection for “family balancing,” that is, to
have a child of the other sex.
Currently, reliable techniques for
selecting sex are limited to postfertilization
methods. Postfertilization methods include
techniques used during pregnancy as well
as techniques used in assisted reproduction
before the transfer of embryos created in
vitro. Attention also has focused on precon-
ception techniques, particularly flow cytom-
etry separation of X-bearing and Y-bearing
The American College
of Obstetricians spermatozoa before intrauterine insemina-
and Gynecologists tion or in vitro fertilization (IVF).
Women’s Health Care *Update of “Sex Selection,” in Ethics in Obstetrics and
Physicians Gynecology, Second Edition, 2004.
In this Committee Opinion, the Ameri-
can College of Obstetricians and Gyneco­
logists’ Committee on Ethics presents various
ethical considerations and arguments relevant
to both prefertilization and postfertilization
techniques for sex selection. It also provides
recommendations for health care profession-
als who may be asked to participate in sex
selection.
Indications
The principal medical indication for sex selec-
tion is known or suspected risk of sex-linked
genetic disorders. For example, 50% of males
born to women who carry the gene for hemo-
philia will have this condition. By identifying
the sex of the preimplantation embryo or fetus,
a woman can learn whether or not the 50%
risk of hemophilia applies, and she can receive
appropriate prenatal counseling. To ensure
that surviving offspring will not have this con-
dition, some women at risk for transmitting
hemophilia choose to abort male fetuses or
choose not to transfer male embryos. Where
the marker or gene for a sex-linked genetic dis-
order is known, selection on the basis of direct
identification of affected embryos or fetuses,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 103

 rather than on the basis of sex, is possible. Direct identifica-
tion has the advantage of avoiding the possibility of aborting
an unaffected fetus or deciding not to transfer unaffected
embryos. Despite the increased ability to identify genes and
markers, in certain situations, sex determination is the only
current method of identifying embryos or fetuses potentially
affected with sex-linked disorders.
Inevitably, identification of sex occurs whenever
karyotyping is performed. When medical indications for
genetic karyotyping do not require information about sex
chromosomes, the prospective parent(s) may elect not to
be told the sex of the fetus.
Other reasons sex selection is requested are personal,
social, or cultural in nature. For example, the prospective
parent(s) may prefer that an only or first-born child be
of a certain sex or may desire a balance of sexes in the
completed family.
Methods
A variety of techniques are available for sex identifica-
tion and selection. These include techniques used before
fertilization, after fertilization but before embryo transfer
and, most frequently, after implantation.
Prefertilization
Techniques for sex selection before fertilization include
timing sexual intercourse and using various methods
for separating X-bearing and Y-bearing sperm (1–5). No
current technique for prefertilization sex selection has
been shown to be reliable. Recent attention, however, has
focused on flow cytometry separation of X-bearing and
Y-bearing spermatozoa as a method of enriching sperm
populations for insemination. This technique allows
heavier X-bearing sperm to be separated; therefore, selec-
tion of females alone may be achieved with increased
probability (3). More research is needed to determine
whether any of these techniques can be endorsed in terms
of reliability or safety.
Postfertilization and Pretransfer
Assisted reproductive technologies, such as IVF, make
possible biopsy of one or more cells from a develop-
ing embryo at the cleavage or blastocyst stage (6).
Fluorescence in situ hybridization can be used for analy-
sis of chromosomes and sex selection. Embryos of the
undesired sex can be discarded or frozen.
Postimplantation
After implantation of a fertilized egg, karyotyping of fetal
cells will provide information about fetal sex. This pre­
sents patients with the option of terminating pregnancies
for the purpose of sex selection.
Ethical Positions of Other
Organizations
Many organizations have issued statements concerning
the ethics of health care provider participation in sex
COMMITTEE OPINIONS
selection. The ethics committee of the American Society
for Reproductive Medicine maintains that the use of
preconception sex selection by preimplantation genetic
diagnosis for nonmedical reasons is ethically problematic
and “should be discouraged” (7). However, it issued a
statement in 2001 that if prefertilization techniques, par-
ticularly flow cytometry for sperm sorting, were demon-
strated to be safe and efficacious, these techniques would
be ethically permissible for family balancing (8). Because
a preimplantation genetic diagnosis is physically more
burdensome and necessarily involves the destruction and
discarding of embryos, it was not considered similarly
permissible for family balancing (9).
The Programme of Action adopted by the United
Nations International Conference on Population and
Development opposed the use of sex selection techniques
for any nonmedical reason (10). The United Nations
urges governments of all nations “to take necessary mea-
sures to prevent . . . prenatal sex selection.”
The International Federation of Gynecology and
Obstetrics rejects sex selection when it is used as a tool for
sex discrimination. It supports preconception sex selec-
tion when it is used to avoid sex-linked genetic disorders
(11).
The United Kingdom’s Human Fertilisation and
Embryology Authority Code of Practice on preimplanta-
tion genetic diagnosis states that “centres may not use
any information derived from tests on an embryo, or
any material removed from it or from the gametes that
produced it, to select embryos of a particular sex for non-
medical reasons” (12).
Discussion
Medical Testing Not Expressly for the Purpose
of Sex Selection
Health care providers may participate unknowingly in
sex selection when information about the sex of a fetus
results from a medical procedure performed for some
other purpose. For example, when a procedure is done to
rule out medical disorders in the fetus, the sex of a fetus
may become known and may be used for sex selection
without the health care provider’s knowledge.
The American College of Obstetricians and Gyne-
cologists’ Committee on Ethics maintains that when
a medical procedure is done for a purpose other than
obtaining information about the sex of a fetus but will
reveal the fetus’s sex, this information should not be
withheld from the pregnant woman who requests it. This
is because this information legally and ethically belongs
to the patient. As a consequence, it might be difficult for
health care providers to avoid the possibility of unwit-
tingly participating in sex selection. To minimize the
possibility that they will unknowingly participate in sex
selection, physicians should foster open communication
with patients aimed at clarifying patients’ goals. Although
health care providers may not ethically withhold medical
2013 COMPENDIUM OF SELECTED PUBLICATIONS 104
 information from patients who request it, they are not
obligated to perform an abortion, or other medical pro-
cedure, to select fetal sex.
Medical Testing Expressly for the Purpose
of Sex Selection
With regard to medical procedures performed for the
express purpose of selecting the sex of a fetus, the fol-
lowing four potential ethical positions are outlined to
facilitate discussion:
Position 1: Never participate in sex selection. Health care
providers may never choose to perform med-
ical procedures with the intended purpose of
sex selection.
Position 2: Participate in sex selection when medically
indicated. Health care providers may choose
to perform medical procedures with the
intended purpose of preventing sex-linked
genetic disorders.
Position 3: Participate in sex selection for medical indi-
cations and for the purpose of family balanc-
ing. Health care providers may choose to
perform medical procedures for sex selection
when the patient has at least one child and
desires a child of the other sex.
Position 4: Participate in sex selection whenever request-
ed. Health care providers may choose to
perform medical procedures for the purpose
of sex selection whenever the patient requests
such procedures.
The committee shares the concern expressed by
the United Nations and the International Federation
of Gynecology and Obstetrics that sex selection can be
motivated by and reinforce the devaluation of women.
The committee supports the ethical principle of equality
between the sexes.
The committee rejects, as too restrictive, the position
that sex selection techniques are always unethical (posi-
tion 1). The committee supports, as ethically permissible,
the practice of sex selection to prevent serious sex-linked
genetic disorders (position 2). However, the increasing
availability of testing for specific gene mutations is likely
to make selection based on sex alone unnecessary in many
of these cases. For example, it supports offering patients
using assisted reproductive techniques the option of pre-
implantation genetic diagnosis for identification of male
sex chromosomes if patients are at risk for transmitting
Duchenne’s muscular dystrophy. This position is consis-
tent with the stance of equality between the sexes because
it does not imply that the sex of a child itself makes that
child more or less valuable.
Some argue that sex selection techniques can be
ethically justified when used to achieve a “balance” in
a family in which all current children are the same sex
and a child of the opposite sex is desired (position 3).
COMMITTEE OPINIONS
To achieve this goal, couples may request 1) sperm
sorting by flow cytometry to enhance the probability of
achieving a pregnancy of a particular sex, although these
techniques are considered experimental; 2) transferring
only embryos of one sex in assisted reproduction after
embryo biopsy and preimplantation genetic diagnosis; 3)
reducing, on the basis of sex, the number of fetuses in a
multifetal pregnancy; or 4) aborting fetuses that are not
of the desired sex. In these situations, individual parents
may consistently judge sex selection to be an important
personal or family goal and, at the same time, reject the
idea that children of one sex are inherently more valuable
than children of another sex.
Although this stance is, in principle, consistent with
the principle of equality between the sexes, it nonethe-
less raises ethical concerns. First, it often is impossible to
ascertain patients’ true motives for requesting sex selec-
tion procedures. For example, patients who want to abort
female fetuses because they value male offspring more
than female offspring would be unlikely to espouse such
beliefs openly if they thought this would lead physicians
to deny their requests. Second, even when sex selection
is requested for nonsexist reasons, the very idea of pre-
ferring a child of a particular sex may be interpreted as
condoning sexist values and, hence, create a climate in
which sex discrimination can more easily flourish. Even
preconception techniques of sex selection may encourage
such a climate. The use of flow cytometry is experimen-
tal, and preliminary reports indicate that achievement of
a female fetus is not guaranteed. Misconception about
the accuracy of this evolving technology coupled with a
strong preference for a child of a particular sex may lead
couples to terminate a pregnancy of the “undesired” sex.
The committee concludes that use of sex selec-
tion techniques for family balancing violates the norm
of equality between the sexes; moreover, this ethical
objection arises regardless of the timing of selection (ie,
preconception or postconception) or the stage of develop-
ment of the embryo or fetus.
The committee rejects the position that sex selection
should be performed on demand (position 4) because this
position may reflect and encourage sex discrimination.
In most societies where sex selection is widely practiced,
families prefer male offspring. Although this preference
sometimes has an economic rationale, such as the finan-
cial support or physical labor male offspring traditionally
provide or the financial liability associated with female
offspring, it also reflects the belief that males are inherently
more valuable than females. Where systematic preferences
for a particular sex dominate (13, 14), there is a need to
address underlying inequalities between the sexes.
Summary
The committee has sought to assist physicians and other
health care providers facing requests from patients for sex
selection by calling attention to relevant ethical consider-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 105
 ations, affirming the value of equality between the sexes,
and emphasizing that individual health care providers
are never ethically required to participate in sex selec-
tion. The committee accepts, as ethically permissible, the
practice of sex selection to prevent sex-linked genetic dis-
orders. The committee opposes meeting other requests
for sex selection, such as the belief that offspring of a
certain sex are inherently more valuable. The committee
opposes meeting requests for sex selection for personal
and family reasons, including family balancing, because
of the concern that such requests may ultimately support
sexist practices.
Medical techniques intended for other purposes have
the potential for being used by patients for sex selection
without the health care provider’s knowledge or consent.
Because a patient is entitled to obtain personal medi-
cal information, including information about the sex of
her fetus, it will sometimes be impossible for health care
professionals to avoid unwitting participation in sex
selection.
References
1. Gray RH. Natural family planning and sex selection: fact or
fiction? Am J Obstet Gynecol 1991;165:1982–4.
2. Check JH, Kastoff D. A prospective study to evaluate the
efficacy of modified swim-up preparation for male sex
selection. Hum Reprod 1993;8:211–4.
3. Fugger EF, Black SH, Keyvanfar K, Schulman JD. Births of
normal daughters after MicroSort sperm separation and
intrauterine insemination, in-vitro fertilization, or intracy-
toplasmic sperm injection. Hum Reprod 1998;13:2367–70.
4. Michelmann HW, Gratz G, Hinney B. X-Y sperm selec-
tion: fact or fiction? Hum Reprod Genet Ethics 2000;
6:32–8.
5. Schulman JD, Karabinus DS. Scientific aspects of precon-
ception gender selection. Reprod Biomed Online 2005;10
(suppl 1):111–5.
6. Sermon K, Van Steirteghem A, Liebaers I. Preimplantation
genetic diagnosis. Lancet 2004;363:1633–41.
COMMITTEE OPINIONS
7. Sex selection and preimplantation genetic diagnosis. Ethics
Committee of the American Society for Reproductive
Medicine. Fertil Steril 2004;82 (suppl):S245–8.
8. Preconception gender selection for nonmedical reasons.
Ethics Committee of the American Society for Reproduc-
tive Medicine. Fertil Steril 2004;82(suppl):S232–5.
9. Robertson J. Sex selection: final word from the ASRM
Ethics Committee on the use of PGD [news]. Hastings
Cent Rep 2002;32(2):6.
10. United Nations. Gender equality, equity and empower-
ment of women. In: Population and development: pro-
gramme of action adopted at the International Conference
on Population and Development, Cairo, 5–13 September
1994. New York (NY): UN; 1995. p. 17–21.
11. Ethical guidelines on sex selection for non-medical pur-
poses. FIGO Committee for the Ethical Aspects of Human
Reproduction and Women’s Health. Int J Gynaecol Obstet
2006;92:329–30.
12. Human Fertilisation and Embryology Authority. Code of
practice. 6th ed. London: HFEA; 2003.
13. Jha P, Kumar R, Vasa P, Dhingra N, Thiruchelvam D,
Moinedin R. Low female [corrected]-to-male [corrected]
sex ratio of children born in India: national survey of 1.1
million households [published erratum appears in Lancet
2006;367:1730]. Lancet 2006;367:211–8.
14. Hesketh T, Lu L, Xing ZW. The effect of China’s one-child
family policy after 25 years. N Engl J Med 2005;353:1171–6.
Copyright © February 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400
Sex selection. ACOG Committee Opinion No. 360. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:475–8.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 106
 ACOG COMMITTEE OPINION
Number 362 • March 2007

Medical Futility*
Committee on Ethics ABSTRACT: The construct of medical futility has been used to justify a physician’s
unilateral refusal to provide treatment requested or demanded by a patient or the family
Reaffirmed 2008
of a patient. It is important that physicians and their institutions develop a process for
dealing with conflict surrounding the construct of medical futility. Prospective policies
on medical futility are preferable to unilateral decision making by individual physicians.
When there is disagreement, patient and family values regarding treatment options and
the default position of maintaining life ordinarily should take priority.

A proliferation in medical technology has goals of the patient or family, or to achieve a

dramatically increased the number of diag-
nostic and therapeutic options available in
patient care. Health care costs also have
increased as a byproduct of this technologic
expansion. Simultaneously, medical ethics
has undergone a rapid metamorphosis from
a beneficence-focused ethic to one in which
autonomy dominates: that is, from an ethic
in which the physician attempted to deter-
mine what was in the patient’s best interest
and then acted on behalf of the patient to
an ethic in which alternatives are presented
to the patient and the patient makes the
ultimate decision. Thus, both the physician
and the patient may face the daunting task of
selecting from among myriad highly techno-
logic and expensive health care choices.
These choices, among other factors,
have created situations in which patients
or families have sometimes demanded care
that physicians may deem futile, or inca-
pable of producing a desired result. The
construct of medical futility has been used
to justify a physician’s unilateral refusal to
provide treatment requested or demanded
by a patient or the family of a patient. Such
The American College decisions may be based on the physician’s
of Obstetricians perception of the inability of treatment to
and Gynecologists achieve a physiologic goal, to attain other
Women’s Health Care
*Update of “Medical Futility,” in Ethics in Obstetrics and
Physicians Gynecology, Second Edition, 2004.
reasonable quality of life.
Although there is general agreement
with the notion that physicians are not obli-
gated to provide futile care (1), there is
vigorous debate and little agreement on
the definition of futile care, the appropri-
ate determinants of each component of the
definition, and on whose values should
determine the definition of futility. Proposed
definitions of medical futility include one or
more of the following elements:
• The patient has a lethal diagnosis or
prognosis of imminent death.
• Evidence exists that the suggested ther­
apy cannot achieve its physiologic goal.
• Evidence exists that the suggested ther­
apy will not or cannot achieve the
patient’s or family’s stated goals.
• Evidence exists that the suggested
ther­apy will not or cannot extend the
patient’s life span.
• Evidence exists that the suggested ther­
apy will not or cannot enhance the
patient’s quality of life.
The following questions need to be addressed
concerning each of the previously identified
elements:
• What is imminent death? Is it death
that is expected within hours or days,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 107

 or would it include death expected at any time up to
6 months or longer?
• At what point can a therapy be defined as unable to
achieve a physiologic goal? Is futility reached when
the goal could never be achieved or when the goal
could be achieved in less than 1% of the cases, in 5%
of the cases, or within some other established limit?
• What defines when a therapy can no longer achieve
the patient’s or family’s goals, and who should decide
this?
• What constitutes an enhanced life span—1 day, 1
week, 1 month?
• How is quality of life measured, and who should
determine what constitutes a satisfactory quality of
life for a given patient?
What these definitions have in common is an assess-
ment of whether a particular therapy will be effective (ie,
that it might alter the course of the disease or symptoms
of the patient), whether it offers any benefit to the patient,
and whether it adds to the burdens suffered by the patient
(2). It is important to note that the concept of futility does
not apply exclusively to situations in which a patient has
a terminal illness, but can apply to any clinical situation
in which a proposed treatment offers virtually no chance
of achieving a desired result. For example, futility would
be a sufficient reason to refuse in vitro fertilization treat-
ments to a couple who wishes to use their own gametes
when the female partner is older than 50 years and has a
markedly elevated follicle-stimulating hormone level (3).
Disagreements will sometimes occur between stake-
holders in the decision about whether a therapy will be
considered futile or not. These disagreements may con-
cern the definition of futility or whether the conditions
to establish futility have been met. These differences fre-
quently arise because one party places a different value on
one possible outcome of the therapy than the other party.
For example, a patient may judge that even one more
day of life is worth a therapeutic attempt or that living in
a coma is more desirable than death, while a physician
caring for that patient may feel differently. Physicians
or society may be less willing to provide the requested
care as they balance the use of resources and their indi-
vidual or collective view of the potential for and degree
of benefit. Patients may not include the use of resources
in their equation at all but simply balance negative side
effects and risks against the likelihood and degree of a
beneficial outcome. Society may be more likely to accede
to patient wishes when the use of resources is minimal
than when it is significant, regardless of the likelihood
of achieving physiologic goals, increasing life span, or
achieving patient goals. Reasonableness and equity in the
distribution of resources may play a role in determining
whether societal and institutional values should prevail
in contested decisions. When resource distribution is an
issue, however, the values of the patient and the preserva-
tion of life ordinarily take priority and are ethical default
COMMITTEE OPINIONS
positions. Ultimately, these are differences of value, with
individuals placing different values on the likelihood of a
good outcome, different assessments of what would con-
stitute an acceptable outcome, and different views about
how much effort and expense can be justified in the pur-
suit of an unlikely outcome. Consensus is most likely in
situations where the likelihood of achieving an outcome
that anyone would consider valuable is very low. One
suggestion has been that most physicians could agree that
something was futile if it had not worked in the previous
100 similar cases (4).
Litigation also has generally resulted in courts sup-
porting the views of patient or family in cases in which
patient and caregiver disagree regarding withholding
care, at least when withholding or withdrawing a medical
treatment would likely result in the death of the patient
(5–9). Commentators have observed that court decisions
in favor of patient or family wishes appear to be based on
one of the following factors:
• Medicine’s inability to quantify the likelihood of
futility with certainty
• The lack of a prospective and clearly stated process
for determining medical futility
• The courts’ current bias toward autonomy
• A desire to be consistent in upholding the patient’s
rights whether the patient is refusing or requesting
treatment
• Recognition that withdrawal of life-sustaining care
would likely result in the death of the patient
Need for a Medical Futility Policy
Inability to achieve a physiologic goal—strict physi-
ologic futility—is an appropriate basis for a physician
to refuse to provide requested therapeutic intervention.
However, the ability to declare strict physiologic futility
with certainty exists in only a limited number of clinical
situations in which there are conflicts about whether to
continue a therapy.
Other interpretations of medical futility are too sub-
jective to form the basis for unilateral physician decisions.
Therefore, in the absence of strict physiologic futility,
the construct of medical futility should be applied only
according to a prospective organizational policy that pro-
vides a process rather than a rule for resolving conflict.
The preferred approach for resolving all disputes
about whether a particular therapy should be offered
or continued should first be communication between
the patient and the physician. This conversation should
focus on reasonable goals of treatment, with emphasis on
whether the therapy in question can, in fact, achieve the
therapeutic goals set by the patient and physician (10).
The discussion should focus on specific clinical problems,
goals, and therapies rather than on whether the family
wants “everything done,” which represents a meaningless
and misleading request or offer. If resolution cannot be
2013 COMPENDIUM OF SELECTED PUBLICATIONS 108
 achieved through provider–patient communication, an
ethics consultant or ethics committee should be involved
to assist in the resolution of the dispute.
A policy can be valuable in those situations in which
the probability of reaching a physiologic goal or the
potential for enhancement of life’s duration or quality is
remote and there is disparity in the subjective interpreta-
tions by patient (family), physician, institution, and soci-
ety regarding the cost (economic, physical, emotional)
versus benefit ratio. A medical futility policy should
emphasize communication and negotiation rather than
unilateral physician decision making.
Designing a Medical Futility Policy
A medical futility policy should be built on the following
foundations:
• It should be designed to enhance discussion among
the parties.
• The responsible physician should be encouraged to
involve all appropriate members of the treatment
team (eg, house staff, nurses, and social workers)
to help reach an agreement between the patient (or
surrogate), the physician, and other members of the
health care team.
• It should be designed to seek input from other
individuals or groups with expertise in the relevant
medical discipline or medical ethics (including
clergy, attorneys, and ethics committees).
• It should include some formal institutional mecha-
nism for conflict resolution, such as ethics consulta-
tion or an ethics committee that ensures a thorough
review of the institution and provides a fair hearing
for all stakeholders.
• It should allow a patient to select another caregiver
whose view is more consistent with her own and
facilitate transfer of care, without prejudice, by the
original physician.
• If transfer of care is arranged, all ongoing, life-
sustaining treatment and interventions must be
continued while the transfer is awaited.
• If no conciliation of views or patient transfer occurs,
or if no other caregiver or facility is willing to pro-
vide the desired treatment, the caregivers are not
required to provide care that they regard as medi­
cally futile.
• There must be some process of appeal as the situa-
tion comes closer to action by the physician or facil-
ity that is still contested by the patient or family.
• When caregivers refuse to provide a futile interven-
tion or abrogate a certain aspect of treatment on the
basis of its futility, their obligation to provide care is
undiminished. Providing comfort care and palliative
care and maximizing quality of life at the end of life
remain fundamental obligations of the physician
responsible for a patient’s care.
COMMITTEE OPINIONS
• The policy should require documentation that
includes the following information:
—Probable diagnoses
—Probable prognosis
—Physician-recommended alternatives
—Patient-desired pathway
— Process of decision making that was followed,
including notes from relevant meetings
An example of a policy that provides a process for
decision making in medical futility is outlined in the
American Medical Association Council on Ethical and
Judicial Affairs report, “Medical Futility in End-of-Life
Care” (1) (see http://jama.ama-assn.org/cgi/reprint/281/
10/937 for a decision tree). Other institutions have pub-
lished their policies (11), and at least one state (Texas)
provides a law that outlines the conditions under which
a treatment team or institution can unilaterally withhold
or withdraw a therapy that has been deemed futile. These
conditions include 1) notifying the patient or the person
responsible for the health care decisions of the patient
in writing about the hospital’s policy on ethics consulta-
tion, 2) providing the patient or responsible person with
48-hour notice of consultation and inviting him or her
to participate in the consultation, and 3) providing the
patient or responsible person with a written report of the
ethics review process.
Under Texas law, when the ethics consultation pro-
cess fails to resolve the dispute, the hospital must work
with the patient or responsible person to try to arrange
transfer to an institution or physician that will provide
the disputed therapy. If no provider can be found after
10 days, the therapy can be unilaterally withheld or with-
drawn. A judicial appeal for an extension beyond 10 days
can be made by the patient or responsible person, but it
can be granted only if the judge determines there is a rea-
sonable likelihood of finding a provider willing to provide
the disputed treatment. When these conditions are met,
the treatment team and institution receive immunity
from civil or criminal prose­cution (12).
Summary
It is difficult to define medical futility prospectively
and objectively. Nonetheless, as technology continues to
advance and use more resources, it is important that phy-
sicians and their institutions develop a process for dealing
with conflict surrounding the construct of medical futility.
Prospective policies on medical futility are preferable
to unilateral decision making by individual physicians.
Such a medical futility policy should provide a systematic
process for dealing with disagreements, for ensuring that
all parties have received a fair hearing, and for reaching
a fair resolution, as outlined previously. When there is
disagreement, patient and family values regarding treat-
ment options and the default position of maintaining life
ordinarily should take priority. However, situations may
2013 COMPENDIUM OF SELECTED PUBLICATIONS 109
 occur in which claims of reasonableness and equity in the
distribution of resources are so powerful that the views of
caregivers, the institution, and society will prevail.
References
1. Medical futility in end-of-life care: report of the Council on
Ethical and Judicial Affairs. JAMA 1999;281:937–41.
2. Pellegrino ED. Decisions at the end of life—the abuse of the
concept of futility. Pract Bioethics 2005;1(3):3–6.
3. Fertility treatment when the prognosis is very poor or
futile. Ethics Committee of the American Society for
Reproductive Medicine. Fertil Steril 2004;82:806–10.
4. Schneiderman LJ, Jecker NS, Jonsen AR. Medical futil-
ity: its meaning and ethical implications. Ann Intern Med
1990;112:949–54.
5. Capron AM. In re Helga Wanglie. Hastings Cent Rep 1991;
21(5):26–8.
6. Capron AM. Abandoning a waning life. Hastings Cent Rep
1995;25(4):24–6.
7. Angell M. The case of Helga Wanglie. A new kind of “right
to die” case [editorial]. N Engl J Med 1991;325:511–2.
8. Miles SH. Informed demand for “non-beneficial” medical
treatment. N Engl J Med 1991;325:512–5.
9. Diekema DS. What is left of futility? The convergence
of anencephaly and the Emergency Medical Treatment
and Active Labor Act. Arch Pediatr Adolesc Med 1995;
149:1156–9.
COMMITTEE OPINIONS
10. Berg JW, Appelbaum PS, Lidz CW, Parker LS. The role
of informed consent in medical decision making. In:
Informed consent: legal theory and clinical practice. 2nd ed.
New York (NY): Oxford University Press; 2001. p. 167–87.
11. Singer PA, Barker G, Bowman KW, Harrison C, Kernerman
P, Kopelow J, et al. Hospital policy on appropriate use
of life-sustaining treatment. University of Toronto Joint
Centre for Bioethics/Critical Care Medicine Program Task
Force. Crit Care Med 2001;29:187–91.
12. Advance Directives Act. Tex. Health and Safety. §166
(1999). Available at: www.capitol.state.tx.us/statutes/docs/HS/
content/ htm/hs.002.00.000166.00.htm. Retrieved July 28,
2006.
Copyright © March 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400
Medical futility. ACOG Committee Opinion No. 362. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:791–4.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 110
 ACOG COMMITTEE OPINION
Number 363 • April 2007

Patient Testing: Ethical Issues in Selection

and Counseling*
Committee on Ethics ABSTRACT: Recommendations to patients about testing should be based on cur-
rent medical knowledge, a concern for the patient’s best interests, and mutual consulta-
Reaffirmed 2012
tion. In addition to establishing a diagnosis, testing provides opportunities to educate,
inform, and advise. The ethical principles of respect for autonomy (patient choice) and
beneficence (concern for the patient’s best interests) should guide the testing, counsel-
ing, and reporting process. Clear and ample communication fosters trust, facilitates
access to services, and improves the quality of medical care.

In the practice of medicine, clinical evalua-
tion is enhanced by a broad range of tests.
Recommendations to patients about testing
should be based on current medical knowl-
edge, a concern for the patient’s best interests,
and mutual consultation. Patient testing
embodies many scientific and human
ideals. From an ethical perspective, the most
important principles involve a trusting
patient–physician relationship emphasizing
beneficence (the benefits the patient may
derive from testing) and respect for autono-
my (an appreciation that patients make
choices about their medical care). Issues of
nonmaleficence (using tests when the conse-
quences of the test are uncertain) and justice
(applying tests to low-risk groups) also may
be important (1).
Rapid technologic development and the
need to consider legal and sociocultural fac-
tors as well as medical knowledge have
increased the complexity of the decision-
making process. The physician often is in
the position of ordering tests—for human
immunodeficiency virus (HIV) or genetic
markers, for example—that may, unlike a
The American College urinalysis or a hemogram, have a profound
of Obstetricians effect on the patient, her partner, her fam-
and Gynecologists
Women’s Health Care *Update of “Patient Testing,” in Ethics in Obstetrics and
Physicians Gynecology, Second Edition, 2004.
ily, and society in general. This new level of
complexity requires the specification of
both medical and ethical guidelines for
decisions about patient testing. This Com-
mittee Opinion provides ethical guidance for
decisions about ordering tests, counseling
patients, and reporting results.
Ordering Tests
• The physician and the patient have a
shared responsibility. The quality of med-
ical care improves when there is clear
communication and mutual under-
standing between physician and patient.
It is the responsibility of the obstetri-
cian–gynecologist to communicate effec-
tively and to develop skills that promote
a patient–physician relationship that is
characterized by trust and honesty.
Similarly, it is the responsibility of the
patient to provide accurate information
about her lifestyle, health habits, sexual
practices, and religious and cultural
beliefs when these factors may affect
medical judgment. In decisions about
testing, physicians should be guided by
scientific knowledge. Care must be taken
to avoid subjective assumptions based
on bias that could affect the appropriate-
ness of testing (2).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 111

 • Testing should be performed primarily for the benefit of
the patient. Testing at the request of third parties—
partners, health care providers, members of the
patient’s extended family, employers, or health insur-
ers—is justifiable only when the patient or her valid
proxy understands the potential risks and benefits
and gives consent (3). Examples of this type of test-
ing include genetic tests to assist family members
with reproductive decisions, HIV tests to fulfill con-
ditions for the purchase of life insurance, and
requests for patient testing after the occupational
exposure of health care workers.
• The decision to offer or to withhold a test should not
be made solely on the basis of a physician’s assump-
tions about the patient’s expected response to test
results (4). Prejudgments about a patient’s wishes
regarding fetal abnormalities, for example, should
not preclude her being offered prenatal testing. The
patient should join with the physician in deciding the
amount of diagnostic information that is appropri-
ate for making intelligent choices about preventive
care and treatment options. The physician is not,
however, ethically obligated to perform every test a
patient requests, particularly if disease prevalence
and risk factors are low, generating a high false-posi-
tive risk.
• The patient must be informed prospectively about
policies regarding use of information and legal
requirements. The patient must be told what will be
communicated, to whom, and the potential implica-
tions of reporting the information. If, for example, a
patient is concerned about posting HIV test results in
the medical record and who may have access to the
results, she may choose instead to use an anonymous
testing procedure available through another labora-
tory. In some situations, reporting of results is man-
dated by law. Physicians should be familiar with the
laws regarding mandatory testing and reporting
requirements in their own jurisdictions.
• The physician and patient should discuss concerns
about cost containment and reimbursement. The
mutual goal of physician and patient should be to
avoid both undertesting and overtesting. Contem-
porary focus on the economics of health care has cre-
ated worries for both physician and patient about
access to care, limitations to testing, appropriateness
of use, and the impact of financial constraints on
quality of care. Testing done with low probability of
improving patient diagnosis or testing solely for the
sake of professional liability concerns should be
avoided. Open communication about cost concerns
and perceived benefit is the best way to alleviate sus-
picion and to promote trust.
2 ACOG Committee Opinion No. 363
COMMITTEE OPINIONS
Pretest and Posttest Counseling
• Testing that may have multiple medical or psychoso-
cial consequences requires specific counseling. The
extent of counseling beneficial to each patient will
vary depending on the individual and on the impli-
cations inherent in the potential test results. With
simple tests like urinalysis, it is sufficient to provide
information about the nature and purpose of the test
and how the results will guide management. Tests
that may have multiple medical or psychosocial
ramifications require comprehensive explanation of
the process, the goals, and the implications (4).
Counseling can be appropriate for genetic testing
and maternal toxicology assays, for example, because
of the potential for psychologic, social, and econom-
ic effects. Tests with low positive predictive value,
such as cervical cytology and mammography, can
generate the need for additional and more extensive
testing. Testing for HIV or inherited breast cancer
mutations may limit future insurance coverage.
• In some cases, the potential benefits––including socie-
tal benefits––of certain tests may lead some to recom-
mend alternative schemes for counseling and consent in
order to maximize the rate of testing. The U.S. Centers
for Disease Control and Prevention, ACOG, and the
American Academy of Pediatrics have endorsed an
“opt-out” protocol with patient notification for
prenatal HIV testing (5–7). The use of patient notifi-
cation provides women the opportunity to decline
testing but eliminates the requirement to obtain spe-
cific informed consent.
• Autonomy of the individual in shared decision making
should always be respected. It is essential in the
informed consent process that subsequent election of
the patient to forgo a recommended intervention
(informed refusal) be carefully documented in the
patient’s medical record along with the patient’s rea-
son for refusal. Both pretest and posttest counseling
facilitate women’s access to appropriate health care.
Pretest counseling includes both medical considera-
tions and issues such as the availability of emotional
support while waiting for test results. Posttest coun-
seling offers an opportunity to provide access to
resource networks and community-based services.
• Referral may be needed for comprehensive counseling.
If time constraints or lack of technical expertise
make it difficult to offer comprehensive counseling
in a particular practice, appropriate options include
either 1) referral to a specialized center for both
counseling and testing, or 2) referral for counseling
only, with return to the original physician for testing
and medical follow-up.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 112
 Confidentiality and the Reporting
of Test Results
• Information ordinarily may not be revealed without
the patient’s express consent. Physicians have an
obligation to be familiar with federal privacy protec-
tion legislation (Health Insurance Portability and
Accountability Act) (8). Guidance is provided here
for the ethical duty to maintain confidentiality.
Maintaining confidentiality is intrinsic to respect for
patient autonomy and permits the free exchange of
information that is relevant to medical decision
making. Situations may arise, however, in which a
physician has competing obligations: protecting the
patient’s confidentiality or disclosing test results to
prevent harm to a third party. In these situations,
every avenue of communication should be explored
first in discussions with the patient about rights and
responsibilities. Consultation with an institutional
ethics committee or a medical ethics specialist may
be helpful in weighing benefits and harms of disclo-
sure. Legal advice may be prudent.
• A violation of confidentiality may be ethically justified
as a last resort. A violation of confidentiality may be
justifiable only when legally required or when all of
the following conditions have been met: 1) there is a
high probability of harm to a third party, 2) the
potential harm is a serious one, 3) the information
communicated can be used to prevent harm, and 4)
greater good will result from breaking confidentiality
than from maintaining it. Case law has not yet been
developed to address the grey area where, on rare
occasions, legal obligations to protect patient confi-
dentiality and ethical and professional obligations to
act for the benefit of the patient may conflict.
Conclusion
In addition to establishing a diagnosis, testing provides
opportunities to educate, inform, and advise. The ethical
principles of respect for autonomy (patient choice) and
beneficence (concern for the patient’s best interests)
should guide the testing, counseling, and reporting
ACOG Committee Opinion No. 363
COMMITTEE OPINIONS
process. Clear and ample communication fosters trust,
facilitates access to services, and improves the quality of
medical care.
References
1. Beauchamp TL, Childress JF. Priniciples of biomedical
ethics. 5th ed. New York (NY): Oxford University Press;
2001.
2. Malm HM. Medical screening and the value of early detec-
tion. When unwarranted faith leads to unethical recom-
mendations. Hastings Cent Rep 1999;29:26–37.
3. Offit K, Groeger E, Turner S, Wadsworth EA, Weiser MA.
The “duty to warn” a patient’s family members about
hereditary disease risks. JAMA 2004;292:1469–73.
4. McGowan R. Beyond the disorder: one parent’s reflection
on genetic counselling. J Med Ethics 1999;25:195–9.
5. Prenatal and perinatal human immunodeficiency virus
testing: expanded recommendations. ACOG Committee
Opinion No. 304. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;104:1119–24.
6. Revised recommendations for HIV screening of pregnant
women. Centers for Disease Control and Prevention.
MMWR Recomm Rep 2001;50(RR-19):63–85; quiz CE1-
19a2–CE6-19a2.
7. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Joint statement on
human immunodeficiency virus screening. ACOG
Statement of Policy 75. Elk Grove Village (IL): AAP; 2005;
Washington, DC: ACOG; 2006.
8. American College of Obstetricians and Gynecologists.
HIPAA privacy manual. 2nd ed. Washington, DC: ACOG;
2003.
Copyright © April 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical, pho-
tocopying, recording, or otherwise, without prior written permission
from the publisher. Requests for authorization to make photocopies
should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400
Patient testing: ethical issues in selection and counseling. ACOG
Committee Opinion No. 363. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;109:1021–3.
ISSN 1074-861X
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 113
 ACOG COMMITTEE OPINION
Number 364 • May 2007

Patents, Medicine, and the Interests of

Patients*
Committees on ABSTRACT: Many basic scientists and clinicians support the right to obtain and
Ethics and Genetics enforce patents on drugs, diagnostic tests, medical devices, and most recently, genes.
Reaffirmed 2009 Although those who develop useful drugs, diagnostic and screening tests, and medical
This document reflects
technologies have the right to expect a fair return for their efforts and risks, current inter-
emerging scientific advan- pretations of patent law have the potential to impede rather than promote scientific and
ces as of the date issued medical advances. Policies regarding the patenting of scientific inventions, discoveries,
and is subject to change.
The information should not and improvements must balance the need for the open exchange and use of information
be construed as dictating with the need to make the pursuit of such knowledge financially rewarding.
an exclusive course of
treatment or procedure to
be followed.
New technologies and the translation of development and academic collaboration
research discoveries into clinical medicine because a gene sequence, unlike previous
are essential for improvements in patient technical advances, is both a tool for pursu-
care. The increasing commercialization of ing scientific knowledge and the basis for any
medical discoveries, however, may hamper diagnostic or therapeutic application.
the dissemination of new knowledge and the
ability of physicians and patients to benefit Patent Protections
from applications of this knowledge. Many The U.S. Patent and Trademark Office
basic scientists and clinicians support the (PTO) is guided by federal statutes, regu-
right to obtain and enforce patents on drugs, lations, and case law in granting patents.
diagnostic tests, medical devices, and most Patent protection is intended to promote
recently, genes. Some primarily are con- research and discovery and to act as a stimu-
cerned with recovering the costs they incur in lus to progress in science and the useful arts.
developing new treatments and technologies. The PTO evaluates an application for a U.S.
Others see patents in medicine as a legiti- patent to determine whether the claimed
mate means, within a society based on the invention satisfies the following three condi-
principle of free enterprise, of protecting and tions: the invention is a 1) “new” and 2)“use-
enhancing intellectual capital. ful” discovery or improvement that is 3)“not
Such patent protections may be regard- obvious” to individuals with ordinary skill
ed as necessary incentives for the develop- in the art (1, 2). In evaluating patent appli-
ment of new tests and treatments. Also, they cations, the PTO also assesses whether the
may limit the ability of clinicians, patients, specification adequately describes the inven-
and researchers to obtain the right to use tion and enables the skilled artisan to make
these discoveries commercially under rea- and use it. A patent is granted for an inven-
sonable conditions and at an affordable tion that meets the three conditions and
The American College price. Furthermore, the issue of gene patent-
of Obstetricians other requirements, such as being patentable
ing poses unique challenges to knowledge subject matter. For example, “products of
and Gynecologists
*Update of “Patents, Medicine, and the Interests of nature” can be patented if they are in an
Women’s Health Care Patients” in Ethics in Obstetrics and Gynecology, Second
Physicians Edition, 2004.
isolated form that does not occur in nature.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 114

 Patents that may affect the practice of medicine fall
into four categories: 1) patents on medical and surgical
procedures, 2) patents on surgical or diagnostic instru-
ments, 3) patents on drugs, and 4) patents on genes
and gene-based diagnostic or predictive tests. All of
these types of patents raise ethical issues and may cre-
ate conflicts of interest for physicians who contribute to
the development of new products through research. The
commercial potential of medical discoveries may moti-
vate physicians to increase their own incomes in ways
that may jeopardize the care of patients. Academic and
research physicians may be offered incentives by their
institutions to maximize the institution’s extramural
revenues through patent arrangements that restrict use
by other researchers and, thus, act as barriers to further
research discoveries.
Patenting Medical and Surgical Procedures
Historically, physicians have taught and shared medi-
cal information without regarding this knowledge as
trade secrets to be protected from others. Physicians
have a fundamental obligation to provide advice to their
patients about the most appropriate care, without being
influenced by any profit they might gain through asso-
ciated commercial ventures. Open communication of
information gained from research and experience with
medical and surgical procedures is essential if safety and
efficacy are to be validated or refuted by colleagues. It is
through further scientific work by one’s peers that diag-
nostic methodologies and medical procedures are either
validated, refined, and improved or discarded as ineffec-
tive or unhelpful.
Some corporate or individual business arrange-
ments—including the patenting and licensing of medical
and surgical procedures—can be adverse to the welfare
of patients. These arrangements present barriers to the
availability of the protected procedures to other physi-
cians and patients. Moreover, they may inhibit new
research that might otherwise be stimulated by open
access to information about the procedures. Investiga-
tional use of patented procedures is permitted under the
“experimental use doctrine,” which allows a patented
invention to be used in a manner that does not interfere
with the economic interests of the patent holder (ie, used
with no commercial intentions).
For these reasons, the enforceability of patents cov-
ering medical and surgical procedures has been chal-
lenged, both ethically and legally. The American Medical
Association asserts that it is unethical for physicians “to
seek, secure or enforce patents on medical procedures”
because such practices may limit the availability of new
procedures to patients (3). In the 1996 case Pallin v
Singer, Dr. Pallin was prohibited from enforcing his pat-
ent claims on a particular type of incision used in cataract
surgery (4). As a result of this case, Congress enacted a
1996 statute making patents of medical or surgical pro-
cedures unenforceable (5). In the United States, medical
COMMITTEE OPINIONS
and surgical procedures are still patentable, but patent
claims are not enforceable against a medical practitioner
unless the practitioner uses a patented pharmaceutical,
medical device, or biotechnology process. Thus, the U.S.
legal system provides some support for the traditional
ethic of physicians to share their knowledge and the use
of advances in medical and surgical procedures. Other
countries view the patentability of medical procedures
differently than the United States. For instance, the
European Union and Great Britain consider medical pro-
cedures to be nonpatentable subject matter.
Patenting Surgical and Diagnostic Instruments
The U.S. patent system also permits medical and surgical
devices to be patented, including surgical and diagnostic
instruments. The U.S. patent protection permits the pat-
ent holder to exclude other individuals or entities from
making, using, or selling the patented invention in the
United States for a period of 20 years, thus providing
market exclusivity to the patent holder. Both ethically
and legally, physicians may obtain patents on surgical
or diagnostic instruments that they have invented (6).
However, out of concern for the welfare of patients, the
patent holder should make the instrument available at a
fair and reasonable cost.
Patenting Drugs
The granting of patents to pharmaceutical companies
for drugs that they have developed may appear to be
relatively uncontroversial. Drug makers have successfully
argued the need for patent protection to recoup the cost
of their investment in drug research and to gain a profit
before the makers of generic equivalent drugs are permit-
ted to enter the market.
However, some techniques used by pharmaceutical
companies to extend the terms of their patents and their
products’ market exclusivities have recently come under
criticism. For example, companies have paid manufactur-
ers of generic drugs to drop a legal challenge to a patent
or to postpone the manufacture of a generic equivalent,
they have developed minimally altered formulations or
dosages that become eligible for new patents, and they
have lobbied Congress for statutory and legislative patent
extensions on highly profitable drugs. These techniques
may allow the patent holder to continue to charge prices
that are far higher than would be the case in a competitive
market and to extend the government-sanctioned market
exclusivity long beyond when the original patent term
would have expired. As a result, the cost to consumers or
patients may be inflated beyond providing a reasonable
return on research investments and may, in fact, prevent
some patients from using drugs that would be beneficial
to them. As patients bear an increasing share of the cost
of their prescribed drugs, the issue of drug pricing and
extended market exclusivities should be of concern to
physicians. Cost may influence patient compliance with
physician recommendations.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 115
 The Patenting of Genes
Patent and Trademark Office Guidance
The PTO maintains that genes and gene sequences are
patentable subject matter under existing U.S. federal
statutes and case law. Since 1980, more than 20,000 pat-
ents on genes or other gene-related molecules have been
granted, but this total includes gene patents for all organ-
isms, not only humans. More than 25,000 applications
for patents on genes or related molecules are pending (7).
Because of continuing controversy over the grant-
ing of patents on genes and gene sequences, the PTO
has attempted to clarify its standards for granting such
patents in its final guidelines on the written description
and utility requirements of patents. The guidelines were
issued after consideration of public comments on interim
guidelines, and they are pertinent to gene patents. The
PTO guidelines confirm that an isolated and purified
gene (a chemical entity modified from its natural state)
is not a naturally occurring substance. Substances as they
occur in nature in an unisolated form are not patentable.
Under U.S. patent law, the PTO regards a newly
isolated gene or modified gene sequence to be a “com-
position of matter.” This is subject matter that is eligible
for a product patent as long as the product satisfies all
the statutory conditions for a patent. These conditions
require that the patent specification describe an inven-
tion that is a new discovery or improvement (novel),
that is not obvious to those with ordinary skill in the art
(inventive), and that has utility (is useful) (1, 2). Product
patents may be enforced broadly against a variety of uses
of the claimed product. For example, a product patent
claiming an isolated gene sequence can be used to exclude
others from using the sequence for commercial purposes
(ie, both the isolated gene sequence and the methods of
using it in tests and treatments).
If the gene sequence is not new, it may nonetheless
be eligible for a use patent (ie, a patent having claims
directed to the product’s use). The enforcement of a use
patent is narrower, being limited to the patented use.
Although a use patent restricts the right to use a patented
method using a product or composition, it does not
restrict access to the product or composition itself.
A patent claiming an isolated gene covers the iso-
lated gene but does not apply to the gene as it occurs in
nature. Genes as they occur in the body are not patent-
able because they do not exist in an isolated and purified
form. Therefore, individuals who possess such genes in
their bodies would not infringe the patent.
In its final guidelines on the utility requirement
for patentability, the PTO requires that the utility be
“specific, substantial, and credible” (8). To satisfy this
requirement, the inventor must disclose at least one way
in which the purified gene, isolated from its natural state,
may be used or applied, for example, for diagnostic or
predictive genetic testing. However, if the applicant does
not explicitly identify a specific utility for the isolated
COMMITTEE OPINIONS
gene sequence, the guidelines permit the utility require-
ment to be satisfied if the examiner believes that an
individual with ordinary skill in the art would recognize
that the gene or sequence has a readily apparent “well-
established utility.” Some commentators have suggested
that this well-established utility may be simply a compari-
son with a structurally analogous gene or sequence that is
known to have utility.
In the view of some commentators, the PTO guide-
lines do not set a high enough standard for establishing
the usefulness of a gene or gene sequence and, therefore,
may deem a product useful and allow a patent to be
issued covering a gene or gene sequence before the appli-
cant is able to identify a specific practical application (9).
Allowing patents on genes and sequences to be issued
before their function and purpose are adequately identi-
fied could create barriers to other researchers pursuing
such studies or could lessen the incentive for them to do
so. Moreover, researchers warn against relying too heavily
on structural analogues to predict utility because minor
changes in a gene sequence “may produce profound
changes in biological activity” (10).
Gene Patents and the Interests of Patients
Those who support the granting of broad patents believe
that patent protection encourages rather than impedes
research. It was the intent of Congress that the disclosure
required to secure a patent and the limited exclusivity
provided by the patent would stimulate progress in science
and the useful arts. As the PTO notes, a patent application
requires complete public disclosure of the invention, dis-
covery, or improvement and, therefore, may promote dis-
semination of knowledge rather than secrecy. In the PTO’s
view, gene patents foster scientific progress because other
inventors are encouraged to discover new uses beyond the
one specified in the patent application (8). Inventors who
develop new and nonobvious uses for a patented gene may
patent these inventions, according to the PTO, thereby
rewarding researchers who develop the genetic information
to the endpoint of a useful method or product (11, 12).
Opponents of broad gene patenting fear that the
welfare of the patient, the traditional role of the physician,
and the public trust are compromised by gene patents.
According to opponents of gene patenting, the patenting
of genes can impinge on the interests of patients in at least
four ways:
1. By retarding the transmission of knowledge (possible
if researchers choose to delay the announcement or
the publication of their findings until after a patent
application is filed)
2. By inhibiting other researchers from pursuing further
investigation on the patented product (developing a
subsequent invention often is difficult, complicated,
or unprofitable because of the need to coordinate
licensing with the original patent holder)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 116
 3. By establishing a monopoly on all diagnostic and
predictive tests based on a patented gene (such
action would limit the ability of practitioners and
researchers to improve genetic testing by adding
new mutations, devising new testing techniques,
and developing national quality assurance programs
[13])
4. By infringing on the interests of groups of patients
who have provided the original genetic material on
which the discovery of a gene or sequence is based
(they may feel that their concerns are disregarded
because of restrictions on access to tests and treat-
ments made possible by their contribution of bio-
logic material)
European challenges to the patent on the breast can-
cer gene BRCA1 illustrate problems that arise when a pat-
ent holder claims that a patent on a gene precludes other
researchers or organizations from developing their own
tests for gene mutations. French researchers, supported
by the European parliament, argue that such a monopoly
could impede or even prevent the development and use
of cheaper and more effective tests for BRCA1 mutations,
such as tests that cover a broader range of mutations (14,
15).
Similarly, in the clinical setting, experience has
shown that patent holders may in effect deprive patients
and physicians of reasonable access (eg, to a genetic test)
by placing significant hurdles to its use. These hurdles can
include substantial royalties or licensing fees and restric-
tions on the licensing of clinics or on the number of tests
allowed, such as the conditions placed on prenatal and
carrier testing for some autosomal recessive diseases (16).
Responses to the problem of restricted access to
patented genes have led to several proposed solutions.
One proposed solution is to develop a system similar to
the music licensing system, where gene patent holders
would be required to grant nonexclusive licenses for a
reasonable set fee (17). Another proposed solution is that
genes and genetic sequences should not be granted com-
position-of-matter patents because the market exclusivity
of their patents extends beyond the use identified by the
patent applicant and covers uses of the substance that may
be discovered later. Instead, a patent would be granted to
an applicant who identifies a specific function of a gene,
but the patent would cover only the use or utility identi-
fied, such as a particular genetic test. Then researchers
who later discovered additional applications for the gene
would be able to patent these new discoveries (18).
Response to the issue of access to genetic tests has led
some patient advocacy groups to take a proactive stance
at the time that patients provide tissue samples to re-
searchers. To ensure that any genetic tests that result from
their participation will be inexpensive and widely avail-
able, these groups are seeking patents held jointly by the
patient group and the researchers (19). Therefore, rather
than objecting to the patenting of genes and genetic tests,
COMMITTEE OPINIONS
these patients are seeking to use the patent system to pro-
tect their own interests.
Recommendations
Practitioners and researchers need to be aware of public
policies that may jeopardize their ability to advance med-
ical knowledge and provide the best tests and treatments
to patients. Although those who develop useful drugs,
diagnostic and screening tests, and medical technolo-
gies have the right to expect a fair return for their efforts
and risks, current interpretations of patent law have the
potential to impede rather than promote scientific and
medical advances. Because the purpose of the patent
system is to promote the public welfare, practices that are
inimical to the public good and overly protective of com-
mercial monopolies should be altered (18).
Policies regarding the patenting of scientific inven-
tions, discoveries, and improvements must balance the
need for the open exchange and use of information with
the need to make the pursuit of such knowledge finan-
cially rewarding. Therefore, the Committee on Ethics
and the Committee on Genetics of the American College
of Obstetricians and Gynecologists suggest the following
recommendations regarding the patenting of medical
and surgical procedures, medical devices, genes, DNA
sequences, screening and diagnostic tests, and gene-based
therapies:
1. Patents on medical or surgical procedures are ethi-
cally unacceptable, and some are legally unenforce-
able. Physicians may obtain patents on surgical and
diagnostic instruments that they have developed.
However, the patent holders should make these
instruments available at a fair and reasonable cost for
the benefit of patients.
2. Because a patent claiming a gene as a composition
of matter enables a patent holder to control future
applications of the patented gene or sequence, such
patents should not be granted. A patent should
be granted only for the specified use or applica-
tion of the gene or sequence (a “use” patent), thus
enabling others to develop additional applications
(18). Because case law and the PTO interpret a
gene as being a patentable chemical composition
of matter, such a limitation would require con-
gressional intervention. The Committee on Ethics
and the Committee on Genetics support legislation
that would make composition-of-matter patents on
genes unenforceable.
3. If composition-of-matter patents on genes continue
to be enforceable, such patents on genes with clinical
applications should be subject to federal regulation
and oversight to ensure reasonable availability of the
genes and their products for research and clinical
use. Such regulation should include requirements on
licensing arrangements to ensure access for the pub-
lic good, including both the advancement of knowl-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 117
 edge and the clinical care of patients. Specifically,
licensing agreements should permit reasonable but
not excessive royalties and should allow unlimited
access to tests by qualified laboratories, precluding
exclusionary arrangements and quotas on the num-
ber of tests that may be offered.
References
1. Patentability of inventions, 35 U.S.C. §101–103 (2004).
2. Application for patent, 35 U.S.C. §112 (2004).
3. American Medical Association. Patenting of medical pro-
cedures. In: Code of medical ethics of the American
Medical Association: current opinions with annotations.
2006–2007 ed. Chicago (IL): AMA; 2006. p. 292–3.
4. Pallin v Singer 1995 U.S. Dist. LEXIS 20824, 36 U.S.P.Q.2d
(BNA) 1050 (D.Vt. May 1 1995).
5. Remedies for infringement of patent and other actions, 35
U.S.C. §281–297 (2004).
6. American Medical Association. Patent for surgical or
diagnostic instrument. In: Code of medical ethics of the
American Medical Association: current opinions with
annotations. 2006–2007 ed. Chicago (IL): AMA; 2006. p.
291–2.
7. Doll JJ. Talking gene patents. Sci Am 2001;285:28.
8. Utility examination guidelines. United States Patent and
Trademark Office. Fed Regist 2001;66:1092–9.
9. United States Patent and Trademark Office. Public
comments on the United States Patent and Trademark
Office “revised interim utility examination guidelines.”
Alexandria (VA): USPTO; 2000. Available at: http://www.
uspto.gov/web/offices/com/sol/comments/utilguide/
index.html. Retrieved January 5, 2007.
10. Spiegel J. Comment 44. In: United States Patent and
Trademark Office. Public comments on the United States
Patent and Trademark Office “revised interim utility
examination guidelines.” Alexandria (VA): USPTO; 2000.
Available at: http://www.uspto.gov/web/offices/com/sol/
comments/utilguide/nih2.pdf. Retrieved January 5, 2007.
11. Doll JJ. The patenting of DNA. Science 1998;280:689–90.
12. Wheeler DL. Will DNA patents hinder research? Lawyers
say not to worry. Chron High Educ 1999 July 16; 46:A19.
COMMITTEE OPINIONS
13. American College of Medical Genetics. Position statement
on gene patents and accessibility of gene testing. Bethesda
(MD):ACMG;1999. Available at http://genetics.faseb.org/
genetics/acmg/pol-34.htm. Retrieved December 13, 2006.
14. Dorozynski A. France challenges patent for genetic screen-
ing of breast cancer. BMJ 2001;323:589.
15. Watson R. MEPs add their voice to protest at patent for
breast cancer gene. BMJ 2001;323:888.
16. Marshall E. Genetic testing. Families sue hospital, scientist
for control of Canavan gene. Science 2000;290:1062.
17. Heller MA, Eisenberg RS. Can patents deter innovation?
The anticommons in biomedical research. Science 1998;
280:698–701.
18. Williamson AR. Gene patents: socially acceptable monop-
olies or an unnecessary hindrance to research? Trends
Genet 2001;17:670–3.
19. Smaglik P. Tissue donors use their influence in deal over
gene patent terms. Nature 2000;407:821.
Suggested Reading
U.S. Department of Energy Office of Science. Genetics and
patenting. Washington, DC: USDOE; 2002. Available at: http://
www.ornl.gov/hgmis/elsi/patents.html. Retrieved December 13,
2006.
United States Patent and Trademark Office. General infor-
mation concerning patents. Alexandria (VA): USPTO; 2002.
Available at: http://www.uspto.gov/web/offices/pac/doc/general/
index.html. Retrieved December 13, 2006.
Copyright © May 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Patents, medicine, and the interests of patients. ACOG Committee
Opinion No. 364. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2007;109:1249–53.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 118
 ACOG COMMITTEE OPINION
Number 365 • May 2007

Seeking and Giving Consultation*

Committee on Ethics ABSTRACT: Consultations usually are sought when practitioners with primary clinical
responsibility recognize conditions or situations that are beyond their level of expertise
or available resources. One way to maximize prompt, effective consultation and collegial
relationships is to have a formal consultation protocol. The level of consultation should
be established by the referring practitioner and the consultant. The referring practitioner
should request timely consultation, explain the consultation process to the patient, pro-
vide the consultant with pertinent information, and continue to coordinate overall care
for the patient unless primary clinical responsibility is transferred. The consultant should
provide timely consultation, communicate findings and recommendations to the referring
practitioner, and discuss continuing care options with the referring practitioner.

Physicians have a long history of working
together and with other health care profes-
sionals to provide efficient and compre-
hensive care for the patients they serve.
Achieving these goals sometimes requires
that physicians or other care providers seek
consultation from or provide consultation to
their colleagues (1). The basic principles of
consultation for obstetrician–gynecologists
are summarized in the “Code of Professional
Ethics of the American College of Obstet-
ricians and Gynecologists” as follows (2):
• “The obstetrician–gynecologist’s rela-
tionships with other physicians, nurses,
and health care professionals should
reflect fairness, honesty, and integrity,
sharing a mutual respect and concern
for the patient.”
• “The obstetrician–gynecologist should
consult, refer, or cooperate with other
physicians, health care professionals,
and institutions to the extent neces-
sary to serve the best interests of their
patients.”
The American College Often, these relationships among clini-
of Obstetricians cians lead to professional dialogue. In pro-
and Gynecologists
Women’s Health Care *Update of “Seeking and Giving Consultation” in Ethics
Physicians in Obstetrics and Gynecology, Second Edition, 2004.
fessional dialogue, clinicians share their
opinions and knowledge with the aim of
improving their ability to provide the best
care to their patients. Such dialogue may be
part of a clinician’s overall efforts to maintain
current scientific and professional knowledge
or may arise in response to the needs of a
particular patient.
In professional dialogue, a second clini-
cian is typically asked a simple question and
he or she does not talk with or examine the
patient. For example, questions might be
asked regarding the significance of an irregu-
lar blood antibody or the follow-up interval
for an abnormal cervical cytology result. The
second clinician does not make an entry in
the patient’s medical record or charge a fee,
and the first clinician should not attribute an
opinion to the second clinician.
Professional dialogue does not consti-
tute a formal consultation or establish a
patient–consultant relationship. Sometimes,
however, professional dialogue does lead
to a formal request for consultation. If, for
example, a physician is asked to provide
an opinion regarding a patient’s care and
believes an examination of the patient or her
medical record is necessary to answer the
question appropriately, he or she should ask
to see the patient for a formal consultation.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 119

 Although consultation usually is requested in an
efficient manner that expedites patient care, situations
occur in which the relationship between practitioners or
between institutions and practitioners results in an inef-
ficient, less-than-collegial consultative process that may
not be in the best interest of the patient. For example, a
patient and a consultant may be put at serious disadvan-
tage when consultation is requested late in the process
of care or is not accompanied by sufficient background
information or the reason for consultation is not clearly
stated. Conversely, those seeking consultation may be
denied assistance on arbitrary grounds.
This Committee Opinion outlines the purpose of
consultation and referral, states the underlying ethi-
cal foundations that govern consultation and referral,
and elaborates specifically the responsibilities of those
who seek and those who provide consultation. The
Committee Opinion is directed to physicians but it
should be recognized that nonphysician practitioners also
may be involved in consultation.
The Purpose of Consultation and
Referral
Typically, a patient first seeks care from her primary care-
giver, who should be aware that the patient’s needs may
go beyond his or her education, training, or experience
(2–4). Various levels of consultation may be needed to
make correct diagnoses, provide technical expertise, and
recommend a course of action (see the box). Occasion-
ally, consultation or referral may be indicated when a
patient’s request for care is in conflict with her primary
caregiver’s recommendations or preferences. Finally, a
patient may seek consultation with another caregiver to
obtain a second opinion or explore other options for care
(5). In all of these types of consultation, the interests of
the patient should remain paramount (3).
Ethical Foundations
Ethical principles require that the consultative process be
guided by the following concepts (2, 6):
• The welfare of the patient should be central to the
consultant–patient relationship (beneficence).
• The patient should be fully informed about the need
for consultation and participate in the selection of
the consultant (respect for autonomy).
• The patient should have access to adequate consul-
tation regardless of her medical condition, social
status, or financial situation (justice).
• Practitioners must disclose to patients any perti-
nent actual or potential conflict of interest that is
involved in a consultation relationship, including
financial incentives or penalties or restrictive guide-
lines (truth-telling).
In addition, both practitioners with primary clinical
responsibility and consultants must respect the rights of
COMMITTEE OPINIONS
Definitions: Levels of Consultation
Consultation is the act of seeking assistance from another
physician(s) or health care professional(s) for diagnostic
studies, therapeutic interventions, or other services that
may benefit the patient. There are several levels of con-
sultation: single-visit consultations, continuing collabora-
tive care, and transfer of primary clinical responsibility.
Their descriptions are as follows:
• A single-visit consultation involves examination of
the patient or the patient’s medical record and perfor-
mance of diagnostic tests or therapeutic procedures.
The findings, procedures, and recommendations of
the consultant are recorded in the patient’s medical
record or provided to the practitioner with the primary
clinical responsibility for the patient in a written report
or letter, and a fee may be charged. The subsequent
care of the patient continues to be provided by the
referring practitioner. Examples of such consultations
are confirming the findings of a pelvic examination,
performing a specific urodynamic procedure on a
patient with urinary stress incontinence, and interpret-
ing an electronic fetal monitoring tracing or imaging
studies. In the latter two cases, the tracing or other
output can be transmitted electronically, allowing for
the performance of a single-visit consultation without
personal contact between the patient and consultant.
• Continuing collaborative care describes a relation-
ship in which the consultant provides ongoing care in
conjunction with the referring practitioner. Thus, the
consultant assumes at least partial responsibility for
the patient’s care. An example is a high-risk obstetric
patient with a medical complication of pregnancy who
is periodically assessed by the consultant, whereas
the referring practitioner is responsible for the day-to-
day management of the patient.
• Transfer of primary clinical responsibility to the con-
sultant may be appropriate for the management of
problems outside the scope of the referring practitio-
ner’s education, training, and experience or in cases
in which the patient must be transferred to another
facility. Examples are the transfer of care of a patient
in preterm labor from a birth center to a consultant in
a perinatal center or referral of a patient with ovarian
cancer to a gynecologic oncologist. In many of these
situations, patients will eventually return to the care of
the referring practitioner when the problem for which
the consultation was sought is resolved.
the patient and also the rights of their respective profes-
sional colleagues.
Responsibilities Associated With
Consultation
Seeking Consultation and Requesting Referral
Consultations usually are sought when practitioners
with primary clinical responsibility recognize conditions
or situations that are beyond their level of expertise or
2013 COMPENDIUM OF SELECTED PUBLICATIONS 120
 available resources. Historically, these practitioners acted
as independent agents who decided when consultation
was appropriate, determined the level of consultation, and
were free to choose particular consultants. More recently,
as a result of recognition of the importance of respect for
patient autonomy, practitioners now inform patients of
the need for consultation and discuss options with them.
The quality of the consultation often is improved by
this collaborative relationship between practitioners and
patients.
Today, this practitioner–patient partnership operates
under new conditions that may affect the process of con-
sultation. Health care guidelines and protocols used by
certain types of managed care arrangements may limit the
freedom of the practitioner to provide complete care or
to request consultation (7). These guidelines may include
instructions about specific situations or medical condi-
tions in which consultation, second opinion, or referral is
mandated (8). Examples include abnormal labor that may
require operative delivery or chronic uterine bleeding that
may require hysterectomy. Other guidelines may require
that practitioners seek consultation when patients develop
signs and symptoms of severe preeclampsia or if ovarian
cancer is discovered. Such arrangements and guidelines
may be designed to ensure a high level of care for patients
by requiring that consultants be involved appropriately in
certain clinical problems.
Conversely, practitioners may find themselves in
situations that create disincentives to medically appropri-
ate consultation or that mandate the use of a consultant
panel that is not adequate to support appropriate patient
care. The policies that lead to such situations involve
potential conflicts of interest (9) and may have a negative
effect on the patient’s medical needs, thus limiting her
autonomy and her right to informed choice. Under all
conditions of practice—solo or group, fee for service, or
managed care contract—consultation and referral should
be carried out in the patient’s best interest and obtained
with the patient’s consent after full disclosure of limita-
tions and potential conflicts of interest.
It is in everyone’s best interest—practitioners with
primary clinical responsibility, consultants, patients, and
health care plans—that the criteria for consultation be
mutually agreed on in advance and stated clearly in writ-
ing. Financial incentives or penalties for consultation and
referral that exist either overtly or covertly under many
managed care contracts are sources of serious conflicts of
interest. Practitioners must be free to inform patients of
the best medical practice or options of care, even when
the mandate of directed referrals under contracted care
does not include these alternatives. Ethical responsibility
for patients’ best interests demands that practitioners dis-
close any proscriptions to serving as patients’ advocates.
Practitioners have a responsibility to provide patients
with their best medical judgment and serve as advocates
for patients if recommended care is denied. It then
becomes the patients’ responsibility to decide whether to
COMMITTEE OPINIONS
abide by insurance plan restrictions, challenge them, or
seek care outside the scope of coverage.
Giving Consultation and Accepting Referral
Physicians generally provide consultations or accept
referred patients in the interest of providing excellent care
for patients and promoting good relationships among
colleagues. Open communication and established profes-
sional relationships facilitate effective consultation and
referral. However, at times a consultant may be called
on unexpectedly, inconveniently, and sometimes inap-
propriately to be involved in or to assume the care of a
patient. In these situations, a physician is only ethically
obligated to provide consultation or assume the care of
the patient if there is a contractual agreement or a preex-
isting patient–physician relationship or if there is a severe
medical emergency, in which there is no reasonably avail-
able alternative caregiver (10). Hospital or departmental
guidelines for consultation and referral may prevent such
confrontations.
Practical Recommendations
Providing optimal care demands a good working rela-
tionship with a number of other physicians and health
care professionals. Consultation may be needed by the
practitioner with primary clinical responsibility regard-
less of specialty designation or level of training. Ideally,
the referring practitioner–consultant relationship has
been established before the need for consultation or
referral arises, and the referring practitioner–consultant
relationship should be ongoing.
One way to maximize prompt, effective consultation
and collegial relationships is to have a formal consultation
protocol. This may be especially advantageous for family
physicians who provide obstetric or gynecologic care and
for collaborative practice between obstetrician–gynecolo-
gists and nurse practitioners, certified nurse–midwives,
and other health care professionals. Such protocols create
pathways that anticipate difficult or complex situations.
The level of consultation should be established by a dia-
logue between the referring practitioner and the consul-
tant that results in mutual agreement (see the box on the
previous page).
Electronic means of communication, such as e-mail,
may be used as long as the consultant and referring physi-
cian agree to use such media and have established systems
to confirm receipt and transfer of reports to the medical
chart. Electronic communication must be done in a man-
ner that protects patient confidentiality.
Responsibilities of the Referring Practitioner
The responsibilities of the referring practitioner can be
outlined as follows:
1. The referring practitioner should request consulta-
tion in a timely manner, whenever possible before
an emergency arises. A good working relationship
2013 COMPENDIUM OF SELECTED PUBLICATIONS 121
 between the referring practitioner and the consultant
requires shared concern for the patient’s needs and
a commitment to timely and clear-cut communica-
tion.
2. The referring practitioner is responsible for prepar-
ing the patient with an explanation of the reasons for
consultation, the steps involved, and the names of
qualified consultants.
3. The referring practitioner should provide a summary
of the history, results of the physical examination,
laboratory findings, and any other information that
may facilitate the consultant’s evaluation and recom-
mendations (11).
4. Whenever possible, the referring practitioner should
document in the medical record the indications for
the consultation and specific issues to be addressed
by the consultant.
5. The referring practitioner should discuss the consul-
tant’s report with the patient and give his or her own
recommendation based on all available data in order
to serve the best interest of the patient.
6. A complex clinical situation may call for multiple
consultations. Unless authority has been transferred
elsewhere, the responsibility for the patient’s care
should rest with the referring practitioner (3). This
practitioner should remain in charge of communi-
cation with the patient and coordinate the overall
care on the basis of information derived from the
consultants. This will ensure a coordinated effort
that remains in the patient’s best interest.
Responsibilities of the Consultant
The responsibilities of the consultant can be outlined as
References
follows:
1. Consultants should recognize their individual
boundaries of expertise and provide only those
medically accepted services and technical procedures
for which they are qualified by education, training,
and experience.
2. When asked to provide consultation, the consultant
should do so in a timely manner and without regard
to the specialty designation or qualifications of the
referring practitioner.
3. The consultant should effectively communicate find-
ings, procedures performed, and recommendations
to the referring practitioner at the earliest opportu-
nity (12).
4. A summary of the consultation should be included
in the medical record or sent in writing to the refer-
ring practitioner.
5. The extent to which the consultant will be involved
in the ongoing care of the patient should be clearly
established by mutual agreement of the consultant,
COMMITTEE OPINIONS
the referring practitioner, and the patient. At times
it may be appropriate for the consultant to assume
primary clinical responsibility for the patient. Even if
this is only a temporary circumstance, the consultant
should obtain the referring practitioner’s coopera-
tion and assent, whenever possible.
6. When the consultant does not have primary clinical
responsibility for the patient, he or she should try to
obtain concurrence for major procedures or addi-
tional consultants from the referring practitioner.
7. In all that is done, the consultant must respect the
relationship between the patient and the referring
practitioner, being careful not to diminish inappro-
priately the patient’s confidence in her other caregiv-
ers (3).
8. The consultant should be cognizant of the referring
practitioner’s abilities, and the consultant and refer-
ring practitioner should discuss who can best pro-
vide the agreed-upon care. Reliance on the referring
practitioner’s abilities may increase convenience to
the patient, limit transportation needs, and ultimate-
ly result in more cost-effective care. In other cases,
however, it may not be possible for the consultant’s
recommendations to be addressed adequately by the
referring practitioner.
9. If the consultant believes that the referring practitio-
ner is not qualified to provide an appropriate level of
continuing care, the consultant should recommend
to the referring practitioner and, if necessary, to the
patient that the referring practitioner transfer care of
the patient.
1. American Medical Association. Referral of patients. In:
Code of medical ethics of the American Medical Assoc-
iation: current opinions with annotations. 2006–2007 ed.
Chicago (IL): AMA; 2006. p. 116–8.
2. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC: ACOG;
2004. Available at: http://www.acog.org/from_home/
acogcode.pdf. Retrieved January 10, 2007.
3. Snyder L, Leffler C. Ethics manual: fifth edition. Ethics and
Human Rights Committee, American College of Physicians.
Ann Intern Med 2005;142:560–82.
4. American College of Obstetricians and Gynecologists.
Physicians working with physicians. In: The assistant:
information for improved risk management. Washington,
DC: ACOG; 2001. p. 19–20.
5. American Medical Association. Second opinions. In: Code
of medical ethics of the American Medical Association:
current opinions with annotations. 2006–2007 ed. Chicago
(IL): AMA; 2006. p. 198–9.
6. Beauchamp TL, Childress JF. Principles of biomedical eth-
ics. 5th ed. New York (NY): Oxford University Press; 2001.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 122
 7. Wallach EE, Fox HE, Gordon T, Faden R. Symposium:
Copyright © May 2007 by the American College of Obstetricians and
managed care and ethics. Contemp Ob Gyn 1998;43:162–76. Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
8. Chervenak FA, McCullough LB, Chez RA. Responding to DC 20090-6920. All rights reserved. No part of this publication may
the ethical challenges posed by the business tools of man- be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
aged care in the practice of obstetrics and gynecology. Am cal, photocopying, recording, or otherwise, without prior written
J Obstet Gynecol 1996;175:523–7. permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
9. Cain JM, Jonsen AR. Specialists and generalists in obstet- Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
rics and gynecology: conflicts of interest in referral and an
ethical alternative. Womens Health Issues 1992;2:137–45. Seeking and giving consultation. ACOG Committee Opinion No.
365. American College of Obstetricians and Gynecologists. Obstet
10. American Medical Association. Free choice. In: Code of Gynecol 2007;109:1255–9.
medical ethics of the American Medical Association: cur- ISSN 1074-861X
rent opinions with annotations. 2006–2007 ed. Chicago
(IL): AMA; 2006. p. 282–4.
11. Role of the obstetrician–gynecologist in the screening and
diagnosis of breast masses. ACOG Committee Opinion No.
334. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:1213–4.
12. American Medical Association. Consultation. In: Code of
medical ethics of the American Medical Association: cur-
rent opinions with annotations. 2006–2007 ed. Chicago
(IL): AMA; 2006. p. 198.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 123

 ACOG COMMITTEE OPINION
Number 369 • June 2007

Multifetal Pregnancy Reduction*

Committee on Ethics ABSTRACT: Counseling for treatment of infertility should include a discussion of
the risks of multifetal pregnancy, and multifetal pregnancy reduction should be discussed
with patients before the initiation of any treatment that could increase the risk of multi-
fetal pregnancy. In almost all cases, it is preferable to terminate an ovulation induction
cycle or limit the number of embryos to be transferred to prevent a situation in which
fetal reduction will have to be considered. The best interests of the patient and the future
child or children should be at the center of the risk–benefit equation. Although no physi-
cians need to perform fetal reductions if they believe that such procedures are morally
unacceptable, all obstetricians and gynecologists should be aware of the medical and
ethical issues in these complex situations and be prepared to respond in a professional,
ethical manner.

The ethical issues surrounding the use and Background

consequences of reproductive technologies
are highly complex, and no one position
reflects the variety of opinions within the
membership of the American College of
Obstetricians and Gynecologists. The pur-
pose of this Committee Opinion is to review
the ethical issues involved in multifetal preg-
nancy reduction. For the purposes of this
document, multifetal pregnancy reduction is
defined as a first-trimester or early second-
trimester procedure for termination of one
or more fetuses in a multifetal pregnancy,
to increase the chances of survival of the
remaining fetuses and decrease long-term
morbidity for the delivered infants (1).
To many, the ethical issues involved in
multifetal pregnancy reduction are some-
what different from the issues involved in
abortion, as discussed in the “Analysis”
section. Although no physicians need to
perform multifetal pregnancy reductions if
they believe that such procedures are mor-
ally unacceptable, all physicians should be
aware of the medical and ethical issues in
these complex situations and be prepared
to respond in a professional, ethical man-
The American College ner to patient requests for information and
of Obstetricians procedures.
and Gynecologists
Women’s Health Care *Update of “Multifetal Pregnancy Reduction” in Ethics
Physicians in Obstetrics and Gynecology, Second Edition, 2004.
Spontaneous occurrences of multifetal preg-
nancies always have been a medical problem.
More recently, increased use of potent ovu-
lation-induction drugs and assisted repro-
ductive technology (ART), such as in vitro
fertilization (IVF), have been effective in the
treatment of infertility but subsequently also
have increased the risk of multifetal preg-
nancy (2). Thousands of patients previously
unable to have children have been assisted
to achieve conception. In a small percentage
of these patients, the resultant pregnancy
has involved more than two fetuses, thereby
creating potentially serious problems (2–6).
There is widespread agreement that the risks
of perinatal morbidity and mortality and
maternal morbidity increase with the num-
ber of fetuses. Recent reports have shown
improving outcomes with multifetal preg-
nancies, but the risks are still significant (6).
Prevention
The first approach to this problem is or
should be prevention. It might be argued
that the problem is best remedied by dis-
continuing technologic assistance to repro-
duction. On the one hand, this approach
discounts the major benefits that ART offers
to patients and suggests an unwarranted
coercive restriction on parental choice and
autonomy. On the other hand, the associa-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 124

 tion of an increased rate of multifetal pregnancies with
infertility treatment deserves serious attention. Some
multifetal pregnancies will inevitably occur despite the
best of intentions, knowledge, skill, and equipment, but it
is essential that those providing infertility treatment exer-
cise a high degree of diligence to minimize the problem.
Both ovulation induction alone and IVF contribute
to high-order multiple births (more than two). In 1977,
43.3% of all births of triplets or greater were the result
of ART (ie, IVF) and 38.2% were the result of the use
of ovulation drugs (5). In 1996, the order was reversed;
40.4% of births of triplets or greater were the result
of ovulation drugs, whereas 38.7% were the result of
ART (5). According to the Centers for Disease Control
and Prevention, 3,390 infants were born in triplet or
higher-order multiple deliveries after ART treatment in
2003, accounting for 44% of all infants born in triplet or
higher-order multiple deliveries (7). Similar data are not
available for ovulation induction cycles.
Ovulation induction with gonadotropin cycles in
which ultrasound imaging demonstrates the presence of
many mature follicles, each capable of releasing an ovum,
presents a difficult decision on whether to give human
chorionic gonadotropin (hCG) to induce ovulation. If
an hCG injection is withheld, the patient will have spent
considerable time and emotional and financial resources
for a nonovulatory cycle. Yet, if hCG is given to trigger
ovulation, a high-order multifetal pregnancy may result.
Attempts have been made to develop criteria for with-
holding hCG (eg, more than six large follicles or estradiol
levels greater than 1,500 pg/mL). However, a large study
showed that the occurrence of high-order multifetal preg-
nancies after gonadotropin therapy increases with higher
estradiol levels but cannot be reliably predicted by the
number of mature follicles on ultrasound examination
(8). The authors concluded that adherence to criteria for
withholding hCG will not prevent high-order multiple
births and that better criteria cannot easily be established.
They suggest that the use of treatment protocols with
less-intensive stimulation of the ovaries may reduce the
incidence of high-order multifetal pregnancies, but only
to a limited extent and at the expense of pregnancy rates.
When many follicles are present, alternative approaches
would be conversion of the gonadotropin cycle to an IVF
cycle or selective aspiration of the supernumerary follicles
(9).
In ART, there may be pressure to be successful
because of both prospective parents’ and programs’ inter-
ests. Direct costs for IVF cycles are many times higher
than those for ovulation induction alone with gonado-
tropins. Ovulation induction with gonadotropins may
be more likely to be covered by insurance. Patients who
choose to undergo IVF may be paying for treatment out
of pocket, and this may add pressure to achieve preg-
nancy on the first attempt. In addition, IVF programs
face public scrutiny not faced by programs that offer only
ovulation induction. Although success rates for individ-
COMMITTEE OPINIONS
ual IVF programs are public information, published by
the Centers for Disease Control and Prevention, similar
reporting is not done for ovulation induction alone (2).
As the number of embryos transferred increases, program
success rates may increase, but so does the risk of a mul-
tifetal pregnancy (2).
The physician who makes decisions about the cir-
cumstances for triggering ovulation or guidelines for
embryo transfer must, as in any medical situation, place
the best interests of the patient and the future child or
children at the center of the risk–benefit equation. In
some countries, such as England, where ART is cen-
trally regulated, limitations are placed on the number of
embryos that can be transferred, and subsequently fewer
multifetal pregnancies result.
In the United States, the decision is left to individual
physicians and programs. In almost all cases, it is prefer-
able to terminate a gonadotropin cycle used for ovula-
tion induction alone or limit the number of embryos
to be transferred in IVF to prevent a situation in which
patients and physicians will have to consider fetal reduc-
tion. The Practice Committee of the American Society for
Reproductive Medicine (ASRM) has issued a report sug-
gesting prognosis-dependent guidelines for limiting the
number of embryos to be transferred. These guidelines
limit risk while allowing individualization of patient care
for optimal results (10). Multifetal pregnancy reduction
should be viewed as a response to a consequence of ovu-
lation induction that cannot always be avoided; it should
not be a routinely accepted treatment for an iatrogenic
problem.
The ultimate goal in prevention is to significantly
reduce the likelihood that any multifetal pregnancy will
occur, including twins. This will require patients, phy-
sicians, and payers to support a culture in which IVF
may replace gonadotropin-only therapy in treatment
algorithms. When IVF is performed, the eventual goal in
the future may be to transfer only the embryo with the
greatest chance for growth and implantation; currently
ASRM recommends that consideration be given to trans-
ferring only a single embryo for patients with the most
favorable prognosis (10). Nonetheless, data from the
Centers for Disease Control and Prevention indicate that
approximately 56% of embryo transfers that used fresh
nondonor eggs in 2003 involved the transfer of three or
more embryos (2).
Another strategy under study is transfer of blas-
tocysts instead of cleavage-stage embryos, hoping that
higher pregnancy rates would allow fewer embryos to
be transferred. Yet, although some randomized trials
have found higher pregnancy or live-birth rates with
the transfer of a single blastocyst-stage embryo over a
single cleavage-stage embryo (11, 12), the transfer of
blastocyst-stage embryos has not been supported by
others (13). The current position of ASRM is that either
blastocyst transfer or cleavage stage-embryo transfer may
be performed (10).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 125
 Counseling
As with all medical care, counseling for treatment of
infertility should incorporate discussions of risks, ben-
efits, and treatment alternatives, including the option for
no treatment. Counseling should be considered an ongo-
ing process, beginning before treatment decisions are
made and continuing throughout the patient’s care. The
risks of certain treatments of infertility include, but are
not limited to, the occurrence of multifetal pregnancy,
with its associated risks of spontaneous abortion, preterm
labor and delivery, and neonatal morbidity and mortality.
The informed consent process must include information
about the potential for multifetal pregnancy and associ-
ated maternal risks, such as prolonged hospitalization,
antepartum bleeding, postpartum hemorrhage, hyper-
tensive diseases of pregnancy, and an increased rate of
cesarean delivery. Whether patients decide to maintain or
to reduce high-order multiple pregnancies, they should
be assured that they will receive the best available care
(14).
It also is the responsibility of the physician to inform
the patient that fetal reduction as a response to multifetal
pregnancy has inherent medical risks to the remaining
fetuses. Pregnancy loss rates of approximately 4–6%
have been reported for triplet-to-twin reduction in large
samples (15–17), but higher rates also have been reported
(18). Reports of lower birth weights for twins reduced
from triplets also are of concern (19–20), although more
recent reports have suggested that reduction from triplets
or quadruplets to twins is associated with an outcome as
good as with an unreduced twin gestation (15, 22–26).
Nonetheless, patients should not be given the impression
that multifetal pregnancies are without problems because
fetal reduction is available.
Patients struggle with the ethical and emotional
issues of fetal reduction. In a postdelivery informational
survey of couples who had undergone multifetal preg-
nancy reduction, few of the small sample of respondents
reported that they understood the procedure or its conse-
quences fully at the time of fetal reduction (27). In semi-
structured interviews of 10 women who had undergone
multifetal pregnancy reduction, one third reported still
feeling guilt 1 year after the procedure (28). Many infer-
tility patients have unrealistic ideas about the outcomes
for high-order multifetal pregnancies that leave them
unprepared for feelings of loss and grief at the time of a
reduction procedure (29, 30). However, in studies that
used standard psychologic tests to assess the emotional
state of patients after multifetal pregnancy reduction,
serious long-term psychologic sequelae were not identi-
fied. Among women who underwent multifetal preg-
nancy reduction and subsequently miscarried the entire
pregnancy, depression scores were similar to scores for
a control group of women who did not undergo fetal
reduction and subsequently miscarried the entire preg-
nancy (31).
COMMITTEE OPINIONS
A report that 93% of patients who decided to pro-
ceed with fetal reduction would make that decision again
despite their experience of stress and sadness is somewhat
reassuring, but the number of patients studied was quite
small (n = 91) (32). The ethical issues that this option
involves should be discussed with patients before the
initiation of any treatment that could increase the risk
of multifetal pregnancy. Although patients should be
encouraged to examine their feelings about these risks
and options at the onset, the counseling process should
encourage them to continue this assessment at appropri-
ate points in the treatment process (33).
Options
In the presence of an already established multifetal preg-
nancy, the options are inevitably difficult. No choice
is without potential consequences, and the potential
benefits must be carefully weighed against the potential
harms. There are three options in multifetal pregnancies:
1. Abort the entire pregnancy (all of the fetuses).
2. Continue the pregnancy (all of the fetuses).
3. Perform multifetal pregnancy reduction on one or
more of the fetuses.
The first option involves aborting the entire multife-
tal pregnancy. However, for some patients, aborting the
pregnancy is not an acceptable option. For other patients
who may have achieved pregnancy after infertility treat-
ment, this option may be considered the least desirable.
The second option is attempting to carry the multi-
fetal pregnancy to term. However, the risks of perinatal
and maternal morbidity and mortality increase directly
with the number of fetuses (8). These risks include losing
all of the fetuses or having some survive with permanent
impairment as a consequence of extreme preterm birth.
The assessment of what constitutes “significant risk”
varies among patients and physicians and, therefore, is
not amenable to uniform definition. Physicians should
respect their patients’ conclusions about which risks are
acceptable and which are too high.
The third option in multifetal pregnancies is mul-
tifetal pregnancy reduction. The technique brings about
the demise of one or more fetuses with the intent to allow
continuation of the pregnancy, resulting in the delivery of
fewer infants with lower risks of preterm birth, morbid-
ity, and mortality. Although this procedure is successful
in most cases, it may raise some unsettling ethical con-
cerns. There is a complex interrelationship between the
intention to reduce the morbidity of a smaller number
of surviving fetuses and the intentional sacrifice of others
that demands an ethical as well as medical assessment
of the relative benefits and risks of multifetal pregnancy
reduction. What follows is an attempt to outline such an
assessment, with the understanding that each case ulti-
mately must be examined on its own merits.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 126
 Analysis
Many would argue that there are differences between the
ethical analyses involved in multifetal pregnancy reduc-
tion and elective abortion because the intent is different.
A woman has an elective abortion because, for many
complex and varied reasons, she does not wish or feels
unable to have a child. In contrast, an infertility patient
who has a multifetal pregnancy undergoes fetal reduc-
tion precisely because she does wish to bear a child. The
patient and her physician may conclude that fetal reduc-
tion is the preferred way to continue her pregnancy. For
some individuals, the primary intention justifying fetal
reduction may be the life and well-being of the fetuses
that do survive and continue to develop. For others, it is
unethical to terminate an apparently healthy fetus, even
for the sake of the survival or well-being of other fetuses
in the pregnancy.
Some individuals who believe that abortion is gen-
erally unacceptable find multifetal pregnancy reduction
to be justified ethically when the risks of carrying the
pregnancy are considerable and could be reduced if the
number of fetuses were fewer. Individual patients will
evaluate varying degrees of risk differently. As advances
in maternal–fetal and neonatal medicine continue, the
risk of extreme preterm birth is expected to decrease. The
issues of patient choice and physician participation and
consultation need to be analyzed on a case-by-case basis.
Summary
Although physicians may choose not to participate in
multifetal pregnancy reduction, they should be knowl-
edgeable about this procedure and be prepared to react
in a professional and ethical manner to patient requests
for information or services or both. The first approach to
the problem of multifetal pregnancies should be preven-
tion. Although fetal reduction will be ethically acceptable
to many as a response to an unforeseen and unavoidable
contingency, in almost all cases, it is preferable to termi-
nate a gonadotropin cycle or limit the number of embry-
os to be transferred to prevent a situation in which the
patient and physician need to consider fetal reduction.
Counseling for treatment of infertility should include a
discussion of the risks of multifetal pregnancy, and the
ethical issues surrounding fetal reduction should be dis-
cussed with patients before the initiation of any treatment
that could increase the risk of multifetal pregnancy.
References
1. Berkowitz RL, Lynch L. Selective reduction: an unfortunate
misnomer. Obstet Gynecol 1990;75:873–4.
2. Centers for Disease Control and Prevention. 2004 Assisted
reproductive technology success rates: national summary
and fertility clinic reports. Atlanta (GA): CDC; 2006.
Available at: http://ftp.cdc.gov/pub/Publications/art/2004
ART508.pdf. Retrieved January 11, 2007.
COMMITTEE OPINIONS
3. Multiple gestation: complicated twin, triplet, and high-
order multifetal pregnancy. ACOG Practice Bulletin No.
56. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:869–83.
4. Perinatal risks associated with assisted reproductive tech-
nology. ACOG Committee Opinion No. 324. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2005;106:1143–6.
5. Contribution of assisted reproductive technology and
ovulation-inducing drugs to triplet and higher-order mul-
tiple births––United States, 1980–1997. Centers for Disease
Control and Prevention (CDC). MMWR Morb Mortal
Wkly Rep 2000;49:535–8.
6. Jones HW, Schnorr JA. Multiple pregnancies: a call for
action. Fertil Steril 2001;75:11–3.
7. Wright VC, Chang J, Jeng G, Macaluso M. Assisted repro-
ductive technology surveillance—United States, 2003.
MMWR Surveill Summ 2006;55(SS-4):1–22.
8. Gleicher N, Oleske DM, Tur-Kaspa I, Vidali A, Karande V.
Reducing the risk of high-order multiple pregnancy after
ovarian stimulation with gonadotropins. N Engl J Med
2000;343:2–7.
9. Ethical issues related to multiple pregnancies in medically
assisted procreation. ESHRE Task Force on Ethics and Law.
Hum Reprod 2003;18:1976–9.
10. Guidelines on number of embryos transferred. The Practice
Committee of the Society for Assisted Reproductive
Technology and the Practice Committee of the American
Society for Reproductive Medicine. Fertil Steril 2006;
86(suppl 5):S51–2.
11. Papanikolaou EG, Camus M, Kolibianakis EM, Van
Landuyt L, Van Steirteghem A, Devroey P. In vitro fertiliza-
tion with single blastocyst-stage versus single cleavage-stage
embryos. N Engl J Med 2006;354:1139–46.
12. Gardner DK, Surrey E, Minjarez D, Leitz A, Stevens J,
Schoolcraft WB. Single blastocyst transfer: a prospective
randomized trial. Fertil Steril 2004;81:551–5.
13. Blake DA, Proctor M, Johnson NP. The merits of blastocyst
versus cleavage stage embryo transfer: a Cochrane review
[published erratum appears in Hum Reprod 2004;19:2174].
Hum Reprod 2004;19:795–807.
14. Ethical recommendations on multiple pregnancy and mul-
tifetal reduction. FIGO Committee for the Ethical Aspects
of Human Reproduction and Women’s Health. Int J
Gynaecol Obstet 2006;92:331–2.
15. Evans MI, Berkowitz RL, Wapner RJ, Carpenter RJ,
Goldberg JD, Ayoub MA, et al. Improvement in outcomes
of multifetal pregnancy reduction with increased experi-
ence. Am J Obstet Gynecol 2001;184:97–103.
16. Timor-Tritsch IE, Bashiri A, Monteagudo A, Rebarber A,
Arslan AA. Two hundred ninety consecutive cases of multi-
fetal pregnancy reduction: comparison of the transabdomi-
nal versus the transvaginal approach. Am J Obstet Gynecol
2004;191:2085–9.
17. Stone J, Eddleman K, Lynch L, Berkowitz RL. A single
center experience with 1000 consecutive cases of multife-
tal pregnancy reduction. Am J Obstet Gynecol 2002;187:
1163–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 127
 18. Antsaklis A, Souka AP, Daskalakis G, Papantoniou N,
Koutra P, Kavalakis Y, et al. Embryo reduction versus
expectant management in triplet pregnancies. J Matern
Fetal Neonatal Med 2004;16:219–22.
19. Silver RK, Helfand BT, Russell TL, Ragin A, Sholl JS,
MacGregor SN. Multifetal reduction increases the risk of
preterm delivery and fetal growth restriction in twins: a
case-control study. Fertil Steril 1997;67:30–3.
20. Groutz A, Yovel I, Amit A, Yaron Y, Azem F, Lessing JB.
Pregnancy outcome after multifetal pregnancy reduction to
twins compared with spontaneously conceived twins. Hum
Reprod 1996;11:1334–6.
21. Depp R, Macones GA, Rosenn MF, Turzo E, Wapner RJ,
Weinblatt VJ. Multifetal pregnancy reduction: evalua-
tion of fetal growth in the remaining twins. Am J Obstet
Gynecol 1996;174:1233–8; discussion 1238–40.
22. Papageorghiou AT, Liao AW, Skentou C, Sebire NJ,
Nicolaides KH. Trichorionic triplet pregnancies at 10–14
weeks: outcome after embryo reduction compared to
expectant management. J Matern Fetal Neonatal Med
2002;11:307–12.
23. Miller VL, Ransom SB, Shalhoub A, Sokol RJ, Evans MI.
Multifetal pregnancy reduction: perinatal and fiscal out-
comes. Am J Obstet Gynecol 2000;182:1575–80.
24. Yaron Y, Bryant-Greenwood PK, Dave N, Moldenhauer JS,
Kramer RL, Johnson MP, et al. Multifetal pregnancy reduc-
tions of triplets to twins: comparison with nonreduced
triplets and twins. Am J Obstet Gynecol 1999;180:1268–71.
25. Torok O, Lapinski R, Salafia CM, Bernasko J, Berkowitz
RL. Multifetal pregnancy reduction is not associated with
an increased risk of intrauterine growth restriction, except
for very-high-order multiples. Am J Obstet Gynecol 1998;
179:221–5.
26. Dodd J, Crowther C. Multifetal pregnancy reduction of
triplet and higher-order multiple pregnancies to twins.
Fertil Steril 2004;81:1420–1.
COMMITTEE OPINIONS
27. Vauthier-Brouzes D, Lefebvre G. Selective reduction in
multifetal pregnancies: technical and psychological aspects.
Fertil Steril 1992;57:1012–6.
28. Garel M, Stark C, Blondel B, Lefebvre G, Vauthier-Brouzes
D, Zorn JR. Psychological reactions after multifetal preg-
nancy reduction: a 2-year follow-up study. Hum Reprod
1997;12:617–22.
29. Goldfarb J, Kinzer DJ, Boyle M, Kurit D. Attitudes of in
vitro fertilization and intrauterine insemination couples
toward multiple gestation pregnancy and multifetal preg-
nancy reduction. Fertil Steril 1996;65:815–20.
30. Baor L, Blickstein I. En route to an “instant family”: psy-
chosocial considerations. Obstet Gynecol Clin North Am
2005;32:127–39, x.
31. McKinney M, Leary K. Integrating quantitative and quali-
tative methods to study multifetal pregnancy reduction. J
Womens Health 1999;8:259–68.
32. Schreiner-Engel P, Walther VN, Mindes J, Lynch L,
Berkowitz RL. First-trimester multifetal pregnancy reduc-
tion: acute and persistent psychologic reactions. Am J
Obstet Gynecol 1995;172:541–7.
33. Zaner RM, Boehm FH, Hill GA. Selective termination in
multiple pregnancies: ethical considerations. Fertil Steril
1990;54:203–5.
Copyright © June 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Multifetal pregnancy reduction. ACOG Committee Opinion No.
369. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:1511–5.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 128
 ACOG COMMITTEE OPINION
Number 370 • July 2007

Institutional Responsibility to Provide

Legal Representation*
Committee on Ethics ABSTRACT: Hospitals, academic institutions, professional corporations, and other
Reaffirmed 2012 health care organizations should have policies and procedures by which alleged viola-
tions of professional behavior can be reported and investigated. These institutions
should adopt policies on legal representation and indemnification to protect those whose
responsibilities in managing such investigations may expose them to potentially costly
legal actions. The American College of Obstetricians and Gynecologists’ Committee on
Ethics supports the position of the American Association of University Professors regard-
ing institutional responsibility for legal demands on faculty.

The “Code of Professional Ethics of the
American College of Obstetricians and
Gynecologists” states, “The obstetrician–
gynecologist should strive to address through
the appropriate procedures the status of
those physicians who demonstrate question-
able competence, impairment, or unethical
or illegal behavior. In addition, the obste-
trician–gynecologist should cooperate with
appropriate authorities to prevent the con-
tinuation of such behavior” (1). The Code
also identifies those “appropriate proce-
dures” and “appropriate authorities”: “The
obstetrician–gynecologist should respect
all laws, uphold the dignity and honor of
the profession, and accept the profession’s
self-imposed discipline. The professional
competence and conduct of obstetrician–
gynecologists are best examined by pro-
fessional associations, hospital peer-review
committees, and state medical and licens-
ing boards. These groups deserve the full
cooperation of the obstetrician–gynecolo-
gist” (1).
Academic institutions, professional
corporations, hospitals, and other health
care organizations should have policies and
procedures by which alleged violations of
professional behavior can be reported and
The American College investigated. Also, it is necessary for these
of Obstetricians
and Gynecologists *Update of “Institutional Responsibility to Provide Legal
Women’s Health Care Representation” in Ethics in Obstetrics and Gynecology,
Physicians Second Edition, 2004.
institutions to adopt policies on legal rep-
resentation and indemnification for their
employees or others acting in an official
capacity who, in discharging their obligations
relative to unethical or illegal behavior of
individuals, are exposed to potentially costly
legal actions.
The American College of Obstetricians
and Gynecologists agrees with the position
of the American Association of University
Professors in its 1998 statement, “Institutional
Responsibility for Legal Demands on Fac-
ulty,” that institutions should “ensure effec-
tive legal and other necessary representation
and full indemnification in the first instance
for any faculty member named or included
in lawsuits or other extra-institutional legal
proceedings arising from an act or omission
in the discharge of institutional or related
professional duties or in the defense of aca-
demic freedom at the institution” (2).
Reference
1. American College of Obstetricians and
Gynecologists. Code of professional ethics
of the American College of Obstetricians and
Gynecologists. Washington, DC: ACOG;
2004. Available at: http://www.acog.org/
from_ home/acogcode.pdf. Retrieved January
11, 2007.
2. Institutional responsibility for legal de-
mands on faculty. American Association
of University Professors. Academe 1999;85
(1):52.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 129

 Copyright © July 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Institutional responsibility to provide legal representation. ACOG
Committee Opinion No. 370. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:215–6.
ISSN 1074-861X

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 130

 ACOG COMMITTEE OPINION
Number 371 • July 2007

Sterilization of Women, Including Those

With Mental Disabilities*
Committee on Ethics ABSTRACT: Sterilization, like any other surgical procedure, must be carried out
Reaffirmed 2009 under the general ethical principles of respect for autonomy, beneficence, and justice.
Women requesting sterilization should be encouraged to discuss their decision and asso-
ciated issues with their husbands or other appropriate intimate partners. The physician
who objects to a patient’s request for sterilization solely as a matter of conscience has
the obligation to inform the patient that sterilization services may be available elsewhere
and should refer the patient to another caregiver. The presence of a mental disability does
not, in itself, justify either sterilization or its denial. When a patient’s mental capacity is
limited and sterilization is considered, the physician must consult with the patient’s fam-
ily, agents, and other caregivers in an effort to adopt a plan that protects what the con-
sulted group believes to be the patient’s best interests while, at the same time,
preserving, to the maximum extent possible, the patient’s autonomy.

Sterilization, like any other surgical proce-
dure, must be carried out under the general
ethical principles of respect for autonomy,
beneficence, and justice. Special ethical con-
siderations are imposed by the unique attri-
butes of sterilization. The procedure usually
is done not for medical indications but elec-
tively for family planning. It may have a sig-
nificant impact on individuals other than the
patient, especially her partner. It is intended
to be permanent, although techniques are
available to attempt reversal or circumvent
sterility. Finally, sterilization affects procre-
ation and, therefore, may conflict with the
moral beliefs of the patient, her family, or the
physician. When the patient has diminished
mental abilities or chronic mental illness,
even more stringent ethical constraints apply.
General Ethical Principles
Under the principle of respect for autonomy,
patients have the right to seek, accept, or
refuse care. Respecting the patient’s auton-
omy means that the physician cannot impose
treatments. It does not mean that the physi-
cian must provide treatment, especially if
The American College
of Obstetricians
the physician considers it inappropriate or
and Gynecologists *Update of “Sterilization of Women, Including Those
With Mental Disabilities” in Ethics in Obstetrics and
Women’s Health Care
Gynecology, Second Edition, 2004.
Physicians
harmful (eg, an 18-year-old patient who asks
to undergo sterilization).
Sterilization is for many a social choice
rather than purely a medical issue, but all
patient-related activities engaged in by
physicians are subject to the same ethical
guidelines. Patients sometimes request a
physician’s counsel in deciding whether to
request sterilization. Physicians should be
cautious in giving advice and making recom-
mendations that go beyond health-related
issues, even though nonmedical factors might
be the most compelling for the patient. It
may be difficult for the physician to address
nonmedical issues without bias. Also, the
physician may not have a full understand-
ing of the patient’s situation. However, it is
entirely appropriate for the physician to assist
the patient in exploring and articulating the
reasons for her decision.
Although a woman’s request for steriliza-
tion may conflict with the physician’s medi-
cal judgment or moral beliefs, the patient’s
values and request cannot be dismissed or
ignored. In such cases, the physician has an
obligation to inform the patient of his or
her professional recommendation and the
medical reasons for it. The physician remains
responsible for his or her actions and gener-
ally is not obligated to act in violation of

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 131

 personal principles of conscience, but the patient should
be informed when personal principles limit action or
treatment. If the patient still desires sterilization, the
physician who objects solely as a matter of conscience
has the obligation to inform her that sterilization services
may be available elsewhere and should refer her to another
caregiver. The physician’s values; sense of societal goals;
and racial, ethnic, or socioeconomic issues should not be
the basis of a recommendation to undergo sterilization.
Sterilization requires the patient’s informed consent
for ethical and medical–legal reasons. The physician per-
forming the procedure has the responsibility of ensuring
that the patient is properly counseled concerning the
risks and benefits of sterilization. The patient should
receive comprehensive and individualized counseling on
reversible alternatives to sterilization (1). The procedure’s
intended permanence should be stressed, as well as the
possibility of future regret. An estimate of the procedure’s
failure rate and risk of ectopic pregnancy should be pro-
vided. A variety of patient education materials are avail-
able to assist in preoperative counseling, but it is essential
for the patient to be given the opportunity to discuss all
relevant issues with her physician and to ask questions.
The physician should be familiar with any laws
and regulations that may constrain sterilization, such as
limitations on the patient’s age and requirements for the
consent process. The physician should inform the patient
that insurance coverage for sterilization is variable so that
she can discuss this issue with her insurer.
Specific Ethical Issues
Because sterilization may have important effects on indi-
viduals other than the patient, women requesting steril-
ization should be encouraged to discuss the issues with
their husbands or other appropriate intimate partners.
In many cases, it is preferable for the male partner to be
sterilized. It may be helpful for the physician to counsel
the partner directly, with the patient’s consent.
Hysterectomy solely for the purpose of sterilization
is inappropriate. The risks and cost of the procedure are
disproportionate to the benefit, given the available alter-
natives. In disabled women with limited functional
capability, indications for major surgical procedures
remain the same as in other patients. In all cases, indica-
tions for surgery must meet standard criteria, and the
benefits of the procedure must exceed known procedural
risks. Disabled women with limited functional capac-
ity may sometimes be physically unable to care for their
menstrual hygiene and are profoundly disturbed by their
menses. On occasion, such women’s caretakers have
sought hysterectomy for these indications. Hysterectomy
for the purpose of cessation of normal menses may be
considered only after other reasonable alternatives have
been attempted.
Women may be vulnerable to various forms of
coercion in their medical decision making. For example,
the withholding of other medical care by linking it to
COMMITTEE OPINIONS
the patient’s consent to undergo sterilization is ethically
unacceptable. Laws, regulations, and reimbursement
restrictions concerning sterilization have been created
to protect vulnerable individuals, including those with
mental disabilities, from abuse. However, sterilization
should not be denied to individuals simply because they
also may be vulnerable to coercion. Physicians caring for
patients who request or require procedures that result in
sterilization may find themselves in a dilemma when legal
and reimbursement restrictions interfere with a patient’s
choice of treatment. Rigid timing and age requirements
can restrict access to good health care and result in
unnecessary risk (2). Physicians are encouraged to seek
legal or ethical consultation or both whenever necessary
in their efforts to provide care that is most appropriate in
individual situations.
At a public policy level, medical professionals have
an opportunity to be a voice of reason and compassion
by pointing out when legislative and regulatory measures
intended to be safeguards interfere with patient choice
and appropriate medical care.
Special Considerations Concerning
Patients With Mental Disabilities
As used in this Committee Opinion, the term “women
with mental disabilities” refers to individuals whose abil-
ity to participate in the informed consent process is, or
might be, limited and whose autonomy is, or might be,
thereby impaired. Such individuals constitute a hetero-
geneous group, including those with varying degrees of
presumably irreversible “mental retardation” as well as
those with varying types and degrees of “chronic mental
illness.” Some of these illnesses are reversible to varying
degrees and for varying periods. The concept of “chroni-
cally and variably impaired autonomy” has been pro-
posed to describe such situations (3).
Physicians who perform sterilizations must be aware
of widely differing federal, state, and local laws and
regulations, which have arisen in reaction to a long and
unhappy history of sterilization of “unfit” individuals in
the United States and elsewhere. The potential remains
for serious abuses and injustices. Individuals who are
capable of reproducing and parenting without a pre-
sumptive risk of child neglect or abuse may be deprived
of their procreative rights simply because they carry a
label, such as mild retardation, that suggests an inher-
ent unfitness to parent. The implications of this labeling
process for reproductive rights should be examined as
thoroughly and objectively as possible before making a
decision about sterilization.
Conversely, individuals for whom pregnancy is a
serious burden or harm may be denied the opportunity
for a full range of contraceptive options. For example, fed-
eral funds may not be used for the sterilization of “men-
tally incompetent” or “institutionalized” individuals (2).
Physicians always should have the maximum respect for
2013 COMPENDIUM OF SELECTED PUBLICATIONS 132
 patient autonomy, and the presence of a mental disability
does not, in itself, justify either sterilization or its denial.
Determination of Ability to Give
Informed Consent
Before carrying out any surgical procedure, the physi-
cian has the important responsibility of ascertaining the
patient’s capacity to provide informed consent. It may be
difficult to be sure that patients with normal intellectual
function understand the complexities of some situations;
when the patient has a mental disability, the task is more
difficult and the responsibility is more challenging.
Evaluating a mentally impaired patient’s ability to
provide informed consent is seldom straightforward (4).
For example, although degrees of mental retardation
have been defined according to intelligence quotient,
there is no direct relationship between such diagnostic
categories and the capacity to consent. Among the issues
that may need to be considered in the assessment are the
patient’s language and culture, the quality of informa-
tion provided (clarity, completeness, and lack of bias),
the setting of counseling (privacy and comfort), and
possible fluctuations in the patient’s comprehension.
Such fluctuations may result from various stressors and
medications. Multiple interviews over an adequate period
may be required. Obtaining the assistance of profession-
als trained in communicating with mentally disabled
individuals is essential. These professionals may include
special educators, psychologists, nurses, attorneys famil-
iar with disability law, and physicians accustomed to
working with mentally disabled patients.
The process of evaluating a patient’s ability to give
informed consent may be set forth in laws of the jurisdic-
tion involved, and legal requirements for the determina-
tion of competence vary greatly. The concept of legal
competence is quite complex. Standards for the defini-
tion of competence may vary with the specific purpose
(eg, marriage; making a will; consenting to or refusing
life-saving treatment; or, as in the case of sterilization,
consenting to elective surgery).
Court approval of sterilization may be required
by law or may be necessary in difficult cases because of
disagreement among the patient’s caregivers and consul-
tants. In most jurisdictions, court action is not required
to carry out a sterilization procedure if there is agreement
among these consultants that a nonminor is capable
of consenting. Certain jurisdictions may not recognize
guardian consent for sterilization of minors with mental
disabilities under any circumstances. Whether or not
recourse to the courts is necessary, every effort should be
made to conduct the determination of competence fairly
and to preserve autonomy.
Ethical Issues When the Patient
Cannot Give Informed Consent
When the patient has been determined to be irreversibly
incapable of participating in all or part of the informed
COMMITTEE OPINIONS
consent process, others must make beneficence-based
decisions regarding medical treatment. Such a deter-
mination is relatively uncommon. Even in these situa-
tions, it often is possible and highly desirable to obtain
at least the patient’s assent. The initial premise should
be that nonvoluntary sterilization generally is not ethi-
cally acceptable because of the violation of privacy, bodily
integrity, and reproductive rights that it may represent.
Physicians and other caregivers should avoid pater-
nalistic decisions in all cases in which the individual may
be capable of participating to some degree in decisions
regarding her care. The following recommendations are
based in part on those of McCullough et al (3). They do
not apply to mentally impaired individuals who can par-
ticipate in the consent process.
For patients with chronically and variably impaired
autonomy, initial efforts should be directed toward
restoring decision-making ability by such means as
adjustment of medication and avoidance of stressors.
This may allow the patient to exercise full autonomy. For
cases in which these efforts fail, the following guidelines
are recommended:
• Efforts should be made to conform to the patient’s
expressed values and beliefs regarding reproduction.
Such information may be available from interview-
ing the patient, her family, caregivers, and others in
her environment. If possible, alternatives (including
no action) consistent with her beliefs, medical con-
dition, and social situation should be presented to
decision makers.
• Physicians should be aware of the possibility of
undue pressure from family members whose inter-
ests, no matter how legitimate, may not be the
same as the patient’s. When appropriate, the patient
should have the opportunity to be interviewed with-
out family members present.
• Noninvasive modalities designed to assist family
members and other caregivers with setting behavioral
limits should be considered as alternatives to ster-
ilization. These resources may include socialization
training, sexual abuse avoidance training, supportive
family therapy, and sexuality education.
• Consideration should be given to the degree of cer-
tainty of various adverse outcomes. For example,
given the patient’s living circumstances, how likely
is it that she might be sexually exploited? Given
available knowledge concerning her reproductive
potential (ovulatory status and tubal patency), how
likely is it that she will become pregnant? How likely
are adverse medical or social consequences from a
pregnancy? Because it is uncommon for such risks to
be reliably predicted, it may be preferable to recom-
mend a reversible long-term form of contraception,
such as an intrauterine device, long-term inject-
able progestin, or long-acting subdermal progestin
implants (if available), instead of sterilization. In
2013 COMPENDIUM OF SELECTED PUBLICATIONS 133
 most cases, the chosen method of contraception
should be the least restrictive in preserving future
reproductive options. This is especially true when a
major factor in the request for sterilization is concern
about burdens for others. At the same time, risks and
inconveniences of contraception over a long period,
as compared with a single, relatively simple, and
definitive surgical procedure, should not be ignored.
• The well-being of a child potentially conceived also
should receive consideration.
Summary
Sterilization is an elective procedure with permanent
and far-reaching consequences. Physicians who perform
sterilization have ethical responsibilities of the high-
est order to counsel patients fully and without bias.
Physicians must assess thoroughly the capacity of patients
with impaired mental abilities to participate fully in the
informed consent process. When this capacity is lim-
ited, the physician must consult with the patient’s other
caregivers in reaching a decision, which is based on the
patient’s best interests and preserves her autonomy to the
maximum extent possible. In difficult cases, a hospital
ethics committee may provide useful perspectives.
COMMITTEE OPINIONS
References
1. Benefits and risks of sterilization. ACOG Practice Bulletin
No. 46. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2003;102:647–58.
2. Sterilization of persons in federally assisted family planning
projects. 42 C.F.R. § 50 Subpart B (2006).
3. McCullough LB, Coverdale J, Bayer T, Chervenak FA.
Ethically justified guidelines for family planning interven-
tions to prevent pregnancy in female patients with chronic
mental illness. Am J Obstet Gynecol 1992;167:19–25.
4. Appelbaum PS, Grisso T. Assessing patients’ capacities to
consent to treatment [published erratum appears in N Engl
J Med 1989;320:748]. N Engl J Med 1988;319:1635–8.
Copyright © July 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Sterilization of women, including those with mental disabilities. ACOG
Committee Opinion No. 371. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:217–20.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 134
 ACOG COMMITTEE OPINION
Number 373 • August 2007

Sexual Misconduct*
Committee on Ethics ABSTRACT: The physician–patient relationship is damaged when there is either
confusion regarding professional roles and behavior or clear lack of integrity that allows
sexual exploitation and harm. Sexual contact or a romantic relationship between a physi-
cian and a current patient is always unethical, and sexual contact or a romantic relation-
ship between a physician and a former patient also may be unethical. The request by
either a patient or a physician to have a chaperone present during a physical examination
should be accommodated regardless of the physician’s sex. If a chaperone is present
during the physical examination, the physician should provide a separate opportunity for
private conversation. Physicians aware of instances of sexual misconduct have an obliga-
tion to report such situations to appropriate authorities.

The privilege of caring for patients, often
over a long period, can yield considerable
professional satisfaction. The obstetrician–
gynecologist may fill many roles for patients,
including primary physician, technology
expert, prevention specialist, counselor, and
confidante. Privy to both birth and death,
obstetrician–gynecologists assist women as
they pass through adolescence; grow into
maturity; make choices about sexuality, part-
nership, and family; experience the sorrows
of reproductive loss, infertility, and illness;
and adapt to the transitions of midlife and
aging. The practice of obstetrics and gynecol-
ogy includes interaction at times of intense
emotion and vulnerability for the patient and
involves both sensitive physical examinations
and medically necessary disclosure of espe-
cially private information about symptoms
and experiences. The relationship between
the physician and patient, therefore, requires
a high level of trust and professional respon-
sibility.
Trust of this sort cannot be maintained
without a basic understanding of the limits
and responsibilities of the professional’s role.
Physician sexual misconduct is an example
of abuse of limits and failure of responsibil-
ity. The valued human experience of the
The American College physician–patient relationship is damaged
of Obstetricians when there is either confusion regarding
and Gynecologists
*Update of “Sexual Misconduct” in Ethics in Obstetrics
Women’s Health Care and Gynecology, Second Edition, 2004.
Physicians
professional roles and behavior or clear lack
of integrity that allows sexual exploitation
and harm.
Sexual misconduct is of particular con-
cern in today’s environment of shifting roles
for women and men, greater sexual freedom,
and critical evaluation of power relations in
society (1–4). Prohibitions against sexual
contact between patient and physician are
not new; they can be found in the earli-
est guidelines in western antiquity. From
the beginning, physicians were enjoined to
“do no harm” and specifically avoid sexual
contact with patients (5). In the interven-
ing centuries, as the study of medical ethics
has evolved, attention has been focused on
respect for individual rights, the problem
of unequal power in relationships between
professionals and patients, and the potential
for abuse of that power (6).
In this context, the American Medical
Association’s Council on Ethical and Judicial
Affairs developed a report, “Sexual Miscon­
duct in the Practice of Medicine,” condemn-
ing sexual relations between physicians and
current patients (7). It raises serious ques-
tions about the ethics of romantic relation-
ships with former patients. It is summarized
as follows (8):
Sexual contact that occurs concurent
with the physician–patient relation-
ship constitutes sexual misconduct.
Sexual or romantic interactions between

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 135

 physicians and patients detract from the goals of the
physician–patient relationship, may exploit the vul-
nerability of the patient, may obscure the physician’s
objective judgment concerning the patient’s health
care, and ultimately may be detrimental to the pa-
tient’s well-being.
If a physician has reason to believe that non-sexual
contact with a patient may be perceived as or may
lead to sexual contact, then he or she should avoid
the non-sexual contact. At a minimum, a physician’s
ethical duties include terminating the physician–
patient relationship before initiating a dating, roman-
tic, or sexual relationship with a patient.
Sexual or romantic relationships between a physician
and a former patient may be unduly influenced by
the previous physician–patient relationship. Sexual
or romantic relationships with former patients are
unethical if the physician uses or exploits trust, knowl-
edge, emotions, or influence derived from the previ-
ous professional relationship.
The Council provides clear guidelines (7):
• Mere mutual consent is rejected as a justification
for sexual relations with patients because the dispar-
ity in power, status, vulnerability, and need make it
difficult for a patient to give meaningful consent to
sexual contact or sexual relations.
• Sexual contact or a romantic relationship concurrent
with the physician–patient relationship is unethical.
• Sexual contact or a romantic relationship with a for-
mer patient may be unethical under certain circum-
stances (9). The relevant standard is the potential
for misuse of physician power and exploitation of
patient emotions derived from the former relation-
ship.
• Education on ethical issues involved in sexual mis-
conduct should be included throughout all levels of
medical training (10–13).
• Physicians have a responsibility to report offending
colleagues to disciplinary boards.
The Society of Obstetricians and Gynaecologists of
Canada has adopted a similar statement that “acknowl-
edges and deplores the fact that incidents of physicians
abusing patients do occur” and finds that “these inci-
dents include ‘sexual impropriety’ due to poor clinical
skills, chauvinism, or abuse of the power relationship,
and outright systematic sexual abuse” (14). The Society
also supports the right to “informed, safe, and gender-
sensitive” care and the right of victims of abuse to receive
“prompt treatment.” “Identification, discipline, and,
where possible, rehabilitation of the perpetrators” is
recommended.
Although much discussion of sexual misconduct by
health care professionals has centered around the par-
ticular vulnerability that exists within the relationship a
COMMITTEE OPINIONS
woman has with her mental health care professional (15,
16), sexual contact between patients and obstetrician–
gynecologists also has been documented (3, 4). Physicians
themselves acknowledge that there is a problem, but the
extent of the problem is difficult to determine because
information relies on self-reporting, which carries the
potential for bias in response.
The Committee on Ethics of the American College
of Obstetricians and Gynecologists endorses the ethical
principles expressed by the American Medical Associa-
tion and the Society of Obstetricians and Gynaecologists
of Canada and affirms the following statements:
• Sexual contact or a romantic relationship between a
physician and a current patient is always unethical.
• Sexual contact or a romantic relationship between a
physician and a former patient also may be unethi-
cal. Potential risks to both parties should be con-
sidered carefully. Such risks may stem from length
of time and intensity of the previous professional
relationship; age differences; the length of time since
cessation of the professional relationship; the former
patient’s residual feelings of dependency, obligation,
or gratitude; the former patient’s vulnerability to
manipulation as a result of private information dis-
closed during treatment; or physician vulnerability if
a relationship initiated with a former patient breaks
down.
• Physicians should be careful not to mix roles that are
ordinarily in conflict. For example, they should not
perform breast or pelvic examinations on their own
minor children unless an urgent indication exists.
Children and adolescents are particularly vulnerable
to emotional conflict and damage to their developing
sense of identity and sexuality when roles and role
boundaries with trusted adults are confused. It is
essential to ensure the young individual’s privacy and
prevent subtly coercive violations from occurring.
• The request by either a patient or a physician to
have a chaperone present during a physical exami-
nation should be accommodated regardless of the
physician’s sex. Local practices and expectations
differ with regard to the use of chaperones, but the
presence of a third party in the examination room
can confer benefits for both patient and physician,
regardless of the sex of the chaperone. Chaperones
can provide reassurance to the patient about the
professional context and content of the examination
and the intention of the physician and offer witness
to the actual events taking place should there be any
misunderstanding. The presence of a third party in
the room may, however, cause some embarrassment
to the patient and limit her willingness to talk open-
ly with the physician because of concerns about con-
fidentiality. If a chaperone is present, the physician
should provide a separate opportunity for private
2013 COMPENDIUM OF SELECTED PUBLICATIONS 136
 conversation. If the chaperone is an employee of
the practice, the physician must establish clear rules
about respect for privacy and confidentiality. In
addition, some patients (especially, but not lim-
ited to, adolescents) may consider the presence of
a family member as an intrusion. Family members
should not be used as chaperones unless specifically
requested by the patient and then only in the pres-
ence of an additional chaperone who is not a family
member.
• Examinations should be performed with only the
necessary amount of physical contact required to
obtain data for diagnosis and treatment. Appropriate
explanation should accompany all examination pro-
cedures.
• Physicians should avoid sexual innuendo and sexu-
ally provocative remarks.
• When physicians have questions and concerns about
their sexual feelings and behavior, they should seek
advice from mentors or appropriate professional
organizations (16, 17).
• It is important for physicians to self-monitor for any
early indications that the barrier between normal
sexual feelings and inappropriate behavior is not
being maintained (4, 16, 18). These indicators might
include special scheduling, seeing a patient outside
normal office hours or outside the office, driving a
patient home, or making sexually explicit comments
about patients.
• Physicians involved in medical education should
actively work to include as part of the basic curricu-
lum information about both physician and patient
vulnerability, avoidance of sexually offensive or den-
igrating language, risk factors for sexual misconduct,
and procedures for reporting and rehabilitation.
• Physicians aware of instances of sexual miscon-
duct on the part of any health professional have an
obli­gation to report such situations to appropriate
authorities, such as institutional committee chairs,
department chairs, peer review organizations, super-
visors, or professional licensing boards.
• Physicians with administrative responsibilities in
hospitals, other medical institutions, and licens-
ing boards should develop clear and public guide-
lines for reporting instances of sexual misconduct,
prompt investigation of all complaints, and appro-
priate disciplinary and remedial action (19).
Sexual misconduct on the part of physicians is an
abuse of professional power and a violation of patient
trust. It jeopardizes the well-being of patients and carries
an immense potential for harm. The ethical prohibition
against physician sexual misconduct is ancient and force-
ful, and its application to contemporary medical practice
is essential.
COMMITTEE OPINIONS
References
1. Gabbard GO, Nadelson C. Professional boundaries in the
physician-patient relationship [published erratum appears
in JAMA 1995;274:1346]. JAMA 1995;273:1445–9.
2. Gawande A. Naked. N Engl J Med 2005;353:645–8.
3. Dehlendorf CE, Wolfe SM. Physicians disciplined for sex-
related offenses. JAMA 1998;279:1883–8.
4. Enbom JA, Parshley P, Kollath J. A follow-up evalua-
tion of sexual misconduct complaints: the Oregon Board
of Medical Examiners, 1998 through 2002. Am J Obstet
Gynecol 2004;190:1642–50; discussion 1650–3; 6A.
5. Campbell ML. The Oath: an investigation of the injunction
prohibiting physician–patient sexual relations. Perspect Biol
Med 1989;32:300–8.
6. Beauchamp TL, Childress JF. Principles of biomedical eth-
ics. 5th ed. New York (NY): Oxford University Press; 2001.
7. Sexual misconduct in the practice of medicine. Council on
Ethical and Judicial Affairs, American Medical Association.
JAMA 1991;266:2741–5.
8. American Medical Association. Sexual misconduct in the
practice of medicine. In: Code of medical ethics of the
American Medical Association: current opinions with anno-
tations. 2006–2007 ed. Chicago (IL): AMA; 2006. p. 255–8.
9. Hall KH. Sexualization of the doctor-patient relationship: is
it ever ethically permissible? Fam Pract 2001;18:511–5.
10. Goldie J, Schwartz L, Morrison J. Sex and the surgery:
students’ attitudes and potential behaviour as they pass
through a modern medical curriculum. J Med Ethics 2004;
30:480–6.
11. White GE. Setting and maintaining professional role bound-
aries: an educational strategy. Med Educ 2004;38: 903–10.
12. White GE. Medical students’ learning needs about setting
and maintaining social and sexual boundaries: a report.
Med Educ 2003;37:1017–9.
13. Spickard A, Swiggart WH, Manley G, Dodd D. A con-
tinuing education course for physicians who cross sexual
boundaries. Sex Addict Compulsivity 2002;9:33–42.
14. Sexual abuse by physicians. SOGC Policy Statement No.
134. Society of Obstetricians and Gynaecologists of Canada.
J Obstet Gynaecol Can 2003;25:862.
15. Gabbard GO, editor. Sexual exploitation in professional
relationships. Washington, DC: American Psychiatric Press;
1989.
16. Simon RI. Therapist–patient sex. From boundary viola-
tions to sexual misconduct. Psychiatr Clin North Am 1999;
22:31–47.
17. Crausman RS. Sexual boundary violations in the physician-
patient relationship. Med Health R I 2004;87:255–6.
18. Searight HR, Campbell DC. Physician–patient sexual con-
tact: ethical and legal issues and clinical guidelines. J Fam
Pract 1993;36:647–53.
19. Federation of State Medical Boards. Addressing sexual
boundaries: guidelines for state medical boards. Dallas
(TX): FSMB; 2006. Available at: http://www.fsmb.org/pdf/
GRPOL _Sexual%20Boundaries.pdf. Retrieved January 23,
2007.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 137
 Copyright © August 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Sexual misconduct. ACOG Committee Opinion No. 373. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2007;
110:441–4.
ISSN 1074-861X

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 138

 ACOG COMMITTEE OPINION
Number 374 • August 2007

Expert Testimony*
Committee on Ethics ABSTRACT: It is the duty of obstetricians and gynecologists who testify as expert
witnesses on behalf of defendants, the government, or plaintiffs to do so solely in accor-
Reaffirmed 2010
dance with their judgment on the merits of the case. Obstetrician–gynecologists must
limit testimony to their sphere of medical expertise and must be prepared adequately.
They must make a clear distinction between medical malpractice and medical maloccur-
rence. The acceptance of fees that are greatly disproportionate to those customary for
professional services can be construed as influencing testimony given by the witness,
and it is unethical to accept compensation that is contingent on the outcome of litigation.

The American College of Obstetricians and
Gynecologists (ACOG) recognizes that it is
the duty of obstetricians and gynecologists
who testify as expert witnesses on behalf of
defendants, the government, or plaintiffs to
do so solely in accordance with their judg-
ment on the merits of the case. Furthermore,
ACOG cannot condone the participation of
physicians in legal actions where their tes-
timony will impugn performance that falls
within accepted standards of practice or,
conversely, will support obviously deficient
practice. Because the experts articulate the
standards in a given case, care must be
exercised to ensure that such standards do
not narrowly reflect the experts’ views to the
exclusion of other choices deemed acceptable
by the profession. The American College of
Obstetricians and Gynecologists considers
unethical any expert testimony that is mis-
leading because the witness does not have
appropriate knowledge of the standard of
care for the particular condition at the rel-
evant time or because the witness knowingly
misrepresents the standard of care relevant
to the case.
The Problem of Professional
Liability—Reality and
Perceptions
The American College of Obstetricians and
The American College Gynecologists recognizes its responsibility,
of Obstetricians and that of its Fellows, to continue efforts
and Gynecologists
Women’s Health Care *Update of “Expert Testimony” in Ethics in Obstetrics
Physicians and Gynecology, Second Edition, 2004.
to advance health care for women through
every available method of quality assessment
and improvement. The American College of
Obstetricians and Gynecologists also recog-
nizes, however, that many claims of profes-
sional liability represent the response of a
litigation-oriented society to a technologi-
cally advanced form of health care that has
fostered unrealistic expectations. As tech-
nology becomes more complex, associated
benefits and risks may increase, making the
complication-free practice of medicine less
possible.
It therefore becomes important to dis-
tinguish between medical “maloccurrence”
and medical “malpractice.” Medical maloc-
currence is defined as a bad or undesirable
outcome that is unrelated to the quality of
care provided. In some cases, specific medi-
cal or surgical complications may be antici-
pated but are felt by the patient and the
health care provider to be offset by the bal-
ance of benefits from the planned interven-
tion and, therefore, represent unavoidable
risks of appropriate medical care. There are
other types of complications that cannot be
anticipated and in their unpredictability are
similarly unavoidable. Still other complica-
tions occur as a result of decisions that have
been made carefully by patients and physi-
cians with fully informed consent but appear,
in retrospect, to have been a less optimal
choice among several options. Each of these
situations represents a type of maloccur-
rence, rather than an example of malpractice,
and is the result of the uncertainty inherent

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 139

 in all of medicine. Malpractice, in contrast, requires a
demonstration of negligence (ie, substandard practice
that causes harm). The potential for personal, profes-
sional, and financial rewards from expert testimony may
encourage testimony that undermines the distinction
between unavoidable maloccurrence and actual medical
malpractice. It is unethical to distort or to represent a
maloccurrence as an example of medical malpractice or,
conversely, represent malpractice as a case of maloccur-
rence.
The American College of Obstetricians and Gynecol-
ogists supports the concept of appropriate and prompt
compensation to patients for medically related injuries.
Any such response, however, also should reflect the dis-
tinction between medical maloccurrence, for which all
of society should perhaps bear financial responsibility,
and medical malpractice, for which health care providers
should be held responsible.
Responsibility of Individual Physicians
The moral and legal duty of physicians who testify before
a court of law is to do so in accordance with their exper-
tise. This duty implies adherence to the strictest personal
and professional ethics. Truthfulness is essential. Misrep-
resentation of one’s personal clinical opinion as absolute
right or wrong may be harmful to individual parties and
to the profession at large. The obstetrician–gynecologist
who is an expert witness must limit testimony to his or
her sphere of medical expertise and must be prepared
adequately. Witnesses who testify as experts must have
knowledge and experience that are relevant to obstetric
and gynecologic practice at the time of the occurrence
and to the specific areas of clinical medicine they are dis-
cussing. The acceptance of fees that are greatly dispropor-
tionate to those customary for professional services can
be construed as influencing testimony given by the wit-
ness. It is unethical for a physician to accept compensa-
tion that is contingent on the outcome of litigation (1, 2).
The American College of Obstetricians and Gyne-
cologists encourages the development of policies and stan-
dards for expert testimony. Such policies should address
safeguards to promote truth-telling and to encourage
openness of the testimony to peer review. These policies
also would encourage testimony that does not assume an
advocacy or partisan role in the legal proceeding.
The following principles are offered as guidelines for
the physician who assumes the role of an expert witness:
1. The physician must have experience and knowledge
in the areas of clinical medicine that enable him or
her to testify about the standards of care that applied
at the time of the occurrence that is the subject of the
legal action.
COMMITTEE OPINIONS
2. The physician’s review of medical facts must be thor-
ough, fair, and impartial and must not exclude any
relevant information. It must not be biased to create
a view favoring the plaintiff, the government, or the
defendant. The goal of a physician testifying in any
judicial proceeding should be to provide testimony
that is complete, objective, and helpful to a just reso-
lution of the proceeding.
3. The physician’s testimony must reflect an evalua-
tion of performance in light of generally accepted
standards, neither condemning performance that
falls within generally accepted practice standards
nor endorsing or condoning performance that falls
below these standards. Experts and their testimony
should recognize that medical decisions often must
be made in the absence of diagnostic and prognostic
certainty.
4. The physician must make a clear distinction between
medical malpractice and medical maloccurrence.
5. The physician must make every effort to assess the
relationship of the alleged substandard practice to
the outcome. Deviation from a practice standard is
not always substandard care or causally related to a
bad outcome.
6. The physician must be prepared to have testimony
given in any judicial proceeding subjected to peer
review by an institution or professional organization
to which he or she belongs.
References
1. American Medical Association. Medical testimony. In: Code
of medical ethics of the American Medical Association: cur-
rent opinions with annotations. 2006–2007 ed. Chicago
(IL): AMA; 2006. p. 286–9.
2. American Bar Association. Rule 3.4. Fairness to opposing
party and counsel. In: Annotated model rules of profes-
sional conduct. 5th ed. Chicago (IL): ABA; 2003. p. 347–58.
Copyright © August 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Expert testimony. ACOG Committee Opinion No. 374. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2007;
110:445–6.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 140
 ACOG COMMITTEE OPINION
Number 377 • September 2007

Research Involving Women*

Committee on Ethics ABSTRACT: All women should be presumed to be eligible for participation in clini-
cal studies. The potential for pregnancy should not automatically exclude a woman from
participating in a clinical study, although the use of contraception may be required for
participation. Research objectives should not interfere with appropriate clinical manage-
ment. If a conflict arises between medically appropriate patient care and research
objectives, patient care should prevail. Consent of the pregnant woman alone is sufficient
for most research. Pregnant women considering participation in a research study should
determine the extent to which the father is to be involved in the process of informed con-
sent and the decision.

Attitudes concerning inclusion of women
in research trials have changed dramati-
cally over the past four decades. In the
1970s and 1980s, women were systematically
excluded from participating in research tri-
als either because of the fear that unrecog-
nized pregnancy might place an embryo at
risk or because a uniform all-male sample
would simplify analysis of data. In addition,
pregnant women were excluded from most
research trials because they were viewed as
a vulnerable population requiring special
protection, and there was concern that trial
participation would result in harm to the
fetus. Another fear was that participation
of pregnant women in research trials would
result in increased liability risk for research-
ers. In the 1990s, there was a dramatic policy
shift toward wide-scale inclusion of women
in research trials. This policy shift is a direct
result of a conscious effort by government
agencies to expand participation of women
in research in order to obtain valid, evidence-
based information about health and disease
in this population (1).
This Committee Opinion is designed to
provide reasonable guidelines for research
involving women. The American College of
Obstetricians and Gynecologists’ Committee
on Ethics affirms both the need for women to
The American College
serve as participants in research and the obli-
of Obstetricians
and Gynecologists gation for researchers, institutional review
Women’s Health Care *Update of “Research Involving Women,” in Ethics in
Physicians Obstetrics and Gynecology, Second Edition, 2004.
boards (IRBs), and others reviewing clinical
research to evaluate the potential effect of
proposed research on women of childbearing
potential, pregnant women, and the develop-
ing fetus.
Rationale for Including Women
in Research
All women should be presumed to be eli-
gible for participation in clinical studies. The
potential for pregnancy should not automati-
cally exclude a woman from participating in
a clinical study, although the use of contra-
ception may be required for participation.
Inclusion of women in clinical studies is
necessary for valid inferences about health
and disease in women. The generalization to
women of results from trials conducted in
men may yield erroneous conclusions that
fail to account for the biologic differences
between men and women.
The rationale for conducting research in
women is to advance knowledge in the fol-
lowing areas:
• Medical conditions in women (eg, car-
diovascular disease)
• Physiology of women
• Sex differences in responses to drugs (eg,
antiretroviral agents)
• Sex differences in drug toxicities
• Sex differences in responses to disease
(eg, mental disorders)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 141

 • Effects of hormonal contraceptives on response to
other therapies (eg, seizure medication)
• Variations in response to therapy at different stages
of the menstrual cycle and the life cycle
The rationale for conducting research in pregnant
and postpartum women is to advance knowledge in the
following areas:
• Medical conditions (eg, human immunodeficiency
virus [HIV]) in women who become pregnant
• Medical conditions unique to pregnancy (eg, pre-
eclampsia)
• Conditions that threaten the successful course of
pregnancy (eg, preterm labor)
• Prenatal conditions that might threaten the health of
the fetus (eg, diaphragmatic hernia)
• Physiologic changes that accompany pregnancy and
lactation
• Medical conditions related to pregnancy that might
affect the future health of women (eg, gestational
diabetes)
• Safety of medication during pregnancy and breast-
feeding
Human experimentation is a necessary and impor-
tant part of biomedical research because certain infor-
mation can be obtained in no other way. Guidelines for
protection of research participants have been established
and are applicable to women of childbearing potential
as well as to pregnant women (2–4). Additional protec-
tions have been established for pregnant women (5, 6).
Participants in research should expect full disclosure of
the known burdens and benefits of the research study
and should understand the potential risks as well as
benefits. Investigators must use research design methods
that aim to maximize safety and minimize risk. A fully
informed consent process and review of study protocols
by IRBs help to ensure that efforts to increase access to
and participation of women in clinical trials will not
result in procedural shortcuts that violate basic ethical
standards.
Involvement in research protocols should not
diminish a woman’s expectation that she will receive
appropriate medical care during the study and in the
future. Health care professionals have a responsibility
to provide the most appropriate clinical management,
whether or not a woman is a participant in research.
Research objectives should not affect clinical manage-
ment. If a conflict arises between medically appropriate
patient care and research objectives, patient care should
prevail. For example, it is inappropriate to attempt to
delay a medically indicated induction of labor solely
to meet gestational age criteria for participation in a
research project. The welfare of the patient and, in the
case of pregnancy, the patient and her fetus is always the
primary concern.
COMMITTEE OPINIONS
The Ethical Context
Ethical Requirements for Research
To be considered ethically justified, research on human
participants must satisfy several conditions. These include
a reasonable prospect that the investigation will produce
the knowledge that is being sought, a favorable balance
of benefits over risks, a proven necessity to use human
participants, a system for independent monitoring of
outcomes and protection of human participants, and a
fair allocation of the burdens and benefits of the research
among potential groups of participants (7). These prin-
ciples should not be weakened by attempts to increase
participation of women in research trials.
Although it is important to try to distinguish ethical
problems involving patient care from ethical issues relat-
ed to research, a definitive line cannot always be drawn
between the two areas. The dual role that physicians often
assume as research scientists and clinical practitioners
may result in conflict of interest because each role has
different goals and priorities. For example, the primary
goal of the investigator is to generate knowledge that has
the potential to benefit patients in the future, whereas
clinicians are expected to act in the best interests of their
current patients. Researchers need to recognize potential
conflicts, strive to resolve them before beginning specific
research projects, and inform patients about potential
conflicts as they seek consent for research participation.
The potential for role conflict becomes readily
apparent when innovative therapies are introduced (8).
In the context of maternal–fetal surgery, for example,
innovative surgical procedures have been conducted, but
the long-term impact on both the woman and the fetus is
unclear. In this context, it is important to conduct rigor-
ous scientific evaluation of maternal–fetal surgery before
these innovative therapies are offered as routine care.
Ethical Principles Supporting the Inclusion of
Women
The recent movement to enroll more women in clinical
research can be justified by ethical principles: benefi-
cence, nonmaleficence, respect for autonomy, and justice.
Because disease processes may have different character-
istics in women and men and because women and men
may respond differently to treatments and interven-
tions, women need to be included as participants in
clinical research. For women to benefit from the results of
research (beneficence), the research must be designed to
provide a valid analysis as to whether women are affected
differently than men (1). Such differential analysis is
necessary not only to benefit women, but also to prevent
harm; if data from studies with men are inappropriately
extrapolated to women, women may actually suffer harm
(nonmaleficence).
Arguments previously advanced to defend the exclu-
sion of women from research often cited the possibility of
harm to women of reproductive potential or to pregnant
2013 COMPENDIUM OF SELECTED PUBLICATIONS 142
 women and their fetuses, harm that did not apply to men.
However, the risk of such harm can be minimized and,
in itself, does not justify the exclusion of women from
research that is needed to make valid inferences about the
medical treatment of women.
Women have frequently been regarded as a vul-
nerable population that needs to be protected. Today,
however, both civil society and medical ethics recognize
the right and the capacity of women to make decisions
regarding their own lives and their medical care (respect
for autonomy). Similarly, women have the right and
the capacity to weigh the risks and potential benefits of
participation in research and to decide for themselves
whether to consent to participate. This autonomy right
is limited, however, by the responsibility of investigators
and IRBs to take precautions to limit the risk for research
participants, including pregnant women and their fetuses.
Systematic exclusion of women from research vio-
lates the ethical principle of justice, which first requires
that persons be given what is due them. If the medical
treatment of women is invalidly based on studies that
excluded women, then women are not receiving fair
treatment. Justice requires that women be included
in clinical studies in sufficient numbers to determine
whether their responses are different from those of men.
In the research setting, justice requires that the ben-
efits of scientific advancement be shared fairly between
men and women. Both women and men should be
encouraged to participate in research. Researchers should
specifically address those obstacles to participation that
are experienced disproportionately by women—for
example, problems obtaining and paying for adequate
child care during time spent as a research participant.
Because of a history of systematic exclusion of women
from research, in 1993 Congress directed that women
were to be included in all federally funded research proj-
ects (9). Consequently, the National Institutes of Health
(NIH) now require that women be included in all NIH-
funded clinical research, unless a clear and compelling
rationale establishes that such involvement would be
inappropriate or unsafe (1). Particular focus on the health
needs of women is justifiable at this time in view of a his-
tory of neglect of such studies.
Informed Consent
Appropriate and adequately informed consent by the
potential participant or another authorized person and
an independent review of the risks and benefits of
research by appropriate institutions or agencies (or both)
are fundamental to the formulation of any research
protocol (10). The informed consent process should
not be weakened to benefit the researcher. The consent
document should be understandable and written in
simple language. In situations in which English is not
the primary language of the potential study participant,
an interpreter should be used for the consent process to
verify the participant’s level of understanding of the issues
COMMITTEE OPINIONS
related to risk and benefit. The statement of informed
consent may need to be translated into the participant’s
native language. Researchers should be familiar with fed-
eral and state laws and regulations for informed consent
in settings where pregnant minors and adolescents may
be recruited as participants (11).
The researcher has an obligation to disclose to the
woman and discuss with her all material risks affect-
ing her; in the case of a pregnant woman, this includes
all material risks to the woman and her fetus (12).
Disclosure should include risks that are likely to affect
the patient’s decision to participate or not to participate
in the research. Because the process of informed con-
sent cannot anticipate all conceivable risks, women who
develop unanticipated complications should be instruct-
ed to contact the researcher or a representative of the IRB
immediately. Pregnant women who enroll in a research
trial and experience a research-related injury should
be informed about their therapeutic options, including
those related to the pregnancy.
The potential participant should be encouraged to
consult her physician independently before deciding
to participate in a research study (13). At the woman’s
request, the researcher should provide information about
the study to her physician. If relevant, this information
may include the requirements of the study and its pos-
sible outcomes and complications.
Both the researcher and the primary caregiver should
guard against inflating the patient’s perception of the ther-
apeutic benefit expected from participating in the study.
Studies have shown that research participants tend to
believe, despite careful explanation of research protocols,
that they will always benefit from participation or that
the level of actual benefit will be greater than stated in the
consent process (14). This risk of “therapeutic misconcep-
tion” may be increased when the patient’s own physician
is involved in the consent process, especially when one
physician serves as both researcher and clinician.
Consent of the pregnant woman alone is sufficient
for most research. When research has the prospect of
direct benefit to the fetus alone, paternal consent also
may be required (see Table 1). Federal regulations that
call for involvement of the father in the consent process
for research intended to benefit the fetus are controver-
sial and have generated vigorous debate. Proponents of
paternal consent endorse this requirement because they
believe that the requirement is consistent with recogni-
tion of and respect for the rights of the father in protect-
ing the welfare of his unborn child. They believe that this
represents a reasonable compromise between acknowl-
edging paternal rights and reducing barriers to participa-
tion in research by pregnant women.
The Committee on Ethics, however, does not sup-
port recognition of distinct paternal rights before the
birth of a child. Recognition of paternal rights dur-
ing pregnancy may infringe on and weaken maternal
autonomy—the right of a woman, when pregnant, to
2013 COMPENDIUM OF SELECTED PUBLICATIONS 143
 Table 1. Selected Federal Regulations on Informed Consent for Participants in Human Research*
Issue Citation Regulation

Maternal consent 45 C.F.R. §46.204(d) If the research holds out the prospect of direct benefit to the pregnant woman,
the prospect of a direct benefit both to the pregnant woman and the fetus, or no
prospect of benefit for the woman nor the fetus when risk to the fetus is not
greater than minimal and the purpose of the research is the development of
important biomedical knowledge that cannot be obtained by any other means, her
consent is obtained in accord with the informed consent provisions of subpart A†

of this part;

Paternal consent 45 C.F.R. §46.204(e) If the research holds out the prospect of direct benefit solely to the fetus then the
consent of the pregnant woman and the father is obtained in accord with the
informed consent provisions of subpart A† of this part, except that the father’s
consent need not be obtained if he is unable to consent because of unavailability,
incompetence, or temporary incapacity or the pregnancy resulted from rape or
incest.
*Federal regulations on protection of human research participants are found in the Code of Federal Regulations in Title 45, Part 46. Selected sections of the regulations
dealing with informed consent are reprinted here; the complete, current version may be found at http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.htm.
Basic HHS policy for protection of human research subjects. 45 C.F.R. §46.101–124 Subpart A (2006).
†

independent action in decisions that affect her body and
her health. As in clinical situations, the pregnant woman’s
consent should be sufficient for research interventions
that affect her or her fetus. To further complicate matters,
the interpretation as to whether research is intended for
the benefit of the pregnant woman, the fetus, or both may
be subjective. Two researchers conducting identical stud-
ies may reach different conclusions as to whether benefits
of the research apply to the pregnant woman, the fetus, or
both (eg, maternal–fetal surgery for spina bifida).
Informed consent means that women have the right
to choose not to participate in a research protocol and
the right to withdraw from a study at any time. The
participation of a woman in a research study is based on
the expectation that she will consider carefully her own
interests. The participation of a pregnant woman in a
research study is based on the expectation that she will
consider carefully her own interests as well as those of
her fetus. Typically, pregnant women are quite willing
to take personal risks for the benefit of their fetuses;
combined with society’s expectation that they will do
so, women may find themselves under pressure to par-
ticipate in research that carries risk to them. Such pres-
sure actually may interfere with the ability of the pregnant
woman to give fully free consent. In these situations,
special care should be taken to ensure that a woman’s
consent is truly voluntary.
Research Related to Diagnosis and
Therapy
Research that consists of observation and recording
without clinical intervention (descriptive research) is of
ethical concern primarily to the extent that it requires
informed consent and the preservation of confidentiality.
In research trials where clinical intervention is a compo-
nent, the benefits and burdens of the trial must be clearly
articulated to the participant by the researcher (12). In
research studies conducted in pregnant women, both
the potential benefit to the woman, the fetus, and society
as a whole and the level of risk that may be incurred as a
result of participation in the study should be considered.
The involvement of the participant’s obstetrician ordi-
narily is appropriate. All parties concerned need to strive
for clear communication with regard to the following
questions:
• Does the research involve intervention or diagnosis
that might affect the woman’s or the fetus’s well-
being, or is the goal of the study to produce scien-
tific results that will be likely to be useful to future
patients but offer no demonstrable benefit to current
participants?
• Can the prospective participant expect any explicit
benefit as a result of participating in the study? If not,
she must be apprised of this fact. Those studies that
search for general information and are not associated
with diagnostic or treatment modalities would be
less likely to create the impression that the research
will result in direct benefit to the participant. The re-
searcher is still obligated to verify that the participant
has understood this aspect of the study correctly.
• Is there more than “minimal risk” to the fetus gener-
ated by the research?
According to applicable federal regulations, “mini-
mal risk means that the probability and magnitude
of harm or discomfort anticipated in the research are
not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of
routine physical or psychological examinations or tests”
(15). It has been questioned whether the “daily life” used

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 144

 for comparison should be that of the general population
or that of the participant. Using the participant’s daily life
as the standard might make a higher level of risk accept-
able; therefore, the general population standard is advised
(10). Anything beyond minimal risk must be weighed
carefully against the potential benefits to the woman and
the fetus when the advisability of participation is con-
sidered. When a pregnancy has been exposed to risk in
the conduct of research, the woman should be strongly
encouraged to participate in follow-up evaluations to
assess the impact on her and her fetus or child.
It is appropriate for investigators and sponsors, with
the approval of the IRB, to require a negative pregnancy
test result as a criterion for participation in research when
the research may pose more than minimal risk to the
fetus. For an adolescent, the process of informed consent
should include a discussion about pregnancy testing and
the management of pregnancy test results, including
whether the results will be shared with her parents or
guardian.
Similarly, it is reasonable for investigators and
research sponsors, with the IRB’s approval, to require
the use of effective birth control measures for women of
reproductive capacity as an inclusion criterion for partici-
pation in research that may entail more than minimal risk
to the fetus. Consultation with an obstetrician–gynecolo-
gist or other knowledgeable professional is encouraged if
questions arise about efficacy and risk of contraceptive
measures.
Some study protocols mandate use of a specific
contraceptive method, such as oral contraceptives or an
intrauterine device. These mandates are inappropriate
based on the principles of respect for autonomy, benefi-
cence, and justice. A woman should be allowed to choose
a birth control method, including abstinence, according
to her needs and values (16). Requiring birth control use
by women who are not sexually active violates a commit-
ment to respect them as persons. Hormonal contracep-
tive methods that could interfere with study results may
be excluded on scientific grounds, but additional restric-
tions are inappropriate.
After informed discussion about the research trial,
some women will decline to participate. Researchers
should respect this decision and not allow patient refusal
to affect subsequent clinical care. Reasonable compensa-
tion for a woman’s time, effort, and expense as a partici-
pant in a research study is both acceptable and desired,
but researchers should not offer inducements, finan-
cial or otherwise, to influence participation in research
beyond reasonable compensation for the woman’s time,
effort, and expense.
Recommendations of the Committee
on Ethics
Federal and state laws and regulations governing research
involving women should be observed (2, 5, 11). In addi-
COMMITTEE OPINIONS
tion, the Committee on Ethics makes the following rec-
ommendations for research involving women:
1. Women should be presumed to be eligible for
participation in all clinical studies except for those
addressing health concerns solely relevant to men.
2. Women should be included in research in sufficient
numbers to ensure that inferences from a clinical
trial apply validly to both sexes.
3. All research on women should be conducted in a
manner consistent with the following ethical prin-
ciples:
—Research should conform to general scientific stan-
dards for valid research.
—Research may be conducted only with the informed
consent of the woman.
—Researchers should not offer inducements, finan-
cial or otherwise, to influence participation in
research beyond reasonable compensation for the
woman’s time, effort, and expense.
—Conscientious efforts should be made to avoid
any conflicts between appropriate health care
and research objectives. Health care needs of the
individual woman should take precedence over
research interests in all situations affecting clinical
management.
4. Research involving pregnant women should conform
to the following recommendations:
—Research may be conducted only with the informed
consent of the woman. Pregnant women con-
sidering participation in a research study should
determine the extent to which the father is to be
involved in the process of informed consent and
the decision.
—Informed consent of the father must be obtained
when federal regulations require it for research that
has the prospect of direct benefit to the fetus alone.
—Research protocols should be evaluated for their
potential impact on both the woman and the fetus,
and that evaluation should be made as part of the
process of informed consent.
In this Committee Opinion, an attempt has been
made to take into account protection of human partici-
pants, the eligibility of women to participate in research,
and the benefits that society could derive from participa-
tion of women in research. These potential benefits include
reduction in morbidity and mortality from sex-specific
disease processes, as well as reduction in fetal, infant, and
maternal morbidity and mortality.
References
1. National Institutes of Health. NIH policy and guidelines
on the inclusion of women and minorities as subjects in
clinical research – Amended, October, 2001. Bethesda
(MD): NIH; 2001. Available at http://grants.nih.gov/grants/
funding/women_min/guidelines_amended_10_2001.htm.
Retrieved May 1, 2007.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 145
 2. Protection of human subjects. 45 C.F.R. §46 (2006).
3. National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (US). The
Belmont Report: ethical principles and guidelines for the
protection of human subjects of research. Washington,
DC: U.S. Government Printing Office; 1979. Available
at: http://www.hhs.gov/ohrp/humansubjects/guidance/
belmont.htm. Retrieved May 1, 2007.
4. World Medical Association. Declaration of Helsinki:
Ethical principles for medical research involving human
subjects. Ferney-Voltaire (France): WMA; 2004. Available
at: http:// www.wma.net/e/policy/pdf/17c.pdf. Retrieved
May 1, 2007.
5. Additional protections for pregnant women, human fetuses
and neonates involved in research. 45 C.F.R. §§46.201-207
Subpart B (2006).
6. Research on transplantation of fetal tissue. Informed con-
sent of donor. 42 U.S.C. §289g-1(b) (2000).
7. Beauchamp TL. The intersection of research and practice.
In: Goldworth A, Silverman W, Stevenson DK, Young EW,
Rivers R. Ethics and perinatology. New York (NY): Oxford
University Press; 1995. p. 231–44.
8. Innovative practice: ethical guidelines. ACOG Committee
Opinion No. 352. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2006;108:1589–95.
9. NIH Revitalization Act of 1993, Pub. L. No. 103-43 (1993).
10. National Bioethics Advisory Commission. Ethical and
policy issues in research involving human participants.
Bethesda (MD): NBAC; 2001. Available at: http://www.
georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf.
Retrieved May 1, 2007.
COMMITTEE OPINIONS
11. Additional protections for children involved as subjects in
research. 45 C.F.R. §§46.401–409 Subpart D (2006).
12. General requirements for informed consent. 45 CFR
§46.116 (2006).
13. Institute of Medicine (US). Women and health research:
ethical and legal issues of including women in clinical
studies. Vol. 1. Washington, DC: National Academy Press;
1994.
14. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade
W. False hopes and best data: consent to research and the
therapeutic misconception. Hastings Cent Rep 1987;17(2):
20–4.
15. Definitions. 45 C.F.R. §46.102 (2006).
16. Anderson JR, Schonfeld TL, Kelso TK, Prentice ED.
Women in early phase trials: an IRB’s deliberations. IRB
2003;25 (4):7–11.
Copyright © September 2007 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Research involving women. ACOG Committee Opinion No. 377.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:731–6.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 146
 ACOG COMMITTEE OPINION
Number 385 • November 2007

The Limits of Conscientious Refusal in

Reproductive Medicine
Committee on Ethics ABSTRACT: Health care providers occasionally may find that providing indicated,
even standard, care would present for them a personal moral problem—a conflict of
Reaffirmed 2010
conscience—particularly in the field of reproductive medicine. Although respect for
conscience is important, conscientious refusals should be limited if they constitute an
imposition of religious or moral beliefs on patients, negatively affect a patient’s health,
are based on scientific misinformation, or create or reinforce racial or socioeconomic
inequal­ities. Conscientious refusals that conflict with patient well-being should be accom-
modated only if the primary duty to the patient can be fulfilled. All health care providers
must provide accurate and unbiased information so that patients can make informed
decisions. Where conscience implores physicians to deviate from standard practices,
they must provide potential patients with accurate and prior notice of their personal moral
commitments. Physicians and other health care providers have the duty to refer patients
in a timely manner to other providers if they do not feel that they can in conscience
provide the standard reproductive services that patients request. In resource-poor areas,
access to safe and legal reproductive services should be maintained. Providers with moral
or religious objections should either practice in proximity to individuals who do not share
their views or ensure that referral processes are in place. In an emergency in which refer-
ral is not possible or might negatively have an impact on a patient’s physical or mental
health, providers have an obligation to provide medically indicated and requested care.

Physicians and other providers may not
always agree with the decisions patients make
about their own health and health care.
Such differences are expected—and, indeed,
underlie the American model of informed
consent and respect for patient autonomy.
Occasionally, however, providers anticipate
that providing indicated, even standard, care
would present for them a personal moral
problem—a conflict of conscience. In such
cases, some providers claim a right to refuse
to provide certain services, refuse to refer
patients to another provider for these ser-
vices, or even decline to inform patients of
their existing options (1).
Conscientious refusals have been par-
ticularly widespread in the arena of repro-
The American College ductive medicine, in which there are deep
of Obstetricians divisions regarding the moral acceptability of
and Gynecologists pregnancy termination and contraception.
Women’s Health Care In Texas, for example, a pharmacist rejected
Physicians a rape victim’s prescription for emergency
contraception, arguing that dispensing the
medication was a “violation of morals” (2).
In Virginia, a 42-year-old mother of two
was refused a prescription for emergency
contraception, became pregnant, and ulti-
mately underwent an abortion she tried to
prevent by requesting emergency contracep-
tion (3). In California, a physician refused
to perform intrauterine insemination for a
lesbian couple, prompted by religious beliefs
and disapproval of lesbians having children
(4). In Nebraska, a 19-year-old woman with
a life-threatening pulmonary embolism at 10
weeks of gestation was refused a first-trimes-
ter pregnancy termination when admitted to
a religiously affiliated hospital and was ulti-
mately transferred by ambulance to another
facility to undergo the procedure (5). At the
heart of each of these examples of refusal is
a claim of conscience—a claim that to pro-
vide certain services would compromise the
moral integrity of a provider or institution.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 147

 In this opinion, the American College of Obste­
tricians and Gynecologists (ACOG) Committee on Ethics
considers the issues raised by conscientious refusals in
reproductive medicine and outlines a framework for
defining the ethically appropriate limits of conscientious
refusal in reproductive health contexts. The commit-
tee begins by offering a definition of conscience and
describing what might constitute an authentic claim of
conscience. Next, it discusses the limits of conscientious
refusals, describing how claims of conscience should
be weighed in the context of other values critical to the
ethical provision of health care. It then outlines options
for public policy regarding conscientious refusals in
reproductive medicine. Finally, the committee proposes
a series of recommendations that maximize accommo-
dation of an individual’s religious or moral beliefs while
avoiding imposition of these beliefs on others or interfer-
ing with the safe, timely, and financially feasible access to
reproductive health care that all women deserve.
Defining Conscience
In this effort to reconcile the sometimes competing
demands of religious or moral freedom and reproductive
rights, it is important to characterize what is meant by
conscience. Conscience has been defined as the private,
constant, ethically attuned part of the human charac-
ter. It operates as an internal sanction that comes into
play through critical reflection about a certain action
or inaction (6). An appeal to conscience would express
a sentiment such as “If I were to do ‘x,’ I could not live
with myself/I would hate myself/I wouldn’t be able to
sleep at night.” According to this definition, not to act in
accordance with one’s conscience is to betray oneself—to
risk personal wholeness or identity. Thus, what is taken
seriously and is the specific focus of this document is not
simply a broad claim to provider autonomy (7), but rather
the particular claim to a provider’s right to protect his or
her moral integrity—to uphold the “soundness, reliability,
wholeness and integration of [one’s] moral character” (8).
Personal conscience, so conceived, is not merely a
source of potential conflict. Rather, it has a critical and
useful place in the practice of medicine. In many cases, it
can foster thoughtful, effective, and humane care. Ethical
decision making in medicine often touches on individu-
als’ deepest identity-conferring beliefs about the nature
and meaning of creating and sustaining life (9). Yet,
conscience also may conflict with professional and ethical
standards and result in inefficiency, adverse outcomes,
violation of patients’ rights, and erosion of trust if, for
example, one’s conscience limits the information or care
provided to a patient. Finding a balance between respect
for conscience and other important values is critical to
the ethical practice of medicine.
In some circumstances, respect for conscience must
be weighed against respect for particular social values.
Challenges to a health care professional’s integrity may
occur when a practitioner feels that actions required by an
COMMITTEE OPINIONS
external authority violate the goals of medicine and his or
her fiduciary obligations to the patient. Established clini-
cal norms may come into conflict with guidelines imposed
by law, regulation, or public policy. For example, poli-
cies that mandate physician reporting of undocumented
patients to immigration authorities conflict with norms
such as privacy and confidentiality and the primary prin-
ciple of nonmaleficence that govern the provider–patient
relationship (10). Such challenges to integrity can result in
considerable moral distress for providers and are best met
through organized advocacy on the part of professional
organizations (11, 12). When threats to patient well-being
and the health care professional’s integrity are at issue,
some individual providers find a conscience-based refusal
to comply with policies and acceptance of any associated
professional and personal consequences to be the only
morally tenable course of action (10).
Claims of conscience are not always genuine. They
may mask distaste for certain procedures, discriminatory
attitudes, or other self-interested motives (13). Providers
who decide not to perform abortions primarily because
they find the procedure unpleasant or because they fear
criticism from those in society who advocate against it do
not have a genuine claim of conscience. Nor do providers
who refuse to provide care for individuals because of fear
of disease transmission to themselves or other patients.
Positions that are merely self-protective do not constitute
the basis for a genuine claim of conscience. Furthermore,
the logic of conscience, as a form of self-reflection on and
judgment about whether one’s own acts are obligatory or
prohibited, means that it would be odd or absurd to say
“I would have a guilty conscience if she did ‘x.’” Although
some have raised concerns about complicity in the con-
text of referral to another provider for requested medical
care, the logic of conscience entails that to act in accor-
dance with conscience, the provider need not rebuke
other providers or obstruct them from performing an
act (8). Finally, referral to another provider need not be
conceptualized as a repudiation or compromise of one’s
own values, but instead can be seen as an acknowledg-
ment of both the widespread and thoughtful disagree-
ment among physicians and society at large and the
moral sincerity of others with whom one disagrees (14).
The authenticity of conscience can be assessed
through inquiry into 1) the extent to which the underly-
ing values asserted constitute a core component of a pro-
vider’s identity, 2) the depth of the provider’s reflection
on the issue at hand, and 3) the likelihood that the pro-
vider will experience guilt, shame, or loss of self-respect
by performing the act in question (9). It is the genuine
claim of conscience that is considered next, in the context
of the values that guide ethical health care.
Defining Limits for Conscientious
Refusal
Even when appeals to conscience are genuine, when
a provider’s moral integrity is truly at stake, there are
2013 COMPENDIUM OF SELECTED PUBLICATIONS 148
 clearly limits to the degree to which appeals to conscience
may justifiably guide decision making. Although respect
for conscience is a value, it is only a prima facie value,
which means it can and should be overridden in the
interest of other moral obligations that outweigh it in
a given circumstance. Professional ethics requires that
health be delivered in a way that is respectful of patient
autonomy, timely and effective, evidence based, and
nondiscriminatory. By virtue of entering the profession
of medicine, physicians accept a set of moral values—and
duties—that are central to medical practice (15). Thus,
with professional privileges come professional respon-
sibilities to patients, which must precede a provider’s
personal interests (16). When conscientious refusals con-
flict with moral obligations that are central to the ethical
practice of medicine, ethical care requires either that the
physician provide care despite reservations or that there
be resources in place to allow the patient to gain access
to care in the pre­sence of conscientious refusal. In the
following sections, four criteria are highlighted as impor-
tant in determining appropriate limits for conscientious
refusal in reproductive health contexts.
1. Potential for Imposition
The first important consideration in defining limits for
conscientious refusal is the degree to which a refusal
constitutes an imposition on patients who do not share
the objector’s beliefs. One of the guiding principles in
the practice of medicine is respect for patient autonomy,
a principle that holds that persons should be free to
choose and act without controlling constraints imposed
by others. To respect a patient’s autonomy is to respect
her capacities and perspectives, including her right to
hold certain views, make certain choices, and take certain
actions based on personal values and beliefs (17). Respect
involves acknowledging decision-making rights and act-
ing in a way that enables patients to make choices for
themselves. Respect for autonomy has particular impor-
tance in reproductive decision making, which involves
private, personal, often pivotal decisions about sexuality
and childbearing.
It is not uncommon for conscientious refusals to
result in imposition of religious or moral beliefs on a
patient who may not share these beliefs, which may
undermine respect for patient autonomy. Women’s
informed requests for contraception or sterilization, for
example, are an important expression of autonomous
choice regarding reproductive decision making. Refusals
to dispense contraception may constitute a failure
to respect women’s capacity to decide for them­selves
whether and under what circumstances to become
pregnant.
Similar issues arise when patients are unable to
obtain medication that has been prescribed by a physi-
cian. Although pharmacist conduct is beyond the scope
of this document, refusals by other professionals can have
an important impact on a physician’s efforts to provide
COMMITTEE OPINIONS
appropriate reproductive health care. Providing com-
plete, scientifically accurate information about options
for reproductive health, including contraception, ster-
ilization, and abortion, is fundamental to respect for
patient autonomy and forms the basis of informed deci-
sion making in reproductive medicine. Providers refusing
to provide such information on the grounds of moral
or religious objection fail in their fundamental duty to
enable patients to make decisions for themselves. When
the potential for imposition and breach of autonomy is
high due either to controlling constraints on medication
or procedures or to the provider’s withholding of infor-
mation critical to reproductive decision making, consci-
entious refusal cannot be justified.
2. Effect on Patient Health
A second important consideration in evaluating consci-
entious refusal is the impact such a refusal might have on
well-being as the patient perceives it—in particular, the
potential for harm. For the purpose of this discussion,
harm refers to significant bodily harm, such as pain, dis-
ability, or death or a patient’s conception of well-being.
Those who choose the profession of medicine (like those
who choose the profession of law or who are trustees) are
bound by special fiduciary duties, which oblige physicians
to act in good faith to protect patients’ health—particu-
larly to the extent that patients’ health interests conflict
with physicians’ personal or self-interest (16). Although
conscientious refusals stem in part from the commitment
to “first, do no harm,” their result can be just the oppo-
site. For example, religiously based refusals to perform
tubal sterilization at the time of cesarean delivery can
place a woman in harm’s way—either by putting her at
risk for an undesired or unsafe pregnancy or by necessi-
tating an additional, separate sterilization procedure with
its attendant and additional risks.
Some experts have argued that in the context of
pregnancy, a moral obligation to promote fetal well-being
also should justifiably guide care. But even though views
about the moral status of the fetus and the obligations
that status confers differ widely, support of such moral
pluralism does not justify an erosion of clinicians’ basic
obligations to protect the safety of women who are, pri-
marily and unarguably, their patients. Indeed, in the vast
majority of cases, the interests of the pregnant woman
and fetus converge. For situations in which their interests
diverge, the pregnant woman’s autonomous decisions
should be respected (18). Furthermore, in situations “in
which maternal competence for medical decision making
is impaired, health care providers should act in the best
interests of the woman first and her fetus second” (19).
3. Scientific Integrity
The third criterion for evaluating authentic conscientious
refusal is the scientific integrity of the facts supporting
the objector’s claim. Core to the practice of medicine is
a commitment to science and evidence-based practice.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 149
 Patients rightly expect care guided by best evidence as
well as information based on rigorous science. When
conscientious refusals reflect a misunderstanding or
mistrust of science, limits to conscientious refusal should
be defined, in part, by the strength or weakness of the sci-
ence on which refusals are based. In other words, claims
of conscientious refusal should be considered invalid
when the rationale for a refusal contradicts the body of
scien­tific evidence.
The broad debate about refusals to dispense emer-
gency contraception, for example, has been complicated
by misinformation and a prevalent belief that emergency
contraception acts primarily by preventing implantation
(20). However, a large body of published evidence sup-
ports a different primary mechanism of action, namely
the prevention of fertilization. A review of the literature
indicates that Plan B can interfere with sperm migra-
tion and that preovulatory use of Plan B suppresses the
luteinizing hormone surge, which prevents ovulation or
leads to the release of ova that are resistant to fertilization.
Studies do not support a major postfertilization mecha-
nism of action (21). Although even a slight possibility of
postfertilization events may be relevant to some women’s
decisions about whether to use contraception, provider
refusals to dispense emergency contraception based on
unsupported beliefs about its primary mechanism of
action should not be justified.
In the context of the morally difficult and highly
contentious debate about pregnancy termination, scien-
tific integrity is one of several important considerations.
For example, some have argued against providing access
to abortion based on claims that induced abortion is
associated with an increase in breast cancer risk; however,
a 2003 U.S. National Cancer Institute panel concluded
that there is well-established epidemiologic evidence that
induced abortion and breast cancer are not associated
(22). Refusals to provide abortion should not be justified
on the basis of unsubstantiated health risks to women.
Scientific integrity is particularly important at the
level of public policy, where unsound appeals to science
may have masked an agenda based on religious beliefs.
Delays in granting over-the-counter status for emergency
contraception are one such example. Critics of the U.S.
Food and Drug Administration’s delay cited deep flaws
in the science and evidence used to justify the delay,
flaws these critics argued were indicative of unspoken
and misplaced value judgments (23). Thus, the scientific
integrity of a claim of refusal is an important metric in
determining the acceptability of conscience-based prac-
tices or policies.
4. Potential for Discrimination
Finally, conscientious refusals should be evaluated on
the basis of their potential for discrimination. Justice is
a complex and important concept that requires medical
professionals and policy makers to treat individuals fairly
and to provide medical services in a nondiscriminatory
COMMITTEE OPINIONS
manner. One conception of justice, sometimes referred
to as the distributive paradigm, calls for fair allocation of
society’s benefits and burdens. Persons intending consci-
entious refusal should consider the degree to which they
create or reinforce an unfair distribution of the benefits of
reproductive technology. For instance, refusal to dispense
contraception may place a disproportionate burden on
disenfranchised women in resource-poor areas. Whereas
a single, affluent professional might experience such a
refusal as inconvenient and seek out another physician, a
young mother of three depending on public transporta-
tion might find such a refusal to be an insurmountable
barrier to medication because other options are not
realistically available to her. She thus may experience loss
of control of her reproductive fate and quality of life for
herself and her children. Refusals that unduly burden the
most vulnerable of society violate the core commitment
to justice in the distribution of health resources.
Another conception of justice is concerned with
matters of oppression as well as distribution (24). Thus,
the impact of conscientious refusals on oppression of
certain groups of people should guide limits for claims
of conscience as well. Consider, for instance, refusals to
provide infertility services to same-sex couples. It is likely
that such couples would be able to obtain infertility ser­
vices from another provider and would not have their
health jeopardized, per se. Nevertheless, allowing physi-
cians to discriminate on the basis of sexual orientation
would constitute a deeper insult, namely reinforcing
the scientifically unfounded idea that fitness to parent is
based on sexual orientation, and, thus, reinforcing the
oppressed status of same-sex couples. The concept of
oppression raises the implications of all conscientious
refusals for gender justice in general. Legitimizing refus-
als in reproductive contexts may reinforce the tendency
to value women primarily with regard to their capacity
for reproduction while ignoring their interests and rights
as people more generally. As the place of conscience
in reproductive medicine is considered, the impact of
permissive policies toward conscientious refusals on the
status of women must be considered seriously as well.
Some might say that it is not the job of a physician
to “fix” social inequities. However, it is the responsibility,
whenever possible, of physicians as advocates for patients’
needs and rights not to create or reinforce racial or socio­
economic inequalities in society. Thus, refusals that cre-
ate or reinforce such inequalities should raise significant
caution.
Institutional and Organizational
Responsibilities
Given these limits, individual practitioners may face
difficult decisions about adherence to conscience in
the context of professional responsibilities. Some have
offered, however, that “accepting a collective obligation
does not mean that all members of the profession are
forced to violate their own consciences” (1). Rather, insti-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 150
 tutions and professional organizations should work to
create and maintain organizational structures that ensure
nondiscriminatory access to all professional services and
minimize the need for individual practitioners to act
in opposition to their deeply held beliefs. This requires
at the very least that systems be in place for counseling
and referral, particularly in resource-poor areas where
conscientious refusals have significant potential to limit
patient choice, and that individuals and institutions
“act affirmatively to protect patients from unexpected
and disruptive denials of service” (13). Individuals and
institutions should support staffing that does not place
practitioners or facilities in situations in which the
harms and thus conflicts from conscientious refusals are
likely to arise. For example, those who feel it improper
to prescribe emergency contraception should not staff
sites, such as emergency rooms, in which such requests
are likely to arise, and prompt disposition of emergency
contra­ception is required and often integral to profes-
sional practice. Similarly, institutions that uphold doctri-
nal objec­tions should not position themselves as primary
providers of emergency care for victims of sexual assault;
when such patients do present for care, they should be
given prophylaxis. Institutions should work toward struc-
tures that reduce the impact on patients of professionals’
refusals to provide standard reproductive services.
Recommendations
Respect for conscience is one of many values important
to the ethical practice of reproductive medicine. Given
this framework for analysis, the ACOG Committee on
Ethics proposes the following recommendations, which
it believes maximize respect for health care professionals’
consciences without compromising the health and well-
being of the women they serve.
1. In the provision of reproductive services, the patient’s
well-being must be paramount. Any conscientious
refusal that conflicts with a patient’s well-being
should be accommodated only if the primary duty
to the patient can be fulfilled.
2. Health care providers must impart accurate and unbi-
ased information so that patients can make informed
decisions about their health care. They must disclose
scientifically accurate and professionally accepted
characterizations of reproductive health services.
3. Where conscience implores physicians to deviate
from standard practices, including abortion, steril-
ization, and provision of contraceptives, they must
provide potential patients with accurate and prior
notice of their personal moral commitments. In the
process of providing prior notice, physicians should
not use their professional authority to argue or advo-
cate these positions.
4. Physicians and other health care professionals have
the duty to refer patients in a timely manner to other
providers if they do not feel that they can in con-
COMMITTEE OPINIONS
science provide the standard reproductive services
that their patients request.
5. In an emergency in which referral is not possible or
might negatively affect a patient’s physical or men-
tal health, providers have an obligation to provide
medically indicated and requested care regardless of
the provider’s personal moral objections.
6. In resource-poor areas, access to safe and legal repro-
ductive services should be maintained. Conscien­
tious refusals that undermine access should raise
significant caution. Providers with moral or religious
objections should either practice in proximity to
individuals who do not share their views or ensure
that referral processes are in place so that patients
have access to the service that the physician does not
wish to provide. Rights to withdraw from caring for
an individual should not be a pretext for interfering
with patients’ rights to health care services.
7. Lawmakers should advance policies that balance
protection of providers’ consciences with the critical
goal of ensuring timely, effective, evidence-based,
and safe access to all women seeking reproductive
services.
References
1. Charo RA. The celestial fire of conscience––refusing to
deliver medical care. N Engl J Med 2005;352:2471–3.
2. Denial of rape victim’s pills raises debate: moral, legal ques-
tions surround emergency contraception. New York (NY):
Associated Press; 2004. Available at: http://www.msnbc.
msn.com/id/4359430. Retrieved July 10, 2007.
3. L D. What happens when there is no plan B? Washing­
ton Post; June 4, 2006. p. B1. Available at: http://www.
washingtonpost.com/wp-dyn/content/article/2006/06/02/
AR2006060201405.html. Retrieved July 10, 2007.
4. Weil E. Breeder reaction: does everyone now have a right
to bear children? Mother Jones 2006;31(4):33–7. Available
at: http://www.motherjones.com/news/feature/2006/07/
breeder_reaction.html. Retrieved July 10, 2007.
5. American Civil Liberties Union. Religious refusals and
reproductive rights: ACLU Reproductive Freedom Project.
New York (NY): ACLU; 2002. Available at: http://www.
aclu. org/FilesPDFs/ACF911.pdf. Retrieved July 10, 2007.
6. Childress JF. Appeals to conscience. Ethics 1979;89:315–35.
7. Wicclair MR. Conscientious objection in medicine.
Bioethics 2000;14:205–27.
8. Beauchamp TL, Childress JF. Principles of biomedical eth-
ics. 5th ed. New York (NY): Oxford University Press; 2001.
9. Benjamin M. Conscience. In: Reich WT, editor. Encyclo-
pedia of bioethics. New York (NY): Simon & Schuster
Macmillan; 1995. p. 469–73.
10. Ziv TA, Lo B. Denial of care to illegal immigrants.
Proposition 187 in California. N Engl J Med 1995;332:
1095–8.
11. American College of Obstetricians and Gynecologists. Code
of professional ethics of the American College of Obste­-
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 tricians and Gynecologists. Washington, DC: ACOG; 2004.
Available at: http://www.acog.org/from_home/acogcode.
pdf. Retrieved July 10, 2007.
12. American Medical Association. Principles of medical eth-
ics. In: Code of medical ethics of the American Medical
Association: current opinions with annotations. 2006–2007
ed. Chicago (IL): AMA; 2006. p. xv.
13. Dresser R. Professionals, conformity, and conscience.
Hastings Cent Rep 2005;35:9–10.
14. Blustein J. Doing what the patient orders: maintain-
ing integrity in the doctor-patient relationship. Bioethics
1993;7:290–314.
15. Brody H, Miller FG. The internal morality of medicine:
explication and application to managed care. J Med Philos
1998;23:384–410.
16. Dickens BM, Cook RJ. Conflict of interest: legal and ethical
aspects. Int J Gynaecol Obstet 2006;92:192–7.
17. Faden RR, Beauchamp TL. A history and theory of informed
consent. New York (NY): Oxford University Press; 1986.
18. Maternal decision making, ethics, and the law. ACOG
Committee Opinion No. 321. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2005;106:
1127–37.
19. International Federation of Gynecology and Obstetrics.
Ethical guidelines regarding interventions for fetal well
being. In: Ethical issues in obstetrics and gynecology.
London (UK): FIGO; 2006. p. 56–7. Available at: http://
www.figo.org/docs/Ethics%20Guidelines.pdf. Retrieved
July 10, 2007.
COMMITTEE OPINIONS
20. Cantor J, Baum K. The limits of conscientious objection—
may pharmacists refuse to fill prescriptions for emergency
contraception? N Engl J Med 2004;351:2008–12.
21. Davidoff F, Trussell J. Plan B and the politics of doubt.
JAMA 2006;296:1775–8.
22. Induced abortion and breast cancer risk. ACOG Committee
Opinion No. 285. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2003;102:433–5.
23. Grimes DA. Emergency contraception: politics trumps
science at the U.S. Food and Drug Administration. Obstet
Gynecol 2004;104:220–1.
24. Young IM. Justice and the politics of difference. Princeton
(NJ): Princeton University Press; 1990.
Copyright © November 2007 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
The limits of conscientious refusal in reproductive medicine. ACOG
Committee Opinion No. 385. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1203–8.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 152
 ACOG COMMITTEE OPINION
Number 389 • December 2007

Human Immunodeficiency Virus*

Committee on Ethics ABSTRACT: Because human immunodeficiency virus (HIV) infection often is detected
through prenatal and sexually transmitted disease testing, an obstetrician–gynecologist
may be the first health professional to provide care for a woman infected with HIV.
Universal testing with patient notification and right of refusal (“opt-out” testing) is rec-
ommended by most national organizations and federal agencies. Although opt-out and
“opt-in” testing (but not mandatory testing) are both ethically acceptable, the former
approach may identify more women who are eligible for therapy and may have public
health advantages. It is unethical for an obstetrician–gynecologist to refuse to accept a
patient or to refuse to continue providing health care for a patient solely because she is,
or is thought to be, seropositive for HIV. Health care professionals who are infected with
HIV should adhere to the fundamental professional obligation to avoid harm to patients.
Physicians who believe that they have been at significant risk of being infected should
be tested voluntarily for HIV.

Between 1 million and 1.2 million individu-
als in the United States are estimated to be
living with human immunodeficiency virus
(HIV) or acquired immunodeficiency syn-
drome (AIDS) (1). Women represent the
fastest-growing group of individuals with
new HIV infections (2). Many women who
are infected with HIV are not aware of their
serostatus (3).
Human immunodeficiency virus often
is diagnosed in women during prenatal
antibody screening or in conjunction with
screening for sexually transmitted diseases
(STDs). Because many women initially iden-
tified as infected with HIV are not aware
that they have been exposed to HIV and
do not consider themselves to be at risk,
universal testing with patient notification
is more effective than targeted, risk-based
testing in identifying those who are infected
with HIV (4). The tension between compet-
ing goals for HIV testing—testing broadly
in order to treat the maximum number of
women infected with HIV and, if pregnant,
to protect their newborns, and counseling
thoroughly in order to maximally protect a
The American College woman’s autonomy and right to participate
of Obstetricians in decision making—has sparked consider-
and Gynecologists able debate.
Women’s Health Care *Update of “Human Immunodeficiency Virus” in Ethics
Physicians in Obstetrics and Gynecology, Second Edition, 2004.
Because HIV infection often is detected
through prenatal and STD screening, it is
not uncommon for an obstetrician–gyne-
cologist to be the first health professional
to provide care for an infected woman. This
Committee Opinion is designed to provide
guidance to obstetrician–gynecologists re-
garding ethical issues associated with HIV
testing, including the use of newly developed
rapid HIV tests and disclosure of positive
test results. It also outlines responsibilities
related to patient care for women who are
infected with HIV, access for affected cou-
ples to assisted reproductive technology, and
the health care professional who is infected
with HIV.
Human Immunodeficiency
Virus Counseling and Testing
The major ethical principles that must be
considered when formulating policies for
HIV counseling and testing include respect
for autonomy, confidentiality, justice, pro-
tection of vulnerable individuals, and benefi-
cence to both the woman tested and, if she is
pregnant, to her newborn as well. Individuals
offering testing need to be mindful not only
of the benefits of testing but also its poten-
tial risks because, if a woman’s test result is
positive, she faces the possibility of being

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 153

 ostracized by her family, friends, and community or
being subjected to intimate partner violence. In addi-
tion, although the overt stigma of HIV infection has
been reduced over the past 20 years, the potential for
job discrimination, loss of health insurance, and loss of
housing still exists.
Over time, three potential strategies for HIV testing
have been considered by public health and public policy
officials: 1) universal testing with patient notification and
right of refusal, also called “opt-out” testing; 2) volun-
tary testing with pretest counseling regarding risks and
benefits, also called “opt-in” testing; and 3) mandatory
testing with no right of refusal. In order to understand
their ethical merits, each is considered briefly in the sec-
tions that follow. Increasingly, national organizations and
federal agencies have recommended opt-out testing in
preference to other strategies.
Universal Testing With Patient Notification and
Right of Refusal—Opt-Out Testing
Opt-out testing removes the requirement for pretest
counseling and detailed, testing-related informed con-
sent. Under the opt-out strategy, physicians must inform
patients that routine blood work will include HIV testing
and that they have the right to refuse this test. The goal
of this strategy is to make HIV testing less cumbersome
and more likely to be performed by incorporating it
into the routine battery of tests (eg, the first-trimester
prenatal panel or blood counts and cholesterol screening
for annual examinations). In theory, if testing barriers
are reduced, more physicians may offer testing, which
may lead to the identification and treatment of more
women who are infected with HIV and, if pregnant, to
the prevention of mother-to-infant transmission of HIV.
This testing strategy aims to balance competing ethi-
cal considerations. On the one hand, personal freedom
(autonomy) is diminished. On the other hand, there are
medical and social benefits for the woman and, if she is
pregnant, her newborn from identifying HIV infection.
Although many welcome the now widely endorsed opt-
out testing policy for the potential benefits it confers,
others have raised concerns about the possibility that
the requirement for notification before testing will be
ignored, particularly in today’s busy practice environ-
ment. Indeed, the opt-out strategy is an ethically accept-
able testing strategy only if the patient is given the option
to refuse testing. In the absence of that notification, this
approach is merely mandatory testing in disguise. If opt-
out testing is elected as a testing strategy, a clinician must
notify the patient that HIV testing is to be performed.
Refusal of testing should not have an adverse effect on
the care the patient receives or lead to denial of health
care. This guarantee of a right to refuse testing ensures
that respect for a woman’s autonomy is not completely
abridged in the quest to achieve a difficult-to-reach pub-
lic health goal.
COMMITTEE OPINIONS
Voluntary Testing With Pretest Counseling
Regarding Risks and Benefits—Opt-In Testing
Voluntary testing with counseling is the strategy most
consistent with respect for patient autonomy. Under
this option, physicians provide both pretest and posttest
counseling. Some physicians may perform such counsel-
ing themselves, whereas others may prefer to refer the
patient for counseling and testing. (Such specialized HIV
counseling was more widely available in previous years
but has become less available as more health care profes-
sionals have become more comfortable treating patients
with HIV and as the opt-out approach to testing—an
approach that places less emphasis on pretest counsel-
ing—has become more common.) In addition to medical
information, such counseling could include information
regarding potential uses of test information and legal
requirements pertaining to the release of information.
Patients should be told what information will be com-
municated and to whom and the possible implications
of reporting the information. This approach to testing
maintains HIV’s status as being in a class by itself (sui
generis), even as many ethicists have acknowledged the
end to the exceptionalism that marked this disease in the
early years of the epidemic (5).
Mandatory Testing With No Right of Refusal
Mandatory testing strategies are problematic because
they abridge a woman’s autonomy. In addition, during
pregnancy, the public health objective of this strategy,
identification of women who are infected with HIV who
will benefit from treatment, has been accomplished in
certain populations by other ethically sound testing strat-
egies noted previously (6). Some see mandatory testing
as a more efficient way of achieving universal testing.
Advocates support this strategy, believing it provides
the greatest good for the greatest number and that
the potential benefit to the woman and, if pregnant,
her newborn justifies abridging a woman’s autonomy.
However, because of the limits it places on autonomy,
the Committee on Ethics believes that mandatory HIV
screening without informing those screened and offering
them the option of refusal is inappropriate. Mandatory
prenatal testing is difficult to defend ethically and has few
precedents in modern medicine, although HIV testing of
newborns is now required in New York, Connecticut, and
Illinois (There are provisions, however, that permit refusal
in a few defined circumstances.) (7, 8). Importantly,
mandatory testing may compromise the ability to form
an effective physician–patient relationship at the very
time when this relationship is critical to the success of
treatment.
Selecting a Testing Strategy
Among these three strategies, the opt-out approach is
now recommended by most national organizations and
federal agencies. For prenatal HIV testing, universal
testing with patient notification and right of refusal was
2013 COMPENDIUM OF SELECTED PUBLICATIONS 154
 recommended by the Institute of Medicine to address
clinicians’ concerns that pretest counseling and informed
consent mandates for routine voluntary testing in preg-
nancy were too time consuming and, thus, reduced the
likelihood of testing being offered (9). The Centers for
Disease Control and Prevention, the American Academy
of Pediatrics, and the American College of Obstetricians
and Gynecologists (ACOG) endorse this approach (10,
11). Evidence suggests that this strategy may be accept-
able to many pregnant women (12, 13). “To expand the
gains made in diagnosing HIV infection among pregnant
women,” the Centers for Disease Control and Prevention
(14) has recently released, and ACOG (15) has adopted,
recommendations to make HIV testing a “routine part
of medical care” using a similar opt-out approach for all
women at the time of routine health care visits.
In recommending the opt-out approach for prenatal
HIV testing, ACOG encouraged Fellows to include coun-
seling as a routine part of care but not as a prerequisite
for, or barrier to, prenatal HIV testing (11). Similarly, the
American Medical Association, in recommending that
universal HIV testing of all pregnant women with patient
notification of the right of refusal be a routine compo-
nent of prenatal care, indicated that basic counseling on
HIV prevention and treatment also should be provided
to the patient, consistent with the principles of informed
consent (16). Accordingly, if adopting this option, phy-
sicians should be prepared to provide both pretest and
posttest counseling. Broad implementation of an opt-out
strategy, however, will require changing laws in states
that require detailed and specific counseling and consent
before testing. Physicians should be aware of the laws in
their states that affect HIV testing. The National HIV/
AIDS Clinicians’ Consultation Center at the University
of California—San Francisco maintains an online com-
pendium of state HIV testing laws that can be a useful
resource (see http://www.ucsf.edu/hivcntr/).
The benefits of identifying those with HIV infection
will be limited if necessary treatments are unavailable or
not covered by appropriate insurance. Where access to
HIV treatment is limited, Fellows should advocate for
changes in existing policies to broaden access.
Special Issues Involved With Rapid
Human Immunodeficiency Virus
Testing
Technologies have recently become available that allow
for testing with rapid results (eg, turnaround less than
1 hour). The advantage of these tools is that patients can
be informed of their results at the same visit at which the
testing occurs. In that manner, it is possible to lower the
rate of loss to follow-up associated with the traditional
two-stage testing and notification approach. Nothing
about rapid testing precludes the need for a patient to
opt-in or to be offered the opportunity to opt-out of
testing (depending on which strategy is adopted). Rapid
COMMITTEE OPINIONS
testing should not be implemented either as mandatory
testing or testing performed without informing the
patient that she will be tested.
In communities with a relatively low prevalence of
HIV, rapid testing can present certain logistic difficulties.
With the traditional approach, testing would occur dur-
ing an initial visit, and results would be provided during
a follow-up encounter. That would give the health care
professional an opportunity to arrange for an individual
with expertise in posttest counseling to be available in a
circumstance in which the health care professional knew
that a patient was returning to receive a positive result.
A program of testing and notification at the same visit
does not allow the health care professional the luxury
of notifying a counselor before a patient who is infected
with HIV returns for a visit or of steering an individual
who is infected with HIV to a certain session at which the
counselor is routinely available. However, the obligation
to make sure that appropriate counseling and support
services are available still holds. Health care professionals
should develop links with individuals who can provide
those services on an emergent basis or train their own
staff to handle the initial encounter and thereafter transi-
tion infected individuals to professionals who can serve as
ongoing resources to them.
Human Immunodeficiency Virus
Reporting and Partner Notification
The clinician providing care for a woman who is infected
with HIV has important responsibilities concerning dis-
closure of the patient’s serostatus. Clinicians providing
health care should be aware of and respect legal require-
ments regarding confidentiality and disclosure of HIV-
related clinical information.
In considering disclosure, clinicians may have com-
peting obligations: protecting the patient’s confiden-
tiality, on the one hand, and disclosing test results to
prevent substantial harm to a third party, on the other.
In some jurisdictions, a breach of confidentiality may
be required by mandatory reporting regulations. Even
absent legal requirements, in some situations the need
to protect potentially exposed third parties may seem
compelling. In these situations, the clinician first should
educate the patient about her rights and responsibilities
and encourage her to inform any third parties involved.
If she remains reluctant to voluntarily share information
regarding her infection, consultation with an institutional
ethics committee, a medical ethics specialist, or an attor-
ney may be helpful in deciding whether to disclose her
HIV status. In general, a breach of confidentiality may
be ethically justified for purposes of partner notification
when all of the following four conditions are met:
1. There is a high probability of harm to the partner.
2. The potential harm is serious.
3. The information communicated can be used to pre-
vent harm.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 155
 4. Greater good will result from breaking confiden-
tiality rather than maintaining it.
Indeed, many if not all of these conditions are likely
met for intimate partners of women and men who are
infected with HIV. Nevertheless, when a breach of con-
fidence is contemplated, practitioners should weigh the
potential harm to the patient and to society at large.
Negative consequences of breaking confidentiality may
include the following situations:
• Personal risks to the individual whose confidence
is breached, such as serious implications for the
patient’s relationship with family and friends, the
threat of discrimination in employment and hous-
ing, intimate partner violence, and the impact on
family members
• Loss of patient trust, which may reduce the physician’s
ability to communicate effectively and provide services
• A ripple effect among cohorts of women that may
deter other women at risk from accepting testing and
have a serious negative impact on the educational
efforts that lie at the heart of attempts to reduce the
spread of disease
If, on balance, a breach of confidence is deemed nec-
essary, practitioners should work in advance to anticipate
and manage potentially negative consequences (ie, reac-
tions of intimate partners, family). As well, practitioners
should consider whether the goal of maintaining patient
privacy would be better served by personal communica-
tion with the individual placed at risk by the patient’s
seropositivity or by notification of local public health
authorities. In some areas, anonymous notification of
sexual contacts is possible through local or state depart-
ments of health. As a practical matter, because disclosure
is only possible when the index case freely identifies
at-risk partners, superseding an individual’s refusal to
disclose should be a rare occurrence.
Confidentiality should not be breached solely be-
cause of perceived risk to health care workers. Health
care workers should rely on strict observance of standard
precautions rather than obtaining information about a
patient’s serostatus to minimize risk. Even in the setting of
an accidental needle-stick or other exposure, the patient’s
consent for release of serostatus (or for testing) should be
obtained. Efforts to protect patient confidentiality should
not prevent other health care professionals caring for the
patient from learning her serostatus, information they
need to ensure optimal medical management.
Health Care Professionals’ Obligation
to Provide Care
It is unethical for an obstetrician–gynecologist to refuse to
accept a patient or to refuse to continue providing health
care for a patient solely because she is, or is thought to be,
seropositive for HIV. Refusing to provide care to women
COMMITTEE OPINIONS
who are infected with HIV for fear of contracting HIV
infection or simply as a practice preference is unreason-
able, unscientific, and unethical.
Epidemiologic studies have shown that the risk of
HIV transmission from patient to health care profes-
sional is exceedingly low and is related to needle stick
or intraoperative injury or to potentially infectious fluid
that comes in contact with a mucous membrane (17).
Most contacts between health care professionals and
women who are infected with HIV occur, however, dur-
ing routine obstetric and gynecologic care. Health care
practitioners should observe standard precautions with
all patients to minimize skin, mucous membrane, and
percutaneous exposure to blood and body fluids to pro-
tect against a variety of pathogens, including HIV.
Health care professionals who fail to provide care to
women who are infected with HIV because of personal
practice preferences violate professional ethical stan-
dards. The public appropriately expects that health care
practitioners will not discriminate based on diagnosis,
provided that the patient’s care falls within their scope of
practice. Physicians should demonstrate integrity, com-
passion, honesty, and empathy. Failure to provide health
care to a woman solely because she is infected with HIV
violates these fundamental characteristics. As with any
other patient, it is acceptable, however, to refer women
who are infected with HIV for care that the physician is
not competent to provide or if care elsewhere would be
more convenient or associated with decreased financial
burden to the patient.
Assisted Reproductive Technology
There is an emerging consensus that indications for
assisted reproductive technology use should not vary
with HIV serostatus; therefore, assisted reproductive
technology should be offered to couples in which one
or both partners are infected with HIV. This approach
is consistent with the principles of respect for autonomy
and beneficence (18, 19). In addition, those who advocate
providing these services cite three clinical arguments to
support their position:
1. Therapeutic improvements in the management of
HIV infection have enhanced both quality and
length of life for individuals who are seropositive for
HIV.
2. Advances in prenatal therapy have substantially
reduced the risk of mother-to-infant HIV trans-
mission.
3. Current assisted reproductive technology methods
may reduce transmission of HIV from an infected
partner to an uninfected partner relative to natural
means of conception.
The Ethics Committee of the American Society for
Reproductive Medicine has said, “Health care workers
who are willing to provide reproductive assistance to
2013 COMPENDIUM OF SELECTED PUBLICATIONS 156
 couples whose offspring are irreducibly at risk for a seri-
ous genetic disease should find it ethically acceptable to
treat HIV-positive individuals or couples who are willing
to take reasonable steps to minimize the risks of transmis-
sion.” (20).
Those who oppose offering these technologies to
couples who are infected with HIV cite two major objec-
tions:
1. Uncertain long-term parental prognosis
2. The continuing risk of mother-to-infant HIV trans-
mission
The ethical underpinning of this opposition is that
it is not felt to be in the best interest of the child to be
born to a parent who may not be available for continued
child-rearing. In addition, the risk of mother-to-infant
transmission places the infant at risk of acquiring a highly
debilitating illness. Yet as stated previously, HIV infection
currently is a manageable chronic illness with a life-expec-
tancy equivalent to that with many other chronic diseases
for which assisted reproductive technology is not routinely
precluded. Further, interventions, such as antiretroviral
therapy or cesarean delivery or both, reduce the absolute
risk of transmission to a level comparable, again, to risks
significantly lower than those tolerated among couples
choosing assisted reproductive technology (eg, parents
who are carriers of autosomal recessive conditions) or risks
often assumed as part of assisted reproductive technology
(eg, risks of prematurity from multiple pregnancies).
Health Care Professionals
Who Are Infected With Human
Immunodeficiency Virus
In making decisions about patient care, health care pro-
fessionals who are infected with HIV should adhere to
the fundamental professional obligation to avoid harm
to patients. Physicians who have reason to believe that
they have been at significant risk of being infected should
be tested voluntarily for HIV for the protection of their
patients as well as for their own benefit. The physician
as a patient is entitled to the same rights to privacy and
confidentiality as any other patient.
Although the risk of clinician-to-patient transmis-
sion is extremely low, all infected physicians must make
a decision as to which procedures they can continue to
perform safely. This decision primarily will depend on
the particular surgical technique involved and also on
the physician’s level of expertise and medical condition,
including mental status. The clinician’s decision should
be made in consultation with a personal physician and
may possibly involve such other responsible individuals
as the chief of the department, the hospital’s director
of infectious diseases, the chief of the medical staff, or a
specialized advisory panel. If physicians avoid procedures
that place patients at risk of harm, they have no obliga-
tion to inform the patient of their positive HIV serosta-
COMMITTEE OPINIONS
tus. Physicians who are infected with HIV should follow
standard precautions, including the appropriate use of
hand-washing, protective barriers, and care in the use and
disposal of needles and other sharp instruments.
Recommendations
The Committee on Ethics makes the following recom-
mendations:
• All women, pregnant or not, should have the oppor-
tunity to learn their HIV serostatus.
• Women should, at a minimum, be told that they are
being tested and that they may refuse such tests.
• Although opt-out and opt-in testing are both ethic-
ally acceptable, the former approach may identify
more women who are eligible for therapy and may
have public health advantages.
• Rapid testing carries the same ethical responsibilities
as “standard” testing.
• It is unethical for an obstetrician–gynecologist to
refuse to accept a patient or to discontinue provid-
ing health care for a patient solely because she is, or
is thought to be, seropositive for HIV.
• Seropositivity for HIV per se should not be used as
a reason to refuse to provide assisted reproductive
technology to a family.
References
1. Epidemiology of HIV/AIDS––United States, 1981–2005.
MMWR Morb Mortal Wkly Rep 2006;55:589–92.
2. Chou R, Smits AK, Huffman LH, Fu R, Korthuis PT.
Prenatal screening for HIV: a review of the evidence for
the U.S. Preventive Services Task Force. U.S. Preventive
Services Task Force. Ann Intern Med 2005;143:38–54.
3. Gwinn M, Wortley PM. Epidemiology of HIV infection
in women and newborns. Clin Obstet Gynecol 1996;39:
292–304.
4. Revised recommendations for HIV screening of pregnant
women. MMWR Recomm Rep 2001;50(RR–19):63–85;
quiz CE1–19a2–CE6–19a2.
5. Bayer R, Fairchild AL. Changing the paradigm for HIV
testing––the end of exceptionalism. N Engl J Med 2006;355:
647–9.
6. Prenatal discussion of HIV testing and maternal HIV test-
ing––14 states, 1996–1997. MMWR Morb Mortal Wkly
Rep 1999;48:401–4.
7. HIV testing among pregnant women––United States and
Canada, 1998–2001. MMWR Morb Mortal Wkly Rep 2002;
51:1013–6.
8. Perinatal HIV Prevention Act. 410 ILCS § 335 (2006).
9. Institute of Medicine (US). Reducing the odds: prevent-
ing perinatal transmission of HIV in the United States.
Washington, DC: National Academy Press; 1999.
10. Prenatal and perinatal human immunodeficiency virus
testing: expanded recommendations. ACOG Committee
Opinion No. 304. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;104:1119–24.
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 11. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Joint statement on human
immunodeficiency virus screening. Elk Grove Village
(IL): AAP; Washington, DC: ACOG; 2006. Available at:
http://www.acog.org/publications/policy_statements/
sop9905.cfm. Retrieved July 10, 2007.
12. Stringer EM, Stringer JS, Cliver SP, Goldenberg RL,
Goepfert AR. Evaluation of a new testing policy for human
immunodeficiency virus to improve screening rates. Obstet
Gynecol 2001;98:1104–8.
13. Jayaraman GC, Preiksaitis JK, Larke B. Mandatory report-
ing of HIV infection and opt-out prenatal screening for
HIV infection: effect on testing rates. CMAJ 2003;168:
679–82.
14. Branson BM, Handsfield HH, Lampe MA, Janssen RS,
Taylor AW, Lyss SB, et al. Revised recommendations for
HIV testing of adults, adolescents, and pregnant women
in health-care settings. MMWR Recomm Rep 2006;55
(RR–14):1–17; quiz CE1–4.
15. Primary and preventive care: periodic assessments. ACOG
Committee Opinion No. 357. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2006;108:
1615–22.
16. American Medical Association. Universal, routine screen-
ing of pregnant women for HIV infection. CSA Report I–01.
Council on Scientific Affairs. Chicago (IL): AMA; 2001.
Available at: http://www.ama-assn.org/ama/pub/category/
13548.html. Retrieved July 10, 2007.
COMMITTEE OPINIONS
17. Updated U.S. Public Health Service guidelines for the
management of occupational exposures to HBV, HCV, and
HIV and recommendations for postexposure prophylaxis.
MMWR Recomm Rep 2001;50(RR–11):1–52.
18. Anderson DJ. Assisted reproduction for couples infected
with the human immunodeficiency virus type 1. Fertil Steril
1999;72:592–4.
19. Minkoff H, Santoro N. Ethical considerations in the treat-
ment of infertility in women with human immunodefi-
ciency virus infection. N Engl J Med 2000;342:1748–50.
20. Human immunodeficiency virus and infertility treatment.
Ethics Committee of the American Society for Reproduc-
tive Medicine. Fertil Steril 2002;77:218–22.
Copyright © December 2007 by the American College of Obste-
tricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization
to make photocopies should be directed to: Copyright Clearance
Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Human immunodeficiency virus. ACOG Committee Opinion No. 389.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:1473–8.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 158
 ACOG COMMITTEE OPINION
Number 390 • December 2007

Ethical Decision Making in Obstetrics and

Gynecology*
Committee on Ethics ABSTRACT: Physicians vary widely in their familiarity with ethical theories and
Reaffirmed 2010 methods and their sensitivity toward ethical issues. It is important for physicians to
improve their skills in addressing ethical questions. Obstetrician–gynecologists who are
familiar with the concepts of medical ethics will be better able to approach complex ethi-
cal situations in a clear and structured way. By considering the ethical frameworks involv-
ing principles, virtues, care and feminist perspectives, concern for community, and case
precedents, they can enhance their ability to make ethically justifiable clinical decisions.
Guidelines, consisting of several logical steps, are offered to aid the practitioner in analyz-
ing and resolving ethical problems.

The importance of ethics in the practice
of medicine was manifested at least 2,500
years ago in the Hippocratic tradition, which
emphasized the virtues that were expected
to characterize and guide the behavior of
physicians. Over the past 50 years, medical
technology expanded exponentially, so that
obstetrician–gynecologists have had to face
complex ethical questions regarding assisted
reproductive technologies, prenatal diagno-
sis and selective abortion, medical care at
the beginning and end of life, the use of
genetic information, and the like. Medical
knowledge alone is not sufficient to solve
these problems. Instead, responsible deci-
sions in these areas depend on a thoughtful
consideration of the values, interests, goals,
rights, and obligations of those involved. All
of these are the concern of medical ethics.
The formal discipline of biomedical ethics
and structured ethical analysis can help phy-
sicians resolve ethical dilemmas.
Physicians vary widely in their familiar-
ity with ethical theories and methods and
their sensitivity toward ethical issues. It is
important for physicians to improve their
skills in addressing ethical questions through
formal undergraduate and graduate medical
The American College education, organized continuing education,
of Obstetricians
and Gynecologists *Update of “Ethical Decision Making in Obstetrics and
Women’s Health Care Gynecology” in Ethics in Obstetrics and Gynecology,
Physicians Second Edition, 2004.
or personal experience and reading as well as
discussion with others.
Ethical Frameworks and
Perspectives
Principle-Based Ethics
In recent decades, medical ethics has been
dominated by principle-based ethics (1–3).
In this approach, four principles offer a
systematic and relatively objective way to
identify, analyze, and address ethical issues,
problems, and dilemmas: 1) respect for patient
autonomy, 2) beneficence, 3) nonmaleficence,
and 4) justice. (These four principles will be
discussed in some detail in subsequent sec-
tions.) However, critics claim that a principle-
based approach cannot adequately resolve
or even helpfully evaluate many difficult
clinical problems. As a result, several other
perspectives and frameworks have emerged:
virtue-based ethics, an ethic of care, feminist
ethics, communitarian ethics, and case-based
reasoning, all of which have merit as well
as limitations (2–8). As this discussion will
stress, these different perspectives and frame-
works are not necessarily mutually exclu-
sive. They often are complementary because
each emphasizes some important features of
moral reasoning, agents, situations, actions,
or relationships. Perspectives such as an ethic
of care or feminist ethics also may change the
lens through which to view both principles

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 159

 and particular situations in which decisions have to be
made.
Virtue Ethics
A virtue-based approach relies on qualities of character
that dispose health professionals to make choices and deci-
sions that achieve the well-being of patients, respect their
autonomous choices, and the like (8, 9). These qualities
of character include trustworthiness, prudence, fairness,
fortitude, temperance, integrity, self-effacement, and com-
passion. Virtues need not replace principles as a basis for
ethical decision making or conduct. Indeed, some virtues
correlate with principles and dispose people to act accord-
ing to those principles—for instance, the virtue of benevo-
lence disposes agents to act beneficently. Virtues also can
complement and enhance the principles of medical ethics.
Interpreting the principles, applying them in concrete
situations, and setting priorities among them require the
judgment of morally sensitive professionals with good
moral character and the relevant virtues. Furthermore,
in deliberating what to do, a physician may find helpful
guidance by asking, “What would a good, that is, morally
virtuous, physician do in these circumstances?” Ethical
insight may come from imagining which actions would be
compatible with, for instance, being a compassionate or
honest or trustworthy physician.
Care-Based Ethics
Care-based ethics, also called “the ethic of care,” directs
attention to dimensions of moral experience often exclud-
ed from or neglected by traditional ethical theories (10). It
is concerned primarily with responsibilities that arise from
attachment to others rather than with impartial principles
so emphasized in many ethical theories. The moral founda-
tions of an ethic of care are located not in rights and duties,
but rather in commitment, empathy, compassion, caring,
and love (11). This perspective also pays closer attention
to context and particularity than to abstract principles
and rules. It suggests that good ethical decisions both
result from personal caring in relationships, and should
consider the impact of different possible actions on those
relationships. An ethic of care overlaps with a virtue ethic,
in emphasizing the caregiver’s orientation and qualities.
In this ethical approach, care represents the fundamental
orientation of obstetrics and gynecology as well as much
of medicine and health care, and it indicates the direction
and rationale of the relationship between professionals
and those who seek their care. An ethic of care also joins
case-based approaches in focusing on particular contexts
of decision making.
Feminist Ethics
Feminist ethics uses the tools of feminist theory to examine
ethical issues in at least three distinctive ways (12). First,
it indicates how conceptions of sex often distort people’s
view of the world and, more specifically, how gendered
conceptions constrain and restrict women. For instance,
COMMITTEE OPINIONS
feminist theory shows how human society tends to be
androcentric, or male centered, so that man becomes the
generic representative for what it means to be human,
and woman is viewed as different or deviant. Thus,
feminist ethics can expose forms of androcentric reason-
ing in ethics of clinical care and public policy, calling
into question, for example, the rationale for excluding
women from participation in clinical research. Second,
feminist ethics indicates how gendered thinking has dis-
torted the tools that philosophers and bioethicists use to
examine ethical issues. Historically entrenched associa-
tions between man and reason, woman and emotion—
dubious in and of themselves—have contributed to the
tendency in moral theory to view emotion as irrelevant
or, at worst, distorting. Some, including many feminist
thinkers, however, have argued that appropriate emo-
tion (eg, empathy) is indispensable to moral reasoning
in the ethical conduct of medical care. This position,
bolstered further by recent empirical research (13, 14), is
consistent with the perspective represented by the ethic
of care (see previous section). Third, in calling attention
to and attempting to redress the ways that gendered con-
cepts have produced constraints on women, feminism is
concerned with oppression as a pervasive and insidious
moral wrong (15, 16). The tools of feminist ethics can
help to identify and challenge dominance and oppression
not only of women, but also of other groups oppressed
because of race, class, or other characteristics. These tools
also can help to detect more subtle gender and other
biases and assist in addressing significant health dispari-
ties. Rather than rejecting such principles as respect for
autonomy and justice, feminist thinkers may interpret
and apply these principles to highlight and redress vari-
ous kinds of domination, oppression, and bias.
Communitarian Ethics
Communitarian ethics challenges the primacy often
attributed to personal autonomy in contemporary bio-
medical ethics (17). A communitarian ethic emphasizes
a community’s other shared values, ideals, and goals and
suggests that the needs of the larger community may take
precedence, in some cases, over the rights and desires
of individuals. If proponents of a communitarian ethic
accept the four principles of Beauchamp and Childress
(1), they will tend to interpret those principles through
the lens of community, stressing, for example, benefits
and harms to community and communities as well as
the need to override autonomy in some cases. Major
examples arise in the context of public health. However,
in considering the proper framework for communitarian
ethics, questions arise in a pluralistic society about which
community is relevant. For instance, is the relevant
commun­ity one embodied in particular traditions (eg,
one religion) or is it the broader, pluralistic society? Even
though there is a broad consensus that communal val-
ues and interests sometimes trump personal autonomy,
disputes persist about exactly when it is justifiable to
2013 COMPENDIUM OF SELECTED PUBLICATIONS 160
 override personal autonomy. To take one example, apart
from laws that specify which diseases are reportable, phy-
sicians may have to balance a patient’s claims of privacy
and confidentiality against risks to others. Different judg-
ments about the appropriate balance often hinge on an
assessment of risks: How probable and serious must the
harm be to justify a breach of privacy and confidentiality?
Case-Based Reasoning
In a final approach, case-based reasoning (sometimes
called casuistry), ethical decision making builds on prece-
dents set in specific cases (18, 19). This is analogous to the
role of case law in jurisprudence in that an accumulated
body of influential cases and their interpretation provide
moral guidance. This approach analyzes current cases
requiring decisions in light of relevantly similar cases that
have already been settled or gained a rough consensus.
Case-based reasoning asserts the priority of practice over
both ethical theory and moral principles. It recognizes the
principles that emerge by a process of generalization from
the analysis of cases but views these principles as always
open to future revision. In considering a particular case,
someone taking this approach would seek to determine
whether there are any relevantly similar cases, either posi-
tive or negative, that enjoy an ethical consensus. If, for
example, a new research protocol is relevantly similar to
an earlier and widely condemned one (eg, the Tuskegee
Syphilis Study), that similarity is a reason for moral sus-
picion of the new protocol. A question for this approach
is how to identify relevant similarities and differences
among cases and whether ethical principles are some-
times useful in this process.
Ethics as Toolbox
An example of how the different ethical frameworks and
perspectives might address a particular case is shown in
the box. From this analysis of different approaches, it is
plausible to derive the following conclusion: enlightened
ethical decision making in clinical medicine cannot
rely exclusively on any single fundamental approach to
biomedical ethics. The metaphor of toolbox or toolkit
may provide a useful way to think about these different
approaches to ethical decision making (20). Some ethical
tools may fit some contexts, situations, and cases better
than others, and more than one—or even all of them—
usually are valuable.
It is helpful to have access to a variety of ethical tools
because clinical problems often are too complex to be
resolved by using simple rules or by rigidly applying ethi-
cal principles. Indeed, virtues such as prudence, fairness,
and trustworthiness enable clinicians to apply ethical
principles sensitively and wisely in situations of conflict.
The specific virtues that are most important may vary
from one circumstance to another, but in women’s health
care, there must be particular sensitivity to the needs of
women. Furthermore, in many, perhaps most, difficult
situations requiring ethical insight, tensions exist between
COMMITTEE OPINIONS
the well-being and interests of the individual patient and
the interest of the “community,” however that is defined.
Finally, current ethical decisions can be improved by
awareness of and guidance from existing precedents.
In short, even though a principle-based approach may
provide a reasonable starting point for ethical decision
making, it is not adequate by itself and needs the valuable
contributions and insights of other approaches. Principles
often serve as initial points of reference in ethical decision
making in obstetrics and gynecology, however, and the
next section examines several ethical principles in detail.
Ethical Principles
Clinicians and others often make decisions without
appealing to principles for guidance or justification. But
when they experience unclear situations, uncertainties,
or conflicts, principles often can be helpful. The major
principles that are commonly invoked as guides to profes-
sional action and for resolving conflicting obligations in
health care are respect for autonomy, beneficence and
nonmaleficence, and justice (1). Other principles or rules,
such as fidelity, honesty, privacy, and confidentiality, also
are important, whether they are viewed as derived from
the four broad principles or as independent.
Respect for Autonomy
Autonomy, which derives from the Greek autos (“self”)
and nomos (“rule” or “governance”), literally means
self-rule. In medical practice, the principle of respect for
autonomy implies personal rule of the self that is free
both from controlling interferences by others and from
personal limitations that prevent meaningful choice, such
as inadequate understanding (1). Respect for a patient’s
autonomy acknowledges an individual’s right to hold
views, to make choices, and to take actions based on her
own personal values and beliefs. Respect for autonomy
provides a strong moral foundation for informed consent,
in which a patient, adequately informed about her medi-
cal condition and the available therapies, freely chooses
specific treatments or nontreatment. Respect for patient
autonomy, like all ethical principles, cannot be regarded
as absolute. At times it may conflict with other principles
or values and sometimes must yield to them.
Beneficence and Nonmaleficence
The principle of beneficence, which literally means doing
or producing good, expresses the obligation to promote
the well-being of others. It requires a physician to act in
a way that is likely to benefit the patient. Nonmaleficence
is the obligation not to harm or cause injury, and it is
best known in the maxim, primum non nocere (“First, do
no harm.”). Although there are some subtle distinctions
between nonmaleficence and beneficence, they often are
considered manifestations of a single principle. These
two principles taken together are operative in almost
every treatment decision because every medical or surgi-
cal procedure has both benefits and risks, which must
2013 COMPENDIUM OF SELECTED PUBLICATIONS 161
 One Case Study: Five Approaches
Although the several approaches to ethical decision mak-
ing may all produce the same answer in a situation that
requires a decision, they focus on different, though related,
aspects of the situation and decision. Consider, for instance,
how they might address interventions for fetal well-being
if a pregnant woman rejects medical recommendations or
engages in actions that put the fetus at risk.*
A principle-based approach would seek to identify the
principles and rules pertinent to the case. These might
include beneficence–nonmaleficence to both the pregnant
woman and her fetus, justice to both parties, and respect
for the pregnant woman’s autonomous choices. These
principles cannot be applied mechanically. After all, it may
be unclear whether the pregnant woman is making an
autonomous decision, and there may be debates about the
balance of probable benefits and risks of interventions to all
the stakeholders as well as about which principle should
take priority in this conflict. Professional codes and com-
mentaries may offer some guidance about how to resolve
such conflicts.
A virtue-based approach would focus on the courses of
action to which different virtues would and should dispose
the obstetrician–gynecologist. For instance, which course
of action would follow from compassion? From respectful-
ness? And so forth. In addition, the obstetrician–gynecolo-
gist may find it helpful to ask more broadly: Which course
of action would best express the character of a good
physician?
An ethic of care would concentrate on the implications
of the virtue of caring in the obstetrician–gynecologist’s
special relationship with the pregnant women and with the
fetus. In the process of deliberation, individuals using this
approach generally would resist viewing the relationship
between the pregnant woman and her fetus as adversarial,
acknowledging that most of the time women are paradig-
matically invested in their fetus’ well-being and that mater-
nal and fetal interests usually are aligned.* If, however,
a real conflict does exist, the obstetrician–gynecologist
should resist feeling the need to take one side or the other.
Instead, he or she should seek a solution in identifying and
balancing his or her duties in these special relationships,
situating these duties in the context of a pregnant woman’s
be balanced knowledgeably and wisely. Beneficence, the
obligation to promote the patient’s well-being, may
sometimes conflict with the obligation to respect the
patient’s autonomy. For example, a patient may desire to
deliver a fatally malformed fetus by cesarean because she
believes that this procedure will increase the newborn’s
chance of surviving, if only for a few hours. However, in
the physician’s best judgment, the theoretical benefit to a
“nonviable” infant may not justify the risks of the surgical
delivery to the woman. In such a situation, the physician’s
task is further complicated by the need to consider the
patient’s psychologic, physical, and spiritual well-being.
COMMITTEE OPINIONS
values and concerns, instead of specifying and balancing
abstract principles or rights.
To take one example, in considering a case of a pregnant
woman in preterm labor who refuses admission to the
hospital for bed rest or tocolytics, Harris combines a care
or relational perspective with a feminist perspective to pro-
vide a “much wider gaze” than a principle-based approach
might*:
The clinician would focus attention on important
social and family relationships, contexts or con-
straints that might come to bear on [a] pregnant
[woman’s] decision making, such as her need to care
for other children at home or to continue working
to support other family members, or whatever life
project occupied her, and attempt to provide relief
in those areas….[Often] fetal well-being is achieved
when maternal well-being is achieved.
As this example suggests, a feminist ethics approach
would attend to the social structures and factors that limit
and control the pregnant woman’s options and decisions
in this situation and would seek to alter any that can be
changed.* It also would consider the implications any
intervention might have for further control of women’s
choices and actions—for instance, by reducing a pregnant
woman, in extreme cases, to the status of “fetal container”
or “incubator.”
Finally, a case-based approach would consider whether
there are any relevantly similar cases that constitute prec-
edents for the current one. For instance, an obstetrician–
gynecologist may wonder whether to seek a court order for
a cesarean delivery that he or she believes would increase
the chances of survival for the child-to-be but that the preg-
nant woman continues to reject. In considering what to do,
the physician may ask, as some courts have asked, whether
there is a helpful precedent in the settled consensus of not
subjecting a nonconsenting person to a surgical procedure
to benefit a third party, for instance, by removing an organ
for transplantation.†
*Harris LH. Rethinking maternal-fetal conflict: gender and equality
in perinatal ethics. Obstet Gynecol 2000;96:786–91.
In re A.C., 572 A.2d 1235 (D.C. Ct. App. 1990).
†
Justice
Justice is the principle of rendering to others what is due
to them. It is the most complex of the ethical principles
to be considered because it deals not only with the physi-
cian’s obligation to render to a patient what is owed but
also with the physician’s role in the allocation of limited
medical resources in the broader community. In addi-
tion, various criteria such as need, effort, contribution,
and merit are important in determining what is owed
and to whom it is owed. Justice is the obligation to treat
equally those who are alike or similar according to what-
ever criteria are selected. Individuals should receive equal
treatment unless scientific and clinical evidence establish-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 162
 es that they differ from others in ways that are relevant to
the treatments in question. Determination of the criteria
on which these judgments are based is a highly complex
moral process, as exemplified by the ethical controversies
about providing or withholding renal dialysis and organ
transplantation.
The principle of justice applies at many levels. At
the societal level, it addresses the criteria for allocating
scarce resources, such as organs for transplantation. At a
more local level, it is relevant to questions such as which
patients (and physicians) receive priority for operating
room times. Even at the level of the physician–patient
relationship, the principle of justice applies to matters
such as the timing of patient discharge. The principle also
governs relationships between physicians and third par-
ties, such as payers and regulators. In the context of the
physician–patient relationship, the physician should be
the patient’s advocate when institutional decisions about
allocation of resources must be made.
Balancing the Principles
In order to guide actions, each of these broad principles
needs to be made more concrete. Sometimes the principles
can be addressed in more definite rules—for instance, rules
of voluntary, informed consent express requirements of
the principle of respect for personal autonomy, and rules
of confidentiality rest on several principles (see “Common
Ethical Issues and Problems in Obstetrics and Gynecol-
ogy”). Nevertheless, conflicts may arise among these vari-
ous principles and rules. In cases of conflict, physicians
have to determine which principle(s) should have priority.
Some ethical theories view all of these principles as prima
facie binding, resist any effort to prioritize them apart from
particular situations, and call for balancing in particular
situations (1). Some other theories attempt to rank prin-
ciples in advance of actual conflicts (21).
Obstetrician–gynecologists, like other physicians,
often face a conflict between principles of beneficence–
nonmaleficence in relation to a patient and respect for
that patient’s personal autonomy. In such cases, the
physician’s judgment about what is in the patient’s best
interests conflicts with the patient’s preferences. The phy-
sician then has to decide whether to respect the patient’s
choices or to refuse to act on the patient’s preferences in
order to achieve what the physician believes to be a better
outcome for the patient. Paternalistic models of physi-
cian–patient relationships have been sharply challenged
and often supplanted by other models. At the other end of
the spectrum, however, the model of following patients’
choices, whatever they are, as long as they are informed
choices, also has been criticized for reducing the physi-
cian to a mere technician (22). Other models have been
proposed, such as negotiation (23), shared decision mak-
ing (24), or a deliberative model, in which the physician
integrates information about the patient’s condition with
the patient’s values to make a cogent recommendation
(22). Whatever model is selected, a physician may still,
COMMITTEE OPINIONS
in a particular situation, have to decide whether to act on
the patient’s request that does not appear to accord with
the patient’s best interests. These dilemmas are consid-
ered in greater detail elsewhere (25).
Common Ethical Issues and Problems
in Obstetrics and Gynecology
Almost everything obstetrician–gynecologists do in their
professional lives involves one or more of the ethical
principles and personal virtues to a greater or lesser
degree. Nevertheless, several specific areas deserve special
attention: the role of the obstetrician–gynecologist in the
society at large; the process of voluntary, informed con-
sent; confidentiality; and conflict of interest.
The Obstetrician–Gynecologist’s Role in
Society at Large
In addition to their ethical responsibilities in direct
patient care, obstetrician–gynecologists have ethical
responsibilities related to their involvement in the orga-
nization, administration, and evaluation of health care.
They exercise these broader responsibilities through
membership in professional organizations; consulta-
tion with and advice to community leaders, government
officials, and members of the judiciary; expert witness
testimony; and education of the public. Justice is both the
operative principle and the defining virtue in decisions
about the distribution of scarce health care resources and
the provision of health care for the medically indigent
and uninsured. Obstetricians and gynecologists should
offer their support for institutions, policies, and practices
that ensure quality of and more equitable access to health
care, particularly, but not exclusively, for women and
children. The virtues of truthfulness, fidelity, trustwor-
thiness, and integrity must guide physicians in their roles
as expert witnesses, as consultants to public officials, as
educators of the lay public, and as health advocates (26).
Informed Consent Process
Often, informed consent is confused with the consent
form. In fact, informed consent is “the willing acceptance
of a medical intervention by a patient after adequate dis-
closure by the physician of the nature of the intervention
with its risks and benefits and of the alternatives with their
risks and benefits” (27). The consent form only documents
the process and the patient decision. The primary purpose
of the consent process is to protect patient autonomy.
By encouraging an ongoing and open communication
of relevant information (adequate disclosure), the physi-
cian enables the patient to exercise personal choice. This
sort of communication is central to a satisfactory physi-
cian–patient relationship. Unfor­tunately, discussions for
the purpose of educating and informing patients about
their health care options are never completely free of the
informant’s bias. Practitioners should seek to uncover
their own biases and endeavor to maintain objectivity
in the face of those biases, while disclosing to the patient
2013 COMPENDIUM OF SELECTED PUBLICATIONS 163
 any personal biases that could influence the practitioner’s
recommendations (28, 29). A patient’s right to make her
own decisions about medical issues extends to the right
to refuse recommended medical treatment. The freedom
to accept or refuse recommended medical treatment has
legal as well as ethical foundations.
As previously noted, one of the most important ele-
ments of informed consent is the patient’s capacity to
understand the nature of her condition and the benefits
and risks of the treatment that is recommended as well
as those of the alternative treatments (30). A patient’s
capacity to understand depends on her maturity, state of
consciousness, mental acuity, education, cultural back-
ground, native language, the opportunity and willingness
to ask questions, and the way in which the information
is presented. Diminished capacity to understand is not
necessarily the same as legal incompetence. Psychiatric
consultation may be helpful in establishing a patient’s
capacity, or ability to comprehend relevant information.
Critical to the process of informing the patient is the
physician’s integrity in choosing the information that is
given to the patient and respectfulness in presenting it in
a comprehensible way. The point is not merely to disclose
information but to ensure patient comprehension of
relevant information. Voluntariness—the patient’s free-
dom to choose among alternatives—is also an important
element of informed consent, which should be free from
coercion, pressure, or undue influence (31).
Confidentiality
Confidentiality applies when an individual to whom
information is disclosed is obligated not to divulge this
information to a third party. Rules of confidentiality are
among the most ancient and widespread components of
codes of medical ethics. Confidentiality is based on the
principle of respect for patient autonomy, which includes
a patient’s right to privacy, and on the physician’s fidelity-
based responsibility to respect a patient’s privacy. Rules
of confidentiality also are justified by their good effects:
Assurance of confidentiality encourages patients to dis-
close information that may be essential in making an
accurate diagnosis and planning appropriate treatment.
However, rules of confidentiality are not absolute, either
legally or ethically. Legal exceptions to confidential-
ity include the requirements to report certain sexually
transmitted diseases or suspected child abuse. Ethically,
breaches of confidentiality also may be justified in rare
cases to protect others from serious harm.
The need for storing and transmitting medical infor-
mation about patients is a serious threat to confidential­ity
and privacy, a problem made more complex by the use
of electronic storage and transmission of patient data.
The recent increase in the use of genetic testing and
screening also highlights the need for strong protections
of confidentiality and patient privacy because genetic
information has lifelong implications for patients and
their families.
COMMITTEE OPINIONS
Obstetrician–gynecologists also are confronted with
issues of confidentiality in dealing with adolescents,
especially regarding the diagnosis and treatment of sexu-
ally transmitted diseases, contraceptive counseling, and
pregnancy (32). The physician’s willingness and ability to
protect confidentiality should be discussed with all
adolescent patients early in their care. Many state laws
protect adolescent confidentiality in certain types of situ-
ations, and obstetrician–gynecologists should be aware
of the laws in their own states.
Conflict of Interest
It is necessary to distinguish conflicts of interest from
conflicts of obligation. A conflict of obligation exists
when a physician has two or more obligations that some-
times conflict—for example, an obligation to patients
and an obligation to a managed care organization. By
contrast, a conflict of interest exists when a primary
interest (usually the patient’s well-being) is in conflict
with a physician’s secondary interest (such as his or her
financial interest). A conflict of interest is not necessarily
wrong, but it creates the occasion and temptation for the
physician to breach a primary obligation to the patient.
Many kinds of conflicts of interest arise in obstetrics
and gynecology; some are obvious, others more subtle.
Following are a few examples: a managed care guideline
limits coverage for diagnostic tests that physicians con­
sider necessary for patients and penalizes physicians
who order such tests (or rewards physicians who do not
order such tests); a physician recommends products to
patients that are sold for a profit in his or her office (33);
a physician refers patients for tests or procedures at an
entity in which the physician has a financial interest; a
physician accepts gifts from a pharmaceutical or medi-
cal device company (34). It is important for physicians
to be attentive to the wide range of actual and perceived
conflicts of interest. Even perceived conflicts of interest
can threaten patient and societal trust.
There is ever-increasing intrusion into the patient–
physician relationship by government and by the mar-
ketplace. Care plans, practice guidelines, and treatment
protocols may substantially limit physicians’ ability to
provide what they consider proper care for patients. If
the conflict is too great, the physician should withdraw
from the organization. In addition to such conflicts of
obligation, a conflict of interest exists if the organiza-
tion’s incentive plans create inducements to limit care
in the interest of increasing physicians’ incomes. At
one time, the tension between physicians’ financial
self-interest and patients’ interests often encouraged
unnecessary testing and excessive treatment, but the
current tension may provide incentives for too little
care. Conflicts of interest should be avoided whenever
possible, and when they are unavoidable and material to
patients’ decisions, it is the physician’s responsibility to
disclose them to patients. Serious ethical problems arise
2013 COMPENDIUM OF SELECTED PUBLICATIONS 164
 if organizational rules (so-called “gag rules”) preclude
such disclosures.
Guidelines for Ethical Decision
Making
Often, more than one course of action may be morally
justifiable. At times, however, no course of action may
seem acceptable because each may result in significant
harms or compromise important principles or values.
Nevertheless, the clinician must select one of the available
options, justify that decision by ethical reasons, and apply
the same critical thinking faculties that would be applied
to issues of medical evidence. An analysis of the various
factors involved in ethical decisions can aid attempts
to resolve difficult cases. In addition, the involvement
of individuals with a variety of backgrounds and per-
spectives can be useful in addressing ethical questions.
Informal or formal consultation with those from related
services or with a hospital ethics committee can help
ensure that all stakeholders, viewpoints, and options are
considered as a decision is made.
It is important for the individual physician to find
or develop guidelines for decision making that can be
applied consistently in facing ethical dilemmas. Guide-
lines consisting of several logical steps can aid the prac-
titioner analyzing and resolving an ethical problem. The
approach that follows incorporates elements of several
proposed schemes (27, 35–38).
1. Identify the decision makers. The first step in address-
ing any problem is to answer the question, “Whose
decision is it?” Generally, the patient is presumed to
have the authority and capacity to choose among
medically acceptable alternatives or to refuse treat-
ment.
a. Assess the patient’s ability to make a decision. At
times, this is not clear. An individual’s capacity to
make a decision depends on that individual’s abil-
ity to understand information and appreciate the
implications of that information when making a
personal decision (30). In contrast, competence
and incompetence are legal determinations that
may or may not truly reflect functional capac-
ity. Assessment of a patient’s capacity to make
decisions must at times be made by professionals
with expertise in making such determinations.
Decisions about competence can be made only in
a court of law.
b. Identify a surrogate decision maker for incompe-
tent patients. If a patient is thought to be incapa-
ble of making a decision or has been found legally
incompetent, a surrogate decision maker must be
identified. In the absence of a durable power of
attorney, family members have been called on to
render proxy decisions. In some situations, the
court may be called on to appoint a guardian. A
surrogate decision maker should make the deci-
COMMITTEE OPINIONS
sion that the patient would have wanted or, if the
patient’s wishes are not known, that will promote
the best interests of the patient. The physician has
an obligation to assist the patient’s representatives
in examining the issues and reaching a resolution.
c. In the obstetric setting, recognize that a compe-
tent pregnant woman is the appropriate decision
maker for the fetus that she is carrying.
2. Collect data, establish facts.
a. Be aware that perceptions about what may or
may not be relevant or important to a case reflect
values—whether personal, professional, institu­
tional, or societal. Hence, one should strive to be
as objective as possible when collecting the infor-
mation on which to base a decision.
b. Use consultants as needed to ensure that all avail-
able information about the diagnosis, treatment,
and prognosis has been obtained.
3. Identify all medically appropriate options.
a. Use consultation as necessary.
b. Identify other options raised by the patient or
other concerned parties.
4. Evaluate options according to the values and principles
involved.
a. Start by gathering information about the values
of the involved parties, the primary stakehold-
ers, and try to get a sense of the perspective each
is bringing to the discussion. The values of the
patient generally will be the most important con-
sideration as decision making proceeds.
b. Determine whether any of the options violates
ethical principles that all agree are important.
Eliminate those options that, after analysis, are
found to be morally unacceptable by all parties.
c. Reexamine the remaining options according to
the interests and values of each party. Some alter-
natives may be combined successfully.
5. Identify ethical conflicts and set priorities.
a. Try to define the problem in terms of the ethical
principles involved (eg, beneficence versus respect
for autonomy).
b. Weigh the principles underlying each of the argu-
ments made. Does one of the principles appear
more important than others in this conflict? Does
one proposed course of action seem to have more
merit than the others?
c. Consider respected opinions about similar cases
and decide to what extent they can be useful in
addressing the current problem. Look for mor-
ally relevant differences and similarities between
this and other cases. Usually, physicians find that
the basic dilemma at hand is not a new one and
that points considered by others in resolving past
dilemmas can be useful.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 165
 6. Select the option that can be best justified. Try to arrive
at a rational resolution to the problem, one that can
be justified to others in terms of widely recognized
ethical principles.
7. Reevaluate the decision after it is acted on. Repeat the
evaluation of the major options in light of informa-
tion gained during the implementation of the deci-
sion. Was the best possible decision made? What
lessons can be learned from the discussion and reso-
lution of the problem?
Summary
Obstetrician–gynecologists who are familiar with the
concepts of medical ethics will be better able to approach
complex ethical situations in a clear and structured way.
By considering the ethical frameworks involving prin-
ciples, virtues, care and feminist perspectives, concern
for community, and case precedents, they can enhance
their ability to make ethically justifiable clinical decisions.
They also need to attend to the kinds of ethical issues and
problems that arise particularly or with special features
in obstetrics and gynecology. Finally, obstetricians and
gynecologists can enhance their decision-making process
by considering when it would be useful to seek a formal
or informal ethics consult as well as which guidelines
would be most helpful to them as they move from case to
case and decision to decision.
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 33. Commercial enterprises in medical practice. ACOG
Committee Opinion No. 359. American College of
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38. Fletcher JC, Spencer EM, Lombardo P, editors. Fletcher’s
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University Publishing Group; 2005.
Copyright © December 2007 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this
publication may be reproduced, stored in a retrieval system, posted
on the Internet, or transmitted, in any form or by any means, elec-
tronic, mechanical, photocopying, recording, or otherwise, without
prior written permission from the publisher. Requests for authoriza-
tion to make photocopies should be directed to: Copyright Clearance
Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Ethical decision making in obstetrics and gynecology. ACOG
Committee Opinion No. 390. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1479–87.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 167
 ACOG COMMITTEE OPINION
Number 395 • January 2008

Surgery and Patient Choice*

Committee on Ethics ABSTRACT: Acknowledgment of the importance of patient autonomy and increased
patient access to information has prompted more patient-generated requests for surgi-
cal interventions not necessarily recommended by their physicians. Decision making
in obstetrics and gynecology should be guided by the ethical principles of respect for
patient autonomy, beneficence, nonmaleficence, justice, and veracity. Each physician
should exercise judgment when determining whether information presented to the
patient is adequate. When working with a patient to make decisions about surgery, it is
important for obstetricians and gynecologists to take a broad view of the consequences
of surgical treatment and to acknowledge the lack of firm evidence for the benefit of one
approach over another when evidence is limited.

Is it ethical to perform an elective cesar-
ean delivery for a woman with a normal
pregnancy, a prophylactic oophorectomy for
a 30-year-old patient with no family his-
tory of ovarian cancer, or a tubal ligation
for an 18-year-old nulligravid woman? How
should the physician respond to a patient
who requests a specific surgical therapy with-
out having an accepted medical indication?
Should health care options be regarded in
the same way as choice of cereal in the super-
market: the consumer makes a choice based
on appearance, content, and cost, and the
grocer takes the money and bags the corn-
flakes, without providing any direction? Is
choosing a medical procedure so radically
different and complex that this analogy is
inappropriate?
Years ago, patients presented to their
physicians with symptoms, and the physicians
would establish diagnoses then make recom-
mendations for therapy; usually recommen-
dations were accepted by patients without
question. An example of that paternalistic
model was the widespread practice of “twi-
light sleep” for labor and delivery. Physicians
administered a narcotic and scopolamine,
and decisions during labor and delivery were
delegated to the medical team. In contrast,
The American College today the first prenatal visit may open with a
of Obstetricians discussion of the patient’s birth plan, includ-
and Gynecologists
ing her preferences for anesthesia, episiotomy,
Women’s Health Care
Physicians
*Update of “Surgery and Patient Choice,” in Ethics in
Obstetrics and Gynecology, Second Edition, 2004.
forceps use, cesarean delivery, and breastfeed-
ing. The purpose of this Committee Opinion
is to provide the obstetrician–gynecologist
with an approach to decision making based
on ethics in an environment of increased
patient information, recognition of patient
autonomy, direct-to-consumer marketing,
often incomplete evidence, and a plethora
of alternative, investigational, or unproven
treatments for many conditions.
Ethical Principles
Decision making in obstetrics and gynecol-
ogy should be guided by the ethical principles
of respect for patient autonomy, beneficence,
nonmaleficence, justice, and veracity and as
set forth throughout this document and in the
“Code of Professional Ethics of the American
College of Obstetricians and Gynecologists”
(1). Although obligations to the patient are
paramount, in addition, the obstetrician–
gynecologist must consider resolution of con-
flicts of interest, acknowledgment of the pro-
fession’s responsibility to society as a whole,
and the maintenance of the dignity and honor
of the discipline of obstetrics and gynecol-
ogy and its standards of care. Issues related to
surgery are addressed in this Committee
Opinion; however, the ethical principles are
the same as for other health care decisions
(eg, diagnostic testing or medical therapy).
Patient autonomy and the concept of
informed consent or refusal are central to
issues regarding patient choice to have or not

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 168

 have a surgical procedure. It is the obligation of the obste-
trician–gynecologist to fully inform the patient regarding
treatment options and the potential risks and benefits of
those options. In discussing these options, the physician
should take into account the context of the patient’s deci-
sion making, including the potential influences of family
and society (2). Once the physician is satisfied that the
patient fully comprehends the options, her autonomous
decision ordinarily should be respected and supported.
Patients should be encouraged to seek second opinions
when in doubt or in need of reassurance. However, even
though the decision of the patient should be respected,
respect might not include supporting the decision, par-
ticularly when doing so is in direct conflict with other
guiding ethical principles. At times, these other principles
may take priority over supporting the patient’s decisions.
The principle of beneficence refers to the ethical
obligation of the physician to promote the health and
welfare of the patient. The complementary principle of
nonmaleficence refers to the physician’s obligation to
not harm the patient. When a patient refuses surgery
or another treatment that the obstetrician–gynecologist
believes is necessary for her health and welfare, benefi-
cence and nonmaleficence can conflict with respect for
patient autonomy. In almost all situations, the patient
has a right to refuse unwanted treatment. She does not,
however, have a parallel right of access to treatment that
the physician believes is unwise or overly risky.
Justice, as an ethical principle, applies to the physi-
cian, the hospital, the payer, and society, as well as to the
individual patient. Although there are many theories of
justice, in the medical context, this principle requires that
medical professionals treat individuals fairly. Further, it
is important for the physician to consider the impact on
not only the individual patient but also society. At the
level of the physician–patient relationship, justice implies,
for instance, that physicians consider a patient’s request
for an elective procedure in the context of similar types
of requests by other patients. At the societal level, justice
directs physicians to consider the impact of their decision
to perform a procedure in terms of the allocation of scarce
resources.
Veracity, or truth telling, is important in surgi-
cal counseling and decision making. When the patient
requests a procedure to which the physician is morally
opposed (such as abortion or permanent sterilization),
the physician may have a limited right to refuse to provide
the service; however, the physician must disclose scientifi-
cally accurate information, convey to the patient that this
refusal is based on moral (not medical) grounds, and refer
the patient in a timely manner (3). The obstetrician–gyne-
cologist should not misrepresent his or her experience
with the proposed treatment or knowledge regarding
potential long-term outcomes.
The Physician–Patient Relationship
Four models of the relationship between the physician and
patient have been described: 1) paternalistic, 2) informa-
COMMITTEE OPINIONS
tive, 3) interpretive, and 4) deliberative (4). Depending on
which model is used, different ethical principles emerge as
relevant to ethical decision making. The ideal model for
the physician–patient relationship has been the subject
of considerable debate. In fact, physicians probably use
all four models, depending on the individual patient, her
situation, and the disease process involved (4).
Paternalistic Model
In the paternalistic physician–patient model (4), the
physician might present only information on risks and
benefits of a procedure that he or she thinks will lead the
patient to make the “right” decision (ie, in this model, the
physician-supported decision) regarding health care. One
example of the paternalistic model would be the ethically
and professionally problematic practice of recommend-
ing amniocentesis for a 35-year-old pregnant patient but
offering no alternatives.
This model is not appropriate when the patient is
competent to make informed decisions, but it may be
the best choice in situations of last resort, such as uncon-
scious patients in the emergency department when no
surrogate decision maker is present. When the patient is
ill and unable to engage, either physically or mentally, in a
discussion of the risks and benefits of a particular surgical
intervention and there is neither an advance directive nor
an assigned proxy for health care decisions, a paternalistic
physician–patient relationship may be the only way to
adhere to the ethical principles of beneficence and non-
maleficence with impaired patient autonomy.
Informative Model
At the opposite end of the spectrum, the informative
model describes a physician–patient relationship in which
the physician is a provider of objective and technical infor-
mation regarding the patient’s medical problem and its
potential therapeutic solutions. The patient has complete
control over surgical decision making, and the physician’s
values are not discussed. An example is a physician offer-
ing a patient with an abnormal cervical cytology result
the options of watchful waiting, colposcopy, loop elec-
trosurgical excision procedure, laser ablation, cold knife
conization, and hysterectomy. The discussion includes a
complete description of advantages, disadvantages, risks,
and complications of each option. The discussion does
not include any statement about the physician’s recom-
mendations or prioritization of the options.
A serious drawback of this model is the physician’s
abandonment of the role of a caring partner and medi-
cal expert in the decision-making process. This model
also assumes that patients have set values and are able to
completely integrate the sometimes complex medical and
surgical treatment decisions with those values. However,
when the physician–patient relationship is necessarily
brief and there are multiple treatment options with com-
parable risks and benefits, the informative model may be
appropriate. One example is the choice of having a genetic
2013 COMPENDIUM OF SELECTED PUBLICATIONS 169
 amniocentesis for advanced maternal age versus multiple
marker testing or no testing.
One of the many unfortunate consequences of the
professional liability crisis is the unsubstantiated belief of
some physicians that the informative model reduces the
physician’s risk of liability. Such a belief raises concerns
about physicians protecting themselves rather than work-
ing in the best interests of their patients.
This model may not be ideal for patient care in most
situations because the physician’s professional judgment
generally is of considerable value to patients. In any case,
it probably is impossible for a physician to counsel a
patient with complete objectivity and without introduc-
ing some implied preference for one of many options (5).
Interpretive Model
Other models for physician–patient relationships strike
a middle ground between the extremes of the paternal-
istic and informative models. In the interpretive model,
the physician helps the patient clarify and integrate her
values into the decision-making process while acting as
an information source regarding the technical aspects of
any given medical procedure. In this model, the physician
aids the patient in “self-understanding; the patient comes
to know more clearly who he or she is and how various
medical options bear on his or her identity” (4).
Application of this model to an example of cervical
dysplasia might result in the physician noting that the
patient had a history of moderate symptoms associated
with menses, had completed her childbearing, and was
very fearful of cancer. On that basis, the physician rec-
ommends hysterectomy over other options, although he
or she describes and discusses other options and their
potential implications for the patient. When implement-
ing this model, the physician must be careful to help the
patient clarify her values while not imposing his or her
own values or beliefs on the patient.
Deliberative Model
In the deliberative model, the physician’s role is to guide
the patient in taking the most admirable or moral (based
on her values, needs, and fears) course of treatment or
health-related action (4). It is similar to the interpretive
model in that it includes a discussion of not only the
medical benefits and risks but also the patient’s indi-
vidual priorities, values, and fears. It goes beyond the
interpretive model in that the physician must consciously
communicate to the patient his or her health values;
however, the physician should not use the moral discus-
sion to dictate to the patient the best course of action (4).
Because of the potential for an unequal balance of power
in the physician–patient relationship, great care should
be taken in this model to avoid subjecting the patient to
undue pressure.
The case of a patient with a history of tubal ligation
considering her fertility options may illustrate the delib-
erative model. In this case, the patient’s understanding of
COMMITTEE OPINIONS
the moral status of the human embryo might influence
whether tubal anastomosis or in vitro fertilization is pur-
sued. The physician would provide technical information
about the options but might also convey information
about how individuals and organizations have formu-
lated the discussion of the moral status of embryos. This
deliberation then may assist the patient by providing tools
with which the patient might examine her values in sup-
port of a treatment decision.
The Process of Decision Making
Each physician should exercise judgment when deter-
mining whether information presented to the patient
is adequate. The practice of evidence-based medicine
involves understanding the scientific basis of treatment
and the strength of the evidence and applying the results
of the strongest evidence available to medical decision
making. Frequently, both surgical and medical decisions
need to be made in a context in which the scientific
evidence supporting one treatment option over another
is incomplete, of poor quality, or totally lacking. There
is no ethical imperative to initiate discussion of treat-
ment options that are either unproven or not part of
accepted medical practice. The physician may, however,
want to discuss investigational options so that the patient
understands the unproven nature of these options and
can make an informed decision about them. Surgical
and medical advice or guidance for many obstetric and
gynecologic problems is based in part on science, in part
on the experience and values of the physician, and in part
on the physician’s understanding of the patient’s prefer-
ences, values, and desired outcome.
When working with a patient to make decisions
about surgery, it is important for obstetricians and gyne-
cologists to take a broad view of the consequences of
surgical treatment and to acknowledge the lack of firm
evidence for the benefit of one approach over another
when evidence is limited. For example, a discussion
of treatment options for menorrhagia associated with
leiomyoma should include the fact that the long-term
risks and benefits of some treatment options have not
been compared directly (6). Recommendation for a
particular option is dictated by many factors, including
patient age, leiomyoma size, bleeding severity, and coex-
isting medical conditions, but in many cases two or more
therapeutic options probably would be regarded as equally
medically sound. Comparing possible long-term com-
plications of hysterectomy, such as bowel obstruction
and loss of vaginal support, with the risks of more con-
servative surgical approaches, such as the possible need
for future treatment of recurrent leiomyomata, is an
important part of informed consent. Helping patients
understand potential long- and short-term consequences
of any given decision as well as giving patients an appre-
ciation of the quality of evidence on which each option
is based are critical parts of informed consent. In addi-
tion, the physician must be aware of potential personal
2013 COMPENDIUM OF SELECTED PUBLICATIONS 170
 conflicts of interest that may be present, such as personal
financial gain related to the provision or nonprovision of
surgical care, and he or she must guard against this as an
influence when giving guidance to patients as they make
treatment choices.
An Example of the Process
Elective cesarean delivery is offered as an example to
illustrate an ethical framework physicians may use in
responding to patient requests for treatment for which
evidence of benefit is absent or imperfect or which the
health care professional would not usually recommend.
In using this example, the Committee on Ethics does
not mean to comment on the clinical appropriateness of
or medical evidence supporting elective cesarean deliv-
ery, which would require a review beyond the scope of
this document and the Committee on Ethics and have
recently been addressed by the Committee on Obstetric
Practice (7).
In obstetrics, the ethical issues of informed consent
and patient choice are exemplified in the current debate
regarding whether elective cesarean delivery should be
offered as a birth option in normal pregnancy (8). The
wide range of opinion on this issue is reflected in the
language that is used, with varying terms reflecting differ-
ent views of the physician–patient relationship. “Cesarean
delivery on demand” reflects the informative model, in
which the physician simply describes options and pro-
vides the service chosen by the patient. The phrase “elec-
tive cesarean delivery” is more suggestive of the delibera-
tive and interpretive models, in which the physician and
patient also discuss concerns, needs, and values.
The ethical evaluation is clouded by the limitations
of data regarding relative short- and long-term risks
and benefits of cesarean delivery versus vaginal delivery
(9). For example, limitations that need to be acknowl-
edged on both sides of the debate include evidence for
long-term reduction in pelvic floor disorders in women
undergoing elective cesarean delivery and lack of exten-
sive morbidity and mortality data comparing routine
cesarean delivery with vaginal delivery.
Each of the ethical principles contributes to the
decision-making process regarding elective cesarean
delivery. However, none alone is sufficient for making
the decision.
If taken in a vacuum, the principle of respect for
patient autonomy would lend support to the permissibil-
ity of elective cesarean delivery in a normal pregnancy
(after adequate informed consent). To ensure that the
patient’s consent is in fact informed, the physician should
explore the patient’s concerns. For example, a patient may
request elective cesarean delivery because she is afraid of
discomfort during labor (10). In this case, providing her
with information about procedures available for effec-
tive pain relief during labor would actually enhance the
patient’s capacity for autonomous choice and may result
in an agreement to proceed without surgery (11).
COMMITTEE OPINIONS
The ethical principle of justice regarding the allo-
cation of medical resources must be considered in the
debate over elective cesarean delivery and informed
patient choice. It is not clear whether widespread imple-
mentation of elective cesarean delivery would increase or
decrease resources required to provide delivery services.
Comprehensive analysis of costs and benefits for current
and subsequent pregnancies would provide a basis for
application of the principle of justice (12).
Application of the principles of beneficence and
nonmaleficence (a physician should offer only treatments
that promote the health and welfare of the patient) is
made problematic by the limitations of the scientific data
described previously. Different interpretations of the risks
and benefits are the basis for reasonable differences among
obstetricians regarding this challenging issue. In addition,
different patients may place considerably different values
on known risks and benefits. How certain is it that elec-
tive cesarean delivery really protects pelvic support 20
years later? How different is the maternal mortality rate of
elective or repeat cesarean delivery in healthy women
compared with that of women who have had one or two
vaginal deliveries? Are there any desirable or undesirable
psychosocial effects of elective cesarean delivery? The
currently available data do not adequately represent the
comparative populations in question. For instance, data
regarding outcomes of cesarean delivery usually involve
complicated pregnancies or women in whom a trial of
labor has failed. These outcomes are compared with those
involving probably healthier women who were able to give
birth vaginally. As better data accumulate, the principle of
beneficence may result in a shift in clinical practice.
Based on these principles, is it ethical to agree to
a patient request for elective cesarean delivery in the
absence of an accepted medical indication? The response
must begin with the physician’s assessment of the cur-
rent data regarding the relative benefits and risks of the
two approaches. In the absence of significant data on
the risks and benefits of cesarean delivery, the burden of
proof should fall on those who are advocates for a change
in policy in support of elective cesarean delivery (ie, the
replacement of usual care in labor with a major surgical
procedure). If the physician believes that cesarean deliv-
ery promotes the overall health and welfare of the woman
and her fetus more than vaginal delivery, he or she is ethi-
cally justified in performing a cesarean delivery. Similarly,
if the physician believes that performing a cesarean
delivery would be detrimental to the overall health and
welfare of the woman and her fetus, he or she is ethically
obliged to refrain from performing the surgery. In this
case, a referral to another health care provider would be
appropriate if the physician and patient cannot agree on
a route of delivery.
Given the lack of data, it currently is not ethically nec-
essary to initiate discussion regarding the relative risks and
benefits of elective cesarean delivery versus vaginal delivery
with every pregnant patient. There is no obligation to initi-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 171
 ate discussion about procedures that the physician does
not consider medically acceptable or that are unproven.
On the basis of the ethical principles of beneficence
and respect for patient autonomy, an algorithm has been
proposed for deciding between the performance of a
cesarean delivery and making a referral in cases in which
the physician’s recommendation is vaginal delivery and
the informed patient makes the autonomous decision to
request a cesarean delivery (13). The Committee on Ethics
addresses other special considerations involving patient
choice in obstetric decision making elsewhere (14).
Summary
Although informed refusal of care by the patient is a
familiar situation for most clinicians in the practice
of both obstetrics and gynecology, acknowledgment
of the importance of patient autonomy and increased
patient access to information, such as information on the
Internet, has prompted more patient-generated requests
for surgical interventions not necessarily recommended
by their physicians. A patient request for elective cesar-
ean delivery, prompted by a perception of lower risk to
the woman (of pelvic floor and sexual dysfunction) and
her fetus with cesarean delivery, is an obstetric example.
Other examples include requests for prophylactic oopho-
rectomy to reduce risk of ovarian cancer in otherwise
healthy women at low risk.
The response to such requests must begin with the
physician having a good understanding of the scientific
evidence for and against the requested procedure. With
that information, the physician should counsel the patient
within the framework of the ethical principles of respect
for autonomy, beneficence, nonmaleficence, veracity, and
justice. The ethical models described in this document
provide an approach for using these principles. The physi-
cian should use the opportunity that this kind of request
presents to explore the patient’s concerns and values. In
most cases, providing information and careful counseling
will allow patients and their physicians to reach a mutu-
ally acceptable decision. If an acceptable balance cannot
be reached by the patient and physician, the patient may
choose to continue care with another provider.
References
1. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC: ACOG;
2008. Available at: http://www.acog.org/from_home/
acogcode.pdf. Retrieved January 2, 2008.
2. Mackenzie C, Stoljar N. Relational autonomy: feminist
perspectives on autonomy, agency, and the social self. New
York (NY): Oxford University Press; 2000.
COMMITTEE OPINIONS
3. The limits of conscientious refusal in reproductive med-
icine. ACOG Committee Opinion No. 385. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110;1203–8.
4. Emanuel EJ, Emanuel LL. Four models of the physician-
patient relationship. JAMA 1992;267:2221–6.
5. Mahowald MB. On the treatment of myopia: feminist
standpoint theory and bioethics. In: Wolf S, editor.
Feminism and bioethics: beyond reproduction. New York
(NY): Oxford University Press; 1996. p. 95–115.
6. Myers ER, Barber MD, Gustilo-Ashby T, Couchman G,
Matchar DB, McCrory DC. Management of uterine leiomy-
omata: what do we really know? Obstet Gynecol 2002;100:
8–17.
7. Cesarean delivery on maternal request. ACOG Committee
Opinion No. 394. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1501–4.
8. Minkoff H, Chervenak FA. Elective primary cesarean deliv-
ery. N Engl J Med 2003;348:946–50.
9. Cesarean delivery on maternal request March 27–29, 2006.
National Institutes of Health state-of-the-science confer-
ence statement. Obstet Gynecol 2006;107:1386–97.
10. Bewley S, Cockburn J. Responding to fear of childbirth.
Lancet 2002;359:2128–9.
11. Saisto T, Salmela-Aro K, Nurmi JE, Kononen T, Halmesmaki
E. A randomized controlled trial of intervention in fear of
childbirth. Obstet Gynecol 2001;98:820–6.
12. Morrison J, MacKenzie IZ. Cesarean section on demand.
Semin Perinatol 2003;27:20–33.
13. Chervenak FA, McCullough LB. An ethically justified algo-
rithm for offering, recommending, and performing ces-
arean delivery and its application in managed care practice.
Obstet Gynecol 1996;87:302–5.
14. Maternal decision making, ethics, and the law. ACOG
Committee Opinion No. 321. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2005;
106:1127–37.
Copyright © January 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Surgery and patient choice. ACOG Committee Opinion No. 395.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2008;111:243–7.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 172
 ACOG COMMITTEE OPINION
Number 397 • February 2008

Surrogate Motherhood*
Committee on Ethics ABSTRACT: Ethical responsibilities are described for obstetrician–gynecologists
who choose to participate in surrogacy arrangements by 1) advising couples who are
considering surrogacy, 2) counseling potential surrogate mothers, 3) providing obstetric
services for pregnant women participating in surrogacy, or 4) offering assisted reproduc-
tive technologies related to surrogacy. Although the obligations of physicians will vary
depending on the type and level of their involvement, in all cases physicians should care-
fully examine all relevant issues related to surrogacy, including medical, ethical, legal, and
psychologic aspects.

Although the practice of surrogate moth-
erhood has become more common since
the American College of Obstetricians and
Gynecologists (ACOG) issued its first state-
ment on this subject in 1983, it continues
to be controversial. There are those who
believe that surrogacy should be permitted
because such arrangements can be beneficial
to all parties, and to prohibit them would
limit the autonomy of infertile couples and
women who wish to help them through
surrogate gestation. Others believe that the
risks outweigh the benefits or that because of
shifting emotions and attitudes toward the
fetus during gestation, it is not possible for a
pregnant woman to give truly informed con-
sent to relinquish an infant until after birth
has occurred (1).
Many issues related to surrogate moth-
erhood have not been resolved, and con-
siderable disagreement persists within the
medical profession, the medical ethics com-
munity, state legislatures, the courts, and the
general public. Similarly, no one position
reflects the variety of opinions on surrogacy
within ACOG’s membership. Although these
differences of opinion are recognized, the
purpose of this Committee Opinion is to
focus on the ethical responsibilities of obste-
trician–gynecologists who choose to partici-
pate in surrogacy arrangements on a variety
The American College of levels, including caring for the pregnant
of Obstetricians woman and her fetus.
and Gynecologists
Women’s Health Care *Update of “Surrogate Motherhood” in Ethics in
Physicians Obstetrics and Gynecology, Second Edition, 2004.
The first part of this Committee Opinion
provides an overview of public policy issues,
descriptions of the types of surrogacy, argu-
ments supporting and opposing surrogacy
arrangements, and particular concerns relat-
ed to payment and commercialization. The
second part offers ethical recommendations
to physicians and patients who may partici-
pate in surrogacy. The ethical obligations of
physicians will vary depending on the type
and level of their involvement in surrogacy
arrangements.
General Issues
Public Policy
In some states, the practice of surrogate
motherhood is not clearly covered under
existing law. There is a split among the states
that have statutes. Some states prohibit sur-
rogacy contracts or make them void and
unenforceable, whereas others permit such
agreements (2, 3).
When a court is asked to decide a dis-
pute regarding parental rights or custody
of a child born as a result of a surrogacy
arrangement, existing statutes may not prove
adequate given the complexity of the prob-
lem. Courts faced with such decisions have
given preference to different factors: the
best interest of the child, the rights of the
birth mother (as in adoption situations), the
genetic link between the child and the genetic
parents, and the intent of the couple who
entered into a surrogacy contract to become
parents. Often two or more of these factors

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 173

 conflict with each other, and there is not a consensus in
the legal or ethical communities as to which factor should
have priority (2, 4–7).
The obstetrician–gynecologist who facilitates sur-
rogacy arrangements should be aware of any statutes or
court cases in the state in which he or she practices. In
counseling individuals seeking a child through surrogacy
or a woman who is considering surrogate gestation, the
physician should encourage consideration of the possible
consequences of a surrogacy arrangement, including
potential legal complications.
Types of Surrogacy
Surrogacy can be classified on the basis of the source
of the genetic material. Eggs, sperm, or both may be
donated, thereby altering the “intended parents’” biologic
relationship to the child.
In one type of surrogacy arrangement, the intend-
ed parents are a couple who reach an agreement with
a woman (the “surrogate mother”) who will be arti-
ficially inseminated with sperm provided by the male
partner of the couple seeking surrogacy services. Thus,
the genetic and gestational mother of any resultant
child is the surrogate mother, and the genetic father is
the intended father. The intended parents plan to be
the “social” or “rearing” parents of the child. Although
this Committee Opinion refers to intended parents as a
couple, individual men and women also may seek sur-
rogacy services.
In another type of surrogacy, in vitro fertilization and
embryo transfer are combined with surrogacy arrange-
ments. In this case, it is possible for both the intended
father and the intended mother to be the genetic parents
of the child, and the surrogate fulfills only the role of
gestational mother. This type of arrangement originally
was called surrogate gestational motherhood, and now
the carrying woman is called the “gestational carrier” or
“gestational surrogate.”
The different types of relationships that are pos-
sible—genetic (either, both, or neither intended parent),
gestational (the surrogate mother), and social or rearing
(the intended parents)—give rise to both conceptual
challenges regarding the nature of parenthood and legal
problems as to who should be considered the parents
responsible for the child.
Major Arguments for and Against Surrogacy
Arrangements
Surrogacy can allow a couple to have a child when they
would otherwise be unable to do so except by adoption
because of an inability to achieve pregnancy or medical
contraindications to pregnancy for the intended mother.
Adoption, however, does not provide a genetic link to the
child, an important consideration for some prospective
parents. Surrogacy is chosen by some prospective parents
because of a desire for genetic linkage or for practical rea-
sons, such as the scarcity of adoptable children.
COMMITTEE OPINIONS
Arguments based on reproductive liberty also sup-
port surrogacy arrangements. In the United States, the
freedom to decide whether and when to conceive or bear
a child is highly valued and protected. Thus, some have
argued that intended parents and surrogate mothers
should be free to cooperate in procreating, at least in cases
of medical need and where care is taken to avoid harm-
ing others, especially the prospective child. Furthermore,
women willing to participate in surrogacy may derive
satisfaction from helping the intended parents. Many
women participate in surrogacy primarily for altruistic
reasons and see their services as a gift.
The primary arguments against surrogate mother-
hood are based on the harms that the practice may be
thought to produce—harms to the child that is born,
harms to the surrogate mother herself, harms to her
existing children if she has children, and harms to soci-
ety as a whole. It is surely harmful to any child to be the
object of a custody dispute. In addition, the rejection of
an infant—for example, rejection of an infant with a dis-
ability by both intended parents and surrogate mother—
is a significant harm. If an existing relationship is used
to coerce relatives or close friends to become surrogate
mothers, that coercion is a harm resulting from the prac-
tice of surrogate motherhood. The existing children of a
surrogate mother may be harmed if her pregnancy and
relinquishment result in high levels of stress for the surro-
gate mother or her family. These children and society as
a whole may be harmed by the perception that reproduc-
tion is trivialized by transactions that translate women’s
reproductive capacities and the infants that result into
commodities to be bought and sold. Depersonalization of
a pregnant woman as a “vehicle” for the genetic perpetu-
ation of other individuals may harm not only surrogate
mothers but also the status of women as a whole. There
also is a concern that redefining concepts of motherhood
may threaten traditional understandings of parenting and
family.
Children are much more vulnerable than adults.
Harms to children who have no choice in a matter are
more serious, from an ethical standpoint, than harms to
adults who make a choice that they later regret. Further,
a distinction should be drawn between harms that inevi-
tably, or almost invariably, are associated with a practice
and harms that likely could be avoided through advance
planning, appropriate counseling, or oversight mecha-
nisms.
Few studies provide data about harms and ben-
efits resulting from surrogacy arrangements. Absent
such data, discussion about possible outcomes does not
provide a solid foundation for ethical conclusions and
clinical guidelines. It is important to know whether
these outcomes actually occur and, if so, how frequently.
Studies that will provide more data of this type are needed
(8, 9).
In summary, there are strong arguments both for
and against the practice of surrogacy. Physicians will be
2013 COMPENDIUM OF SELECTED PUBLICATIONS 174
 on both sides of this debate. If, after careful consideration
of the arguments, a physician chooses to facilitate or
recommend surrogacy arrangements, then precautions
should be taken to prevent medical, psychologic, and
legal harms to the intended parents, the potential sur-
rogate mother, and the prospective child.
Payment to the Surrogate Mother
Perhaps no topic related to surrogate motherhood is
more contentious than compensation of the surrogate
mother by the intended parents (10). Payment often is
substantial because of the duration and complexity of
involvement. As noted previously, some states specifi-
cally prohibit surrogacy contracts that involve payment.
Several questions about payment for surrogacy have been
raised:
For what is payment made? Although there is debate on
this point, it is clear that payment must not be made
contingent on the delivery of an “acceptable product”—a
live-born, healthy child. Rather, payment should be con-
strued as compensation for the surrogate mother’s time
and effort, her initiating and carrying the pregnancy, her
participation in labor and delivery, her acceptance of the
risks of pregnancy and childbirth, and her possible loss of
employment opportunities.
Why is payment offered or requested? In many surrogacy
arrangements among close friends or relatives, there is no
payment for the services of the surrogate mother. Rather,
she may provide her services as an act of altruism, and the
intended parents will be asked to reimburse her only for
out-of-pocket expenses connected with the pregnancy.
However, most women are understandably reluctant to
undertake the burdens and risks of pregnancy on behalf
of strangers without some kind of compensation for their
time, effort, and risk.
Is payment likely to lead to the exploitation of potential
surrogate mothers? Surrogacy arrangements often take
place between parties with unequal power, education,
and economic status (11). Unless independent legal rep-
resentation and mental health counseling are mandated,
women serving as surrogate mothers may be particularly
vulnerable to being exploited. If a payment offered to
a candidate for surrogacy is too low, it may be said to
exploit her by not providing adequate compensation; if
the payment is too high, it may be said to exploit her by
being irresistible and coercive. Opponents of surrogate
motherhood also have argued that if a fee must be paid
to the surrogate mother, only affluent couples will be able
to seek surrogacy services. This access barrier, however
problematic, exists for most services related to infertility,
for certain other medical procedures, and for adoption
and, thus, is not specific to surrogacy agreements.
Responsibilities of Obstetrician–
Gynecologists
In this Committee Opinion, the Committee on Ethics
makes ethical recommendations for four categories of
COMMITTEE OPINIONS
physician involvement: 1) advising couples who are
considering surrogacy, 2) counseling potential surrogate
mothers, 3) providing obstetric services for pregnant
surrogates, and 4) offering assisted reproductive tech-
nologies related to surrogacy. Although the obligations
of physicians will vary depending on the type and level of
their involvement, in all cases physicians should carefully
examine all relevant issues related to surrogacy, including
medical, ethical, legal, and psychologic aspects.
Intended parents and surrogate mothers have both
divergent and common interests. Because of these diver-
gent interests, one professional individual (eg, physician,
attorney, or psychologist) or agency should not represent
the interests of both major parties in surrogacy arrange-
ments. The physician who treats the intended parents
should not have the surrogate mother as an obstetric
patient because conflicts of interest may arise that would
not allow the physician to serve all parties properly.
Responsibilities of Physicians to Couples
Considering Surrogacy
When approached by a couple considering surrogacy, the
physician should, as in all other aspects of medical care,
be certain that there will be a full discussion of ethical and
legal issues as well as medical risks, benefits, and alterna-
tives, many of which have been addressed in this state-
ment. An obstetrician–gynecologist who is not familiar
with these issues should refer the couple for appropriate
counseling. Additional recommendations for advising
couples considering surrogacy are as follows:
• Because of the risks inherent in surrogacy arrange-
ments, such arrangements should be considered
only in the case of infertility or serious health-related
needs, not for convenience alone.
• A physician may justifiably decline to participate in
initiating surrogacy arrangements for personal, ethi-
cal, or medical reasons.
• If a physician decides to become involved in facilitat-
ing surrogate motherhood arrangements, the follow-
ing guidelines should be used:
—The physician should be assured that appropri-
ate procedures are used to screen the intended
parents and the surrogate mother. Such screening
should include appropriate fertility studies, medi-
cal screening, and psychologic assessment.
— Mental health counseling should be provided
before initiation of a pregnancy 1) to permit the
potential surrogate mother and the intended par-
ents to explore the range of outcomes and possible
long-term effects and 2) to consider possible psy-
chologic risks to and vulnerabilities of both parties
and the prospective child.
— It is preferable that surrogacy arrangements be
overseen by private nonprofit agencies with cre-
dentials similar to those of adoption agencies.
However, many existing agencies are entrepre-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 175
 neurial and for-profit (9). A physician making a
referral to an agency must have assurance that the
agency is medically and ethically reputable and
that it is committed to protecting the interests of
all parties involved.
— The physician should receive only usual compen-
sation for medical services. Referral fees and other
arrangements for financial gain beyond usual fees
for medical services are inappropriate.
— The physician should not refer patients to surro-
gacy programs in which the financial arrange-
ments are likely to exploit any of the parties.
• The obstetrician–gynecologist should urge the
intended parents to discuss preconditions and pos-
sible contingencies with the surrogate mother or
her representative and to agree in advance on the
response to them. These issues include, but may not
be limited to, the expected health-related behaviors
of the surrogate mother; the prenatal diagnosis of a
genetic or chromosomal abnormality; the inability
or unwillingness of the surrogate mother to carry the
pregnancy to term; the death of one of the intended
parents or the dissolution of the couple’s marriage
during the pregnancy; the birth of an infant with
a disability; a decision by the surrogate mother to
abrogate the contract and to contest custody of an
infant conceived with the sperm of the intended
father; or, in the case of gestational surrogacy, the
option of registering the intended parents as the legal
parents.
• The obstetrician–gynecologist should urge the par-
ties involved to record in writing the preconditions
and contingency plans on which they have agreed
to make explicit the intentions of the parties, to
facilitate later recollection of these intentions, and to
help promote the interests of the future child. In the
preparation of this agreement, both parties should
be encouraged to have independent legal represen-
tation.
• Whatever compensation is provided to the surrogate
mother should be paid solely on the basis of her
time and effort, her initiation and continued gesta-
tion of the pregnancy, her participation in labor and
delivery, her acceptance of the risks of pregnancy
and childbirth, and her possible loss of employment
opportunities. Compensation must not be contingent
on a successful delivery or on the health of the child.
• Where possible, obstetrician–gynecologists should
cooperate with and participate in research intended to
provide data on outcomes of surrogacy arrangements.
Responsibilities of Physicians to Potential
Surrogate Mothers
When approached by a patient considering becoming a
surrogate mother, the physician should address ethical
and legal concerns fully along with medical risks and
COMMITTEE OPINIONS
benefits as part of the initial consultation. In particular,
the physician should be sure that preconditions and
contingencies, such as those outlined in the previous
section, have been thoroughly considered and that the
potential surrogate mother recognizes the importance
of having explicit written precondition and contingency
agreements. In the preparation of this agreement, both
the intended parents and the potential surrogate mother
should be encouraged to have independent legal repre-
sentation. Additional recommendations for counseling
and providing other services for potential surrogate
mothers are as follows:
• To avoid conflict of interest, the physician should
not facilitate a woman’s becoming a surrogate moth-
er for a couple whom the physician also is treating.
• The physician should ensure that appropriate pro-
cedures are used to screen and counsel both the
intended parents and the surrogate mother. Referral
for mental health counseling should be provided
before initiation of a pregnancy 1) to permit the
potential surrogate mother to explore the range of
outcomes and possible long-term effects and 2) to
evaluate her psychologic risks and vulnerabilities as
well as the possible effects of surrogacy on her exist-
ing relationships and on any existing children.
• A physician who provides examinations and per-
forms procedures for an agency that arranges sur-
rogacy contracts should be aware of the policies of
the agency and should decline involvement with any
agency whose policies are not consistent with the
ethical recommendations of this Committee Opinion
and those of other professional organizations related
to reproductive medicine, such as the American
Society for Reproductive Medicine (formerly known
as the American Fertility Society) (8, 9, 12).
• Whatever compensation is provided to the surrogate
mother should be paid solely on the basis of her
time and effort, her initiation and continued gesta-
tion of the pregnancy, her participation in labor and
delivery, her acceptance of the risks of pregnancy
and childbirth, and her possible loss of employment
opportunities. Compensation must not be contingent
on a successful delivery or on the health of the child.
• The physician should avoid participation in medical
care arising from surrogacy arrangements in which
the financial or other arrangements are likely to
exploit any of the parties. The physician, therefore, is
obliged to become as informed as possible about the
financial and other arrangements between the sur-
rogate mother and intended parents to make ethical
decisions about providing medical care. A physician
who agrees to provide medical care in what he or she
later recognizes as clearly exploitative circumstances
has a responsibility to discuss and, if possible, resolve
problematic arrangements with all parties and may
choose to transfer care when it is possible to do so.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 176
 Responsibilities of Physicians to Pregnant
Women Participating in Surrogacy
When a woman participating in surrogacy seeks medi-
cal care for an established pregnancy, the obstetrician
should explore with the woman her understanding of her
contract with the intended parents and any provisions of
it that may affect her care. If the physician believes that
provisions of the contract may conflict with his or her
professional judgment, the physician may refuse to accept
the patient under those terms. Once accepted as a patient,
she should be cared for as any other obstetric patient,
regardless of the method of conception, or referred to
an obstetrician who will provide that care. Even if she
has already undergone screening by an agency, a physi-
cian–patient relationship exists between her and the
obstetrician. The obstetrician has the attendant obliga-
tions of this relationship. Additional recommendations
regarding the provision of obstetric services in this setting
are as follows:
• The obstetrician’s professional obligation is to sup-
port the well-being of the pregnant woman and her
fetus, to support the pregnant woman’s goals for the
pregnancy, and to provide appropriate care regard-
less of the patient’s plans to keep or relinquish the
future child. If a physician’s discomfort with sur-
rogacy arrangements might interfere with that obli-
gation, the patient should be referred to another
obstetrician.
• The pregnant woman should be the sole source of
consent regarding clinical intervention and manage-
ment of the pregnancy, labor, and delivery.
• Agreements the surrogate mother has made with the
intended parents regarding her care and behavior
during pregnancy and delivery should not affect the
physician’s care of the patient. The obstetrician must
make recommendations that are in the best interests
of the pregnant woman and her fetus, regardless
of prior agreements between her and the intended
parents.
• Confidentiality between the physician and the preg-
nant patient should be maintained. The intended
parents may have access to the patient’s medical
information only with the pregnant woman’s explicit
consent.
• Obstetrician–gynecologists are encouraged to assist
in the development of hospital policies to address
labor, delivery, postpartum, and neonatal care in
situations in which surrogacy arrangements exist.
Responsibilities of Infertility Specialists and
Reproductive Endocrinologists to Intended
Parents and Surrogate Mothers
In providing medical services related to surrogate moth-
erhood arrangements, infertility specialists and reproduc-
tive endocrinologists should follow the recommendations
COMMITTEE OPINIONS
in the two previous sections. In particular, these special-
ists should ensure that appropriate procedures are used to
screen the intended parents and the surrogate mother and
that mental health counseling is provided to all parties
before initiation of a pregnancy. Additional recommen-
dations regarding the provision of assisted reproductive
technologies are as follows:
• A physician who performs artificial insemination or
in vitro fertilization as a part of surrogacy services
necessarily will be involved with both the intended
parents and the surrogate mother. However, the
intended parents and the surrogate mother should
have independent counseling and independent legal
representation, and the surrogate mother should
obtain obstetric care from a physician who is not
involved with the intended parents.
• A physician who provides examinations and per-
forms procedures for an agency that arranges sur-
rogacy contracts should be aware of the policies of
the agency and should decline involvement with
any agency whose policies are not consistent with
the ethical recommendations of this Committee
Opinion and those of other professional organiza-
tions related to reproductive medicine (8, 9, 12).
• Specialists in infertility and reproductive endocrinol-
ogy are encouraged to participate in research that is
intended to provide data on the outcomes of surro-
gacy arrangements.
Summary
The obstetrician–gynecologist has an ethical responsibil-
ity to review the risks and benefits of surrogacy fully
and fairly with couples who are considering surrogacy
arrangements. The obstetrician who is consulted by a
pregnant woman who is participating in a surrogacy
arrangement owes her the same care as any pregnant
woman and must respect her right to be the sole source
of consent for all matters regarding prenatal care and
delivery. The gynecologist or specialist in reproductive
endocrinology who performs procedures required for
surrogacy should be guided by the same ethical principles
aimed at safeguarding the well-being of all participants,
including the future child.
References
1. Lederman RP. Psychosocial adaptation in pregnancy:
assessment of seven dimensions of maternal development.
2nd ed. New York (NY): Springer Publishing Company;
1996.
2. The American Surrogacy Center. Legal: state by state over-
view. Kennesaw (GA): TASC; 2005. Available at: http://
www.surrogacy.com/Articles/cate_list.asp?ID=7&n=Legal
%3A++State+by+State+Overview. Retrieved July 10, 2007.
3. National Conference of Commissioners on Uniform State
Laws. Gestational agreement. Article 8. In: Uniform parent-
age act. Chicago (IL): NCCUSL; 2002. p. 68–78.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 177
 4. Andrews LB. Alternative modes of reproduction. In: Cohen
S, Taub N, editors. Reproductive laws for the 1990s. Clifton
(NJ): Humana Press; 1989. p. 361–403.
5. Serratelli A. Surrogate motherhood contracts: should the
British or Canadian model fill the U.S. legislative vacuum?
George Washington J Int Law Econ 1993;26:633–74.
6. Field M. Reproductive technologies and surrogacy: legal
issues. Creighton Law Rev 1992;25:1589–98.
7. New York State Task Force on Life and the Law. Assisted
reproductive technologies: analysis and recommendations
for public policy. New York (NY): NYSTF; 1998.
8. Surrogate gestational mothers: women who gestate a genet-
ically unrelated embryo. American Fertility Society. Fertil
Steril 1994;62(suppl 1):67S–70S.
9. Surrogate mothers. American Fertility Society. Fertil Steril
1994;62(suppl 1):71S–77S.
10. Moody-Adams MM. On surrogacy: morality, markets, and
motherhood. Public Aff Q 1991;5:175–90.
COMMITTEE OPINIONS
11. Harrison M. Financial incentives for surrogacy. Womens
Health Issues 1991;1:145–7.
12. Family members as gamete donors and surrogates. Ethics
Committee Report. American Society for Reproductive
Medicine. Fertil Steril 2003;80:1124–30.
Copyright © February 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Surrogate motherhood. ACOG Committee Opinion No. 397.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2008;111:465–70.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 178
 ACOG COMMITTEE OPINION
Number 403 • April 2008

End-of-Life Decision Making*

Committee on Ethics ABSTRACT: The purpose of this Committee Opinion is to discuss issues related
to end-of-life care, including terms and definitions, ethical principles, legal constructs,
physician–patient communication, and educational opportunities pertinent for specialists
in obstetrics and gynecology. Assumptions about the objectives of care—which may be
understood differently by the patient and her caregivers—inevitably shape perceptions
about appropriate treatment. Because unarticulated commitments to certain goals may
lead to misunderstanding and conflict, the goals of care should be identified through
shared communication and decision making and should be reexamined periodically. A
good opportunity to initiate the discussion of caregiving goals, including end-of-life care,
is during well-patient care. Physicians must be careful not to impose their own concep-
tion of benefit or burden on a patient. End-of-life care is particularly challenging for preg-
nant women, whose autonomy is limited in many states. Many apparent conflicts will be
averted by recognizing the shared interests of the woman and her fetus. When interests
diverge, however, pregnant women’s autonomous decisions should be respected.

Obstetricians and gynecologists, including Patient Benefit

those in training, care for women through-
out their life span and not infrequently need
to participate in end-of-life decision making.
Tragic accidents occasionally threaten the life
of a pregnant woman and her fetus, and ter-
minal outcomes occur for some patients with
gynecologic cancer. As a result, physicians
are expected to present options and guide
patients as they make decisions in the face
of such events. Life-threatening situations
are never easy to deal with, even for the well
trained. The purpose of this Committee
Opinion is to discuss issues related to end-
of-life care, including terms and definitions,
ethical principles, legal constructs, physi-
cian–patient communication, and educa-
tional opportunities pertinent for specialists
in obstetrics and gynecology.
The Ethical Basis of Medical
Practice
The moral foundation of medicine includes
three values central to the healing relation-
The American College ship. These are patient benefit, patient self-
of Obstetricians determination, and the moral and ethical
and Gynecologists integrity of the health care professional (1, 2).
Women’s Health Care *Update of “End-of-Life Decision Making” in Ethics in
Physicians Obstetrics and Gynecology, Second Edition, 2004
The obligation to promote the good of the
patient is a basic presumption of medical
caregiving and a defining feature of the physi-
cian’s ethical responsibility. The ethical prin-
ciple of beneficence upholds the physician’s
duty to seek to promote the patient’s good,
providing care in which benefits outweigh
burdens or harms. Providing benefit at the
end of life when further medical interven-
tion may be deemed futile may at first seem
challenging, but further consideration sug-
gests that the principle of beneficence may be
manifested in many dimensions. In some
situations, it may be manifested by provid-
ing treatment to improve health or prolong
life. In other situations, it may be exhibited
through the elimination of false hope, avoid-
ance of unwarranted tests and therapies, and
assistance for patients and their families in
reconciling themselves to the limitations of
available medical options and achieving peace
of mind. Indeed, in considering end-of-life
care, benefits are understood only relative
to the goals that the patient and physician
hope to achieve through medical care. At
times, what is beneficent in the patient’s eyes
may seem to the physician to cause more
suffering or involve the inappropriate use of

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 179

 medical resources. These complicated issues of futility are
addressed further elsewhere (3).
Patient Self-Determination
The inherent value of individual autonomy or self-
determination is one of the fundamental principles of
democracy and represents the basis for many individual
rights and protections in the United States. In health care,
the value of individual autonomy is affirmed in the ethi-
cal and legal doctrine of informed consent (4, 5). Under
this doctrine, the patient has a right to control what hap-
pens to her body. This means that in nonemergent situ-
ations, no treatment may be given to the patient without
her consent (or, if she lacks decision-making capacity,
the consent of her valid surrogate). Treatment otherwise
given to the patient without her consent may be judged
in some cases to be assault and battery. A patient’s right
to informed consent or refusal is not contingent on the
presence or absence of terminal illness, on the agreement
of family members, or on the approval of physicians or
hospital administrators.
In the medical context, physician respect for patient
self-determination consists of an active inclusion of
the patient in decisions regarding her own care. This
involves frank discussion of diagnoses and prognoses
(an essential part of an informed consent); the relative
risks and benefits of alternatives, including the option
of refusing all curative treatments; and, based on these
discussions, a mutual identification of the operative goals
of care. Studies suggest that most patients want to know
the reality of their conditions and benefit from an honest
communication with the physician (6, 7). It is unethical
for a physician to deny patients important information
in order to avoid physician–patient interactions that are
difficult or uncomfortable. Moreover, appropriate regard
for patient autonomy involves respecting the patient’s
considered choice to change therapeutic modalities to
better meet her current goals of care. The patient’s choice
may be conveyed through an instructional directive or
a surrogate with power of attorney (see box). Advance
directives will be discussed in later sections.
Ethical Integrity of the Health Care Professional
Because physicians, like patients, are autonomous agents,
they usually cannot be compelled to violate personal ethi-
cal or religious commitments in service to the patient (8).
If physicians have moral reservations about providing
certain forms of caregiving or about stopping treatment,
they should (if appropriate to the circumstances) make
that known at the outset. Physicians must not stand in
the way of patients’ desires to seek other caregivers and
should, where possible, help guide the transition.
The profession of medicine is guided by its moral
commitment to avoid subjecting a patient to harms
that are greater than potential benefits (the principle of
nonmaleficence). On this basis, physicians have a pre-
sumptive obligation not to provide treatments that are
COMMITTEE OPINIONS
untested, contraindicated, or useless. For this reason, a
patient’s demand for care that she deems desirable is not
sufficient to impose on providers an absolute obligation
to provide care that is futile or likely to be harmful with-
out offering corresponding benefit.
Legal Developments That Bear on
End-of-Life Decision Making
In addition to the emotional and medical challenges
that accompany decisions at the end of life, care in such
situations may be shaped by statute and legislation. Laws
governing such situations vary from state to state. In the
1990s, there were a number of developments in law that
influence end-of-life decision making.
First, in June 1990, in Cruzan v. Director of the
Missouri Dept. of Health, the United States Supreme
Court affirmed that patients have a constitutionally pro-
tected right to refuse unwanted medical treatments (9).
The ruling also affirms the states’ authority to adopt pro-
cedural requirements for the withdrawal and withholding
of life-prolonging medical interventions.
A second legal development was the passage of the
federal Patient Self-Determination Act (PSDA), which
went into effect December 1, 1991 (10). The PSDA
requires Medicaid- and Medicare-participating health
care institutions to inform all adult patients of their rights
“to make decisions concerning medical care, including
the right to accept or refuse medical or surgical treatment
and the right to formulate an advance directive.” Under
the PSDA, institutions that receive Medicare or Medicaid
reimbursement are legally required to provide this
information to patients on admission for care or on
enrollment in a health maintenance organization. The
institution must note in the medical record the existence
of an advance directive and must respect these directives
to the fullest extent under state law. Put simply, the aim
of the PSDA is to empower patients to make decisions
regarding their medical care.
Advance Directives
An advance directive is the formal mechanism by which
a patient may express her values regarding her future
health status. It may take the form of a proxy directive or
an instructional directive or both:
• Proxy directives, such as the durable power of attor-
ney for health care, designate a surrogate to make
medical decisions on behalf of the patient who is no
longer competent to express her choices. The terms
health care proxy, health care agent, and surrogate
can be used interchangeably. The term surrogate is
used in this Committee Opinion.
• Instructional directives, such as living wills, focus on
the types of life-sustaining treatment that a patient
would or would not choose in various clinical circum-
stances.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 180
 A third development is found in legislation and legal
rulings concerning the autonomy of the pregnant woman
to refuse treatment. Although courts at times have inter-
vened to impose treatment on a pregnant woman, cur-
rently there is general agreement that a pregnant woman
who has decision-making capacity has the same right to
refuse treatment as a nonpregnant woman (11). When a
pregnant woman does not have decision-making capac-
ity, however, legislation frequently limits her ability to
refuse treatment through an advance directive. As of
2006, 31 states had living will statutes that explicitly for-
bid the withholding or withdrawal of life support either
from all pregnant patients or from pregnant patients
whose fetuses could become, or currently are, viable (12).
Only four states specifically permit a woman to choose
to refuse life-sustaining treatment if she is pregnant. The
other states either have no living will statute or make no
mention of pregnancy. Similar types of restrictions exist
in some states with respect to a surrogate who is appoint-
ed to make decisions on behalf of a pregnant woman
(11). Statutes that prohibit pregnant women from exer-
cising their right to determine or refuse current or future
medical treatment are unethical. (An ethical framework
for addressing end-of-life decisions in pregnant women
is discussed later in this Committee Opinion.)
A final development pertains to euthanasia and phy-
sician-assisted suicide. Euthanasia refers to the adminis-
tration of drugs with the intention of ending a patient’s
life at her request (13). Physician-assisted suicide refers to
supplying a patient with drugs or a prescription for drugs
knowing one is enabling a patient to kill herself. Oregon’s
1997 Death With Dignity Act, which permits physicians
to write prescriptions for a lethal dosage of medication
to people with a terminal illness, was upheld January
2006 by the Supreme Court. No other state in the United
States allows such acts, but other countries that authorize
physician-assisted suicide or euthanasia include Belgium,
The Netherlands, and Australia.
In contrast to the previous decisions and legislation,
some have argued that irrespective of the individuals’
specific circumstances, support should be offered to
maintain life. These arguments were made perhaps most
prominently in debate and legislation surrounding the
care of Terry Schiavo. As discussed in the following
section, more than perhaps anything else, this case illus-
trated the advantage of all individuals providing advance,
written instructions concerning their wishes for end-of-
life care.
Physician–Patient Communication and
the Goals of Care
The practice of obstetrics and gynecology involves many
different types of care. These include but are not limited
to preventive care; periodic examinations; family plan-
ning; the provision of prenatal and delivery care; medical
and surgical intervention for conditions that threaten a
patient’s fertility, life, or quality of life; long-term care
COMMITTEE OPINIONS
for patients with chronic illness; and palliative care for
patients whose illnesses offer no chance of cure or remis-
sion. The combination of medical and surgical treatment
approaches, as well as the intimate nature of the special-
ized care offered by obstetrician–gynecologists, allows for
a long-term close relationship with many opportunities
for communication with patients. Questions about the
use of specific therapeutic modalities become meaning-
ful often only in relation to the goals of management for
a particular patient (14). Goals of care in obstetrics and
gynecology include:
•
Relief of symptoms, pain, and suffering
•
Achievement of cure or remission
•
Achievement or prevention of pregnancy
•
Optimization of pregnancy outcomes
•
Prevention of illness in a woman or her fetus or both
•
Maintenance or restoration of biologic function
•
Performance of palliative surgery or chemotherapy
•
Maximization of comfort
•
Achievement or maintenance of a certain quality
of life
• Education of the patient about her medical condition
The ultimate goals of care are properly identified
through a process of shared and ongoing communication
and decision making between the patient and physician
(15–17). Skilled, honest communication is key in this pro-
cess. Explicit discussion about the goals of care is impor-
tant for a number of reasons. First, assumptions about
the objectives of care inevitably shape perceptions about
the appropriate course of treatment. Second, these objec-
tives may be understood differently by the patient and her
caregivers. Third, unarticulated commitments to certain
goals may lead to misunderstanding and conflict. Finally,
the goals of care are fluid and may evolve and change in
response to clinical or other factors.
A comprehensive and ongoing process of communi-
cation not only advances patient self-determination but
also is the basis for “preventive ethics”; that is, the estab-
lishment of a moral common ground that may prevent
ethical conflict and crisis (18). The benefits of engaging
in and becoming skilled at such conversations are many
and include optimizing care, diminishing family burden,
diminishing stress among members of the health care team,
and utilizing resources more effectively. Inadequate com-
munication, whether from inappropriate training, personal
provider discomfort with death, or differences in personal
or cultural values, has the potential to impair the process
of informed consent and may result in overtreatment, pain
and suffering, undue burden on the patient and family,
misuse of resources, and loss of the peace of mind that can
result from including interdisciplinary care such as hospice
and palliative care departments.
The well-publicized and discussed case of Terri
Schiavo emphasizes the need to discuss these issues with
2013 COMPENDIUM OF SELECTED PUBLICATIONS 181
 loved ones and also the need to put them in writing. In
this case, the diagnosis of a permanent vegetative state
and the unwritten wishes of the patient contributed to
painful conflicts between the patient’s husband and her
parents regarding the effort to keep her alive by tube feed-
ings (19). Even if patients do all they can to make their
wishes known, conflicts may still occur.
Shared Decision Making Regarding
the End of Life
The process of decision making regarding the end of life
may take place under two different circumstances. In the
first, decisions are made in an acute situation of present
health crisis; these are immediate choices that determine
actual end-of-life treatment. In the second, decisions are
made that proactively provide for possible future end-
of-life situations; these decisions are expressed through
advance directives. In practice, however, the distinction
may not be drawn sharply, and such decision making
often is more appropriately thought of as an ongoing
process or conversation. Because circumstances may
change, goals also may change over time and will need to
be readdressed with all involved parties on a regular basis.
Communication Regarding Immediate Health
Status
An ongoing process of informed consent requires physi-
cians to communicate information regarding the patient’s
health status and comparative risks and benefits of treat-
ment (including no treatment) so that she or, if she lacks
decision-making capacity, her surrogate may determine
goals of her care. If the patient decides that the maximiza-
tion of comfort is her desired goal of care, the practitio-
ner’s responsibilities will focus on palliative strategies,
such as pain relief, attentive and responsive communi-
cation with the patient about her health status, and the
facilitation of communication with the patient’s involved
family and loved ones. These components of care are
essential to the physician’s positive therapeutic role and
are often the most valuable services that can be offered.
The expression “nothing more can be done” is misleading
shorthand that improperly equates care with cure and, in
so doing, ignores the importance of the physician’s role in
providing comfort to the dying patient (20–22).
If the patient or surrogate and physician finally dis-
agree on the goals that should guide care, a clearly defined
process of discussion and consultation should be fol-
lowed to resolve the disagreement. Examples of a process
are available (3, 23). In many institutions, such disagree-
ments are first addressed by an ethics consultation service
or an ethics committee. By using consultative services to
clarify the cultural, religious, or personal considerations
that shape decision making, the parties may be able to
resolve apparent conflict. The specific details of this pro-
cess may vary by institution and locality.
Results of such a consultation may include the trans-
fer of care to another physician. In other circumstances,
COMMITTEE OPINIONS
the assistance of a palliative care team to bridge the transi-
tion to palliative care may be helpful. Some patients who
are near the end of life and who anticipate ever-increasing
pain and suffering may inquire about the alternative of
physician-assisted suicide. It currently is not legal for
physicians to participate in physician-assisted suicide
in states other than Oregon. When a patient inquires
about physician-assisted suicide as a possible option, the
physician should explore with her the nature of her fears
and her expectations and should be prepared to offer
reassurances regarding palliative care plans for relieving
distress at the end of life. Physicians should be aware that
a request for physician-assisted suicide may be a marker
for treatable depression or inadequately treated pain.
Communication Regarding Future Health
Status: Advance Directives
In many cases, it is the obstetrician–gynecologist who not
only acts as the principal physician for female patients
but also has the most contact with them throughout their
lives. For these reasons, the obstetrician–gynecologist is
in an ideal position to discuss with the patient her values
and wishes regarding future care and to encourage her to
formulate an advance directive (see box).
A good opportunity to initiate the discussion of
caregiving goals, including end-of-life care, is during
well-patient care, either at the time of the periodic
examination or during pregnancy. Because a patient’s
wishes regarding care might change over time or under
different conditions of illness, these discussions should
include occasional reexamination of values and goals and,
if necessary, updating of her advance directives and other
documentation. Decision making should be treated as a
process rather than an event.
To facilitate the initiation of these discussions, the
patient history form could contain questions about a
patient’s execution of an instructional directive and her
designation of a surrogate or next of kin as her medi-
cal proxy. If the patient has an instructional directive or
durable power of attorney or both, they should become
part of her medical record. If the patient does not have
an advance directive, assistance in executing one might
be provided by the social services or nursing staff of a
hospital or clinical practice.
Ideally, these discussions serve an educational pur-
pose for both patient and physician. For the physician,
these discussions establish a basis for future care and pro-
vide an opportunity for the candid expression of personal
values regarding care. For the patient, the discussions
provide the opportunity to learn about advance direc-
tives, to formulate and articulate her values regarding the
goals of care, and to understand the compatibility of these
goals with the values of the health care provider.
Although it is the physician’s responsibility to edu-
cate patients about possible future health status and
rights regarding medical care, it is the responsibility of the
patient to thoughtfully assess her values and goals and to
2013 COMPENDIUM OF SELECTED PUBLICATIONS 182
 make them clearly known to those involved in her care.
Again, the explicit discussion and continued reevaluation
of caregiving goals provides an optimal mechanism for
shared decision making.
Potential Physician Influence
In the face of end-of-life decision making, physicians
trained to prize interventionist strategies must be espe-
cially careful not to impose their own conception of
benefit or burden on a patient or to use coercive means
to establish or achieve goals that are not shared by the
patient. The obstetrician–gynecologist should recognize
that the harms associated with prolonged attempts at cure
may not be acceptable to some patients. However, neither
the presence of a “do not resuscitate” order nor spe-
cific directives regarding limitation of other treatments
remove the responsibility for providing palliative care.
Moreover, the physician should not rely on the presence
or absence of a do-not-resuscitate order to make assump-
tions about the appropriateness of other treatment but
rather should be guided by the explicitly identified goals
of care.
There is considerable evidence that sociocultural and
gender differences between patients and their physicians
may subtly influence the style and content of physician–
patient communication and the care that patients receive
(24–31). Physicians who are aware of these potential
problems can guard against the influence of bias in judg-
ments concerning patient choices. Differences in gender
and in ethnic, social, religious, and economic background
between patients and physicians may complicate com-
munication, but they should not compromise care.
An additional area of potential conflict is research.
The dual role that physicians often assume as research
scientists and clinical practitioners can be challenging
because the goals and priorities of science and clinical
practice may be different (32). For example, one should
not overlook the potential conflict that may arise during
a patient’s end-of-life transition when the primary physi-
cian is also a primary investigator for an oncology trial
for which the patient is eligible. Both the researcher and
the primary caregiver should guard against inflating the
patient’s perception of the therapeutic benefit expected
from participating in clinical trials. Studies have shown
that research participants tend to believe, despite careful
explanation of research protocols, that they will likely
benefit from participation or that the level of actual ben-
efit will be greater than stated in the consent process (33).
A patient’s decision to participate in research should be
consistent with her end-of-life goals.
Surrogate Decision Making
If the patient who lacks decision-making capacity has not
designated a surrogate, state law may dictate the order in
which relatives should be asked to serve in this role. The
individual selected should be someone who knows the
patient’s values and wishes and will respect them in his
COMMITTEE OPINIONS
or her role as surrogate decision maker. If there is con-
flict regarding the designation of a surrogate, it may be
appropriate to seek the advice of an ethics committee or
consultant or, possibly, the courts. The benefit of choos-
ing a surrogate is immeasurable because this individual
has the same authority the patient would if she were able
to make decisions. The surrogate has the legal right to
all confidential medical information and ideally would
be someone trusted and chosen by the patient herself.
Proactively choosing a surrogate allows the opportunity
to discuss pertinent religious or moral beliefs with that
individual. One additional precaution a patient can take
to be sure her wishes are respected is the execution of a
living will.
The surrogate decision maker is ethically obligated to
base decisions on the wishes and values of the patient. If
these wishes and values have been explicitly stated, either
in writing or in oral discussion, the surrogate has to inter-
pret and apply them in the current situation. If wishes
and values have not been explicitly stated beforehand, the
surrogate has to attempt to extrapolate them from what
is known about the patient. In some cases (for example,
a never-competent patient), the surrogate will have to
decide entirely on the basis of what is in the best interests
of this particular patient.
Pregnant Patients and End-of-Life
Decisions: Preventing Conflict
For the overwhelming majority of pregnant women, the
welfare of the fetus is of the utmost concern. This concern
motivates women to modify their behaviors for months
at a time and to undergo the discomforts and risks of
pregnancy and delivery. This maternal interest in fetal
welfare traditionally has been the basis of the fundamen-
tal ethical commitment of obstetrician–gynecologists:
that they are responsible for both the pregnant woman
and her fetus and that they must optimize the benefits to
both while minimizing the risks to each.
In recent years, some have advanced the view of the
“fetus as patient”—an ethics framework that highlights
questions about what should be done in cases in which
the pregnant woman’s decisions about her own health
seem unlikely to optimize fetal well-being. Many of these
apparent conflicts will be averted by recognizing the
interconnectedness of the pregnant woman and fetus
with an approach that emphasizes their shared interests.
For cases in which their interests do diverge, however,
candid discussion of these matters in advance of a situ-
ation, conflict, or crisis is important. Pregnant women’s
autonomous decisions should be respected, and concerns
about the impact of those decisions on fetal well-being
should be discussed in the context of medical evidence
and understood within the context of the women’s values
and social context (11).
Within the context of obstetric care, situations rarely
arise when a dying pregnant woman must decide between
caregiving goals that emphasize palliative management
2013 COMPENDIUM OF SELECTED PUBLICATIONS 183
 for her own illness or an interventionist strategy, such as
cesarean delivery, for the sake of her fetus. Likewise, she
might be forced to decide between a curative strategy,
such as chemotherapy, for her metastatic breast cancer
and a course that poses less risk to her fetus but offers
her less anticipated benefit. In either case, it is safe to
assume that having been provided with all of the clinical
information necessary to make her decision, she regards
the choice as a difficult, possibly excruciating one and
one that she wishes she did not have to make. The patient
with a life-threatening condition identifies treatment
goals by considering her beliefs and values in the context
of obligations and concerns for her family, her fetus, and
her own health and life prospects.
The obstetrician–gynecologist, as the woman’s advo-
cate, should attempt to ensure that the wishes of the preg-
nant patient are followed. Even if the patient is no longer
able to make her own decisions, her previously expressed
wishes and values (whether expressed as an instructional
directive or through the appointment of a surrogate deci-
sion maker) should guide the course of treatment, when-
ever legally possible. When this is not possible, clinicians
should advocate changes in the law (34, 35).
Clinician Education
The need for effective end-of-life education for physi-
cians in training is obvious, not only for the benefit of
patients but also for physicians, to avoid burnout and to
help them manage anxiety with issues of mortality. In a
survey of six medical schools, only 22–53% of fourth-year
medical students felt prepared by the end-of-life educa-
tion they received (36). A study of 157 first-year internal
medicine residents (interns) identified very little class-
room teaching, clinical observation, or clinical experience
with end-of-life communication and, perhaps as a con-
sequence, reported low self-perceived comfort and skill
in this area (37). Finally, in a study of general surgeons,
84% reported receiving no education in palliative care in
residency, and 44% indicated that they had not had suf-
ficient continuing medical education on the topic (38).
One particularly beneficial educational example is
that of the Giving Bad News script (39), but also helpful
are courses such as the Healer’s Art, designed by Rachael
Naomi Remen (40), and techniques such as Narrative
Medicine (41), designed for physicians to remain self-
reflective about issues of humane caring and differences
in their own concerns about life and death.
Conclusion
Effective proactive communication between the patient
and the physician is the cornerstone of the therapeutic
relationship. Explicit identification of the operative goals
of care is important for four reasons:
1. Assumptions about the objectives of care inevitably
shape perceptions about the appropriate course of
treatment.
COMMITTEE OPINIONS
2. These objectives may be understood differently by
the patient and her caregivers.
3. Unarticulated commitments to certain goals may
lead to misunderstanding and conflict.
4. The goals of care may evolve and change in response
to clinical or other factors.
In the course of providing comprehensive care,
obstetrician–gynecologists are in an excellent position to
encourage women to formulate advance directives. The
discussion of the advance directive should be regarded
as integral to the ongoing process of communication to
be initiated by the health care provider. Special attention
should be given to the discussion of treatment wishes
with pregnant women facing end-of-life decisions, espe-
cially in view of current state restrictions on the applica-
tion of advance directives during pregnancy.
Sometimes the maximization of comfort is the cho-
sen therapeutic goal. In this case, the care offered by the
physician can continue to benefit the patient in a number
of important ways by providing humane and supportive
care at the end of life.
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Copyright © April 2008 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
End-of-life decision making. ACOG Committee Opinion No. 403.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2008;111:1021–7.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 185
 ACOG COMMITTEE OPINION
Number 409 • June 2008

Direct-to-Consumer Marketing of Genetic

Testing
Committee on ABSTRACT: Marketing of genetic testing, although similar to direct-to-consumer
Genetics advertising of prescription drugs, raises additional concerns and considerations. These
Committee on Ethics include issues of limited knowledge among patients and health care providers of avail-
This document reflects
able genetic tests, difficulty in interpretation of genetic testing results, lack of federal
emerging clinical and sci- oversight of companies offering genetic testing, and issues of privacy and confidential­ity.
entific advances as of the Until all of these considerations are addressed, direct or home genetic testing should be
date issued and is subject
to change. The information discouraged because of the potential harm of a misinterpreted or inaccurate result.
should not be construed
as dictating an exclusive
course of treatment or With the increase in the number of clini- Physicians should use mechanisms in their
procedure to be followed. cal genetic tests requested by health care practice environment that would provide the
providers, there has been an increase in reassurance that women seek when being test-
direct-to-consumer advertising and offer- ed for gene mutations associated with disease.
ing of genetic tests, including at-home tests Some companies offering direct–to-
and those provided by private companies. consumer testing promote the increased pri-
Although similar to direct-to-consumer ad- vacy of a direct test in their marketing efforts.
vertising of prescription drugs, marketing of However, patients are not made aware that
genetic testing raises additional concerns and failure to indicate results of genetic testing
considerations. These include issues of lim- in life insurance or disability applications
ited knowledge among patients and health could be considered fraud. In addition, many
care providers of available genetic tests, dif- laboratories have not indicated their policies
ficulty in interpretation of genetic testing on what is done with the DNA sample after
results, lack of federal oversight of companies analysis. To ensure privacy, DNA samples
offering genetic testing, and issues of privacy should be destroyed after the requested test is
and confidentiality. performed. Those overseeing procedures for
All genetic testing, including at-home testing should continue to work to address
tests, should be considered medical test- patient privacy concerns.
ing because results might have an impact The U.S. Federal Trade Commission,
on future medical care and clinical deci- U.S. Food and Drug Administration, and the
sion making. Although some tests have been Centers for Disease Control and Prevention
marketed as nonmedical, such as paternity have issued a public message about at-home
testing and early fetal sex prediction from genetic tests. They advise consumers to be
maternal blood, these also should be consid- skeptical of the claims of the tests that are
ered medical tests. Decisions based on these offered. Many tests may be of questionable
results regarding a pregnancy may cause a value. The agencies also advise talking to a
patient to seek further medical treatment or health care practitioner or genetic counselor
intervention. before and after testing to help ensure under-
Despite the clear limitations of direct- standing of what the test offers and what the
to-consumer genetic testing, women still use results of testing reveal. In addition, they
The American College the service. Physicians should acknowledge point out that unlike other home-use medical
of Obstetricians that one factor that might contribute to this tests, the U.S. Food and Drug Administration
and Gynecologists trend is the belief among some patients that has not reviewed any of the at-home genetic
Women’s Health Care adequate privacy safeguards do not exist when tests. Because of this, the validity and accu-
Physicians genetic testing is performed in the office. racy of many of these tests are unknown.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 186

 All genetic testing should be provided only after
consultation with a qualified health care professional.
For complex testing, this may involve referral to a genetic
counselor or a medical geneticist. Appropriate pretest
and posttest counseling should be provided, including
a discussion of the risks, benefits, and limitations of the
testing. It must be recognized that direct-to-consumer
genetic testing will create downstream needs for coun-
seling, support, and care for those identified as carriers
of genes associated with undesired medical conditions.
In many locales, the current health care system is not
sufficient to meet those needs. Although some compa-
nies offer genetic counseling, concerns have been raised
regarding a potential conflict of interest when the com-
pany providing the testing employs the genetic counselor
because a company advertising directly to consumers
may receive no compensation for counseling alone and is
compensated only if the test is ordered by the consumer.
Until all of these considerations are addressed, direct
and home genetic testing should be discouraged because
of the potential harm of a misinterpreted or inaccurate
result.
Resources
Bianchi DW. At-home fetal DNA gender testing: caveat emptor.
Obstet Gynecol 2006;107:216–8.
COMMITTEE OPINIONS
Federal Trade Commission (US). At-home genetic tests: a healthy
dose of skepticism may be the best prescription. Washington,
DC: FTC; 2006. Available at: http://www.ftc.gov/ bcp/edu/pubs/
consumer/health/hea02.shtm. Retrieved March 10, 2008.
Gollust SE, Wilfond BS, Hull SC. Direct-to-consumer sales of
genetic services on the Internet. Genet Med 2003;5:332–7.
Gollust SE, Hull SC, Wilfond BS. Limitations of direct-to-con-
sumer advertising for clinical genetic testing. JAMA 2002;288:
1762–7.
Roche PA, Annas GJ. DNA testing, banking, and genetic privacy.
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Copyright © June 2008 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Direct-to-consumer marketing of genetic testing. ACOG Committee
Opinion No. 409. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2008;111:1493–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 187
 ACOG COMMITTEE OPINION
Number 410 • June 2008

Ethical Issues in Genetic Testing

Committee on Ethics ABSTRACT: Genetic testing is poised to play an increasing role in the practice of
Committee on obstetrics and gynecology. To assure patients of the highest quality of care, physicians
Genetics should become familiar with the currently available array of genetic tests and the tests’
This document reflects
limitations. Clinicians should be able to identify patients within their practices who are
emerging clinical and sci- candidates for genetic testing. Candidates will include patients who are pregnant or
entific advances as of the considering pregnancy and are at risk for giving birth to affected children as well as
date issued and is subject
to change. The information gynecology patients who, for example, may have or be predisposed to certain types of
should not be construed cancer. The purpose of this Committee Opinion is to review some of the ethical issues
as dictating an exclusive
course of treatment or related to genetic testing and provide guidelines for the appropriate use of genetic tests
procedure to be followed. by obstetrician–gynecologists. Expert consultation and referral are likely to be needed
when obstetrician–gynecologists are confronted with these issues.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
Although ethical questions related to genetic
testing have been recognized for some time,
they have gained a greater urgency because of
the rapid advances in the field as a result of
the success of the Human Genome Project.
That project—a 13-year multibillion-dollar
program—was initiated in 1990 to identify
all the estimated 20,000–25,000 genes and to
make them accessible for further study. The
project harnessed America’s scientists in a
quest for rapid completion of a high-priority
mission but left a series of ethical challenges
in its wake. When developing the authorizing
legislation for the federally funded Human
Genome Project, Congress recognized that
ethical conundrums would result from the
project’s technical successes and included the
need for the development of federally funded
programs to address ethical, legal, and social
issues. Accordingly, the U.S. Department
of Energy and the National Institutes of
Health earmarked portions of their budgets
to examine the ethical, legal, and social issues
surrounding the availability of genetic infor-
mation.
The purpose of this Committee Opinion
is to review some of the ethical issues related
to genetic testing and provide guidelines
for the appropriate use of genetic tests by
obstetrician–gynecologists. It is important
to note at the outset, given the increasing
complexity of this field and the quickness
with which it advances, that expert consulta-
tion and referral are likely to be needed when
obstetrician–gynecologists are confronted
with many of the issues detailed in this
Committee Opinion.
The pace at which new information
about genetic diseases is being developed and
disseminated is astounding. Thus, the ethical
obligations of clinicians start with the need
to maintain competence in the face of this
evolving science. Clinicians should be able to
identify patients within their practices who
are candidates for genetic testing. Candidates
will include patients who are pregnant or
considering pregnancy and are at risk for giv-
ing birth to affected children as well as gyne-
cology patients who, for example, may have
or be predisposed to certain types of cancer.
If a patient is being evaluated because
of a diagnosis of cancer in a biologic relative
and is found to have genetic susceptibility
to cancer, she should be offered counseling
and follow-up, with referral as appropriate,
to ensure delivery of care consistent with
current standards. In fact, genetic screening
for any clinical purpose should be tied to the
availability of intervention, including prena-
tal diagnosis, counseling, reproductive deci-
sion making, lifestyle changes, and enhanced
phenotype screening.
One of the pillars of professionalism is
social justice, which would oblige physicians

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 188

 to “promote justice in the health care system, including
the fair distribution of health care resources” (1). In the
context of genetic testing, justice would require clinicians
to press for resources, independent of an individual’s
ability to pay, when they encounter barriers to health care
for their patients who require care as a consequence of
genetic testing and diagnosis (1).
Obstetrician–gynecologists also are ideally posi-
tioned to educate women. When they, or experts in
genetics to whom they refer, counsel on genetics, they
should provide accurate information and, if needed,
emotional support for patients burdened by the results or
consequences of genetic diagnoses, be they related to pre-
conception or prenatal care, cancer risks, or other impli-
cations for health. Finally, clinicians should familiarize
their patients with steps that can be taken to mitigate
health risks associated with their genetic circumstance
(eg, having a colonoscopy if there is a predisposition to
colon cancer) (2).
It recently has been suggested that each person’s
entire genome may be available for use by physicians
for diagnostic and therapeutic purposes in the not-too-
distant future (3). Although that might seem like a medi-
cal panacea, the potential risks associated with wide-scale
genetic testing are substantial. Many incidental findings
will come to light, and yet, although those tested may
be tempted to believe otherwise, genetic findings do not
equate directly with either disease or health: “one hun-
dred percent accurate identification of such incidental
pathologies will lead to iatrogenic pathology… the belief
that genetics completely determines phenotypic outcome
must be informed by an understanding that most genetic
measurements only shift the probability of an outcome,
which often depends on other environmental triggers and
chance” (4).
Informed Consent
Genetic Exceptionalism
Before the appropriate process for obtaining consent
for genetic tests is considered, it is necessary to confront
the broader question of whether the consequences of
the results of those tests are substantively different from
the consequences of other “medical” tests, for which spe-
cific consent is not always obtained. Some ethicists argue
against what has been called the “exceptionalism” of
genetic tests (5). They maintain that many medical tests
have consequences for patients that are similar to those
of genetic tests. For example, there can be discrimination
by insurance companies against individuals either with
a genetic disease or with a disease that is not linked to
any particular gene. Results of nongenetic tests, as
well as genetic tests, can divulge information about fam-
ily members (eg, tests for sexually transmitted diseases).
Additionally, both genetic and nongenetic tests can
provide information about a person’s medical future. As
such, some authors have concluded that many genetic
test results “may cause stigmatization, family discord
and psychological distress. Regardless of whether a test is
COMMITTEE OPINIONS
genetic, when this combination of characteristics is pres-
ent…testing should be performed with particular caution
and the highest standards of informed consent and privacy
protection should be applied” (6).
However, others argue that genetics should be treat-
ed as a unique class and be subject to a more rigorous
process for consent. They base their belief on several
factors. Genes, they argue, do not merely inform patients
and their health care providers about the diagnosis of
an extant illness. They also foretell the possibility (or
in some cases the certainty) of a future disease, thus
allowing “perfectly healthy” individuals to be subject to
discrimination based on a predisposing gene. The DNA
sample—which can be viewed as “a coded probabilistic
medical record”—“makes genetic privacy unique and
differentiates it from the privacy of medical records” (7).
Some believe that this information is even more sensi-
tive given the uncertainties attached to genetic results
(ie, the reliability of tests, the penetrance of genes, and
the unavailability of efficacious interventions to reduce
the consequences of genetic diseases). Additionally, the
consequence of being found to carry a particular gene has
resonance not only for the individual who is tested but
also for family members.
Patients should be informed that genetic testing
could reveal that they have, are at risk for, or are a car-
rier of a specific disease. The results of testing might
have important consequences or require difficult choices
regarding their current or future health, insurance cover-
age, career, marriage, or reproductive options.
Role of the Obstetrician–Gynecologist
In addition to needing to ensure proper consent, the
obstetrician–gynecologist who orders genetic tests should
be aware of when it is appropriate to test, which particular
test to order, and “what information the test can provide,
the limitations of the test, how to interpret positive and
negative results in light of the patient’s medical or family
history, and the medical management options available”
(8). The health care provider ordering tests has a respon-
sibility to use and interpret those tests correctly or to refer
to someone with relevant expertise. Because completing
all these tasks is particularly difficult when direct-to-
consumer marketing of genetic tests is used, that mar-
keting approach has significant limitations (9). These
enterprises receive compensation only if an individual,
after counseling, chooses to undergo a test, bringing the
standard of neutral counseling into question and further
rendering the use of a market-driven approach to test-
ing ethically problematic (10). In the end, the physician
plays an important role in providing adequate, neutral
counseling; ensuring informed consent; and providing
follow-up for genetic tests. Neutral counseling also may
be compromised through the use of patient educational
materials or counselors that are provided by a company
that might profit from a patient’s decision to undergo
testing.
Particular caution should be exercised when obtain-
ing consent for collecting genetic material that may
2013 COMPENDIUM OF SELECTED PUBLICATIONS 189
 be stored and, therefore, can have future clinical or
research applications. The American College of Medical
Genetics (ACMG) recommends that when samples are
obtained for clinical tests, counseling should address the
anticipated use of samples, including whether their use
will be restricted for the purpose for which they were
collected and if and when they will be destroyed (11).
When samples will be used for research or the develop-
ment of diagnostic tests, the ACMG recommends that
consent should include a description of the work (eg, its
purposes, limitations, possible outcomes, and methods
for communicating and maintaining confidentiality of
results). There should be a discussion with the research
participant about whether she wishes to give permission
to use her samples without identifiers for other types
of research, and she should be informed of the institu-
tion’s policy regarding recontacting participants in the
future. Current and future use of samples for research
should follow state and federal regulations governing
protection of human participants in research (12). Two
authors recently suggested that the “best consumer
advice, given current law, is that one should not send
a DNA sample to anyone who does not guarantee to
destroy it on completion of the specified test” (7).
Others argue for the creation of a repository of samples
donated by genetic altruists to be used for many differ-
ent types of research (4).
Genetic Testing in Children and Adolescents
Testing of children presents unique issues in counseling
and consent. Although it is most commonly pediatri-
cians or geneticists who are called on to test children
for genetic diseases, obstetricians may be asked to test
already born children of parents who, through the pro-
cess of prenatal testing, have been found to be carriers of
genetic diseases. In such cases, the physician should bal-
ance the rights of the parents to have information that
can optimize the ongoing health care of their children
against the rights of the children to have their best inter-
ests protected. There will be circumstances in which it
can be determined that a child is at risk for an untoward
clinical event in the future, but there may be no infor-
mation about interventions that have the potential to
reduce the likelihood of that event or the magnitude of
its effect. In that circumstance, the benefits of testing a
child are not always clear (eg, BRCA testing in a young
child).
The American Society of Human Genetics (ASHG)
and ACMG together have suggested, “Counseling and
communication with the child and family about genetic
testing should include the following components: 1)
assessment of the significance of the potential benefits
and harms of the test, 2) determination of the decision-
making capacity of the child, and 3) advocacy on behalf
of the interests of the child” (13). These societies high-
lighted additional points about benefits and burdens
COMMITTEE OPINIONS
that should be included in counseling, some of which
follow:
• Timely medical benefit to the child should be the
primary justification for genetic testing in children
and adolescents. If the medical benefits are uncertain
or will be deferred to a later time, this justification for
testing is less compelling.
• If the medical or psychosocial benefits of a genetic
test will not accrue until adulthood, as in the case of
carrier status or adult-onset diseases, genetic testing
generally should be deferred. Further consultation
with other genetic services providers, pediatricians,
psychologists, and ethics committees may be appro-
priate to evaluate these conditions.
• Testing should be discouraged when the health care
provider determines that potential harms of genetic
testing in children and adolescents outweigh the
potential benefits. A health care provider has no
obligation to provide a medical service for a child or
adolescent that is not in the best interest of the child
or adolescent.
The ASHG and ACMG concluded, “Providers who
receive requests for genetic testing in children must weigh
the interests of children and those of their parents and
families. The provider and the family both should con-
sider the medical, psychosocial, and reproductive issues
that bear on providing the best care for children” (8).
Physicians (obstetricians and pediatricians) also
have a responsibility to provide information to patients
regarding newborn screening. The primacy of the child’s
welfare should animate these discussions as well. More
detail about this issue can be found elsewhere (14).
Prenatal Genetic Testing
Genetic testing of the fetus offers both opportunities
and ethical challenges. Preconception and prenatal
genetic screening and testing are recommended for a
limited number of severe child-onset diseases because
such screening and testing provides individuals with the
chance to pursue assisted reproductive technology in
order to avoid conception of an affected child, to consider
termination of a pregnancy, or to prepare for the birth of
a chronically ill child. With advancing genetic technology,
however, physicians may increasingly face requests for
testing of fetuses for less severe child-onset conditions,
adult-onset conditions, or genetically linked traits.
Principles regarding testing of children provide some
guidance for when prenatal testing might be appropri-
ate but this decision is significantly complicated by the
various purposes that prenatal testing can have: to detect
a fetal condition for pregnancy termination, to allow
patients to prepare for the birth and care of a potentially
affected child, or, more rarely, to detect and treat a fetal
condition in utero. Furthermore, many times, a woman’s
intentions regarding pregnancy termination evolve as
2013 COMPENDIUM OF SELECTED PUBLICATIONS 190
 genetic information becomes available to her. Therefore,
testing the fetus for adult-onset disorders with no known
therapeutic or preventive treatment (save prevention by
pregnancy termination) should raise caution in a way
similar to the manner in which testing of children can.
In pregnancies likely to be carried to term, consideration
should be given to whether, as in the case of testing
children, the decision to test should be reserved for the
child to make upon reaching adulthood. However, con-
sideration also should be given to personal preference,
that is, the interests individuals may have in terminating
a pregnancy that may result in a life (such as life that
will be affected by Huntington chorea) that they feel
morally obliged or prefer not to bring into the world.
Because these often are wrenching decisions for parents,
referral to parent support networks (eg, National Down
Syndrome Society, if that is the diagnosis of concern),
counselors, social workers, or clergy may provide addi-
tional information and support (15).
Genetic Data and the Family
In a large number of instances, when patients receive
the results of genetic tests, they are party to information
that directly concerns their biologic relatives as well.
This familial quality of genetic information raises ethical
quandaries for physicians, particularly related to their
duty of confidentiality. In these circumstances, some have
posited an ethical tension between obligations the clini-
cian has to protect the confidentiality of the individual
who has consented to a test on the one hand and a physi-
cian’s duty to protect the health of a different individual
on the other hand. For example, a woman who discovers
that she is a carrier of an X-linked recessive disease dur-
ing the workup of an affected son might choose not to
tell her pregnant sister about her carrier status because
she does not believe in abortion and fears that her sister
might consider an abortion (16). In another example, a
woman identified as a carrier of a gene predisposing indi-
viduals to cancer might not wish to share the information
with relatives, some of whom might even be patients of
the same physician who tested her, because such sharing
would disclose her own status as a carrier.
In both the previously cited cases, information
obtained with the consent of one individual could assist
in the management of another. However, medical eth-
ics as reflected in American Medical Association (AMA)
policies recognizes a physician’s duty to safeguard patient
confidences in such cases (with a few notable exceptions,
often mandated by law—for example, communicable
diseases and gunshot and knife wounds should be report-
ed as required by applicable statutes or ordinances) (17).
How assiduously that confidentiality needs to be guarded
is the subject of some debate. Some have argued that
genetic information should be subject to stringent safe-
guards because, even though there may be uncertainty
about the ultimate biologic consequence of a given gene,
the social consequences (discrimination and stigmatiza-
COMMITTEE OPINIONS
tion) can be substantial (18). The AMA’s Council on
Ethical and Judicial Affairs has argued that physicians do
indeed have an obligation to pay almost unlimited obei-
sance to a patient’s confidentiality save only for “certain
circumstances which are ethically and legally justified
because of overriding social considerations” (19).
Conversely, there are those who argue against the
withholding of important information from potentially
affected family members (20). Those who subscribe to
this belief feel that when information applies to fam-
ily as much as to the proband, an obligation arises that
extends from the physician to those potentially affected
family members but no further. This view is consistent
with court rulings in three states, which have held that a
physician owes a duty to the patient’s potentially affected
family members (21–24). Two of these rulings addressed
the question of how physicians must fulfill this duty and
reached different conclusions. In one case, the court held
that the physician can discharge the duty by informing
the patient of the risk and is not required to inform the
patient’s child (22). In another case, the court did not
decide how the physician could satisfy the duty to warn,
other than requiring that “reasonable steps be taken to
assure that the information reaches those likely to be
affected or is made available for their benefit” (23). As
these alternate decisions illustrate, the legal limits of
privacy are evolving, emphasizing the need for patient
communication and case-by-case evaluation.
Recommendations of Other Organizations
Organizations that promulgate guidelines for genet-
ic care and counseling also have proposed different
approaches to the disclosure of genetic information. The
ASHG tailors its recommendations to the magnitude and
immediacy of risk faced by kindred (25), encouraging
voluntary disclosure by the proband but also articulating
circumstances in which the proband’s refusal to do so
should not preclude disclosure by the health care pro-
vider. According to the ASHG, disclosure is acceptable if
“the harm is likely to occur, and is serious, immediate and
foreseeable.” It adds that the at-risk relative must be iden-
tifiable and that there must be some extant intervention
that can have a salutary effect on the course of the genetic
disease. In summary, “the harm from failing to disclose
should outweigh the risk from disclosure.” Although this
suggestion to disclose seems unequivocal, it also posits
circumstances for its exercise that are highly unlikely at
the current time (ie, very few genetic diagnoses pose an
immediate risk, let alone ones that can be substantively
modified with an intervention [25]).
The President’s Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral
Research also suggested circumstances in which a health
care provider should disclose information in the absence
of the proband’s permission to do so (26). The com-
mission indicated that disclosure is required when four
conditions are present: 1) efforts to elicit voluntary
2013 COMPENDIUM OF SELECTED PUBLICATIONS 191
 disclosure by the proband have failed, 2) there is a high
probability that harm will occur if disclosure is not made,
and intervention can avert that harm, 3) the harm would
be serious, and 4) efforts are made to limit disclosed
information to genetic information needed for diagnosis
and treatment. Although the commission did not cite
a requirement for an immediate risk, the requirements
for a high probability of harm and for the availability of
an efficacious intervention make it likely that adherence
to these guidelines rarely will result in cases in which a
patient’s rights of confidentiality are overridden in order
to inform relatives at risk.
Role of the Obstetrician–Gynecologist
The best way for the obstetrician–gynecologist to avoid
the challenging choice between involuntary disclosure and
being passive in the face of risks to kindred is to anticipate
the issue and raise it at the first genetic counseling session.
At that session, the patient needs to be educated about the
implications of findings for relatives and why voluntary
disclosure would in many circumstances be encouraged
(as well as the possibility that relatives might prefer not to
know the results). Some bioethicists have even suggested
that these sessions should be used as an opportunity for
clinicians to articulate the circumstances under which
they would consider disclosure obligatory, thus allowing
patients to seek care elsewhere if they found the conditions
for testing unacceptable (Macklin has referred to this as
the “genetic Miranda warning”) (27). Similarly, even if the
health care provider would not disclose without consent
under any circumstance, the initial counseling session
could allow the health care provider to refer the patient
elsewhere if they find they have an irreconcilable differ-
ence or have an objection of conscience in expectations
about disclosure. Physicians also should make themselves
available to assist patients at the time of disclosure if that
will help assuage their patients’ concerns.
A particularly thorny issue related to the owner-
ship of genetic information might be results that bear
on paternity. It is possible that prenatal assessments and
family testing might reveal that the husband, partner, or
other putative father is not the biologic father. In 1994,
the Committee on Assessing Genetic Risks of the Institute
of Medicine recommended that in such situations the
health care provider should inform a woman but should
not disclose this information to her partner (28). The
Institute of Medicine’s reason for withholding such
information was that “genetic testing should not be used
in ways that disrupt families.” Another reason may be
that the physician–patient relationship exists solely with
the woman. Others have disagreed with the Institute of
Medicine’s recommendation (29). In some cases, it is not
merely a matter of acting to protect families. For example,
suppose a child is born with a disease that is caused by an
autosomal recessive gene, and the husband does not carry
the deleterious gene because he is not actually the father.
If the physician were to maintain the charade of pater­nity,
COMMITTEE OPINIONS
then the counseling given to both parents (ie, there is one
chance in four that each subsequent child will have the
same disease) would be false and might lead the husband
to argue against more children or for unnecessary amnio-
centeses in all future pregnancies, or inappropriately lead
to concern for others in his family.
Other circumstances exist in which the interests of a
pregnant woman and family members might diverge. For
example, if the husband’s father has Huntington chorea
(an autosomal dominant trait), the pregnant woman
might wish to test the fetus for the gene. If the father did
not want to know his own status, a conflict would arise,
pitting her right to know about her fetus against his right
not to know about himself. Another example of conflict
would be if problems arose during diagnostic linkage
studies for prenatal or preclinical diagnosis in a family
and some family members did not want to participate in
the testing (eg, testing for thalassemia). It might then be
impossible to make a diagnosis in the index case. Both
ethical and legal precedents, however, argue that indi-
viduals cannot be forced to have such testing.
Genetic Data and Insurers and
Employers
Concerns about access to health and life insurance in the
face of the discovery of a deleterious or predisposing gene
is one of the most nettlesome issues facing health care
providers who wish to use genetic testing to improve the
health of their patients. In some ways, the importance
of this issue is more pronounced in the United States
because of the manner in which health care coverage is
obtained. In countries with universal health care, indi-
viduals with the diagnosis of a predisposing gene need not
fear the loss of access to health insurance.
In recognition of concerns related to genetic test-
ing, in 1995, the Equal Employment Opportunity Com­
mission issued guidelines stating that individuals who
thought they had been discriminated against by an
employer because of predictive genetic testing had the
right to sue that employer. Additionally, the Health
Insurance Portability and Accountability Act (HIPAA),
enacted in 1996, prevented insurance companies from
denying health care based on predictive testing for
individuals transferring from one plan to another (30).
Physicians should advocate for patients’ ability to obtain
health or life insurance uncompromised by the results of
any genetic tests they might undergo.
Although there is scant evidence of widespread
genetic discrimination, there is clear evidence that fear of
that discrimination can drive patients away from needed
testing or from participation in research and also may
influence physicians’ uses of genetic tests (31). In com-
menting on insurance and discrimination and consider-
ing needed protections and legislation, ACMG makes the
following points: legislation must not impede the ability
of individuals to maximize use of genetic information in
their health care and employment decision making, and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 192
 it must not limit the access of health care providers to
genetic information needed to ensure that the care pro-
vided is beneficial and specific to the needs of the indi-
vidual. Furthermore, the privacy of genetic information
must be adequately protected. Protection against unfair
discrimination on the basis of genetic risk for disease is
achieved only by strategies that restrict use of genetic
information in enrollment and rate-setting. Protected
genetic information must include information based on
evaluation, testing, and family histories of individuals and
their family members (32). Finally, as discussed before, it
must be recognized that the confidentiality of these data
has become difficult to guarantee in this era of electronic
medical records.
Genetics and Assisted Reproductive
Technology
There are at least two issues that relate to the intersec-
tion of genetics and assisted reproductive technology
(ART). In the first instance, there is the need to consider
whether all individuals, regardless of genotype, should
have access to ART using their own gametes. In the past,
individuals who were infected with deleterious viruses
that have the potential to be passed to their children (eg,
human immunodeficiency virus) were denied access to
ART, in part because, before the advent of a variety of
interventions, as many as one in four of their offspring
would acquire an ultimately fatal infection, a risk similar
to that if both parents are carriers for a serious autosomal
recessive disease. Others have argued, however, that “pro-
creative liberty should enjoy presumptive primacy when
conflicts about its exercise arise because . . . [it] is central
to personal identity, to dignity and to the meaning of
one’s life” (33). Such principles would support allowing
prospective parents to be arbiters of the level of risk to
which a child could be exposed.
Second is the question of the extent to which
preimplantation genetics should be used in pursuit
of the “genetically ideal” child. The American College
of Obstetricians and Gynecologists (ACOG) already
opposes all forms of sex selection not related to the diag-
nosis of sex-linked genetic conditions (34). In the near
future, other potentially controversial genetic manipula-
tions may be available. Complex genetic systems such as
cognition and aging soon may be determinable and may
be constituents of potentially desirable characteristics,
such as intelligence or longevity. They could, therefore,
be used or misused as parameters for prenatal diagnosis
(35). Some have argued for a permissive approach, allow-
ing parents to choose from a menu of possible children
the one with the chance for the “best life.” That approach
would allow selection for both disease-related genes (eg,
eliminating carriers of BRCA genes) and nondisease
genes “even if this maintains or increases social inequal-
ity” (36). One author has referred to this as “procreative
beneficence,” defining it as couples selecting, from the
possible children they could have, the child who is expect-
COMMITTEE OPINIONS
ed to have the best life, or at least as good a life as the
others, based on the relevant, available information (36).
Conversely, in the United Kingdom, strict limits are set
on the use of prenatal genetic diagnosis, and clinics must
apply for a license for every new disease they want to
include in screening. However, even in that country, the
list of allowable preimplantation genetic diagnosis tests
has been expanded recently to include susceptibilities for
certain cancers (37, 38).
Parents’ requests to select a certain genetic trait may
pose even greater challenges for reproductive endocrinol-
ogists and embryologists when parents’ choices seem to
be antithetical to the best interests of the future child. For
example, deaf parents may prefer to select for an embryo
that will yield a child who will also be deaf. Couples who
have short stature due to skeletal dysplasia might feel
they would prefer to have a child of similar stature. The
technical ability to provide these choices is not far from
real­ity, but the ethical roadmap that will offer direction to
physicians is not as clearly laid out.
Conclusions
Genetic testing is poised to play a greater and greater role
in the practice of obstetrics and gynecology. To assure
patients of the highest quality of care, physicians should be
familiar with the currently available array of genetic tests,
as well as with their limitations. They also should be aware
of the untoward consequences their patients might sustain
because of a genetic diagnosis. The physician should work
to minimize those consequences. Genetic information
is unique in being shared by a family. Physicians should
inform their patients of that fact and help them to prepare
for dealing with their results, including considering dis-
closure to their biologic family. If the genetic information
could potentially benefit family members (eg, allow them
to improve their own prognosis), physicians should guide
their patients toward voluntary disclosure while assidu-
ously guarding their right to confidentiality.
Recommendations
The ACOG Committees on Ethics and Genetics recom-
mend the following guidelines:
1. Clinicians should be able to identify patients within
their practices who are candidates for genetic test-
ing and should maintain competence in the face of
increasing genetic knowledge.
2. Obstetrician–gynecologists should recognize that
geneticists and genetic counselors are an important
part of the health care team and should consult with
them and refer as needed.
3. Discussions with patients about the importance of
genetic information for their kindred, as well as a
recommendation that information be shared with
potentially affected family members as appropriate,
should be a standard part of genetic counseling.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 193
 4. 
Obstetrician–gynecologists should be aware that
genetic information has the potential to lead to dis-
crimination in the workplace and to affect an individ-
ual’s insurability adversely. In addition to including
this information in counseling materials, physicians
should recognize that their obligation to profession-
alism includes a mandate to prevent discrimination.
Steps that physicians can take to fulfill this obligation
could include, among others, advocacy for legislation
to ban genetic discrimination.
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Association: current opinions with annotations. 2006-2007
ed. Chicago (IL): AMA; 2006. p. xv–lvii.
18. Annas GJ, Glantz LH, Roche PA. Drafting the Genetic
Privacy Act: science, policy, and practical considerations.
J Law Med Ethics 1995;23:360–6.
19. American Medical Association. Confidentiality. In: Code
of medical ethics of the American Medical Association:
current opinions with annotations. 2006-2007 ed. Chicago
(IL): AMA; 2006. p. 136–50.
20. Wachbroit R. Rethinking medical confidentiality: the impact
of genetics. Suffolk Univ Law Rev 1993;27:1391–410.
21. Offit K, Groeger E, Turner S, Wadsworth EA, Weiser MA.
The “duty to warn” a patient’s family members about
hereditary disease risks. JAMA 2004;292:1469–73.
22. Pate v. Threlkel, 661 So.2d 278 (Fla. 1995).
23. Safer v. Estate of Pack, 291 N.J. Super. 619, 677 A.2d 1188
(1996).
24. Molloy v. Meier, 679 N.W.2d 711, 718 (Minn. 2004).
25. Professional disclosure of familial genetic information.
ASHG statement. The American Society of Human Genetics
Social Issues Subcommittee on Familial Disclosure. Am J
Hum Genet 1998;62:474–83.
26. President’s Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral
Research. Screening and counseling for genetic condi-
tions: a report on the ethical, social, and legal implica-
tions of genetic screening, counseling, and education
programs. Washington, DC: U.S. Government Printing
Office; 1983.
27. Macklin R. Privacy and control of genetic information. In:
Annas GJ, Elias S, editors. Gene mapping: using law and
ethics as guides. New York (NY): Oxford University Press;
1992. p. 157–72.
28. Institute of Medicine (US). Assessing genetic risks: impli-
cations for health and social policy. Washington, DC:
National Academy Press; 1994.
29. Ross LF. Disclosing misattributed paternity. Bioethics
1996;10:114–30.
30. Fulda KG, Lykens K. Ethical issues in predictive genetic test-
ing: a public health perspective. J Med Ethics 2006;32:143–7.
31. Hudson KL. Prohibiting genetic discrimination. N Engl J
Med 2007;356:2021–3.
32. Watson MS, Greene CL. Points to consider in prevent-
ing unfair discrimination based on genetic disease risk:
a position statement of the American College of Medical
Genetics. Genet Med 2001;3:436–7.
33. Robertson JA. Children of choice: freedom and the new
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Univer­sity Press; 1994.
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 34. Sex selection. ACOG Committee Opinion No. 360. Amer­
ican College of Obstetricians and Gynecologists. Obstet
Gynecol 2007;109:475–8.
35. Henn W. Consumerism in prenatal diagnosis: a challenge
for ethical guidelines. J Med Ethics 2000;26:444–6.
36. Savulescu J. Procreative beneficence: why we should select
the best children. Bioethics 2001;15:413–26.
37. Braude P. Preimplantation diagnosis for genetic suscepti-
bility. N Engl J Med 2006;355:541–3.
38. Human Fertilisation and Embryology Authority. Authority
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sion_-_Choices_and_boundaries.pdf. Retrieved January 9,
2008.
COMMITTEE OPINIONS
Copyright © June 2008 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Ethical issues in genetic testing. ACOG Committee Opinion No.
410. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2008;111:1495–502.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 195
 ACOG COMMITTEE OPINION
Number 422 • December 2008 (Replaces No. 294, May 2004)

At-Risk Drinking and Illicit Drug Use:

Ethical Issues in Obstetric and Gynecologic
Practice
Committee on Ethics ABSTRACT: Drug and alcohol abuse is a major health problem for American women
regardless of their socioeconomic status, race, ethnicity, and age. It is costly to individu-
als and to society. Obstetrician–gynecologists have an ethical obligation to learn and use
a protocol for universal screening questions, brief intervention, and referral to treatment
in order to provide patients and their families with medical care that is state-of-the-art,
comprehensive, and effective. In this Committee Opinion, the American College of
Obstetricians and Gynecologists’ Committee on Ethics proposes an ethical rationale for
this protocol in both obstetric and gynecologic practice, offers a practical aid for incorpo-
rating such care, and provides guidelines for resolving common ethical dilemmas related
to drug and alcohol use that arise in the clinical setting.

Drug and alcohol abuse is a major health
problem for American women regardless of
their socioeconomic status, race, ethnicity,
and age. It is costly to individuals and to
society. Among 18–25-year-old women, 34%
binge drink and 10% are heavy drinkers.
These rates are lower among women aged 26
years or older (12.8% binge drink and 2.4%
are heavy drinkers), but 6.3% of females
aged 12 years or older have been classified
as dependent on alcohol or illegal drugs
(1). Heavy drinking (five or more drinks
on one occasion on five or more days in
the last 30 days) carries a higher risk of car-
diac and hepatic complications for women
than men. The alcohol-associated mortality
rate is 50–100 times higher, and there is an
increased burden of mental and physical
disability (2). Among pregnant women aged
15–44 years, 11.8% admit to drinking some
alcohol during the previous month (1),
which may put the fetus at risk for fetal
alcohol syndrome (FAS), the leading cause
of mental retardation in the United States
The American College (3), and 0.7% reported heavy drinking (1).
of Obstetricians Maternal alcoholism is one of the leading
and Gynecologists preventable causes of fetal neurodevelop-
Women’s Health Care mental disorders (4). The economic costs of
Physicians FAS for 2003 are estimated at $5.4 billion.
Each case prevented is predicted to save
$860,000 in lifetime direct and indirect costs
(5). Illicit drug use has major physical and
mental health consequences and is associated
with increased rates of sexually transmit-
ted infections in women, including hepatitis
and human immunodeficiency virus (HIV),
as well as depression, domestic violence,
poverty, and significant prenatal and neo-
natal complications (6, 7). Overall, 10% of
nonpregnant women and 4% of pregnant
women report illicit drug use, but among
pregnant women aged 15–17 years, the rate
of use is 15.5% (8). Drug abuse costs are
estimated at more than $180 billion yearly,
including $605 million associated with health
care costs for drug-exposed newborns (9).
As a result of intensive research in addic-
tion over the past decade, evidence-based
recommendations have been consolidated
into a protocol for universal screening ques-
tions, brief intervention, and referral to treat-
ment (10). The abstinence rate after drug
abuse treatment (the treatment success rate)
is now comparable to the level of medication
compliance achieved in diabetes, hyperten-
sion, or other chronic illnesses (11). Brief
physician advice has been shown unequivo-
cally to be both powerful and feasible in a

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 196

 clinical office setting (10, 12, 13). The American Medical
Association has endorsed universal screening (14), and
health services researchers have determined that treat-
ment saves $7 for every dollar spent (15). For these
reasons, the American College of Obstetricians and
Gynecologists (ACOG) collaborated with the Physician
Leadership on National Drug Policy at Brown University
to produce a slide–lecture presentation that addresses
the identification and treatment of drug abuse (16). The
presentation was distributed to obstetric–gynecologic
clerkship and residency program directors and is avail-
able at www.acog.org.
Physicians have been slow to implement universal
screening, and rates of detection and referral to treat-
ment among nonpregnant women remain very low (17).
Studies using simulated patients have demonstrated that
women are less likely than men to be screened or referred
(18, 19). Physicians lack accurate knowledge about physi-
ology (ie, the equivalency of 1.5 oz of distilled spirits, 12 oz
of beer or wine cooler, and 5 oz of wine), risk factors, and
sex differences in problem presentation and treatment
response (20). These knowledge gaps are compounded
by state laws designed to criminalize drug use during
pregnancy, by women’s fears that they might lose custody
of their children, and by the social stigma experienced by
women who abuse alcohol or use illicit drugs (21, 22). In
one study, for example, the physicians surveyed defined
“light drinking” as an average of 1.2 drinks per day, an
amount that exceeds the National Institute on Alcohol
Abuse and Alcoholism’s (NIAAA) guidelines for at-risk
drinking for women (23). Furthermore, communicating
about difficult issues takes time, requires skills, and is
poorly reimbursed by procedure-oriented insurance cov-
erage. Physicians are concerned about the consequences
of legally mandated reporting, they lack familiarity with
treatment resources, and they do not have the extensive
time required to make an appropriate referral (11). These
are all problems that must be solved in order to provide
medically appropriate and ethically necessary care to
women who engage in at-risk drinking or use illicit drugs.
Many physicians are understandably reluctant to take
on a new responsibility in the context of time constraints
and the already intense demands of practice (24), but
there are practical measures that can be taken to make
screening and brief intervention feasible for many, if not
all, patients. Universal screening can be accomplished by
adding a few questions to a standard intake form (see
box “Substance Abuse Screening”). In an office practice,
1 in 20 patients will require further intervention (25, 26).
Intervention for these patients can be started effectively
in 5 minutes, as demonstrated in a busy academic emer-
gency department setting (27). Referrals can be provided
as a handout, with a nurse or office assistant available to
help the patient make contact with treatment if desired.
Because more women than men are hidden drinkers, and
many see the obstetrician or gynecologist as their principle
source of care, the opportunity to screen and intervene,
COMMITTEE OPINIONS
with benefits to women, their children, and society, are
too great to be missed. In recognition of the impor-
tance of this activity, Current Procedural Terminology
and Healthcare Common Procedure Coding System
(Medicare) codes have been established for screening,
brief intervention, and referral performed by a physician
or by an educator under the physician’s direction. Further,
the Centers for Medicare & Medicaid Services and many
non-Medicare payers provide coverage for these services.
Substance abuse presents complex ethical issues and
challenges. This Committee Opinion proposes an ethical
rationale for universal screening questions, brief inter-
vention, and referral to treatment in both obstetric and
gynecologic practice, offers a practical aid for incorporat-
ing such care (see box “BNI-ART Institute Intervention
Algorithm”), and provides guidelines for resolving com-
mon ethical dilemmas that arise in the clinical setting.
The Ethical Rationale for Universal
Screening Questions, Brief
Intervention, and Referral to
Treatment
Support for universal screening questions, brief interven-
tion, and referral to treatment is derived from four basic
principles of ethics. These principles are 1) beneficence,
2) nonmaleficence, 3) justice, and 4) respect for autonomy.
Beneficence
Therapeutic intent, or beneficence, is the foundation of
medical knowledge, training, and practice. Experts at
the NIAAA and the National Institute on Drug Abuse
confirm that addiction is not primarily a moral weak-
ness, as it has been viewed in the past, but a “brain dis-
ease” that should be included in a review of systems just
like any other biologic disease process (28). A medical
diagnosis of addiction requires medical intervention in
the same manner that a diagnosis of diabetes requires
nutritional counseling or therapeutic agents or both.
Positive behavior change arises from the trust implicit
in the physician– patient relationship, the respect that
patients have for physicians’ knowledge, and the abil-
ity of physicians to help patients see the links between
substance use behaviors and real physical consequences.
Brief physician advice has been shown to be as effective
as conventional treatment for substance abuse and can
produce dramatic reductions in drinking and drug use,
improved health status, and decreased costs to society
(10, 13, 15, 17, 29–31). The Center for Substance Abuse
Prevention has now implemented more than 147 projects
for pregnant and postpartum women and their children
(32), and there are several different successful models for
prevention and treatment for women and their families:
AR-Cares (34), Choices (35), SafePort (36), Early Start
(37), and the Mom/ Kid Trial (38).
Given this capacity for dramatic improvement in
health status, physicians have an obligation to be thera-
peutic—in this case to learn the techniques of screening
2013 COMPENDIUM OF SELECTED PUBLICATIONS 197
 Substance Abuse Screening
T-ACE
T Tolerance: How many drinks does it take to make you
feel high? More than 2 drinks is a positive response—
score 2 points.
A Have people Annoyed you by criticizing your drinking?
If “Yes”—score 1 point.
C Have you ever felt you ought to Cut down on your drink-
ing? If “Yes”—score 1 point.
E Eye opener: Have you ever had a drink first thing in the
morning to steady your nerves or get rid of a hangover?
If “Yes”—score 1 point.
A total score of 2 or more points indicates a positive screen
for pregnancy risk drinking.
Reprinted from the American Journal of Obstetrics & Gynecology,
Vol 160, Sokol RJ, Martier SS, Ager JW, The T-ACE questions: prac-
tical prenatal detection of risk drinking, 863–8; discussion 868–70,
Copyright 1989, with permission from Elsevier.
TWEAK
T Tolerance: How many drinks can you hold? If 6 or more
drinks, score 2 points.
W Have close friends or relatives Worried or complained
about your drinking in the past year? If “Yes” 2 points.
E Eye opener: Do you sometimes take a drink in the morn-
ing when you get up? If “Yes” 1 point.
A Amnesia: Has a friend or family member ever told you
about things you said or did while you were drinking
that you could not remember? If “Yes” 1 point.
K(C) Do you sometimes feel the need to Cut down on your
drinking? If “Yes” 1 point.
and brief intervention—and to inform themselves as they
would if a new test or therapy were developed for any
other recognized disease entity. The practice of universal
screening questions, brief intervention, and referral to
treatment falls well within the purview of the obstetri-
cian–gynecologist’s role as a provider of primary care
to women and has potential for major impact on recog-
nized obstetric and gynecologic outcomes. Furthermore,
if the topic is raised respectfully, the physician–patient
relationship may be substantially enhanced, even if no
substantive changes in lifestyle are achieved immediately.
Therapy is called “patient care” because both physicians
and patients recognize and value the commitment of the
medical profession to engage in a nurturing relationship
in the course of providing carefully selected therapeutic
modalities. Nurturance of healthy behaviors through uni-
versal screening questions, brief intervention, and referral
to treatment is, thus, part of the traditional healing role
and an appropriate focus for the obstetrician–gynecolo-
gist’s role as a primary care provider.
COMMITTEE OPINIONS
The TWEAK is used to screen for pregnant at-risk drinking,
defined here as the consumption of 1 oz or more of alcohol
per day while pregnant. A total score of 2 points or more
indicates a positive screen for pregnancy risk drinking.
Adapted from Russell M. New assessment tools for risk drinking
during pregnancy: T-ACE, TWEAK, and others. Alcohol Health Res
World 1994;18:55–61.
NIAAA Questionnaire
Do you drink?
Do you use drugs?
On average, how many days per week do you drink alcohol
(beer, wine, liquor)?
On a typical day when you drink, how many drinks do you
have?
Positive score: >14 drinks per week for men and >7 drinks
per week for women
What is the maximum number of drinks you had on any given
occasion during the past month?
Positive score: >4 for men and >3 for women
National Institute on Alcohol Abuse and Alcoholism. Helping
patients who drink too much: a clinician’s guide. Updated 2005 ed.
NIH Publication No. 07-3769. Bethesda (MD): NIAAA; 2007. Available
at: http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide
2005/guide.pdf. Retrieved January 23, 2008.
Nonmaleficence
The obligation to do no harm, or nonmaleficence, also
applies to universal screening questions, brief interven-
tion, and referral to treatment. Medical care can be com-
promised if physicians are unaware of a patient’s alcohol
or drug abuse and, thus, miss related diagnoses or medi-
cation interactions with alcohol or illegal substances.
If the problem is not identified, major health risks, such
as HIV exposure and depression, also may be missed.
These are examples of harms that may occur as a result
of omission (nondetection of a serious problem). Fur-
thermore, patients may be harmed when substance abuse
is treated by a physician as a moral rather than medical
issue (38). Women who abuse alcohol or use illicit drugs
are more likely than men to be stigmatized and labeled
as hopeless (39). In particular, physicians should avoid
using humiliation as a tool to force change because
such behavior is ethically inappropriate, engenders resis-
tance, and may act as a barrier to successful treatment
and recovery.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 198
 BNI-ART Institute Intervention Algorithm
The BNI-ART Institute (Brief Negotiated Interview and Active Referral to Treatment) is a program of Boston University School
of Public Health and the Youth Alcohol Prevention Center in collaboration with Boston Medical Center. Among its tools is a
two-sided card that summarizes the process of a brief intervention and referral for treatment.
Front of Card

BNI STEPS DIALOGUE/PROCEDURES

1. Raise subject and ask permission • Would you mind taking a few minutes to talk with me confidentially
about your use of [X]? <<PAUSE and LISTEN>>
• Before we start, could you tell me a little about your goals for your-
self…What’s important to you?
2. Provide feedback • From what I understand, you are using [insert screening data]…
• Review screen We know that drinking above certain levels, smoking and/or use
of illicit drugs can cause problems, such as [insert medical info].
• For alcohol… • These are the upper limits of low risk drinking for your age and sex.
Show NIAAA guidelines & norms By low risk we mean you would be less likely to experience illness
or injury if you stay within the guidelines.
• Make connection • If there is a possible connection between use of [X] and today’s
(no arguing) medical problem, ask, “What connection (if any) do you see between
your use of [X] and this visit today?”
If patient does not see connection: make one using specific
medical information
3. Enhance motivation
• Explore Pros and Cons Ask pros and cons
• Help me to understand what you enjoy about [X]? <<PAUSE AND
LISTEN>>
• Use reflective listening • Now tell me what you enjoy less about [X] or regret about your use
of [X] <<PAUSE AND LISTEN>>
On the one hand you said…
<<RESTATE PROS>>
On the other hand you said…
<<RESTATE CONS>>
• Readiness to change • So tell me, where does this leave you? [show readiness ruler]
On a scale from 1-10, how ready are you to change any aspect of
your use of [X]?
• Reinforce positives • Ask: Why did you choose that number and not a lower one like a 1
or a 2? Other reasons for change?
• Develop discrepancy between ideal and • Ask: How does this fit with where you see yourself in the future?
present self
4. Negotiate & advise What’s the next step?
• Negotiate goal • What do you think you can do to stay healthy and safe?
• Benefits of change • If you make these changes what do you think might happen?
• Reinforce resilience/resources • What have you succeeded in changing in the past? How?
Could you use these methods to help you with the challenges
of changing?
• Summarize • This is what I’ve heard you say…Here’s an action plan I would
like you to fill out, reinforcing your new goals. This is really an
agreement between you and yourself.
• Provide handouts • Provide agreement and information sheet
• Thank patient for his/her time.
Boston University School of Public Health. BNI-ART Institute intervention algorithm. Available at:
http://www.ed.bmc.org/sbirt/docs/aligo_adult.pdf. Retrieved January 23, 2008.
(continued)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 199

 BNI-ART Institute Intervention Algorithm (continued)
Back of Card
READINESS RULER
On a scale of 1 to 10, how ready are you to make any changes?
NOT READY VERY READY
| | | | | | | | | |
1 2 3 4 5 6 7 8 9 10
Source: BNI-ART Institute, Boston University School of Public Health
Justice
The ethical principle of justice governs access to care
and fair distribution of resources. Elimination of health
disparities and promotion of quality care for all are at
the top of the list of goals for Healthy People 2010, the
nation’s health agenda. Injustice may result from a variety
of sources.
Physicians may fail to apply principles of universal
screening. When women are less likely to be screened
or referred for treatment, their burden of disability is
increased and health status decreased. The principle of
justice requires that screening questions related to alcohol
and drug use should be asked equally of men and women,
regardless of race or economic status. It also requires that
women be screened with tests such as TWEAK, T-ACE,
or the NIAAA quantity and frequency questions that are
more accurate in detecting women’s patterns of sub-
stance abuse, which differ from those of men (40) (see
box “Substance Abuse Screening”). Women, for example,
are more likely to be hidden drinkers and frequently
underreport alcohol use, especially during pregnancy.
Tests to detect the problem in women must include ques-
tions about tolerance, which are not included in the most
commonly used screen, CAGE, which has a sensitivity of
only 75% compared with 87% for TWEAK (41).
Pregnant women are more likely to be screened than
nonpregnant women. Although the vulnerability of the
fetus is an important concern, the lives of nonpregnant
women also have compelling value, and there is much
evidence to suggest that women who abuse alcohol or
use illicit drugs have coexisting or preexisting conditions
(ie, mental health disorders, domestic violence, stress,
childhood sexual abuse, poverty, and lack of resources)
that put them in a vulnerable status (6, 42, 43). Universal
application of screening questions, brief intervention,
and referral to treatment eliminates these disparities
related to justice.
Additionally, failure to diagnose and treat substance
abuse with the same evidence-based approach applied to
other chronic illnesses reduces patients’ access to health
services and resources. Justice requires that physicians
COMMITTEE OPINIONS
counsel patients who have drug or alcohol problems and
refer them to an appropriate treatment resource when
available. No physician would withhold hypertension
therapy because the medication adherence rate is only
60%. Physicians who detect the serious medical condition
of addiction are equally obligated to intervene.
Respect for Autonomy
No person has a right to use illegal drugs, and a pregnant
woman has a moral obligation to avoid the use of both
illicit drugs and alcohol in order to safeguard the welfare
of her fetus. At the same time, effective intervention with
respect to substance abuse by a pregnant or a nonpreg-
nant woman requires that a climate of respect and trust
exist within the physician–patient relationship. Patients
who begin to disclose behaviors that are stigmatized
by society may be harmed if they feel that their trust is
met with disrespect. Criticism and shaming statements
actually increase resistance and impede change. Effective
interventions, as summarized in the NIAAA Treatment
Improvement Protocol number 35, are designed to
increase motivation to change by respecting autonomy,
supporting self-efficacy, and offering hope and resources
(10).
Effective intervention also requires that universal
screening questions, brief intervention, and referral to
treatment be conducted with full protection of confiden-
tiality. Patients who fear that acknowledging substance
abuse may lead to disclosure to others will be inhibited
from honest reporting to their physicians (44). A difficult
dilemma is created by state laws that require physicians
to report the nonmedical use of controlled substances by
a pregnant woman or that require toxicology tests after
delivery when there is evidence of possible use of a con-
trolled substance (eg, Minnesota statutes 626.5561 and
626.5562). Although such laws have the goals of refer-
ring the pregnant woman for assessment and chemical
dependency treatment if indicated and of protecting
fetuses and newborns from harm, these laws may unwit-
tingly result in pregnant women not seeking prenatal care
or concealing drug use from their obstetricians. Although
2013 COMPENDIUM OF SELECTED PUBLICATIONS 200
 it is always appropriate for a physician to negotiate with a
patient about her willingness to accept a medical recom-
mendation, respect for autonomy includes respect for
refusal to be screened.
Special Responsibilities to Pregnant
Patients
Federal warnings about the need to abstain from alcohol
use in pregnancy were first issued in 1984. The American
College of Obstetricians and Gynecologists recommend-
ed screening early in pregnancy in its 1977 Standards for
Ambulatory Obstetric Care, and a pamphlet was issued
in 1982 entitled “Alcohol and Your Unborn Baby.”
Screening during pregnancy was subsequently supported
in a variety of documents and is recommended in a joint
publication issued by ACOG and the American Academy
of Pediatrics (AAP) (45). Although obstetricians report
screening 97% of pregnant women for alcohol use, only
25% used any of the standard screening tools, and only
20% of those surveyed knew that abstinence is the only
known way to avoid all four adverse pregnancy outcomes
(spontaneous abortion, nervous system impairment,
birth defects, and FAS). This is a particularly significant
gap in knowledge because there is no level of alcohol use,
even minimal drinking, that has been determined to be
absolutely safe. More than one half of the respondents
(63%) reported that they lacked adequate informa-
tion about referral resources (46). Screening rates for
illicit drugs are lower than for alcohol (89%, according to
unpublished ACOG survey data).
Ethical issues related to beneficence and nonmalefi-
cence and the ethics of care (47) are similar for pregnant
and nonpregnant women and for women who do and
do not have children. In each of these cases, universal
screening questions, brief intervention, and referral to
treatment enables physicians to collaborate with patients
to improve their own health, reduce the likelihood of
preterm birth and neonatal complications in both cur-
rent and future pregnancies, and improve the parenting
capacity of the family unit.
As noted previously, autonomy issues are particu-
larly challenging in pregnancy. In a survey of obstetri-
cians, pediatricians, and family practice physicians, more
than one half of the respondents believed that pregnant
women have a legal as well as moral responsibility to
ensure that they have healthy newborns (48). Although
61% were concerned that fear of criminal charges would
be a barrier to receiving prenatal care, more than one
half supported a statute that would permit removal of
children from any woman who abused alcohol or drugs
(48). This position is particularly troubling because
these physicians did not state that there needed to be
evidence of physical or emotional neglect (adverse effects
on basic needs and safety) for children to be so removed.
Both ethical and legal perspectives require that the best
interests of the child be served, which requires both pro-
tecting children and assisting their mothers to be healthy
COMMITTEE OPINIONS
so as to provide an optimal situation for growth and
development.
Physicians’ concerns about mothers who abuse alco-
hol or drugs undoubtedly reflect a desire to protect
children. However, recommended screening and referral
protocols may be perceived as punitive measures when
they are connected with legally mandated testing, or
reporting, or both. Such measures endanger the rela-
tionship of trust between physician and patient, place
the obstetrician in an adversarial relationship with the
patient, and possibly conflict with the therapeutic obliga-
tion. If pregnant women become reluctant to seek medi-
cal care because they fear being reported for alcohol or
illegal drug use, these strategies will actually increase the
risks for the woman and the fetus rather than reduce the
consequences of substance abuse. Furthermore, threats
and incarceration have proved to be ineffective in reduc-
ing the incidence of alcohol or drug abuse, and removing
children from the home may only subject them to worse
risks in the foster care system (49). Treatment is both
more effective and less expensive than restrictive poli-
cies (50), and it results in a mean net saving of $4,644 in
medical expenses per mother–infant pair (51). Moreover,
women who have custody of their children complete
treatment at a higher rate than those who do not. Putting
women in jail, where drugs may be available but treat-
ment is not, jeopardizes the health of pregnant women
and that of their existing and future children (52).
Referral to treatment, especially if combined with
training in parenting skills, is the clinically appropriate
recommendation, both medically and ethically (37).
Criminal charges against pregnant women on grounds
of child abuse have been struck down in almost all cases
because courts have upheld the right to privacy, which
includes the right to decide whether to have a child, the
right to bodily integrity, and the right to “be let alone”
(53), and have found that states could better protect
fetal health through “education and making available
medical care and drug treatment centers for women”
(54). The United States Supreme Court recognized the
importance of privacy to the physician–patient relation-
ship when it ruled in 2001 to prohibit a public hospital
from performing nonconsensual drug tests on pregnant
women without a warrant and providing police with
positive results (55). Despite more than a decade of
efforts and the 1992 passage of a federal Alcohol Drug
Abuse and Mental Health Administration Reorganization
Act explicitly prohibiting pregnancy discrimination, few
treatment programs focus on the needs of pregnant
women. In the absence of appropriate and adequate drug
treatment services for pregnant women, criminal charges
on grounds of child abuse are unjust in that they indict
women for failing to seek treatment that actually may not
be available to them.
Justice issues also are problematic in that punitive
measures are not applied evenly across sex, race, and
socioeconomic status. Although several types of legal
2013 COMPENDIUM OF SELECTED PUBLICATIONS 201
 sanctions against pregnant women who abuse alcohol or
drugs are being tested in the courts, there has been no
attempt to impose similar sanctions for paternal drug
use (56), despite the significant involvement of male
partners in pregnant women’s substance abuse (57).
In a landmark study among pregnant women anony-
mously tested for drug use, drug prevalence was similar
between African-American women and white women,
but African-American women were 10 times more likely
than white women to be reported as a result of positive
screen results (58). Similar patterns of injustice have been
noted for the types of drugs for which sanctions exist in
the legal system. For example, mandatory incarceration
and more severe penalties are applied to crack cocaine,
which is primarily used by African Americans, than to
powder cocaine or heroin, which is primarily used by
whites. In the case of Ferguson v. City of Charleston, an
overwhelming majority of the pregnant women arrested
in the immediate postpartum period because of cocaine-
positive drug screen results were African American.
When the results of similarly drawn drug screens were
positive for methamphetamine or heroin, which were
more commonly used by white patients, physicians
were more likely to refer to social services rather than to
the courts (55).
Some physicians are reluctant to record informa-
tion related to alcohol or drug abuse in medical records
because of competing obligations. On the one hand,
the physician may be concerned about nonmaleficence.
Because medical records may not be safe from inap-
propriate disclosure despite federal and state privacy
protections, the patient may experience real harms—such
as job loss unrelated to workplace performance issues,
eviction from public housing, or termination of insur-
ance—if a diagnosis of dependency is recorded in the
medical record. Although legal redress for harms that
result from inappropriate transfer of information may be
possible, it may not be feasible for a woman in straitened
circumstances. On the other hand, the principle of benef-
icence often requires disclosure of information needed
by the medical team to provide appropriate medical care.
Without this disclosure, a physician treating the patient
for a problem unrelated to pregnancy or an emergency
department physician seeing the patient for the first time
may miss a major complication related to substance
abuse. Concerns about protection of confidentiality and
nonmaleficence can be addressed most appropriately by
including only medically necessary, accurate information
in the medical record and informing the patient about the
purpose of any disclosure.
Responsibilities to Neonates
The use of illicit drugs and alcohol during pregnancy
has demonstrated adverse effects on the neonate, and
these newborns are subsequently at risk for altered
neurodevelopmental outcome and poor health status
(59). Detection and treatment are essential precursors of
COMMITTEE OPINIONS
appropriate therapeutic intervention in the immediate
setting. Early recognition of parental substance abuse
also may lead to interventions designed to decrease asso-
ciated risks to a child’s physical and psychologic health
and safety (32–37). Doing so may obviate the necessity
for placement in an already overburdened foster care
system (60). Underrecognition of prenatal alcohol and
drug effects is common, however (61). A toxicology
screen and scoring for craniofacial features suggestive
of FAS should be performed by the neonate’s physician
whenever clinically indicated. According to the AAP’s
statement on neonatal drug withdrawal (62), mater-
nal characteristics that suggest a need for biochemi-
cal screening of the neonate include no prenatal care,
previous unexplained fetal demise, precipitous labor,
abruptio placentae, hypertensive episodes, severe mood
swings, cerebrovascular accidents, myocardial infarc-
tion, and repeated spontaneous abortions. Infant char-
acteristics that may be associated with maternal drug use
include preterm birth, unexplained intrauterine growth
restriction, neurobehavioral abnormalities, congenital
abnormalities, atypical vascular incidents, myocardial
infarction, and necrotizing enterocolitis in otherwise
healthy term infants. The legal implications of testing
and the need for maternal consent vary from state to
state; therefore, physicians should be aware of local laws
that may influence regional practice.
Biophysical testing, however, has major limitations
(63–65). Both urine and meconium screens have a high
rate of false-negative results because of factors related
to the timing and amount of the last maternal drug use
(for urine) and the failure to detect drug metabolites
(for meconium). Hair is associated with a substantial
false-positive rate because of passive exposure to min-
ute quantities of illicit substances in the environment.
Physicians and nurses often fail to recognize the physical
manifestations of FAS (66). Maternal self-report of use
or consent to testing, elicited using nonjudgmental, sup-
portive interview techniques within a physician–patient
relationship of trust, can thus provide the best informa-
tion for guiding neonatal treatment and the best progno-
sis for family intervention. Maternal substance abuse does
not by itself guarantee child neglect or prove inadequate
parenting capacity (67, 68). Parenting skills programs,
assistance with employment and housing issues, and
access to substance abuse treatment have been shown to
be successful support mechanisms for families of affected
neonates, and these elements should be part of a compre-
hensive approach to substance abuse problems. If there
is evidence to suggest the likelihood of neglect or abuse,
referral to children’s protective services may be indicated
(69). A children’s protective services referral should never
be undertaken as a punitive measure, but with the aim
of evaluating circumstances, protecting the child, and
providing services to maintain or reunify the family unit
if at all possible.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 202
 Special Issues for Girls and
Young Women
Use of alcohol and illicit drugs among youth is prevalent,
and studies that included both male and female youth
indicate that age of first use is decreasing. Youth who
begin drinking at age 14 years are at least three times
more likely to experience dependence (using criteria
from the Diagnostic and Statistical Manual of Mental
Disorders, 4th Edition) than those who delay drinking
to age 21 years (70). Early onset of drinking increases
the likelihood of alcohol-related unintentional injuries
(71), motor vehicle crash involvement after drinking
(72), unprotected intercourse (73), and getting into
fights after drinking, even after controlling for frequency
of heavy drinking, alcohol dependence, and other fac-
tors related to age of onset (74). A study among a large
community sample of lifetime drinkers showed that
those who reported first drinking at the ages of 11–14
years experienced a rapid progression to alcohol-related
harm, and 16% developed dependence by age 24 years
(75). Among youth aged 21–25 years surveyed in 2006,
27.3% drove under the influence of alcohol (1). The use
of alcohol and illicit substances by youth and the impact
of parental alcohol and substance use on children have
adverse health outcomes (76, 77). Prevention (universal
screening questions, brief intervention, and referral to
treatment) has thus been described by leaders in obstet-
rics and gynecology and by pediatricians as a moral
obligation (78). In 1993, the AAP developed substance
abuse guidelines for clinical practice. These guidelines
have now been refined and developed into competencies
that provide practical direction for clinicians engaged in
educating, supporting, and treating patients and families
affected by substance abuse (79).
Confidentiality is as essential to the physician–
patient relationship with children as it is with adults.
Many state laws protect the confidentiality of minors
with regard to substance abuse detection and treatment
(79). Autonomy issues are of particular importance
in the detection and treatment of substance abuse for
adolescents, who are at a developmental stage in which
it is a normative task to test new identities and engage in
risk-taking in the process (80). The ACOG Committee
on Adolescent Health Care lists the following key points
concerning informed consent, parental permission, and
assent (81):
• Concern about confidentiality is a major obstacle in
the delivery of health care to adolescents. Physicians
should address confidentiality issues with the adoles-
cent patient to build a trusting relationship with her
and to facilitate a candid discussion regarding her
health and health-related behaviors.
• Physicians also should discuss confidentiality issues
with the parent(s) or guardian(s) of the adolescent
patient. Physicians should encourage their involve-
COMMITTEE OPINIONS
ment in the patient’s health and health care decisions
and, when appropriate, facilitate communication
between the two.
• The right of a “mature minor” to obtain selected
medical care has been established in most states.
In a document about testing for drugs of abuse in
children and adolescents, AAP states that the goal of care
is a therapeutic, rather than adversarial, relationship with
the child and, therefore, makes the following recommen-
dations (82):
• Screening or testing under any circumstances is
improper if clinicians cannot be reasonably certain
that the laboratory results are valid and that patient
confidentiality is ensured.
• Diagnostic testing for the purpose of drug abuse
treatment is within the ethical tradition of health
care, and in the competent patient, it should be con-
ducted noncovertly, confidentially, and with informed
consent in the same context as for other medical
conditions.
• Parental permission is not sufficient for involuntary
testing of the adolescent with decisional capacity.
• Suspicion that an adolescent is using a psychoactive
drug does not justify involuntary testing, and testing
adolescents requires their consent unless 1) the patient
lacks decision-making capacity or 2) there are strong
medical indications or legal requirements to do so.
• Minors should not be immune from the criminal
justice system, but physicians should not initiate or
participate in a criminal investigation, except when
required by law, as in the case of court-ordered drug
testing or child abuse reporting.
Guidance for Physicians
The health care system as it is currently constituted creates
barriers to the practice of universal screening questions,
brief intervention, and referral to treatment for alcohol
and drug abuse. Because of a lack of medical school
curricular content about addiction, physicians often are
unfamiliar with screening procedures. Many institutions
do not have appropriate protocols in place for interven-
tion and referral. Time constraints, mandatory report-
ing laws, and lack of treatment resources may impede
both screening and referral, and some of these problems
may be beyond the ability of the individual physician to
modify. Nevertheless, in fulfillment of the therapeutic
obligation, physicians must make a substantial effort to:
• Learn established techniques for rapid, effective
screening, intervention, and referral, and practice
universal screening questions, brief intervention, and
referral to treatment in order to provide benefit and
do no harm. Where possible, create a team approach
to deal with barriers of time limitations, using the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 203
 skills of social workers, nurses, and peer educators
for universal screening questions, brief intervention,
and referral to treatment. Use external resources (eg,
hospital social worker, health department, addiction
specialist) to develop a list of treatment resources.
• Treat the patient with a substance abuse problem
with dignity and respect in order to form a therapeu-
tic alliance.
• Protect confidentiality and the integrity of the physi-
cian–patient relationship wherever possible within
the requirements of legal obligations, and commu-
nicate honestly and directly with patients about what
information can and cannot be protected. In states
where there are laws requiring disclosure, inform
patients in advance about specific items for which
disclosure is mandated.
• Recognize that the most effective safeguard for chil-
dren is treatment for family members who have a
substance abuse problem.
• Balance competing obligations carefully, consulting
with other physicians or an ethicist if troubling situ-
ations arise.
• Participate, whenever possible, in the policy process
at institutional, state, and national levels as an advo-
cate for the health care needs of patients.
• Consider whether elements of personal beliefs and
values may be resulting in biases in medical practice.
Be aware that some physicians minimize the uni-
versality and impact of alcohol or prescription drug
abuse to protect against evaluating their own alcohol
or substance abuse problems. A physician who has
questions about his or her own use should seek help.
Conclusion
Substance abuse is a common medical condition that can
have devastating physical and emotional consequences
for women and their children. The traditional role of
healer, the contemporary role of medical expert, and the
newer role of primary care physician all require obstetri-
cian–gynecologists to develop an evidence-supported
knowledge base about methods for detection and treat-
ment of substance abuse. The close working relationship
between the physician and the patient that is both a goal
of care and a means to improved health outcomes offers
tremendous potential to influence patients’ lifestyles
positively. Despite this relationship, physicians seldom
practice universal screening because of a lack of apprecia-
tion of prevalence, misunderstandings about treatment
success rates, unfamiliarity with treatment resources, and
inadequate knowledge about sex differences in presenta-
tion and the course of the disease. However, common
barriers to universal screening questions, brief inter-
vention, and referral to treatment can and should be
addressed. Physicians have an ethical obligation to learn
and use techniques for universal screening questions,
COMMITTEE OPINIONS
brief intervention, and referral to treatment in order to
provide patients and their families with medical care that
is state-of-the-art, comprehensive, and effective.
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COMMITTEE OPINIONS
Copyright © December 2008 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
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At-risk drinking and illicit drug use: ethical issues in obstetric and
gynecologic practice. ACOG Committee Opinion No. 422. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2008;
112:1449–60.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 207
 ACOG COMMITTEE OPINION
Number 439 • August 2009

Informed Consent*
Committee on Ethics ABSTRACT: Obtaining informed consent for medical treatment, for participation
in medical research, and for participation in teaching exercises involving students and
residents is an ethical requirement that is partially reflected in legal doctrines and
requirements. As an ethical doctrine, informed consent is a process of communica-
tion whereby a patient is enabled to make an informed and voluntary decision about
accepting or declining medical care. In this Committee Opinion, the American College
of Obstetricians and Gynecologists’ Committee on Ethics describes the history, ethical
basis, and purpose of informed consent and identifies special ethical questions pertinent
to the practice of obstetrics and gynecology. Two major elements in the ethical concept
of informed consent, comprehension (or understanding) and free consent, are reviewed.
Limits to informed consent are addressed.

Informed consent is an ethical concept that 4. Communication is necessary if informed

has become integral to contemporary medi-
cal ethics and medical practice. In recogni-
tion of the ethical importance of informed
consent, the Committee on Ethics of the
American College of Obstetricians and Gyne-
cologists (ACOG) affirms the following eight
statements:
1. Obtaining informed consent for medical
treatment, for participation in medical
research, and for participation in teach-
ing exercises involving students and resi-
dents is an ethical requirement that is
partially reflected in legal doctrines and
requirements.
2. Seeking informed consent expresses
respect for the patient as a person; it par-
ticularly respects a patient’s moral right
to bodily integrity, to self-determination
regarding sexuality and reproductive
capacities, and to support of the patient’s
freedom to make decisions within caring
relationships.
3. Informed consent not only ensures the
protection of the patient against unwant-
ed medical treatment, but it also makes
The American College possible the patient’s active involvement
of Obstetricians in her medical planning and care.
and Gynecologists
*Update of “Informed Consent” in Ethics in Obstetrics
Women’s Health Care and Gynecology, Second Edition, 2004.
Physicians
consent is to be realized, and physicians
can and should help to find ways to
facilitate communication not only in
individual relations with patients but
also in the structured context of medical
care institutions.
5. Informed consent should be looked on
as a process rather than a signature on
a form. This process includes a mutual
sharing of information over time between
the clinician and the patient to facilitate
the patient’s autonomy in the process of
making ongoing choices.
6. The ethical requirement to seek informed
consent need not conflict with phy-
sicians’ overall ethical obligation of
beneficence; that is, physicians should
make every effort to incorporate a com-
mitment to informed consent within a
commitment to provide medical benefit
to patients and, thus, to respect them as
whole and embodied persons.
7. When informed consent by the patient
is impossible, a surrogate decision
maker should be identified to represent
the patient’s wishes or best interests. In
emergency situations, medical profes-
sionals may have to act according to
their perceptions of the best interests of
the patient; in rare instances, they may

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 208

 have to forgo obtaining consent because of some
other overriding ethical obligation, such as protect-
ing the public health.
8. Because ethical requirements and legal requirements
cannot be equated, physicians also should acquaint
themselves with federal and state legal require-
ments for informed consent. Physicians also should
be aware of the policies within their own practices
because these may vary from institution to institution.
The application of informed consent to contexts of
obstetric and gynecologic practice invites ongoing clari-
fication of the meaning of these eight statements. What
follows is an effort to provide this.
Historical Background
In 1980, the Committee on Ethics developed a statement
on informed consent. This statement, “Ethical Consider-
ations Associated with Informed Consent,” was subse-
quently approved and issued in 1980 as a Statement of
Policy by ACOG’s Executive Board. The 1980 statement
reflected what is now generally recognized as a paradigm
shift in the understanding of the ethics of the physician–
patient relationship. During the 1970s, a marked change
took place in the United States from a traditional almost
singular focus on the benefit of the patient as the govern-
ing ethical principle of medical care to a new and dra-
matic emphasis on a requirement of informed consent.
That is, a central and often sole concern for the medical
well-being of the patient was modified to include concern
for the patient’s autonomy in making medical decisions.
In the 1980s, this national shift was both reinforced
and challenged in medical ethics. Clinical experience as
well as developments in ethical theory generated further
questions about the practice of informed consent and the
legal doctrine that promoted it. If in the 1970s informed
consent was embraced as a corrective to paternalism, in
the 1980s and 1990s shared decision making was increas-
ingly viewed as a necessary corrective to the exaggerated
individualism that patient autonomy had sometimes pro-
duced. At the same time, factors such as the proliferation
of medical technologies, the bureaucratic and financial
complexities of health care delivery systems, and the
growing sophistication of the general public regarding
medical limitations and possibilities continued to under-
gird an appreciation of the importance of patient auton-
omy and a demand for its promotion in and through
informed consent.
In the early 21st century, there are good reasons for
considering once again the ethical significance and prac-
tical application of the requirement to seek informed
consent. This is particularly true in the context of obstet-
ric and gynecologic practice because medical options,
public health problems, legal interventions, and political
agendas have expanded and interconnected with one
another in unprecedented ways. The concern of ACOG
COMMITTEE OPINIONS
for these matters is reflected in its more recent docu-
ments on informed consent and on particular ethical
problems that arise in the context of maternal–fetal
relationships, decisions about relationships, sterilization,
surgical options, and education in the health professions
(1–7). Although a general doctrine of informed consent
cannot by itself resolve problems like these, it is none-
theless necessary for understanding and responding to
them.
Informed consent for medical treatment and for
participation in medical research is both a legal and an
ethical matter. In the recent history of informed consent,
statutes and regulations as well as court decisions have
played an important role in the identification and sanc-
tioning of basic duties. Judicial decisions have sometimes
provided insights regarding rights of self-determination
and of privacy in the medical context. Government
regulations have rendered operational some of the most
general norms formulated in historic ethical codes†.
Yet, recent developments in the legal doctrine are few,
and the most serious current questions are ethical ones
before they become issues in the law. As the President’s
Commission reported in 1982, “Although the informed
consent doctrine has substantial foundations in law, it
is essentially an ethical imperative” (8). What above all
bears reviewing, then, is the ethical dimension of the
meaning, basis, and application of informed consent.
Although informed consent has both legal and ethi-
cal implications, its purpose is primarily ethical in nature.
As an ethical doctrine, informed consent is a process of
communication whereby a patient is enabled to make
an informed and voluntary decision about accepting or
declining medical care. There are important legal aspects
to informed consent that should not be overlooked. It is
critical for physicians to document the contents of this
conversation as part of the permanent medical record.
A signed consent document, however, does not ensure
that the process of informed consent has taken place in
a meaningful way or that the ethical requirements have
been met.
The Ethical Meaning of Informed
Consent
The ethical concept of “informed consent” contains two
major elements: 1) comprehension (or understanding)
and 2) free consent. Both of these elements together
constitute an important part of a patient’s “self-deter-
mination” (the taking hold of her own life and action,
determining the meaning and the possibility of what
she undergoes as well as what she does). Both of these
elements presuppose a patient’s capacity to understand
†
The Nuremberg Code in 1948 and the World Medical Association’s
Declaration of Helsinki in 1964 identified ethical restrictions for medi-
cal research on human subjects. For a history of the development of
such codes and a general history of the ethical and legal concept of
informed consent, see Faden RR, Beauchamp TL. A history and theory
of informed consent. New York (NY): Oxford University Press; 1986.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 209
 and to consent, a presupposition that will be examined
later.
Comprehension (as an element in informed con-
sent) includes the patient’s awareness and understanding
of her situation and possibilities. It implies that she has
been given adequate information about her diagnosis,
prognosis, and alternative treatment choices, including
the option of no treatment. Moreover, this information
should be provided in language that is understandable to
the particular patient, who may have linguistic or cogni-
tive limitations. Comprehension in this sense is necessary
for freedom in consenting.
Free consent is an intentional and voluntary choice
that authorizes someone else to act in certain ways. In
the context of medicine, it is an act by which an indi-
vidual freely authorizes a medical intervention in her
life, whether in the form of treatment or participation
in research or medical education. Consenting freely is
incompatible with being coerced or unwillingly pressured
by forces beyond oneself. It involves the ability to choose
among options and to select a course other than what
may be recommended. It is important for physicians to
be cognizant of their own beliefs and values during the
informed consent process. Physicians should have insight
into how their opinions may affect the way in which
information is presented to patients and, as a result, influ-
ence the patient’s decision to accept or decline a therapy.
Different models of the physician–patient relationship
exist, and the degree to which a physician would share
his or her values and professional opinions with patients
varies (5). In many cases, the physician’s personal and
professional values and clinical experiences do, to some
degree, influence the presentation and discussion of ther-
apeutic options with patients. Although not considered
frank manipulation or coercion, care should be taken
that the physician’s perspectives do not unduly influence
a patient’s voluntary decision making.
Free consent, of course, admits of degrees, and its
presence is not always verifiable in concrete instances.
If free consent is to be operative at all in the course of
medical treatment, it presupposes knowledge about and
understanding of all the available options.
Many thoughtful individuals have different beliefs
about the actual achievement of informed consent and
about human freedom. Many philosophical disputes have
raged about what freedom is and whether it exists. These
differences in underlying philosophical perspectives do
not, however, alter the general agreement about the need
for informed consent and about its basic ethical signifi-
cance in the context of medical practice and research. It
is still important to try to clarify, however, who and what
informed consent serves and how it may be protected and
fostered. This clarification cannot be achieved without
some consideration of its basis and goals and the concrete
contexts in which it must be realized.
COMMITTEE OPINIONS
The Ethical Basis and Purpose of
Informed Consent
One of the important arguments for the ethical require-
ment of informed consent is an argument from utility,
or from the benefit that can come to patients when they
actively participate in decisions about their own medical
care. The involvement of patients in such decisions is
good for their health—not only because it helps protect
against treatment that patients might consider harmful,
but also because it often contributes positively to their
well-being. There are at least two presuppositions here: 1)
patients know something experientially about their own
medical condition that can be helpful and even necessary
to the sound management of their medical care, and 2)
wherever it is possible, patients’ active role as primary
guardian of their own health is more conducive to their
well-being than is a passive and submissive “sick role.”
The positive benefits of patient decision making are obvi-
ous, for example, in the treatment of alcohol abuse. But
the benefits of active participation in medical decisions
are multifold for patients, whether they are trying to
maintain their general health, recover from illness, con-
ceive and give birth to healthy newborns, live responsible
sexual lives, or accept the limits of medical technology.
Utility, however, is not the only reason for protect-
ing and promoting patient decision making. Indeed, the
most commonly accepted foundation for informed con-
sent is the principle of respect for persons. This principle
expresses an ethical requirement to treat persons as “ends
in themselves” (that is, not to use them solely as means
or instruments for someone else’s purposes and goals).
This requirement is based on the belief that all persons,
as persons, have certain features or characteristics that
constitute the source of an inherent dignity, a worthiness
and claim to be affirmed in their own right. One of these
features has come to be identified as personal autono-
my—a person’s capacity for self-determination (for self-
governance and freedom of choice). To be autonomous
is to have the capacity to set one’s own agenda. Given this
capacity in persons, it is ordinarily an ethically unaccept-
able violation of who and what persons are to manipulate
or coerce their actions or to refuse their participation in
important decisions that affect their lives.
An important development in ethical theory in
recent years is the widespread recognition that autonomy
is not the only characteristic of persons that is a basis for
the requirement of respect. Human beings are essentially
social beings, relational in the structure of their person-
alities, their needs, and their possibilities. As such, then,
the goal of human life and the content of human well-
being cannot be adequately understood only in terms
of self-determination—especially if self-determination is
understood individualistically and if it results in human
relationships that are primarily adversarial. A sole or
even central emphasis on narrow conceptions of patient
autonomy that presume a highly individualistic agent in
2013 COMPENDIUM OF SELECTED PUBLICATIONS 210
 the informed consent process in the medical context risks
replacing paternalism with a distanced and impersonal
relationship of strangers negotiating rights and duties. If
persons are to be respected and their well-being promot-
ed, informed consent must be considered in the context
of individuals’ various relationships.
Patients approach medical decisions with a history
of relationships, personal and social, familial and institu-
tional. They make decisions in the context of these rela-
tionships, shared or not shared, as the situation allows.
One such relationship is between patient and physician
(or often between patient and multiple professional
caregivers).
The focus, then, for understanding both the basis
and the content of informed consent must shift to include
the many facets of the physician–patient relationship.
Informed consent, from this point of view, is not an end,
but a means. It is a means not only to the responsible
participation by patients in their own medical care but
also to a relationship between physician (or any medical
caregiver) and patient. From this perspective, it is pos-
sible to see the contradictions inherent in an approach to
informed consent that would, for example:
• Lead a physician (or anyone else) to say of a patient,
“I consented the patient”
• Assume that informed consent is achieved simply by
the signing of a document
• Consider informed consent primarily as a safeguard
for physicians against professional liability
This view of informed consent posits a dialogue
between patient and health care provider in support of
respect for patient autonomy. A major objective of this
view is to prevent the practitioner from imposing treat-
ments. It does not, however, require practitioners to
accede to patient requests for unproven or harmful treat-
ment modalities.
Obstetrics and Gynecology: Special
Ethical Concerns for Informed Consent
The practice of obstetrics and gynecology has always
faced special ethical questions in the implementation of
informed consent. How, for example, can the autonomy
of patients best be respected when serious decisions
must be made in the challenging situations of labor and
delivery? What kinds of guidelines can physicians find
for respecting the autonomy of adolescents, when society
acknowledges this autonomy by and large only in the
limited spheres of sexuality and reproduction? In the con-
text of genetic counseling, where being “non-directive” is
the norm, is it ever appropriate to recommend a specific
course of action? How much information should be given
to patients about controversies surrounding specific treat-
ments? How are beneficence requirements (regarding the
well-being of the patient) to be balanced with respect for
autonomy, especially in a field of medical practice where
COMMITTEE OPINIONS
so many key decisions are irreversible? These and many
other questions continue to be important for fulfilling the
ethical requirement to seek informed consent.
Developments in the ethical doctrine of informed
consent (regarding, for example, the significance that
relationships have for decision making) have helped to
focus some of the concerns that are particularly impor-
tant in the practice of obstetrics and gynecology (1).
Where women’s health care needs are addressed, and
especially where these needs are related to women’s
sexuality and reproductive capacities, the issues of patient
autonomy and its relational nature come to the forefront.
Perspectives and insights for interpreting these issues
are now being articulated by women out of their experi-
ence—that is, their experience specifically in the medical
setting, but also more generally in relation to their own
bodies, in various patterns of relation with other individ-
uals, and in the larger societal and institutional contexts
in which they live. These perspectives and insights offer
both a help and an ongoing challenge to professional self-
understanding and practice of obstetricians and gyne-
cologists (whether they themselves are women or men).
New models for the active participation of health
care recipients have been created in obstetrics and gyne-
cology. Some of these developments are the result of
arguments that pregnancy and childbirth should not
be thought of as diseases, although they bring women
importantly into relation with medical professionals and,
in some cases, carry a potential for morbidity or mortal-
ity. Even when women’s medical needs pointedly require
diagnosis and treatment, their concerns to hold together
the values of both autonomy and their relationships have
been influential in shaping not only ethical theory but
also medical practice. Women themselves have ques-
tioned, for example, whether autonomy can really be
protected if it is addressed in a vacuum, apart from an
individual’s concrete roles and relationships. But women
as well as men also have recognized the ongoing impor-
tance of respect for autonomy, although they suggest it
should be reconceptualized as less individualistic and
more “relational” (9). They call for attention to the com-
plexity of the relationships that are involved, especially
when sexuality and parenting are at issue in medical care,
while upholding the importance of bodily integrity and
self-determination.
The difficulties that beset the full achievement of
informed consent in the practice of obstetrics and gyne-
cology are not limited to individual and interpersonal fac-
tors. Both health care providers and recipients of medical
care within this specialty have recognized the influence of
such broad social problems as the historical imbalance of
power in gender relations and in the physician–patient
relationship, the constraints on individual choice posed
by complex medical technology, and the intersection of
gender bias with race and class bias in the attitudes and
actions of individuals and institutions. None of these
problems makes the achievement of informed consent
2013 COMPENDIUM OF SELECTED PUBLICATIONS 211
 impossible. But, they point to the need to identify the
conditions and limits, as well as the central requirements,
of the ethical application of this doctrine.
Ethical Applications of Informed
Consent
Insofar as comprehension and voluntariness are the basic
ethical elements in informed consent, its efficacy and
adequacy will depend on the fullness of their realization
in patients’ decisions. There are ways of assessing this and
strategies for achieving informed consent, even though it
involves a process that is not subject to precise measure-
ment.
It is difficult to specify what consent consists of and
requires because it is difficult to describe a free decision
in the abstract. Two things can be said about it in the
context of informed consent to a medical intervention,
however, elaborating on the conceptual elements identi-
fied previously in this Committee Opinion. The first is
to describe what consent is not, what it is freedom from.
Informed consent includes freedom from external coer-
cion, manipulation, or infringement of bodily integrity.
It is freedom from being acted on by others when they
have not taken account of and respected the individual’s
own preference and choice. This kind of freedom for
a patient is not incompatible with a physician’s giving
reasons that favor one option over another. Medical rec-
ommendations, when they are not coercive or deceptive,
do not violate the requirements of informed consent. For
example, to try to convince a patient to take a medication
that will improve her health is not to take away her free-
dom (assuming that the methods of persuasion respect
and address, rather than overwhelm, her freedom).
Second, although informed consent to a medical
intervention may be an authorization of someone else’s
action toward one’s self, it is—more profoundly—an
active participation in decisions about the management
of one’s medical care. It is (or can be), therefore, not only
a “permitting” but a “doing.” It can include decisions to
make every effort toward a cure of a disease; or when a
cure is no longer a reasonable goal, to maintain func-
tional equilibrium; or, finally, to receive only supportive
or palliative care. The variety of choices that are possible
to a patient ranges, for example, from surgery to medical
therapy, from diagnostic tests to menopausal hormone
therapy, and from one form of contraception to another.
For women in the context of obstetrics and gynecology,
the choices may be positive determination of one kind of
assisted reproduction or another or one kind of preven-
tive medicine or another—choices that are best described
as determinations of their own actions rather than passive
“receiving” of care.
Consent in this sense requires not only external
freedom and freedom from inner compulsion, but also
(as previously noted in this document) freedom from
ignorance. Hence, to be ethically valid, consent must be
“informed.”
COMMITTEE OPINIONS
Consent is based on the disclosure of information
and a sharing of interpretations of its meaning by a medi-
cal professional. The accuracy of disclosure, insofar as it is
possible, is governed by the ethical requirement of truth-
telling. The adequacy of disclosure has been judged by
various criteria, which may include the following:
1. The common practice of the profession
2. The reasonable needs and expectations of the ordi-
nary individual who might be making a particular
decision
3. The unique needs of an individual patient faced with
a given choice‡
Although these criteria have been generated in the
rulings of courts, the courts themselves have not provided
a unified voice as to which of these criteria should be
determinative. Trends in judicial decisions in most states
were for a time primarily in the direction of the “profes-
sional practice” criterion, requiring only the consistency
of a physician’s disclosure with the practice of disclosure
by other physicians. Now the trend in many states is more
clearly toward the “reasonable person” criterion, holding
the medical profession to the standard of what is judged
to be material to an ordinary individual’s decision in the
given medical situation. The criterion of the subjective
needs of the patient in question generally has been too
difficult to implement in the legal arena, but its ethical
force is significant.
Health care providers should engage in some ethical
discernment of their own as to which criteria are most
faithful to the needs and rightful claims of patients for
disclosure. All three criteria offer reminders of ethical
accountability and guidelines for practice. All three can
help to illuminate what needs to be shared in the signifi-
cant categories for disclosure: diagnosis and description
of the patient’s medical condition, description of the
proposed treatment and its nature and purpose, risks and
possible complications associated with the treatment,
alternative treatments or the relative merits of no treat-
ment at all, and the probability of success of the treatment
in comparison with alternatives.
Listing categories of disclosure does not by itself
include all the elements that are important to adequacy of
disclosure. Among other matters, the obligation to pro-
vide adequate information to a patient implies an obliga-
tion for physicians to be current in their own knowledge,
for instance, about treatments and disease processes. As
an aid to physicians in communicating information to
patients, ACOG makes available more than 100 patient
education pamphlets on a wide variety of subjects. When
physicians make informed consent possible for patients
by giving them the knowledge they need for choice, it
should be clear to patients that their continued medical
‡
For an overview of legal standards for disclosure and ethical questions
that go beyond legal standards, see Faden RR, Beauchamp TL. A history
and theory of informed consent. New York (NY): Oxford University
Press; 1986.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 212
 care by a given physician is not contingent on their mak-
ing the choice that the physician prefers (assuming the
limited justifiable exceptions to this that will be addressed
later).
Those who are most concerned with problems of
informed consent insist that central to its achievement
is communication—communication between physician
and patient, communication among the many medical
professionals who are involved in the care of the patient,
and communication (where this is possible and appro-
priate) with the family of the patient. Documentation in
a formal process of informed consent can be a help to
necessary communication (depending on the methods
and manner of its implementation). The completion of a
written consent document, whether required by statute,
regulation, policy, or case law, should never be a substi-
tute for the communication involved in disclosure, the
conversation that leads to an informed and voluntary
consent or refusal (6, 10).
To focus on the importance of communication for
the implementation of an ethical doctrine of informed
consent is, then, to underline the fact that informed con-
sent involves a process. There is a process of communica-
tion that leads to initial consent (or refusal to consent)
and that can make possible appropriate ongoing decision
making.
There are, of course, practical difficulties with ensur-
ing the kind of communication necessary for informed
consent. Limitations of time in a clinical context, pat-
terns of authority uncritically maintained, underdevel-
oped professional communication skills, limited English
proficiency, “language barriers” between technical dis-
course and ordinarily comprehensible expression, and
situations of stress on all sides—all of these frequently
yield less than ideal circumstances for communication.
Yet the ethical requirement to obtain informed con-
sent, no less than a requirement for good medical care,
extends to a requirement for reasonable communication.
The conditions for communication may be enhanced by
creating institutional policies and structures that make it
more possible and effective.
Although understanding and voluntariness are basic
elements of informed consent, they admit of degrees.
There will always be varying levels of understanding,
varying degrees of internal freedom. The very matters of
disclosure may be characterized by disagreement among
professionals, uncertainty and fallibility in everyone’s
judgments, the results not only of scientific analysis but
of medical insight and art. And the capacities of patients
for comprehension and consent are more or less acute,
of greater or lesser power, focused in weak or strong
personal integration, and compromised or not by pain,
medication, disease, or social circumstance. Some limita-
tions mitigate the obligation to obtain informed consent,
and some render it impossible. But any compromise
or relaxation of the full ethical obligation to obtain
informed consent requires specific ethical justification.
COMMITTEE OPINIONS
The Limits of Informed Consent
Because informed consent admits of degrees of imple-
mentation, there are limits to its achievement. These are
not only the limits of fallible knowledge or imperfect
communication. They are limitations in the capacity of
patients for comprehension and for choice. Assessment
of patient capacity is itself a complex matter, subject to
mistakes and to bias. Hence, a great deal of attention has
been given to criteria for determining individual capacity
(and the legally defined characteristic of “competence”)
and for just procedures for its evaluation (8). When indi-
viduals are entirely incapacitated for informed consent,
the principles of respect for persons and beneficence
require that the patient be protected. In these situations,
someone else must make decisions on behalf of the
patient. A surrogate decision maker should be identified
to provide a “substituted judgment” (a decision based
on what the patient would have wanted, assuming some
knowledge of what the patient’s wishes would be); if the
patient’s wishes are unknown, the surrogate makes a
decision according to the “best interests” of the patient. If
the patient has previously executed an advance directive,
that document should guide the selection of a surrogate
decision maker or the specific decisions made by the sur-
rogate or both, depending on the nature of the advance
directive.
The judgment that informed consent is impossible in
some circumstances indicates a kind of limit that is differ-
ent from a partial actualization of consent or consent by
an appropriate surrogate. One way to acknowledge this
is to say that there are limits to the obligation to obtain
informed consent at all. There are several exceptions to
the strict rule of informed consent.
First, impossibility of any achievement of informed
consent suspends or limits the ethical obligation. This
is exemplified in emergency situations in which consent
is unattainable and in other situations when a patient is
not at all competent or capable of giving consent and an
appropriate surrogate decision maker is not available.
In the practice of obstetrics and gynecology, as in any
other specialty practice, there are situations where deci-
sions can be based only on what is judged to be in the
best interest of the patient—a judgment made, if pos-
sible, by a designated surrogate, legal guardian, or family
members together with medical professionals. Yet often
when a patient is not able to decide for herself (perhaps,
for example, because of the amount of medication needed
to control pain), a substituted judgment or a judgment
on the basis of prior informed consent can be made with
confidence if care has been taken beforehand to learn
the patient’s wishes. This signals the importance of early
communication so that what a patient would choose in a
developing situation is known—so that, indeed, it remains
possible to respect the self-determination that informed
consent represents.
A second way in which the rule of informed consent
may be suspended or limited is by being overridden by
2013 COMPENDIUM OF SELECTED PUBLICATIONS 213
 another obligation. A number of other ethical obligations
can, in certain circumstances, override or set limits on
the requirement to obtain informed consent. For exam-
ple, strong claims for the public good (specifically, pub-
lic health) may set limits to what a patient can refuse or
choose. That is, although the rights of others not to be
harmed may sometimes take priority over an individual’s
right to refuse a medical procedure (as is the case in
exceptional forms of mandatory medical testing and
reporting), scarcity of personnel and equipment may in
some circumstances mean that individual patients cannot
have certain medical procedures “just for the choosing.”
In rare circumstances, what is known as therapeutic
privilege can override an obligation to disclose informa-
tion and hence to obtain informed consent. Therapeutic
privilege is the limited privilege of a physician to withhold
information from a patient in the belief that this informa-
tion about the patient’s medical condition and options
will seriously harm the patient. Concern for the patient’s
well-being (the obligation of beneficence) thus comes into
conflict with respect for the patient’s autonomy (11). This
is a difficult notion to apply—great caution must be taken
in any appeal to it—and the rationale for withholding
information should be carefully documented. The concept
of therapeutic privilege should not, for example, be used
as a justification for ignoring the needs and rights of ado-
lescents (or adults) to participate in decisions about their
sexuality and their reproductive capacities. It is reasonable
to argue that therapeutic privilege is almost never a basis
for permanently overriding the obligation to seek informed
consent. Ordinarily such overriding represents a tempo-
rary situation, one that will later allow the kind of commu-
nication conducive to the restored freedom of the patient.
Sometimes another exception to the rule of informed
consent is thought to occur in the rare situation when
a patient effectively waives her right to give it. This can
take the form of refusing information necessary for an
informed decision, or simply refusing altogether to make
any decision. However, the following two statements are
reasons for not considering this an exception of the same
type as the other exceptions:
1. A waiver in such instances seems to be itself an
exercise of choice, and its acceptance can be part of
respect for the patient’s autonomy.
2. Implicit in the ethical concept of informed consent is
the goal of maximizing a patient’s freedoms, which
means that waivers should not be accepted compla-
cently without some concern for the causes of the
patient’s desire not to participate in the management
of her care.
In any case, it should be noted that in states where
written documentation of informed consent is required,
it may be necessary to meet this requirement in some
legally acceptable way.
Finally, limits intrinsic to the patient–physician rela-
tionship keep the requirement of informed consent from
ever being absolute. Physicians also are moral agents
COMMITTEE OPINIONS
and, as such, retain areas of free choice—as in the free-
dom in some circumstances not to provide medical care
that they deem either medically inappropriate or ethi-
cally objectionable. It is unethical to prescribe, provide,
or seek compensation for therapies that are of no benefit
to the patient (12). Interpretations of medical need and
usefulness in some circumstances also may lead a physi-
cian to refuse to perform surgery or prescribe medica-
tion. The freedom not to provide standard or potentially
beneficial care to which one ethically objects is some-
times called a right to “conscientious refusal,” although
this right is limited (13). Even in the context of justi-
fied conscientious refusal, physicians must provide the
patient with accurate and unbiased information about
her medical options and make appropriate referrals. In
the mutuality of the patient–physician relationship, each
one is to be respected as a person and supported in her
or his autonomous decisions insofar as those decisions
are not, in particular circumstances, overridden by other
ethical obligations. The existing imbalance of power in
this relationship, however, is a reminder to physicians
of their greater obligation to ensure and facilitate the
informed consent or refusal of each patient. Differences
in knowledge can and should be bridged through efforts
at communication of information; professional respon-
sibilities to be honest and uphold the primacy of patient
welfare should be respected.
Acknowledging the limits of the ethical requirement
to obtain informed consent, then, clarifies but does not
weaken the requirement as such. Hence, the Committee
on Ethics reaffirms the eight statements that were pre-
sented at the beginning of this Committee Opinion.
References
1 Ethical decision making in obstetrics and gynecology.
ACOG Committee Opinion No. 390. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2007;110:
1479–87.
2. Maternal decision making, ethics, and the law. ACOG
Committee Opinion No. 321. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2005;106:
1127–37.
3. Sterilization of women, including those with mental dis-
abilities. ACOG Committee Opinion No. 371. American
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2007;110:217–20.
4. Human immunodeficiency virus. ACOG Committee
Opinion No. 389. American College of Obstetricians and
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5. Surgery and patient choice. ACOG Committee Opinion No.
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Obstet Gynecol 2008;111:243–7.
6. American College of Obstetricians and Gynecologists.
Professional liability and risk management: an essential
guide for obstetrician–gynecologists. Washington, DC:
ACOG;2005.
7. Professional responsibilities in obstetric–gynecologic edu-
cation. ACOG Committee Opinion No. 358. American
2013 COMPENDIUM OF SELECTED PUBLICATIONS 214
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2007;109:239–42.
8. President’s Commission for the Study of Ethical Problems
in Medicine and Biomedical and Behavioral Research.
Making health care decisions: the ethical and legal impli-
cations of informed consent in the patient-practitioner
relationship. Washington, DC: U.S. Government Printing
Office; 1982.
9. Mackenzie C, Stoljar N, editors. Relational autonomy:
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self. New York (NY): Oxford University Press; 2000.
10. American Medical Association. Medicolegal forms with
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relationship. Chicago (IL): AMA; 1999.
11. American Medical Association. Withholding information
from patients. In Code of medical ethics of the American
Medical Association: current opinions with annotations.
2008-2009 ed. Chicago (IL): AMA; 2008. 253–4. Available
at: http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.
pdf. Retrieved February 3, 2009.
12. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC: ACOG;
2008. Available at: http: //www.acog.org/from_home/
acogcode.pdf. Retrieved February 3, 2009.
13. The limits of conscientious refusal in reproductive medi-
cine. ACOG Committee Opinion No. 385. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2007; 110:1203–8.
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ed. New York (NY): Oxford University Press; 2009.
COMMITTEE OPINIONS
Berg JW, Appelbaum PS, Lidz CW, Parker LS. Informed con-
sent: legal theory and clinical practice. New York (NY): Oxford
University Press; 2001.
Faden RR, Beauchamp TL. A history and theory of informed
consent. New York (NY): Oxford University Press; 1986.
Grisso T, Appelbaum PS. Assessing competence to consent to
treatment: a guide for physicians and other health professionals.
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Copyright © August 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Informed consent. ACOG Committee Opinion No. 439. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2009;
114:401–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 215
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians
COMMITTEE OPINION
Number 456 • March 2010
Committee on Ethics
Forming a Just Health Care System
ABSTRACT: In this Committee Opinion, the Committee on Ethics of the American College of Obstetricians
and Gynecologists endorses the College’s ongoing efforts to promote a just health care system, explores justifica-
tions that inform just health care, and identifies professional responsibilities to guide the College and its members
in advancing the cause of health care reform.
If Medicine is to fulfill her great task,
then she must enter the political and social life (1).
The 2008 Reform Agenda of the American College of
Obstetricians and Gynecologists, “Health Care for Women,
Health Care for All,” advocates accessible and affordable
health care for everyone in the United States, regardless
of citizenship or residency status (2). This position is an
evolution of the College’s long-standing call for universal
access to maternity care, a call first made in 1971. In this
Committee Opinion, the College’s Committee on Ethics
endorses the College’s ongoing efforts to promote a just
health care system, explores justifications that inform just
health care, and identifies professional responsibilities to
guide the College and its members in advancing the cause
of health care reform. The following five statements sum-
marize the main points made in this Committee Opinion:
1. Creating a just health care system through necessary
health care reform is primarily a moral issue, even
though it is also political and economic in nature.
The principle of justice (individuals’ obligations to
treat one another fairly) underlying the College’s call
for a sustainable just health care system requires that
patients be treated without discrimination by medical
professionals and policy makers.
2. A just health care system and the health care reforms
necessary to obtain it are grounded in the appropri-
ate goals of medicine. These include the physician’s
traditional duties to promote health, cure disease,
and prevent suffering. Meaningful health care reform
must include significant emphasis on prevention and
wellness promotion as well as innovative and efficient
practice mechanisms.
COMMITTEE OPINIONS
3. The ancient concept of covenant is also relevant to
conceptualizing just health care and health care reform
measures. Traditional notions of the physician’s cove-
nant (based on trust and the physician’s primary com-
mitment to his or her patient) should be expanded to
include a social covenant. The social covenant reflects
community-oriented values regarding what each per-
son, as a fellow human being, owes to another—given
that all persons are ultimately dependent on the care
of others for their health needs. The social covenant
also engages humanitarian and pragmatic concerns for
global health.
4. A just health care system provides universal coverage
in the form of affordable and effective health care for
all residents of the United States regardless of citizen-
ship or employment status.
5. The College and its membership represent expert
voices in the social process of health care reform and
creating and sustaining a just health care system, and
they have a wide range of opportunities to advocate for
and advance the goal of just health care.
Background
The moral imperative of access to health care has been rec-
ognized for decades in the United States and for more than
a century elsewhere in the world (3–5). Organizations and
advisory bodies such as the World Health Organization,
the President’s Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral
Research, the Institute of Medicine, the American Nurses
Association, the American Medical Association, and, more
recently, the President’s Council on Bioethics have joined
the College in engaging the problem of universal access to
health care (4–12).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 216
 The spectrum of inadequate access to health care in
the United States ranges from those who are uninsured
or uninsurable due to eligibility exclusions or immigra-
tion status to those who are underinsured or occasion-
ally insured by virtue of employment contingencies (13).
The effects of inadequate access on the health of women
across the life cycle in the United States are dispropor-
tionate to those of the general population and are particu-
larly egregious. They are starkly illustrated in the Reform
Agenda document “Women and Health Insurance: By
the Numbers,” in ACOG Committee Opinion 416 “The
Uninsured,” and in the most recent U.S. Census Bureau
report on health insurance coverage (2, 14–16). For the
purposes of this discussion it is minimally sufficient to
note that one in five women of childbearing age in the
United States lacks health insurance, a rate far greater
than that of all uninsured Americans. Women of color,
especially Latina women; younger women; those with a
low income; those who are foreign born; and those who
are not citizens are at particular risk of being uninsured
and thus experiencing adverse health outcomes. Working
women, as opposed to working men, are less likely to be
eligible for employer health plans as they are more likely
to work part-time, have lower incomes, or depend on
spousal coverage (making them vulnerable in the event of
loss of a spouse) (14). Unmet health needs both occasion
and exacerbate chronic illness for nonelderly and elderly
women.
Fragmented care for pregnant women is equally
disturbing given that the sequelae of inadequate perinatal
health care reach far beyond women and their newborns
to their families, their communities, and to future gen-
erations. Gaps in services occur in the interconception
(between pregnancies) as well as the postpartum periods.
Lack of insurance coverage is one of the largest barriers
to interconception health care, which aims to reduce risks
and improve maternal and fetal outcomes in subsequent
pregnancies. Loss of health insurance is one of the most
frequent challenges faced by new mothers (17). The chal-
lenges of fragmented care continue despite the best efforts
of the National Healthy Start Association (with almost
100 federally funded projects in the United States) and
others (18, 19). This void in the health care system affects
all those living in the United States. Considerations of
collective welfare have motivated the College to priori-
tize coverage for pregnant women and infants within its
Reform Agenda.
The Nature of the Problem
Moral problems are embedded in daily life, medical prac-
tices, and health care institutions. Issues of morality do
not arise de novo, but emerge from any number of par-
ticular perspectives that enable and inform conscientious
decision making. Understanding of moral problems and
the solutions to them arises from a number of sources.
For each person, the answer to the question, “What
should I do?” when faced with a moral issue generally
reflects the values that have been absorbed from families,
COMMITTEE OPINIONS
peers, communities, religion, education, or the political
philosophy upon which the government rests (20).
The resultant question, “Why is that what I should
do?” requires that actions be justified based on some
sort of rationale or framework and is the realm of moral
theory (13, 20). Applying moral theories, and the prin-
ciples and rules they engender to resolve concrete, real-
life problems, is the task of applied ethics. While most
individuals do not consciously invoke moral theories
when they make personal or professional decisions on a
daily basis, it is important that collective moral decisions,
such as health policy, be well thought out and grounded
in concepts that can be justified, explained, and revisited.
The Committee on Ethics believes that achieving
and maintaining a just health care system is primar-
ily a moral concern. Just health care and the health care
reforms needed to achieve it are problems of moral
theory. They are also subjects of applied ethics given that
it must be determined what methods to use to achieve
the goal of sustainable just health care. Currently in the
United States, justice in health care is best characterized
as a complex, multifactorial, and unsettled issue. Debate
exists about the fundamental nature of the problems
that underlie it—for example, whether needed health
care reforms are substantively issues of morality, politics,
economics, or some combination thereof (12). Other
second-order disagreements cascade from this founda-
tional one.
If, as the Committee on Ethics maintains, achiev-
ing a just health care system with necessary health care
reforms is primarily a moral concern, how is the problem
best conceived within the broad framework of “moral-
ity”? The Committee on Ethics holds that the answer to
this question is “justice,” that is, that the ethical principle
of justice (individuals’ obligations to treat one another
fairly) is the moral basis for health care reform.
Justice can be defined in many ways. It can, for
example, be framed in egalitarian (fair opportunity) or
libertarian (free market) terms. If, as the Committee on
Ethics recommends, justice in health care is viewed as a
concern of fairness and equality, how then should the
application of these concepts be balanced? What does
it mean to be “fair” or “equal” in terms of just health
care? If one embraces an egalitarian, or fair opportunity,
framework, is the problem best defined as one of equal
access to all health care services, or of access to a decent
minimum of care, or by some other criterion?
In exploring the moral justifications for just health
care, the Committee on Ethics examines the foundational
assumptions of the College’s Reform Agenda and its
resultant concerns. The Reform Agenda espouses univer-
sal health insurance coverage. It is thus concerned with
removal of barriers to access to health care. It is concerned
with women, and in particular with pregnant women and
infants. It is equally concerned with the nature and distri-
bution of health services to all, including the underserved
and the vulnerable. It exhorts the use of preventive and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 217
 primary care services. A just health care system provides
universal coverage in the form of affordable and effective
health care for all residents of the United States regardless
of citizenship or employment status.
Does, however, or should a just health care system
promote the attainment of individual health—a frame-
work that invokes both social and biological determi-
nants of health, and collective responsibilities above and
beyond the issue of access to clinical services? Should
the Reform Agenda’s project examine the appropriate
goals of medicine—an approach that might challenge
the “technological imperative” that drives indiscriminate
use of advanced technology (11)? Should it articulate
and reflect individuals’ obligations towards one another
as a matter of professional or social covenant? Each of
these questions represents a unique way of framing and
thus resolving the problem of unmet health needs and is
explored in the sections that follow.
Ethical Justifications for a Reform Agenda
Ethical justifications for health care reform might be
broadly organized into three categories: those of justice
based on rights or entitlement claims; those concerned
with the appropriate goals or ends of medicine; and those
based in covenant, which is grounded in obligation and
trust. The Reform Agenda can be understood to rely on
each of these categories.
Justice
In general terms, “justice is a way of considering the big
picture, but from a point of view somewhere within it”
(20). Justice is grounded in beliefs about oneself and
society and is often understood in terms of equality or
fairness. It is manifest in how individual and communal
decisions are made as to what someone is due or owed
and what they may subsequently claim as entitlements or
rights (21, 22). In many societies, health care is construed
as a right, or a public good, because health is necessary
in order for persons to flourish (23). Health might be
understood as a background condition for the realization
of other goods. It is a prerequisite in order for each per-
son to achieve the fullness of well-being—to attain and
maximize the benefits of such social goods as political
freedom, education, and employment (13).
The principle of comparative or formal justice has
its origins in Aristotelian philosophy. It demands that
equals be treated equally and that unequals be treated
unequally. The principle of formal justice identifies what
to do—treat equals equally—but does not describe how
to do so. It lacks content, which ultimately derives from
individuals’ beliefs about themselves relative to other per-
sons. In order to apply the formal principle of justice, first
a characteristic upon which it is pertinent to act must be
specified. Are, for example, persons treated equally based
on need ? On the basis of merit, or benefits they have pro-
vided others ? On the basis of vulnerability, or risk? These
characteristics all have been identified as potentially
COMMITTEE OPINIONS
pertinent. A prerequisite to applying the formal principle
of justice is to specify a pertinent “material” principle to
guide behavior.
The governing political philosophy should illumi-
nate material principles that differentiate the importance
of health relative to other social goods. The Constitution
of the United States and the principles under which U.S.
citizens are governed are informed by a particular con-
cept of justice known as egalitarianism. Egalitarianism
is concerned with equality, especially in the context of
competing interests. The idea that all in U.S. society are
“created equal” is interpreted to mean that there should
be no discrimination in individuals’ claims to life, liberty,
or other social goods. Historically, the most flagrant vio-
lations of egalitarian social philosophy have been based
on race and gender. The current need for health care
reform represents continued discriminatory practices in
the allocation of health care services and goods based on
a number of factors, including race, gender, and socio-
economic status.
Justice within the health care context has been
defined in a prior Committee on Ethics Committee
Opinion as “a complex and important concept that
requires medical professionals and policy makers to treat
individuals fairly and to provide medical services in a
nondiscriminatory manner” (24). In applying this con-
cept to the medically underserved, the College invokes
a form of justice known as distributive justice, or the
distributive paradigm, which is concerned with the fair
allocation of society’s benefits and burdens.
The Reform Agenda identifies and incorporates a
number of material principles that guide the application
of the formal principle of justice within the distributive
paradigm. It considers discrimination against women
as a class to be morally untenable. Similarly untenable is
discrimination based on race, ethnicity, socioeconomic
status, or sexual orientation (2). The aspiration to elimi-
nate discriminatory health practices is an application of
the “fair opportunity” rule, which prohibits denial of
social benefits based on characteristics or differences such
as nativity (birthplace), age, race, or sex—characteristics
for which a person is not responsible (13).
The Reform Agenda is also concerned with the
collective welfare of society, recognizing that the con-
sequences of a marginal health care system affect all in
the society. The Agenda continues to promote a shared
responsibility model for universal health insurance cover-
age. The College’s model requires employers to provide
coverage, individuals to accept coverage, and the govern-
ment to ensure that quality coverage is made affordable
for everyone.
The College’s approach is consistent with the pref-
erences of the majority of Americans and American
employers (25). Arguments in support of the shared
responsibility approach center on improved employee
health and consequent benefits to morale and productiv-
ity. Employers benefit from enhanced employee recruit-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 218
 ment and retention and from decreased absenteeism and
loss of trained personnel (14). Assuming affordable cover-
age for essential benefits, the Reform Agenda promotes
both individual and social responsibility for health care (2).
As with most health care reform schema, shared
responsibility for health care is a subject of dispute. It has
been dismissed by some critics as a myth and as the fore-
most impediment to meaningful health care reform in
the United States (26). The real costs of health care, such
critics argue, are met not through employer-provided
health insurance but by employees themselves through
lowered wages and higher prices; costs are shouldered not
by federal or state governments through health care sub-
sidies but by citizens through tax increases. Critics of the
shared responsibility model argue that the primary social
and political obstacle to health care reform in the United
States is the belief, held by many Americans, that the costs
of health care benefits are borne by someone else and that
health care is in some way “free.” This belief, they submit,
fosters indifference towards the costs, inefficiencies, and
quality lapses of the health care system and undermines
political will for reform.
While disagreement exists about the financial reali-
ties of shared responsibility, recent data reflect robust
public consensus on the need for health care reform in
the United States. Commonwealth Fund survey data
show that eight of ten adults believe that the health care
system should be either fundamentally changed or com-
pletely rebuilt (25). The College’s Committee on Ethics
believes that the goals of both proponents and detractors
of the shared responsibility model have strong moral
grounding that should not be overshadowed by tactical
differences. While differences between these groups are
substantive, they do not diminish the ethical imperative
that they share, achieving coverage for all persons living
in the United States.
In the pursuit of this end, distributive justice may
not suffice as a singular approach to health care reform.
Some critics of the distributive paradigm argue that, as
a health care reform mechanism, it is too procedurally
oriented and lacks sufficient content to be effective. The
primary critique is that principles of distributive justice
do not indicate how to understand or balance equality
of opportunity. Does universal access mean access to a
decent minimum of health care or to a level of care with
the best achievable health outcomes? Does access to a
decent minimum of health care guarantee health?
Long-term studies in England show that social
inequality plays a role in worse health outcomes given
equal access to health care. Data from the Whitehall
Study of civil servants in England show a severe inverse
relationship between social class and mortality from a
number of diseases (27). This finding argues for a focus
on health and the social determinants of health rather
than access alone. It supports consideration of the goals
of medicine as a complementary framework in resolving
issues of access and health disparities in the United States.
COMMITTEE OPINIONS
Creating a just health care system through necessary
health care reform is primarily a moral issue, even though
it is also political and economic in nature. The principle of
justice (individuals’ obligations to treat one another fairly)
underlying the College’s call for a sustainable just health
care system requires that patients be treated without dis-
crimination by medical professionals and policy makers.
The Appropriate Goals of Medicine
The goals of western medicine grew out of Platonic
notions of individual and social obligations to one another
in achieving the good life (and thus the goods in life) (28).
Intrinsic to the concept of what an ethical physician owed
his or her patients was a sense of the appropriate limits
of medical knowledge. The “art” of medicine entailed
acceptance and practice of the limits of medicine. Central
to this ideology was a focus on promoting and achieving
health. An appropriate balance is evident in the Socratic
articulation of the aims of medicine: to provide cure
sometimes, relieve often, care always. A modern interpre-
tation of this dictum is the duty to promote health, cure
disease, and prevent suffering.
Many in the current health care reform movement
argue that the fragmented health care system in the
United States results from confusion about and an imbal-
ance among the appropriate goals of medicine (11, 12).
This confusion is manifest in an inordinate focus on cure
and technological development as opposed to prevention
and health promotion. Bioethicist Daniel Callahan holds
that gaps in health insurance coverage are fostered by
ever-rising costs of health care, costs that result directly
from the pursuit and application of new technology.
Callahan decries what he terms the “infinity model of
medical progress,” which derives from “the idea that
health can and should be improved indefinitely, even to
the exclusion of other goods” (11).
Driving this engine is the strong individualism rooted
in the political philosophy governing the United States.
Many patients feel entitled to unlimited intensive and
highly technological health care regardless of its cost or
effectiveness. In the clinical context, this engenders what
has been described as the “technological imperative,”
that because technological interventions are available,
they should or must be used (11, 12, 29). It also reflects
a bias towards the unlimited pursuit of medical knowl-
edge, often at the expense of preventive and primary
care. The result, as Callahan has observed, is “a powerful
bias towards cure, rather than care; acute, rather than
chronic, disease; length of life rather than quality of life;
individual benefit rather than population benefit … sub-
specialty medicine, rather than primary and family care;
and increased medicalization of life and social problems”
(11). A concern for the appropriate goals of medicine is
reflected in the Reform Agenda’s call for an investment
in primary and preventive care, continuity of care, and
effective, quality care through evidence-based medicine.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 219
 A just health care system and the health care reforms
necessary to obtain it are grounded in the appropri-
ate goals of medicine. These include the physician’s
traditional duties to promote health, cure disease, and
prevent suffering. Meaningful health care reform must
include significant emphasis on prevention and wellness
promotion as well as innovative and efficient practice
mechanisms.
Covenant and Community
The notion of medical and social covenant has been pro-
moted as a new “third way” between individualism and
egalitarianism (30). It is based on critiques of egalitarian-
ism and its emphasis on rights and entitlements and of
individualism and its overly thin account of communal
interests. Critics of individualism argue that prioritizing
individual over communal health interests has resulted
in the commodification of health care, medical entre-
preneurism, health disparities, and national isolationism
and disregard for the health of others around the globe
(29, 31).
The medical covenant is an ancient concept best
understood as a clinician’s promise to help his or her
patient (30). It engenders trust in the primacy of the phy-
sician’s commitment to his or her patient. Recent argu-
ments in the health care reform arena would expand the
concept of physician covenant to that of social covenant;
from the physician’s obligations to his or her patient, to
what each individual, including a patient in relationship
with her caregivers, and individuals as members of society
owe one another. Social covenant, it is argued, is motivated
both by notions of obligation and, it could be said, by self-
interest, based on the reality that each person will, at some
point, be a patient dependent on the care of others.
In response to these concerns and to the challenges
posed by managed care in the 1990s, leaders in organized
medicine and bioethics exhorted the medical profession
at large to reaffirm the physician’s covenant (32):
…We believe the medical profession must reaffirm
the primacy of its obligation to the patient through
national, state, and local professional societies; our
academic, research, and hospital organizations; and
especially through personal behavior. As advocates
for the promotion of health and support of the sick,
we are called upon to discuss, defend, and promul-
gate medical care by every ethical means available.
Only by caring and advocating for the patient can
the integrity of our profession be affirmed. Thus we
honor our covenant of trust with patients.
By way of its Reform Agenda and its long-standing
call for universal access to maternity care, the College
continues to affirm its covenant with patients in the
United States. Subjects for future organizational consid-
eration include the promotion of health, in addition to
access to care, and a global perspective on health needs.
COMMITTEE OPINIONS
The ancient concept of covenant is also relevant to
conceptualizing just health care and health care reform
measures. Traditional notions of the physician’s covenant
(based on trust and the physician’s primary commitment
to his or her patient) should be expanded to include a
social covenant. The social covenant reflects community-
oriented values regarding what each person, as a fellow
human being, owes to another—given that all persons
are ultimately dependent on the care of others for their
health needs. The social covenant also engages humani-
tarian and pragmatic concerns for global health.
The Role of the College and Its Membership in
Advancing the Reform Agenda
By virtue of its Reform Agenda and their professional
covenant, the College and its members advocate for the
goods and services that patients need to achieve good
health outcomes. The College and its membership rep-
resent expert voices in the social process of health care
reform and in creating and sustaining a just health care
system. A host of opportunities exists to advance the goal
of just health care. To the extent practicable and within
a wide range of possibilities, the College and its members
could:
• Become conversant with the tenets of the Reform
Agenda
• Strive to provide and promote effective, safe, and
evidence-based interventions
• Be prudent in use of health care resources
• Advocate through social and political mechanisms
for the sick and the vulnerable
• Ultimately, in concert with the professional cov-
enant, prioritize the interests of patients and strive in
daily practice and through social and political action
to uphold the ethical values of the profession
References
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Wochenschrift: 1. Und 2. Jahrgang, 1848/49. Repr., Berlin:
Akademie-Verlag, 1983.
2. American College of Obstetricians and Gynecologists.
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3. Derickson A. Health security for all: dreams of universal
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11. Merrill TW. The Council’s inquiry into health care: prog-
ress to date, key questions, and possible future directions. Staff
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on Bioethics; 2007. Available at: http://www.bioethics.gov/
background/merrill_paper.html. Retrieved June 2, 2009.
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bioethics.gov/transcripts/june07/session3.html. Retrieved
June 2, 2009.
13. Beauchamp TL, Childress JF. Principles of biomedical ethics.
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14. The uninsured. ACOG Committee Opinion No. 416. American
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2008;112:731–4.
15. U.S. Census Bureau. Income, poverty, and health insurance
coverage in the United States: 2007. Current Population
Reports P60-235. Washington, DC: USCB; 2008. Available
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Retrieved June 2, 2009.
16. U.S. Census Bureau. Table HI01. Health insurance cover-
age status and type of coverage by selected characteristics:
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and economic supplement. Washington, DC: USCB; 2008.
Available at: http://pubdb3.census.gov/macro/032008/health/
h01_001.htm. Retrieved June 2, 2009.
17. Kanotra S, D’Angelo D, Phares TM, Morrow B, Barfield WD,
Lansky A. Challenges faced by new mothers in the early
postpartum period: an analysis of comment data from
the 2000 Pregnancy Risk Assessment Monitoring System
(PRAMS) survey. Matern Child Health J 2007;11:549–58.
18. Maternal and Child Health Bureau (US). A profile of
Healthy Start findings from phase I of the evaluation 2006.
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Rockville (MD): MCHB; 2006. Available at: ftp://ftp.hrsa.
gov/mchb/HealthystartEval.pdf. Retrieved June 2, 2009.
19. National Healthy Start Association. The Healthy Start Program.
Available at: http://www.healthystartassoc.org/hswpp6.html.
Retrieved June 2, 2009.
20. Aiken HD. The levels of moral discourse. Ethics 1952;62:
235–48.
21. Liaschenko J. Can justice coexist with the supremacy of
personal values in nursing practice? West J Nurs Res 1999;
21:35–50.
22. Fisk M. The problem of justice. In: Justice: key concepts in
critical theory. Atlantic Highlands (NJ): Humanities Press;
1993. p. 1–8.
23. United Nations. The universal declaration of human rights.
New York (NY): UN; 1948. Available at: http://www.un.org/
en/documents/udhr/index.shtml. Retrieved June 3, 2009.
24. The limits of conscientious refusal in reproductive medi-
cine. ACOG Committee Opinion No. 385. American Col-
lege of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:1203 –8.
25. How KS, Shih A, Lau J, Schoen C. Public views on U.S.
health system organization: a call for new directions. New
York (NY): The Commonwealth Fund; 2008.
26. Emanuel EJ, Fuchs VR. Who really pays for health care?
The myth of “shared responsibility”. JAMA 2008;299:1057–9.
27. Marmot MG, Smith GD, Stansfeld S, Patel C, North F,
Head J, et al. Health inequalities among British civil ser-
vants: the Whitehall II study. Lancet 1991;337:1387–93.
28. Daniels N. Justice, fair procedures, and the goals of medi-
cine. Hastings Cent Rep 1996;26:10–2.
29. Dougherty CJ. The excesses of individualism. For meaning-
ful healthcare reform, the United States needs a renewed
sense of community. Health Prog 1992;73:22–8.
30. May WF. The physician’s covenant: images of the healer in
medical ethics. 2nd ed. Louisville (KY): Westminster John
Knox Press; 2000.
31. Crawshaw R, Rogers DE, Pellegrino ED, Bulger RJ,
Lundberg GD, Bristow LR, et al. Patient-physician cov-
enant. JAMA 1995;273:1553.
32. Cassel CK. The patient-physician covenant: an affirmation
of asklepios. Ann Intern Med 1996;124:604–6.
Copyright March 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Forming a just health care system. Committee Opinion No. 456.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2010;115:672–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 221
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 466 • September 2010

Committee on Ethics and Committee on Global Women’s Health

This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians
and Gynecologists as a service to its members and other practicing clinicians. While this document reflects the
current viewpoint of the College, it is not intended to dictate an exclusive course of action in all cases. This
Committee Opinion was approved by the Committee on Ethics and the Executive Board of the American College
of Obstetricians and Gynecologists.

Ethical Considerations for Performing Gynecologic

Surgery in Low-Resource Settings Abroad
ABSTRACT: International humanitarian medical efforts provide essential services to patients who would not
otherwise have access to specific health care services. The Committees on Ethics and Global Women’s Health of
the American College of Obstetricians and Gynecologists encourage College Fellows and other health care profes-
sionals to participate in international humanitarian medical efforts for this reason. However, such programs present
Fellows with a unique set of practical and ethical challenges. It is important for health care providers to consider
these challenges before participating in international surgical efforts in these settings. Health care professionals
should ensure that they have the necessary surgical competence and training, including sufficient mentorship,
prior to functioning as the primary surgeon abroad. Before they perform surgery, health care professionals should
ensure that patients have access to adequate medical resources and preoperative and postoperative care. They
should be willing and prepared to postpone or cancel surgery when the standards of ethical medical care cannot
be met and the members of the surgical team believe that the best interest of the patient cannot be achieved with
the current available resources. Health care professionals’ efforts should contribute to the long-term well-being of
the patients and the communities being served through the ethical practice of medicine, responsible conduct of
research, and investment in the sustainability of services. The care of the patient should be the highest priority for
those participating in these medical programs.

International humanitarian medical efforts provide essen-
tial services to patients who would not otherwise have
access to specific health care services. The Committees
on Ethics and Global Women’s Health of the American
College of Obstetricians and Gynecologists encourage
College Fellows and other health care professionals to
participate in international humanitarian medical efforts
for this reason. International medical programs may be
affiliated with a variety of academic, private, and religious
institutions and organizations. Regardless of the origin of
the program, these efforts present health care profession-
als with a very different clinical environment than what
they may be accustomed to in the United States. Unique
ethical challenges arise in conjunction with the provi-
sion of medical and surgical services for patients in low-
resource communities abroad. It is important for health
care providers to consider these challenges before par-
ticipating in international surgical efforts in these settings.
International medical efforts present the opportunity
to benefit patients through the provision of medical and
surgical services that are not adequately available. At the
same time, some of these activities have the potential to
inadvertently exacerbate the situation of patients, despite
the best intentions to facilitate access to quality health
care. Patients in these situations are exceptionally vulner-
able because of limited resources in their communities.
Many clinicians in the United States are unfamiliar with
the type and degree of vulnerability found in these areas
of the world. Thus, when performing gynecologic surgery
internationally in such settings, it is important for health
care providers to be aware of the important ethical con-
siderations that arise as a result of this vulnerability.
Health care professionals should take the necessary
steps to ensure that patients receiving services ben-
efit from and are not harmed by medical humanitarian
efforts. In the discussion that follows, the Committees

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 222

 on Ethics and Global Women’s Health present com-
monly encountered ethical issues that arise in resource-
limited regions of the world with the intention of helping
health care professionals provide the best care possible
to patients within these uniquely challenging clinical
settings. The Committees make the following recom-
mendations:
• Health care professionals are encouraged to partici-
pate in international humanitarian efforts to provide
essential services to patients who would not other-
wise have access to specific health care services.
• The care of the patient should be the highest pri-
ority for those participating in these medical pro-
grams. When caring for patients in low-resource
settings in other countries, health care professionals
should strive to uphold fundamental standards of
ethical practice afforded to patients in industrialized
nations. As a guideline, health care professionals
should keep the best interests of the patient as a
central tenet to determine what services should and
should not be provided in the local context.
• Before traveling abroad to provide care, health care
professionals should become familiar with the chal-
lenges that arise when caring for patients in the com-
munity and country they will visit and make every
effort to ensure that these challenges will not inter-
fere with the responsible and ethical care of patients.
• Health care professionals should ensure that they
have the necessary surgical competence and training,
including sufficient mentorship, prior to functioning
as the primary surgeon abroad. In-country health
care professionals and leaders within the local com-
munity may be an excellent resource for this type of
mentorship and training.
• Before they perform surgery, health care profes-
sionals should ensure that patients have access to
adequate medical resources and preoperative and
postoperative care.
• Health care professionals should be willing and
prepared to postpone or cancel surgery when the
standards of ethical medical care cannot be met and
the members of the surgical team believe that the
best interest of the patient cannot be achieved with
the current available resources.
• Health care professionals’ efforts should contribute
to the long-term well-being of the patients and the
communities being served through the ethical prac-
tice of medicine, responsible conduct of research,
and investment in the sustainability of services.
Background
There is growing recognition of global disparities in the
health of women. These disparities increasingly attract
the attention of gynecologists who are motivated to
COMMITTEE OPINIONS
use their skills to address deficiencies in international
women’s health care, often in socioeconomically dis-
advantaged areas outside of the United States. These
humanitarian efforts have the capacity to provide specific
surgical expertise to women who could not receive care
otherwise. The experiences of clinicians who embark on
these efforts have brought to light some of the ethical
challenges arising from the provision of health care in
low-resource settings and to the patients who live under
conditions that make them exceptionally vulnerable. It is
important for gynecologists considering participating in
international medical programs to be aware of the unique
vulnerability of these patients and how these conditions
generate ethical questions and challenges. With the
growth of international medical programs, it has become
evident that, even with the best intentions and humani-
tarian goals, some efforts can create ethical challenges for
patients and health care providers of a kind that are not
encountered in industrialized nations (1). It is important
for Fellows to consider these challenges prior to engaging
in medical care in low-resource settings to ensure that
patients are not inadvertently harmed while receiving
much-needed services.
In this document, the Committees on Ethics and
Global Women’s Health highlight some of the particu-
lar ethical issues College Fellows and other health care
professionals should consider when providing medical
and surgical care in low-resource settings. Women in
these countries deserve high-quality medical care that
can prevent illness and restore health, but the constraints
of low-resource settings and the extreme vulnerability of
patients that often exist in such settings can make this
goal difficult to obtain. The case of obstetric fistula that
follows serves as a model condition, exemplifying the
central challenges to providing care in low-resource
settings, regardless of the actual condition that is being
prevented or treated.
Health care providers must give careful consider-
ation to the goal of maintaining the highest standards of
care possible within the limitations of the environment
and the context of the local culture. Strategies to accom-
plish this goal may be organized differently and may
involve the use of technologies other than those Fellows
use in their day-to-day practices. The effort to reduce the
global burden of cervical cancer stands out as an example
of how the provision of health care in international set-
tings can take place in a way that is consistent with this
goal (2).
Although this document focuses on obstetric fistulas,
the issues raised have implications for other women’s
health issues, such as those related to maternity care, fam-
ily planning, and human immunodeficiency virus (HIV)
and other sexually transmitted infections. For this reason,
there is broad relevance in addressing the issues health
care professionals should consider before embarking on
international health care projects, particularly those in
low-resource settings.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 223
 Case Study: Addressing Obstetric
Fistula
Worldwide, there are an estimated 130,000 new cases
of fistulas identified each year and approximately 3.5
million women have fistulas. These numbers may be
an underestimate of the global impact of this condition
because existing data are inadequate. Many cases occur
in women in Sub-Saharan Africa, where a constellation
of issues contribute to fistula formation. Obstetric fistula
results from a complex social and cultural dynamic that
is intertwined with local cultural beliefs, poverty, lack of
education, malnutrition, and limited access to antepar-
tum and postpartum care (3). Specific factors also include
the tradition of childhood marriage, which leads to child-
bearing at an age before maturation of the female pelvis;
inadequate nutrition; and lack of access to adequate and
timely health care (4–6).
Most obstetric fistulas are preventable with attention
to the progress of labor and the provision of emergency
obstetric care. However, many women in resource-poor
settings do not have access to such services for a variety
of reasons, including lack of trained medical personnel,
insufficient financial resources, absence of transportation
to medical facilities, or lack of recognition of the need
for skilled care during labor. Often, women will labor for
many days without delivery. Prolonged pressure from an
obstructed fetal head causes tissue necrosis that can lead
to extensive vesicovaginal and rectovaginal fistulas and
fetal death (4). Large fistulas also may occur as a result of
sexual trauma such as rape, an injury known as traumatic
gynecologic fistula (7). Gynecologic fistulas present similar
technical issues as obstetric fistulas. But as survivors of
violent sexual assault, women with traumatic gynecologic
fistulas may have sustained additional physical and psy-
chologic injuries that need to be addressed. They are also
at risk for unwanted pregnancy and sexually transmitted
infections, including HIV.
Once a fistula is formed, women lose control of blad-
der or bowel function or both and constantly leak urine
and feces. The presence of the fistula leads to a series of
health problems, involving the skin, urologic tract, gas-
trointestinal tract, and the joints (eg, contractures) (8).
Because of the lack of local resources to repair fistulas,
a woman’s subsequent medical condition worsens over
time. In addition, women affected with fistulas are often
isolated from their community. The isolation may be
volitional because of embarrassment from associated
odor and secretions. Social ostracism also may occur
from families and communities (9). Without community
and family support systems, women with fistulas suffer
from worsening poverty, health, and social isolation (3,
10).
The problem of obstetric fistula recently has received
considerable attention from the media and health organi-
zations. International efforts have continued to increase
the organization and mobilization of medical equipment
and personnel to low-resource regions of the world where
fistula is prevalent. Gynecologic surgeons and other
health care professionals staff these international medical
COMMITTEE OPINIONS
programs by traveling abroad for a limited time (ranging
from weeks to months) to perform fistula repair.
Caring for Vulnerable Women in
International Settings
Health care professionals who participate in international
medical programs likely will encounter patients living
with a degree of vulnerability beyond that seen in highly
industrialized settings. This exceptional vulnerability is
due to factors such as malnutrition, poor health, poverty,
and social injustice, which may occur alone or in combi-
nation. The lack of local medical resources compounds
the effect of these inequities on the health and well-being
of the local community. Disparities of this sort are not
unique to international settings and are present even here
in the United States. However, the extreme conditions
found in low-resource regions of the world amplify the
effects of chronic illness and injury to an extent to which
most health care professionals are unaccustomed.
Women with obstetric fistulas represent such a vul-
nerable population. Many women who develop fistulas
have been unable to exercise basic human and reproduc-
tive rights (3). Within societies in which fistula is endem-
ic, personal decisions about sexuality and childbearing
are customarily made for women by their families and
communities through the practice of childhood marriage
(11). Girls and women who develop fistulas become mar-
ginalized from their families and communities, result-
ing in additional discrimination, poverty, illness, and
isolation. The unparalleled medical and social needs of
women with fistulas require a unique type of health care.
In the provision of ethically appropriate care in
resource-poor settings, professionals will encounter a
breadth of unique and challenging ethical considerations.
Some of the most commonly encountered issues pertain
to informed consent in the international context, quantity
and quality of medical resources, level of surgical compe-
tence and training required for these efforts, assurance of
adequate preoperative and postoperative care, protection
of human participants in clinical and social research, and
sustainability. Health care providers in the international
arena should strive to adhere to the highest standards of
clinical practice possible while recognizing, in light of the
local resources, this may not be feasible in all cases.
Informed Consent
Just as in the United States, informed consent should pre-
cede any medical and surgical interventions. The ethical
principles of autonomy and respect for persons govern
this practice (12). Informed consent is achieved through
a discussion between a health care professional and
patient in which relevant information about the indica-
tion, risks, benefits, and alternatives of proposed therapy
is presented and discussed. This conversation will help
a patient to make an informed and voluntary decision
about accepting or declining therapy in a manner that
reflects her values.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 224
 There has been some debate about the merits of
informed consent when medicine is practiced in inter-
national contexts: ethical principles valued in one society
may be understood very differently in another (13–15).
Some cultures place a higher value on the role of the
family or community in medical decision making than on
individual autonomy. Despite such cultural differences
in the weight accorded ethical principles, international
health organizations agree that respect for persons is a
universal principle applicable to the global population
(16–18). Thus, despite its challenges, the process of
informed consent is a vital component of the practice of
ethical health care across countries and cultures.
Practitioners should be prepared for challenges that
may arise in seeking consent in low-resource areas,
including limited literacy and language differences. The
informed consent conversation should take place in the
native language of the patient. Ideally, this conversation
would involve a consent process with a medical profes-
sional fluent in the language of the local community,
but quality consent also can be obtained with a qualified
on-site medical interpreter. The interpreter should be
sufficiently skilled to provide an accurate and culturally
sensitive translation of medical information. The content
of information must be tailored to the education of the
patient. Ineffective communication can have a negative
impact on the quality of health care provided to the
patient (19–21). Leaders of international health teams
should work with local community members to establish
a decision-making process that promotes informed and
voluntary choice.
Medical Resources
Health care professionals should be aware of the poten-
tial limits of the local medical resources before traveling
abroad to perform surgery. Well in advance of embark-
ing, leadership of the health care team should make pro-
visions to bring supplemental equipment or supplies to
perform the planned surgery and necessary postoperative
care as follows:
• Surgical equipment: Surgeons should have access
to necessary equipment in good working condition.
Although the use of the most up-to-date technol-
ogy might be ideal, surgeons should be prepared
to use older but adequate models. Surgeons should
anticipate a lack of imaging and automated instru-
ments that may be readily available at their home
institutions. Additionally, surgeons should prepare
themselves to use instruments with a different design
and nomenclature from those to which they are
accustomed. Flexibility and the ability to adapt to
foreign instrument sets or techniques are extremely
important. It is also necessary to have an effective
method of cleaning and sterile processing. Health
care professionals’ choices about if or how to use
these local medical and surgical resources should
always be guided by their obligation to patient safety
and outcomes.
COMMITTEE OPINIONS
• Pharmaceutical agents: Surgical management of
patients will require adequate medications. At mini-
mum, appropriate anesthetics, antibiotics, and pain
medications should be available.
• Basic supplies: Patients should have access to clean,
potable water; food to provide adequate nutritional
support for wound healing; and medical supplies
necessary for wound care.
• Personnel: Sufficient trained personnel should staff
surgical centers to care for patients at all stages
of treatment. This includes individuals trained to
provide nursing care and adequate translation of
medical information. If trained surgical assistants
are unavailable in the local community, the surgeon
should ensure that they are part of the traveling
team.
Despite the best preparatory efforts, the circum-
stances of some health care settings abroad may not be
evident until the international medical program is under
way. When the standards of medical care cannot be met
and the members of the surgical team believe that the best
interest of the patient cannot be achieved with the current
available resources, the health care professional should be
prepared to postpone or cancel surgery.
Surgical Competence and Training
Most health care professionals practicing in the industri-
alized world do not have experience with the specific type
or severity of medical or surgical conditions present in
low-resource settings. For this reason, additional educa-
tion and training is often needed for participants before
engaging in international medical programs. Health care
professionals must candidly and carefully consider their
surgical competence and training for the specific gyne-
cologic condition before traveling abroad. With this in
mind, they must be prepared to provide care at a level
at which they are qualified and opt out of procedures in
which they do not have adequate experience. Just as with
all procedures, practitioners should not undertake com-
plex surgery without adequate mentorship, training, and
experience. The risks of doing so include injury, wors-
ened disability, or death to the patient and loss of trust of
the health care system.
If surgeons do not have the adequate training and
experience needed for the type of services that must be
provided, then an experienced mentor should take on
the role of primary surgeon. In-country expertise may
exist and can provide an excellent resource for this kind
of mentorship and training. In this situation, the traveling
professional should undergo a period of on-site training
as an assistant before taking on primary surgeon respon-
sibilities. It is the ethical duty of the traveling physician
to ensure that an experienced surgical practitioner will be
available when needed.
Even in the context of adequate training and surgi-
cal skills, there may be some patients who would not
benefit from surgery given the medical condition or local
2013 COMPENDIUM OF SELECTED PUBLICATIONS 225
 resources for postoperative care. Health care providers
also must be prepared to recognize the situation in which
a patient may have injuries that are too extensive to be
corrected with the resources within the community and
be ready and able to formulate alternative management
approaches.
In preparation for medical programs focusing on
women with fistulas, health care professionals should
be prepared to meet the specific needs of these patients
through the appropriate cultural, medical, and surgical
training and experience. Obstetric fistulas are rare in
industrialized nations because of the medical and sur-
gical resources available to manage labor and delivery.
When fistula is encountered in industrialized nations, it
is often of a very different nature than that observed in
low-resource settings and, thus, surgical experience for
the correction of these types of defects does not necessar-
ily provide sufficient skills for the management of more
complicated obstetric fistulas. Compared with postsurgi-
cal fistulas, obstetric fistulas are commonly much larger
and require more complex surgery to achieve continence
of urine and feces. In some cases, surgical repair of the
fistula entails sequential pelvic reconstruction, requiring
more than one surgical procedure to restore anatomy and
function. Furthermore, tissues surrounding the obstetric
fistula are often compromised, resulting in additional
challenges of tissue reapproximation and wound healing.
Preoperative and Postoperative Care
Preoperative and postoperative care are essential parts of
responsible surgical management. Lack of adequate peri-
operative management places patients at increased risk
for injury and complications such as wound dehiscence,
infection, and death. The complexity of some surgical
procedures, such as those for fistula repair, demands that
patients receive postoperative care by trained caregivers
to optimize the chances of restoration of bladder or bowel
function.
Health care professionals most often participate in
short-term international medical programs, because they
can take only a limited number of weeks from their own
practice to perform surgery abroad. However, they must
ensure that their surgical patients will have continuity
of care during the postoperative period. Just as they do
when practicing in their home country, practitioners
have an ethical obligation not to abandon their patients.
When a surgeon will no longer be able to provide
care, he or she should facilitate the transfer of care to
another qualified health care professional. This could
require arranging for an equally proficient medical prac-
titioner to arrive onsite and accept the transfer of care
before the physician’s departure. Another possibility is
transferring care to a local health care professional who
has been specifically trained to care for these postopera-
tive patients.
Adequate postoperative care for patients also should
incorporate health care issues not directly related to the
COMMITTEE OPINIONS
surgical repair. Fistula illustrates both the complexity
and the importance of adequate short- and long-term
postoperative management. Family planning is espe-
cially important for those women who have experienced
gynecologic morbidity secondary to pregnancy or lack of
adequate antepartum and postpartum care. Furthermore,
these patients also should have access to family planning,
including contraceptive management, fertility preserva-
tion, and management of future pregnancies. Another
important postoperative consideration is the reentry of
patients with extensive gynecologic injury, such as fistula,
back into the local community. For many women, this
includes addressing the social marginalization experi-
enced before undergoing surgical reconstruction that
separates them from their families and networks within
their communities. The care of patients with fistula
illustrates how postoperative care extends beyond medi-
cal and surgical issues in the immediate postoperative
period. As a result, health care professionals participating
in international medical programs must be prepared to
support such services.
Clinical and Social Research
Clinical research has an important role in the care of
patients in international settings. Research extrapolated
from other populations provides imperfect guidance
because the incidence and exacerbation of disease found
in resource-limited areas are often a function of local
culture, environment, and resources. Without popula-
tion-specific data, patients will be subject to therapies or
procedures that either are not evidence based or may not
be relevant to their population. For example, there is a
need for well-designed research to establish optimal treat-
ment guidelines for complex obstetric fistula in interna-
tional settings. Much of what is known about the care of
obstetric fistula has been acquired from informal studies,
case reports, and on-the-ground experience, rather than
from well-designed clinical studies. Important clinical
questions remain, such as the optimal timing of fistula
repair, the best technique to correct large and complex
defects, the usefulness of urinary diversion, and the dura-
tion of postoperative catheterization. Social research
questions to be investigated include appropriate strate-
gies to help patients reintegrate into their communities
after an attempt at fistula repair. This information is
necessary to provide continuous quality improvement
with the goal of optimizing the care delivered to these
patients (22, 23).
Health care professionals may not have the primary
intention of performing research while participating in
an international medical program. However, they may
find that their sponsoring organization conducts clini-
cal research in conjunction with clinical services. They
should be aware that they may be directly or indirectly
contributing to clinical research (eg, collecting data about
new techniques, devices, or therapeutics) when providing
health care abroad.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 226
 Research standards should not change from country
to country, although the application of such standards
generates controversy. Given the unique vulnerabilities of
many populations, international standards for protection
of human research participants should exist to prevent
harm to research participants (24). Although a complete
discussion of the conduct of ethical research in inter-
national settings is beyond the scope of this document,
listed as follows are guidelines for ethical and responsible
conduct of research:
• All studies should be well designed and reflect
research integrity. Informal trials and other investi-
gations that do not meet the standards of scientific
rigor should not be conducted.
• The institutional review board at the researcher’s
home institution should approve a research proto-
col before it is conducted. In addition, mechanisms
should exist for review and oversight by the local
community or institution.
• Informed consent for clinical research should be
obtained in a separate manner from informed
consent for clinical care. Researchers must inform
patients that they are participating in research and
explain the differences between clinical care and
clinical research before their participation is secured.
Limitations presented by a perceived lack of resourc-
es among the local community do not preclude follow-
ing these standards for the ethical conduct of research.
Health care professionals who feel that the sponsoring
organization is not meeting these standards of research
should not participate in any research component while
practicing abroad and are encouraged to discuss their
concerns with the appropriate review board. Exclusion
from research participation may not necessarily preclude
health care providers from providing medical and surgi-
cal care apart from research efforts.
Sustainability
Sustainability is an essential component of all efforts to
deliver medical care to individuals in resource-limited
areas. This entails an investment of education, medical
supplies, and personnel to the resource-limited country
so that local community members can take an active role
in maintaining and improving the health of the popula-
tion and in preventing disease.
Practitioners who perform surgery abroad should
contribute to the sustainability of their efforts. Although
the temporary nature of overseas efforts means that many
practitioners cannot personally participate in continued
efforts to provide care, there are several opportunities to
contribute to the goal of sustainability.
Health care professionals should collaborate with
organizations demonstrating a long-term interest in the
health of the local community, particularly when those
organizations have a continuing community presence
after the surgical teams leave. Education is one of the
COMMITTEE OPINIONS
most effective opportunities to advance sustainability.
Efforts to educate members of the community and health
care professionals are a vital part of instituting enduring
sustainability after the departure of the traveling health
care team. Before departure, traveling health care profes-
sionals should assist the community in the identification
and utilization of resources from within the local envi-
ronment for the management of gynecologic patients.
Community leaders serving as advocates for women’s
health and locally available medical and surgical equip-
ment are examples of the resources available at a local
level that can be mobilized for sustainability. Issues such
as the primary prevention of fistula, management of
fistula both before and after repair, and rehabilitation
are the key components to combating the condition of
fistula.
Conclusion
International surgical programs present Fellows with
a unique set of practical and ethical challenges. This
document has highlighted some of the leading issues that
health care professionals should consider before partici-
pating in these endeavors. Because this document cannot
address all issues that may arise, the surgeon should
always keep the interests of the patient as a central tenet
to guide adaptations of medical care to the local context.
References
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COMMITTEE OPINIONS
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2002.htm. Retrieved April 16, 2010.
Copyright September 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Ethical considerations for performing gynecologic surgery in low-
resource settings abroad. Committee Opinion No. 466. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2010;
116:793–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 228
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 480 • March 2011
Committee on Ethics
This Committee Opinion was developed by the Committee on Ethics of the American College
of Obstetricians and Gynecologists as a service to its members and other practicing clinicians.
While this document reflects the current viewpoint of the College, it is not intended to dictate
an exclusive course of action in all cases. This Committee Opinion was approved by the
Committee on Ethics and the Executive Board of the American College of Obstetricians and
Gynecologists.

Empathy in Women’s Health Care

ABSTRACT: Empathy is the process through which one attempts to project oneself into another’s life and
imagine a situation from his or her point of view. Most individuals do have an innate capacity to show empathy
toward others. Empathy is as important to being a good physician as technical competence. However, at times
the health care environment and educational process overly emphasize technological competence, curing dis-
ease rather than healing the patient, or the economic aspects of medicine. This may interfere with an empathic
approach in the clinical setting. In this Committee Opinion, the Committee on Ethics of the American College of
Obstetricians and Gynecologists defines empathy and related terms, describes the role of empathy in medicine,
outlines objections and barriers to incorporating empathy into clinical care, reviews research on measuring empa-
thy, discusses the inclusion of empathy in medical education, and makes recommendations about empathic care
for health care providers and the health care system.

Empathy is the process through which one attempts to
project oneself into another’s life and imagine a situa-
tion from his or her point of view (1, 2). Empathy plays
an important role in caring for and healing the whole
patient, as demonstrated by the inclusion of the subject
of empathy in the curriculum of all levels of medical
education. Providing empathic care improves the physi-
cian–patient relationship, resulting in improved patient
outcomes and satisfaction (3). This is particularly true
in reproductive medicine, where events often take place
at critical stages of the development of individuals and
families. Most individuals do have an innate capacity to
show empathy towards others. However, at times the
health care environment and educational process over-
ly emphasize technological competence, curing disease
rather than healing the patient, or the economic aspects of
medicine. This may interfere with an empathic approach
in the clinical setting. Therefore, the Committee on Ethics
makes the following recommendations:
• Empathy is as important to being a good physician al states, inviting patients to express their concerns.
as technical competence. Physicians should continue
to incorporate empathy into their interactions with
patients because this contributes to the restoration of
emotional, spiritual, and physical health of patients.
• Empathy needs to be effectively reinforced through
regular use at all stages of physicians’ training and
careers or it will be lost from physicians’ profes-
sional identities and skill sets. Medical students and
residents should continue to be taught the skills of
empathic care as part of their training. After resi-
dency, empathy should continue to be reinforced
regularly through continuing medical education.
• An empathic relationship can be established with a
patient in one encounter. Physicians should make
every effort to do so because empathy helps physicians
enter into the patient’s perspective, leading them to
be attuned to aspects of the patient’s world that phy-
sicians may otherwise overlook.
• Physicians should aim to become proficient at iden-
tifying and responding to the verbal and nonverbal
clues that patients often give regarding their emotion-
• Changes are needed throughout the health care sys-
tem to promote empathy. These changes include cul-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 229

 tural and financial shifts that value empathy. Making
empathy part of relationships between all levels of
health care providers and also part of relationships
between health care providers and administrators
also is needed. Improving physician well-being will
improve empathy toward patients.
Imagine a patient: a 34-year-old pregnant woman
comes to the office with vaginal bleeding. Ultrasonography
reveals the demise of a 14-week-old fetus. How should a
physician relate this information to her? Does the physi-
cian’s demeanor change if this was an undesired preg-
nancy or a fetus with a previously or newly diagnosed
lethal abnormality? How differently might the physician
approach her if this was a pregnancy achieved after years
of infertility or if the patient had experienced other losses
like this in the past?
The physician may sympathize and say, “I’m so sorry
for your loss.” This general statement of sympathy is a
useful first step, but an empathic response goes a step fur-
ther and uses knowledge about the personal meaning of
this loss and the circumstances that surround the experi-
ence to help the patient. Empathy allows the physician to
better understand each patient’s feelings and perspective.
By empathizing with the patient, the physician can help
her more effectively cope with this loss, providing her
with the appropriate physical, emotional, and spiritual
support she needs.
Empathy gives insight into how the patient’s life-
long identity shapes the patient’s view of her illness and
decisions about her illness (4). It allows physicians to
understand a patient’s relationship with her family and
how that relationship may influence her autonomy and
decision making. Empathy is as important to being a
good physician as technical competence. This is especially
true in reproductive medicine where emotional concerns
may be as important to patients as physical concerns.
Moreover, not empathizing with a patient because of
time or other constraints may limit the quality of medical
care a physician provides and may introduce a greater
margin for medical error (5).
Empathy, Sympathy, and Compassion
The three related terms 1) empathy, 2) sympathy, and 3)
compassion all play an important part in physicians’ rela-
tionships with their patients. However, the three terms,
although very similar, are not completely interchangeable
because each has a distinct meaning and role in the care
of patients.
Empathy
Empathy is the process through which a physician
attempts to project himself or herself into the patient’s
life and imagine the situation from the patient’s point
of view (1, 2). It goes beyond sympathy and compas-
sion because it involves an appreciation of each patient’s
story and an understanding of the differences among
2 Committee Opinion No. 480
COMMITTEE OPINIONS
individual patients and their situations (6, 7). Empathy
enhances the physician’s ability to understand individual
patients’ unique concerns, life experiences, and decisions.
It also allows for the provision of medical care that is
more effective and acceptable to patients because the care
is consistent with their values and needs.
Sympathy
Sympathy has etymological roots that mean “feeling
with” or “like-feeling” (8). Sympathy allows the physi-
cian to know the patient’s emotions, resulting in parallel
feelings between the physician and patient. Sympathy is
described as “an effortless feeling of sharing or joining the
patient’s pain and suffering” (9). It also can mean feeling
sorry for another. Unlike empathy, sympathy does not
require the physician to understand from the patient’s
point of view what the patient is feeling or experiencing.
Empathy is a genuine attempt to understand the patient’s
unique experience (6, 9).
Compassion
Compassion, the sharing of another’s emotional burden,
goes beyond merely feeling another’s suffering as occurs
with sympathy. Compassion engenders a desire that the
physician then acts upon to relieve the patient’s suffering.
But it does not involve the insight into the unique context
of a patient’s life that empathy provides (10, 11).
Role of Empathy in Medicine
Empathy is at the heart of the physician–patient relation-
ship because it promotes the physician’s understand-
ing of the patient’s perspective (12). Studies show that
empathy enhances the physician–patient relationship by
improving trust, diagnostic accuracy, communication,
clinical outcomes, and both physician and patient satis-
faction (12, 13). Studies also show that empathy not only
decreases professional liability claims, but also enables
patients to better understand and cope with their illness
(12, 14).
In the clinical setting, empathy enables the physician
to “(a) understand the patient’s situation, perspective
and feelings; (b) to communicate that understanding and
check its accuracy; and, (c) to act on the understanding
with the patient in a helpful (therapeutic) way” (3).
However, it is impossible to know exactly how the patient
feels or to completely share the patient’s experience (15).
Empathy requires imagination, patience, and curiosity on
the part of physicians as they attempt to enter a patient’s
world, because this world can be very different from their
own (13, 16). Empathy allows the physician to become
attuned to aspects of the patient’s world that the physi-
cian may otherwise overlook.
Being empathic with patients who do not share the
physician’s culture or values or who are nonadherent to
medical recommendations can be challenging (15). But
empathy can help resolve conflicts with difficult or angry
patients. The curiosity and imagination that are a part of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 230
 empathy allow the physician to understand the difficult
patient’s position more effectively than an intellectual,
detached approach (17). Empathy also allows physicians
to be open to a greater understanding of an individual
patient’s cultural experiences that shape each patient’s
unique approach to her illness.
Counterintuitively, empathic responses to patients
throughout the clinical encounter actually shorten the
patient visit. When patients’ emotional concerns are not
acknowledged by physicians, patients will continue to
make multiple attempts to express these concerns until
they are addressed, thereby lengthening the visit (18,
19). Studies show that effective empathic responses can
be brief, as short as one sentence, and do not require the
physician to greatly alter his or her style (19).
Empathy is not only important to the patient–physi-
cian relationship, but it is also important to relationships
between health care team members because it improves
interactions between clinicians. Clinicians’ understanding
of and respect for other colleagues’ views and concerns
promotes teamwork, bridges differences, and allows col-
laborative learning to occur (20). The results are produc-
tive resolution of disagreements, decreased staff turnover,
and increased staff recruitment, along with improved
communication, trust, and mutual respect between staff,
and a greater likelihood that staff will regularly reach
personal and professional goals (20). Increased com-
munication, trust, and respect between clinicians leads
to increased collaboration in patient care among health
care team members and improved patient outcomes (21).
Objections and Barriers to
Incorporating Empathy Into
Clinical Care
Professional Training Issues
Positive empathic and communication role models are
crucial to medical education at all levels. Such positive
role models for medical students and clinicians are pres-
ent in all learning environments, including the clinical
setting. Observing and interacting with these exemplary
role models is one part of an informal or hidden curricu-
lum that is important in learning how to be a physician.
The hidden curriculum results from “the processes, pres-
sures, and constraints which fall outside of, or are embed-
ded within, the formal curriculum, and that are often
unarticulated or unexplored” (22). This hidden curricu-
lum can have both positive and negative influences. In
most instances this informal curriculum models positive
behavior, including empathy. These positive influences
include attending physicians, residents, nurses, and other
personnel who take time to listen, communicate with
patients, and understand what each individual patient
is experiencing with her illness. However, negative role
models can contribute problematic aspects to the hid-
den curriculum (23, 24). The ever-expanding volume of
information that must be included in the medical educa-
Committee Opinion No. 480
COMMITTEE OPINIONS
tion curriculum at all levels may limit the time available
for learning empathy and communication skills (13, 25,
26). For example, on the wards, a medical student may
see overworked residents, nurses, or attending physicians
who lack the time or training to express empathy. The
medical student may incorrectly assume from this that
empathy may not always be as important as he or she had
learned in the classroom or had seen in other positive role
models for empathy in the clinical setting.
Fear of Overattachment
Another concern with empathy is that it may lead to
some physicians becoming too attached or emotionally
involved with patients, resulting in a loss of objectivity
(16, 27, 28). Other physicians and health care providers
may find trying to imagine the experience of a patient
uncomfortable or even frightening in some cases, causing
them to distance themselves emotionally from a patient,
because it raises the possibility that they or their loved
ones could experience the same medical problems (16).
This distancing can sometimes result in patients’ wishes
and desires for care being overlooked to some degree.
“Empathetic equipoise” is the midpoint that avoids
these two extremes of involvement and detachment
(28). Physicians achieve this by learning about their own
emotional responses to patients and how to appropri-
ately deal with these emotions. The responses will vary
with each individual patient and influence how detached
or empathic the physician may want to be. However, as
physicians gain more experience in managing their own
emotional responses to patients, they can achieve more
meaningful interactions with patients without becoming
too detached or involved (29, 30).
Financial Obstacles to Empathy
Changes in the economic and business aspects of medi-
cine can present other obstacles to empathy in medicine.
Many health care systems, businesses, and insurance
companies are justifiably concerned with controlling
costs associated with providing health care (9). The result
may be less time overall for physicians and other health
care professionals to spend with patients, frequent physi-
cian changes by patients because of changing or lack of
insurance coverage, and decreases in staffing for patient
care because of reduced reimbursements (25). This may
result in physicians communicating less with patients and
overlooking opportunities to incorporate empathy into
clinical care.
Health Information and Misinformation
Information-based obstacles to empathy include the large
amount of medical and technical information that physi-
cians must keep up with and the large volume of both
accurate and inaccurate information available to patients
about their illnesses from the Internet and other sources.
Some physicians’ negative reactions to patient research
and the time required to correct the misinformation
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 231
 patients find on their own may create yet another obstacle
to incorporating empathy into clinical care.
The Culture of Health Care Delivery Systems
The culture of the health care system that physicians
practice within can be an additional barrier to empathy.
Researchers have found that “the energy and enthusiasm
that a practitioner brings into the consultation with a
patient is profoundly influenced by the practice and larger
organization’s values and integrity” (20). Lack of empath-
ic relationships within a medical practice, with adminis-
trators, or between consulting specialists may affect the
physician’s relationships with his or her patients because
the physician may be forced to engage with patients in
a manner that can be different from how he or she is
treated by others in the health care system. Health care
system cultures that do not value empathy will not reward
physicians’ empathic relationships with patients and may
actively discourage physicians from being empathic with
patients.
Research on Empathy and Clinical
Outcomes
Because empathy is important to the physician–patient
relationship, more research is being conducted on empa-
thy and how to measure it, with methodological tools
evolving rapidly. The Jefferson Scale of Physician Empa-
thy has been developed and validated for measuring
empathy of physicians, medical students, residents, and
nurses using a self-reporting method. A similar tool is
the Jefferson Scale of Patient Perceptions of Physician
Empathy in which patients fill out a questionnaire con-
cerning how empathic they perceive their physicians to be
(31–33). These tools are available from their authors and
in the book Empathy in Patient Care by Mohammadreza
Hojat (9).
Studies of Physician Behavior
Studies conducted using the Jefferson Scale of Physician
Empathy and the Jefferson Scale of Patient Perceptions
of Physician Empathy show that both physicians’ abil-
ity to be empathic and patients’ perceptions of physician
empathy affect clinical outcomes. The findings also dem-
onstrate that an empathic relationship can be established
in just one visit (31).
Additional research on empathy examined recorded
interactions between patients and primary care physi-
cians, oncologists, and surgeons, looking for the number
of empathic responses from these physicians during
patient visits. Empathic responses to patients by physi-
cians ranged from 10% to 22% in two studies of can-
cer patients (5, 19). Empathic responses were greater
from younger physicians, female physicians with female
patients, and oncologists who characterized themselves
as having a “socioemotional” orientation rather than a
technical orientation (5). A different study of primary
care physicians found that patients usually offer clues that
4 Committee Opinion No. 480
COMMITTEE OPINIONS
physicians need to acknowledge and encourage patients
to elaborate upon, as opposed to patients providing direct
and spontaneous expressions of emotions to which physi-
cians can respond (18). The researchers hope that these
studies will eventually evolve into educational models for
physicians to use to improve empathic communication
with patients by teaching physicians to become proficient
at recognizing and responding empathically to patients’
verbal and nonverbal clues, thereby inviting patients to
express their concerns.
Studies of Empathy in Medical Education
Research using the Jefferson Scale of Physician Empathy
and Jefferson Scale of Patient Perceptions of Physician
Empathy demonstrated a decrease in empathy among
third-year medical students (34). Medical students with
higher empathy scores performed better during clinical
clerkships, but not on objective examinations of medical
knowledge such as the Medical College Admission Test
and the United States Medical Licensing Examination
(12, 34). An additional study of internal medicine resi-
dents found a correlation between empathy and resident
well-being, with higher mental well-being associated with
higher cognitive empathy scores (35).
Teaching and Reinforcing Empathy in
Medical Practice
Medical educators are increasingly recognizing the
importance of empathy in improving physician–patient
interactions and relationships, thereby improving patient
outcomes and satisfaction (9). Empathy is successfully
being incorporated into the formal curriculum of medi-
cal schools, especially in the clinical setting (3). Empathy
is included in the Accreditation Council for Graduate
Medical Education competency requirements for resi-
dency training under the categories of patient care, inter-
personal and communication skills, and professionalism
(36). Empathy is also the focus of continuing medical
education courses for physicians after residency.
There is no one specific model for teaching empathy
to medical students and physicians. The use of narratives
and stories, patient histories, role playing, and conver-
sations are effective ways of teaching empathy. This
includes physicians and medical students paying atten-
tion to patients’ stories of illness in the context of the
patients’ lives, especially when taking patient histories.
Physicians and medical students also can learn empathy
by developing narrative competence, which is the abil-
ity to acknowledge, absorb, interpret, and respond to a
patient’s story and plight. Narrative competence allows
physicians and medical students to join patients in their
illnesses (37).
Physicians’ personal experiences with illness or learn-
ing about experiences of illness through novels, fictional
stories, and paintings also effectively teach empathy (38).
Point-of-view writing from the patient’s perspective by
medical students increases the students’ empathy, abil-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 232
 ity to identify others’ feelings, expression of emotions,
and development of insight (39). Minimizing medical
students’ and physicians’ distress and improving their
quality of life and the work environment increases empa-
thy towards patients (35). Providing medical students
with physician role models who demonstrate empathy
towards patients, along with showing students how to
overcome their anxieties associated with patients’ illness-
es and suffering, also increases medical students’ empathy
toward patients (27, 40). Physicians and medical students
also should take time to learn about the availability of
resources and other professionals (eg, counselors, clergy,
and psychologists) in their area who can provide addi-
tional support and empathy to patients when indicated.
However, these other resources should not be a substitute
for physicians and medical students learning how to be
empathic toward their patients.
Communication is vital to empathy in the physician–
patient relationship. Teaching medical students and phys-
icians the use of open-ended questions and continuers
(phrases that invite the patient to continue expressing
her thoughts and feelings), techniques for recognizing
patients’ verbal and nonverbal emotional cues, and lan-
guage for empathic responses to patients results in
improved communication and understanding (5, 40–42).
Please see Box 1 for examples of open-ended questions,
continuers, phrases to facilitate empathy, and examples
of direct and indirect opportunities for empathy that
arise in the course of the patient–physician encounter.
Regardless of how it is taught, empathy requires
effective reinforcement through regular use at all stages of
physicians’ training and careers or it will disappear from
physicians’ professional identities and skill sets. Empathy
is a “use it or lose it” skill (9). It is important for physi-
cians to use and not lose the ability to be empathic toward
patients because empathy contributes to the restoration
of emotional, spiritual, and physical health of patients.
References
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Knowing what others know, feeling what others feel: a con-
trolled study of empathy in psychotherapists. J Nerv Ment
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2. Callahan S. The psychology of emotion and the ethics of
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ethics of care. Washington, DC: Georgetown University
Press; 2001. p. 141–61.
3. Mercer SW, Reynolds WJ. Empathy and quality of care. Br J
Gen Pract 2002;52 Suppl:S9–12.
4. Nelson JL, Lindemann H. What families say about
surrogacy: a response to “autonomy and the family
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Ethics 2007;18:219, 26; discussion 233–4.
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Abernethy AP, et al. Oncologist communication about
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Clin Oncol 2007;25:5748–52.
Committee Opinion No. 480
COMMITTEE OPINIONS
Box 1. Communication Tools for
Improving Empathy
Examples of Open-Ended Questions and Phrases*
“Tell me more.”
“How did you feel?”
“Anything else?”
“What concerns do you have?”
Examples of Phrases to Facilitate Empathy†
“I want to make sure I really understand what you are
telling me.”
“I don’t want us to go further until I’m sure that I’ve gotten
it right.”
Examples of Continuers‡
“I can see this is making you angry.”
“I can imagine how scary this must be for you.”
“Tell me more about what is upsetting you.”
Examples of Empathic Opportunities Expressed by
Patients‡
Direct empathic opportunity (explicit verbal expression
of emotion) – “I have been really depressed lately.” “I’m
scared about what my test result means.”
Indirect empathic opportunity (implicit verbal expression
of emotion) – “Does this mean I’m going to die?” “Oh no.
What do we do now?”
*Marvel MK, Epstein RM, Flowers K, Beckman HB. Soliciting
the patient’s agenda: have we improved? JAMA 1999;281:283–7.
†
Halpern J. Practicing medicine in the real world: challenges to
empathy and respect for patients. J Clin Ethics 2003;14:298–307.
‡
Pollak KI, Arnold RM, Jeffreys AS, Alexander SC, Olsen MK,
Abernethy AP, et al. Oncologist communication about emotion
during visits with patients with advanced cancer. J Clin Oncol
2007;25:5748–52.
6. Koehn D. Rethinking feminist ethics: care, trust, and empa-
thy. New York (NY): Routledge; 1998.
7. McCurdy DB. Respecting autonomy by respecting per-
sons: taking the patient’s story seriously. Humane Med
1990;6:107–12.
8. Bryan CS. “Aequanimitas” Redux: William Osler on
detached concern versus humanistic empathy. Perspect
Biol Med 2006;49:384–92.
9. Hojat M. Empathy in patient care: antecedents, develop-
ment, measurement, and outcomes. New York (NY):
Springer; 2007.
10. Taigman M. Can empathy and compassion be taught?
JEMS 1996;21:42, 3, 45–46, 48.
11. Pellegrino ED, Thomasma DC. The Christian virtues in
medical practice. Washington, DC: Georgetown University
Press; 1996.
12. Hojat M, Gonnella JS, Mangione S, Nasca TJ, Veloski JJ,
Erdmann JB, et al. Empathy in medical students as related
to academic performance, clinical competence and gender.
Med Educ 2002;36:522–7.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 233
 13. Larson EB, Yao X. Clinical empathy as emotional labor in
the patient-physician relationship. JAMA 2005;293:1100–6.
14. Mercer SW, Watt GC, Reilly D. Empathy is important for
enablement. BMJ 2001;322:865.
15. Nadelson CC. Ethics, empathy, and gender in health care.
Am J Psychiatry 1993;150:1309–14.
16. Gianakos D. Empathy revisited. Arch Intern Med 1996;
156:135–6.
17. Halpern J. Empathy and patient-physician conflicts. J Gen
Intern Med 2007;22:696–700.
18. Suchman AL, Markakis K, Beckman HB, Frankel R. A
model of empathic communication in the medical inter-
view. JAMA 1997;277:678–82.
19. Morse DS, Edwardsen EA, Gordon HS. Missed opportuni-
ties for interval empathy in lung cancer communication.
Arch Intern Med 2008;168:1853–8.
20. Beach MC, Inui T, Relationship-centered care. A con-
structive reframing. Relationship-Centered Care Research
Network. J Gen Intern Med 2006;21Suppl 1:S3–8.
21. Baggs JG, Schmitt MH. Nurses’ and resident physicians’
perceptions of the process of collaboration in an MICU.
Res Nurs Health 1997;20:71–80.
22. Stephenson A, Higgs R, Sugarman J. Teaching professional
development in medical schools. Lancet 2001;357:867–70.
23. Hafferty FW, Franks R. The hidden curriculum, ethics
teaching, and the structure of medical education. Acad Med
1994;69:861–71.
24. Hicks LK, Lin Y, Robertson DW, Robinson DL, Woodrow SI.
Understanding the clinical dilemmas that shape medical
students’ ethical development: questionnaire survey and
focus group study. BMJ 2001;322:709–10.
25. Cluff LE. Reflections on the lost art of caring. Pharos Alpha
Omega Alpha Honor Med Soc 2002;65:27–32.
26. Hollis RS. Caring: a privilege and our responsibility. Obstet
Gynecol 1994;83:1–4.
27. Rosenfield PJ, Jones L. Striking a balance: training medi-
cal students to provide empathetic care. Med Educ 2004;
38:927–33.
28. Trotter G. Virtue, foible, and practice—medicine’s arduous
moral triad. Bioethics Forum 2002;18:30–6.
29. Chen PW. When patients feel abandoned by doctors. N.Y.
Times, March 19, 2009. Available at: http://www.nytimes.
com/2009/03/12/health/12chen.html?_r=1. Retrieved June
9, 2010.
30. Back AL, Young JP, McCown E, Engelberg RA, Vig EK,
Reinke LF, et al. Abandonment at the end of life from
patient, caregiver, nurse, and physician perspectives: loss
of continuity and lack of closure. Arch Intern Med 2009;
169:474–9.
31. Glaser KM, Markham FW, Adler HM, McManus PR,
Hojat M. Relationships between scores on the Jefferson
6 Committee Opinion No. 480
COMMITTEE OPINIONS
Scale of physician empathy, patient perceptions of physi-
cian empathy, and humanistic approaches to patient care: a
validity study. Med Sci Monit 2007;13:CR291–4.
32. Fields SK, Hojat M, Gonnella JS, Mangione S, Kane G,
Magee M. Comparisons of nurses and physicians on an
operational measure of empathy. Eval Health Prof 2004;
27:80–94.
33. Hojat M, Mangione S, Kane GC, Gonnella JS. Relationships
between scores of the Jefferson Scale of Physician Empathy
(JSPE) and the Interpersonal Reactivity Index (IRI). Med
Teach 2005;27:625–8.
34. Hojat M, Mangione S, Nasca TJ, Rattner S, Erdmann JB,
Gonnella JS, et al. An empirical study of decline in empathy
in medical school. Med Educ 2004;38:934–41.
35. Shanafelt TD, West C, Zhao X, Novotny P, Kolars J,
Habermann T, et al. Relationship between increased per-
sonal well-being and enhanced empathy among internal
medicine residents. J Gen Intern Med 2005;20:559–64.
36. Accreditation Council for Graduate Medical Education.
Outcome Project. Available at: http://www.acgme.org/
outcome. Retrieved June 1, 2010.
37. Charon R. The patient-physician relationship. Narrative
medicine: a model for empathy, reflection, profession, and
trust. JAMA 2001;286:1897–902.
38. Spiro H. What is empathy and can it be taught? Ann Intern
Med 1992;116:843–6.
39. Shapiro J, Rucker L, Boker J, Lie D. Point-of-view writing: a
method for increasing medical students’ empathy, identifi-
cation and expression of emotion, and insight. Educ Health
(Abingdon) 2006;19:96–105.
40. Spencer J. Decline in empathy in medical education: how
can we stop the rot? Med Educ 2004;38:916–8.
41. Halpern J. Practicing medicine in the real world: chal-
lenges to empathy and respect for patients. J Clin Ethics
2003;14:298–307.
42. Marvel MK, Epstein RM, Flowers K, Beckman HB.
Soliciting the patient’s agenda: have we improved? JAMA
1999;281:283–7.
Copyright March 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
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Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Empathy in women’s health care. Committee Opinion No. 480.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;117:756–61.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 234
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 500 • August 2011 (Replaces No. 358, January 2007)
Committee on Ethics
This Committee Opinion was developed by the Committee on Ethics of the American College
of Obstetricians and Gynecologists as a service to its members and other practicing clinicians.
Although this document reflects the current viewpoint of the College, it is not intended to
dictate an exclusive course of action in all cases. This Committee Opinion was approved by
the Committee on Ethics and the Executive Board of the American College of Obstetricians
and Gynecologists.

Professional Responsibilities in Obstetric–Gynecologic

Medical Education and Training
ABSTRACT: The education of health care professionals is essential to maintaining standards of medical
competence and access to care by patients. Inherent in the education of health care professionals is the problem
of disparity in power and authority, including the power of teachers over learners and the power of practitioners
over patients. Although there is a continuum of supervision levels and independence from student to resident to
fellow, the ethical issues that arise during interactions among all teachers, learners, and their patients are similar.
In this Committee Opinion, the Committee on Ethics of the American College of Obstetricians and Gynecologists
discusses and offers recommendations regarding the professional conduct and ethical responsibilities of practi-
tioners toward patients and participants in research in educational settings; of learners and teachers toward one
another; and of institutions toward patients, learners, and teachers.

Education in obstetrics and gynecology, as in other fields
of medicine, carries professional obligations to patients
as well as obligations between teachers and students.
Students in the context of this Committee Opinion
include medical students, residents, and fellows and are
referred to as “learners” in the course of this document.
In order to help clarify both the professional responsibili-
ties of practitioners and learners to those patients whose
care provides educational opportunities and the respon-
sibilities of teachers and learners toward one another, the
Committee on Ethics makes the following recommenda-
tions and conclusions:
• The education of health care professionals is essential must provide care or perform procedures for which
to maintaining standards of medical competence and
access to care by patients.
• Disparities of power and authority exist in the rela-
tionships between teachers and learners and between
practitioners and patients that have an effect on the
educational process.
• Respect for patient autonomy requires that patients patients, and teachers, including an obligation to pro-
be allowed to choose not to be cared for or treated by
learners when this is feasible.
• Pelvic examinations on an anesthetized woman that
offer her no personal benefit and are performed solely
for teaching purposes should be performed only with
her specific informed consent obtained before her
surgery.
• It is the responsibility of the teacher to impart wis-
dom, experience, and skill for the benefit of the
learner, without expectation of personal service by or
reward from the learner.
• Amorous relationships between teachers and their
current learners are never appropriate.
• Learners should not be placed in situations where they
they are not qualified or not adequately supervised.
• Communication between learner and teacher is
essential in fostering an atmosphere that will allow,
and even encourage, learners to request help and
constructive feedback.
• Institutions have ethical obligations to learners,
vide a work environment that enhances professional
competence.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 235

 • Institutions have an obligation to protect patients veniences associated with education in clinical medicine.
and learners from unprofessional health care pro- However, although these benefits generally accrue to
viders. society at large, the burdens fall primarily on individual
• Medical education and postgraduate training of patients, especially the economically disadvantaged or the
learners assisting in research with human partici- very ill, who are more likely to receive their care at teach-
pants should include a curriculum on research ethics ing hospitals (3).
and study design. Physicians must learn new skills and techniques in a
manner consistent with the ethical obligations to benefit
the patient, to do no harm, and to respect a patient’s right
Background to make informed decisions about health matters. These
The education of health care professionals is essential obligations must never be subordinated to the need and
to maintaining standards of medical competence and desire to learn new skills. In consideration of society’s
access to care by patients. Inherent in the education of interest in the education of physicians, all patients should
health care professionals is the problem of disparity in be considered “teaching patients.” Patient characteristics
power and authority, including the power of teachers such as race, ethnicity, or socioeconomic status should
over learners and the power of practitioners over patients not be the basis for selection of patients for teaching.
(1). Residents have a dual responsibility as teacher and Although patients are given the opportunity to con-
learner and must understand their ethical responsibilities sent to or refuse treatment by learners, the obligations
to both the learners they teach and the patients for whom of the profession, the institution, and patients should be
they provide care. Physicians in postgraduate fellowship uniform and explicit. Professional obligations include
programs face the same issues as residents and, for the disclosure of the risks and benefits inherent in the teach-
purposes of this Committee Opinion, are treated identi- ing setting and provision of adequate supervision at all
cally. Although there is a continuum of supervision levels levels of training. The patient should be encouraged to
and independence from student to resident to fellow, participate in the teaching process to contribute her fair
the ethical issues that arise during interactions among share to the development of a new generation of health
all teachers, learners, and their patients are similar. It care providers. A situation may arise in which a patient
also should be noted that the line between learners and refuses, for whatever reason, to have a learner involved
teachers in medicine is fluid and nonlinear. All clinicians in her health care. For example, a patient may express
learn from and teach each other at every point in their concerns about receiving care from an inexperienced
professional development. In this statement, the ethical learner or a learner of a particular gender or even cultural
obligations of teachers apply to all of those in the teaching background. Such refusals should initiate discussion and
role, wherever they may be in the educational continuum, counseling and should be handled with compassion
and the obligations of learners apply to all of those in the and respect. Respect for patient autonomy requires that
learning role. patients be allowed to choose not to be cared for or
treated by learners when this is feasible (4, 5).
Ethical Responsibilities Toward Some procedures, such as pelvic examinations under
Patients in Educational Settings anesthesia, require specific consent (6). In women under-
At the turn of the 20th century, some medical educators going surgery, the administration of anesthesia results in
were concerned about the needs of patients in “teaching increased relaxation of the pelvic muscles, which may be
hospitals,” and they took steps to ensure that patients’ beneficial in some educational contexts. However, if any
rights would be protected. However, the prevailing opin- pelvic examination planned for an anesthetized woman
ion was more aptly characterized by this statement from offers her no personal benefit and is performed solely
one medical school faculty member: “Patients must for teaching purposes, it should be performed only with
clearly understand from the beginning that they are her specific informed consent, obtained before her sur-
admitted for teaching purposes and that they are to be gery (7, 8). When patients are not making decisions for
willing to submit to this when pronounced physically fit” themselves, as may be the case with minors or those with
(2). This sentiment persists as an unstated presumption brain injury or intellectual disability, consent for these
in some contemporary education programs and opposes pelvic examinations under anesthesia must be obtained
the respect for patient autonomy that is due to patients in from the patient’s surrogate decision maker (eg, a parent,
educational settings. Moreover, if the power inherent in spouse, designated health care proxy, or guardian); how-
the role of medical practitioner is misused in educational ever, when possible and clinically appropriate, the health
settings, this misuse may carry over into attitudes and care provider should also obtain the assent of the patient
relationships with future patients as well. herself for such examinations.
If health care professionals are to benefit society, they Alternatives to teaching pelvic examinations exist
must be well educated and experienced. The benefits to that do not raise the challenges of securing informed con-
society of educating health care professionals provide the sent. Today, many medical schools employ surrogates for
justification for exposure of patients to risks and incon- patients to teach learners how to perform pelvic examina-

2 Committee Opinion No. 500

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 236

 tions. These surrogates are variously referred to as gyne- to spend time that is out of proportion to the educational
cology teaching associates, professional patients, patient value involved on a research project, but gives little or no
surrogates, standardized patients, or patient simulators. credit for such a contribution. In this regard, the behavior
Improvements in technology continue to allow for of teachers toward learners is a powerful example of eth-
increased training in the virtual setting for learners. Spe- ics in action. Learners are likely to model their behavior
cifically, technology has allowed surgical training using on that of their teachers (10).
laparoscopic and hysteroscopic surgery simulation and The relationship of a teacher to a learner involves
has improved resident education in these areas. Obstet- not only trust and confidence but also power and depen-
ric simulators also have allowed for teaching emergency dency. It is the role of the teacher to foster independence
techniques, maneuvers, and management strategies with- in the learner while nurturing the learner in the learning
out putting patient safety at risk. Although simulation process. This is a complex relationship, the boundaries
often improves clinical education, simulation cannot of which can become obscured in the intense setting of a
completely substitute for educational experiences with clinical preceptorship (11). For example, the long hours
real patients. spent by teachers and learners in relatively arduous and
Learners must hold in confidence any information isolated circumstances may foster amorous (romantic
about patients acquired in the context of a professional or sexual) relationships. Regardless of the situation,
relationship. They should discuss specific patient care the power imbalance makes an amorous relationship
matters only in appropriate settings, such as teaching con- between a teacher and learner ethically suspect. Such
ferences or patient care rounds. Conversations in public relationships between teachers and their current learn-
places, such as hospital corridors or elevators, involving ers are never appropriate. Institutional policies may be
comments about patients, their families, or the care they more restrictive, and both teachers and learners should be
are receiving are inappropriate (9). Furthermore, as aware of these policies and adhere to them. Occasionally,
medical records are increasingly kept in electronic form, situations may arise that challenge these proscriptions;
it is important to ensure patient privacy and security of for example, the spouse of a professor of obstetrics and
information in accordance with the Health Insurance gynecology might matriculate at the professor’s medi-
Portability and Accountability Act of 1996 regulations. cal school. These are rare circumstances, however, and
Accordingly, learners should only access charts of patients should not contravene the general rule of avoiding these
for whom they are providing care. relationships.
Adequate and appropriate supervision of learners is
Ethical Responsibilities of Learners of utmost importance. Learners should not be placed in
Assisting in Research situations where they must provide care or perform pro-
Learners in academic centers may elect to assist in human cedures for which they are not qualified or not adequately
research studies as collaborators with faculty researchers, supervised. To do otherwise violates an ethical respon-
as recruiters of research participants, or both. Because sibility to the learner as well as to the patient. A healthy
of this, medical education and postgraduate training of relationship between teachers and learners allows learn-
these learners should include a curriculum on research ers to request assistance or supervision without fear of
ethics and study design. In addition, there may be institu- humiliation or retribution. Teaching should take place in
tional requirements of all researchers (eg, online learning an atmosphere that fosters mutual respect. Furthermore,
modules or institutional review board certification) that learners should never independently attempt procedures
learners of any level must fulfill if they are assisting in or even counsel patients if they lack the experience,
such studies. knowledge, or skills to do so without supervision. In rare
circumstances, learners should have the right to decline
Ethical Responsibilities of Teachers to participation in a patient’s care when participation in this
Learners care creates a clear conflict of conscience for the learner
(12).
The relationship between teacher and learner in medical
Both teachers and learners should be aware that
education inevitably involves the problem of imbalance
the behaviors and attitudes of teachers are being keenly
of power and the risk of exploitation of a learner for the
observed by learners and constitute part of the “hidden
benefit of the teacher (1). The teacher–learner relation-
curriculum” on which the Committee on Ethics has pre-
ship exists at multiple levels among faculty members,
viously commented in Committee Opinion Number 480
medical students, residents, and fellows. There is a fun-
Empathy in Women’s Health Care (13):
damental ethical responsibility at all levels for the teacher
to impart wisdom, experience, and skill for the benefit of The hidden curriculum results from “the pro-
the learner, without expectation of personal service by cesses, pressures, and constraints which fall
or reward from the learner. Because so much of medi- outside of, or are embedded within, the formal
cine is learned in a preceptor–learner relationship, great curriculum, and that are often unarticulated
care must be taken that the teacher does not exploit the or unexplored” (14). This hidden curriculum
learner. An example is the teacher who expects a learner can have both positive and negative influences.

Committee Opinion No. 500 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 237

 In most instances this informal curriculum providing adequate ancillary and administrative support
models positive behavior, including empathy. services, and, in the case of residents and fellows, provid-
These positive influences include attending ing reasonable salaries and benefits (22).
physicians, residents, nurses, and other per- A source of substantial stress for some learners is the
sonnel who take time to listen, communicate conflict between family responsibilities and the demands
with patients, and understand what each indi- of medical education (23). For many learners, sleep
vidual patient is experiencing with her illness. deprivation caused by long work hours results in fatigue,
However, negative role models can contribute irritability, and anxiety. The inability to relate with con-
problematic aspects to the hidden curriculum sideration or affection to a partner or spouse or to partici-
(15, 16). pate in any effective way with child care or other domestic
responsibilities may seriously impair family relationships.
Conduct and Responsibilities of Also, because residents and fellows are often at an age
when they begin families, the demands of pregnancy, the
Learners Toward Their Teachers postpartum period, and child rearing (for both male and
Learners have the obligation to be honest, conscientious, female residents and fellows) are often paralleling their
and respectful in their relationships with their teachers. ongoing career goals, which can lead to both personal
They should act in ways that preserve the dignity of and institutional conflicts requiring special attention.
patients and do not undermine relationships between Providing ample time for all residents and fellows to sus-
patients and their physicians. It is the learner’s respon- tain family relationships without adversely affecting the
sibility to ask for assistance and supervision when it is educational experience or imposing excessive burdens
needed. Unfettered communication between learner on colleagues is a challenging task, but one that must be
and teacher is essential in fostering an atmosphere that confronted. Shared positions and more flexible timelines
will allow, and even encourage, learners to request help for completing educational requirements can be helpful
and constructive feedback. When such communication in solving such problems. Nevertheless, despite the need
does not occur, both education and patient care are for institutions to support both learners and teachers in
impaired. maintaining healthy and fulfilling lives outside of their
Inherent in the teacher–learner relationship is the medical careers, it must be recognized that the decision
vulnerability of the learner in dealing with perceived to pursue the profession of medicine entails a duty to
unethical behavior or incompetent conduct of a teacher. patients that may at times require the subjugation of
If a learner observes such behavior or conduct, the mat- personal needs.
ter should be brought to the attention of the appropriate Institutions have an obligation to protect patients
institutional authority. Mechanisms that are nonjudg- and learners from unprofessional health care providers.
mental and without penalty should be clearly defined Institutions should maintain a well-established reporting
to encourage an open dialogue about these observed and review process for investigating allegations of unethi-
behaviors. cal behavior or incompetent conduct by its teachers and
learners. Access to such a process can protect patients and
Institutional Responsibilities facilitate fair and just relationships between learners and
Institutions have ethical obligations to learners, patients, teachers in these scenarios. It is the responsibility of any
and teachers, including an obligation to provide a work teacher to address unprofessional behavior in learners
environment that enhances professional competence. because this behavior has been shown to be predictive
The health care system often has exploited learners at all of unprofessional behavior in the workforce later on in
levels of education. Learners may be viewed as a source life (24).
of cheap labor, especially in busy hospitals on a teach- Finally, as concerns about cost containment increase,
ing service. However, the goals of providing a broad education could become a low priority. The process of
clinical experience and maintaining continuity of care for medical education may reduce the efficiency of patient
patients must be balanced against the neglect of learners’ care and increase costs. It is the responsibility of all physi-
physical health and mental health as well as patient safety cians and institutions involved in the education of health
(17, 18). Lack of sleep, heavy workloads, and increasing care professionals to ensure that cost-reduction efforts do
amounts of responsibility without commensurate levels not diminish the opportunities for education in clinical
of authority are sources of great stress in medical educa- medicine. Institutions have an ethical responsibility to
tion, especially during residency (19–21). The potentially develop policy statements and guidelines for the inclu-
negative effect of such an educational experience on the sion of learners in patient care in ways that ensure sound
learner’s developing attitude toward patients and the pro- medical education and high-quality medical care.
fession should be considered. The obligation to provide a
good work environment includes ensuring that learners References
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medical education and responsibility for patient care, New Haven (CT): Yale University Press; 1992. p. 12–25.

4 Committee Opinion No. 500

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 238

 2. Ludmerer KM. The rise of the teaching hospital. In: 14. Stephenson A, Higgs R, Sugarman J. Teaching professional
Learning to heal: the development of American medical development in medical schools. Lancet 2001;357:867–70.
education. New York (NY): Basic Books; 1985. p. 219–33. 15. Hafferty FW, Franks R. The hidden curriculum, ethics
3. Kahn KL, Pearson ML, Harrison ER, Desmond KA, Rogers teaching, and the structure of medical education. Acad Med
WH, Rubenstein LV, et al. Health care for black and poor 1994;69:861–71.
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2nd ed. Chicago (IL): University of Chicago Press; 2003. Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
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Committee Opinion No. 500 5

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 239

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 501 • August 2011
American College of Obstetricians and Gynecologists
Committee on Ethics
American Academy American Academy of Pediatrics Committee on Bioethics
of Pediatrics This document reflects emerging clinical and scientific advances as of the date issued and is
DEDICATED TO THE HEALTH OF ALL CHILDREN TM subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Maternal–Fetal Intervention and Fetal Care Centers

ABSTRACT: The past two decades have yielded profound advances in the fields of prenatal diagnosis and
fetal intervention. Although fetal interventions are driven by a beneficence-based motivation to improve fetal and
neonatal outcomes, advancement in fetal therapies raises ethical issues surrounding maternal autonomy and deci-
sion making, concepts of innovation versus research, and organizational aspects within institutions in the develop-
ment of fetal care centers. To safeguard the interests of both the pregnant woman and the fetus, the American
College of Obstetricians and Gynecologists and the American Academy of Pediatrics make recommendations
regarding informed consent, the role of research subject advocates and other independent advocates, the avail-
ability of support services, the multidisciplinary nature of fetal intervention teams, the oversight of centers, and
the need to accumulate maternal and fetal outcome data.

The past two decades have yielded profound advances
in the fields of prenatal diagnosis and fetal intervention.
Ultrasonography and magnetic resonance imaging have
led to the diagnosis of fetal anomalies that can affect
many organ systems. Concomitantly, improvements in
minimally invasive techniques and in the understand-
ing of fetal physiology have allowed for more successful
and less invasive or risky interventions for fetal diseases
in utero. Intervention has been offered for a variety of
fetal diseases, including structural abnormalities, cardiac
arrhythmias, fetal metabolic diseases, and abnormalities
of the placental vessels or membranes. Many of these dis-
eases would be lethal without treatment; some (eg, spina
bifida or hypoplastic left heart syndrome) are not neces-
sarily lethal postnatally, but efforts to treat them in utero
have been offered with the goal of improving long-term
outcomes for the child. Many interventions are offered
within the construct of a research protocol. Although fetal
interventions are driven by a beneficence-based motiva-
tion (ie, a desire to do good, to improve fetal and neonatal
outcomes, and to ameliorate suffering), advancement in
fetal therapies raises ethical issues surrounding maternal
autonomy and decision making, concepts of innovation
versus research, and organizational aspects within institu-
tions in the development of fetal care centers.
The Decision-Making Process
The overarching goal of fetal interventions is clear: to
improve the health of children by intervening before birth
to correct or treat prenatally diagnosed abnormalities.
This stems from a beneficence-based obligation to the
fetus. Any fetal intervention, however, has implications
for the pregnant woman’s health and necessarily her bodily
integrity and, therefore, cannot be performed without her
explicit informed consent (1). It is impossible to treat the
fetus without going through the pregnant woman either
physically (in the case of surgical treatments) or phar-
macologically (as in the case of medications given to the
woman that then cross the placenta to treat the fetus).
Because the pregnant woman who chooses to undergo
these procedures and treatments must assume some of
the risk, respect for her autonomy requires a thorough
discussion and evaluation of the maternal risks and harms
of any of these therapies as well as her valid consent (2).
A pregnant woman’s right to informed refusal must be
respected fully (3).
For many women, as well as the physicians caring for
them, decision-making considerations relevant to fetal
treatment may seem to parallel the parental decision-
making process in determining treatment of childhood
ailments. Women weigh the risks and benefits of the

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 240

 intervention for the fetus against the possible outcomes
without intervention. For those few treatments that have
been shown to be effective and be of low risk or minimal
invasiveness, most women will agree to the treatment
out of a beneficence-based obligation to their fetuses.
Nonetheless, consent still must be based on the pregnant
woman’s assessment of her own interests. Although a
parental decision may, in certain circumstances, be over-
ridden for a child after birth, even the strongest evidence
for fetal benefit would not be sufficient ethically to ever
override a pregnant woman’s decision to forgo fetal treat-
ment (4, 5).
A pregnant woman will often assume quite signifi-
cant risks for her fetus, and some women might find it
difficult to forgo these interventions because of pressures
from within themselves, from their families, from their
communities, or even from their health care providers
(6). A pregnant woman’s decision may be affected by fac-
tors such as her family’s or society’s expectations regard-
ing her responsibility as a prospective mother, maternal
feelings of guilt and her desire to try and make things
“right,” or even the psychosocial “therapeutic misconcep-
tion,” that is, the presumption that an intervention with
no proven efficacy will actually work merely because it is
offered by a center, is under a study protocol, or has been
covered by the news media (7, 8). The informed consent
process should, therefore, contain reasonable safeguards
against limits to voluntariness, ranging from undue influ-
ence to coercion.
Safeguards should be in place to protect women
considering fetal research. One possible safeguard would
be to have a research subject advocate who does not have
direct ties to the experimental protocol so that this indi-
vidual can act as an independent advocate for the preg-
nant woman, especially when the proposed intervention
poses significant risks to the pregnant woman (9). This
advocate should be nondirective in his or her support of
the woman’s decision and focus on meeting the woman’s
decision-making needs. Involving someone who has an
understanding of the culture of research and yet main-
tains separateness from the research team can provide an
ethical safeguard to support the pregnant woman (10).
But even outside a research protocol, a pregnant woman
receiving treatment that is not experimental may also
benefit from an independent advocate who might be her
obstetric provider, a perinatal nurse, or a specially trained
advocate.
Other family members involved in these decisions
also need consideration. Pregnant women have a variety
of support persons, including spouses and partners of
either sex. The interests of others involved vary depend-
ing on their relationship to the woman and fetus. Because
families come in differing forms, the woman herself
should define these relationships and determine who
should assist in any decision making. In this Committee
Opinion, the American College of Obstetricians and
Gynecologists (the College) and the American Academy
2 Committee Opinion No. 501
COMMITTEE OPINIONS
of Pediatrics (the Academy) write about the interests of
the father but recognize that the father of the fetus may
be absent or uninvolved and that the involved partner
may be a man or a woman who is not biologically related
to the fetus.
In most cases, the father has a moral interest in the
health of the fetus and the pregnant woman, just as he
would have interests in the health of the mother and
child after delivery. It is appropriate for women to involve
fathers in these decisions for good reasons: they will usu-
ally be raising this future child together, they will make
joint decisions about health issues, and their relation-
ship may be one of mutual support in family decision
making. It may be problematic for a woman to proceed
with these interventions without consulting the father. It
must be recognized that, postnatally, pediatric care com-
monly involves shared decision making between a child’s
mother and father, making the recommendation not to
grant any authority to the father in the prenatal period
uncomfortable for many pediatricians. However, for the
reasons stated earlier, the pregnant woman’s interests and
final decisions regarding fetal interventions assume prior-
ity in the prenatal period. Although it may be appropriate
and helpful for the father to be involved in these decisions
and have complete access to information (with proper
authorization from the pregnant woman), to assign him
any authority to assent or dissent would unjustifiably
erode the autonomous decision-making capacity of the
pregnant woman. The College addressed paternal con-
sent for research in a previous Committee Opinion (3,
11). The College concluded that paternal consent for
research on fetuses should not be required but recognizes
that federal regulations continue to require this consent
in some circumstances.
Pregnant Women Require Information
on Risks, Benefits, Outcomes, and
Alternatives for Both the Fetus and
Themselves
One of the challenges surrounding fetal interventions is
the difficulty in delivering information to prospective
parents that is both thorough and unbiased. Not only do
prospective parents need to be informed of the goals of
treatment, but they also need to know about the some-
times conflicting data, or more commonly the paucity of
data, that support offering or performing interventions.
The risks and possible benefits to the fetus undergoing
an intervention need to be weighed against the risks and
benefits of obstetric and neonatal care without the inter-
vention (which is often the standard of care). Moreover,
the range of outcomes of all options must be presented,
because prospective parents may erroneously believe that
there are only two possible results: 1) success (fetal cure)
or 2) failure (fetal death).
In addition to information regarding the risks and
benefits to the fetus or neonate, women require a frank
2013 COMPENDIUM OF SELECTED PUBLICATIONS 241
 discussion of the maternal risks of any fetal interven-
tion. The morbidity and mortality associated with some
interventions may be quite small (insertion of an amnio-
centesis needle and use of many maternal medications)
or quite significant (the performance of laparotomy and
hysterotomy). Maternal hysterotomy may increase the
risk of uterine rupture to rates as high as those after a
classical cesarean delivery (4–9%) (12); these ruptures are
associated with significant maternal and neonatal mor-
bidities and mortalities. Moreover, these risks will persist
in subsequent pregnancies as well. A thorough disclosure
of these risks is always necessary.
Innovative and Experimental Care
One vital, although sometimes difficult, distinction that
should be made to prospective parents concerns which
fetal interventions are standard or evidence-based ther-
apy and which are innovative or experimental. Certainly,
any intervention that is being studied as part of a research
protocol requires formal institutional review board (IRB)
oversight and an approved informed consent process.
Federal guidelines indicate that novel interventions that
deviate substantially from standard practice do not need
to be performed within a research protocol but should
eventually be developed into a protocol subject to IRB
oversight (13):
When a clinician departs in a significant way
from standard or accepted practice, the inno-
vation does not, in and of itself, constitute
research. The fact that a procedure is “experi-
mental,” in the sense of new, untested or dif-
ferent, does not automatically place it in the
category of research. Radically new procedures
of this description should, however, be made
the object of formal research at an early stage
in order to determine whether they are safe and
effective. Thus, it is the responsibility of medical
practice committees, for example, to insist that a
major innovation be incorporated into a formal
research project.
An attempt should be made to make clear to patients
the distinction between the goals of therapeutic medicine
(eg, cure, treatment, or palliation) versus the goals of
research (eg, answering a scientific question that con-
tributes to generalizable knowledge). In addition, there
is often a blurring of boundaries between research and
innovative practice associated with the rapidly developing
technologies used in fetal interventions that raises con-
cerns about the protection of pregnant women and their
fetuses from the risks of unproven therapies. Although
the first few uses of a new intervention may be motivated
by a desire to help particular fetuses, once feasibility and
potential benefit have been identified, innovations should
be subjected to systematic formal research as soon as fea-
sible (14). This benefits science, because evaluation of new
procedures might be hindered if new procedures continue
Committee Opinion No. 501
COMMITTEE OPINIONS
to be considered “innovative therapy” rather than part of
careful research. Pregnant women and their fetuses who
undergo these interventions must have at least the same
protections afforded to other research participants, and
studies should be designed to assess the full effect of risks
and benefits of these interventions on both the woman
and the fetus, for both short- and long-term outcomes.
Alternatives to Intervention
The case of prospective parents electing to forgo fetal
intervention also needs further exploration. Given the
maternal morbidities and experimental nature of many
fetal interventions, some women may understandably
elect to carry the pregnancy to term but not to undergo
fetal intervention. It is critical, therefore, for those centers
offering fetal interventions to provide care, support, and
appropriate referral services for these women and their
families. For the fetus with anomalies such as spina bifida,
this will involve postnatal neurosurgical treatment, which
is currently standard care. For the fetus with lethal abnor-
malities, this may take the form of access to palliative care
or perinatal hospice programs. In the situation in which
the fetal intervention is being offered in an attempt to
avoid fetal death, these services could be offered alongside
the intervention in case it is unsuccessful.
Finally, the clinical reality of serving women dur-
ing pregnancy is that some women will elect pregnancy
termination when facing the diagnosis of significant fetal
anomalies. Centers offering fetal intervention should
evaluate pregnant women in a timely fashion, counsel
them adequately and nondirectively about all options,
and for women who might opt for pregnancy termina-
tion, have in place appropriate mechanisms, including the
ability and resources for referral, to support these women
through a difficult decision. An integrated palliative care,
hospice, or bereavement service can help support women
who elect to terminate their pregnancies as well.
Thus, the ethical provision of fetal intervention
requires that women are not only well informed but also
have, to the greatest extent possible, meaningful access
to alternatives to intervention. Practitioners participat-
ing in fetal care centers may face significant difficulties
in presenting in as nonbiased a fashion as possible these
four distinct options: 1) fetal intervention, 2) postnatal
therapy, 3) palliative care, or 4) pregnancy termination.
Certainly each pediatrician, surgeon, and obstetrician
involved in these decisions may have his or her own dis-
tinct views about the best course of action for any given
disease entity, and thus, the counseling of the pregnant
woman becomes complicated. Coordination of care and
good communication between health care providers can
help to minimize the conflicting information and opin-
ions that may be given to patients.
Other Necessary Support Services
The complex emotional stressors that pregnant women
and their families may experience when considering fetal
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 242
 intervention may necessitate access to a variety of support
services. These may include social services, palliative care
and perinatal hospice services, genetic counseling, and
ethics consultation, when appropriate.
Fetal Care Centers
Diagnostic and therapeutic efforts are being combined
frequently and marketed in the form of fetal care or
treatment centers. Fetal care centers can exist in many
forms, having developed through a variety of multi-
disciplinary collaborative relationships among pediat-
ric subspecialists, maternal–fetal medicine specialists,
and radiologists. Often, they are freestanding centers,
but they also can exist within established pediatric or
obstetric departments. Regardless of their origin or site,
they typically offer a wide variety of fetal diagnostic
services as well as proven therapies and experimental
practices of unproven benefit. These centers are driven
by a beneficence-based motivation to improve fetal and
neonatal outcomes and have frequently been the site
of innovation and research that has furthered this end
(15, 16). It should be noted that most maternal–fetal
medicine divisions already provide such fetal care along
with care of pregnant women; these divisions routinely
call on pediatric surgeons and other subspecialists to
consult with pregnant women without having any direct
affiliation with a formal fetal care center. The dilemmas
that may arise in the context of fetal care are, thus, not
unique to fetal care centers; many of these dilemmas are
faced by anyone caring for pregnant women. However,
in marketing these centers around the fetus and its care,
these centers require heightened scrutiny so that the
needs and the interests of pregnant women are being
adequately addressed (17).
Conflicts of interest may arise in providing fetal
intervention services, because these services may be
financially lucrative for the institutions and may benefit
the careers of the centers’ practitioners. Furthermore,
institutional use of resources by a fetal care center for the
few women and fetuses who may benefit from an inter-
vention may not be the most just or fair distribution of
resources. Even if centers do not perform an intervention
in the majority of cases they see, this may simply mean
that prenatal counseling is a major component of most
fetal care and is, in fact, a good justification for the use of
resources in this fashion.
Cooperation between fetal care centers should be
encouraged to establish collaborative research networks
(especially for rare diseases and procedures) and to
support multicenter trials to accumulate more robust
short- and long-term maternal and fetal outcome data
on all categories of fetal intervention. In addition, the
establishment of centers of excellence for those proce-
dures that are particularly challenging and rare may help
to optimize fetal and maternal outcomes (18). As with
many rare specialty-specific endeavors, the balance of
offering geographic access while having the quantity of
4 Committee Opinion No. 501
COMMITTEE OPINIONS
cases necessary to develop clinical expertise and quality
outcomes is difficult to achieve. Limiting interventions
to a few centers of excellence for the sake of quality of
care will create both geographic and financial barriers to
access. Furthermore, those centers not participating in
multicenter trials must consider whether to refer patients
to centers that are participating to facilitate these research
studies and find answers that cannot be discovered by
offering interventions “off-study.”
Oversight and Governance
To protect the panoply of interests involved (fetal,
maternal, professional, and institutional), centers per-
forming fetal interventions should have organizational
structures or groups to provide oversight of both clinical
and nonclinical activities. Multidisciplinary teams should
be assembled to oversee the care being offered and to
ensure that appropriate informed consent is obtained.
To protect the interests of the pregnant woman, such
teams should include a maternal–fetal medicine special-
ist. Indeed, because of their particular training, maternal–
fetal medicine specialists are best suited to direct the care
of the pregnant woman undergoing fetal interventions.
Neonatologists also should be involved, because they will
typically be the primary physicians managing the care of
the neonate and dealing with the medical consequences
of the antenatal intervention. Including a variety of other
professionals on the team, such as nurses, pediatric and
surgical subspecialists, genetic counselors, chaplains, eth-
icists, and other members of institutional ethics commit-
tees, is vital. Ideally, this group would include members,
both professionals and nonprofessionals, without direct
ties to the center involved. This group can help explore
conflicts of interest, distinguish between innovation and
research, and ensure that pregnant women are not being
unduly influenced, coerced, or taken advantage of in
what may be a time of crisis.
There also may be clinical management conflicts that
arise between the obstetric and pediatric staff caring for
these women, because the focus of care of the two groups
can differ. Organizational structures within fetal care cen-
ters that foster consensus building are crucial to resolving
these conflicts. The obstetrician, however, must remain in
charge of the pregnant woman’s overall care. Moreover,
these centers must be able to provide the high-risk and
obstetric critical care that these women often need; this
may be a challenge when centers are housed in pediatric
hospitals, but it is necessary to optimize the well-being of
the pregnant woman.
Finally, to protect against institutional conflicts of
interest, an external advisory group may be necessary
to monitor the center’s nonclinical activities, includ-
ing marketing, outreach, and community relations. A
memorandum of understanding should be developed
that delineates the oversight group’s authority to veto or
halt activities that do not provide adequate benefits or
pose inordinate risks.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 243
 Recommendations
To safeguard the interests of both the pregnant woman
and the fetus, the College and the Academy make the fol-
lowing recommendations:
• Because it is impossible to treat the fetus without and to support multicenter trials to accumulate more
going through the pregnant woman either physi-
cally or pharmacologically, any fetal intervention
has implications for the pregnant woman’s health
and necessarily her bodily integrity and, therefore,
cannot be performed without her explicit informed
consent.
• Distinctions should be made to prospective par-
ents between which protocols are standard or evi-
dence-based therapies and which are innovative or
experimental interventions. Ordinarily, innovations
should be subjected to systematic formal research
as soon as feasible. Research must always be offered
under proper oversight by an IRB.
• The informed consent process should involve thor-
ough discussion of the risks and benefits for both
the fetus and the pregnant woman. The full range
of options, including fetal intervention, postnatal
therapy, palliative care, or pregnancy termination,
should be discussed. The informed consent process
should contain reasonable safeguards against limits
to voluntariness, ranging from undue influence to
coercion.
• Safeguards should be in place to protect women the law. Int J Obstet Anesth 2006;15:95–7.
considering fetal research. One possible safeguard
would be to have a research subject advocate who
does not have direct ties to the experimental proto-
col so that this individual can act as an independent
advocate for the pregnant woman, especially when
the proposed intervention poses significant risks to
the pregnant woman. Similarly, a woman receiving
treatment that is not experimental may also benefit
from an independent advocate who might be her
obstetric provider, a perinatal nurse, or a specially
trained advocate.
• The complex emotional stressors that pregnant 10. Silber TJ. Human gene therapy, consent, and the realities of
women and their families may experience when
considering fetal interventions may necessitate access
to a variety of support services. These may include
social services, palliative care and perinatal hospice
services, genetic counseling, and ethics consultation,
when appropriate.
• The organization and governance of centers provid-
ing fetal interventions should involve a diverse group
of professionals. Maternal–fetal medicine specialists
and neonatologists should be included in this group.
Including a variety of other professionals on the
team, such as nurses, pediatric and surgical subspe-
cialists, genetic counselors, chaplains, ethicists, and
other members of institutional ethics committees,
is vital. Ideally, this group would include members,
Committee Opinion No. 501
COMMITTEE OPINIONS
both professionals and nonprofessionals, without
direct ties to the center involved.
• Cooperation between fetal care centers should be
encouraged to establish collaborative research net-
works (especially for rare diseases and procedures)
robust short- and long-term maternal and fetal out-
come data on all categories of fetal intervention. In
addition, the establishment of centers of excellence
for those procedures that are particularly challeng-
ing and rare may help to optimize fetal and maternal
outcomes.
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Copyright August 2011 by the American College of Obstetricians
and Gynecologists and the American Academy of Pediatrics.
The American College of Obstetricians and Gynecologists, 409
12th Street, SW, PO Box 96920, Washington, DC 20090-6920.
All rights reserved. No part of this publication may be repro-
duced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Maternal–fetal intervention and fetal care centers. Committee Opinion
No. 501. American College of Obstetricians and Gynecologists and
American Academy of Pediatrics. Obstet Gynecol 2011;118:405–10.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 245
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 510 • November 2011 (Replaces No. 341, July 2006)
Committee on Ethics
This Committee Opinion was developed by the Committee on Ethics of the American College
of Obstetricians and Gynecologists as a service to its members and other practicing clinicians.
Although this document reflects the current viewpoint of the College, it is not intended to dictate
an exclusive course of action in all cases. This Committee Opinion was approved by the Committee
on Ethics and the Executive Board of the American College of Obstetricians and Gynecologists.

Ethical Ways for Physicians to Market a Practice

ABSTRACT: It is ethical for physicians to market their practices provided that the communication is truthful
and not misleading, deceptive, or discriminatory. All paid advertising must be clearly identified as such. Producing
fair and accurate advertising of medical practices and services can be challenging. It often is difficult to include
detailed information because of cost and size restrictions or the limitations of the media form that has been
selected. If the specific advertising form does not lend itself to clear and accurate description, an alternative media
format should be selected. Advertising that seeks to denigrate the competence of other individual professionals
or group practices is always unethical.

Traditionally, physicians and medical societies have raised
concerns that advertising commercializes the practice of
medicine and does not respect the dignity of the profession.
Physicians have been expected to generate referrals from
other physicians and from satisfied patients by providing
good care to their patients. In the past, some state and
national professional medical societies prohibited adver-
tising in their code of ethics. In 1982, the United States
Supreme Court affirmed a ruling in favor of the Federal
Trade Commission (FTC) in its determination that the pro-
hibition on advertising contained in the American Medical
Association’s code of ethics was an unlawful restraint of
competition (1). The FTC argued that all businesses and
professionals have the right to inform the public of the
services they provide and that all consumers have the
right to make informed choices based on truthful adver-
tising. The purpose of this Committee Opinion is to pro-
vide objective criteria to help members of the American
College of Obstetricians and Gynecologists determine
whether or not a certain advertisement or method of mar-
keting is ethical. In considering appropriate marketing
practices, physicians should evaluate not only their own
actions but also those undertaken on their behalf by hos-
pitals or other health care centers that may be marketing
their services. To this end, the Committee on Ethics makes
the following recommendations and conclusions:
• It is ethical for physicians to market their practices. be unprofessional. Physicians should consider not just
• Advertisements must be truthful and not deceptive the intent of any advertisement but also its effect on the
or misleading.
• Advertisements must not convey discriminatory atti-
tudes.
• Advertising that seeks to denigrate the competence
of other individual professionals or group practices
is always unethical.
• All paid advertising must be clearly identified as such.
• Physicians should consider not just the intent of any
advertisement but also its effect on the public’s view
of the profession.
Appropriate Forms of Communication
According to the FTC, physicians must be allowed to
make their services known through advertising to assist
the public in obtaining medical services. A physician or
practice should not be restricted from marketing medical
services using public media, such as newspapers, maga-
zines, telephone directories, radio, the Internet, televi-
sion, and direct mail. All of these media formats have the
potential for both effective, ethical communication as
well as misrepresentation, depending on their form and
content. Advertising in any format may be ethical but still
reflect poorly on the profession and undermine the public
impressions of the profession. For example, use of a large
billboard or television infomercials to advertise services
is not unethical but still might be considered by many to
public’s view of the profession.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 246

 A paid advertisement promoting the activities of a
physician or practice must be clearly identified as adver-
tising. It is not ethical to compensate the communication
media in any way for publicity in a news item. If a televi-
sion infomercial is used to inform the public of services
available, it should be very clear at all times that this is
paid advertising and not part of a news program.
Care should be taken to choose information appro-
priate to the form of communication. The complexity of
medical terms and treatments may not always lend itself
to the restrictions of a particular advertisement design
or media format. For example, the brevity of television
and radio advertisements may require the omission of
so much information that the advertisement becomes
misleading.
The location in which an advertisement is placed also
may contribute to deception. For example, some read-
ers may assume that a physician who advertises his or
her practice under the subheading “Infertility” in the
telephone directory has received extensive subspecialty
training in that area and regularly treats patients with
these problems. Advertisers should be careful not to imply
subspecialty training when none exists.
Actively approaching specific individuals, in person
or by phone, with the purpose of attracting them as
patients usually is not considered ethical because the risk
of undue pressure from the solicitor is too great. Com-
mon expectations for a physician–patient relationship
may make the prospective patient feel obligated to
respond affirmatively to the encounter. Although many
physicians view such active approaches as always being
unprofessional, they may be ethical in rare circumstances
if extraordinary care is taken to avoid undue pressure.
For example, it may be appropriate to pass out cards to
potential clients at a community health fair.
Appropriate Content of
Advertisements
Advertisements must be truthful and not deceptive or
misleading. Specifically, this means that all information
must be accurate and must not create false or unjustified
expectations. The omission of information should not
render the advertisement misleading. Images and graph-
ics can be as deceptive or misleading as text. The physi-
cian or clinic must be able to substantiate all claims made
in the advertisement. Advertisements may include non-
deceptive information, such as address, phone numbers,
web site address, office hours, languages spoken, board
certification, contracted insurance plans, publications by
physicians, teaching positions, hospital affiliations, and
methods of payment accepted.
Terms such as “top,” “world-famous,” “world-class,”
or even “pioneer,” usually are misleading and designed to
attract vulnerable patients. Statements that rank the com-
petence of physicians or the quality of medical services
usually are not factually supportable. If attributions of
this type are used, the advertisement must describe how
2 Committee Opinion No. 510
COMMITTEE OPINIONS
these rankings were established. The testimonial of one or
two satisfied patients may mislead the public into believ-
ing that all patients, even those with dissimilar histories,
have similar outcomes. The designation of “Top Doctor”
as voted by magazine readers, other doctors, or specific
groups may be used in promotional material because the
term is a factual statement of the results of a survey.
However, advertisements must state if such a designa-
tion involved payment by the physician. Furthermore,
any advertising that seeks to denigrate the competence of
other individual professionals or group practices is always
unethical.
Care must be taken in advertising procedures that
are experimental or have never been proved to result in
the desired outcome. It is deceptive to give the public the
impression that experimental or unstudied procedures
are of proven value or accepted practice.
Claims that a physician or group of physicians have a
unique skill or offer a unique test or treatment often may
be deceptive and rarely should be used. If a physician has
carefully verified that he or she is the only practitioner to
offer a certain treatment in a particular geographic area,
then this information may be dispersed. If the uniqueness
results from a restrictive commercial agreement, this fact
needs to be disclosed in the advertisement.
Specific outcomes should rarely be advertised
because the definition of a success rate, the selection of
eligible patients for consideration in calculating rates,
and the predictive value of rates are all important in
accurately assessing outcomes. Whereas these should be
discussed with an individual patient in the context of her
care, they cannot be interpreted accurately by someone
viewing an advertisement and may be very confusing or
misleading to the patient trying to determine where to
seek care. For example, a fertility clinic’s success rate for
assisted reproductive technologies is dependent on the
patient’s age, the clinic’s patient selection and exclusion
policies, and the clinic’s criteria for cycle cancellation.
Success may be stated in many ways, each of which results
in a different rate, such as clinical pregnancies, single-
ton pregnancies, or live births per started cycle, per egg
retrieval, or per embryo transfer. The Society for Assisted
Reproductive Technology requires reporting of live birth
rates when these data are available (2). Comparing hospi-
tals by cesarean delivery rate is similarly difficult because
rates vary with the characteristics of a patient population
or the presence of a neonatal intensive care unit or both.
Furthermore, a new program or site should not present
the success rates of the parent site as its own, because
its new facilities are untested. When advertisements do
involve success rates or other outcomes, all claims must
be supported by valid, reproducible data, must clearly
state the method used to calculate outcomes, and must
not lead patients or the public to believe that outcomes
are better than they are (2).
Fee structures and costs may be advertised as long
as the information is complete and the titles for spe-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 247
 cial programs do not mislead or encourage inaccurate
assumptions. For example, promises of a money-back
guarantee are frequently misleading because they usually
refund only a portion of the patient’s money if the desired
outcome does not occur. Shared-risk plans usually do not
share risk between the patient and the clinic, but among a
group of patients. “Do one, get one free” treatments may
involve extraordinary requirements and expenses for the
initial treatment and may not truly save the patient any
money. A free initial consultation should not contain any
hidden costs or routinely involve recommendations for
expensive tests or treatments. Any advertisements that
involve such financial plans should contain enough infor-
mation that the prospective patients are neither misled
nor unduly induced to seek services at that clinic.
Producing fair and accurate advertising of medical
practices and services can be challenging, even with the
best intentions. It often is difficult to include detailed
information because of cost and size restrictions or the
limitations of the media form that has been selected. If
the specific advertising form does not lend itself to a clear
and accurate description, an alternative media format
should be selected.
Concerns About Discrimination in
Advertisements
Discriminatory attitudes about race, color, national ori-
gin, religion, or any characteristic that would constitute
illegal discrimination are not acceptable in advertise-
ments (3). Moreover, discriminatory language should be
avoided even if such discrimination might be legal. For
example, sexual orientation and perceived gender are cat-
egories that do not have legal protections from discrimi-
nation in many jurisdictions; however, it is unethical for
a physician to discriminate on such characteristics. A
factual line item stating that a health care provider speaks
Spanish or Cantonese accurately describes the services
provided and would not be considered discriminatory.
Conversely, a factual statement that the health care pro-
viders in a certain clinic are all women may not be ethical
if the wording suggests that health care provided solely
by women is superior to health care provided by men;
this would be considered discriminatory and, therefore,
unethical in the absence of evidence supporting that
Committee Opinion No. 510
COMMITTEE OPINIONS
claim. If the intent of stating the facts is to imply a value
judgment rather than to offer supportable or useful infor-
mation about access, then even a statement of fact may
be unethical.
Vulnerable Groups
Certain individuals and groups of individuals may be
more easily misled by some claims made in advertise-
ments. Special care should be taken when designing a
marketing plan that targets these groups. Perimenopausal
and postmenopausal women who are fearful of cancer
may embrace natural therapies, even when these thera-
pies have not been evaluated adequately for efficacy or
risk. Patients with advanced cancer may be more likely
to pursue unapproved procedures or pharmaceuticals.
Patients with infertility or recurrent pregnancy losses who
are desperate to have a child often are willing to pursue
expensive new treatments that are completely unproved.
References
1. American Medical Assoc v FTC, 455 US 676 (1982).
2. Society for Assisted Reproductive Technology. SART pol-
icy for advertising by ART programs. Birmingham (AL):
SART; 2009. Available at: http://www.sart.org/uploaded
Files/Affiliates/SART/Members/Executive_Council/sart-
advertising-policy-4-2009.pdf. Retrieved June 17, 2011.
3. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC: Ameri-
can College of Obstetricians and Gynecologists; 2011.
Available at: http://www.acog.org/from_home/acogcode.pdf.
Retrieved July 29, 2011.
Copyright November 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Ethical ways for physicians to market a practice. Committee Opinion
No. 510. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;118:1195–7.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 248
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 528 • June 2012 (Replaces No. 368, June 2007)
Committee on Ethics
This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians
and Gynecologists as a service to its members and other practicing clinicians. Although this document reflects
the current viewpoint of the College, it is not intended to dictate an exclusive course of action in all cases. This
Committee Opinion was approved by the Committee on Ethics and the Executive Board of the American College of
Obstetricians and Gynecologists.

Adoption
ABSTRACT: Obstetrician–gynecologists may find themselves at the center of adoption issues because of
their expertise in the assessment and management of infertility, pregnancy, and childbirth. The lack of clarity about
both ethical issues and legal consequences may create challenges for physicians. Therefore, the Committee on
Ethics of the American College of Obstetricians and Gynecologists discusses ethical issues, proposes safeguards,
and makes recommendations regarding the role of the physician in adoption.

Adoption is a commonly used alternative strategy for
family building. Although adoption is not a medical event
per se, obstetrician–gynecologists may find themselves at
the center of adoption issues because of their expertise
in the assessment and management of infertility, preg-
nancy, and childbirth. There are several specific roles that
the obstetrician–gynecologist may be asked to assume
regarding adoption. Physicians commonly provide infor-
mation, advice, and counsel, and they refer birth parents
and prospective adoptive parents to adoption agencies.
Sometimes, they are asked to provide information about
prospective adoptive parents to adoption agencies.
Additionally, the obstetrician may deliver the infant to be
relinquished. In each of these roles, it is important that
obstetrician–gynecologists consider the rights, respon-
sibilities, and safety of all concerned parties: the child,
the birth parents, the prospective adoptive parents, and
themselves. However, their primary responsibility is to
their own individual patients. To clarify the role of the
physician in adoption, the Committee on Ethics of the
American College of Obstetricians and Gynecologists
makes the following recommendations:
• Physicians have a responsibility to provide informa-
tion about adoption to appropriate patients. The
information provided should be accurate and as free
as possible of personal bias and opinions.
• A physician’s primary responsibility in caring for a the biologic father cannot be located.
woman considering adoption is to her and not to the
prospective adoptive parents.
• Physicians should be aware of adoption resources
in their areas and refer patients to licensed adoption
agencies.
• When physicians complete medical screening forms
for prospective adoptive parents, the physician’s
role is to provide truthful, accurate information to
screening agencies.
• Because of ethical issues related to undue influence,
competing obligations, and lack of expertise, physi-
cians should not serve as brokers of adoptions.
Developments in Adoption Practices
Principles in Adoption
Consent of the birth mother and placing the child with
suitable adoptive parents remain stable and consistent
practices. However, many principles that have historically
guided adoption practices are undergoing redefinition
and reconsideration. The evolving context around adop-
tion has led to new layers of complexity (1):
• Although consent of the birth mother has been a nec-
essary precondition for adoption, presumed waiver
of consent by absent birth fathers had been routine.
More recently there has been an increased emphasis
on the rights of biologic fathers and less reliance on
a waiver process to release a child for adoption when
• Historically, adoption practices were based on altru-
ism, and all financial transactions suggestive of

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 249

 purchase of a child were prohibited. Presently, the
unmet demand for adoptive infants, as well as more
straightforward desires to support the birth mother,
can lead to offers of subsidy for medical care and
other support. This can raise concerns about induce-
ments and can make the altruistic nature of adoption
less clear and free of financial conflict.
• In the past, relinquishing birth mothers and prospec-
tive adoptive parents were assured that their con-
fidentiality and anonymity would be protected. In
other words, the adoptions were “closed.” However,
it is no longer possible to guarantee absolute confi-
dentiality to either birth or adoptive parents. Many
states have laws that give adopted individuals access
to their birth records.
• Traditionally, relationships with adoptive parents
were expected to substitute entirely for relationships
with biologic parents. However, in some cases, adop-
tion may include ongoing relationships with birth
parents. Even in a “closed” adoption, the adopted
child and adoptive parents may need to have access
to relevant genetic and medical information about
the biologic parents.
• Adoptive relationships were presumed to be per-
manent once they were finalized in court. Adoption
is usually irrevocable, but rare cases have arisen in
which adoptive relationships were terminated by
adoptive parents, biologic parents, or adopted chil-
dren after a final adoption decree had been granted.
Models of Adoption
There are many types of adoption, and the face of adopted
families is changing, including same-sex couples, single-
parent families, and older relatives raising a child. In this
Committee Opinion, the Committee on Ethics addresses
issues regarding prospective adoptive parents and rec-
ognizes that the adoptive parent may be an individual
man or woman. In addition to the classic adoption of
newborns, other models of adoption are becoming more
common, including kinship adoptions, relinquishment
of children through social service removal, and inter-
national adoptions. Most physicians are not experts in
these varied adoption processes and laws. However, it is
important to be aware of these complex family dynamics
and to be able to refer patients to appropriate resources.
Domestic adoptions still account for most adop-
tions in the United States, but international adoption is
increasing in popularity (2). Children who are adopted
internationally often come from developing countries
that are politically and economically unstable. For this
reason, the opportunities for adoption from various
countries are continuously in a state of flux. International
adoption is regulated by The Hague Convention as well as
by each involved country’s own laws. There are a variety available to support this educational role (7, 8). Patients
of organizations that specialize in international adoptions
2 Committee Opinion No. 528
COMMITTEE OPINIONS
to which physicians can refer their interested patients
(see Resources).
The adoption of older children is increasing and usu-
ally involves a less-conventional model of adoption. One
type of adoption is kinship adoption, whereby a relative
adopts a child from another relative. Another important
source of adoptive children is the foster care system. For
example, it is estimated that there are more than 26,000
preteens available for adoption (3). Adoptive children
enter the foster care system through either social service
removal or relinquishment at safe havens. Safe havens are
locations, such as hospitals or fire stations, where parents
(and sometimes other individuals) may leave infants
anonymously without fear of prosecution for abandon-
ment or neglect. Most states have enacted safe haven laws,
but the specifics vary by state (4).
Physician Roles in Adoption
The lack of clarity about both ethical issues and legal
consequences may create challenges for physicians. In the
following sections, the different roles that the obstetrician–
gynecologist may be asked to play in adoption are
described, ethical issues are discussed, and safeguards are
proposed.
Education and Counseling
Adoption may be relevant in myriad situations, and
physicians have the responsibility to educate appropriate
patients about this option. These obligations can be met,
for some patients, by placing literature about adoption
in the reception area, thereby validating adoption as a
legitimate, respected choice. A discussion of the risks and
benefits of adoption may be indicated for other patients.
In some situations, a referral to another professional with
relevant expertise, such as social work, may be appropri-
ate. Regardless of how information is conveyed, it should
be clear and accurate.
Physicians have a responsibility to provide infor-
mation about adoption to appropriate patients. The
information provided should be accurate and as free
as possible of personal bias and opinions (5). Pregnant
women who may be ambivalent about their pregnancies
should be informed in a balanced manner about their
full range of reproductive options. Physicians should not
advocate for or against any particular option, including
adoption. Nor should they avoid discussing these issues
when they are appropriate to the patient’s situation.
There is an ethical obligation to provide accurate infor-
mation that is required for the patient to make a fully
informed decision.
Adoption should also be considered an option for
certain patients who are looking to build their families.
For example, a discussion about adoption may be appro-
priate for patients who are infertile or for patients in
whom pregnancy may be dangerous (6). Fact sheets are
often ask their physicians, “Doctor, what do you think I
2013 COMPENDIUM OF SELECTED PUBLICATIONS 250
 should do?” (9). There may be a temptation to advocate
for a specific position, but it should be avoided. The
physician’s role is to provide accurate, unbiased infor-
mation that is appropriate for the situation. This may
include infertility treatments, adoption, and child-free
living. The patient can decide which course is most con-
sonant with her own values and life circumstances.
Physicians may have both positive and negative per-
sonal biases about adoption for various reasons. For
example, physicians with personal experience of adop-
tion in their own families of origin, or who have cho-
sen adoption as their own method of family building,
may present this option either positively or negatively,
depending on their individual experiences. Physicians
should be aware of how their own experiences may influ-
ence their attitudes and should disclose this information
when appropriate.
Patients count on the guidance of physicians for
medical decisions. Adoption, however, is only tangen-
tially a medical matter, and few physicians are experts in
this field. Furthermore, for the physician, the particular
encounter with an individual patient or couple occurs
only during a finite point in time. The patients will be
living with the lifelong consequences of these decisions.
Therefore, when discussing the option of adoption with
patients, physicians should guard against advocating
for a particular course of action. The best counsel will
permit the involved parties to explore their options fully
and make a decision that arises out of their own beliefs,
values, needs, and circumstances.
Referrals
The physician’s role in referrals is to identify appropriate physician’s duty to advocate for his or her patient and to
resources. Physicians often may best fulfill their obliga-
tions to patients through referral to other professionals
who have the appropriate skills and expertise to address
the complex issues raised by adoption. For example,
referral to a mental health professional for short-term
counseling provides an opportunity for both birth and
prospective adoptive parents to explore their emotional
reactions and the ways that different alternatives may
affect their lives. Some patients may feel more comfort-
able having a discussion of this type with someone who is
not involved with their ongoing medical care.
Physicians should be aware of adoption resources
in their areas and refer patients to licensed adoption
agencies (10). There are many sources of information
available to assist physicians in developing their own lists
of referral alternatives (see Resources). Also, many local
hospitals maintain referral rosters.
Screening
When working with patients who have decided to pur-
sue adoption, physicians are sometimes asked by those
patients to fill out forms requesting information about
their psychologic and medical suitability as prospective
Committee Opinion No. 528
COMMITTEE OPINIONS
adoptive parents. The physician’s role in such cases is to
provide truthful, accurate information to screening agen-
cies, whose responsibilities are to safeguard and protect
the needs and interests of adoptive children. Physicians
are bound by ethical precepts to be truthful and to act in
their patients’ best interests, and in some circumstances,
these may be in conflict with each other. For example,
a patient may request that a physician not reveal to the
agency the extent of her chronic illness and its potential
effect on her life expectancy. Although a physician may
wish to advocate for a patient, there is an obligation to be
truthful and to let patients know that relevant informa-
tion cannot be hidden.
Some agency forms may request the treating physi-
cian to certify that the individual or couple is fit to par-
ent. If the physician believes that he or she does not have
enough information to make a judgment, the agency may
count that as evidence against the couple. The physi-
cian must be honest and speak accurately to the ques-
tions asked with the information that is available. One
approach is for the physician to disclose to the patient
what will be written in the report before it is filed.
Hospital Care for Birth Mothers Relinquishing
Infants
Obstetrician–gynecologists may find themselves caring
for a patient who has made the choice to relinquish her
child after delivery. These women should be supported
in making a decision that is often extremely difficult. In
addition to the usual demands of labor and delivery, she
may be coping with feelings of grief and loss. This may
leave the woman in a vulnerable position, and it is the
set a kind and caring tone. A physician’s primary respon-
sibility in caring for a woman considering adoption is to
her and not to the prospective adoptive parents.
Physicians should be familiar with their hospitals’
policies regarding adoptive parents and the care of
women relinquishing their infants. In the past, it was
thought best to remove the baby before the woman had
a chance to see or hold her infant. This was thought
to make it easier for her to relinquish the child. Views
on the treatment of the birth mother have significantly
changed. Now, depending on her preferences, the birth
mother may choose options such as holding the baby,
keeping the infant with her until she leaves the hospital,
or breastfeeding. Appropriate acceptance and support of
the birth mother can prevent the disenfranchised grief
that relinquishing an infant may cause her (11).
Limits to the Physician’s Role
Because of ethical issues related to undue influence,
competing obligations, and lack of expertise, physicians
should not serve as brokers of adoptions. In fact, many
hospitals have bylaws prohibiting staff physicians from
direct involvement as adoption brokers.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 251
 One of the reasons physicians should not act as Child Welfare Information Gateway
brokers is the power of undue influence. If a physician Children’s Bureau/ACYF
has acted as a broker and the adoption agreement falls 1250 Maryland Avenue, SW, Eighth Floor
through, he or she will be aware of the loss experienced Washington, DC 20024
by the other party, may feel responsible, and may be (800) 394-3366
tempted to use the power of the physician–patient rela- http://www.childwelfare.gov
tionship to influence the patient to fulfill the original The Child Welfare Information Gateway, a comprehen-
promise. The physician’s ability to provide current or sive resource on all aspects of adoption, is a service of the
future medical care for this patient may be compromised U.S. Department of Health and Human Services.
by these events.
Although both birth parents and prospective adop- National Council for Adoption
tive parents generally view the adoption agreement as 225 North Washington Street
binding, either or both parties may find themselves Alexandria, VA 22314-2561
unable or unwilling to fulfill that agreement after delivery (703) 299-6633
of the child. The pregnant woman who agreed to relin- https://www.adoptioncouncil.org
quish her child may have done so in good faith with the The National Council for Adoption is a nonprofit agency
best knowledge available to her at that time. She may not that focuses on adoption.
know whether she can really do what she agreed to until
she has given birth to this child, held him or her, and Perspectives Press
experienced the extent of loss. The couple who agreed to PO Box 90318
accept a child may regret that decision and feel unable to Indianapolis, IN 46290-0318
keep their part of the agreement if, for example, the child (317) 872-3055
is born with serious medical problems. For these and http://www.perspectivespress.com
similar reasons, no adoption is final until after the birth Perspectives Press concentrates on issues related to adoption.
of the child.
Physicians should avoid matching prospective adop- Resolve, The National Infertility Association
tive parents with women who are choosing to relinquish 1760 Old Meadow Road, Suite 500
their children and should instead refer patients to agencies McLean, VA 22102
or other adoption resources. Physicians should receive (703) 556-7172
only the usual compensation for medical and counsel- http://www.resolve.org
ing services. Referral fees and other arrangements for Resolve is an organization for infertile couples. It main-
financial gain beyond usual fees for clinical services are tains a directory of nationally and locally recognized and
inappropriate. accredited organizations and individuals who provide
When physicians also are prospective adoptive par- adoption support.
ents, there may be a temptation to adopt an infant from
one of their own patients. This arrangement is ethically United States Department of State
problematic. It takes advantage of the physician–patient Bureau of Consular Affairs
relationship and the power differential inherently built Office of Children’s Issues
into this relationship. Physicians are advised to del- SA-29
egate to an independent authority all responsibility for 2201 C Street, NW
matching pregnant women with prospective adoptive Washington, DC 20520
parents. (888) 407-4747; (202) 501-4444
http://adoption.state.gov
Conclusion The Office of Children’s Issues is part of the Bureau of
Obstetricians who care for pregnant women considering Consular Affairs at the U.S. Department of State. It serves
adoption play an important role in providing the medical as the U.S. Central Authority for the Hague Convention
and emotional support these women deserve. Supporting on Protection of Children and Co-operation in Respect
these women through the process of relinquishing their of Intercountry Adoption. The office produces and main-
children while sharing in the joy of the adoptive parents tains country-specific information about intercountry
can be a challenge, but one that embraces the art and adoption; issues adoption notices and alerts to inform
science of medicine. The obstetrician’s obligation to the prospective adoptive parents about developments in a
pregnant woman, however, remains paramount. country; serves as a resource to prospective adoptive
parents, adoption service providers, and members of
Resources Congress; works with U.S. embassies and consulates
Arcus D. Adoption. In: Strickland B, editor. The Gale on adoption-related diplomatic efforts; and monitors
encyclopedia of psychology. 2nd ed. Detroit (MI): Gale complaints against Hague-accredited adoption service
Group; 2001. p. 15–9. providers.

4 Committee Opinion No. 528

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 252

 References 8. American Society for Reproductive Medicine. Adoption:
a guide for patients. Birmingham (AL): ASRM; 2006.
1. Hollinger JH. Adoption law. Future Child 1993;3:43–61. Available at: http://www.reproductivefacts.org/uploaded
2. Families and adoption: the pediatrician’s role in support- Files/ASRM_Content/Resources/Patient_Resources/
ing communication. American Academy of Pediatrics Fact_Sheets_and_Info_Booklets/adoption.pdf. Retrieved
Committee on Early Childhood, Adoption, and Dependent December 19, 2011.
Care. Pediatrics 2003;112:1437–41. 9. Minkoff H, Lyerly AD. “Doctor, what would you do?”
3. Administration for Children and Families. The AFCARS Obstet Gynecol 2009;113:1137–9.
report: preliminary FY 2010 estimates as of June 2011 (18). 10. Seeking and giving consultation. ACOG Committee Opin-
Washington (DC): ACF; 2011. Available at: http://www.acf. ion No. 365. American College of Obstetricians and Gyne-
hhs.gov/programs/cb/stats_research/afcars/tar/report18. cologists. Obstet Gynecol 2007;109:1255–60.
pdf. Retrieved December 19, 2011.
11. Doka KJ. Disenfranchised grief: recognizing hidden sorrow.
4. Child Welfare Information Gateway. Infant safe haven laws: Lexington (MA): Lexington Books; 1989.
summary of state laws. Washington, DC: CWIG; 2010.
Available at: http://www.childwelfare.gov/systemwide/laws_
policies/statutes/safehaven.pdf. Retrieved December 19,
2011.
5. The limits of conscientious refusal in reproductive medi-
cine. ACOG Committee Opinion No. 385. American College
Copyright June 2012 by the American College of Obstetricians and
of Obstetricians and Gynecologists. Obstet Gynecol 2007; Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
110:1203–8. DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
6. Kaunitz AM, Grimes DA, Kaunitz KK. A physician’s guide or transmitted, in any form or by any means, electronic, mechani-
to adoption. JAMA 1987;258:3537–41. cal, photocopying, recording, or otherwise, without prior written per-
7. American Society for Reproductive Medicine. Patient’s mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
fact sheet: adoption. Birmingham (AL): ASRM; 2003. Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Available at: http://www.reproductivefacts.org/uploaded-
Files/ASRM_Content/Resources/Patient_Resources/Fact_ ISSN 1074-861X
Sheets_and_Info_Booklets/Adoption-Fact.pdf. Retrieved Adoption. Committee Opinion No. 528. American College of Obste-
December 19, 2011. tricians and Gynecologists. Obstet Gynecol 2012;119:1320–4.

Committee Opinion No. 528 5

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 253

 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 541 • November 2012 (Replaces Committee Opinion No. 401, March 2008)
Committee on Ethics
This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians
and Gynecologists as a service to its members and other practicing clinicians. While this document reflects the
current viewpoint of the College, it is not intended to dictate an exclusive course of action in all cases. This
Committee Opinion was approved by the Committee on Ethics and the Executive Board of the American College of
Obstetricians and Gynecologists.

Professional Relationships With Industry

ABSTRACT: The American College of Obstetricians and Gynecologists (the College) has a long history
of leadership in ensuring that its educational mission is evidence based and unbiased. A predecessor to this
Committee Opinion was published in 1985, making the College one of the first professional associations to pro-
vide guidance on this issue. The College has continued to update the ethical guidance on physician interactions
with industry periodically. Obstetrician–gynecologists’ relationships with industry should be structured in a manner
that will enhance, rather than detract from, their obligations to their patients. The ideal behaviors set forth in this
Committee Opinion will contribute toward maintaining patient trust in the specialty and avoiding conflicts of inter-
est by College members.

Industrial development of pharmaceutical agents and
medical devices is important for continuing improvement
in health care. Developers and manufacturers of phar-
maceutical agents and medical devices assist physicians
in the pursuit of their educational goals and objectives
through financial support of various medical, research,
and educational programs. The goals of industry, how-
ever, may conflict with physicians’ duties to their patients.
Industry in general has the goal of optimizing profit by
providing useful goods and services. Physicians have a
primary responsibility to act as protectors of the interests
of their patients (1). In many cases, industry’s goals and
physicians’ duties converge; however, physicians must
be aware that industry’s interests and patients’ interests
may significantly diverge. The guidance on relationships
with industry in this document is for members of the
American College of Obstetricians and Gynecologists (the
College).
In the past, physicians accepted gifts from the health
care industry with the belief that such gifts did not
necessarily create undue influence on medical practice.
Examples of such gifts include, but are not limited to,
office supplies, meals, trips, gift certificates, cash, and
honoraria. As used in this document, “gifts” refers to
items and services that are intended to influence the
relationship between a physician and a pharmaceutical or
medical device company or that, regardless of the giver’s
intent, may be perceived by the public as influencing
the relationship. Evidence has accumulated that gifts
from industry often misdirect physicians from their
primary responsibility, which is to act consistently in the
best interests of their patients (2). Several studies have
demonstrated that the prescribing practices of physicians
are influenced by both subtle and obvious marketing
messages and gifts. Marketing influence on prescribing
was found even when the gifts were of nominal value
and delivered in an educational context. The physicians
studied did not recognize or admit to any changes in their
practice of medicine (3–5).
Corporations may seek to influence physician behav-
ior in several ways. In 2010, IMS HEALTH estimated that
$5.8 billion was spent on sales representative detailing to
professionals (6). In data disclosed by 12 drug compa-
nies, the public interest group ProPublica reported that
more than $761.3 million was given to physicians from
2009 to early 2011 (7). The combined prescription drug
sales of these companies comprised approximately 40%
of the U.S. market in 2010, but ProPublica reported that
“the data may not be wholly representative of the indus-
try.” Data may be influenced by differing definitions of
payments, data updates, different ways of reporting, or
reporting of data from a minority of corporations.
In a survey of more than 3,000 physicians conducted
in 2003–2004, 78% reported that they received phar-
maceutical samples, 83% received meals, 35% received
reimbursement for continuing medical education (CME)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 254

 expenses, and 28% received payment for consulting or
serving on an advisory board or speakers’ bureau (8).
According to a recent study of College members, obstetri-
cian–gynecologists who received more meals or samples
from pharmaceutical representatives were more likely to
agree strongly that those representatives were a valuable
source of information about products (9).
Ethical Responsibilities of the
Profession
Physicians have long been held to a high moral standard
in the patient–physician relationship. This relationship
is not egalitarian, but instead, physicians have control
over knowledge and, often, access to treatment. This
imbalance creates a beneficence-based duty to pro-
tect the patient’s best interest. In this relationship the
patient is given priority, and there is a responsibility to
serve as personal advocate for the patient and to elimi-
nate impediments to the promotion of patient welfare.
Physicians are obligated to ensure that the best medical
advice is transmitted to the patient and is not prejudiced
in any manner by industry inducements. Interactions
with industry carry some expectations of reciprocity.
Even when most health care professionals deny that gifts
could influence behavior, they often are unable to remain
objective (3, 10).
When any product promotion or research project
tied to a specific drug or device leads to inappropriate or
unbalanced medical advice to patients, an ethical prob-
lem exists. The public expects physicians to avoid con-
flicts of interest in decisions about patient care. Conflicts
of interest may involve the direct treatment of patients,
although such conflicts also may arise in purchasing deci-
sions by hospitals and group practices.
Although disclosure of conflict of interest is impera-
tive to preserve transparency and trust in the profession,
disclosure alone may not be sufficient to nullify the effect
of the conflict (11). The Institute of Medicine (IOM)
opines that disclosure is a necessary first step for manage-
ment of conflict of interest, but it is insufficient on its
own. The “degree of severity” of the conflict of interest
also must be considered (11). The duration of the con-
flict of interest, amount of money involved, and role of
the physician in relation to the conflict of interest are all
salient points for consideration. Depending on the nature
of the activity, peer review can be effective in mitigating
bias for a presentation; recusal can be considered in the
case of a consultative activity, such as a formulary com-
mittee; or referral for a second opinion can be offered in
the case of a clinical patient recommendation.
Recommendations of Other
Organizations
Several professional and regulatory organizations have
put forth positions regarding industry’s relationship to
individual physician practices and educational activities
(12–22). The Council on Ethical and Judicial Affairs of the
2 Committee Opinion No. 541
COMMITTEE OPINIONS
American Medical Association played an early and pivotal
role in defining physician relationships with industry.
In 2009, the IOM published a report on conflicts of
interest in medical research, education, and practice (23).
The IOM recommendations discourage physicians from
accepting items of material value from companies outside
of a legitimate service contract. Physicians may partici-
pate in consulting if the consulting services are stipulated
in a contract at fair market value. The IOM also calls for
a national reporting program to increase disclosure of
individual physician–industry relationships. In addition,
the IOM opines that physicians should not participate
in educational presentations or writings in which the
physician does not have full control of the content or if
industry provides the content. Physicians are discouraged
from meeting with industry representatives in the medi-
cal office, except by appointment and invitation from
the physician. Finally, the IOM discourages the use of
medication samples except for patients who lack access to
medications as a result of financial barriers.
Faculty, medical students, and residents in academic
medical centers have taken the lead in restricting rela-
tionships with industry. The Pew Prescription Project,
developed by Pew Charitable Trusts in 2007, organized
exemplary policies from various medical institutions
(24). For example, several prominent teaching institu-
tions have taken the step of banning gifts, lunches, sam-
ples, and educational events sponsored by industry both
on and off campus (25). The American Medical Student
Association launched the “PharmFree Campaign” initia-
tive in 2002, which encouraged medical students to use
evidence-based prescribing and to avoid all pharmaceuti-
cal advertisements and sponsorships (26).
A growing number of professional leaders have called
for similar restrictions on industry–physician interactions
in educational settings other than training programs.
They postulate that conflict of interest is inherent in all
educational ventures promoted by the health care indus-
try, despite restrictions put in place by industry, profes-
sional societies, and government agencies (10, 27). The
Council of Medical Specialty Societies adopted a code for
interactions with companies to ensure that educational
programs are nonpromotional, transparent, and free of
commercial influence and bias (28). The Accreditation
Council for Continuing Medical Education has bolstered
its stance to increase transparency and disclosure of com-
mercialism (19). In response to this increased scrutiny
and call for transparency, many pharmaceutical com-
panies have changed their practice of providing direct
funding for CME by providing unrestricted educational
grants to academic institutions, hospitals, and profes-
sional organizations. Those contributions are made via a
central office to preserve CME independence and avoid
the appearance of conflict of interest. The IOM has gone
so far as to endorse industry-free CME (23).
The Pharmaceutical Research and Manufacturers
of America developed guidelines for the pharmaceutical
2013 COMPENDIUM OF SELECTED PUBLICATIONS 255
 industry’s relationship with health care professionals (20).
These voluntary guidelines took effect in 2009. Similarly,
in 2009 the Advanced Medical Technology Association
adopted a code of ethics to guide its members (medical
technology companies) in interacting with health care
professionals. This code of ethics generally addressed the
same issues as the Pharmaceutical Research and Manu-
facturers of America guidelines but also addressed grants
to institutions to subsidize fellows (21).
Many states have implemented regulations that
require industry to register gifts or payments of any value
in a national and publicly accessible database. Many
pharmaceutical companies have exceeded these recom-
mendations and have changed their practice of provid-
ing funding for CME through grants toward academic
institutions, hospitals, and professional organizations
and now make those contributions via a central office to
preserve CME independence and avoid the appearance of
conflict of interest.
The federal government has issued guidance as
well. In 2003, the Office of Inspector General at the
U.S. Department of Health and Human Services issued
a notice regarding voluntary compliance programs for
pharmaceutical manufacturers. Among the written poli-
cies and procedures suggested by the Office of Inspector
General were a code of conduct and identification of
specific risk areas, including relationships with purchas-
ers, physicians, and sales agents. The Office of Inspector
General guidance covered gifts, entertainment, per-
sonal compensation, education grants, and research
funding and referenced and endorsed the voluntary
Pharmaceutical Research and Manufacturers of America
guidelines (22). The National Institutes of Health (NIH)
also has acted to proscribe interactions of NIH employ-
ees with pharmaceutical and device industries, among
other “significantly affected organizations.” Employees
of NIH may not be employed by a significantly affected
organization, engage in a self-employed business activity
with a significantly affected organization, or receive com-
pensation for teaching, speaking, writing, or editing for a
significantly affected organization (29, 30). These policies
regarding the disclosure of conflict of interest also apply
to principal investigators for NIH-funded research (31).
Significant financial interests for investigators include a
minimal value of $5,000 for payments and equity inter-
ests, including any equity interest in nonpublicly traded
entities. The NIH specifically excludes income from
seminars, lectures, teaching, and service on advisory pan-
els for the government, higher education, and academic
centers. The NIH also excludes investment income if the
account is not directly managed by the physician or prin-
cipal investigator.
As a part of the Patient Protection and Affordable
Care Act, manufacturers of “a covered drug, device,
biological, or medical supply” that provide “payment
or other transfer of value” to physicians are required to
submit information on the payment or transfer to the
Committee Opinion No. 541
COMMITTEE OPINIONS
Secretary of Health and Human Services, who will make
the disclosures publicly available (32, 33). Although the
statute indicated that information was to be collected
beginning January 1, 2012, the Centers for Medicare and
Medicaid Services did not meet the deadline stipulated in
the Affordable Care Act for finalizing procedures for sub-
mitting and publishing the information. In its proposed
rule, the Centers for Medicare and Medicaid Services sug-
gests requiring applicable manufacturers to collect data as
of January 1, 2013 (34).
Recommendations of the American
College of Obstetricians and
Gynecologists’ Committee on Ethics
The American College of Obstetricians and Gynecologists
has a long history of leadership in ensuring that its educa-
tional mission is evidence based and unbiased. A prede-
cessor to this Committee Opinion was published in 1985,
making the College one of the first professional associa-
tions to provide guidance on this issue. The College has
continued to update the ethical guidance on physician
interactions with industry periodically. The following dis-
cussion updates recommendations to address College
members’ current relationships with industry.
Industry–physician interactions can be divided into
major types, as characterized in the following sections.
Ethical implications specific to each type of interac-
tion are discussed. In providing recommendations, the
Committee on Ethics recognizes both the effort its
Fellows and other members have made to meet past
recommendations and the challenges in meeting the
ideal behaviors outlined. In presenting these paradigms,
the Committee wishes to commend behaviors that will
reduce influence that may bias College members’ practice
and behavior and promote continued confidence in indi-
vidual health care providers and the specialty.
Product Promotion to Individual Physicians
by Advertising, Personal Communication, and
Provision of Samples
Because acceptance of even small gifts may influence or
appear to influence prescribing practices and, thereby,
have an effect on patient care, the Committee on Ethics
makes the following recommendations:
• To minimize both true and perceived conflicts of
interest, physicians have an ethical obligation to set
guidelines for themselves and their office staff for
interaction with representatives.
• Physicians have an obligation to seek the most
accurate, up-to-date, evidence-based, and balanced
sources of information about new products that they
contemplate using. They should not base decisions
solely or primarily on information provided by the
products’ marketers.
• Physicians involved in institutional decision mak-
ing for formularies should declare financial ties
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 256
 with industry and disclose any conflict of interest.
Institutions should have a management plan for any
declared conflicts, including possible recusal.
• Although the provision of pharmaceutical samples directly to the designated trainee (ie, the company
offers potential benefits to patients, samples may
inappropriately influence prescribing behavior. Phys-
icians may choose to provide samples or vouch-
ers; however, they should be aware that providing
samples may promote patients’ ongoing use of a
particular medication, when other potential alterna-
tives exist. When vouchers or samples are dispensed,
consideration should be given to providing them
preferentially to those patients with a true need and
dispensing a supply sufficient for a full course of
therapy. Dispensing should be done from a central
distribution source that can track to whom and
where samples were given in the event of recalls or
other problems with the medication (35). Physicians
who choose to dispense samples should know the
applicable state and federal regulations regarding this
practice.
• Physicians should understand that gifts tied to pro-
motional information, even small gifts and meals,
are designed to influence their behavior. The accep-
tance of any gift, even of nominal value, tied to
promotional information is strongly discouraged.
However, acceptance of cash donations, trips, and
services directly from industry by individual physi-
cians raises clear conflicts and is not ethical.
• When an obstetrician–gynecologist receives any-
thing of substantial value, including royalties, from
companies in the health care industry, such as a
manufacturer of pharmaceutical agents and medical
devices, this fact should be disclosed to patients and
colleagues when material (36).
• Physicians should not engage in agreements in which independent of the event’s educational value.” (37). The
companies make donations to a third party (eg, a
hospital or charitable organization) that is contin-
gent on the physicians’ use or advocacy of a product.
Support of Educational Activities for Individual
Physicians
Limitations on commercial support of CME have been
published by the Accreditation Council for Continuing
Medical Education, the Council of Medical Specialty
Societies, and the American Medical Association and
are beyond the scope of the current document. Recom-
mendations for educational support for individual physi-
cians are as follows (12, 13, 19, 28):
• The gift of special funds to permit medical students, sible time.
residents, and fellows to attend carefully selected
educational conferences may be permissible as long
as the selection of the students, residents, or fellows
is made by the academic or training institution or by
the accredited CME provider with the full concur-
4 Committee Opinion No. 541
COMMITTEE OPINIONS
rence of the academic or training institution. These
funds should be deposited at a central office within
the training institution that can dispense these funds
does not directly disperse funds to the trainee).
• Payments to defray the costs of attending a CME
or professional conference should not be accepted
directly from the company by physicians attending
the conference. Subsidies from industry should not be
accepted directly to pay for the costs of travel, lodging,
or other personal expenses. Subsidies should not be
accepted to compensate attendees for their time.
• Commercially supported social events and industry
symposia, regardless of whether they are affiliated
with a program offering CME credits, are essentially
gifts and are designed to influence physician behavior.
Industry-Sponsored Device Training
When new medical devices are approved or cleared by
the U.S. Food and Drug Administration (FDA), access
to training on those devices may be tightly regulated by
the FDA and may require training by the manufacturer.
The company may require physicians to travel to non-
CME seminars designed to familiarize the physician with
the new equipment. This presents an ethical difficulty
for the physician. This problem has been considered by
other professional organizations, such as the Society of
Thoracic Surgeons and the American Association for
Thoracic Surgery. They suggest that their members may
attend such industry-sponsored events “only when the
major purpose of the event is education and training
in the proper use of the company’s products; the only
financial considerations should be reimbursement for
travel, meals, and lodging. Members should not accept
reimbursement for attending such an education event
if the event’s location constitutes an inducement that is
Committee on Ethics makes the following recommenda-
tions regarding industry-sponsored device training:
• Training in proper use of devices encountered in
the practice of obstetrics and gynecology is ideally
provided through professional societies with CME
accreditation.
• When training is not available from an accredited
CME provider, or industry training is mandated by
the FDA, and industry offers appropriate education,
the obstetrician–gynecologist may participate if the
training is focused on the safe, medically relevant,
and FDA-cleared or FDA-approved indications for
use of the equipment or device in the shortest pos-
Industry Sponsorship of Research
When companies conduct clinical research to obtain
approval for the marketing of new products, collaboration
with physicians and clinical institutions is essential. The
2013 COMPENDIUM OF SELECTED PUBLICATIONS 257
 Committee on Ethics recommends the following guide-
lines for engaging in industry-sponsored research:
• Research trials should be conducted in accordance is strongly discouraged. Speakers’ bureaus are a com-
with the federal guidelines for the protection of
human participants (38). Approval by the institu-
tional review board of a medical school or hospital
provides adequate ethical and scientific review. If
the project is to be conducted in a private medi-
cal office, investigators must ascertain the nature
of the ethical and scientific review process by the
sponsoring corporation. Submission of the project
to the researcher’s institution usually is required and
helpful. If there is any question about the adequacy
or efficacy of this review, investigators should seek
independent consultation for research oversight.
• Reimbursement to investigators and their institu-
tions for involvement in research, including recruit-
ment of participants, should not exceed reasonable
costs. Payments made specifically to physicians for
recruitment of their patients should be disclosed to
potential study participants before trial enrollment
(39).
• Investigators may accept reasonable compensation gives the commercial entity control of the slide
(at fair market value) for consultation after partici-
pation in industry-sponsored research.
• Once a clinical investigator becomes involved in a commensurate with the value of their time and reim-
research project for a company or knows that he or
she might become involved, the investigator, as an
individual, cannot ethically buy or sell the company’s
stock until the results of the research are published
or otherwise disseminated to the public and the
involvement ends (40).
• The following guidelines should govern control over also is appropriate for consultants who provide genuine
information gained from research (41):
— All obligations of investigators and sponsors
should be contractually defined.
— Scientific freedom of independent investigators
(those not employed by the funding organization)
should be preserved.
— Principal investigators should be involved in deci-
sions regarding the publication of data from
their trials. Short delays in the dissemination of
data generated by industry-sponsored research are
acceptable to protect a patent or related propri-
etary interest. Prolonged delays, or suppression of
information harmful to the sponsor’s interests, are
unethical.
— Investigators should control the use of their names
in promotions.
— Project funding should not be contingent on
results.
— Investigators should disclose their relationships
with industry funders in publications or lectures
based on the research.
Committee Opinion No. 541
COMMITTEE OPINIONS
Speakers’ Bureaus
Participating in an industry-sponsored speakers’ bureau
mon marketing strategy to promote a particular prod-
uct through the use of recognized professional leaders
(“thought leaders”) as paid spokespersons. Speakers’
bureaus are an efficient way to communicate information
about a specific product but are subject to a high potential
for bias, unbalanced information, and conflict of interest.
Audiences may not be able to identify bias when it occurs
(10).
Physicians who choose to participate in industry-
sponsored speaking should adhere to the following
specific ethical guidelines to reduce the risk of undue
influence:
• Speakers must disclose the extent and nature of their
relationship with the sponsoring entity.
• Speakers must ensure that the information in their
presentation is accurate, balanced, evidence based,
and free of undue commercial influence. The speaker
should have final control of any slides used in the
presentation and should not sign a contract that
content.
• Speakers must accept only reasonable honoraria
bursement for travel, lodging, and expenses.
Physicians as Consultants to Industry
Consulting with industry on the development of new
medical devices or pharmaceutical agents can play an
important role in the progress of scientific discovery. It
services to receive reasonable reimbursement for travel,
lodging, and meal expenses, as well as value of their time.
Token consulting or advisory arrangements cannot be
used to justify the compensation of physicians for their
time or their travel, lodging, and other out-of-pocket
expenses. It must be recognized, however, that industry
may use consulting arrangements in order to influence
the consultant. Physicians who consult with industry on
the development of new medical devices or pharmaceuti-
cal agents must disclose this information to their patients,
colleagues, and medical institutions when material.
Ghostwriting
The practice of ghostwriting, or unacknowledged medical
writing sponsored by the pharmaceutical or other indus-
try, is unacceptable because it is inherently deceptive.
Authors should write and assume responsibility for the
content of all publications for which they receive author-
ship credit. Ghostwriting, in which a writer produces
content attributed to another, should be distinguished
from acknowledged authorship and peer editing, which
may serve important communication functions.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 258
 Summary
Obstetrician–gynecologists’ relationships with industry
should be structured in a manner that will enhance,
rather than detract from, their obligations to their
patients. The ideal behaviors set forth in this Committee
Opinion will contribute toward maintaining patient
trust in the specialty and avoiding conflicts of interest by
College members.
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10. Brennan TA, Rothman DJ, Blank L, Blumenthal D,
Chimonas SC, Cohen JJ, et al. Health industry practices that
create conflicts of interest: a policy proposal for academic
medical centers. JAMA 2006;295:429 –33. [PubMed] [Full
Text] ^
11. Kofke WA. Disclosure of industry relationships by anes-
thesiologists: is the conflict of interest resolved? Curr Opin
Anaesthesiol 2010;23:177– 83. [PubMed] ^
12. American Medical Association. Gifts to physicians from
industry. In: Code of medical ethics of the American
Medical Association: current opinions with annotations.
2010-2011 ed. Chicago (IL): AMA; 2010. p. 243 – 8. ^
13. American Medical Association. Clarification of opinion
8.061, “gifts to physicians from industry”. In: Code of
6 Committee Opinion No. 541
COMMITTEE OPINIONS
medical ethics of the American Medical Association: cur-
rent opinions with annotations. 2010-2011 ed. Chicago
(IL): AMA; 2010. p. 248 – 57. ^
14. American Medical Association. Report 1 of the Council on
Ethical and Judicial Affairs (A-11): financial relationships
with industry in continuing medical education. Chicago
(IL): AMA; 2011. Available at: http://www.ama-assn.org/
resources/doc/ethics/ceja-1a11.pdf. Retrieved December 20,
2011. ^
15. Coyle SL. Physician-industry relations. Part 1: individ-
ual physicians. Ethics and Human Rights Committee,
American College of Physicians–American Society of
Internal Medicine. Ann Intern Med 2002;136:396 – 402.
[PubMed] [Full Text] ^
16. Coyle SL. Physician-industry relations. Part 2: organiza-
tional issues. Ethics and Human Rights Committee, Amer-
ican College of Physicians–American Society of Internal
Medicine. Ann Intern Med 2002;136:403 – 6. [PubMed]
[Full Text] ^
17. Turton FE, Snyder L. Physician-industry relations. Ann
Intern Med 2007;146:469. [PubMed] [Full Text] ^
18. Accreditation Council for Graduate Medical Education.
Principles to guide the relationship between graduate
medical education, industry, and other funding sources
for programs and sponsoring institutions accredited by
the ACGME. Chicago (IL): ACGME; 2011. Available at:
http://www.acgme.org/acWebsite/positionPapers/pp_
GMEGuide.pdf. Retrieved September 20, 2012. ^
19. Accreditation Council for Continuing Medical Education.
Standards for commercial support: standards to ensure
independence in CME activities. Available at: http://www.
accme.org/requirements/accreditation-requirements-cme-
providers/standards-for-commercial-support. Retrieved
September 20, 2012. ^
20. Pharmaceutical Research and Manufacturers of America.
Code on interactions with healthcare professionals. Wash-
ington, DC: PhRMA; 2009. Available at: http://www.phrma.
org/sites/default/files/108/phrma_marketing_code_2008.
pdf. Retrieved December 20, 2011. ^
21. Advanced Medical Technology Association. Code of ethics
on interactions with health care professionals. Washington,
DC: AdvaMed; 2009. Available at: http://www.advamed.
org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6C
E347585/0/AdvaMedCodeofEthicsRevisedandRestated
Effective20090701.pdf. Retrieved September 20, 2012. ^
22. Office of Inspector General. Compliance program guid-
ance for pharmaceutical manufacturers. Washington, DC:
OIG; 2003. Available at: http://oig.hhs.gov/fraud/docs/com
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23. Institute of Medicine. Conflict of interest in medical
research, education, and practice. Washington, DC:
National Academies Press; 2009. ^
24. The Prescription Project. Time for change: addressing con-
flicts of interest at academic medical centers. Boston (MA):
The Prescription Project; 2007. Available at: http://www.
ohsu.edu/xd/about/services/integrity/coi/gifts/upload/
AMC-Policy-Briefs-Gifts.pdf. Retrieved December 20, 2011.
^
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 25. American Medical Student Association. AMSA PharmFree
Scorecard 2010. Sterling (VA): AMSA; 2010. Available at:
http://www.amsascorecard.org. Retrieved December 20,
2011. ^
26. American Medical Student Association. PharmFree. The
campaign: history. Available at: http://www.pharmfree.org/
campaign?id=0004. Retrieved July 19, 2012. ^
27. Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC,
DeAngelis CD, Hale RW, et al. Professional medical associ-
ations and their relationships with industry: a proposal for
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28. Council of Medical Specialty Societies. Code for interactions
with companies. Chicago (IL): CMSS; 2011. Available at:
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Companies%20Approved%20Revised%20Version%20
3-19-11CLEAN.pdf. Retrieved December 20, 2011. ^
29. Supplemental standards of ethical conduct for employees of
the Department of Health and Human Services, 5 C.F.R. pt.
5501 (2011). ^
30. Supplemental financial disclosure requirements for employ-
ees of the Department of Health and Human Services, 5
C.F.R. pt. 5502 (2011). ^
31. Responsibility of applicants for promoting objectivity in
research for which public health service funding is sought
and responsible prospective contractors. Fed Regist 2011;
76:53256 – 93. (to be codified at 42 C.F.R. pt. 50, 45 C.F.R.
pt. 94). ^
32. Health Care and Education Reconciliation Act of 2010,
Pub. L. No. 111-152, 124 Stat. 1029 (2010). ^
33. Patient Protection and Affordable Care Act, Pub. L. No.
111-148, 124 Stat. 119 (2010). ^
34. Medicare, Medicaid, Children’s Health Insurance Pro-
grams; transparency reports and reporting of physician
ownership or investment interests; proposed rule. Fed
Regist 2011;76:78742–73. ^
Committee Opinion No. 541
COMMITTEE OPINIONS
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Guidelines for women’s health care: a resource manual.
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36. American College of Obstetricians and Gynecologists.
Code of professional ethics of the American College of
Obstetricians and Gynecologists. Washington, DC:
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Retrieved September 20, 2012. ^
37. Mack MJ, Sade RM. Relations between cardiothoracic
surgeons and industry. American Association for Thoracic
Surgery Ethics Committee, Society of Thoracic Surgeons
Standards and Ethics Committee. Ann Thorac Surg 2009;
87:1334–6. [PubMed] ^
38. Protection of human subjects, 45 C.F.R. pt. 46 (2010). ^
39. Morin K, Rakatansky H, Riddick FA Jr, Morse LJ, O’Bannon
JM 3rd, Goldrich MS, et al. Managing conflicts of interest
in the conduct of clinical trials. JAMA 2002;287:78–84.
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40. American Medical Association. Conflicts of interest: bio-
medical research. In: Code of medical ethics of the American
Medical Association: current opinions with annotations.
2010-2011 ed. Chicago (IL): AMA; 2010. p. 216–8. ^
41. Chren MM. Independent investigators and for-profit
companies. Guidelines for biomedical scientists consider-
ing funding by industry. Arch Dermatol 1994;130:432–7.
[PubMed] ^
Copyright November 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Professional relationships with industry. Committee Opinion No. 541.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:1243–9.
7
2013 COMPENDIUM OF SELECTED PUBLICATIONS 260
COMMITTEE OPINIONS
Committee on Genetics

2013 COMPENDIUM OF SELECTED PUBLICATIONS 261

 ACOG
Committee on
Genetics
Reaffirmed 2010
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject to
change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © October 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Screening for Tay–Sachs disease.
ACOG Committee Opinion No. 318.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2005;106:893–4.
COMMITTEE OPINIONS
Committee
Opinion
Number 318, October 2005 (Replaces No. 162, November 1995)
Screening for Tay–Sachs Disease
ABSTRACT: Tay–Sachs disease (TSD) is a severe progressive neurologic dis-
ease that causes death in early childhood. Carrier screening should be offered
before pregnancy to individuals and couples at high risk, including those of
Ashkenazi Jewish, French–Canadian, or Cajun descent and those with a fam-
ily history consistent with TSD. If both partners are determined to be carriers
of TSD, genetic counseling and prenatal diagnosis should be offered.
Tay–Sachs disease (TSD) is a lysosomal storage disease in which GM2
gangliosides accumulate throughout the body. The accumulation of these
gangliosides in the central nervous system results in a severe progressive
neurologic disease that causes death in early childhood.
The TSD carrier rate in Jewish individuals of Eastern European descent
(Ashkenazi) is approximately 1 in 30; the carrier rate for non-Jewish indi-
viduals is estimated to be 1 in 300. It has been determined that individuals
of French–Canadian and Cajun descent also have a greater carrier frequency
than the general population.
The enzyme hexosaminidase occurs in two principal forms, Hexosa-
minidase A and Hexosaminidase B. Hexosaminidase A is composed of one
α subunit and one β subunit, whereas Hexosaminidase B is composed of two
β subunits. Tay–Sachs disease is caused by a deficiency of Hexosaminidase A,
whereas Sandhoff disease is caused by a deficiency of both Hexosaminidase
A and Hexosaminidase B. Both of these diseases are transmitted in an auto-
somal recessive fashion. Laboratories report Hexosaminidase A levels as a
percentage of total hexosaminidase activity. Hexosaminidase A is almost
completely absent in patients with classical TSD. The percentage of Hexos-
aminidase A activity in carriers usually is less than 55% of total activity,
whereas Hexosaminidase A activity in noncarriers generally is more than
60% of total activity. Tay­–Sachs disease can be diagnosed prenatally by
measuring hexosaminidase activity in samples obtained by amniocentesis or
by chorionic villus sampling.
Carrier screening can be performed by molecular analysis, biochemical
analysis, or both. Molecular analyses of the α subunit gene for TSD have been
reported in both Jewish and non-Jewish populations. Molecular analysis of
three mutations will detect 94% of carriers in the Ashkenazi Jewish popula-
tion, compared with biochemical analysis, which will detect 98% of carriers.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 262
 Different mutations have been found in other ethnic
groups. Biochemical analysis should be used in low-
risk populations because molecular analysis detects
less than 50% of carriers in these populations.
Test results of biochemical carrier screening
using serum are inaccurate when performed in
women who are pregnant or taking oral contracep-
tives. If the serum test is used for pregnant women,
many of them will be misclassified as carriers. If
biochemical testing is to be done in women who are
pregnant or taking oral contraceptives, leukocyte
testing must be used. If both partners are determined
to be carriers of TSD, genetic counseling and prena-
tal diagnosis should be offered.
When the serum test result is inconclusive,
biochemical analysis should be performed on leuko-
cytes from peripheral blood. DNA analysis may be
helpful for those individuals whose leukocyte test
results are inconclusive and those individuals whose
test results are positive to rule out a rare pseudode-
ficiency condition.
Pseudodeficiency refers to a state in which
asymptomatic individuals have a low amount of
Hexosaminidase A activity when tested with con-
ventional artificial substrate. However, these normal
individuals without Hexosaminidase A are able to
catalyze the breakdown of natural substrate GM2
ganglioside. Pseudodeficiency mutations comprise
approximately one third of the mutations identi-
fied in non-Jewish individuals. Because some of
these individuals are compound heterozygotes for a
Tay–Sachs mutation and a pseudodeficiency allele,
the delineation of their precise genotype for repro-
ductive purposes usually requires further biochemi-
cal assessment complemented with DNA analysis.
Based on the preceding information, the
Committee on Genetics makes the following recom-
mendations:
1. Screening for TSD should be offered before
pregnancy if both members of a couple are of
Ashkenazi Jewish, French–Canadian, or Cajun
descent. Those with a family history consistent
with TSD also should be offered screening.
2. When one member of a couple is at high risk
(ie, of Ashkenazi Jewish, French–Canadian, or
Cajun descent or has a family history consistent
with TSD) but the other partner is not, the high-
risk partner should be offered screening. This
is particularly important if there is uncertainty
COMMITTEE OPINIONS
about ancestry or if there is a family history
consistent with TSD. If the high-risk partner
is determined to be a carrier, the other partner
also should be offered screening. If the woman
is already pregnant, it may be necessary to offer
screening to both partners simultaneously to
ensure that results are obtained promptly and
that all options are available to the couple.
3. Biochemical analysis should be used for indi-
viduals in low-risk populations.
4. If TSD biochemical screening is performed in
women who are pregnant or taking oral contra-
ceptives, leukocyte testing must be used.
5. Ambiguous screening test results or positive
screening test results in individuals should be
confirmed by biochemical and DNA analysis
for the most common mutations. This will detect
patients who carry genes associated with mild
disease or pseudodeficiency states. Referral to
a specialist in genetics may be helpful in these
cases.
6. If both partners are determined to be carriers of
TSD, genetic counseling and prenatal diagnosis
should be offered.
Bibliography
Prenatal and preconceptional carrier screening for genetic
diseases in individuals of Eastern European Jewish descent.
ACOG Committee Opinion 298. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2004;104:
425–8.
Kaback M, Lim-Steele J, Dabholkar D, Brown D, Levy N,
Zeiger K. Tay-Sachs disease—carrier screening, prenatal
diagnosis, and the molecular era. An international perspective,
1970 to 1993. The International TSD Data Collection Network.
JAMA 1993;270:2307–15.
Mules EH, Hayflick S, Dowling CE, Kelly TE, Akerman BR,
Gravel RA, et al. Molecular basis of hexosaminidase A defi-
ciency and pseudodeficiency in the Berks County Pennsylvania
Dutch. Hum Mutat 1992;1:298–302.
Prence EM, Natowicz MR, Zalewski I. Unusual thermolab-
ility properties of leukocyte beta-hexosaminidase: implica-
tions in screening for carriers of Tay-Sachs disease. Clin Chem
1993;39:1811–4.
Triggs-Raine BL, Feigenbaum AS, Natowicz M, Skomorowski
MA, Schuster SM, Clarke JT, et al. Screening for carriers of
Tay-Sachs disease among Ashkenazi Jews. A comparison of
DNA-based and enzyme-based tests. N Engl J Med 1990;
323:6–12.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 263
 ACOG
Committee on
Obstetric Practice
Committee on
Gynecologic Practice
Committee on
Genetics
Reaffirmed 2007
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject to
change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © November 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Perinatal risks associated with conceived by IVF and 1.9 million spontaneously conceived singleton infants
assisted reproductive technology.
ACOG Committee Opinion No. 324.
American College of Obstetricians and
Gynecologists. Obstet Gynecol 2005;
106:1143–6.
COMMITTEE OPINIONS
Committee
Opinion
Number 324, November 2005
Perinatal Risks Associated With
Assisted Reproductive Technology
ABSTRACT: Over the past two decades, the use of assisted reproductive
technology (ART) has increased dramatically worldwide and has made
pregnancy possible for many infertile couples. A growing body of evidence
suggests an association between pregnancies resulting from ART and
perinatal morbidity (possibly independent of multiple births), although the
absolute risk to children conceived through ART is low. Prospective studies
are needed to further define the risk of ART to offspring. The single most
important health effect of ART for the offspring remains iatrogenic multiple
fetal pregnancy. The American College of Obstetricians and Gynecologists
supports the effort toward lowering the risk of multiple gestation with ART.
Over the past two decades, the use of assisted reproductive technology
(ART) has increased dramatically worldwide and has made pregnancy pos-
sible for many infertile couples. The American Society for Reproductive
Medicine defines ART as treatments and procedures involving the handling
of human oocytes and sperm, or embryos, with the intent of establishing a
pregnancy (1). By this definition, ART includes in vitro fertilization (IVF)
with or without intracytoplasmic sperm injection (ICSI), but it excludes
techniques such as artificial insemination and superovulation drug therapy.
Several studies have been conducted to describe and compare the obstet-
ric outcome of pregnancies resulting from ART with those of pregnancies
conceived without treatment. Some retrospective and prospective follow-up
studies suggest that pregnancies achieved by ART are associated with an
increased risk of prematurity, low birth weight, and neonatal encephalopathy
and a higher perinatal mortality rate, even after adjusting for age, parity, and
multiple gestation (2, 3). Even in studies limited to singleton ART pregnan-
cies, the prematurity rate is twice as high, and the proportion of infants with
low birth weight is three times as high as that of the general population
(4, 5). A meta-analysis of 15 studies comprising 12,283 singleton infants
showed significantly higher odds of perinatal mortality (odds ratio [OR],
2.2), preterm delivery (OR, 2.0), low birth weight (OR, 1.8), very low birth
weight (OR, 2.7), and small for gestational age status (OR, 1.6) in IVF preg-
nancies, after adjusting for maternal age and parity (6).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 264
 It is difficult to determine the degree to which
these associations are specifically related to the ART
procedures versus any underlying factors within
the couple, such as coexisting maternal disease,
the cause of infertility, or differences in behavioral
risk (eg, smoking). Many of the adverse obstetric
outcomes associated with ART may actually be
linked to infertility rather than the treatment for this
disorder. Continued research is needed to examine
possible confounding variables for these obser-
vations. Patients undergoing superovulation drug
therapy alone, IVF alone, and IVF with ICSI should
be examined as three distinct risk populations, and
control populations should ideally consist of two
separate groups—normal fertile couples and infer-
tile couples who conceive without treatment.
Assisted reproductive technology has been asso-
ciated with a 30-fold increase in multiple pregnan-
cies compared with the rate of spontaneous twin
pregnancies (1% in the general white population). The
obstetric and neonatal risks associated with multiple
gestation include preeclampsia, gestational diabetes,
preterm delivery, and operative delivery. Multifetal
births account for 17% of all preterm births (before
37 weeks of gestation), 23% of early preterm births
(before 32 weeks of gestation), 24% of low-birth-
weight infants (< 2,500 g), and 26% of very-low-
birth-weight infants (< 1,500 g) (7–10). In a large
population-based cohort study in the United States
from 1996 to 1999, the proportion of multiple births
attributable to ovulation induction or ART was 33%
(11), although the rate of high-order multiple gesta-
tions from ART decreased significantly between
1998 and 2001 (12). Methods to limit high-order
multiple pregnancies include monitoring hormone
levels and follicle number during superovulation
and limiting transfer to fewer embryos in IVF cycles
(12–14). Transferring two embryos can limit the
occurrence of triplets in younger candidates who
have a good prognosis without significantly decreas-
ing the overall pregnancy rate (15, 16). The Ameri-
can Society for Reproductive Medicine and the
Society for Assisted Reproductive Technology have
developed updated recommendations on the number
of embryos per transfer to reduce the risk of multiple
gestation (1). The multiple gestation risk of ART,
unlike that of superovulation, can be effectively
managed by limiting the number of embryos trans-
ferred. When considering how to minimize multiple
gestation, ART can be viewed as the safer and more
favorable approach compared with superovulation.
COMMITTEE OPINIONS
Informing couples of the obstetric risks as well
as the socioeconomic consequences of multiple
gestations may modify their decisions regarding the
number of embryos to be transferred (17). Patients
undergoing ART procedures should be counseled
in advance regarding the option of multifetal preg-
nancy reduction to decrease perinatal risks if a
high-order multiple pregnancy occurs. Because the
intense motivation for a successful outcome and the
substantial out-of-pocket cost of ART may increase
patients’ desire for the transfer of an excessive num-
ber of embryos, it is critical that couples be aware
of the risk and associated morbidity of high-order
multiple gestation.
Most retrospective and prospective follow-up
studies of children born as a result of ART have
provided evidence for congenital malformation rates
similar to those reported in the general population
(18–20). In contrast, an Australian study of 4,916
women found that the risk of one or more major
birth defects in infants conceived with ART was
twice the expected rate (8.6% for ICSI and 9.0% for
IVF, compared with 4.2% in the general population)
(21). As with other studies, the control group was
not ideal because it did not include couples with
infertility who conceived without ART. Prospective
studies are needed to further define the risk of ART
to offspring.
Male factor infertility is now recognized as
an inherited disorder for some infertile couples. In
vitro fertilization offers the opportunity to achieve
pregnancy while increasing the couple’s awareness
of possible inherited disorders in their offspring.
Genetic conditions can predispose to abnormal
sperm characteristics that may be passed to male
children. In addition, azoospermia is associated with
congenital bilateral absence or atrophy of the vas
deferens in men with gene mutations associated with
cystic fibrosis. Congenital bilateral absence or atro-
phy of the vas deferens accounts for approximately
2% of all cases of male infertility (22, 23). There-
fore, all patients with congenital bilateral absence
or atrophy of the vas deferens and their partners
considering IVF by sperm extraction procedure with
ICSI should be offered genetic counseling to discuss
testing for cystic fibrosis.
Approximately 10–15% of azoospermic and
severely oligospermic (< 5 million/mL) males have
microdeletions of their Y chromosome that can be
passed on to their male offspring (24, 25). There is
speculation that a deletion could potentially expand
2013 COMPENDIUM OF SELECTED PUBLICATIONS 265
 in successive generations; however, the reproduc-
tive and nonreproductive health implications of this
possibility are unknown (26). Some studies have
suggested a 1% increased risk for fetal sex chro-
mosome abnormalities following ICSI conception
(27–29), but others have yielded conflicting results
(30). Subfertile men, with a higher proportion of
aneuploid sperm, may have an increased risk of
transmitting chromosomal abnormalities to their
children (31). These men should be aware of the
possible reproductive consequences in their male
offspring and the options for prenatal diagnosis.
There is some concern that the micromanipula-
tion of the early embryonic environment in IVF may
result in imprinting errors. Genomic imprinting is
an epigenetic phenomenon in which one of the two
alleles of a subset of genes is expressed differen-
tially according to its parental origin. Imprinting is
established early in gametogenesis and maintained
in embryogenesis. Recent case series have reported
an overrepresentation of two syndromes associ-
ated with abnormal imprinting in IVF offspring—
Beckwith–Wiedemann syndrome and Angelman’s
syndrome (32, 33). Both of these conditions may be
associated with severe learning disabilities, mental
retardation, and congenital malformations. Because
these conditions are so rare (1 in 100,000–1 in
300,000), large prospective studies of offspring
conceived with ART would be necessary to confirm
an increased risk (34). Currently, the risk of imprint-
ing disorders with offspring conceived with ART is
largely theoretical but warrants further investigation.
A growing body of evidence suggests an asso-
ciation between ART pregnancies and perinatal
morbidity (possibly independent of multiple births),
although the absolute risk to children conceived with
IVF is low. There is observational evidence linking
ART and chromosomal abnormalities following
ICSI in severe male factor cases, and concerns have
been raised about a possible relationship to genomic
imprinting modifications. Given the large sample
sizes required to firmly answer these questions,
particularly for rare genetic disorders, no causal
relationship can be established at this time. It is still
unclear to what extent these associations are related
to the underlying cause(s) of infertility versus the
treatment. It would be prudent to acknowledge these
possibilities and to counsel patients accordingly.
The single most important health effect of ART for
the offspring remains iatrogenic multiple fetal preg-
nancy. The American College of Obstetricians and
COMMITTEE OPINIONS
Gynecologists supports the effort toward lowering
the risk of multiple gestation with ART.
References
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Committee of the Society for Assisted Reproductive
Technology and the American Society for Reproductive
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O’Sullivan F, Burton PR, et al. Antepartum risk factors
for newborn encephalopathy: the Western Australian
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3. Ozturk O, Bhattacharya S, Templeton A. Avoiding mul-
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through December 1994. Am J Obstet Gynecol 1998;
179:1632–9.
11. Lynch A, McDuffie R, Murphy J, Faber K, Leff M,
Orleans M. Assisted reproductive interventions and mul-
tiple birth. Obstet Gynecol 2001;97:195–200.
12. Jain T, Missmer SA, Hornstein MD. Trends in embryo-
transfer practice and in outcomes of the use of assisted
reproductive technology in the United States. N Engl J
Med 2004;350:1639–45.
13. Gleicher N, Oleske DM, Tur-Kaspa I, Vidali A, Karande
V. Reducing the risk of high-order multiple pregnancy
after ovarian stimulation with gonadotropins. N Engl J
Med 2000;343:2–7.
14. Licciardi F, Berkeley AS, Krey L, Grifo J, Noyes N. A
two- versus three-embryo transfer: the oocyte donation
model. Fertil Steril 2001;75:510–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 266
 15. Staessen C, Janssenswillen C, Van den Abbeel E, Devroey
P, Van Steirteghem AC. Avoidance of triplet pregnancies
by elective transfer of two good quality embryos. Hum
Reprod 1993;8:1650–3.
16. Templeton A, Morris JK. Reducing the risk of multiple
births by transfer of two embryos after in vitro fertiliza-
tion. N Engl J Med 1998;339:573–7.
17. Grobman WA, Milad MP, Stout J, Klock SC. Patient per-
ceptions of multiple gestations: an assessment of knowl-
edge and risk aversion. Am J Obstet Gynecol 2001;185:
920–4.
18. Bergh T, Ericson A, Hillensjo T, Nygren KG, Wennerholm
UB. Deliveries and children born after in-vitro fertilisa-
tion in Sweden 1982–95: a retrospective cohort study.
Lancet 1999;354:1579–85.
19. Ericson A, Kallen B. Congenital malformations in infants
born after IVF: a population-based study. Hum Reprod
2001;16:504–9.
20. Wennerholm UB, Bergh C, Hamberger L, Lundin K,
Nilsson L, Wikland M. Incidence of congenital mal-
formations in children born after ICSI. Hum Reprod
2000;15:944–8.
21. Hansen M, Kurinczuk JJ, Bower C, Webb S. The risk of
major birth defects after intracytoplasmic sperm injection
and in vitro fertilization. N Engl J Med 2002;346:725–30.
22. Chillon M, Casals T, Mercier B, Bassas L, Lissens W,
Silber S, et al. Mutations in the cystic fibrosis gene in
patients with congenital absence of the vas deferens. N
Engl J Med 1995;332:1475–80.
23. Dork T, Dworniczak B, Aulehla-Scholz C, Wieczorek D,
Bohm I, Mayerova A, et al. Distinct spectrum of CFTR
gene mutations in congenital absence of vas deferens.
Hum Genet 1997;100:365–77.
24. Dohle GR, Halley DJ, Van Hemel JO, van den Ouwel
AM, Pieters MH, Weber RF, et al. Genetic risk factors in
infertile men with severe oligozoospermia and azoosper-
mia. Hum Reprod 2002;17:13–6.
COMMITTEE OPINIONS
25. Feng HL. Molecular biology of male infertility. Arch
Androl 2003;49:19–27.
26. Tournaye H. ICSI: a technique too far? Int J Androl 2003;
26:63–9.
27. Bonduelle M, Aytoz A, Van Assche E, Devroey P,
Liebaers I, Van Steirteghem A. Incidence of chromosom-
al aberrations in children born after assisted reproduction
through intracytoplasmic sperm injection. Hum Reprod
1998;13:781–2.
28. Bonduelle M, Ponjaert I, Van Steirteghem A, Derde MP,
Devroey P, Liebaers I. Developmental outcome at 2 years
of age for children born after ICSI compared with chil-
dren born after IVF. Hum Reprod 2003;18:342–50.
29. In’t Veld P, Brandenburg H, Verhoeff A, Dhont M, Los
F. Sex chromosomal abnormalities and intracytoplasmic
sperm injection. Lancet 1995;346:773.
30. Loft A, Petersen K, Erb K, Mikkelsen AL, Grinsted J,
Hald F, et al. A Danish national cohort of 730 infants born
after intracytoplasmic sperm injection (ICSI) 1994–1997.
Hum Reprod 1999;14:2143–8.
31. Calogero AE, Burrello N, De Palma A, Barone N,
D’Agata R, Vicari E. Sperm aneuploidy in infertile men.
Reprod Biomed Online 2003;6:310–7.
32. Cox GF, Burger J, Lip V, Mau UA, Sperling K, Wu BL,
et al. Intracytoplasmic sperm injection may increase the
risk of imprinting defects. Am J Hum Genet 2002;71:
162–4.
33. DeBaun MR, Niemitz EL, Feinberg AP. Association of in
vitro fertilization with Beckwith–Wiedemann syndrome
and epigenetic alterations of L1T1 and H19. Am J Hum
Genet 2003;72:156–60.
34. Niemitz EL, Feinberg AP. Epigenetics and assisted repro-
ductive technology: a call for investigation. Am J Hum
Genet 2004;74:599–609.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 267
 ACOG COMMITTEE OPINION
Number 399 • February 2008 (Replaces No. 183, April 1997)

Umbilical Cord Blood Banking

Committee on ABSTRACT: Two types of banks have emerged for the collection and storage of
Obstetric Practice umbilical cord blood—public banks and private banks. Public banks promote allogenic
Committee on (related or unrelated) donation, analogous to the current collection of whole blood units
Genetics in the United States. Private banks were initially developed to store stem cells from
umbilical cord blood for autologous use (taken from an individual for subsequent use
Reaffirmed 2010
by the same individual) by a child if the child develops disease later in life. If a patient
This document reflects
emerging clinical and sci- requests information on umbilical cord blood banking, balanced and accurate information
entific advances as of the regarding the advantages and disadvantages of public versus private banking should be
date issued and is subject
to change. The informa- provided. The remote chance of an autologous unit of umbilical cord blood being used
tion should not be con- for a child or a family member (approximately 1 in 2,700 individuals) should be disclosed.
strued as dictating an
exclusive course of treat- The collection should not alter routine practice for the timing of umbilical cord clamping.
ment or procedure to be Physicians or other professionals who recruit pregnant women and their families for
followed.
for-profit umbilical cord blood banking should disclose any financial interests or other
potential conflicts of interest.

Introduction hematopoietic malignancies, and genetic dis-

Once considered a waste product that was
discarded with the placenta, umbilical cord
blood is now known to contain potentially
life-saving hematopoietic stem cells. When
used in hematopoietic stem cell transplan-
tation, umbilical cord blood offers several
distinct advantages over bone marrow or
peripheral stem cells. Biologically, a greater
degree of human leukocyte antigen mis-
match is tolerated by the recipient and the
incidence of acute graft-versus-host reaction
is decreased when umbilical cord blood is
used (1, 2). The predominant disadvantage
of umbilical cord blood use is related to
the low number of stem cells acquired per
unit. However, the use of combined units of
umbilical cord blood allows for the expan-
sion of umbilical cord blood volume (and
increased number of stem cells) to be used
for adult hematopoietic transplants. Studies
are currently underway evaluating the feasi-
bility of ex vivo expansion of the units (3, 4).
The American College Since the first successful umbilical cord blood
of Obstetricians transplant in 1988, it has been estimated
and Gynecologists that more than 7,000 transplants have been
Women’s Health Care performed in children and adults for the
Physicians correction of inborn errors of metabolism,
orders of the blood and immune system (5).
Two types of banks have emerged for
the collection and storage of umbilical cord
blood—public banks and private banks. The
first public bank was established at the New
York Blood Center in 1991 and other public
banks have since been established in various
regions of the country. In 1999, the National
Bone Marrow Donor Program established a
network of these banks listing their units on
the National Bone Marrow Donor Program
Registry and established the Center for Cord
Blood in 2005 (6). As part of this effort, spe-
cific subcommittees have been established to
address issues related to umbilical cord blood
banking, such as standards, quality improve-
ment, donor recruitment, collection, testing,
and processing methodology. In December
2005, federal legislation was enacted that
provides funding for continued growth of a
national umbilical cord blood registry in the
United States through the C.W. Bill Young
Cell Transplantation Act. Some states have
passed legislation requiring physicians to
inform their patients about umbilical cord
blood banking options. Clinicians should
consult their state medical associations for
more information regarding state laws.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 268

 Public banks promote allogenic (related or unrelat-
ed) donation, analogous to the current collection of whole
blood units in the United States. These banks typically are
associated with a local network of obstetric hospitals that
send their units of blood to a central processing facility. A
minority of public banks will accept units from any pro-
vider through shipment by an overnight express courier
(7). Units of umbilical cord blood collected for public
banks must meet rigorous standards of donor screening
and infectious disease testing as outlined by the U.S. Food
and Drug Administration. Initial human leukocyte anti-
gen typing of these units allows them to be entered into
computerized registries so that when the need arises, a
specific unit can be rapidly located for a patient.
Private banks were initially developed to store stem
cells from umbilical cord blood for autologous use (taken
from an individual for subsequent use by the same indi-
vidual) by a child if the child develops disease later in life.
There is a cost associated with the initial specimen pro-
cessing and an annual storage fee for for-profit umbilical
cord blood banks (8).
The utility of long-term storage of autologous
umbilical cord blood has been questioned. There is no
accurate estimate of an individual’s likelihood of using
an autologous unit of umbilical cord blood. One estimate
is approximately 1 in 2,700 individuals, whereas others
argue that the rate would be even lower (9). Stem cells
obtained from banked umbilical cord blood cannot cur-
rently be used to treat inborn errors of metabolism or
other genetic diseases in the same individual from whom
they were collected because the genetic mutation would
already be present in the stem cells. Autologous umbilical
cord blood is not used as a source of stem cells to treat
childhood leukemia because chromosomal translocations
in fetal blood have been detected in some children who
ultimately develop leukemia (10, 11). In addition, the use
of autologous stem cells would negate the beneficial graft-
versus-leukemic effect that occurs with allogenic stem cell
transplants (9).
Recommendations and Conclusions
• If a patient requests information on umbilical cord
banking, balanced and accurate information regard-
ing the advantages and disadvantages of public ver-
sus private umbilical cord blood banking should be
provided. The remote chance of an autologous unit
being used for a child or a family member (approxi-
mately 1 in 2,700 individuals) should be disclosed.
• Discussion may include information regarding
maternal infectious disease and genetic testing, the
ultimate outcome of use of poor quality units of
umbilical cord blood, and a disclosure that demo-
graphic data will be maintained on the patient.
• Some states have passed legislation requiring physi-
cians to inform their patients about umbilical cord
blood banking options. Clinicians should consult
COMMITTEE OPINIONS
their state medical associations for more information
regarding state laws.
• Directed donation of umbilical cord blood should
be considered when there is a specific diagnosis of
a disease known to be treatable by hematopoietic
transplant for an immediate family member.
• Obstetric providers are not obligated to obtain con-
sent for private umbilical cord blood banking.
• The collection should not alter routine practice for
the timing of umbilical cord clamping.
• Physicians or other professionals who recruit preg-
nant women and their families for for-profit umbili-
cal cord blood banking should disclose any financial
interests or other potential conflicts of interest.
References
1. Laughlin MJ, Eapen M, Rubinstein P, Wagner JE, Zhang
MJ, Champlin RE, et al. Outcomes after transplantation
of cord blood or bone marrow from unrelated donors in
adults with leukemia. N Engl J Med 2004;351:2265–75.
2. Rocha V, Labopin M, Sanz G, Arcese W, Schwerdtfeger
R, Bosi A, et al. Transplants of umbilical-cord blood or
bone marrow from unrelated donors in adults with acute
leukemia. Acute Leukemia Working Party of European
Blood and Marrow Transplant Group; Eurocord-Netcord
Registry. N Engl J Med 2004;351:2276–85.
3. Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB,
Miller JS, et al. Transplantation of 2 partially HLA-matched
umbilical cord blood units to enhance engraftment in
adults with hematologic malignancy. Blood 2005;105:
1343–7.
4. Jaroscak J, Goltry K, Smith A, Waters-Pick B, Martin PL,
Driscoll TA, et al. Augmentation of umbilical cord blood
(UCB) transplantation with ex vivo-expanded UCB cells:
results of a phase 1 trial using the AastromReplicell System.
Blood 2003;101:5061–7.
5. Moise KJ Jr. Umbilical cord stem cells. Obstet Gynecol
2005;106:1393–407.
6. National Marrow Donor Program. Where to donate cord
blood. Minneapolis (MN): NMDP; 2007. Available at: http://
www.marrow.org/HELP/Donate_Cord_Blood_Share_
Life/How_to_Donate_Cord_Blood/CB_Participating_
Hospitals/nmdp_cord_blood_hospitals.pl. Retrieved
August 22, 2007.
7. Parent’s Guide to Cord Blood. Public cord blood banks in
the USA. Available at: http://parentsguidecordblood.org/
content/usa/banklists/publicbanks_new.shtml?navid=9.
Retrieved August 22, 2007.
8. Parent’s Guide to Cord Blood. Family cord blood banks in
the USA. Available at: http://parentsguidecordblood.org/
content/usa/banklists/listusa.shtml?navid=11. Retrieved
August 22, 2007.
9. Johnson FL. Placental blood transplantation and autolo-
gous banking—caveat emptor. J Pediatr Hematol Oncol
1997;19:183–6.
10. Rowley JD. Backtracking leukemia to birth. Nat Med
1998;4:150–1.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 269
 11. Greaves MF, Wiemels J. Origins of chromosome translo-
cations in childhood leukaemia. Nat Rev Cancer 2003;3: Copyright © February 2008 by the American College of Obstetricians
639–49. and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
Additional Resources or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
National Marrow Donor Program permission from the publisher. Requests for authorization to make
3001 Broadway Street, NE photocopies should be directed to: Copyright Clearance Center, 222
Minneapolis, MN 55413 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
612-627-5000 or 1-800-627-7692 Umbilical cord blood banking. ACOG Committee Opinion No. 399.
http://www.marrow.org American College of Obstetricians and Gynecologists. Obstet
Gynecol 2008;111:475–7.
Parent’s Guide to Cord Blood Banks
http://parentsguidecordblood.org
ISSN 1074-861X
American Academy of Pediatrics
141 Northwest Point Boulevard.
Elk Grove Village, IL 60007
847-434-4000
http://www.aap.org
American Association of Blood Banks
8101 Glenbrook Road
Bethesda, MD 20814
301-907-6977
http://www.aabb.org

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 270

 ACOG COMMITTEE OPINION
Number 430 • March 2009

Preimplantation Genetic Screening for

Committee on
Genetics
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
Aneuploidy
ABSTRACT: Preimplantation genetic screening differs from preimplantation genetic
diagnosis for single gene disorders and was introduced for the detection of chromosomal
aneuploidy. Current data does not support a recommendation for preimplantation genetic
screening for aneuploidy using fluorescence in situ hybridization solely because of mater-
nal age. Also, preimplantation genetic screening for aneuploidy does not improve in vitro
fertilization success rates and may be detrimental. At this time there are no data to sup-
port preimplantation genetic screening for recurrent unexplained miscarriage and recur-
rent implantation failures; its use for these indications should be restricted to research
studies with appropriate informed consent.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
Preimplantation genetic screening differs
from preimplantation genetic diagnosis
(PGD) for single gene disorders. In order
to perform genetic testing for single gene
disorders, PGD was introduced in 1990 as a
component of in vitro fertilization programs.
Such testing allows the identification and
transfer of embryos unaffected by the disor-
der in question and may avoid the need for
pregnancy termination (1). Assessment of
polar bodies as well as single blastomeres from
cleavage stage embryos has been reported,
although the latter is the approach most wide-
ly practiced. Preimplantation genetic diagno-
sis has become a standard method of testing
for single gene disorders, and there have been
no reports to suggest adverse postnatal effects
of the technology. Preimplantation genetic
diagnosis has been used for diagnosis of trans-
locations and single-gene disorders, such as
cystic fibrosis, X-linked recessive conditions,
and inherited mutations, which increase one’s
risk of developing cancer.
In contrast, in the latter half of the 1990s,
preimplantation genetic screening was intro-
duced for the detection of chromosomal aneu-
ploidy (2–4). Aneuploidy leads to increased
pregnancy loss with increasing maternal age
and also was thought to be a major cause of
recurrent pregnancy loss in patients using
assisted reproductive technologies. However,
when compared with the molecular diagnos-
tics available for PGD of single gene disor-
ders, the current technologies available for
preimplantation genetic screening for aneu-
ploidy are more limited. Preimplantation
genetic screening using fluorescence in situ
hybridization is constrained by the technical
limitations of assessing the numerical status
of each chromosome. Typically assessed are
the chromosome abnormalities associated
with common aneuploidies found in sponta-
neous abortion material, and because of this,
and other limitations noted in this Committee
Opinion, a significant false-negative rate exists.
Therefore, this form of testing should be
considered a screening test, and not a diag-
nostic test, as is the case for PGD for single
gene disorders.
Because preimplantation chromosome
assessment tests a single cell, there are certain
limitations:
• Testing a single cell prohibits confirma-
tion of results.
• There is a limit to the number of tests
that can be done with a single cell.
• Embryo mosaicism of normal and aneu-
ploid cell lines may not be clinically
significant.
Guidelines for counseling on limitations
of this screening have been developed by the
American Society for Reproductive Medicine
(5).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 271

 Nonrandomized studies of preimplantation genetic
screening in women with advanced maternal age suggested
improved implantation rates and decreased spontaneous
abortion rates but did not document an improvement in
live birth rates (3–6). A study of women with recurrent
miscarriages found no evidence of benefit of preimplan-
tation genetic screening in women of any age (7). There
have now been two randomized trials for women older
than 35 years comparing in vitro fertilization with and
without preimplantation genetic screening for aneuploidy
(8–9). Neither study provides support for preimplantation
genetic screening in women older than 35 years, and one
study suggests lowered live birth rates, possibly due to the
impact of the biopsy on the embryo’s ability to implant
(8).
Recommendations
• Current data does not support a recommendation
for preimplantation genetic screening for aneu-
ploidy using fluorescence in situ hybridization solely
because of maternal age.
• Preimplantation genetic screening for aneuploidy
does not improve in vitro fertilization success rates
and may be detrimental.
• At this time there are no data to support preimplan-
tation genetic screening for recurrent unexplained
miscarriage and recurrent implantation failures; its
use for these indications should be restricted to
research studies with appropriate informed consent.
References
1. Handyside AH, Kontogianni EH, Hardy K, Winston
RM. Pregnancies from biopsied human preimplantation
embryos sexed by Y-specific DNA amplification. Nature
1990;344:768–70.
2. Gianaroli L, Magli MC, Ferraretti AP, Fiorentino A, Garrisi
J, Munne S. Preimplantation genetic diagnosis increases the
implantation rate in human in vitro fertilization by avoid-
ing the transfer of chromosomally abnormal embryos.
Fertil Steril 1997;68:1128–31.
3. Munne S, Magli C, Cohen J, Morton P, Sadowy S, Gianaroli
L, et al. Positive outcome after preimplantation diagnosis
COMMITTEE OPINIONS
of aneuploidy in human embryos. Hum Reprod 1999;14:
2191–9.
4. Gianaroli L, Magli MC, Ferraretti AP, Munne S.
Preimplantation diagnosis for aneuploidies in patients
undergoing in vitro fertilization with a poor prognosis:
identification of the categories for which it should be pro-
posed. Fertil Steril 1999;72:837–44.
5. Preimplantation genetic testing: a Practice Committee
opinion. Practice Committee of the Society for Assisted
Reproductive Technology; Practice Committee of the
American Society for Reproductive Medicine. Fertil Steril
2007;88:1497–504.
6. Munne S, Chen S, Fischer J, Colls P, Zheng X, Stevens J,
et al. Preimplantation genetic diagnosis reduces pregnancy
loss in women aged 35 years and older with a history of
recurrent miscarriages. Fertil Steril 2005;84:331–5.
7. Munne S, Fischer J, Warner A, Chen S, Zouves C, Cohen
J. Preimplantation genetic diagnosis significantly reduces
pregnancy loss in infertile couples: a multicenter study.
Referring Centers PGD Group. Fertil Steril 2006;85:326–32.
8. Platteau P, Staessen C, Michiels A, Van Steirteghem A,
Liebaers I, Devroey P. Preimplantation genetic diagnosis
for aneuploidy screening in patients with unexplained
recurrent miscarriages. Fertil Steril 2005;83:393,7; quiz
525–6.
9. Staessen C, Platteau P, Van Assche E, Michiels A, Tournaye
H, Camus M, et al. Comparison of blastocyst transfer with
or without preimplantation genetic diagnosis for aneu-
ploidy screening in couples with advanced maternal age:
a prospective randomized controlled trial. Hum Reprod
2004;19:2849–58.
Copyright © March 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Preimplantation genetic screening for aneuploidy. ACOG Committee
Opinion No. 430. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2009;113:766–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 272
 ACOG COMMITTEE OPINION
Number 432 • May 2009

Spinal Muscular Atrophy

Committee on ABSTRACT: Spinal muscular atrophy (SMA) is an autosomal recessive neurode-
Genetics generative disease that results from degeneration of spinal cord motor neurons leading
This document reflects to atrophy of skeletal muscle and overall weakness. In current practice, patients with a
emerging clinical and sci-
entific advances as of the family history of SMA are being offered carrier screening for the survival motor neuron
date issued and is subject gene (SMN1) deletion mutations. Recent marketing and public awareness campaigns
to change. The information
should not be construed by laboratories and advocacy organizations are promoting widespread population-based
as dictating an exclusive carrier screening for SMA in the prenatal or preconception setting, regardless of family
course of treatment or
procedure to be followed. history. However, the American College of Obstetricians and Gynecologists’ Committee
on Genetics agrees that preconception and prenatal screening for SMA is not recom-
mended in the general population at this time.

Spinal muscular atrophy (SMA) is an auto-
somal recessive neurodegenerative disease
that results from degeneration of spinal cord
motor neurons leading to atrophy of skeletal
muscle and overall weakness. The disorder
is caused by a mutation in the gene known
as the survival motor neuron gene (SMN1),
which is responsible for the production of
a protein essential to motor neurons. There
has been recent interest, by both private and
professional organizations, in carrier screen-
ing for SMA in the general prenatal popula-
tion (1). This interest has been prompted
both by the severity of the disease and rela-
tively high carrier frequency, as well as the
advent of improved DNA diagnostic assays
for mutations in the disease causing gene
(SMN1). The genetics of SMA is complex,
and because of limitations in the molecular
diagnostic assays available, accurate predic-
tion of the phenotype in affected fetuses may
be not be possible.
The incidence of SMA is approximately
1 in 10,000 live births and it is reported to
be the leading genetic cause of infant death.
Carrier frequencies are estimated at 1 in 40
to 1 in 60. There is no effective treatment
for the disease. The most severe form, type I
The American College (Wernig–Hoffman), has symptomatic onset
of Obstetricians of the disease before 6 months of age and
and Gynecologists death from respiratory failure within the
Women’s Health Care first 2 years of life. Type II, the most com-
Physicians mon form of SMA disease, is of intermediate
severity, with typical onset before 2 years
of age. Affected children are able to sit
but few are able to stand or walk unaided.
Respiratory insufficiency is a frequent cause
of death during adolescence; however, the
lifespan of patients with SMA type II var-
ies from 2 years to the third decade of
life. A milder form, type III (Kugelberg–
Welander), has typical symptomatic onset
after 18 months of age. However, the symp-
tom profile of affected children is quite vari-
able. They typically reach all major motor
milestones, but function ranges from requir-
ing wheelchair assistance in childhood to
completely unaided ambulation into adult-
hood with minor muscular weakness. Many
patients have normal life expectancies. There
are other forms of SMA-like disorders with
similar symptoms as those described previ-
ously, but they are linked to genes other than
SMN1.
Molecular Genetics
There are two nearly identical survival motor
neuron genes present in humans, known
as SMN1 and SMN2. SMN1 is considered
the active gene for survival motor neuron
protein production and more than 98% of
patients with SMA have an abnormality in
both SMN1 genes, which can be caused by
a deletion (95%), or other mutation. There
is generally one, but occasionally two, cop-
ies of SMN1 per chromosome and a vari-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 273

 able number of SMN2 gene copies (ranging from zero
to three). The SMN2 gene does not produce much in
the way of functional survival motor neuron protein.
However, the primary genetic feature, which determines
the severity of SMA, appears to be the number of gene
copies of SMN2 in a given individual. Studies have
shown that a higher number of SMN2 copies correlates
with generally milder clinical phenotypes. The modula-
tion of clinical severity due to variable copy numbers
of SMN2 is the result of a small amount of full-length
survival motor neuron transcripts and the protein gen-
erated by SMN2. This protein product can partially
compensate for the complete absence of protein from
the SMN1 alleles. However, accurate prediction of the
SMA phen-otype based on SMN2 copy number is not
possible. Although most of the population has one to
three copies of SMN2, approximately 15% of normal
individuals have no SMN2 gene.
DNA Assay
For diagnosis of SMA, it is sufficient to simply detect the
classic SMN1 deletion using DNA analysis in both SMN1
alleles. This is approximately 95% sensitive (100% spe-
cific) for patients with clinical features suspicious for
SMA. However, this approach is not sufficient to identify
patients who are heterozygous, or carriers, for the SMN1
deletion. Carrier testing requires a quantitative poly-
merase chain reaction assay that provides a measure of
SMN1 copy number. Detection of a single normal copy
of SMN1 would indicate the carrier state.
There are limitations, however, to the use of this
assay to determine carrier status. Approximately 3–4%
of the general population, having two SMN1 copies on
one chromosome and no copies on the other, will be
incorrectly identified as being negative, or not carriers of
SMA. These individuals are carriers because one of their
chromosomes is missing the SMN1 allele. Another 2%
of the general population has SMN1 mutations that are
not detectable by the polymerase chain reaction method
of SMN1 dosage analysis. Therefore, the counseling of
patients who are tested for carrier status must account
for the residual risk present when carrier screening assay
results are negative, particularly in patients from SMA
affected families.
Carrier Screening
In current practice, patients with a family history of SMA
are being offered carrier screening for the SMN1 deletion
mutations. Recent marketing and public awareness cam-
paigns by laboratories and advocacy organizations are
promoting widespread population-based carrier screen-
ing for SMA in the prenatal or preconception setting,
regardless of family history. The American College of
Medical Genetics has recently recommended offering
carrier testing to all couples regardless of race or ethnicity
(1). However, to date, no pilot studies have been com-
pleted in the United States that would determine best
COMMITTEE OPINIONS
practices for pretest and posttest education and counsel-
ing with specific regard to SMA screening. In addition,
there have been no studies to date to determine patient
preferences and utility measures that would allow the
completion of an analysis of the cost-effectiveness of
widespread carrier screening for SMA.
From a public policy perspective, there are generally
accepted criteria that a candidate disease should meet
before widespread screening is instituted. Briefly, these
criteria are: 1) the disease significantly impairs health
in the affected offspring; 2) there is a high frequency of
carriers in the population to be screened; 3) technically
and clinically valid screening methods are available to the
population, and screening is cost-effective; 4) testing is
voluntary, and informed consent and pretest and posttest
counseling are available and effective; 5) fetal testing is
available for couples whose screening results are posi-
tive and reproductive options are readily available in a
time-sensitive manner. In addition to these well-accepted
criteria, it is imperative that any screening program be
carried out in a manner by which a patient’s privacy is
protected so that risks of discrimination and stigmati-
zation in the community are minimized. Nevertheless,
public awareness campaigns regarding the disease and
carrier screening availability will enhance knowledge of
SMA and SMA testing in the prenatal population. This
may lead to patients requesting SMA carrier testing.
Although SMA does meet some of the criteria cited
previously for population-based carrier screening, there
are specific areas that have not yet been addressed. In
general terms, the question of what threshold for carrier
frequency any disease must meet to be considered for
widespread screening has never been formally addressed
by genetics and public policy professionals. In the case
of SMA, carrier frequencies in the general population
(1 in 40 to 1 in 60) may be in the range of those found
in diseases such as Tay–Sachs (1 in 31), where screening
programs are already in place in specific ethnic popula-
tions. However, offering SMA carrier screening to the
entire prenatal population raises logistic, educational,
and counseling issues on a much different scale com-
pared with those screening programs aimed at a small
subset of the population. Successful programs for carrier
screening in the Eastern European Jewish community
that came about with the previously mentioned criteria
met and involved a well-informed patient population.
In contrast, the well-documented failures of the early
sickle cell carrier screening programs highlight the need
for appropriate pretest and posttest counseling and for
greater attention to the social and clinical needs of the
at-risk community. Before panethnic prenatal screening
for SMA can be recommended there should be a variety
of issues addressed which include, but may not be limited
to, critical assessment of pilot screening programs, cost
effectiveness analysis, development of appropriate edu-
cational materials for both patients and primary obstetri-
cian–gynecologists, and the development of laboratory
assay standards and result reporting.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 274
 Recommendations
1. Preconception and prenatal screening for SMA is not
recommended in the general population at this time.
2. Genetic counseling and SMA carrier screening should
be offered to the following patients or couples:
a. Those with a family history SMA or SMA-like
disease
b. Those who request SMA carrier screening and
have completed genetic counseling that included
discussion of the sensitivity, specificity, and limi-
tations of screening.
3. All identified carriers for SMA should be referred
for follow-up genetic counseling for a discussion
of risk to the fetus and future pregnancies. Prenatal
and preimplantation diagnosis should be discussed,
including gamete donations (egg and sperm donors).
4. Patients requesting fetal testing for SMA should
be referred to an appropriate provider of prenatal
genetic counseling and testing services. If needed,
referral for medical and genetic counseling should
be made for patients with a fetus found to be affected
with SMA.
5. Physicians and counselors involved in carrier screen-
ing should make every effort to provide reassurance
to patients that the results of screening and diagnos-
tic testing will be held confidentially and that their
right to privacy, as with all genetic information, will
be respected.
Resources
Lunn MR, Wang CH. Spinal muscular atrophy. Lancet.
2008;371:2120–33.
Markowitz JA, Tinkle MB, Fischbeck KH. Spinal mus-
cular atrophy in the neonate. J Obstet Gynecol Neonatal
Nurs 2004;33:12–20.
COMMITTEE OPINIONS
National Human Genome Research Institute. Summary
of population-based carrier screening for single gene dis-
orders: lessons learned and new opportunities. Bethesda
(MD): NHGRI; 2008. Available at: http://www.genome.
gov/27026048. Retrieved January 16, 2009.
National Institute of Neurological Disorders and Stroke:
Spinal muscular atrophy fact sheet. Bethesda (MD):
NINDS;2008. Available at: http://www.ninds. nih.gov/
disorders/sma/detail_sma.htm. Retrieved January 16,
2009.
Ogino S, Leonard DG, Rennert H, Ewens WJ, Wilson
RB. Genetic risk assessment in carrier testing for spinal
muscular atrophy. Am J Med Genet 2002;110:301–07.
Pearn J. Classification of spinal muscular atrophies.
Lancet 1980;1:919–22.
Russman BS. Spinal muscular atrophy: clinical class-
ification and disease heterogeneity. J Child Neurol 2007;
22:946–51.
Reference
1. Prior TW. Carrier screening for spinal muscular atrophy.
Professional Practice and Guidelines Committee. Genet
Med 2008;10:840–2.
Copyright © May 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Spinal muscular atrophy. ACOG Committee Opinion No. 432.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;113:1194–6.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 275
 ACOG COMMITTEE OPINION
Number 442 • October 2009 (Replaces No. 298, August 2004)

Preconception and Prenatal Carrier

Screening for Genetic Diseases in
Individuals of Eastern European
Jewish Descent
Committee on ABSTRACT: Certain autosomal recessive disease conditions are more prevalent in
Genetics individuals of Eastern European Jewish (Ashkenazi) descent. Previously, the American
This document reflects College of Obstetricians and Gynecologists recommended that individuals of Eastern
emerging clinical and sci-
entific advances as of the European Jewish ancestry be offered carrier screening for Tay–Sachs disease, Canavan
date issued and is subject disease, and cystic fibrosis as part of routine obstetric care. Based on the criteria used
to change. The information
should not be construed to justify offering carrier screening for Tay–Sachs disease, Canavan disease, and cys-
as dictating an exclusive tic fibrosis, the American College of Obstetricians and Gynecologists’ Committee on
course of treatment or
procedure to be followed. Genetics recommends that couples of Ashkenazi Jewish ancestry also should be offered
carrier screening for familial dysautonomia. Individuals of Ashkenazi Jewish descent may
inquire about the availability of carrier screening for other disorders. Carrier screening is
available for mucolipidosis IV, Niemann-Pick disease type A, Fanconi anemia group C,
Bloom syndrome, and Gaucher disease.

Carrier screening for specific genetic condi-
tions often is determined by an individual’s
ancestry. Certain autosomal recessive disease
conditions are more prevalent in individu-
als of Eastern European Jewish (Ashkenazi)
descent. Most individuals of Jewish ances-
try in North America are descended from
Ashkenazi Jewish communities and, thus,
are at increased risk for having offspring with
one of these conditions. Many of these disor-
ders are lethal in childhood or are associated
with significant morbidity.
Screening options continue to evolve.
The American College of Medical Genetics
has recently recommended additional carrier
screening for the Ashkenazi Jewish popula-
tion. The basis for these recommendations
seems to be the high detection rate (Table
1). The Committee on Genetics reaffirms
support for screening for Tay-Sachs disease,
The American College Canavan disease, cystic fibrosis, and familial
of Obstetricians dysautonomia.
and Gynecologists Tay–Sachs disease (TSD) was one of the
Women’s Health Care first disorders available for carrier screen-
Physicians ing. As a result of carrier screening pro-
grams established in the 1970s, the incidence
of TSD in the North American Ashkenazi
Jewish population has decreased by more
than 90%. Carrier screening also is recom-
mended for individuals of French Canadian
and Cajun descent. Initially, carrier screen-
ing was based on the measurement of hex-
osaminidase A levels (the enzyme deficient
in TSD) in serum or leukocytes. As the genes
for TSD and other diseases more prevalent in
Ashkenazi Jews were identified, DNA carrier
tests were developed. Because each of these
disorders is caused by a small number of
common mutations, the carrier tests are very
sensitive (94–99% detection rates). Previously,
the American College of Obstetricians and
Gynecologists recommended that individu-
als of Eastern European Jewish ancestry be
offered carrier screening for TSD, Canavan
disease, and cystic fibrosis as part of routine
obstetric care. Because of recent advances
in genetics, additional carrier tests are now
available (Table 1).
In 2001, the gene for familial dysautono-
mia was identified. At least 2 mutations in the

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 276

 Table 1. Recessive Genetic Diseases Frequent Among Individuals of Eastern European Jewish Descent Amenable to Carrier
Screening
Disorder Disease Incidence Carrier Frequency* Detection Rate*

Tay–Sachs disease 1/3,000 1/30 98% by hexosaminidase A test,

94% by DNA-based test
Canavan disease 1/6,400 1/40 98%
Cystic fibrosis 1/2,500–3,000 1/29 97%
Familial dysautonomia 1/3,600 1/32 99%
Fanconi anemia group C 1/32,000 1/89 99%
Niemann-Pick disease type A 1/32,000 1/90 95%
Mucolipidosis IV 1/62,500 1/127 95%
Bloom syndrome 1/40,000 1/100 95–97%
Gaucher disease 1/900 1/15 95%
*Non-Jewish carrier frequency and detection rates are unknown except for Tay–Sachs disease and cystic fibrosis. Carrier frequency for Tay–Sachs disease is 1 in 30 if French
Canadian or Cajun ancestry and 1 in 300 for others with a 98% carrier detection rate by hexosaminidase A test.
Modified from March of Dimes. Genetic screening pocket facts. White Plains (NY): MOD; 2001.

familial dysautonomia gene, IKBKAP, have been identi-
fied in patients with familial dysautonomia of Ashkenazi
Jewish descent. One of the mutations (IVS20 +6T»C) is
found in more than 99% of patients with familial dys-
autonomia. It occurs almost exclusively in individuals
of Ashkenazi Jewish descent; the carrier rate (1 in 32) is
similar to TSD and cystic fibrosis. Familial dysautonomia,
a disorder of the sensory and autonomic nervous system,
is associated with significant morbidity. Clinical features
include abnormal suck and feeding difficulties, episodic
vomiting, abnormal sweating, pain and temperature
insensitivity, labile blood pressure levels, absent tearing,
and scoliosis. Treatment is available, which can improve
the length and quality of life, but there currently is no
cure. Based on the criteria used to justify offering carrier
screening for TSD, Canavan disease, and cystic fibrosis,
the ACOG Committee on Genetics recommends that
couples of Ashkenazi Jewish ancestry also should be
offered carrier screening for familial dysautonomia.
Carrier screening tests are available for several dis-
eases that are less common (carrier rates 1 in 89 to 1 in
127), including Fanconi anemia group C, Niemann-Pick
disease type A, Bloom syndrome, and mucolipidosis IV.
These conditions are associated with significant neuro-
logic or medical problems and very limited treatment
options (see Box 1). Carrier screening also is available for
Gaucher disease, the most common disorder in Eastern
European Jews. Although Gaucher disease affects 1 in
900 individuals, the age of onset (from a few months to
90 years) and severity are variable (see Box 1). Gaucher
disease can be very mild, and treatment is available.
All of these tests have a high sensitivity in the Jewish
population. The prevalence of these disorders in non-
Jewish populations, except for TSD and cystic fibrosis,
is unknown. The sensitivity of these carrier tests in non-
Jewish populations has not been established. The muta-
tions may be different and more diverse. Consequently,
when only one partner is Jewish, it is difficult to assess
the risk of having an affected offspring. Therefore, carrier
screening of the non-Jewish partner is of limited value.
Based on these developments, the ACOG Committee
on Genetics makes the following seven recommendations:
1. The family history of individuals considering preg-
nancy, or who are already pregnant, should deter-
mine whether either member of the couple is of
Eastern European (Ashkenazi) Jewish ancestry or has
a relative with one or more of the genetic conditions
listed in Table 1.
2. Carrier screening for TSD, Canavan disease, cys-
tic fibrosis, and familial dysautonomia should be
offered to Ashkenazi Jewish individuals before con-
ception or during early pregnancy so that a couple
has an opportunity to consider prenatal diagnostic
testing options. If the woman is already pregnant, it
may be necessary to screen both partners simulta-
neously so that the results are obtained in a timely
fashion to ensure that prenatal diagnostic testing is
an option.
3. Individuals of Ashkenazi Jewish descent may inquire
about the availability of carrier screening for other dis-
orders. Carrier screening is available for mucolipidosis
IV, Niemann-Pick disease type A, Fanconi anemia
group C, Bloom syndrome, and Gaucher disease.
Patient education materials can be made available so
that interested patients can make an informed decision
about having additional screening tests . Some patients
may benefit from genetic counseling.
4. When only one partner is of Ashkenazi Jewish
descent, that individual should be screened first. If
it is determined that this individual is a carrier, the
other partner should be offered screening. However,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 277

 the couple should be informed that the carrier fre-
quency and the detection rate in non-Jewish indi-
viduals is unknown for all of these disorders, except
for TSD and cystic fibrosis. Therefore, it is difficult to
accurately predict the couple’s risk of having a child
with the disorder.
5. Individuals with a positive family history of one of
these disorders should be offered carrier screening
for the specific disorder and may benefit from genetic
counseling.
6. When both partners are carriers of one of these dis-
orders, they should be referred for genetic counsel-
ing and offered prenatal diagnosis. Carrier couples
should be informed of the disease manifestations,
range of severity, and available treatment options.
Prenatal diagnosis by DNA-based testing can be
performed on cells obtained by chorionic villus sam-
pling and amniocentesis.
Box 1. Clinical Features of Autosomal Recessive Genetic Diseases Frequent Among Individuals
of Eastern European Jewish Descent
Bloom syndrome is a genetic condition associated with
increased chromosome breakage, a predisposition to infec-
tions and malignancies, prenatal and postnatal growth
deficiency, skin findings (such as facial telangiectasias or
abnormal pigmentation), and in some cases learning dif-
ficulties and mental retardation. The mean age of death is 27
years and usually is related to cancer. No effective treatment
currently is available.
Canavan disease is a disorder of the central nervous system
characterized by developmental delay, hypotonia, large
head, seizures, blindness, and gastrointestinal reflux. Most
children die within the first several years of life. Canavan
disease is caused by a deficiency of the aspartoacylase
enzyme. No treatment currently is available.
Familial dysautonomia is a neurologic disorder character-
ized by abnormal suck and feeding difficulties, episodic vom-
iting, abnormal sweating, pain and temperature insensitivity,
labile blood pressure levels, absent tearing, and scoliosis.
There currently is no cure for familial dysautonomia, but
some treatments are available that can improve the length
and quality of a patient’s life.
Fanconi anemia group C usually presents with severe
anemia that progresses to pancytopenia, developmental
delay, and failure to thrive. Congenital anomalies are not
uncommon, including limb, cardiac, and genital–urinary
defects. Microcephaly and mental retardation may be pres-
ent. Children are at increased risk for leukemia. Some
children have been successfully treated with bone marrow
transplantation. Life expectancy is 8–12 years.
Gaucher disease is a genetic disorder that mainly affects
the spleen, liver, and bones; it occasionally affects the
lungs, kidneys, and brain. It may develop at any age. Some
COMMITTEE OPINIONS
7. When an individual is found to be a carrier, his or
her relatives are at risk for carrying the same muta-
tion. The patient should be encouraged to inform his
or her relatives of the risk and the availability of car-
rier screening. The provider does not need to contact
these relatives because there is no provider–patient
relationship with the relatives, and confidentiality
must be maintained.
Carrier screening is voluntary. Informed consent and
assurance of confidentiality are required. For all of these
disorders, a negative screening test result for one or both
partners significantly reduces the possibility of an affected
offspring. However, it does not exclude the possibility
because the test sensitivity is less than 100% so not all
carriers can be identified.
The number and choice of genetic tests available
to patients is likely to increase as a result of the Human
individuals are chronically ill, some are moderately affected,
and others are so mildly affected that they may not know that
they have Gaucher disease. The most common symptom is
chronic fatigue caused by anemia. Patients may experience
easy bruising, nosebleeds, bleeding gums, and prolonged
and heavy bleeding with their menses and after childbirth.
Other symptoms include an enlarged liver and spleen, osteo-
porosis, and bone and joint pain. Gaucher disease is caused
by the deficiency of the β-glucosidase enzyme. Treatment is
available through enzyme therapy, which results in a vastly
improved quality of life.
Mucolipidosis IV is a neurodegenerative lysosomal storage
disorder characterized by growth and psychomotor retarda-
tion, corneal clouding, progressive retinal degeneration,
and strabismus. Most affected infants never speak, walk, or
develop beyond the level of a 1–2 year old. Life expectancy
may be normal, and there currently is no effective treatment.
Niemann-Pick disease type A is a lysosomal storage dis-
order typically diagnosed in infancy and marked by a rapid
neurodegenerative course similar to Tay–Sachs disease.
Affected children die by age 3–5 years. Niemann-Pick dis-
ease type A is caused by a deficiency of the sphingomyelin-
ase enzyme. There currently is no treatment.
Tay–Sachs disease (TSD) is a severe, progressive disorder of
the central nervous system leading to death within the first few
years of life. Infants with TSD appear normal at birth but by age
5–6 months develop poor muscle tone, delayed development,
loss of developmental milestones, and mental retardation.
Children with TSD lose their eyesight at age 12–18 months. This
condition usually is fatal by age 6 years. Tay–Sachs disease is
caused by a deficiency of the hexosaminidase A enzyme. No
effective treatment currently is available.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 278
 Genome Project and advances in technology. For some
patients, it can be difficult to decide whether to have a
specific test. There are many factors patients may con-
sider, including the prevalence of the disease, the carrier
risk, the disease severity and treatment options, cost, and
reproductive choices. Counseling by a genetic counselor,
geneticist, or physician with expertise in these diseases
may assist patients in making an informed decision about
carrier testing.
Bibliography
Screening for Tay-Sachs disease. ACOG Committee Opinion
No. 318. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:893–4.
Dong J, Edelmann L, Bajwa AM, Kornreich R, Desnick RJ.
Familial dysautonomia: detection of the IKBKAP IVS20
(+6T —> C) and R696P mutations and frequencies among
Ashkenazi Jews. Am J Med Genet 2002;110:253–7.
COMMITTEE OPINIONS
Eng CM, Desnick RJ. Experiences in molecular-based prenatal
screening for Ashkenazi Jewish genetic diseases. Adv Genet
2001;44:275–96.
Zlotogora J, Bach G, Munnich A. Molecular basis of mendelian
disorders among Jews. Mol Genet Metab 2000;69:169–80.
Copyright © October 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Preconception and prenatal carrier screening for genetic diseases in
individuals of Eastern European Jewish descent. ACOG Committee
Opinion No. 442. American College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2009;114:950–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 279
 ACOG COMMITTEE OPINION
Number 446 • November 2009

Array Comparative Genomic Hybridization

Committee on
Genetics
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
in Prenatal Diagnosis
ABSTRACT: The widespread use of array comparative genomic hybridization (CGH)
for the diagnosis of genomic rearrangements in children with idiopathic mental retarda-
tion, developmental delay, and multiple congenital anomalies has spurred interest in
applying array CGH technology to prenatal diagnosis. The use of array CGH technology in
prenatal diagnosis is currently limited by several factors, including the inability to detect
balanced chromosomal rearrangements, the detection of copy number variations of
uncertain clinical significance, and significantly higher costs than conventional karyotype
analysis. Although array CGH has distinct advantages over classic cytogenetics in certain
applications, the technology is not currently a replacement for classic cytogenetics in
prenatal diagnosis.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
Completion of the Human Genome Project
stimulated development of ancillary technol-
ogies that continue to revolutionize medical
sciences and diagnostic techniques. Current
conventional cytogenetic analysis (G-banded
karyotype) can detect unbalanced structural
rearrangements and numeric abnormalities,
as well as apparently balanced rearrange-
ments within the limits of resolution of the
technique. The resolution of the current
conventional cytogenetic analyses lies in the
range of 3–10 Mb (1 Mb = 1 million base
pairs) and requires dividing cells. Therefore,
chromosomal microdeletions or microdu-
plications (those smaller than 3 Mb) will go
undetected with conventional cytogenetic
analyses. These submicroscopic rearrange-
ments may account for a sizable portion of
the human genetic disease burden, with some
estimates as high as 15% (1). Fluorescence in
situ hybridization technology can be used to
detect chromosomal abnormalities smaller
than 3 Mb (DiGeorge syndrome for exam-
ple), but because of technical limitations, it
can only screen for a limited number of chro-
mosomal abnormalities at one time.
Genomic microarray-based technolo-
gies can theoretically detect human genomic
DNA variation at virtually any site in the
human genome. Genomic microarrays can
detect both duplications and deletions, also
referred to in the literature as genomic copy
number variants. Genomic copy number
variants are defined as deletions and dupli-
cations of DNA segments larger than 1,000
bases and up to several megabases in size.
Genomic microarrays can be used to per-
form karyotyping, which often is referred to
as array comparative genomic hybridization
or array CGH. Array CGH improves resolu-
tion over conventional G-banded karyotype
in detecting chromosomal abnormalities
smaller than 3 Mb. Array CGH has been
reported to be useful in detecting causative
genomic imbalances in as many as 10% of
patients with unexplained mental retarda-
tion and previously normal conventional
karyotype (2). In addition, array CGH has
been a useful tool in discovering underlying
genetic mutations in known, but genetically
undefined, human genetic syndromes (3).
The potential advantages of array CGH
over conventional karyotyping in prenatal
diagnosis include higher resolution, avoid-
ance of culturing amniocytes or chorionic villi,
automation, and faster turnaround times. In
addition, array CGH does not require divid-
ing cells, which is useful in the case of fetal
demise where the ability to successfully cul-
ture cells may be compromised (4). The dis-
advantages of array CGH include the inability
to detect balanced inversions or translocations

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 280

 as well as certain forms of triploidy, and array CGH costs
significantly more than conventional karyotype analysis.
The technique detects a large number of either benign
copy number variants or copy number variants of uncer-
tain clinical significance and is unlikely to detect mosaic-
ism below 20% (5).
The two types of arrays currently available are tar-
geted and genome-wide arrays. Targeted arrays are cur-
rently preferred in clinical genetic practice because they
can detect chromosomal abnormalities for known genetic
syndromes. This allows genetic counseling with more
certainty regarding phenotype and long-term prognosis.
Targeted arrays, however, can miss novel pathologic copy
number variants, which may explain a constellation of
congenital anomalies that do not fit any particular known
syndrome. In approximately 12–15% of samples, copy
number variants of uncertain clinical significance will
be detected among currently used targeted arrays (6). In
such cases, DNA from the biological mother and father
must also be analyzed by microarray to distinguish copy
number variants that were inherited from the parents
(inherited copy number variants) versus copy number
variants that are absent in the parents and arose spon-
taneously in the child (de novo copy number variants).
Inherited copy number variants are relatively common
and represent benign polymorphisms in most cases.
However, a recent report has indicated that inherited
copy number variants from seemingly “normal” parents
can cause major pathology in the offspring (7). De novo
copy number variants are more likely to be the cause of
congenital and developmental abnormalities compared
with inherited copy number variants, but interpretation
of copy number variant results can be clinically complex.
A genetics professional should be involved in the inter-
pretation of both inherited and de novo copy number
variants.
Genome-wide arrays, however, are designed to cover
a greater portion of the human genome than targeted
arrays. Genome-wide arrays have been particularly use-
ful in research efforts to discover new submicrosco-
pic syndromes (8, 9). However, at this point in time,
genome-wide arrays will detect many more copy number
variants of unknown clinical significance. Growing clini-
cal experience with genome-wide arrays and the develop-
ment of copy number variant databases of both healthy
and affected individuals will reduce the number of copy
number variants of unknown clinical significance and will
make genome-wide arrays more useful in clinical practice.
Several reports have now shown the potential utility
of array CGH in prenatal diagnosis (10, 11). In a relatively
large series of fetuses with ultrasound abnormalities and
normal conventional karyotype, array CGH detected
chromosomal abnormalities in 5% of fetuses and up to
10% in those with three or more anatomic abnormalities.
In addition, array CGH was found to detect two genetic
syndromes among 300 amniocentesis or chorionic villus
samples that otherwise would not have been detected by
COMMITTEE OPINIONS
conventional karyotype or aneuploidy fluorescence in
situ hybridization (11). Data from this and other studies
have generated increasing interest in the utilization of
array CGH as an additional assay for fetal abnormali-
ties, beyond conventional cytogenetic analysis. However,
many of the known genomic disorders that can be
detected on current targeted arrays do not show read-
ily detectable fetal abnormalities on prenatal ultrasound
examinations. Therefore, ordering array CGH only in
the presence of ultrasound abnormalities may limit the
diagnostic potential of this assay (11).
The usefulness of array CGH as a first-line tool in
detecting chromosomal abnormalities in all amniocente-
sis or chorionic villus samples is still unknown. The addi-
tional detection rate of chromosomal abnormalities using
array CGH, as compared with conventional karyotype,
for routine fetal chromosomal analysis, awaits a larger
population-based study, which is currently underway in
the United States. The answers to these and other ques-
tions are required before the routine clinical use of array
CGH in prenatal diagnosis can be recommended.
Recommendations
• Conventional karyotyping remains the principal cyto-
genetic tool in prenatal diagnosis.
• Targeted array CGH, in concert with genetic coun-
seling, can be offered as an adjunct tool in prenatal
cases with abnormal anatomic findings and a normal
conventional karyotype, as well as in cases of fetal
demise with congenital anomalies and the inability
to obtain a conventional karyotype.
• Couples choosing targeted array CGH should receive
both pretest and posttest genetic counseling. Follow-
up genetic counseling is required for interpretation
of array CGH results. Couples should understand that
array CGH will not detect all genetic pathologies and
that array CGH results may be difficult to interpret.
• Targeted array CGH may be useful as a screening
tool; however, further studies are necessary to fully
determine its utility and its limitations.
References
1. Vissers LE, Veltman JA, van Kessel AG, Brunner HG.
Identification of disease genes by whole genome CGH
arrays. Hum Mol Genet 2005;14(spec no. 2):R215–23.
2. de Vries BB, Pfundt R, Leisink M, Koolen DA, Vissers LE,
Janssen IM, et al. Diagnostic genome profiling in mental
retardation. Am J Hum Genet 2005;77:606–16.
3. Vissers LE, van Ravenswaaij CM, Admiraal R, Hurst JA, de
Vries BB, Janssen IM, et al. Mutations in a new member
of the chromodomain gene family cause CHARGE syn-
drome. Nat Genet 2004;36:955–7.
4. Schaeffer AJ, Chung J, Heretis K, Wong A, Ledbetter DH,
Lese Martin C. Comparative genomic hybridization-array
analysis enhances the detection of aneuploidies and sub-
microscopic imbalances in spontaneous miscarriages. Am
J Hum Genet 2004;74:1168–74.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 281
 5. Stankiewicz P, Beaudet AL. Use of array CGH in the evalu-
ation of dysmorphology, malformations, developmental
delay, and idiopathic mental retardation. Curr Opin Genet
Dev 2007;17:182–92.
6. Sahoo T, Cheung SW, Ward P, Darilek S, Patel A, del
Gaudio D, et al. Prenatal diagnosis of chromosomal abnor-
malities using array-based comparative genomic hybridiza-
tion. Genet Med 2006;8:719–27.
7. Mefford HC, Sharp AJ, Baker C, Itsara A, Jiang Z, Buysse
K, et al. Recurrent rearrangements of chromosome 1q21.1
and variable pediatric phenotypes. N Engl J Med 2008;359:
1685–99.
8. Slavotinek AM. Novel microdeletion syndromes detected
by chromosome microarrays. Hum Genet 2008;124:1–17.
9. Koolen DA, Vissers LE, Pfundt R, de Leeuw N, Knight SJ,
Regan R, et al. A new chromosome 17q21.31 microdeletion
syndrome associated with a common inversion polymor-
phism. Nat Genet 2006;38:999–1001.
10. Le Caignec C, Boceno M, Saugier-Veber P, Jacquemont S,
Joubert M, David A, et al. Detection of genomic imbalances
by array based comparative genomic hybridisation in fetuses
with multiple malformations. J Med Genet 2005;42:121–8.
COMMITTEE OPINIONS
11. Van den Veyver IB, Patel A, Shaw CA, Pursley AN, Kang
SH, Simovich MJ, et al. Clinical use of array comparative
genomic hybridization (aCGH) for prenatal diagnosis in
300 cases. Prenat Diagn 2009;29:29–39.
Copyright © November 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Array comparative genomic hybridization in prenatal diagnosis. ACOG
Committee Opinion No. 446. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2009;114:1161–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 282
 ACOG COMMITTEE OPINION
Number 449 • December 2009 (Replaces No. 230, January 2000)

Maternal Phenylketonuria
Committee on ABSTRACT: Phenylketonuria (PKU) is an autosomal recessive disorder of phenylala-
Genetics nine (Phe) metabolism characterized by a deficiency of the hepatic enzyme, phenylala-
This document reflects nine hydroxylase, an enzyme responsible for the conversion of phenylalanine to tyrosine,
emerging clinical and sci-
entific advances as of the and elevated levels of Phe and Phe metabolite. All women with PKU or hyperphenylal-
date issued and is subject aninemia should be strongly encouraged to receive family planning and preconception
to change. The information
should not be construed counseling. Women with PKU or hyperphenylalaninemia should begin appropriate, medi-
as dictating an exclusive cally directed dietary phenylalanine restriction before conception.
course of treatment or
procedure to be followed.
Phenylketonuria is an autosomal recessive health challenge because of the significant
disorder of phenylalanine (Phe) metabolism fetal consequences of maternal hyperphen-
characterized by a deficiency of the hepatic ylalaninemia. Importantly, phenylalanine
enzyme, phenylalanine hydroxylase (PAH), crosses the placenta by an active transport
an enzyme responsible for the conversion process that results in a fetal-to-maternal
of phenylalanine to tyrosine, and elevated plasma phenylalanine ratio of 1.5. Therefore,
levels of Phe and Phe metabolite. More than higher levels of phenylalanine exist in fetal
400 mutations of the PAH gene have been blood than would be expected based on
described, and the severity of the disorder is the maternal blood level. The developing
dependent on the type of mutation present. brain and heart are particularly vulnerable
A deficiency of the PAH enzyme results in to high concentrations of blood phenylala-
increased blood phenylalanine levels, which nine. Children born to women with PKU on
are toxic. If untreated, phenylketonuria (PKU) unrestricted diets have a 92% risk for mental
can result in fetal growth failure, micro- retardation, a 73% risk for microcephaly, and
cephaly, seizures, and mental retardation. a 12% risk for congenital heart defects (1).
Two aspects of this metabolic disorder are If phenylalanine levels are normalized (Phe
particularly relevant to the obstetrician– levels between 120–360 micromole/L) before
gynecologist—the prevention of fetal embry- conception or by 8 weeks of gestation, there
opathy associated with maternal hyperphe- is evidence to suggest a reduction in the
nylalaninemia and the risk of genetic trans- fetal sequelae of hyperphenylalaninemia (2).
mission of PKU. Reduction of the maternal blood phenyl-
alanine level to 600 micromole/L or less,
Prevention of Fetal Embryo- reduced the incidence of microcephaly from
pathy Associated With Maternal 73% to 8% (3). The challenge of identifying
Hyperphenylalaninemia and educating women about dietary restric-
In the United States, approximately 3,000 tion before conception is highlighted by a
women of reproductive age are affected with study that found 64% of women failed to
PKU. Although evidence suggests that women achieve blood phenylalanine control by 8
with PKU will benefit from remaining on weeks of gestation (4). The crucial role played
a phenylalanine-free diet throughout their by dietary restriction should be stressed in
lives, many are not adherent to such a diet the patient with PKU, preferably 3 months
The American College because of the unpalatable nature of many before conception, to normalize the blood
of Obstetricians phenylalanine-free products. The failure of phenylalanine level and optimize neural and
and Gynecologists cardiac developmental outcomes for the
young women with PKU to adhere to dietary
Women’s Health Care modification represents a significant public fetus.
Physicians

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 283

 Risk of Genetic Transmission of
Phenylketonuria
Children of women with PKU will carry at least one
abnormal gene, which is inherited from their homozy-
gous-affected mother. The carrier frequency for PKU
is approximately 1 in 60. Given an affected mother,
approximately 1 in 120 children will inherit an abnormal
PAH gene from both parents and will be affected with
PKU. Children of women with PKU are carriers and
should receive genetic counseling in the future. If the
mutations are known, further consultation and screen-
ing with a genetics professional to discuss reproductive
options should be recommended. Universal neonatal
PKU screening in the United States has facilitated early
detection of these newborns.
Conclusions and Recommendations
• All women with PKU or hyperphenylalaninemia
should be strongly encouraged to receive family
planning and preconception counseling.
• Women with PKU or hyperphenylalaninemia should
begin appropriate, medically directed dietary phe-
nylalanine restriction before conception (5).
• Ideally, pregnant women with PKU or hyperphenyl-
alaninemia should be managed in consultation with
practitioners from experienced PKU centers.
Resource
Maternal phenylketonuria. American Academy of Pedi-
atrics. Pediatrics 2008;122:445–9.
COMMITTEE OPINIONS
References
1. Lenke RR, Levy HL. Maternal phenylketonuria and hyper-
phenylalaninemia. An international survey of the outcome
of untreated and treated pregnancies. N Engl J Med 1980;
303:1202–8.
2. Widaman KF, Azen C. Relation of prenatal phenylalanine
exposure to infant and childhood cognitive outcomes:
results from the International Maternal PKU Collaborative
Study. Pediatrics 2003;112:1537–43.
3. Matalon KM, Acosta PB, Azen C. Role of nutrition in preg-
nancy with phenylketonuria and birth defects. Pediatrics
2003;112:1534–6.
4. Brown AS, Fernhoff PM, Waisbren SE, Frazier DM, Singh
R, Rohr F, et al. Barriers to successful dietary control among
pregnant women with phenylketonuria. Genet Med 2002;
4:84–9.
5. Levy HL, Waisbren SE, Lobbregt D, Allred E, Schuler A,
Trefz FK, et al. Maternal mild hyperphenylalaninaemia:
an international survey of offspring outcome. Lancet 1994;
344:1589–94.
Copyright December 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Maternal phenylketonuria. ACOG Committee Opinion No. 449.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;114:1432–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 284
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 469 • October 2010 (Replaces No. 338, June 2006)

Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Carrier Screening for Fragile X Syndrome

Abstract: Fragile X syndrome is the most common inherited form of mental retardation. The syndrome
occurs in approximately 1 in 3,600 males and 1 in 4,000–6,000 females. Approximately 1 in 250 females carry the
premutation. DNA-based molecular analysis is the preferred method of diagnosis for fragile X syndrome and its
premutations. Prenatal testing for fragile X syndrome should be offered to known carriers of the fragile X premuta-
tion or full mutation. Women with a family history of fragile X-related disorders, unexplained mental retardation or
developmental delay, autism, or premature ovarian insufficiency are candidates for genetic counseling and fragile
X premutation carrier screening.

Fragile X syndrome is the most common inherited form
of mental retardation. The syndrome occurs in approxi-
mately 1 in 3,600 males and 1 in 4,000–6,000 females
from a variety of ethnic backgrounds. Mental retarda-
tion or impairment ranges from borderline, including
learning disabilities, to severe, presenting with cogni-
tive and behavioral disabilities, including autism. Most
affected males have significant intellectual disability.
Fragile X syndrome is the most common known cause of
autism or “autisticlike” behaviors. Other associated phe-
notypic abnormalities include distinctive facial features in
males (including long narrow face and prominent ears),
enlarged testicles (macroorchidism), connective tissue
problems, and speech and language problems. The abnor-
mal facial features are subtle and become more noticeable
with age, making phenotypic diagnosis difficult, especially
in the newborn. Affected females may have a more subtle
phenotype, and it is sometimes hard to establish the diag-
nosis based on clinical findings alone.
Fragile X syndrome is transmitted as an X-linked
disorder. However, the molecular genetics of the syn-
drome are complex. The disorder is caused by expansion
of a repeated trinucleotide segment of DNA, cytosine–
guanine–guanine (CGG), that leads to altered transcrip-
tion of the fragile X mental retardation 1 (FMR1) gene.
The number of CGG repeats varies among individuals
and has been classified into four groups depending on the
repeat size: 1) unaffected, 2) intermediate, 3) premuta-
tion, and 4) full mutation (1, 2) (see Table 1). A person
with 55–200 repeats usually is phenotypically normal
and is said to have a premutation. When more than 200
repeats are present, an individual has a full mutation that
results in the full expression of fragile X syndrome in
males and variable expression in females secondary to X
chromosome inactivation. The large number of repeats in
a full mutation allele causes the FMR1 gene to become
methylated. Methylation “turns off” the regulatory region
of a gene, thereby preventing DNA transcription and
FMR1 protein production. The number of repeats and
the status of gene methylation are determined by use of
DNA-based molecular tests (eg, Southern blot analysis
and polymerase chain reaction). In rare cases, the size
of the triplet repeat and the methylation status do not
correlate, making prediction of the clinical phenotype
difficult. Fetal DNA analysis from amniocentesis or cho-
rionic villus sampling (CVS) is reliable for determining
the number of triplet repeats. However, in some cases,
particularly in male fetuses, an analysis of FMR1 gene
methylation in full mutations from samples of chorionic
Table 1. Mutation in the Fragile X Mental Retardation 1 Gene
Number of Triplet Repeats
Status of Individual (Cytosine–Guanine–Guanine)
Unaffected Less than 45
Intermediate
(also called “grey zone”) 45–54
Premutation 55–200
Full mutation More than 200

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 285

 villi may not be accurate. Gestational age differences in
the methylation of specific genes in the chorionic villi
may preclude determining the true methylation status
of the FMR1 gene (3). Therefore, findings of full FMR1
mutations (greater than 200 repeats) on fetal DNA analy-
sis from CVS may require a follow-up amniocentesis to
accurately determine the methylation status of the gene.
Transmission of a disease-producing mutation to a
fetus depends on the sex of the parent and the number of
CGG repeats present in the parental gene. A woman who
carries a premutation can transmit either her normal or
premutation allele; the premutation allele may expand,
resulting in the birth of an affected child. The larger the
size of the premutation repeat, the more likely the expan-
sion to a full mutation (Table 2). The smallest repeat size
reported to expand to a full mutation in one generation
is 59 repeats (4). Diagnosis of mutation size may vary by
as many as 3 or 4 repeats. The frequency of premutation
allele carriers (repeat size greater than 54) in the popula-
tion has been reported to be as high as 1 in 157 in a large
Israeli study of women (more than 36,000 individuals)
without a family history of mental retardation or devel-
opmental abnormalities (5). The most recent prevalence
data from the United States reported a carrier frequency
of 1 in 86 for those with a family history of mental retar-
dation and 1 in 257 for women with no known risk fac-
tors for fragile X syndrome (6).
Women with an intermediate number of triplet
repeats (45–54) do not transmit a full mutation to their
sons and daughters, although there may be expansion to
a premutation allele in their offspring. Genetic counsel-
ing for intermediate results may be useful. Males will
transmit the unexpanded premutation gene to their
daughters, but expansion to a full mutation is extremely
rare. Empirically determined risks are available for the
purposes of genetic counseling.
Fragile X-Associated Disorders
Carriers of premutation alleles do not display any of the
classic phenotypic features associated with full muta-
tion expansions. However, males and, to a lesser extent,
Table 2. Full Mutation Expansion from Maternal
Premutation Allele
Maternal Repeat Size Full Mutation Expansion (%)
55–59 4
60–69 5
70–79 31
80–89 58
90–99 80
100–200 98
Data from Nolin SL, Brown WT, Glicksman A, Houck GE Jr, Gargano AD, Sullivan
A, et al. Expansion of the fragile X CGG repeat in females with premutation or
intermediate alleles. Am J Hum Genet 2003;72:454–64.
COMMITTEE OPINIONS
females carrying a premutation are at an increased risk
of a late-onset neurodegenerative disorder (with onset
usually after age 50 years) characterized by progressive
cerebellar ataxia and intention tremor, called fragile X
tremor ataxia syndrome or FXTAS. The risk and the
severity of the disorder appear to be related to the size of
the premutation repeat, with the highest risk associated
with larger repeats. The true incidence of this new neuro-
logic syndrome among premutation carriers remains to
be established and is an area of ongoing active research.
Women carrying a premutation are at an increased
risk (20%) of premature ovarian failure or insufficiency
(7). Fragile X-associated ovarian dysfunction is now
commonly called fragile X-associated primary ovarian
insufficiency. The carrier frequency of a fragile X premu-
tation is approximately 3% for women with “sporadic”
premature ovarian failure and 12% for women with
a family history of premature ovarian failure (8). If a
woman has a personal or family history of ovarian failure
or an elevated follicle-stimulating hormone level before
age 40 years without a known cause, fragile X premuta-
tion carrier testing should be offered (9, 10).
Preconception or Prenatal Carrier
Screening
Current consensus guidelines from professional genet-
ics organizations recommend carrier screening only for
women with a family history of fragile X syndrome or
undiagnosed mental retardation, developmental delay,
or autism or for those with ovarian insufficiency (6).
Although following these guidelines will not detect most
premutation carriers in the population, it does target
a higher prevalence group based on current data with
regard to carrier frequency. However, patients with-
out a family history may visit their obstetric providers
informed about fragile X syndrome and ask to have
screening to determine their carrier status. In addition,
commercial laboratories have marketed the availability
of FMR1 mutation analysis directly to obstetricians. The
current commercially available DNA assays for fragile
X repeat expansion analysis are intended for diagnosis
and not specifically for screening. Thus, they are costly,
time consuming, and have limited utility for widespread
population-based screening. Recent technical advances
in high throughput DNA analysis offer the possibility of
low-cost, screening-specific tests in the near future (11).
The American College of Obstetricians and Gynecol-
ogists’ Committee on Genetics recommends testing for
fragile X syndrome as follows:
• Women with a family history of fragile X-related
disorders, unexplained mental retardation or devel-
opmental delay, autism, or premature ovarian insuf-
ficiency are candidates for genetic counseling and
fragile X premutation carrier screening.
• If a woman has ovarian insufficiency or failure or an
elevated follicle-stimulating hormone level before
2013 COMPENDIUM OF SELECTED PUBLICATIONS 286
 age 40 years without a known cause, fragile X car-
rier screening should be considered to determine
whether she has an FMR1 premutation.
• Women who request fragile X carrier screening,
regardless of family history, should be offered FMR1
DNA mutation analysis after genetic counseling
about the risks, benefits, and limitations of screening.
• All identified carriers of a fragile X premutation
(or full mutation) should be referred for follow-up
genetic counseling to discuss the risk to their fetuses
of inheriting an expanded full mutation fragile X
allele and to discuss fragile X associated disorders
(premature ovarian insufficiency and fragile X trem-
or ataxia syndrome). Prenatal and preimplantation
diagnoses and donor eggs should be discussed.
• Prenatal testing for fragile X syndrome by amniocen-
tesis or CVS should be offered to known carriers of
the fragile X premutation or full mutation. Although
amniocentesis and CVS are reliable for determin-
ing the number of triplet repeats, CVS may not
adequately determine the methylation status of the
FMR1 gene.
• DNA-based molecular analysis (eg, Southern blot
analysis and polymerase chain reaction) is the pre-
ferred method of diagnosis of fragile X syndrome
and of determining FMR1 triplet repeat number
(eg, premutations). In rare cases where there is dis-
cordance between the triplet repeat number and the
methylation status, the patient should be referred to
a genetics professional.
References
1. Kronquist KE, Sherman SL, Spector EB. Clinical signifi-
cance of tri-nucleotide repeats in Fragile X testing: a clarifi-
cation of American College of Medical Genetics guidelines.
Genet Med 2008;10:845–7.
2. American College of Medical Genetics. Technical standards
and guidelines for fragile X testing: a revision to the disease-
specific supplements to the Standards and Guidelines for
Clinical Genetics Laboratories of the American College of
Medical Genetics. Bethesda (MD): ACMG; 2005. Available
at: http://www.acmg.net/Pages/ACMG_Activities/stds-2002/
fx.htm. Retrieved June 29, 2010.
3. Willemsen R, Bontekoe CJ, Severijnen LA, Oostra BA.
Timing of the absence of FMR1 expression in full mutation
chorionic villi. Hum Genet 2002;110:601–5.
4. Nolin SL, Brown WT, Glicksman A, Houck GE Jr,
Gargano AD, Sullivan A, et al. Expansion of the fragile X
CGG repeat in females with premutation or intermediate
alleles. Am J Hum Genet. 2003;72:454­– 64.
5. Pesso R, Berkenstadt M, Cuckle H, Gak E, Peleg L,
Frydman M, et al. Screening for fragile X syndrome in
women of reproductive age. Prenat Diagn 2000;20:611–4.
COMMITTEE OPINIONS
6. Cronister A, Teicher J, Rohlfs EM, Donnenfeld A, Hallam S.
Prevalence and instability of fragile X alleles: implications
for offering fragile X prenatal diagnosis. Obstet Gynecol
2008;111:596–601.
7. Ennis S, Ward D, Murray A. Nonlinear association between
CGG repeat number and age of menopause in FMR1 pre-
mutation carriers. Eur J Hum Genet. 2006;14:253–5.
8. Sherman SL. Premature ovarian failure in the fragile X syn-
drome. Am J Med Genet 2000;97:189–94.
9. Wittenberger MD, Hagerman RJ, Sherman SL, McConkie-
Rosell A, Welt CK, Rebar RW, et al. The FMR1 premuta-
tion and reproduction. Fertil Steril. 2007;87:456–65.
10. Sherman S, Pletcher BA, Driscoll DA. Fragile X syndrome:
diagnostic and carrier testing. Genet Med 2005;7:584–7.
11. Dodds ED, Tassone F, Hagerman PJ, Lebrilla CB. Poly-
merase chain reaction, nuclease digestion, and mass spec-
trometry based assay for the trinucleotide repeat status of
the fragile X mental retardation 1 gene. Anal Chem 2009;
81:5533–40.
Resources
Hagerman RJ, Hagerman PJ, editors. Fragile X syndrome:
diagnosis, treatment, and research. 3rd ed. Baltimore (MD):
Johns Hopkins University Press; 2002.
Hagerman PJ, Hagerman RJ. The fragile-X premutation: a
maturing perspective [published erratum appears in Am J Hum
Genet 2004;75:352]. Am J Hum Genet 2004;74:805–16.
Jacquemont S, Leehey MA, Hagerman RJ, Beckett LA,
Hagerman PJ. Size bias of fragile X premutation alleles in
late-onset movement disorders. J Med Genet 2006;43:
804–9.
Warren ST, Sherman SL. The fragile X syndrome. In:
Scriver CR, Beaudet AL, Sly WS, Valle D, editors. The met-
abolic and molecular bases of inherited disease. 8th ed.
New York (NY): McGraw-Hill; 2001. p. 1257–89.
Copyright October 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Carrier screening for fragile X syndrome. Committee Opinion No.
469. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2010;116:1008–10.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 287
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 478 • March 2011
Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Family History as a Risk Assessment Tool

ABSTRACT: Family history plays a critical role in assessing the risk of inherited medical conditions and single
gene disorders. Several methods have been established to obtain family medical histories, including the family
history questionnaire or checklist and the pedigree. The screening tool selected should be tailored to the practice
setting and patient population. It is recommended that all women receive a family history evaluation as a screening
tool for inherited risk. Family history information should be reviewed and updated regularly, especially when there
are significant changes to family history. Where appropriate, further evaluation should be considered for positive
responses, with referral to genetic testing and counseling as needed.

Family history plays a critical role in assessing the risk of
inherited medical conditions and single gene disorders.
Certain types of cancer, such as breast cancer and colon
cancer, appear more frequently in some families, as do
some adverse birth outcomes. Coronary artery disease,
type 2 diabetes mellitus, depression, and thrombophilias
also have familial tendencies. The U.S. Surgeon General’s
Family History Initiative was launched in 2004. The goal
of this initiative is to educate both health care providers
and patients about the value of collecting a family history
as a screening tool and to increase its use and effectiveness
in clinical care by simplifying the collection process and
analysis of the family history (1). Over the past 20 years,
the Human Genome Project has afforded us a better
understanding of the effect of genetic variation on health
and disease. This has furthered research in identifying
genotype–phenotype correlations and enhanced the abil-
ity to predict those at risk of developing inherited medical
conditions. With increased awareness of the importance
of using family history as a screening tool and of the value
of preventive measures and increased surveillance, there
is hope for improved outcomes.
Tools for Collecting the Family History
Several methods have been established to obtain family
medical histories, each with its own advantages and dis-
advantages. A common tool used in general practice is
the family history questionnaire or checklist. Having the
patient complete the questionnaire at home allows extra
time for the patient to contact family members and pro-
vide more accurate information. Direct patient question-
ing permits clarification of medical terminology that may
be unclear to the patient. Any positive responses on the
questionnaire should be followed up by the health care
provider to obtain more detail, including the relationship
of the affected family member(s) to the patient, exact
diagnosis, age of onset, and severity of disease (2).
Another family history assessment tool, commonly
used by genetics professionals, is the pedigree. The health
care provider may decide to complete a detailed pedigree
or refer the patient to a genetics professional for further
evaluation. A pedigree ideally shows at least three genera-
tions and involves the use of standardized symbols, which
clearly mark individuals affected with a specific diagnosis
to allow for easy identification (see Fig. 1). The pedigree
may visibly assist in determining the size of the family and
the mode of inheritance of a specific condition, and it may
facilitate identification of members at increased risk of
developing the condition (see Box 1). A pedigree should
indicate the age of individuals; if deceased, the age and
cause of death; and any relevant health history, illnesses,
and age of onset. If any genetic testing has been performed
on family members, the results should be indicated on
the pedigree. The ethnic background of each grandparent
should be listed as well as any known consanguinity (3). A
general inquiry about the more distant relatives should be
made in case there is a possible X-linked disorder or auto-
somal dominant disorder with reduced penetrance (4).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 288

 Polish English Italian Irish/German

1 2 3 4 5 6
I 80 y.o. 75 y.o. 81 y.o. 77 y.o. d. at 73 y.o. 83 y.o.
lung cancer type 2 diabetes
type 2 diabetes dx at 62 y.o.
dx at 40 y.o.

1 2 3 4 5 6 7 8 9
II
54 y.o. 56 y.o. 55 y.o. 51 y.o. 58 y.o. 57 y.o. 50 y.o. 51 y.o. 54 y.o.
type 2 diabetes type 2 diabetes
dx 51 y.o. dx 45 y.o.

28y.o.
1 2 3 4 5 6 7 8 9 10 11
III 23 y.o. 21 y.o. 31y.o. 29 y.o. 33 y.o. 34 y.o. 33 y.o. 11 y.o. 9 y.o. 6 y.o. 17 y.o.
gestational
diabetes at
age 32

P
IV 1 2
2 y.o. 2 y.o.
Key
gestational diabetes
type 2 diabetes
deceased
female
male
gender unknown

Figure 1. Example of a nonconsanguineous pedigree demonstrating a familial tendency for type 2 diabetes. Abbreviations: d, deceased;
dx, diagnosed; P, pregnant; y.o., years old.

The screening tool selected should be tailored to Reproductive Planning:

the practice setting and patient population, taking into
consideration patient education level and cultural com-
petence. Whether the pedigree or questionnaire is used,
it is important to review and update the family his-
tory periodically for new diagnoses within the family and
throughout pregnancy as appropriate. A family history
screening tool will allow the health care provider to strat-
ify levels of risk (5). Moreover, the use of a family his-
tory screening tool (pedigree or questionnaire) has been
shown to increase the likelihood of detecting a patient at
high risk of developing an inherited medical condition
by 20% compared with medical record review alone (7).
The Preconception Period
Women often discuss their pregnancy plans with their
obstetrician–gynecologist before conception. The pre-
conception period is an ideal time to provide personal-
ized recommendations based on family history. The
preconception consultation is also an optimal time to
review family history and discuss with a couple the option
of undergoing carrier screening for genetic conditions.
It is also an opportunity to address any medication con-
cerns before pregnancy (eg, the importance of taking a
folic acid supplement and avoiding medications such as

2 Committee Opinion No. 478

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 289


Box 1. Red Flags for Genetic Conditions
• Family history of a known or suspected genetic Many common adult-onset disorders demonstrate fam-
condition
• Ethnic predisposition to certain genetic disorders
• Consanguinity (blood relationship of parents)
• Multiple affected family members with the same or changes, weight loss, exercise, and glucose monitoring
related disorders
• Earlier than expected age of onset of disease history of type 2 diabetes mellitus. Similarly, individuals
• Diagnosis in less-often-affected sex
• Multifocal or bilateral occurrence of disease (often pressure and cholesterol levels, and those at risk of osteo-
cancer) in paired organs
• Disease in the absence of risk factors or after applica-
tion of preventive measures
• One or more major malformations
• Developmental delays or mental retardation
• Abnormalities in growth (growth restriction, asymmet-
ric growth, or excessive growth)
• Recurrent pregnancy losses (two or more)
Modified from the National Coalition for Health Professional
Education in Genetics (NCHPEG). Genetic Red Flags: Quick Tips intestinal cancer may be associated with a single familial
for Risk Assessment. Available online at: http://www.nchpeg.
org/. Retrieved on September 3, 2010.
angiotensin-converting enzyme inhibitors) and to ensure
that medical conditions are being carefully evaluated. It
is important to obtain the family and medical history of
both the patient and her partner, including their ethnic
backgrounds, any adverse pregnancy outcomes as a
couple or with other partners, and any known causes of
infertility if applicable. Positive responses will need to be
followed up by performance of appropriate risk assess-
ment, testing, and genetic counseling if needed.
Any genetic counseling and testing that can be
completed before conception is beneficial to the couple,
allowing a broader array of options and more time for
decision making. Couples may decide not to conceive, or
they may consider using a gamete donor or obtaining a
preimplantation genetic diagnosis if available.
A patient who has had a past adverse pregnancy out-
come or has a family history of other adverse pregnancy
outcomes, such as miscarriage, preterm birth, a newborn
screening test result indicating an abnormality, or birth
defects, might be at increased risk of these disorders.
Because both genetic and environmental factors may
contribute to these outcomes, advising a patient that
she is at increased risk of an adverse pregnancy outcome
based on family history might motivate her to reduce her
environmental risk by, for example, stopping smoking or
achieving a healthy weight (8).
Committee Opinion No. 478
COMMITTEE OPINIONS
Common Diseases of Adult Onset and
Significance of Family History
ilial tendencies. However, these disorders often have
complex genetic–environmental interactions for which
environmental modifications can improve the outcome
or delay the onset of symptoms (5). For example, diet
may improve the outcome for an individual with a family
at risk of cardiovascular disease can benefit from envi-
ronmental modifications, such as achieving normal blood
porosis can undertake calcium supplementation, weight
bearing exercise, and bone density screening to improve
their long-term bone health.
Some family histories show obvious evidence of
cancer risk, such as a family in which there are several
members with early-onset breast cancer or colon cancer.
In assessing family history of cancer risk, it is important
to check for evidence of cancer that might be linked to a
single underlying genetic cause, such as Lynch syndrome,
in which colon, endometrial, ovarian, urinary, or gastro-
gene mutation.
The pedigree in Figure 1 demonstrates a clear famil-
ial tendency for type 2 diabetes. The proband, or patient
noted in generation III-6, is at increased risk of develop-
ing type 2 diabetes not only because of her family his-
tory of the disease but also because of her development
of gestational diabetes in her previous pregnancy. This
patient should be counseled not only about maintaining
an appropriate diet and exercise routine to lower her risk
but also about obtaining an earlier glucose screening in
her current pregnancy.
Limitations
Adoption and limited family size might trigger a lower
threshold in detecting family history.
Recommendations
• All women should have a family history evaluation as
a screening tool for inherited risk.
• Family history information should be reviewed and
updated regularly, especially when there are signifi-
cant changes to family history.
• Where appropriate, further evaluation should be
considered for positive responses, with referral to
genetic services as needed.
Resources
The following resources are for information purposes
only. Referral to these resources and web sites does
not imply the endorsement of the American College of
Obstetricians and Gynecologists. Further, the American
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 290
 College of Obstetricians and Gynecologists does not
endorse any commercial products that may be advertised
or available from these organizations or on these web
sites. This list is not meant to be comprehensive. The
exclusion of a source or web site does not reflect the qual-
ity of that source or web site. Please note that web sites
and URLs are subject to change without notice.
National Society of Genetic Counselors:
Your Family History
http://www.nsgc.org/About/FamilyHistoryTool/tabid/
226/Default.aspx
Surgeon General’s Family Health History Initiative
http://www.hhs.gov/familyhistory
March of Dimes: Your Family Health History
http://www.marchofdimes.com/pnhec/4439_1109.asp
American Medical Association: Family Medical History
http://www.ama-assn.org/ama/pub/physician-resources/
medical-science/genetics-molecular-medicine/family-
history.shtml
U.S. National Library of Medicine: Genetics Home
Reference: Why is it important to know my family
medical history?
http://ghr.nlm.nih.gov/info=inheritance/show/family_
history
Cincinnati Children’s Hospital Medical Center:
Genetics Education Program for Nurses (GEPN)
Independent Self-Paced Modules
http://www.cincinnatichildrens.org/ed/clinical/gpnf/ce/
skill/default.htm
Centers for Disease Control and Prevention:
Pediatric Genetics
http://www.cdc.gov/ncbddd/pediatricgenetics
References
1. Yoon P, Scheuner M. The family history public health
initiative. In: Centers for Disease Control and Prevention.
Genomics and population health: United States 2003.
Atlanta (GA): CDC; 2004. p. 39–45.
4 Committee Opinion No. 478
COMMITTEE OPINIONS
2. Rich EC, Burke W, Heaton CJ, Haga S, Pinsky L, Short MP,
et al. Reconsidering the family history in primary care
[published erratum appears in J Gen Intern Med 2005;
20:315]. J Gen Intern Med 2004;19:273–80.
3. Bennett RL. The practical guide to the genetic family his-
tory. 2nd ed. Hoboken (NJ): Wiley-Blackwell; 2010.
4. Plunkett KS, Simpson JL. A general approach to genetic
counseling. Obstet Gynecol Clin North Am 2002;29:
265–76.
5. Scheuner MT, Wang SJ, Raffel LJ, Larabell SK, Rotter JI.
Family history: a comprehensive genetic risk assessment
method for the chronic conditions of adulthood. Am J Med
Genet 1997;71:315–24.
6. Fuchs CS, Giovannucci EL, Colditz GA, Hunter DJ, Speizer
FE, Willett WC. A prospective study of family history
and the risk of colorectal cancer. N Engl J Med 1994;331:
1669–74.
7. Frezzo TM, Rubinstein WS, Dunham D, Ormond KE. The
genetic family history as a risk assessment tool in internal
medicine. Genet Med 2003;5:84–91.
8. Dolan SM, Moore C. Linking family history in obstetric
and pediatric care: assessing risk for genetic disease and
birth defects. Pediatrics 2007;120(suppl 2):S66–70.
Copyright March 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Family history as a risk assessment tool. Committee Opinion No.
478. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;117:747–50.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 291
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 481 • March 2011 (Replaces No. 393, December 2007)
Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Newborn Screening
ABSTRACT: Newborn screening programs are mandatory, state-based public health programs. They provide
newborns in the United States with presymptomatic testing and necessary follow-up care for a variety of medical
conditions for which early intervention will improve neonatal and long-term health outcomes for the individual.
Although current state requirements vary, the results of surveys and focus groups of expectant parents dem-
onstrate that women and their families would like to receive information about newborn screening during their
prenatal care. The Committee on Genetics recommends that obstetric care providers make resources regarding
newborn screening available to patients through informational brochures, electronic sources, or through discussion
during prenatal visits.

Newborn screening programs are mandatory, state-based
public health programs that provide newborns in the
United States with presymptomatic testing and neces-
sary follow-up care for a variety of medical conditions.
The goal of these essential public health programs is
to decrease morbidity and mortality by screening for
disorders for which early intervention will improve neo-
natal and long-term health outcomes for the individual.
Newborn screening programs test infants for various
congenital disorders, including genetic and metabolic
conditions, hearing loss, hemoglobinopathies, and infec-
tious diseases such as human immunodeficiency virus
(HIV) and toxoplasmosis. Most of the disorders screened
through these programs have no clinical findings at birth.
In 2006, the Centers for Disease Control and Prevention
estimated that approximately 68% of children identified as
screen positive by newborn screening in the United States
were affected by galactosemia, the major hemoglobinopa-
thies, phenylketonuria, and congenital hypothyroidism
(2). The remaining one third were affected by one of
the other disorders identified as recommended targets
for newborn screening (see Table 1 and “Recommended
Uniform Screening Panel” as follows).
Newborn screening programs are developed and
managed on the state level and operate through col-
laborations between public health programs, laboratories,
hospitals, pediatricians, subspecialists, and specialty diag-
nostic centers. Their functions include the initial screen-
ing of all newborns, identifying screen-positive neonates,
diagnosing conditions, communicating with families,
ensuring that affected children are referred to treatment
centers, following long-term outcomes, and educating
physicians and the public according to individual state
guidelines.
States test newborns primarily through blood sam-
ples collected from heel pricks that are placed on a spe-
cial filter paper. The specimens are sent to a designated
state newborn screening laboratory within 24 hours.
Limitations for obtaining specimens include newborns
that require a transfusion or total parenteral nutrition,
sick or preterm infants, or infants born out of the hospital
setting. These newborns still require testing, but screen-
ing takes place in a variable time frame, with adjustments
made according to circumstances.
Recommended Uniform Screening
Panel
In 2006, the American College of Medical Genetics
published an Executive Summary (1), commissioned by
the Maternal and Child Health Bureau of the Health
Resources and Services Administration to establish a pro-
cess of standardization for state health departments,
including establishing collection procedures and outcome
data for newborn screening. This summary was based
on recommendations from a multidisciplinary team of
experts and recommended a uniform panel of 29 core

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 292

 Table 1. Recommended Uniform Newborn Screening Panel as of May 2010*
Disease Categories Diseases

Inborn errors of organic acid metabolism Isovaleric acidemia

Glutaric acidemia type 1
3-hydroxy 3-methylglutaric aciduria
Holocarboxylase synthase deficiency
Methylmalonic acidemia (mutase)
3-Methylcrotonyl-CoA carboxylase deficiency
Methylmalonic acidemia (Cbl A, B)
Propionic acidemia
b-Ketothiolase deficiency
Inborn errors of fatty acid metabolism Medium-chain acyl-CoA dehydrogenase deficiency
Very long-chain acyl-CoA dehydrogenase deficiency
Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency
Trifunctional protein deficiency
Carnitine uptake/transport defect
Inborn errors of amino acid metabolism Classic phenylketonuria
Maple syrup urine disease
Homocystinuria
Citrullinemia, type I
Argininosuccinic aciduria
Tyrosinemia, type I
Hemoglobinopathies S,S disease (Sickle cell anemia)
S, beta-thalassemia
S,C disease
Miscellaneous multisystem diseases Primary congenital hypothyroidism
Biotinidase deficiency
Congenital adrenal hyperplasia
Classic galactosemia
Cystic fibrosis
Severe combined immunodeficiency
Newborn screening by methods other than blood testing Congenital hearing loss

*For updated information, please see http://www.hrsa.gov/heritabledisorderscommittee/default.htm.

Data from Maternal and Child Health Bureau: Health Resources and Services Administration. Newborn Screening: Toward a Uniform Screening Panel
and System. Federal Register: March 8, 2005 (Volume 70, Number 44). Available at http://mchb.hrsa.gov/screening. Retrieved on September 14, 2010.

conditions for which all newborns should be screened
(see Table 1). Each condition has a screening test that
can be performed within 24–48 hours after birth, can be
treated, and has a known natural history. It is intended
that this core panel remain flexible, and criteria have
been established to perform evidence-based reviews and
expand this panel over time.
In September 2006, this panel of 29 core conditions
was adopted by the U.S. Secretary of Health and Human
Services’ Advisory Committee on Heritable Disorders in
Newborns and Children as their Recommended Uniform
Panel and was endorsed by the U. S. Secretary of Health
and Human Services in May 2010. Subsequently, after
reviewing the evidence, a 30th condition, severe combined
immunodeficiency, was added to the Recommended
Uniform Screening Panel by the Secretary of Health and
Human Services at the advice of the Secretary’s Advisory
Committee on Heritable Disorders in Newborns and
Children. The list of recommended conditions for new-
born screening programs is continually being evaluated;
for an updated list, see the Secretary’s Advisory Committee
on Heritable Disorders in Newborns and Children web
site, available at http://www.hrsa.gov/heritabledisorders
committee/uniformscreeningpanel.htm.

2 Committee Opinion No. 481

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 293

 Secondary Targets
The introduction into newborn screening programs of
tandem mass spectrometry, a method of measuring the
molecular mass of a sample, has made it possible to detect
many more disorders. Additional disorders identified
using tandem mass spectrometry are included in some
states’ newborn screening panels. These secondary targets
are believed to be clinically significant, but they have an
unclear natural history or lack an appropriate medical
therapy that affects long-term outcome.
State Guidelines
Almost all states have adopted the guidelines suggested
by the Secretary’s Advisory Committee on Heritable
Disorders in Newborns and Children. The selection
of disorders screened for is affected by the disease
prevalence within the state, detection rates, treatment
availability, and cost considerations (3). A current list
of conditions screened for in each state is maintained
online by the National Newborn Screening and Genetic
Resource Center, available at http://genes-r-us.uthscsa.
edu/resources/consumer/statemap.htm.
Informed Consent
All U.S. states, U.S. territories, and the District of
Columbia have individual newborn screening programs.
Statutes and regulations are variable across states. Some
programs require that parents be given the option to pro-
vide consent. Other states require the parent (or guard-
ian) to provide consent if identifiable information will be
disclosed outside the program. Penalties exist for violat-
ing newborn screening regulations in several states (4).
Parent Education and the Role of the
Obstetrician–Gynecologist
Currently, approximately 20 states mandate the dissemi-
nation of newborn screening information through birth-
ing facilities and have state-specific information that they
distribute (4). The results of surveys and focus groups
of expectant parents demonstrate that women and their
families would like to receive information about newborn
screening during their prenatal care visits (5, 6). Thus,
integrating education about newborn screening into pre-
natal care is desirable and would allow parents to be pre-
pared for receiving newborn screening test results after
birth. Providing newborn screening information during
prenatal care visits can be accomplished in a number of
ways. For example, newborn screening information could
be provided during the first trimester education session
and included in a pamphlet along with other patient edu-
cation materials given at the first obstetric visit, or given
to patients later in pregnancy when other educational
information is distributed. Information on newborn
screening also could be provided to patients during dis-
cussion of past adverse pregnancy outcomes regarding
a positive newborn screening test result or birth defect.
Committee Opinion No. 481
COMMITTEE OPINIONS
The American College of Obstetricians and Gyne-
cologists has published three patient education brochures
on newborn screening that are available online:
1. Quick Reference to Newborn Screening Disorders
http://www.acog.org/departments/newborn
Screening/nbsQuickRef.pdf
2. These Tests Could Save Your Baby’s Life: Newborn
Screening Tests
http://www.acog.org/departments/newborn
Screening/nbsPamphlet.pdf
3. Seven Things Parents Want to Know About
Newborn Screening
http://www.acog.org/departments/newborn
Screening/nbs7Things.pdf
There are many additional resources available
through a variety of organizations, including videos, print
patient education brochures, and web sites that provide
information for patients and professionals (Box 1 and
Box 2). These resources are available to patients who
desire additional information.
Box 1. Selected Online Patient Resources
on Newborn Screening
• American College of Obstetricians and Gynecologists
—Quick Reference to Newborn Screening Disorders
http://www.acog.org/departments/newborn
Screening/nbsQuickRef.pdf
—These Tests Could Save Your Baby’s Life:
Newborn Screening Tests
http://www.acog.org/departments/newborn
Screening/nbsPamphlet.pdf
—Seven Things Parents Want to Know About
Newborn Screening
http://www.acog.org/departments/newborn
Screening/nbs7Things.pdf
• California Department of Health: Multilingual Patient
Educational Materials on Newborn Screening
http://www.cdph.ca.gov/programs/nbs/Pages/
NBSEducationMaterial.aspx
• March of Dimes Recommended Newborn Screening
Test
http://www.marchofdimes.com/bringinghome_
recommendedtests.html
• National Newborn Screening & Genetics Resource
Center (NNSGRC)
http://genes-r-us.uthscsa.edu/index.htm
The resources listed are for information purposes only. Referral to
these resources and web sites does not imply the endorsement
of the College. Further, the College does not endorse any com-
mercial products that may be advertised or available from these
organizations or on these web sites. These lists are not meant to
be comprehensive. The exclusion of a source or web site does not
reflect the quality of that source or web site. Please note that web
sites and URLs are subject to change without notice.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 294
 Recommendation
Box 2. Selected Online Professional The Committee on Genetics recommends that obstetric
Resources on Newborn Screening care providers make resources regarding newborn screen-
ing available to patients during pregnancy. Information
• American Academy of Pediatrics: National Center for
Medical Home Implementation: Newborn Screening can be disseminated through informational brochures,
Overview electronic sources, or through discussion during prenatal
http://www.medicalhomeinfo.org/how/clinical_care/ visits.
newborn_screening.aspx
References
• American College of Medical Genetics ACT Sheets and
Confirmatory Algorithms 1. Newborn screening: toward a uniform screening panel and
system—executive summary. American College of Medical
http://www.acmg.net/AM/Template.cfm?zSection Genetics Newborn Screening Expert Group. Pediatrics
=ACT_Sheets_and_Confirmatory_Algorithms&Template 2006;117:S296–307.
=/CM/HTMLDisplay.cfm&ContentID=5127
2. Impact of expanded newborn screening—United States,
• California Department of Health: Multilingual Patient 2006. Centers for Disease Control and Prevention (CDC).
Educational Materials on Newborn Screening MMWR Morb Mortal Wkly Rep 2008;57:1012–5.
http://www.cdph.ca.gov/programs/nbs/Pages/NBS 3. National Newborn Screening and Genetics Resource
EducationMaterial.aspx Center. National newborn screening status report. Austin
• Health Resources and Service Administration: Region (TX): NNSGRC; 2010. Available at: http://genes-r-us.
4 Genetics Collaborative: “What Caregivers Need to uthscsa.edu/nbsdisorders.pdf. Retrieved November 1, 2010.
Know” 4. Therrell BL, Johnson A, Williams D. Status of newborn
http://region4genetics.org/online_learning/online_ screening programs in the United States. Pediatrics 2006;
learning_home.aspx 117:S212–52.
• March of Dimes: Genetics & Your Practice 5. Campbell ED, Ross LF. Incorporating newborn screening
http://www.marchofdimes.com/gyponline/index.bm2 into prenatal care. Am J Obstet Gynecol 2004;190:876–7.
• National Newborn Screening & Genetics Resource 6. Davis TC, Humiston SG, Arnold CL, Bocchini JA Jr, Bass PF
Center 3rd, Kennen EM, et al. Recommendations for effective
newborn screening communication: results of focus groups
http://genes-r-us.uthscsa.edu/index.htm
with parents, providers, and experts. Pediatrics 2006;117:
• Secretary’s Advisory Committee on Heritable Disorders S326–40.
in Newborns and Children
http://www.hrsa.gov/heritabledisorderscommittee/
Copyright March 2011 by the American College of Obstetricians and
default.htm Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
The resources listed are for information purposes only. Referral to be reproduced, stored in a retrieval system, posted on the Internet,
these resources and web sites does not imply the endorsement or transmitted, in any form or by any means, electronic, mechani-
of the College. Further, the College does not endorse any com- cal, photocopying, recording, or otherwise, without prior written per-
mercial products that may be advertised or available from these mission from the publisher. Requests for authorization to make
organizations or on these web sites. These lists are not meant to photocopies should be directed to: Copyright Clearance Center, 222
be comprehensive. The exclusion of a source or web site does not Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
reflect the quality of that source or web site. Please note that web ISSN 1074-861X
sites and URLs are subject to change without notice.
Newborn screening. Committee Opinion No. 481. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2011;117:762–5.

4 Committee Opinion No. 481

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 295

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 486 • April 2011 (Replaces No. 325, December 2005)
Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Update on Carrier Screening for Cystic Fibrosis

ABSTRACT: In 2001, the American College of Obstetricians and Gynecologists and the American College of
Medical Genetics introduced guidelines for prenatal and preconception carrier screening for cystic fibrosis. The
American College of Obstetricians and Gynecologists’ Committee on Genetics has updated current guidelines for
cystic fibrosis screening practices among obstetrician–gynecologists.

Cystic fibrosis (CF) is the most common life-threatening
autosomal recessive condition in the non-Hispanic white
population. It is a progressive, multisystem disease that
primarily affects the pulmonary, pancreatic, and gastroin-
testinal systems but does not affect intelligence. The current
median survival is approximately 37 years, with respiratory
failure as the most common cause of death. Approximately
15% of individuals with CF have a mild form of the disease
with a median survival of 56 years (1). More than 95% of
males with CF have primary infertility with obstructive
azoospermia secondary to congenital bilateral absence of
the vas deferens. Cystic fibrosis is caused by mutations in
the CF transmembrane regulator (CFTR) gene, located on
chromosome 7. Two copies of deleterious mutations in this
gene cause CF. The disease incidence is 1 in 2,500 individu-
als in the non-Hispanic white population and considerably
less in other ethnic groups.
Prenatal and preconception carrier screening for
CF was introduced into routine obstetric practice in
2001 (2). The goal of CF carrier screening is to identify
couples at risk of having a child with classic CF, which is
defined by significant pulmonary disease and pancreatic
insufficiency. Cystic fibrosis is more common among the
non-Hispanic white population compared with other
racial and ethnic populations; however, it is becoming
increasingly difficult to assign a single ethnicity to affected
individuals. It is reasonable, therefore, to offer CF carrier
screening to all patients. The sensitivity of the screen-
ing test varies among different ethnic groups (Table 1),
ranging from less than 50% in those of Asian ancestry to
94% in the Ashkenazi Jewish population (3). Therefore,
screening is most efficacious in non-Hispanic white and
Ashkenazi Jewish populations. Because testing is offered
for only the most common mutations, a negative screen-

Table 1. Cystic Fibrosis Detection and Carrier Rates Before and After Testing
Racial or Detection Carrier Risk Approximate Carrier Risk After
Ethnic Group Rate* (%) Before Testing Negative Test Result†

Ashkenazi Jewish 94 1/24 1/380

Non-Hispanic white 88 1/25 1/200
Hispanic white 72 1/58 1/200
African American 64 1/61 1/170
Asian American 49 1/94 1/180
*Detection rate data based on use of a 23-mutation panel.
Bayesian statistics used to calculate approximate carrier risk after a negative test result.
†

Modified from the American College of Medical Genetics. Technical Standards and Guidelines for CFTR Mutation Testing, 2006 Edition.
Available at: http://www.acmg.net/Pages/ACMG_Activities/stds-2002/cf.htm. Retrieved December 16, 2010.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 296

 ing test result reduces, but does not eliminate, the chance
of being a CF carrier and having an affected offspring.
Therefore, if a patient is screened for CF and has a nega-
tive test result, she still has a residual risk of being a car-
rier. The most common CF carrier frequencies as well as
the rates of residual carrier risk after a negative test result
are listed by racial and ethnic group in Table 1.
Screening Considerations for
Cystic Fibrosis
Preconception carrier screening allows couples to con-
sider the most complete range of reproductive options.
Knowledge of the risk of having an affected child may
influence a couple’s decision to conceive or to consider
preimplantation genetic diagnosis, prenatal genetic test-
ing, or the use of donor gametes. Generally, it is more cost
effective and practical to perform initial carrier screening
for the patient only. If the patient is a CF carrier, then her
partner should be tested. During pregnancy, concurrent
screening of the patient and her partner is suggested if
there are time constraints for decisions regarding pre-
natal diagnostic evaluation. Given that CF screening has
been a routine part of reproductive care for women since
2001, it is prudent to determine if the patient has been
previously screened before ordering CF screening that
may be redundant. If a patient has been screened previ-
ously, CF screening results should be documented but
the test should not be repeated. The following are various
carrier screening scenarios with associated management
guidelines:
• A woman is a carrier of a CF mutation and her part-
ner is unavailable for testing or paternity is unknown.
Genetic counseling to review the risk of having an
affected child and prenatal testing options and limi-
tations may be helpful.
• Prenatal diagnosis is being performed for other indica-
tions and CF carrier status is unknown. Cystic fibrosis
screening can be performed concurrently on the
patient and partner. Chorionic villi or amniocytes
may be maintained in culture by the diagnostic labo-
ratory until CF screening results are available for the
patient or couple. If both partners are carriers, the
sample can then be tested for CF.
• Both partners are CF carriers. Genetic counseling is
recommended to review prenatal testing and repro-
ductive options. Prenatal diagnosis should be offered
for the couple’s known specific mutations.
• Both partners are unaffected but one or both has a
family history of CF. Genetic counseling and medi-
cal record review should be performed to identify if
CFTR mutation analysis in the affected family mem-
ber is available.
• A woman’s reproductive partner has CF or apparently
isolated congenital bilateral absence of the vas deferens.
2 Committee Opinion No. 486
COMMITTEE OPINIONS
The couple should be referred to a genetics profes-
sional for mutation analysis and consultation.
• An individual has two CF mutations but has not pre-
viously received a diagnosis of CF. These individuals
usually have a mild form of the disease and should be
referred to a specialist for further evaluation. Genetic
counseling is recommended.
CFTR Mutation Panels
To date, more than 1,700 mutations have been identi-
fied for CF (4). The initial American College of Medical
Genetics Cystic Fibrosis Carrier Screening Working Group
(5) recommended that laboratories use a pan-ethnic panel
of 25 mutations that were present in at least 0.1% of
patients with classic CF. Current guidelines, revised by
the American College of Medical Genetics in 2004, use a
23-mutation panel and were developed after assessing the
initial experiences upon implementation of CF screening
into clinical practice (6). Cystic fibrosis screening also may
identify the 5T/7T/9T variants in the CFTR gene, which
vary between individuals. Genetic counseling is important
to discern whether the combination of mutations and
variants would cause classic or atypical CF.
Complete analysis of the CFTR gene by DNA sequen-
cing is not appropriate for routine carrier screening
because it may yield results that can be difficult to inter-
pret. This type of testing is generally reserved for patients
with CF, patients with a family history of CF, males
with congenital bilateral absence of the vas deferens,
or newborns with a positive newborn screening result
when mutation testing, using the standard 23-mutation
panel, has a negative result. Because carrier screening
detects most mutations, sequence analysis should only be
considered after discussion with a genetics professional
to determine if it will be of value to the evaluation after
standard screening has been performed.
The decision to have CF carrier screening should
be reached by informed choice. Patients should receive
information about CF and its inheritance pattern. (Patient
education brochures are available from the American
College of Obstetricians and Gynecologists at sales.acog.
org, and a sample patient script on CF is included in this
document [see Box 1, “Information on Cystic Fibrosis to
Share With Your Patients”]). It is important for patients
and their partners to recognize the sensitivity and limita-
tions of testing as well as their reproductive options.
All states include CF screening as part of their
newborn screening panel. However, newborn screening
panels that include CF screening do not replace maternal
carrier screening. Because these screening programs gen-
erally identify affected newborns, a negative test result in
an unaffected newborn provides no information regard-
ing the carrier status of the parents. Thus, it is important
that CF screening continues to be offered to women of
reproductive age.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 297

Box 1. Information on Cystic Fibrosis
to Share With Your Patients
Cystic fibrosis (CF) is a genetic disorder that causes
breathing and digestive problems. Intelligence is not
affected by CF. Individuals with CF have a current life
expectancy of approximately 37 years, and the cause of
death usually is lung damage. Approximately 15% of indi-
viduals with CF have a mild form of the disease and live
an average of 56 years. Common symptoms of CF include
coughing, wheezing, loose stools, abdominal pain, failure
to thrive, and, in men, infertility. Treatment involves medi-
cation to aid digestion, proper nutrition, and lung therapy.
Cystic fibrosis is an inherited condition that is caused
by mutations in the CFTR gene. When a patient and her
partner are both carriers of a mutation in the CFTR gene,
they have a 1 in 4 chance of having a child with CF. To
date, more than 1,700 mutations have been identified in
the gene for CF. Screening for the 23 most common muta-
tions is available and can greatly reduce a couple’s risk of
having a child with CF. The risk of being a carrier depends
on an individual’s race and ethnicity and family history.
Cystic fibrosis is most common in non-Hispanic white
individuals and people of Ashkenazi Jewish ancestry. A
genetics specialist can help couples with a risk of having
a child with CF by explaining and providing information
about their reproductive options.
Health Considerations for Women
With Cystic Fibrosis
Given the increasing longevity of affected patients,
women with CF have reasonable fertility and often can
become pregnant without medical assistance. Therefore,
it is recommended that women with CF receive guid-
ance regarding adequate contraception as well as pre-
conception consultation. Affected women also should
be informed that their offspring will be obligate carriers
and that their partners should be tested to determine
their carrier risk. If a woman with CF wants to become
pregnant, a multidisciplinary team should be considered
to manage issues regarding pulmonary function, weight
gain, infections, and the increased risks of diabetes and
preterm delivery.
Recommendations
Based on the preceding information, the Committee on
Genetics provides the following guidelines:
• It is important that CF screening continues to be prenatal [Spanish]. ACOG Patient Education Pamphlet
offered to women of reproductive age. It is becom-
ing increasingly difficult to assign a single ethnicity
to individuals. It is reasonable, therefore, to offer CF
carrier screening to all patients. Screening is most
efficacious in the non-Hispanic white and Ashkenazi
Jewish populations.
Committee Opinion No. 486
COMMITTEE OPINIONS
• It is prudent to determine if the patient has been
previously screened before ordering CF screening
that may be redundant. If a patient has been screened
previously, CF screening results should be docu-
mented but the test should not be repeated.
• Complete analysis of the CFTR gene by DNA sequen-
cing is not appropriate for routine carrier screening.
• Newborn screening panels that include CF screening
do not replace maternal carrier screening.
• If a woman with CF wants to become pregnant,
a multidisciplinary team should be considered to
manage issues regarding pulmonary function, weight
gain, infections, and the increased risks of diabetes
and preterm delivery.
• For couples in which both partners are carriers,
genetic counseling is recommended to review prena-
tal testing and reproductive options.
• For couples in which both partners are unaffected
but one or both has a family history of CF, genetic
counseling and medical record review should be per-
formed to identify if CFTR mutation analysis in the
affected family member is available.
• If a woman’s reproductive partner has CF or appar-
ently isolated congenital bilateral absence of the vas
deferens, the couple should be referred to a genetics
professional for mutation analysis and consultation.
Resources
The resources listed are for information purposes only.
Referral to these resources and web sites does not imply
the endorsement of the American College of Obstetricians
and Gynecologists. Further, the American College of
Obstetricians and Gynecologists does not endorse any
commercial products that may be advertised or avail-
able from these organizations or on these web sites. This
list is not meant to be comprehensive. The exclusion of
a source or web site does not reflect the quality of that
source or web site. Please note that web sites and URLs
are subject to change without notice.
American College of Obstetricians and Gynecologists.
Cystic fibrosis: prenatal screening and diagnosis. ACOG
Patient Education Pamphlet AP171. Washington, DC:
ACOG; 2009. Available at: http://www.acog.org/publica-
tions/patient_education/bp171.cfm. Retrieved December
28, 2010.
American College of Obstetricians and Gynecologists.
La fibrosis quística: pruebas de detección y diagnóstico
SP171. Washington, DC: ACOG; 2009. Available at:
http://www.acog.org/publications/patient_education/
sp171.cfm. Retrieved December 28, 2010.
American College of Obstetricians and Gynecologists.
Screening tests for birth defects. ACOG Patient Education
Pamphlet AP165. Washington, DC: ACOG; 2007. Avail-
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 298
 able at: http://www.acog.org/publications/patient_educa
tion/bp165.cfm. Retrieved December 28, 2010.
American College of Obstetricians and Gynecologists.
Pruebas para la deteccion de defectos congenitos [Spanish].
ACOG Patient Education Pamphlet SP165. Washington,
DC: ACOG; 2007. Available at: http://www.acog.org/
publications/patient_education/sp165.cfm. Retrieved
December 28, 2010.
Grosse SD, Boyle CA, Botkin JR, Comeau AM, Kharrazi M,
Rosenfeld M, et al. Newborn screening for cystic fibrosis:
evaluation of benefits and risks and recommendations
for state newborn screening programs. MMWR Recomm
Rep 2004;53(RR-13):1–36.
Morgan MA, Driscoll DA, Zinberg S, Schulkin J, Mennuti
MT. Impact of self-reported familiarity with guidelines
for cystic fibrosis carrier screening. Obstet Gynecol 2005;
105:1355–61.
Thorpe-Beeston JG. Contraception and pregnancy in cys-
tic fibrosis. J R Soc Med 2009;102(suppl 1):3–10.
References
1. Moskowitz SM, Chmiel JF, Sternen DL, Cheng E, Cutting GR.
CFTR-related disorders. In: Pagon RA, Bird TC, Dolan CR,
Stephens K, editors. GeneReviews. Seattle (WA): University
of Washington; 2008. Available at http://www.ncbi.nlm.
nih.gov/books/NBK1250. Retrieved December 15, 2010.
2. American College of Medical Genetics, American College
of Obstetricians and Gynecologists. Preconception and
prenatal carrier screening for cystic fibrosis: clinical and
laboratory guidelines. Washington, DC: ACOG; Bethesda
(MD): ACMG; 2001.
4 Committee Opinion No. 486
COMMITTEE OPINIONS
3. American College of Medical Genetics. Technical stan-
dards and guidelines for CFTR mutation testing. 2006 ed.
Bethesda (MD): ACMG; 2006. Available at: http://www.
acmg.net/Pages/ACMG_Activities/stds-2002/cf.htm.
Retrieved December 16, 2010.
4. Cystic Fibrosis Centre, Hospital for Sick Children. Cystic
fibrosis mutation database. Available at: http://www.genet.
sickkids.on.ca/cftr/app. Retrieved December 16, 2010.
5. Grody WW, Cutting GR, Klinger KW, Richards CS,
Watson MS, Desnick RJ. Laboratory standards and guide-
lines for population-based cystic fibrosis carrier screening.
Subcommittee on Cystic Fibrosis Screening, Accreditation
of Genetic Services Committee, ACMG. American College
of Medical Genetics. Genet Med 2001;3:149–54.
6. Watson MS, Cutting GR, Desnick RJ, Driscoll DA, Klinger K,
Mennuti M, et al. Cystic fibrosis population carrier
screening: 2004 revision of American College of Medical
Genetics mutation panel [published errata appear in Genet
Med 2005;7:286; Genet Med 2004;6:548]. Genet Med 2004;
6:387–91.
Copyright April 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Update on carrier screening for cystic fibrosis. Committee Opinion No.
486. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;117:1028–31.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 299
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 488 • May 2011
Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Pharmacogenetics
ABSTRACT: Pharmacogenetics is the study of genetic variations in drug response that are determined by
specific genes. It is hoped that the use of pharmacogenetics in clinical practice may improve drug safety and
decrease the rate of adverse drug reactions. Given the potential applications of pharmacogenetics to women’s
health care, obstetricians and gynecologists should be aware of this rapidly developing field. Currently, however,
there are limited clinical indications for the use of pharmacogenetics in routine obstetric and gynecologic practice.

Pharmacogenetics is the study of genetic variations in
drug response that are determined by specific genes.
Pharmacogenomics refers to the interactions of multiple
genetic differences, as well as environmental influence,
and the effect on drug responses. Adverse drug reactions
are one of the leading causes of death in the United States.
A 1998 study of hospitalized patients reported that in
1994, adverse drug reactions accounted for more than 2.2
million serious cases and more than 100,000 deaths (1). It
is hoped that the use of pharmacogenetics may improve
drug safety and decrease the rate of such untoward events.
Currently, there are limited clinical indications for the
use of pharmacogenetics in routine obstetric and gyne-
cologic practice. However, given its potential applications
to women’s health care, obstetricians and gynecologists
should be aware of this rapidly developing field.
Genetic Variation in Drug Response
Individual variation caused by single nucleotide polymor-
phisms in genes that encode drug–metabolizing enzymes,
transporters, ion channels, and drug receptors has been
associated with variation in response to pharmacologic
agents. Mechanisms of such variation include extended
pharmacologic effect, adverse drug reactions, increased
effective dose, and exacerbated drug–drug interactions.
Current research in pharmacogenetics focuses on identify-
ing genes that may be targeted in drug development and on
genetic variation that affects the level of response to a drug.
Cytochrome P450 Enzyme System
Many early investigations in this field have focused on
cytochrome P450, a superfamily of liver enzymes that
catalyzes phase 1 drug metabolism (2). The genes that
code for these enzymes are highly polymorphic, and
enzyme activity may vary markedly depending on indi-
vidual genotype (3). Individuals with decreased enzy-
matic activity (ie, poor metabolizers) would be expected
to have a greater likelihood of an adverse reaction to a
drug, whereas individuals with high enzymatic activ-
ity (ie, ultrametabolizers) would be predicted to have an
inadequate therapeutic response to standard dosages.
Although there has been great hope that the determi-
nation of an individual’s drug metabolism profile could
provide a tailored therapeutic approach to treatment with
faster attainment of therapeutic levels and fewer side
effects, few effective algorithms have been published. This
lack of success is most likely related to the multifactorial
nature of drug responses. In addition to single nucleotide
polymorphisms, other factors that affect drug response
include disease pathophysiology, gene–gene interac-
tion, environmental influences, drug–drug interaction,
drug allergies, patient adherence, habitus, and body mass
index (3).
Warfarin
Warfarin has been the most extensively studied drug in
the field of pharmacogenetics. All warfarin derivatives
inhibit vitamin K epoxide reductase complex, and vari-
ants in the gene for this enzyme (vitamin K epoxide reduc-
tase complex 1) are known to affect response. A recent
review highlights the key issues in the pharmacogenet-
ics of oral anticoagulant therapy, including the effects of
genetic variants on dosage and complications (4). Patients
carrying the cytochrome P450 alleles cytochrome P2C9*2

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 300

 or cytochrome P2C9*3 require a lower mean daily war-
farin dose than patients homozygous for the cytochrome
P2C9*1 allele. These patients show an increased risk of
overanticoagulation and major bleeding in the initial
phase of warfarin therapy. Likewise, polymorphisms in
the vitamin K epoxide reductase complex 1 gene (especially
the 1173 C/T allele) have been associated with lower dose
requirements for warfarin.
Much of the variability in warfarin response appears
to result from the combination of vitamin K epoxide
reductase complex 1 and cytochrome P2C9 genotypes, but
the usefulness of genotype-specific dosages of warfarin is
still unclear; several prospective studies have not demon-
strated improved outcomes. A recent American College
of Medical Genetics policy statement concluded that
there is no direct evidence to advise for or against routine
genotyping before warfarin therapy (5). A similar conclu-
sion was reached in a review that concluded that nomo-
grams based on clinical characteristics and response to
a standardized warfarin dose had similar, if not better,
accuracy when compared with pharmacogenetic-based
algorithms (6).
Pharmacogenetic Testing in Clinical
Practice
Currently, the U.S. Food and Drug Administration recom-
mends pharmacogenetic testing in a few specific instances
(see http://www.fda.gov/Drugs/ScienceResearch/Research
Areas/Pharmacogenetics/ucm083378.htm) (7). Testing is
currently required before administering maraviroc (for
human immunodeficiency virus [HIV] treatment), cetux-
imab (for colorectal cancer treatment), trastuzumab (for
breast cancer treatment), and dasatinib (for acute lym-
phoblastic leukemia treatment). In such specific situa-
tions, pharmacogenetic testing is done to determine if an
individual is likely to benefit from the specific therapeutic
agent, rather than to tailor the dosage.
The use of pharmacogenetics in obstetrics and gyne-
cology practice holds much promise. As in other fields
of medicine, however, there continues to be a lack of
evidence for routine use in current practice. Prospective
clinical trials are needed to develop the appropriate algor-
ithms to introduce pharmacogenomic testing into rou-
tine clinical practice in ways that are demonstrated to
improve health outcomes.
2 Committee Opinion No. 488
COMMITTEE OPINIONS
Recommendation
At this time there are no standard clinical indications for
the use of pharmacogenetic testing in the routine practice
of obstetrics and gynecology, and there is limited use in
other clinical situations.
References
1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse
drug reactions in hospitalized patients: a meta-analysis of
prospective studies. JAMA 1998;279:1200 –5.
2. Evans WE, Relling MV. Pharmacogenomics: translating
functional genomics into rational therapeutics. Science
1999;286:487–91.
3. Gervasini G, Benitez J, Carrillo JA. Pharmacogenetic testing
and therapeutic drug monitoring are complementary tools
for optimal individualization of drug therapy. Eur J Clin
Pharmacol 2010;66:755–74.
4. Schalekamp T, de Boer A. Pharmacogenetics of oral antico-
agulant therapy. Curr Pharm Des 2010;16:187–203.
5. Flockhart DA, O’Kane D, Williams MS, Watson MS,
Flockhart DA, Gage B, et al. Pharmacogenetic testing of
CYP2C9 and VKORC1 alleles for warfarin. ACMG Working
Group on Pharmacogenetic Testing of CYP2C9, VKORC1
Alleles for Warfarin Use. Genet Med 2008;10:139–50.
6. Lazo-Langner A, Kovacs MJ. Predicting warfarin dose. Curr
Opin Pulm Med 2010;16:426–31.
7. U.S. Food and Drug Administration. Table of valid genomic
biomarkers in the context of approved drug labels.
Available at: http://www.fda.gov/Drugs/ScienceResearch/
ResearchAreas/Pharmacogenetics/ucm083378.htm.
Retrieved December 16, 2010.
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Pharmacogenetics. Committee Opinion No. 488. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;117:1240–1.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 301
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 527 • June 2012
Committee on Genetics
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change.
The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Personalized Genomic Testing for Disease Risk

ABSTRACT: Advances in genetic technologies have led to the identification of hundreds of single nucleotide
polymorphisms that are associated with a variety of complex diseases, including cancer, diabetes, cardiovascular
disease, and Alzheimer disease. Although personalized genomic tests that provide information regarding the risk of
development of multiple diseases may be important tools in the near future, their use is not recommended outside
of a clinical trial until these tests are validated as clinically useful in appropriately designed prospective studies.
Testing for single-gene disorders should be approached in accordance with accepted guidelines that address the
evaluation and management of these specific diseases.

Since the completion of the sequencing of the human
genome in 2001, advances in genetic technologies have
led to the identification of hundreds of single nucleotide
polymorphisms (SNPs) that are associated with a variety
of complex diseases, including cancer, diabetes, cardio-
vascular disease, and Alzheimer disease. Single nucleotide
polymorphisms are sequence variations of DNA that
occur when a single nucleotide in the genome sequence
differs between individuals. Although a few disease-
associated SNPs have been associated with a relatively
large (greater than a threefold to fivefold) increase in
the risk of disease, most SNPs are associated with rela-
tively small (less than twofold) changes in the underlying
disease risk. Furthermore, very few SNP disease associa-
tions have undergone rigorous prospective validation of
clinical utility. Regardless, a number of companies and
other entities now offer personalized genomic profile
testing that involves the use of panels of SNPs to provide
individual risk assessment for a variety of diseases. Some
of these entities offer genomic profile testing through
general practice physicians in consultation with genetic
counselors. Others state that the results of this testing are
for informational (nonmedical) purposes only and offer
testing directly to consumers.
Given that the number and availability of these tests
is almost certain to increase in the near future, the Com-
mittee on Genetics of the American College of Obstetri-
cians and Gynecologists (the College) believes that several
issues related to the use of personalized genomic tests for
disease risk assessment should be addressed.
Despite the proliferation of individuals and groups
offering genomic testing for disease-associated SNPs and
the steadily increasing number of diseases and conditions
for which testing is performed, there remains a paucity of
evidence that more than a few of these SNPs, either alone,
in panels, or in combination with other clinical informa-
tion, provide meaningful data regarding the risk of inher-
ited disease (1). Although many disease-associated SNPs
included in genomic risk profiles have been identified in
the setting of whole-genome association studies that ana-
lyze specimens from thousands of participants, few have
been validated in prospective studies as being clinically
useful (1). Given the predominantly retrospective nature
of the studies used to identify disease-associated SNPs,
many of the emerging genetic technologies used to iden-
tify such SNPs may ultimately have the power to transform
the practice of medicine. However, the College’s Commit-
tee on Genetics believes that the use of these technologies
should be viewed as investigational at this time. Until
research is performed to assess prospectively the validity
and utility of incorporating disease-associated SNPs into
specific risk prediction models, the use of SNPs outside of
a research protocol is not recommended.
In addition to identifying disease-associated SNPs,
some genomic tests now include tests for genetic changes
associated with an individual’s carrier status or risk of
specific mendelian (single-gene) diseases, such as cystic
fibrosis, spinal muscular atrophy, and hereditary breast
and ovarian cancer. However, genetic tests for many of
these diseases have specific limitations and frequently

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 302

 require careful interpretation. Challenges that can arise
include the need to determine the residual risk of being a
carrier when the screening does not identify a particular
mutation and the need to assess the risk of developing
a particular disease despite a negative genetic test result.
Given these potential issues, genetic testing for men-
delian diseases should be approached in accordance
with accepted guidelines, such as those provided by
the College (www.acog.org) and the American College of
Medical Genetics (www.acmg.net). When a patient pre-
sents results of a genomic test that putatively assesses the
risk of specific diseases, this patient should be referred
to an appropriate medical professional who is skilled in
risk assessment for the diseases of interest and interpreta-
tion of genetic testing results along with the individual’s
relevant medical and family history.
Another area of concern is the offering of personal-
ized genomic tests for disease risk assessment directly to
consumers. This practice raises the same fundamental
issues and considerations related to direct-to-consumer
marketing of genetic testing. The College’s Committee
Opinion No. 409, which specifically addresses this topic,
states that direct-to-consumer marketing of genetic test-
ing raises issues of “limited knowledge among patients
and health care providers of available genetic tests, dif-
ficulty in interpretation of genetic testing results, lack of
federal oversight of companies offering genetic testing,
and issues of privacy and confidentiality” (2). Therefore,
the College’s Committee on Genetics reaffirms the con-
clusion stated in the Committee Opinion: “Until all of
these considerations are addressed, direct and home gen-
etic testing should be discouraged because of the potential
harm of a misinterpreted or inaccurate result” (2).
Recommendations
The College’s Committee on Genetics presents the fol-
lowing recommendations regarding personalized geno-
mic testing for disease risk:
• Although personalized genomic tests that provide photocopies should be directed to: Copyright Clearance Center, 222
information regarding the risk of development of
multiple diseases may be important tools in the near
future, their use is not recommended outside of a
clinical trial until these tests are validated as clinically
useful in appropriately designed prospective studies.
2 Committee Opinion No. 527
COMMITTEE OPINIONS
• When a patient presents results of a genomic test that
putatively assesses the risk of specific diseases, this
patient should be referred to an appropriate medi-
cal professional who is skilled in risk assessment for
the diseases of interest and interpretation of genetic
testing results along with the individual’s relevant
medical and family history.
• Testing for single-gene disorders should be approached
in accordance with accepted guidelines that address
the evaluation and management of these specific dis-
eases.
Resource
Ethical issues in genetic testing. ACOG Committee Opin-
ion No. 410. American College of Obstetricians and Gyne-
cologists. Obstet Gynecol 2008;111:1495–502. [PubMed]
[Obstetrics & Gynecology]
References
1. Khoury MJ, McBride CM, Schully SD, Ioannidis JP,
Feero WG, Janssens AC, et al. The Scientific Foundation
for personal genomics: recommendations from a National
Institutes of Health-Centers for Disease Control and
Prevention multidisciplinary workshop. Centers for
Disease Control and Prevention. Genet Med 2009;11:559–
67. [PubMed] [Full Text] ^
2. Direct-to-consumer marketing of genetic testing. ACOG
Committee Opinion No. 409. American College of Obste-
tricians and Gynecologists. Obstet Gynecol 2008;111:
1493–4. [PubMed] [Obstetrics & Gynecology] ^
Copyright June 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Personalized genomic testing for disease risk. Committee Opinion
No. 527. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;119:1318–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 303

technology assessment
in obstetrics and gynecology
This Technology Assessment
was developed by the ACOG
Committee on Genetics with the
assistance of Deborah A. Driscoll,
MD, FACOG; Katherine D.
Wenstrom, MD, FACOG, and
John Williams III, MD, FACOG.
This document reflects emerging
clinical and scientific advances
as of the date issued and is sub-
ject to change. The informa-
tion should not be construed
as dictating an exclusive course
of treatment or procedure to
be followed. Variations in prac-
tice may be warranted based
on the needs of the individual
patient, resources, and limita-
tions unique to the institution or
type of practice.
Reaffirmed 2006
the american college
of obstetricians
and gynecologists
women’s health care physicians
COMMITTEE OPINIONS
ACOG
Number 1, July 2002
Genetics and Molecular
Diagnostic Testing
Knowledge of human genetics has increased dramatically in the past few
decades. The genetic basis of disease and the response to therapy is rapidly
being elucidated and may soon become a part of routine medical practice. A
draft of the human genome was published in 2001 (1). This project produced
a detailed map of the genes, markers, and other landmarks along each chro-
mosome. It is hoped that these maps will facilitate the development of genetic
screening and diagnostic tests, as well as novel therapies, technologies, and
strategies for prevention. Obstetricians and gynecologists, who deal with
inheritance and the genetic transmission of traits and disease on a daily basis,
will be called on to incorporate genetics and recent developments in genetic
testing into their medical practice. This document reviews the basics of genet-
ic transmission and genetic technologies in current use. (See the “Glossary”
for definitions of terms for genetics and molecular diagnostic testing.)
Organization of the Genome
There are 2 meters of DNA, including approximately 30,000 genes, in each
human nucleus. The DNA is wrapped very compactly around basic pro-
teins called histones to form nucleosomes, which are then organized into
solenoid structures and looped around a nonhistone protein scaffold to form
chromatin. As the cell enters prophase, the chromatin begins to condense
until it assumes the familiar structure of metaphase chromosomes. Each
chromosome is composed of densely packed nontranscribed DNA near the
centromeres, called heterochromatin, and less densely packed transcribed
DNA called euchromatin.
Seventy-five percent of the genome is unique, single copy DNA, and
the remainder consists of various classes of repetitive DNA. Surprisingly,
virtually all of the repetitive DNA and a large portion of the single copy
DNA have no apparent or recognized function. Less than 10% of the
genome encodes genes. The single copy DNA contains all of the genes
necessary to make and sustain the organism, while the repetitive DNA con-
tains unique markers that identify each individual and can be used to study
genetic variation between individuals.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 304
 Genes
A gene is a unique series of four purine and pyrimi-
dine bases that ultimately specifies an amino acid
sequence for a polypeptide chain of a protein. The
basic gene contains one or more exons, which are
DNA sequences that will be transcribed into mes-
senger RNA (mRNA), and introns (or intervening
sequences), which are noncoding or nontranscribed
regions that separate exons (Fig. 1). The regions
upstream and downstream to the exons are called
the 5´ untranslated region and the 3´ untranslated
region, respectively. These regions are transcribed,
but not translated (as the name implies), and they are
important in gene regulation.
The processes of transcription and translation
are more complex than previously recognized. The
transcription of DNA to mRNA requires transcrip-
tion factors. Enhancers and silencer DNA sequences
located upstream or downstream of a gene can
increase and decrease transcriptional activity of the
gene, respectively. Transcription is initiated when
the enzyme RNA polymerase II binds to the pro-
moter, a DNA sequence upstream of a gene. RNA
polymerase moves along a single strand of DNA
and forms a complementary strand of mRNA. Once
the mRNA is formed, a cap or chemically modified
guanine nucleotide is added to the 5´ end to prevent
the mRNA from being degraded, and a chain of
100–200 adenine bases (poly-A tail) is added to the
3´ end. Before the mRNA leaves the nucleus, the
introns are excised by a process called gene splicing.
The mature mRNA then moves to the ribosomes
for translation. The protein product usually is cre-
ated in a precursor form, and undergoes cleavage
into a smaller active protein or combines with other
polypeptides to form a larger functional protein. The
protein may be further modified in the Golgi appara-
tus of the cell by glycosylation. Some genes contain
more than one promoter in different parts of the
gene or have alternative splice sites, which allows
the same gene to encode different protein products.
Gene expression also is controlled by methyla-
tion of the regulatory region, which prevents gene
transcription and effectively turns the gene off.

Other specific promoter

elements (eg, CACCC TAA, TGA, or TAG
in β-globin) stop codon
“Cap site”
transcription
start site AATAAA
“CCAAT box”
ATG polyadenylation signal
Tissue-
“TATA” initiation codon Site for addition
Enhancer specific box
elements GT AG GT AG of (A)n
Gene
Intron 1 Intron 2 3′
5′
untranslated untranslated
region Transcription region

5′ GU AG GU AG 3′
mRNA precursor Cap AAAAA

Splicing

Mature mRNA Cap AAAAA

Fig. 1. Structure of a typical gene. In this example, the gene has three exons (solid dark regions) and two introns
(white regions), a 5′ untranslated region and 3′ untranslated region. The intron splice donor site (GT) and the splice
acceptor site (AG) identify where introns are removed in mRNA production. The upstream region (5′) contains an
enhancer, tissue specific elements, and promoter elements, such as the CCAAT box and TATA box, which regulate
expression. Typical locations for the translation initiation site (ATG), translation stop codons (TAA, TAG, TGA), and the
polyadenylation signal (AATAAA) are shown. (Gelehrter TD, Ginsburg D, Collins FS. Principles of medical genetics. 2nd
ed. Baltimore: Williams and Wilkins, 1997)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 305

 Methylation serves the important function of con-
trolling tissue-specific gene activation. The expres-
sion of genes that are not essential for each specific
tissue type is prevented by methylation, while nec-
essary genes remain active. For example, the globin
genes are methylated in all nonerythroid tissues
but are not methylated in reticulocytes, ensuring
that only red blood cells produce hemoglobin.
Methylation also allows the temporal control of
gene expression. Parental alleles may demonstrate
different patterns of methylation that are not tissue
specific (see section on “Imprinting”).
Many genes exist in several alternate forms
called alleles. These are normal variants within the
population. For example, there are several normal
alleles for the genes that determine blood type and
Rh status. In contrast, a mutation is an alteration in
the DNA sequence that results in a change in pro-
tein structure or function, which may have adverse
effects. Mutations can occur in the germline (eg,
gametes) and can be transmitted from one genera-
tion to the next, or can occur only in the somatic
cells and can be associated with cancer. There are
many types of mutations, such as single purine or
pyrimidine base substitutions (missense, nonsense),
deletions and insertions of one or more bases, and
visible chromosome deletions and duplications.
Mutations occur infrequently in the population. The
distinction between an allele and a mutation can be
blurred; many normal alleles probably result from
ancient mutations that either did not affect survival
or conferred some selective advantage.
The vast majority (99.8%) of DNA is identi-
cal in all humans. However, minor differences that
distinguish one person from another do exist. These
differences, called polymorphisms, generally con-
sist of a single nucleotide change and occur every
200 to 500 base pairs. Polymorphisms, in general,
do not produce deleterious effects. Some poly-
morphisms may modify gene function (eg, splice
variant or thymidine tract in intron 8 of the cystic
fibrosis [CF] gene can influence the amount of
mRNA produced). In most cases, polymorphisms
are normal variants, which often are used to track
the transmission of disease genes (see sections
on “Restriction Fragment Length Polymorphism
Analysis” and “Linkage Analysis”).
When newly discovered genes are analyzed, it
can be difficult to distinguish a normal allele from
a polymorphism or a mutation. For example, more
than 100 variations of the BRCA1 gene, one of the
major genes associated with familial breast and ovar-
ian cancers, have been identified. It is not currently
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known whether all of these variations are actually
mutations associated with disease, or if some could
be polymorphisms or allelic variants. The ability to
distinguish alleles from mutations is essential for
molecular diagnosis and screening programs.
Single Gene (Mendelian) Disorders
A mendelian trait or disease is determined by a
single gene. Diseases caused solely by abnormalities
in a single gene are relatively rare. The phenotype of
many single gene disorders is influenced by modify-
ing genes, or by the independent actions of a combi-
nation of additional genes, often with environmental
influences.
Autosomal Dominant
All genes come in pairs; one copy of the gene is
present on each of a pair of chromosomes. The influ-
ence of each gene in determining the phenotype is
described as either dominant or recessive. If one of
the genes in a pair specifies the phenotype in prefer-
ence to the other gene, that gene and the trait or dis-
ease it specifies are considered to be dominant. The
carrier of a gene causing an autosomal dominant
disease has a 50% chance of passing on the affected
gene with each conception.
The phenotype of an individual carrying a
dominant gene is determined by several factors. One
factor is penetrance. Penetrance indicates whether
or not the mutant gene is expressed. If a dominant
gene produces some kind of recognizable pheno-
typic expression in all individuals who carry it, it
is said to have complete penetrance. A gene that
is not expressed in all individuals who carry it has
incomplete penetrance. For individuals, penetrance
is an all-or-nothing phenomenon, but penetrance
in a population can be quantitated. For example, a
phenotype that is expressed in 80% of individuals
who carry the gene has 80% penetrance.
Incomplete penetrance may account for some
autosomal dominant diseases that appear to “skip”
generations. Alternatively, the individual carrying
the dominant gene may have very mild phenotypic
abnormalities that have been overlooked, the disease
may have a late onset, the gene carrier is either too
young or died before the gene’s effects were mani-
fest, or phenotypic expression of the dominant gene
could require the presence of a second mutated gene
or certain epigenetic phenomena. An example of
such a disease is retinoblastoma.
The degree to which a penetrant gene is
expressed (the range of phenotypic features) is
2013 COMPENDIUM OF SELECTED PUBLICATIONS 306
 called expressivity. If all individuals carrying the
affected gene do not have identical phenotypes,
the gene has variable expressivity. Such a gene can
produce a range of phenotypic features from mild
to severe. An example of a disease with variable
expressivity is neurofibromatosis.
Autosomal Recessive
Autosomal recessive traits or diseases occur only
when both copies of the gene in question are the
same. Individuals who have only one abnormal
gene (heterozygotes or carriers) may have some
phenotypic alteration recognized at the biochemical
or cellular level, but only individuals who have two
copies of the affected gene (homozygotes) have the
disease. Many enzyme deficiency diseases are auto-
somal recessive. The enzyme level in the carrier of
an abnormal recessive gene will be approximately
50% of normal, but because enzymes are made in
great excess, this reduction usually is not enough to
cause disease. However, the reduced enzyme level
can be used for genetic screening purposes. For
example, to identify carriers of Tay–Sachs disease,
hexosamini-dase A levels are measured. Carriers of
recessive conditions that do not produce any physi-
cal or quantitative biochemical change in the hetero-
zygote can be identified only by molecular methods
(eg, Canavan disease).
The carrier of a gene causing an autosomal
recessive disease usually is recognized after the
birth of an affected child, after the diagnosis of an
affected family member, or as the result of a genetic
screening program. A couple whose child has an
autosomal recessive disease has a 25% recurrence
risk with each conception. The likelihood that a
normal sibling of an affected child is a carrier of the
gene is 2 out of 3 (one fourth of all offspring will
be homozygous normal, two fourths will be hetero-
zygote carriers, and one fourth will be homozygous
abnormal; thus, 3 of 4 children will be phenotypical-
ly normal and 2 of these 3 will be carriers). Carrier
children will not have affected children unless their
partners are gene carriers or are affected. Because
genes leading to rare autosomal recessive conditions
have a low prevalence in the general population, the
chance that the partner will be a gene carrier is low
unless the couple is related (consanguineous). When
individuals inherit two different mutated alleles that
result in abnormal phenotypes, they are called com-
pound heterozygotes. For example, an individual
who inherits a ∆F508 and W1282X mutation in the
CF gene has CF without expressing two identical
alleles.
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Co-Dominant
If the genes in a gene pair are different from each
other, but both are expressed in the phenotype, they
are considered to be co-dominant. For example, the
genes responsible for the hemoglobinopathies are
co-dominant. The individual with one hemoglobin
gene directing the production of sickle hemoglobin,
and the other directing the production of hemoglobin
C, will produce both S and C hemoglobins. Likewise,
the genes that determine blood type are co-dominant,
because an individual is capable of expressing both
A and B red cell antigens simultaneously.
X-Linked
X-linked diseases usually are recessive, and primar-
ily affect men because men have only one copy of
the X chromosome. Examples of X-linked recessive
disorders are color blindness, hemophilia A (clas-
sical hemophilia or factor VIII deficiency), and
Duchenne muscular dystrophy. Women carrying
an X‑linked recessive gene generally are unaffected
unless unfavorable lyonization (the inactivation
of one X chromosome in every cell) results in the
X chromosome carrying the abnormal gene being
active in the majority of cells.
When a woman carries a gene causing an
X-linked recessive condition, there is a 50% chance
of passing on the gene with each conception; each
of her sons has a 50% chance of being affected and
each of her daughters has a 50% chance of being a
carrier. When a man has an X-linked disease, all of
his sons will be unaffected (because they receive
the Y chromosome from their father) and all of his
daughters will be carriers (because they receive
the affected X chromosome from their father).
X-linked dominant disorders have been described,
and affect females predominantly because they tend
to be lethal in male offspring. An example of this is
X-linked hypophosphatemia.
Duplication and Deletion
Syndromes
A deletion refers to a region of a chromosome that
is missing, while a duplication is the presence of an
extra copy of a region of a chromosome. The carrier
of a deletion is effectively monosomic for the genes
in the missing segment, while the carrier of a dupli-
cation is trisomic for the duplicated genes. Deletions
and duplications usually are described by their loca-
tion (eg, duplication 4p) or by the two chromosomal
break points defining the missing or extra segment
(4p15.2→16.1). If the deletion is a common one, it
2013 COMPENDIUM OF SELECTED PUBLICATIONS 307
 may be defined by an eponym (eg, del 1q32-q41
also is called Van der Woude’s syndrome). Terminal
deletions and duplications are caused simply by
chromosome breakage with loss or gain of the termi-
nal chromosome segment. Interstitial deletions and
duplications occur during prophase of meiosis when
homologous chromosomes align and cross-overs
occur. If the chromosomes are misaligned during
this process, the unaligned loop containing the mis-
matched segment could be deleted. Alternatively,
misalignment could lead to unequal crossing over,
so that one chromosome has a deletion and the other
a duplication. A similar problem with meiosis can
produce deletions and duplications in the offspring
of individuals who are carriers of chromosome
inversions. Deletions and duplications also occur as
a result of malsegregation during meiosis in carriers
of balanced translocations.
When a deletion or duplication is identified in
a fetus or child, the parents should be tested to see
if it arose de novo in their offspring or if either par-
ent is a carrier or has a translocation. Deletions and
duplications may be identified by routine or high
resolution cytogenetic analysis. Microdeletions and
duplications, which are too small to be detected
by traditional cytogenetic techniques, can now be
recognized with molecular techniques, such as fluo-
rescence in situ hybridization (FISH) (see section on
“Fluorescence In Situ Hybridization”).
Chromosome deletions and duplications can
result in a constellation of phenotypic abnormalities
with widely varying pathophysiology or pathogen-
esis because the genes that are in close proximity to
one another on a chromosome may have completely
unrelated functions and control independent traits.
Deletion syndromes usually cause more serious
phenotypic and functional abnormalities than dupli-
cation syndromes. Monosomy generally has more
severe consequences than trisomy.
Syndromes caused by a microdeletion involv-
ing genes physically located together in a chromo-
some segment are called contiguous gene deletion
syndromes, and their study has yielded a great deal
of information about gene location and function.
Although deletions can occur in any area of any
chromosome, some deletions occur more frequently
than would be expected by chance alone. Several
common chromosome deletion syndromes have
been recognized, such as DiGeorge syndrome,
which most often results from a microdeletion of
the long arm of chromosome 22 (del 22q11.2).
Affected individuals typically have conotruncal
cardiac defects; thymus and parathyroid gland hypo-
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plasia or aplasia; atypical facies, including short pal-
pebral fissures, micrognathia with a short philtrum,
and ear anomalies; and learning and speech difficul-
ties. Deletions of the terminal portions of the short
arms of chromosomes 4 (4 p- or Wolf-Hirschhorn
syndrome) and 5 (5 p- or cri du chat syndrome) also
occur more frequently than would be expected by
chance alone.
Nonmendelian Patterns of
Inheritance
Hereditary Unstable DNA
Mendel’s first law states that genes are passed
unchanged from parent to progeny. Barring the
occurrence of new mutations, this law still applies
to many genes or traits. However, it is now known
that certain genes are inherently unstable, and their
size and, consequently, their function may be altered
as they are transmitted from parent to child. These
genes generally contain a region of triplet repeats,
such as (CGG)n. The number of triplet repeats in
gametes can increase as meiosis is completed prior
to fertilization. If the number of triplet repeats
reaches a critical level, the gene containing the trip-
lets becomes methylated and is turned off, resulting
in phenotypic abnormalities. Some triplet regions
expand only during female meiosis, while others
can expand when transmitted by either parent. Some
triplet regions have been passed from parent to child
for many generations without expansion, for un-
known reasons.
An example of a genetic disease caused by such
triplet repeats is fragile X syndrome. Fragile X syn-
drome is the most common form of all familial men-
tal retardation, accounting for 4–8% of all individu-
als with mental retardation in all ethnic and racial
groups. Affected individuals have mild to severe
mental retardation, autistic behavior, attention defi-
cit hyperactivity disorder, speech and language
problems, a narrow face with a large jaw, long
prominent ears, and macro‑orchidism (in postpuber-
tal males). Some children also have seizures. The
incidence of the full fragile X syndrome generally is
quoted as 1 per 1,500 males and 1 per 2,500 females.
Until recently, fragile X syndrome was diag-
nosed using a cytogenetic technique. Cells were cul-
tured in a folate deficient medium, which resulted
in fragile sites identified cytogenetically as non-
staining gaps or constrictions on the long arm of
the X chromosome (Xq27‑28). This technique was
unreliable for carrier testing, and less than half the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 308
 cells from affected males manifested the fragile site.
Fortunately, the fragile X gene can now be directly
examined using molecular techniques (see section
on “Trinucleotide Repeat Analysis”).
The fragile X mutation is now known to be
a region of unstable DNA in the X chromosome.
The region is best described as a series of CGG
(cytosine–guanine–guanine) repeats at Xq27. The
number of repeats and the degree of methylation
determines whether or not an individual is affected.
Individuals carrying 2–49 repeats are phenotypi-
cally normal. Individuals carrying 50–199 repeats
are phenotypically normal but have a premutation,
which can expand as it is passed on to their off-
spring, who would then be affected. Those with
more than 200 repeats have the full mutation and, if
methylation occurs, usually are affected. However,
not all individuals carrying the full mutation are
mentally retarded. Phenotypic variability results
from lyonization (in females) and mosaicism for
the size of the expansion, the degree of methylation,
or both during mitosis in the zygote. Therefore, the
phenotype cannot be predicted by analysis of either
the parental gene or fetal cells.
The number of repeats usually remains stable
when the gene is transmitted by a male. However,
when the gene passes through female meiosis, it
can expand. The risk of expansion generally corre-
lates with the number of repeats in the premutation.
Premutations with 100 or more repeats expand on
transmission 100% of the time. The risk of expansion
of mutations with 50–99 repeats increases proportion-
ally with expansion size. If a female carries a premuta-
tion, which then increases in size as she transmits it to
her offspring, it is possible for her to have a child with
fragile X syndrome even though she is unaffected and
has no family history of mental retardation.
The number of CGG repeats and the methylation
status of the gene can be determined using restriction
endonuclease digestion and Southern blot analysis
(see section on “Trinucleotide Repeat Analysis”).
It is now apparent that triplet repeat expansion is
responsible for a number of primarily neurologic
diseases, such as myotonic dystrophy, Huntington’s
chorea, and Friedreich’s ataxia. The expansion of
triplet repeats is an important mechanism of genetic
disease, and is likely to play an important part in
diseases for which preconceptional counseling and
prenatal diagnosis may be considered.
Imprinting
Another tenet of mendelian genetics is that gene
function is not influenced by the sex of the parent
transmitting the gene. In contrast to this rule, it is
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now apparent that the function of certain genes is
altered by the sex of the parent from whom they
were inherited, by a process known as “imprinting.”
Imprinting is a mechanism for epigenetic control
of gene expression; that is, it changes the pheno-
type without permanently altering the genotype.
An imprinted gene is inherited in an inactivated
(transcriptionally silent) state, as the result of meth-
ylation of the promoter region. The extent of the
imprinting, and thus the degree of inactivation, is
determined by the sex of the transmitting parent.
When a gene is inherited in an imprinted
or inactivated state, gene function is necessar-
ily directed entirely by the active co-gene inherited
from the other parent. It appears that imprinting
exerts an effect in part by controlling the dosage of
specific genes. Certain important genes appear to
be monoallelic; that is, under normal circumstances
only one member of the gene pair is functional (as
opposed to most of the genes in the genome, which
are biallelic). Only a fraction of human genes are
imprinted. With imprinted genes, however, normal
development occurs only when both a paternally
derived and a maternally derived copy of the gene
is present.
Imprinting was first recognized in association
with genetic disease. Two very distinct genetic dis-
eases with dissimilar phenotypes were discovered to
be associated with the same chromosomal deletion,
at 15q11-13. One of the diseases is Prader‑Willi
syndrome, which is characterized by obesity; hyper-
phagia; short stature; small hands, feet, and external
genitalia; and mild mental retardation. The other
disorder is Angelman’s syndrome, which includes
normal stature and weight, severe mental retarda-
tion, absent speech, seizure disorder, ataxia and jerky
arm movements, and paroxysms of inappropriate
laughter. Cytogenetic analysis has confirmed that
both diseases are associated with the same dele-
tion. If the maternally derived chromosome 15 is
deleted, the result is Angelman’s syndrome; if the
paternally derived chromosome 15 is deleted, the
result is Prader-Willi syndrome. Furthermore, a
deletion is not required to produce the phenotype.
If an individual has two normal intact copies of
chromosome 15, but both came from the man (see
section on “Uniparental Disomy”), the phenotype
is consistent with Angelman’s syndrome, because
the maternal contribution is missing. Likewise, two
complete copies of chromosome 15 of maternal ori-
gin produces Prader-Willi syndrome. Studies of the
methylation patterns in individuals with the 15q11-
13 deletion have shown that differential methyla-
tion (imprinting) is responsible for these observed
phenotypic differences.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 309
 Several clinical examples from obstetrics illus-
trate the developmental importance of imprinting.
Complete hydatidiform mole, which has an exclu-
sively paternally derived diploid chromosome com-
plement, is characterized by the abundant growth of
placental tissue, but no fetal structures. Conversely,
ovarian teratoma, which has a maternally derived
diploid chromosome complement, is characterized
by the growth of various fetal tissues, but no
placental structures. Triploidy, characterized by a
conceptus with three complete haploid chromo-
some complements (69 chromosomes), has two dis-
tinct phenotypes. If the extra haploid chromosome
complement comes from the man, the embryo will
be lost early in gestation and the placenta will be
large and cystic, and severe early onset preeclamp-
sia is likely to develop; if the extra chromosome
complement comes from the woman, the fetus will
be anomalous and the placenta will be extremely
small. These observations confirm that both the
paternally derived and maternally derived imprinted
genes must be present for normal fetal development
to occur.
Uniparental Disomy
Uniparental disomy is a situation in which both
members of one pair of chromosomes are inherited
from one parent. Every gene on each of the chromo-
somes in question will have come from one parent.
This usually occurs as the result of “correction” of
a trisomic zygote by loss of a chromosome. When a
conceptus with three copies of a chromosome loses
one chromosome and retains the two chromosomes
transmitted by the other parent, this results in het-
erodisomy (inheritance of two different homologous
chromosomes from one parent). Less frequently,
“rescue” of a monosomic conceptus with only one
chromosome from one parent may occur by dupli-
cation of the chromosome during mitosis producing
a cell with two copies of the same chromosome or
uniparental isodisomy. For some chromosomes,
uniparental disomy can result in functional or devel-
opmental fetal abnormalities, particularly if imprint-
ing of the genes on that chromosome exists. Recent
studies have demonstrated clinically significant
uniparental disomy for chromosomes 6, 7, 11, 14,
and 15. Uniparental disomy has no effect on the
majority of chromosomes.
Mitochondrial Inheritance
Every human cell contains hundreds of mitochon-
dria. Because each mitochondrian contains its own
genome and associated replication systems, each
behaves as a virtually autonomous organism. The
COMMITTEE OPINIONS
human oocyte contains approximately 100,000
mitochondria in the cytoplasm and mitochondrial
DNAs. In contrast, a sperm contains only 100 mito-
chondria, which are selectively eliminated during
fertilization. Therefore, mitochondria are inherited
exclusively from the woman. Because mitochondria
contain genetic information, mitochondrial inheri-
tance allows the transmission of genes directly from
the woman to her offspring without the possibility
of recombination.
If a mutation occurs in the mitochondrial DNA,
it may segregate into a daughter cell during cell
division and thus be propagated. Over time, the
percentage of mutant mitochondrial DNAs in differ-
ent cell lines can drift towards either normal or pure
mutant. If an oocyte containing largely mutant mito-
chondrial DNAs is fertilized, the offspring might
have a mitochondrial disease. Several mitochon-
drial genetic diseases have been described. These
include myoclonic epilepsy with ragged red fibers
(MERRF), Leber’s hereditary optic neuropathy,
Kearns–Sayre syndrome, Leigh syndrome (ataxia,
hypotonia, spasticity, and optic abnormalities), and
pigmentary retinopathy.
Germline Mosaicism
Some cytogenetically normal individuals have mosa-
icism (the presence of two or more populations of
cells with different characteristics within one tissue
or organ) confined to their gonads. Gonadal or germ-
line mosaicism can arise as the result of a mitotic
error occurring in the zygote; if the error occurs in
cells destined to become the gonad, a portion of the
germ cells may be abnormal. Because spermatogo-
nia and oogonia continue to divide throughout fetal
development, gonadal mosaicism also could occur as
the result of a meiotic error in the dividing germ cells
of the embryo. Germline mosaicism may explain the
occurrence of a “new” (not previously occurring in a
family) autosomal dominant mutation causing a dis-
ease, such as achondroplasia or osteogenesis imper-
fecta, or a new X-linked disease, such as Duchenne
muscular dystrophy. It also explains the recurrence
of such diseases in more than one offspring in a pre-
viously unaffected family. Because of the potential
for germline mosaicism, the recurrence risk after the
birth of a child with a disease caused by a new muta-
tion is approximately 6%.
Multifactorial and Polygenic Inheritance
Polygenic traits are determined by the combined
effects of many genes; multifactorial traits are deter-
mined by multiple genes and environmental factors.
It is now believed that the majority of inherited traits
2013 COMPENDIUM OF SELECTED PUBLICATIONS 310
 are multifactorial or polygenic. Traits determined
by single genes and transmitted by strict mendelian
inheritance, without the contribution of modifier
genes, are probably relatively rare. Birth defects
caused by multifactorial or polygenic inheritance
are recognized by their tendency to recur in families,
but not according to a mendelian inheritance pattern.
Other characteristics that distinguish multifactorial
traits from those with other inheritance patterns are
listed in the box. When counseling couples regard-
ing their offspring’s risk of a familial multifactorial
trait, it is important to consider the affected relative’s
degree of relatedness to the fetus, not the parents.
The empiric recurrence risk for first-degree relatives
(the fetus’s parents or siblings) usually is quoted as
2–3%, but the risk declines exponentially with suc-
cessively more distant relationships. Multifactorial
traits generally fall into one of the three following
categories: 1) continuously variable, 2) threshold, or
3) complex disorders.
Continuously variable traits have a normal dis-
tribution in the general population. By convention,
abnormality is defined as a trait or measurement
greater than two standard deviations above or below
the population mean. These are typically measurable
or quantitative traits like height or head size, and
are believed to result from the individually small
effects of many genes combined with environmental
factors. Such traits tend to be less extreme in the
offspring of affected individuals, because of the sta-
tistical principle of regression to the mean.
Threshold traits do not appear until a certain
threshold of liability is exceeded. Factors creat-
ing liability to the malformation are assumed to
be continuously distributed in the population; only
individuals who are at the extreme of this distribu-
Multifactorial Inheritance
1. The disorder is familial, but there is no apparent pattern
of inheritance.
2. The risk to first-degree relatives is the square root of
the population risk.
3. The risk is sharply lower for second-degree relatives.
4. The recurrence risk is higher if more than one family
member is affected.
5. The risk is higher if the defect is more severe (ie, the
recurrence risk for bilateral cleft lip is higher than for
unilateral cleft lip).
6. If the defect is more common in one sex, the recur-
rence risk is higher if the affected individual is of the
less commonly affected sex.
COMMITTEE OPINIONS
tion exceed the threshold and have the trait or defect.
The phenotypic abnormality is thus an all or none
phenomenon. Individuals in high-risk families have
enough abnormal genes or environmental influ-
ences that their liability is close to the threshold; for
unknown reasons, some factor or factors increases
the liability for certain family members still further
and the threshold is crossed, resulting in the defect.
Cleft lip and palate and pyloric stenosis are exam-
ples of threshold traits.
Certain threshold traits have a predilection
for one gender, indicating that males and females
have a different liability threshold. When a fam-
ily includes an affected member who is the less
frequently affected sex, this indicates that even
more abnormal genes or environmental influences
are present, and the affected individual (and pos-
sibly the family) has a more extreme position in
the normal distribution of predisposing factors. The
affected person’s first-degree relatives (eg, their
siblings) have a higher liability for that particular
trait. For example, pyloric stenosis is more common
in males. If a girl is born with pyloric stenosis, this
indicates that she or her parents have even more
abnormal genes or predisposing factors than usually
are necessary to produce pyloric stenosis. After the
birth of a girl with pyloric stenosis, the recurrence
risk for her siblings or for her future children will be
higher than expected; male siblings or offspring will
have the highest liability because they are the most
susceptible sex and they will inherit more than the
usual number of predisposing genes.
The recurrence risk for threshold traits also is
higher if the defect is severe, again indicating the
presence of more abnormal genes or influences. For
example, the recurrence risk after the birth of a child
with bilateral cleft lip and palate is 8%, compared
with only 4% after unilateral cleft lip without cleft
palate.
Complex disorders of adult life are traits in
which many genes determine an individual’s sus-
ceptibility to environmental factors, with disease
resulting from the most unfavorable combination of
both. This category includes common diseases, such
as heart disease and hypertension. These disorders
usually are familial and behave as threshold traits
but with a very strong environmental influence.
The genetic mechanisms of many common adult
diseases have not yet been elucidated, although sev-
eral associated genes have been identified. In some
cases, the identity of the associated gene provides a
clue to the pathogenesis of the disease; in others, the
related gene may simply be used as a disease mark-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 311
 er. Premature cardiovascular diseases, for example,
are associated with the gene for apolipoprotein E, a
gene that likely influences the pathology of the dis-
ease. In contrast, the association of type 1 diabetes
with HLA-DR3/4 is less clear.
Molecular Diagnostic Testing
Advances in our understanding of the molecular
basis of inherited disorders have led to the develop-
ment of DNA-based tests, which may be used for
the confirmation of a diagnosis, prenatal diagnosis,
and carrier testing. Molecular diagnostic testing is
now widely available for a number of single gene
disorders, such as Tay–Sachs disease, Canavan dis-
ease, sickle cell disease, CF, muscular dystrophies,
and fragile X syndrome. Molecular-cytogenetic
testing has been developed for the detection of chro-
mosomal abnormalities, including aneuploidy and
submicroscopic deletions and duplications.
DNA can be obtained from many sources,
including blood lymphocytes, skin, hair, cheek cells,
and paraffin tissue blocks. Most diagnostic laborato-
ries prefer either blood samples or buccal swabs for
DNA testing. Cultured amniocytes, chorionic villi,
and fetal blood are used for prenatal DNA testing
of the fetus.
Mutation Detection
Once a gene has been cloned and mutations have
been identified, direct testing for the mutation
is possible. This is the most accurate diagnostic
method. Direct mutation tests usually are per-
formed by commercial and hospital-based labo-
ratories for common mutations, which are well
characterized and account for the majority of
cases. In some cases, the mutations are unique to a
specific ethnicity. For example, two specific muta-
tions in the aspartoacylase gene account for 97%
of the mutations that cause Canavan disease in the
Ashkenazi Jewish population. For some genetic
disorders, the mutations are unique or specific to
an individual family; therefore, mutation testing
may not be routinely provided by a commercial
laboratory. In these cases, there may be only one or
two academic or hospital laboratories in the country
that offer the testing. (This information is provided
by GeneTests, a genetic testing resource web site
at www.genetests.org.) In general, initial screen-
ing of a gene for mutations usually takes place in
research laboratories under approved protocols and
COMMITTEE OPINIONS
is not practical for diagnostic testing. Once a muta-
tion has been identified, it may be possible to offer
diagnostic or carrier testing to individuals at risk.
There are a variety of methods available for
detecting mutations. The methodology usually is
determined by the nature of the specific mutation.
Allele specific oligonucleotide hybridization and
restriction fragment length polymorphisms analy-
sis frequently are used to detect point mutations.
Southern blot analysis and polymerase chain reac-
tion (PCR) often are used to detect gene deletions
associated with disorders such as Duchenne muscu-
lar dystrophy and spinal muscular atrophy. A com-
bination of PCR and Southern blot analysis are used
to determine the number of trinucleotide repeats for
disorders such as fragile X syndrome and myotonic
dystrophy.
Southern Blot Analysis
Southern blot analysis provides a basis for studying
genetic disorders at the DNA level. This procedure,
named after its inventor E. M. Southern, separates
DNA fragments according to size and allows the
identification of specific DNA fragments using
radiolabeled DNA probes.
The steps to prepare a Southern blot are shown
in Figure 2. First, DNA is extracted from nucle-
ated cells (leukocytes, trophoblasts, or amniocytes)
or tissue, and digested into small pieces with a
restriction enzyme. Then, the DNA is loaded into
an agarose gel, an electric current is applied, and
DNA fragments migrate down the gel according
to size (smaller fragments move faster). The DNA
contained within the agarose gel is still double
stranded and must be denatured by alkali treatment
into single-stranded pieces and then transferred to a
nitrocellulose or nylon membrane. The membrane
contains many thousands of fixed DNA fragments.
Specific DNA fragments can be detected using a
DNA probe labeled with a radionuclide, such as 32P,
although nonradioactive substances such as biotin–
avidin may be used. The probes may be complemen-
tary DNA (cDNA), genomic DNA (exons, introns,
or regulatory regions), or short pieces of single-
stranded DNA called oligonucleotides, which usu-
ally range in size from 20 to 50 base pairs. The DNA
probe will hybridize only with DNA fragments on
the blot that are complementary. To visualize the
DNA fragment, the blot is exposed to X-ray film at
-70°C, a process called autoradiography. The film
is developed, and the presence or absence of DNA
bands or fragments can be determined.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 312

Isolate genomic DNA
Digest DNA with
restriction
enzymes
Separate DNA
fragments by
electrophoresis
Transfer DNA
to membrane
Hybridize with
labeled probe
xxxxxxxxxx
Autoradiogram
Specific hybridizing
DNA band
Fig. 2. Southern blot analysis. (Jameson JL. Principles of
molecular medicine. Totowa, NJ: Humana Press, 1998:16)
Polymerase Chain Reaction
The development of the PCR has greatly simpli-
fied DNA analysis and shortened laboratory time.
Polymerase chain reaction allows the exponential
amplification of the targeted gene or DNA sequence.
Only minute quantities of DNA, typically 0.1–1 µg,
are necessary for PCR. DNA can be amplified from
a single cell. One important prerequisite of PCR,
which is not required for Southern blot analysis, is
that the sequence of the gene, or at least the bor-
ders of the region of DNA to be amplified, must be
known.
The PCR procedure has three steps (Fig. 3).
First, DNA is denatured by heating to render it
single stranded. Second, the PCR primers (primer
A and B), which are short pieces of DNA (oligo-
nucleotides) 20–30 base pairs in length exactly
complementary to the ends of each piece of the dou-
ble-stranded DNA to be amplified, anneal to their
complementary regions of the DNA. Third, syn-
thesis of the complementary strand of DNA occurs
COMMITTEE OPINIONS
in the presence of the enzyme Taq polymerase and
nucleotides triphosphates (dATP, dCTP, dGTP, and
dTTP). The reaction cycle of denaturation, anneal-
ing, and extension is repeated 25–30 times to pro-
duce millions of copies of DNA.
Typically, fragments several kilobases (kb) in
size can be amplified, but sequences up to 10 kb
have been successfully amplified. The exact cycling
parameters and conditions for PCR must be deter-
mined empirically for each set of primers. Poly-
merase chain reaction is very sensitive; therefore,
extreme care must be taken to avoid amplification
of contaminant DNA from aerosolized secretions
or sloughed skin cells. These precautions are par-
ticularly important when DNA from a single cell is
being amplified.
Restriction Fragment Length
Polymorphism Analysis
Restriction fragment length polymorphism analy-
sis can be used when a mutation either creates or
destroys a restriction endonuclease site. To detect
the mutation, DNA around the site of the muta-
tion is amplified by the PCR, incubated with the
appropriate restriction enzyme, and analyzed by
agarose gel electrophoresis. When a mutation cre-
ates a new restriction site, two DNA fragments will
be detected if the mutation is present (Fig. 4A). An
individual without the mutation will demonstrate a
single fragment. This method frequently is used for
the prenatal genetic diagnosis of sickle cell disease.
Sickle cell disease is caused by a single base pair
substitution (adenine to thymidine) in codon 6 of the
β-subunit of hemoglobin, which results in the loss of
the MstII restriction site. Individuals with sickle cell
disease are homozygous for this mutation.
Allele Specific Oligonucleotide
Hybridization (Dot Blot)
Allele specific oligonucleotide hybridization (dot
blot) frequently is used to detect point mutations. A
segment of DNA surrounding the mutation is ampli-
fied by PCR and then an aliquot is spotted onto a
filter membrane. The membrane is hybridized with
an oligonucleotide probe specific for the normal
sequence and one specific for the mutation. A posi-
tive hybridization signal is detected only when the
sequence of the PCR product on the membrane is
complementary to the sequence of the oligonucle-
otide. For example, testing an individual who is het-
erozygous for the mutant allele will reveal a positive
hybridization signal with both the normal sequence
and the mutant oligonucleotide probe. DNA from
2013 COMPENDIUM OF SELECTED PUBLICATIONS 313
 Taq polymerase Restriction-enzyme recognition site
5′ 3′ created by mutation
DNA template PCR primer
3′ 5′
Primer A Primer B

Agarose gel
94°C Denature

5′ 3′

3′ 5′
A

50–68°C Anneal primers

2 3
5′ 3′ Repeat for 1
25–30 cycles
3′ 5′
Site of mutation
PCR primer
72°C Polymerize

5′ 3′

3′ 5′
Wild-type
oligonucleotide

Cycle
B Mutant
Fig. 3. Polymerase chain reaction. (Jameson JL. oligonucleotide
Principles of molecular medicine. Totowa, NJ: Humana
Press, 1998:15) WT HET MUT

individuals homozygous for the mutation will only
hybridize to the mutant oligonucleotide (Fig. 4B).
This technique is used for the detection of point
mutations for many single gene disorders, including
CF, Tay–Sachs disease, Gaucher’s disease, Canavan
disease, and sickle cell disease.
Deletion Analysis
Intragenic deletions can be detected by PCR or
Southern blot analysis or both. Polymerase chain
reaction can be used to determine the absence or
presence of exons within a gene. A sample of DNA
is amplified by PCR and then the PCR products
are analyzed by gel electrophoresis, stained with
ethidium bromide to detect the absence or presence
of DNA fragments (Fig. 5). The absence of a DNA
fragment indicates the presence of a deletion. This
method is used routinely for diagnostic and prena-
Fig. 4. Mutation detection. (A) Restriction fragment
length polymorphism (RFLP) analysis. The region of
DNA surrounding the mutation is amplified by specific
PCR primers, digested with a restriction enzyme, and
analyzed by agarose-gel electrophoresis. In this exam-
ple, the mutation creates a new restriction site. Indi-
viduals homozygous for the mutation have two DNA
fragments (Lane 2) while an individual with two normal
copies has one single fragment (Lane 1). A heterozy-
gous individual has one normal uncut fragment and two
cut fragments (Lane 3). (B) Allele specific oligonucle-
otide (ASO) hybridization. The amplified DNA from an
individual homozygous for the mutation only hybridizes
to the mutant oligonucleotide (MUT) whereas a hetero-
zygous individual (HET) hybridizes to both the normal
(wild-type) and the mutant. A normal individual will only
hybridize to the normal oligonucleotide (WT). (Korf B.
Molecular diagnosis. N Engl J Med 1995;332: 1500.
Copyright © 1995 Massachusetts Medical Society. All
rights reserved.)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 314

 tal testing for Duchenne muscular dystrophy, an
X-linked disorder. Approximately 60% of patients
with Duchenne muscular dystrophy have intragenic
deletions in the dystrophin gene and the majority of
these can be detected by PCR. Most laboratories use
a multiplex strategy to examine multiple exons in
one PCR. However, PCR is not useful to determine
carrier status in the mothers of affected males. This
requires Southern blot analysis with cDNA probes
from the dystrophin gene and scanning densitom-
etry to assess gene dosage. Testing of females at
risk to be carriers based on their family history is
less reliable when an affected relative is not avail-
able for DNA testing. Dosage analysis also can be
used to test male patients with Duchenne muscular
dystrophy with a negative result by multiplex PCR
to detect duplications within the dystrophin gene,
which occur in approximately 6% of patients with
Duchenne muscular dystrophy.
Linkage Analysis
When the location of a gene is known but the gene
has not yet been characterized, or when the muta-
tions have not been identified, linkage analysis may
be performed to predict the likelihood that a relative
or fetus has inherited a disease-causing gene within
an at-risk family. Linkage analysis requires that 1)
at least two generations of family members, includ-
ing affected individuals, are available and willing
to be tested, and 2) highly polymorphic markers
such as restriction fragment length polymorphisms,
or short tandem repeat polymorphisms close to or
within the gene are available. These polymorphic
markers result from normal genetic variation and
are not disease causing but may be used to track
the inheritance of genetic diseases within families.
The closer a marker is to a gene, the higher the
likelihood that the marker and gene are transmit-
ted or inherited together (linkage). The accuracy of
linkage analysis depends on the correct diagnosis,
the informativeness of the markers within the fam-
ily, and the distance between the marker and the
disease-causing gene. Markers closest to or within
a gene are less likely to undergo recombination and
will provide the most accurate prediction. Although
linkage analysis is less accurate than direct muta-
tion detection, under the specified circumstances it
may provide families with helpful information.

Multiplex PCR analysis of gene deletions

A B C D

1 2 3 4

Fig. 5. Multiplex gene deletion analysis. Exons A–D are simultaneously ampli-
fied with 4 sets of PCR primers. When an exon is deleted, the DNA fragment
is absent. In lane 2 exon A is absent, in lane 3 exons B and C, and in lane 4
exon C. Lane 1 shows no evidence of a deletion; all 4 DNA products are pres-
ent. (Korf B. Molecular diagnosis. N Engl J Med 1995; 332:1219. Copyright
© 1995 Massachusetts Medical Society. All rights reserved.)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 315

 Trinucleotide Repeat Analysis
The detection of trinucleotide repeat expansions,
associated with diseases such as fragile X syndrome,
myotonic dystrophy, and Huntington’s disease, often
requires a combination of PCR and Southern blot
analysis (Fig. 6). The size of normal alleles, pre-
mutation alleles, and, in some cases, full mutations
can be determined by using PCR. However, full
mutations associated with a large expansion (eg,
>200 repeats in fragile X syndrome) may need to be
detected using Southern blot analysis. It also is used
to assess the methylation status in fragile X patients
and pregnancies with the full mutation. The repeat
region not only expands to more than 200 repeats
but also becomes hypermethylated in affected indi-
viduals. DNA is digested with restriction enzymes
including a methylation-sensitive enzyme such as
BsshII, gel electrophoresed, and hybridized with a
DNA probe from the repeat region of the fragile X
gene (FMR-1).
Fluorescence In Situ Hybridization
Fluorescence in situ hybridization (FISH) is per-
formed on either metaphase chromosome prepara-
tions from cultured lymphocytes, amniocytes, or
villi, or interphase nuclei from blood, tissue, chori-
onic villi, or amniotic fluid. After the chromosomes
or nuclei are fixed on a microscope slide, they are
hybridized with a fluorochrome-labeled DNA probe
specific for a particular region of a chromosome.
The probe will hybridize to complementary DNA
sequences that can be visualized using a fluorescence
microscope. Fluorescence in situ hybridization is
used as an adjunct to routine cytogenetic analysis
for the detection of submicroscopic chromosome
deletions and duplications. These deletions and
duplications often are several 1,000 base pairs but
are too small to be detected by conventional cyto-
genetics. DNA probes have been developed for
the common deletion and duplication syndromes
(Table 1). It also may be used to identify or confirm

CGG repeat region

Coding sequence
Wild type

Premutation

Full mutation

Restriction-enzyme recognition sites

Probe
PCR primers

Asymp- Asymp-
Wild tomatic Full Wild tomatic Full
type carrier mutation type carrier mutation

Southern blot PCR

Fig. 6. Trinucleotide repeat analysis by PCR and Southern blot. A region of DNA containing the CGG repeat is amplified
and the product is analyzed on an agarose gel. The DNA fragment from a carrier with a premutation is larger because
of the expanded number of repeats. Sometimes the expansion is so large that the DNA fails to amplify and the number
of repeats cannot be detected using PCR. In this case, a Southern blot is performed (left panel) and the DNA from an
individual with a full mutation appears as a much larger band. (Korf B. Molecular diagnosis. N Engl J Med 1995;332:
1501. Copyright © 1995 Massachusetts Medical Society. All rights reserved.)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 316

 the presence of a subtle chromosomal rearrange-
ment (eg, translocation) or characterize a marker
chromosome. Fluorescence in situ hybridization of
interphase nuclei is used prenatally for the rapid
detection of common aneuploidies, such as trisomy
21. However, this is generally reserved for cases
where confirmation of a chromosomal abnormality
may influence a couple’s reproductive options or
obstetric management.
Comparative Genomic
Hybridization
Comparative genomic hybridization is a relatively
new DNA-based cytogenetic technique to identify
subtle chromosome deletions and duplications that
have not been detected using traditional cytogenetic
methods. To accomplish this, DNA from a patient
is labeled with a green fluorochrome and normal
control DNA is labeled with a red fluorochrome,
which can be visualized with a fluorescence micro-
scope. The DNA is hybridized to normal metaphase
chromosomes. Wherever a chromosome region
is duplicated, the metaphase chromosome will
hybridize with the excess green-labeled DNA and
appear green. Conversely, deletions will appear
red. Clinically, comparative genomic hybridization
is primarily used to detect cytogenetic changes in
tumors but, it also has been used to identify subtle
unbalanced translocations, the origin of marker or
supernumerary chromosomes, and intrachromo-
somal duplications.
Microarray Technology
DNA chip technology is a high throughput method
used primarily to study gene expression. Miniature
arrays of cDNA clones are spotted onto a glass slide
and hybridized with labeled cDNA prepared from
the tissue of interest. If a gene is strongly expressed
in the tissue, the hybridization signal will be intense.
This technique can analyze the gene expression
of thousands of genes at one time. In the future,
oligonucleotide arrays also may be used to search
for gene mutations and polymorphisms. Chips con-
taining gene specific oligonucleotides matching
normal and single nucleotides substitution sequenc-
es are hybridized with fluorescent-labeled DNA.
Improvements in chip technology will enable whole
genome expression screening as well as improved
mutation detection in the future.
COMMITTEE OPINIONS
Table 1. Microdeletion Syndromes
Syndrome Chromosome Deletion
Aniridia/Wilm’s tumor 11p13
Angelman’s 15q11-13
DiGeorge/velocardiofacial 22q11.2
Langer-Giedion 8q24
Miller-Dieker 17p13.3
Prader-Willi 15q11-13
Smith-Magenis 17p11.2
Williams 7q11.23
Indications for Molecular
Testing
A variety of molecular diagnostic tests are avail-
able to determine whether an individual or fetus
has inherited a disease-causing gene mutation. In
general, testing is offered to individuals or couples
identified as being at risk for a genetic disorder
based on their family history, medical history, or
ethnicity. Determination of an individual’s car-
rier status for a genetic disorder provides a more
accurate estimate of their risk of having an affected
offspring and allows an individual or couple to
consider prenatal testing options. This information
also may assist couples with their reproductive
decisions. Furthermore, it can identify other family
members or relatives at risk for the disorder or at
risk for being a carrier.
Molecular testing also may be used in clinical
and prenatal situations to confirm a diagnosis. For
example, screening for CF mutations may determine
whether an infertile male with congenital bilateral
absence of the vas deferens is a CF carrier. Prenatal
molecular testing for some genetic disorders may
be offered when a congenital anomaly is identified
antenatally. For example, FISH for the 22q11.2
deletion may establish a cause when a conotrun-
cal cardiac defect is detected by ultrasonography.
Establishing an etiology enables clinicians to pro-
vide couples with accurate genetic risk assessments,
prognostic information, and recommendations for
obstetric and neonatal management.
Prior to diagnostic and carrier testing for genetic
disorders, patients should be informed of the natu-
ral history of the disorder and current therapy, the
inheritance and their risk of inheriting or transmit-
ting the gene, benefits and limitations of testing, and
the implications of negative and positive results.
Preconceptional and prenatal testing also should
2013 COMPENDIUM OF SELECTED PUBLICATIONS 317
 include a discussion of reproductive options includ-
ing prenatal testing, adoption, donor programs, and
termination of pregnancy. Written informed consent
should be obtained from all individuals undergoing
genetic screening. Patients should understand that
molecular testing is voluntary and that every effort
will be made to ensure confidentiality of their medi-
cal records and test results.
Accuracy and Limitations of
Molecular Testing
Direct detection of a point mutation, deletion, or
duplication is the most accurate test. However, the
accuracy of molecular diagnosis also is dependent
on an accurate diagnosis. If an affected relative is
not available to identify the presence of a mutation
or if medical records are not available to confirm
the diagnosis, this may decrease the accuracy of
testing for a specific mutation and for the suspected
genetic disorder.
One of the limitations of molecular diagnostic
testing is test sensitivity. There are a number of
factors that determine the ability to detect muta-
tions. Many genetic disorders result from a variety
of genetic alterations. For example, more than 800
mutations have been reported in patients with CF.
The mutation detection rates for many genetic dis-
orders, including neurofibromatosis, CF, and hemo-
philia, are less than 100%. Therefore, the absence
of a mutation does not exclude the possibility that
an individual may be a carrier. Furthermore, there
may be ethnic differences in the detection rates;
97% of CF mutations have been identified in the
Ashkenazi Jewish population while only 30% in
Asian Americans. The incidence and carrier risk for
some genetic disorders also is dependent on ethnic-
ity and has led to the current recommendations
for carrier screening for specific genetic disorders.
Differences in test sensitivity and the prevalence of
mutations must be considered for each individual
genetic disorder and discussed with the patient prior
to testing. Disease prevalence and test sensitivity
should be taken into account in future recommenda-
tions for molecular-based carrier testing.
Another limitation to molecular testing is genet-
ic heterogeneity. In some cases, there may be more
than one gene or chromosomal locus responsible for
a genetic disorder. For example, at least two genes
have been identified that cause tuberous sclerosis,
an autosomal dominant disorder. Conversely, muta-
tions in a single gene can cause different phenotypes.
For example, mutations in fibroblast growth factor
COMMITTEE OPINIONS
receptor 3 (FGFR3) are associated with several
types of skeletal disorders, including achondroplasia,
hypochondroplasia, thanatophoric dysplasia, and
with craniosynostosis (eg, Crouzon’s disease, coro-
nal synostosis).
In some diseases, the identification of a genetic
mutation cannot precisely predict the phenotype
because of reduced penetrance or phenotypic vari-
ability or both. For example, 85% of women with a
BRCA1 mutation develop breast cancer during their
lifetime; therefore, the finding of a BRCA1 mutation
indicates a strong predisposition to breast cancer but
it does not indicate which women with the mutation
will develop a malignancy. Some genetic disorders
are highly variable even within families with the
same mutation. Therefore, it may only be possible
to provide patients with a description of the natural
history of the disorder and an estimate of the fre-
quency of specific features in patients with similar
mutations. The lack of genotype phenotype correla-
tion for some genetic disorders, such as CF, also can
limit the ability to accurately predict the course of
the disease. Therefore, when molecular testing indi-
cates that a patient or fetus has inherited a mutation,
it is helpful to consult a geneticist or someone with
expertise in the specific disorder to provide current
information regarding the prognosis, as well as, the
limitations and accuracy of testing.
Applications in Obstetrics and
Gynecology
Genetics is taking an increasingly prominent role
in the practice of obstetrics and gynecology. Gene
identification, characterization of disease-causing
mutations, and advances in genetic technology have
led to an increased number of available genetic
tests, which may be used for the diagnosis of
genetic disorders, carrier detection, and prenatal
or preimplantation genetic diagnosis. Testing for
a specific genetic disorder most often occurs in an
obstetric setting based on either the family history
or the couple’s ethnicity. Genetic counseling should
be offered to couples at risk so they can review
the nature of the disorder, the inheritance pattern,
their specific risk for being a carrier and for having
a child with the disorder, the current availability
of prenatal and postnatal testing as well the accu-
racy and limitations of testing, and their reproductive
options. Most molecular genetic testing for disor-
ders, such as Duchenne muscular dystrophy, fragile
X syndrome, neurofibromatosis, and hemophilia, is
performed when a couple is at high risk based on
2013 COMPENDIUM OF SELECTED PUBLICATIONS 318
 their family history. Initially, testing is performed to
determine whether the parent is a carrier. If the par-
ent is a carrier, prenatal testing by amniocentesis or
chorionic villus sampling is possible. Some couples
may consider preimplantation genetic diagnosis.
Single gene disorders and chromosomal abnormali-
ties, such as deletions and translocations, may be
identified in an embryo conceived through in vitro
fertilization by testing a single blastomere. Genetic
testing for disorders prevalent in specific ethnic pop-
ulations such as CF for Caucasians and Tay–Sachs
and Canavan disease for individuals of Eastern
European Jewish ancestry, is used to determine if an
individual is a carrier. Prenatal molecular diagnostic
testing is available for couples who are both carriers
of sickle cell disease and thalassemia determined
by hemoglobin electrophoresis. The genetic testing
options in pregnancy are rapidly growing with the
completion of the human genome project; however,
a thorough family history is essential to identify a
couple at risk.
Genetic testing during pregnancy may establish
a diagnosis that may influence obstetric manage-
ment. For example, PCR of amniotic fluid is used
to determine the Rh status of the fetus to determine
if the fetus is at risk for hemolytic disease of the
newborn when the woman is Rh sensitized and the
man is a heterozygous carrier of antigen D. The
fetus at risk will need close surveillance during the
pregnancy. A specific molecular diagnostic test may
be considered when the finding of a fetal malfor-
mation by ultrasonography raises the suspicion of
a genetic disorder. For example, mutation testing
for CF in a fetus with echogenic bowel, fibroblast
growth factor receptor 2 (FGFR2) for suspected
Apert’s syndrome (craniosynostosis), and 22q11.2
deletion testing when a conotruncal cardiac defect is
detected. Identification of an etiology provides the
physician and couple with a better understanding of
the prognosis that influences not only the obstetric
and neonatal care of the infant but also a couple’s
reproductive decisions. Furthermore, it establishes
an accurate assessment of the recurrence risk for this
family and their relatives.
Some of the genes responsible for the inherited
forms of some types of cancer (such as breast, ovari-
an, and colon) have been identified. Risk assessment
for relatives in these families may include genetic
testing in addition to evaluating other risk factors,
such as family history. In some families, breast and
ovarian cancer is attributed to an inherited genetic
COMMITTEE OPINIONS
mutation, BRCA1 or BRCA2. The genes responsible
for hereditary nonpolyposis colorectal cancer, juve-
nile polyposis, and familial adenomatosis polyposis,
have been identified. It is likely that other genes that
contribute to cancer will be identified in the future,
which may be useful for cancer risk assessment and
management.
Genetic screening and testing should be con-
sidered a component of an infertility evaluation.
Preconceptional genetic screening and counseling
can identify couples at risk for having offspring with
a genetic disorder and provide them with informa-
tion that enables them to make informed decisions
regarding their reproductive options. Genetic causes
of severe oligospermia and azoospermia include
balanced translocations, Klinefelter’s syndrome
(47,XXY), and Y chromosome abnormalities and
microdeletions. Cytogenetic studies and PCR-based
Y chromosome deletion testing should be consid-
ered. Approximately two thirds of males with con-
genital bilateral absence of the vas deferens have at
least one CF mutation. Men with congenital bilateral
absence of the vas deferens should be offered CF
carrier testing. Partners of carriers and individuals
with CF should be tested to assess their risk for hav-
ing a child with CF. This information may be useful
for an infertile couple considering their reproductive
options, such as testicular aspiration and biopsy with
intracytoplasmic sperm injection, preimplantation
genetic diagnosis with in vitro fertilization, donor
gamete, adoption, and prenatal testing.
Summary
Human genetics and molecular testing is playing an
increasingly important role in obstetric and gyne-
cologic practice. It is essential that obstetricians
and gynecologists are aware of the advances in our
understanding of genetic disease and the funda-
mental principles of molecular testing and genetic
screening as genetics is integrated into routine
medical practice. In the future, elucidation of the
genetic basis for reproductive disorders, common
diseases, and cancer with improved high throughput
technology for genetic testing will expand testing
opportunities and influence treatment options and
prevention strategies.
Reference
1. The human genome. Science 2001;291:1145­–1434
2013 COMPENDIUM OF SELECTED PUBLICATIONS 319
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Blackwood MA, Weber BL. BRCA1 and BRCA2: from
molecular genetics to clinical medicine. J Clin Oncol 1998;16:
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Brown PO, Botstein D. Exploring the new world of the genome
with DNA microassays. Nat Genet 1999;21(suppl):33–37
Caskey CT. Medical genetics. JAMA 1997;277:1869–1870
Collins FS. Genetics: an explosion of knowledge is transform-
ing clinical practice. Geriatrics 1999;54:41–47;quiz 48
Glossary
Allele: One of two or more alternate forms of a gene.
Allele specific oligonucleotides: Synthetic oligonucleotide
designed to hybridize to a specific sequence, and under the
right conditions, to fail to hybridize to a related sequence.
Allele specific oligonucleotides also are used as PCR primers
in several methods similarly designed to distinguish between
closely related alleles.
Autosomal Dominant: An allele located on an autosome
(nonsex chromosome) that expresses itself phenotypically in
the presence of the same or a different allele (ie, in a homozy-
gous or heterozygous condition).

Cooper DN, Schmidtke J. Diagnosis of human genetic disease
using recombinant DNA. 4th ed. Hum Genet 1993;92:211–236
Davis JG. Predictive genetic tests: problems and pitfalls. Ann
N Y Acad Sci 1997;833:42–46
Jameson JL. Principles of molecular medicine. Totowa, New
Jersey: Humana Press, 1998
Korf B. Molecular diagnosis (1). N Engl J Med 1995;332:
1218–1220
Korf B. Molecular diagnosis (2). N Engl J Med 1995;332:
1499–1502
Makowski DR. The Human Genome Project and the clinician.
J Fla Med Assoc 1996;83:307–314
Mark HF, Jenkins R, Miller WA. Current applications of
molecular cytogenetic technologies. Ann Clin Lab Sci 1997;27:
47–56
Pyeritz RE. Family history and genetic risk factors: forward to
the future. JAMA 1997;278:1284–1285
Autosomal Recessive: An allele located on an autosome that
does not express itself phenotypically in the presence of a
dominant allele (ie, in a heterozygous condition). It is only
phenotypically expressed in a homozygous condition.
Chimera: An organism with tissues composed of two or more
genetically distinct cell types.
Chromatin: An intranuclear and intrachromosomal complex
made up of DNA, and histone and nonhistone proteins.
Co-Dominant: Alleles that are different from each other, but
both are expressed in the phenotype.
Codon: A section of DNA (three nucleotide pairs in length)
that codes for a single amino acid.
Comparative Genomic Hybridization: A cytogenetic meth-
od based on a combination of fluorescence microscopy and
digital image analysis. Differentially labeled test DNA and
normal reference DNA are hybridized simultaneously to nor-
mal chromosome spreads. Hybridization is detected with two
different fluorochromes. Deletions, duplications, or amplifica-
tions are seen as changes in the ratio of the intensities of the
two fluorochromes along the target chromosomes.

Sources of Online Information Complementary DNA (cDNA) Probe: A DNA sequence

that is exactly complementary to mRNA, lacking introns and
Tutorial in Genetics (HHMI) www.hhmi.org/ regulatory regions.
GeneticTrail/
Online Mendelian Inheritance in Man www3.ncbi.nlm. Contiguous Gene Deletion Syndrome: A syndrome caused
nih.gov/Omim/ by a deletion involving genes that are physically located
MEDLINE together in a chromosome segment.
www.ncbi.nlm.nih.gov/PubMed/ Constitutive Heterochromatin: Condensed genetically inac-
GeneTests tive chromatin located in the same regions of both homologous
www.genetests.org chromosomes.
Genome Database
DNA: A double-helical structure composed of two coils of
www.gob.org
nucleotide chains connected by nitrogen bases.
Biochemical testing information biochemgen.ucsd.edu/
wbgtests/dz.tst.htm DNA Hybridization: A process whereby labeled nucleic acid
Alliance of Genetic Support Groups medhlp.netusa.net/ molecules (oligonucleotide probe) bind to a DNA sequence on
www/agsg.htm a target (Southern blot, metaphase chromosomes, or interphase
National Human Genome Research nuclei) that is complementary to its own.
www.nhgri.nih.gov DNA Methylation: A process for control of tissue specific
Centers for Disease Control and Prevention www.cdc. gene expression. Methylation “turns off” the regulatory region
gov/genetics of a gene, thereby preventing DNA transcription.
Gene Clinics Epigenetic: Non–DNA/RNA related process that affects geno-
www.geneclinics.org
type and phenotype (ie, methalization).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 320

 Exon: A region of a gene made up of DNA sequences that will
be transcribed into mRNA.
Expressivity: The degree to which a genotype is expressed in
the phenotype (range of phenotypic features).
Fluorescence in situ Hybridization (FISH): A procedure for
detecting specific nucleic acid sequences in morphologically
preserved chromosomes, cells, and tissue sections using fluo-
rescent labeled oligonucleotide probes.
Gene: A unit of heredity responsible for the inheritance of a
specific trait that occupies a fixed chromosomal site and cor-
responds to a sequence of nucleotides along a DNA molecule.
Genome: The entire complement of genetic material in a
chromosome set.
Genomic Imprinting: The existence of parent-of-origin dif-
ferences in the expression of certain genes.
Germline Mosaicism: Mosaicism that is confined to the gonad.
Hereditary Unstable DNA (Triplet Repeat Expansion):
Gene containing a region of triplet codon repeats such as
(CGC)n. The number of triplet repeats can increase during
meiosis. If the expansion of repeats reaches a critical number,
the gene becomes methylated and is turned off, resulting in
phenotypic abnormalities.
Heterochromatin: Chromatin that remains condensed
throughout interphase. It contains DNA that is genetically
inactive and replicates late in the S phase of the cell cycle.
There are two types of heterochromatin: constitutive and fac-
ultative.
Hybridization (Dot Blot): A semiquantitative technique for
evaluating the relative abundance of nucleic acid sequences
in a mixture or the extent of similarity between homologous
sequences.
Imprinting: The imposition of a stable behavior pattern in
a young animal by exposure, during a particular period in its
development, to one of a restricted set of stimuli.
Intron: A region of a gene, made up of noncoding DNA
sequences that lies between exons.
Karyotype: The chromosome constitution of an individual.
Linkage: The association of genes on the same chromosome.
Methylation: (see DNA Methylation)
Mitochondrial Inheritance: Mitochondria are inherited
exclusively from women. Because they contain DNA, mito-
chondrial inheritance allows transmission of genes directly
from the woman to her offspring.
Mosaicism: The presence of two or more populations of cells
with different characteristics within one tissue or organ.
Multifactorial Inheritance: Inheritance of traits that are
determined by a combination of genetic and environmental
factors.
Mutation: An alteration of DNA sequencing in a gene that
results in a heritable change in protein structure or function that
frequently has adverse effects.
COMMITTEE OPINIONS
Deletion: A mutation that is generated by removal of a
sequence of DNA, with the regions on either side being
joined together.
Expansion (see Hereditary Unstable DNA)
Frame-shift: A mutation caused by deletions or inser-
tions that are not a multiple of three base pairs. Results in
a change in the reading frame in which triplet codons are
translated into protein.
Insertion: A mutation caused by the presence of an addi-
tional sequence of nucleotide pairs in DNA.
Inversion: A mutation involving the removal of a DNA
sequence, its rotation through 180 degrees, and its reinser-
tion in the same location.
Missense: A mutation that alters a codon so that it encodes
a different amino acid.
Northern Blot: A technique for transferring RNA from an
electrophoresis gel to a nitrocellulose filter on which it can be
hybridized to a complementary DNA (cDNA) probe.
Nucleotide: A component of a DNA or RNA molecule com-
posed of a nitrogenous base, one deoxyribose or ribose sugar,
and one phosphate group. In DNA, adenine specifically joins
to thymine and guanine joins to cytosine. In RNA, uracil
replaces thymine.
Oligonucleotide Primer: A short sequence of nucleotides that
is necessary to hybridize to a DNA or RNA strand using the
enzymes DNA polymerase or reverse transcriptase.
Penetrance: The ability of a mutant gene to be expressed in an
individual who carries the gene.
Phenotype: Observable physical characteristics of an organ-
ism resulting from the expression of the genotype and its
interaction with the environment.
Polygenic Inheritance: Inheritance of traits that are deter-
mined by the combined effects of many genes.
Polymerase Chain Reaction (PCR): A method for enzymati-
cally amplifying a short sequence of DNA through repeated
cycles of denaturation, binding with an oligonucleotide primer
and extension of the primers by a DNA polymerase.
Polymorphisms: Minor differences that distinguish one indi-
vidual from another.
Recombinant DNA: A new DNA sequence formed by the
combination of two nonhomologous DNA molecules.
Restriction Endonuclease: An enzyme that recognizes and
cleaves a specific DNA sequence (usually 4–10 nucleotide
bases long).
Restriction Fragment Length Polymorphism: A polymor-
phic difference in DNA sequence between individuals that can
be recognized by restriction endonucleases.
Southern Blot: A technique used to detect specific DNA
sequences by separating restriction enzyme digested DNA
fragments on an electrophoresis gel, transferring (blotting)
these fragments from the gel onto a membrane or nitrocellu-
lose filter, followed by hybridization with a labeled probe to a
specific DNA sequence.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 321
 Spectral Karyotype: A molecular cytogenetic method in
which all of the chromosomes in a metaphase spread are visu-
alized in different colors (multicolor FISH).
Uniparental Disomy: Inheritance of two copies of part or all
of a chromosome from one parent and no copy from the other
parent.
Uniparental Heterodisomy: Inheritance of two homologous
chromosomes from one parent.
Uniparental Isodisomy: Inheritance of two identical chromo-
somes from one parent.
Threshold Traits: Traits that are not manifested until a certain
threshold of liability is exceeded.
Transcription: The process of RNA synthesis from a DNA
template that is directed by RNA polymerase.
Triplet Repeat Expansion (see Hereditary Unstable DNA)
Copyright © July 2002 by the American College of Ob­ste­tri­
cians and Gynecologists. All rights reserved. No part of this
publication may be reproduced, stored in a re­triev­al sys­tem, or
transmitted, in any form or by any means, elec­tron­ic, me­chan­
i­cal, photocopying, recording, or oth­er­wise, without prior writ-
ten permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Genetics and molecular diagnostic testing. ACOG Technology
Assessment in Obstetrics and Gynecology No. 1. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2002;100:193–211.

Trinucleotide Repeat Analysis (Repeats): Unstable DNA

sequences found in several human genes. Normally the triplets
are repeated in tandem 5–50 times. When the number rises
above the normal range, mutant disease syndromes appear.
X-inactivation: A process by which one of the X chromo-
somes in each somatic cell of females is rendered inactive. This
results in a balance in gene expression between the X chromo-
somal and autosomal genes, which is necessary because males
have only one X chromosome.
X-linked: An allele for a trait or disorder that is located on
the X chromosome, and may be either dominant or recessive.
Western Blot: A technique, conceptually related to the Southern
and Northern blot that is used to detect specific proteins.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 322

COMMITTEE OPINIONS
Committee on Gynecologic Practice

2013 COMPENDIUM OF SELECTED PUBLICATIONS 323

 ACOG Committee
Committee on
Gynecologic Practice
Committee on
Obstetric Practice
Reaffirmed 2008
Opinion
Number 240, August 2000 (Replaces No. 145, November 1994)

Statement on Surgical Assistants

Competent surgical assistants should be available for all major obstetric
and gynecologic operations. In many cases, the complexity of the surgery
or the patient’s condition will require the assistance of one or more physi-
cians to provide safe, quality care. Often, the complexity of a given surgical
This document reflects emerg­ing procedure cannot be determined prospectively. Procedures including, but not
clin­i­cal and scientific ad­vanc­ limited to, operative laparoscopy, major abdominal and vaginal surgery, and
es as of the date issued and is
sub­ject to change. The in­for­ma­ cesarean delivery may warrant the assistance of another physician to optimize
tion should not be con­strued as safe surgical care.
dic­tat­ing an ex­clu­sive course The primary surgeon’s judgment and prerogative in determining the
of treat­ment or pro­ce­dure to be number and qualifications of surgical assistants should not be overruled by
followed. public or private third-party payers. Surgical assistants should be appropri-
Copyright © August 2000 ately compensated.
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 324

 ACOG Committee
Committee on
Gynecologic Practice
Reaffirmed 2008
Opinion
(Replaces Statement of Policy on
Number 253, March 2001 Liposuction, January 1988)

Nongynecologic Procedures
Cosmetic procedures (such as laser hair removal, body piercing, tattoo
removal, and liposuction) are not considered gynecologic procedures and,
This document reflects emerg­ing therefore, generally are not taught in approved obstetric and gynecologic
clin­i­cal and scientific ad­vances residencies. Because these are not considered gynecologic procedures, it is
as of the date issued and is sub­
ject to change. The in­for­ma­tion
inappropriate for the College to establish guidelines for training. As with
should not be con­strued as dic­ other surgical procedures, credentialing for cosmetic procedures should be
tat­ing an ex­clu­sive course of based on education, training, experience, and demonstrated competence.
treat­ment or pro­ce­dure to be
followed.
Copyright © March 2001
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 325

 ACOG
Committee on
Gynecologic Practice
Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © November 2002
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Avoiding inappropriate clinical deci-
sions based on false-positive human
chorionic gonadotropin test results.
ACOG Committee Opinion No. 278.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2002;100:1057-9.
COMMITTEE OPINIONS
Committee
Opinion
Number 278, November 2002
Avoiding Inappropriate Clinical
Decisions Based on False-Positive
Human Chorionic Gonadotropin
Test Results
ABSTRACT: Clinically significant false-positive human chorionic gonado-
tropin (hCG) test results are rare. However, some individuals have circulat-
ing factors in their serum (eg, heterophilic antibodies or nonactive forms of
hCG) that interact with the hCG antibody and cause unusual or unexpected
test results. False-positive and false-negative test results can occur with any
specimen, and caution should be exercised when clinical findings and labora-
tory results are discordant. Methods to rule out the presence of interfering
substances include using a urine test, rerunning the assay with serial dilu-
tions of serum, preabsorbing serum, and using another assay. Physicians
must decide whether the risks of waiting for confirmation of results outweigh
the risks of failing to take immediate medical action. Patients should be noti-
fied if they are at risk for recurrent false-positive hCG test results, and this
information should be included in the patient’s medical record.
Clinical management of many gynecologic conditions has improved dra-
matically over recent decades through the development of very sensitive and
highly specific assays for hormones, particularly human chorionic gonado-
tropin (hCG). These assays have revolutionized the management of ectopic
pregnancy and gestational trophoblastic disease, which now have a substan-
tially lower mortality rate as a result of the ability to quantitate circulating
(serum) and urinary hCG.
With the technologic improvements, hCG assays are now capable of
detecting the presence of a pregnancy before a missed menstrual period. It is
vital to remember that, despite technical advances, the ability of laboratory
measurements to guide the clinician appropriately in every circumstance is
limited (1–3). The purpose of this Committee Opinion is to offer recom-
mendations to better manage situations in which hCG assays may provide
false-positive results.
Some individuals have circulating factors in their serum that interact
with the hCG antibody. The most common are heterophilic antibodies.
These are human antibodies directed against animal-derived antigens used
2013 COMPENDIUM OF SELECTED PUBLICATIONS 326
 in immunoassays (1, 4–9). Individuals who have
worked as animal laboratory technicians or in
veterinary facilities or who were reared on farms
are more likely to develop heterophilic antibodies.
Immunoassays of all kinds use animal antibodies.
People with heterophilic antibodies might have
unusual results in a number of different kinds of
assays. However, because the animal antibodies are
used in different amounts and with other reagents
in each assay system, a person with heterophilic
antibodies will not always have an unusual or unex-
pected result. Results can differ depending on the
particular assay used.
Clinically significant false-positive results are
rare. One report noted that 5 of 162 women studied
had evidence of assay interference sufficient to pro-
vide misleading results (10). If results are mislead-
ing, they usually are seen with values below 1,000
mIU/mL. To rule out the presence of heterophilic
antibodies or other interfering substances, several
methods can be used:
• A urine test (either quantitative or qualitative)
for hCG can be performed. Because heterophilic
antibodies are not present in urine, if the urine
test result is negative and the serum test result
is persistently positive, interference in the serum
immunoassay is confirmed if the serum value is
≥ 50 mIU/mL (3).
• The assay can be rerun with serial dilutions of
the serum. Because heterophilic antibodies are
directed to reagents in the immunoassay and not
hCG, their interaction with the hCG curve will
not be linear. Lack of linearity confirms assay
interference.
• Some laboratories can preabsorb serum to remove
heterophilic antibodies before performing the
assay. If the result becomes negative after remov-
al of the heterophilic antibody, interference can
be confirmed (11).
There are other ways in which the amount of
“true” hCG can be measured differently or even
incorrectly by immunoassays. The size of the hCG
molecule circulating in the blood of individuals may
vary as a result of differences in the protein and car-
bohydrate structure of hCG. This type of variation is
called microheterogeneity of hCG, and it sometimes
can account for differences in measurements report-
ed by different assays. Additionally, some indi-
viduals may produce aberrant forms of hCG that are
not biologically active—or are other hormones
COMMITTEE OPINIONS
entirely––that will cross-react with the hCG assays.
Still others may partly break down circulating
hCG into nonbiologically active forms that react
differently with the various assay systems. In these
circumstances, substances other than native, biologi-
cally active hCG may be recognized by the assay
system. Repeating the hCG measurement in a differ-
ent assay system can best detect this problem.
Wide variations between repeat runs of the same
assay could result from serum factors interfering
with the assay. Serial dilution of the specimen will
be helpful in documenting nonlinearity and confirm-
ing the presence of interference.
Finally, inherent assay factors can result in
false-positive hCG results. Repeat testing using a
different assay system may confirm that the result
was falsely positive if the result is now negative.
Patients with evidence of hCG assay interfer-
ence should be notified that they are at risk for recur-
rent false-positive hCG assay results. These patients
should be instructed to inform all future health care
practitioners of this problem, and the information
should be included in the patient’s medical record.
In summary, modern assay methods have almost
eliminated laboratory error. However, false-positive
and false-negative test results can occur with any
specimen. Caution should be exercised whenever
clinical findings and laboratory results are discor-
dant. Although false-positive serum hCG results are
rare, if unrecognized, they may lead to unwarranted
clinical interventions for conditions such as persis-
tent trophoblastic disease. The physician must judge
whether the risks of waiting for confirmation of
results outweigh the risks of failing to take immedi-
ate action.
References
1. Cole LA, Kardana A. Discordant results in human chori-
onic gonadotropin assays. Clin Chem 1992;38:263–70.
2. Cole LA, Rinne KM, Shahabi S, Omrani A. False-positive
hCG assay results leading to unnecessary surgery and
chemotherapy and needless occurrences of diabetes and
coma. Clin Chem 1999;45:313–4.
3. Rotmensch S, Cole LA. False diagnosis and needless
therapy of presumed malignant disease in women with
false-positive human chorionic gonadotropin concentra-
tions. Lancet 2000;355:712–5.
4. Boscato LM, Stuart MC. Incidence and specificity of
interference in two-site immunoassays. Clin Chem 1986;
32:1491–5.
5. Boscato LM, Stuart MC. Heterophilic antibodies: a prob-
lem for all immunoassays. Clin Chem 1988;34:27–33.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 327
 6. Check JH, Nowroozi K, Chase JS, Lauer C, Elkins B, Wu
CH. False-positive human chorionic gonadotropin levels
caused by a heterophile antibody with the immunoradio-
metric assay. Am J Obstet Gynecol 1988;158:99–100.
7. Weber TH, Kapyaho KI, Tanner P. Endogenous interfer-
ence in immunoassays in clinical chemistry. A review.
Scand J Clin Lab Invest Suppl 1990;201:77–82.
8. Berglund L, Holmberg NG. Heterophilic antibodies
against rabbit serum causing falsely elevated gonadotropin
levels. Acta Obstet Gynecol Scand 1989;68:377–8.
COMMITTEE OPINIONS
9. King IR, Doody MC. False-positive hCG by enzyme
immunoassay resulting in repeated chemotherapy. Obstet
Gynecol 1995;86:682–3.
10. Rzasa PJ, Caride VJ, Prokop EK. Discordant inter-kit
results in the radioimmunoassay for choriogonadotropin
in serum. Clin Chem 1984;30:1240–3.
11. Cole LA. Phantom hCG and phantom choriocarcinoma.
Gynecol Oncol 1998;71:325–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 328
 ACOG
Committee on
Gynecologic Practice
Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject to
change. The in­for­ma­tion should not
be con­strued as dic­tat­ing an ex­clu­
sive course of treat­ment or pro­ce­dure
to be followed.
The Committee wishes to thank the
ACOG Preconception Care Work
Group co-chairs, Michele G. Curtis,
MD, and Paula J. Adams Hillard,
MD, and members, Hani K. Atrash,
MD, MPH; Alfred Brann Jr, MD;
Siobhan M. Dolan, MD, MPH; Ann
Lang Dunlop, MD; Ann Weathersby,
CNM, MSN; and Gerald Zelinger,
MD, for their assistance in the devel-
opment of this opinion.
Copyright © September 2005 by the
American College of Obstetricians
and Gynecologists. All rights
reserved. No part of this publica-
tion may be reproduced, stored in a
retrieval system, or transmitted, in
any form or by any means, electronic,
mechanical, photocopying, recording,
or otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to make
pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
The importance of preconception
care in the continuum of women’s
health care. ACOG Committee
Opinion No. 313. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:665–6
COMMITTEE OPINIONS
Committee
Opinion
Number 313, September 2005
The Importance of Preconception
Care in the Continuum of Women’s
Health Care
ABSTRACT: The goal of preconception care is to reduce the risk of adverse
health effects for the woman, fetus, or neonate by optimizing the woman’s health
and knowledge before planning and conceiving a pregnancy. Because reproduc-
tive capacity spans almost four decades for most women, optimizing women’s
health before and between pregnancies is an ongoing process that requires
access to and the full participation of all segments of the health care system.
Although most pregnancies result in good maternal and fetal outcomes, some
pregnancies may result in adverse health effects for the woman, fetus, or
neonate. Although some of these outcomes cannot be prevented, optimizing
a woman’s health and knowledge before planning and conceiving a preg-
nancy—also referred to as preconception care or prepregnancy care—may
eliminate or reduce the risk. For example, initiation of folic acid supple-
mentation at least 1 month before pregnancy reduces the incidence of neural
tube defects such as spina bifida and anencephaly (1–3). Similarly, adequate
glucose control in a woman with diabetes before conception and through-
out pregnancy can decrease maternal morbidity, spontaneous abortion, fetal
malformation, fetal macrosomia, intrauterine fetal death, and neonatal mor-
bidity (4).
Nearly half of all pregnancies in the United States are unintended (5).
Therefore, the challenge of preconception care lies not only in addressing
pregnancy planning for women who seek medical care and consultation
specifically in anticipation of a planned pregnancy but also in educating and
screening all reproductively capable women on an ongoing basis to iden-
tify potential maternal and fetal risks and hazards to pregnancy before and
between pregnancies.
This Committee Opinion reinforces the importance of preconception
care, provides resources for the woman’s health care clinician, and pro-
poses that every reproductively capable woman create a reproductive health
plan. The specific clinical content of preconception care is outlined else-
where (6–8).
Several national and international medical organizations and advocacy
groups have focused on the optimization of health before conception, result-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 329
 ing in the development of clinical recommendations
and educational materials (see Resources). Core
preconception care considerations addressed by all
include the following factors:
• Undiagnosed, untreated, or poorly controlled
medical conditions
• Immunization history
• Medication and radiation exposure in early
pregnancy
• Nutritional issues
• Family history and genetic risk
• Tobacco and substance use and other high-risk
behaviors
• Occupational and environmental exposures
• Social issues
• Mental health issues
As medical care rapidly advances, the list of issues
to consider when planning a pregnancy continues
to grow.
Clinicians should encourage women to formu-
late a reproductive health plan and should discuss
it in a nondirective way at each visit. Such a plan
would address the individual’s or couple’s desire for
a child or children (or desire not to have children);
the optimal number, spacing, and timing of children
in the family; and age-related changes in fertility.
Because many women’s plans change over time,
creating a reproductive health plan requires an ongo-
ing conscientious assessment of the desirability of a
future pregnancy, determination of steps that need to
be taken either to prevent or to plan for and optimize
a pregnancy, and evaluation of current health status
and other issues relevant to the health of a pregnancy.
A question such as “Are you considering preg-
nancy, or could you possibly become pregnant?”
can initiate several preconception care interventions,
including those listed as follows:
• A dialogue regarding the patient’s readiness for
pregnancy
• An evaluation of her overall health and opportu-
nities for improving her health
• Education about the significant impact that
social, environmental, occupational, behavioral,
and genetic factors have in pregnancy
• Identification of women at high risk for an
adverse pregnancy outcome
If pregnancy is not desired, current contraceptive
use and options should be discussed to assist the
patient in identifying the most appropriate and effec-
tive method for her.
COMMITTEE OPINIONS
Preconception and interpregnancy care are com-
ponents of a larger health care goal—optimizing the
health of every woman (9). Because reproductive
capacity spans almost four decades for most women,
optimizing women’s health before and between
pregnancies is an ongoing process that requires
access to and the full participation of all segments
of the health care system.
References
1. Czeizel AE, Dudas I. Prevention of the first occurrence of
neural-tube defects by periconceptional vitamin supple-
mentation. N Engl J Med 1992;327:1832–5.
2. Prevention of neural tube defects: results of the Medical
Research Council Vitamin Study. MRC Vitamin Study
Research Group. Lancet 1991;338:131–7.
3. Botto LD, Moore CA, Khoury MJ, Erickson JD. Neural-
tube defects. N Engl J Med 1999;341:1509–19.
4. Pregestational diabetes mellitus. ACOG Practice Bulletin
No. 60. American College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2005;105:675–85.
5. Henshaw SK. Unintended pregnancy in the United States.
Fam Plann Perspect 1998;30:24–9, 46.
6. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Guidelines for perinatal
care. 5th ed. Elk Grove Village (IL): AAP; Washington,
DC: ACOG; 2002.
7. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care. 2nd ed. Washington,
DC: ACOG; 2002.
8. American College of Obstetricians and Gynecologists,
American College of Medical Genetics. Preconception
and prenatal carrier screening for cystic fibrosis. Clinical
and laboratory guidelines. Washington, DC: ACOG;
2001.
9. American College of Obstetricians and Gynecologists.
Access to women’s health care. ACOG Statement of
Policy. Washington, DC: ACOG; 2003.
Resources
American College of Obstetricians and Gynecologists
www.acog.org
American Academy of Family Physicians
www.aafp.org
American Academy of Pediatrics
www.aap.org
American College of Nurse-Midwives
www.acnm.org
American Society for Reproductive Medicine
www.asrm.org
Association of Women’s Health, Obstetric and Neonatal
Nurses
www.awhonn.org
Centers for Disease Control and Prevention National Center
on Birth Defects and Developmental Disabilities
www.cdc.gov/ncbddd
March of Dimes
www.marchofdimes.com
2013 COMPENDIUM OF SELECTED PUBLICATIONS 330
 ACOG
Committee on
Gynecologic Practice
Reaffirmed 2009
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright © November 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Elective coincidental appendectomy.
ACOG Committee Opinion No. 323.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2005;106:1141–2.
COMMITTEE OPINIONS
Committee
Opinion
Number 323, November 2005 (Replaces No. 164, December 1995)
Elective Coincidental Appendectomy
ABSTRACT: Because of a lack of evidence from randomized trials, it remains
unclear whether the benefits of routine elective coincidental appendectomy
outweigh the cost and risk of morbidity associated with this prophylactic
procedure. Because the risk–benefit analysis varies according to patient age
and history, the decision to perform an elective coincidental appendectomy
at the time of an unrelated gynecologic surgical procedure should be based
on individual clinical scenarios and patient characteristics and preferences.
Elective coincidental appendectomy is defined as the removal of the appen-
dix at the time of another surgical procedure unrelated to appreciable appen-
diceal pathology. Cases in which appendectomy may be indicated on the
basis of appendiceal pathology are not addressed in this document.
The possible benefits of performing elective coincidental appendectomy
include preventing a future emergency appendectomy and excluding appen-
dicitis in patients with complicated differential diagnoses, such as those who
have chronic pelvic pain or endometriosis. Other groups that may benefit
from elective coincidental appendectomy include women in whom pelvic
or abdominal radiation or chemotherapy is anticipated, women undergo-
ing extensive pelvic or abdominal surgery in which major adhesions are
anticipated postoperatively, and patients in whom making the diagnosis of
appendicitis may be difficult because of diminished ability to perceive or
communicate symptoms (eg, the developmentally disabled).
Most studies suggest that there is little, if any, increased morbidity asso-
ciated with elective coincidental appendectomy at the time of gynecologic
surgery, whether performed during an open surgical procedure (1–3) or
during laparoscopy (4, 5). However, most of these studies are affected by
methodological limitations such as retrospective design, small sample size,
and lack of an appropriate control group. One large retrospective study using
discharge data from all general hospitals in Ontario during a 10-year period
highlights some of the challenges of addressing this issue with data from
nonrandomized studies (6). This study compared in-hospital fatality rates,
complication rates, and lengths of hospital stay between patients undergoing
open primary cholecystectomy with and without incidental appendectomy.
Initial results indicated a paradoxical reduction in morbidity and mortality
2013 COMPENDIUM OF SELECTED PUBLICATIONS 331
 after cholecystectomy when incidental appendec-
tomy was performed. This most likely was because
healthier, lower-risk patients are more likely to
undergo an elective coincidental appendectomy.
However, once multivariate adjustments were made
to address these differences in patient characteris-
tics, differences in complication rates were reduced
or eliminated. Furthermore, when the study ex-
cluded high-risk subgroups, a consistently signifi-
cant increase in complication rates among low-risk
patients who underwent incidental appendectomy
was found. These findings suggest that unmea-
sured or uncontrolled confounding or both make
the interpretation of most nonrandomized studies
of this topic difficult, but there is probably a small
increased risk of nonfatal complications associated
with elective coincidental appendectomy.
Given this presumed small but increased risk
of complications, the primary debate surrounding
elective coincidental appendectomy is whether the
additional cost and morbidity incurred at the time
of this prophylactic procedure outweigh the cost
and risk of morbidity from developing appendicitis
in the future. Because the estimated lifetime risk of
appendicitis among women is less than 7% (7), a
number of elective appendectomies will be required
to prevent one case of acute appendicitis. Depending
on hospital costs and physician reimbursement rates,
the cost-effectiveness of this procedure will vary
according to the clinical setting.
Although the incidence of acute appendicitis is
greatest between the ages of 10 and 19 years and
decreases with age (7), the risks associated with
acute appendicitis increase with age. Therefore, the
risk–benefit analysis changes according to patient
age. A study involving open coincidental appen-
dectomies in otherwise healthy women undergoing
gynecologic procedures concluded that the greatest
benefit was in patients younger than 35 years (8).
The study also concluded that patients between 35
years and 50 years of age might benefit from elec-
tive coincidental appendectomy based on specific
clinical circumstances. The data, however, did not
support elective coincidental appendectomy for
patients older than 50 years.
COMMITTEE OPINIONS
The benefit of elective coincidental appendec-
tomy remains controversial and is still open to
debate. It appears, from limited data, that women
35 years of age and younger benefit most from
elective coincidental appendectomy. The decision
to perform elective coincidental appendectomy at
the time of gynecologic procedures should be based
on individual clinical scenarios after a discussion
of risks and benefits with the patient. In light of
the low risk of morbidity based on current limited
data, a patient’s concern about developing future
appendicitis may be considered. If there is a rea-
sonable probability that the benefits outweigh the
risks, based on age or history, elective coincidental
appendectomy during a primary gynecologic pro-
cedure may be appropriate. Because there are clini-
cal situations in which the benefits of an elective
coincidental appendectomy may outweigh the risks,
insurance companies should be encouraged to pay
for this procedure in select cases.
Reference
1. Salom EM, Schey D, Penalver M, Gomez-Marin O,
Lambrou N, Almeida Z, et al. The safety of incidental
appendectomy at the time of abdominal hysterecto-
my. Am J Obstet Gynecol 2003;189:1563–7; discussion
1567–8.
2. Tranmer BI, Graham AM, Sterns EE. Incidental appen-
dectomy?—Yes. Can J Surg 1981;24:191–2.
3. Voitk AJ, Lowry JB. Is incidental appendectomy a safe
practice? Can J Surg 1988;31:448–51.
4. Chiarugi M, Buccianti P, Decanini L, Balestri R,
Lorenzetti L, Franceschi M, et al. “What you see is not
what you get.” A plea to remove a ‘normal’ appendix
during diagnostic laparoscopy. Acta Chir Belg 2001;101:
243–5.
5. Nezhat C, Nezhat F. Incidental appendectomy during vid-
eolaseroscopy. Am J Obstet Gynecol 1991;165: 559–64.
6. Wen SW, Hernandez R, Naylor CD. Pitfalls in nonran-
domized outcomes studies. The case of incidental appen-
dectomy with open cholecystectomy. JAMA 1995;274:
1687–91.
7. Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epide-
miology of appendicitis and appendectomy in the United
States. Am J Epidemiol 1990;132:910–25.
8. Snyder TE, Selanders JR. Incidental appendectomy—yes
or no? A retrospective case study and review of the litera-
ture. Infect Dis Obstet Gynecol 1998;6:30–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 332
 ACOG
Committee on
Obstetric Practice
Committee on
Gynecologic Practice
Committee on
Genetics
Reaffirmed 2007
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright © November 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or other-
wise, without prior written per-
mission from the publisher.
Requests for authorization to
make photocopies should be
directed to:
Copyright Clearance Center
222 Rosewood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Perinatal risks associated with
assisted reproductive technology.
ACOG Committee Opinion No. 324.
American College of Obstetricians and
Gynecologists. Obstet Gynecol 2005;
106:1143–6.
COMMITTEE OPINIONS
Committee
Opinion
Number 324, November 2005
Perinatal Risks Associated With
Assisted Reproductive Technology
ABSTRACT: Over the past two decades, the use of assisted reproductive
technology (ART) has increased dramatically worldwide and has made preg-
nancy possible for many infertile couples. A growing body of evidence sug-
gests an association between pregnancies resulting from ART and perinatal
morbidity (possibly independent of multiple births), although the absolute
risk to children conceived through ART is low. Prospective studies are
needed to further define the risk of ART to offspring. The single most impor-
tant health effect of ART for the offspring remains iatrogenic multiple fetal
pregnancy. The American College of Obstetricians and Gynecologists sup-
ports the effort toward lowering the risk of multiple gestation with ART.
Over the past two decades, the use of assisted reproductive technology
(ART) has increased dramatically worldwide and has made pregnancy pos-
sible for many infertile couples. The American Society for Reproductive
Medicine defines ART as treatments and procedures involving the handling
of human oocytes and sperm, or embryos, with the intent of establishing a
pregnancy (1). By this definition, ART includes in vitro fertilization (IVF)
with or without intracytoplasmic sperm injection (ICSI), but it excludes tech-
niques such as artificial insemination and superovulation drug therapy.
Several studies have been conducted to describe and compare the obstet-
ric outcome of pregnancies resulting from ART with those of pregnancies
conceived without treatment. Some retrospective and prospective follow-up
studies suggest that pregnancies achieved by ART are associated with an
increased risk of prematurity, low birth weight, and neonatal encephalopathy
and a higher perinatal mortality rate, even after adjusting for age, parity, and
multiple gestation (2, 3). Even in studies limited to singleton ART pregnan-
cies, the prematurity rate is twice as high, and the proportion of infants with
low birth weight is three times as high as that of the general population
(4, 5). A meta-analysis of 15 studies comprising 12,283 singleton infants
conceived by IVF and 1.9 million spontaneously conceived singleton infants
showed significantly higher odds of perinatal mortality (odds ratio [OR],
2.2), preterm delivery (OR, 2.0), low birth weight (OR, 1.8), very low birth
weight (OR, 2.7), and small for gestational age status (OR, 1.6) in IVF preg-
nancies, after adjusting for maternal age and parity (6).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 333
 It is difficult to determine the degree to which
these associations are specifically related to the ART
procedures versus any underlying factors within the
couple, such as coexisting maternal disease, the
cause of infertility, or differences in behavioral risk
(eg, smoking). Many of the adverse obstetric out-
comes associated with ART may actually be linked
to infertility rather than the treatment for this disor-
der. Continued research is needed to examine possi-
ble confounding variables for these observations.
Patients undergoing superovulation drug therapy
alone, IVF alone, and IVF with ICSI should be
examined as three distinct risk populations, and con-
trol populations should ideally consist of two sepa-
rate groups—normal fertile couples and infertile
couples who conceive without treatment.
Assisted reproductive technology has been asso-
ciated with a 30-fold increase in multiple pregnancies
compared with the rate of spontaneous twin pregnan-
cies (1% in the general white population). The obstet-
ric and neonatal risks associated with multiple
gestation include preeclampsia, gestational diabetes,
preterm delivery, and operative delivery. Multifetal
births account for 17% of all preterm births (before
37 weeks of gestation), 23% of early preterm births
(before 32 weeks of gestation), 24% of low-birth-
weight infants (< 2,500 g), and 26% of very-low-
birth-weight infants (< 1,500 g) (7–10). In a large
population-based cohort study in the United States
from 1996 to 1999, the proportion of multiple births
attributable to ovulation induction or ART was 33%
(11), although the rate of high-order multiple gesta-
tions from ART decreased significantly between
1998 and 2001 (12). Methods to limit high-order
multiple pregnancies include monitoring hormone
levels and follicle number during superovulation and
limiting transfer to fewer embryos in IVF cycles
(12–14). Transferring two embryos can limit the
occurrence of triplets in younger candidates who
have a good prognosis without significantly decreas-
ing the overall pregnancy rate (15, 16). The Ameri-
can Society for Reproductive Medicine and the
Society for Assisted Reproductive Technology have
developed updated recommendations on the number
of embryos per transfer to reduce the risk of multiple
gestation (1). The multiple gestation risk of ART,
unlike that of superovulation, can be effectively man-
aged by limiting the number of embryos transferred.
When considering how to minimize multiple gesta-
tion, ART can be viewed as the safer and more favor-
able approach compared with superovulation.
2 ACOG Committee Opinion No. 324
COMMITTEE OPINIONS
Informing couples of the obstetric risks as well
as the socioeconomic consequences of multiple ges-
tations may modify their decisions regarding the
number of embryos to be transferred (17). Patients
undergoing ART procedures should be counseled in
advance regarding the option of multifetal preg-
nancy reduction to decrease perinatal risks if a high-
order multiple pregnancy occurs. Because the
intense motivation for a successful outcome and the
substantial out-of-pocket cost of ART may increase
patients’ desire for the transfer of an excessive num-
ber of embryos, it is critical that couples be aware of
the risk and associated morbidity of high-order mul-
tiple gestation.
Most retrospective and prospective follow-up
studies of children born as a result of ART have pro-
vided evidence for congenital malformation rates
similar to those reported in the general population
(18–20). In contrast, an Australian study of 4,916
women found that the risk of one or more major
birth defects in infants conceived with ART was
twice the expected rate (8.6% for ICSI and 9.0% for
IVF, compared with 4.2% in the general population)
(21). As with other studies, the control group was
not ideal because it did not include couples with
infertility who conceived without ART. Prospective
studies are needed to further define the risk of ART
to offspring.
Male factor infertility is now recognized as an
inherited disorder for some infertile couples. In vitro
fertilization offers the opportunity to achieve preg-
nancy while increasing the couple’s awareness of
possible inherited disorders in their offspring.
Genetic conditions can predispose to abnormal
sperm characteristics that may be passed to male
children. In addition, azoospermia is associated with
congenital bilateral absence or atrophy of the vas
deferens in men with gene mutations associated with
cystic fibrosis. Congenital bilateral absence or atro-
phy of the vas deferens accounts for approximately
2% of all cases of male infertility (22, 23). There-
fore, all patients with congenital bilateral absence or
atrophy of the vas deferens and their partners con-
sidering IVF by sperm extraction procedure with
ICSI should be offered genetic counseling to discuss
testing for cystic fibrosis.
Approximately 10–15% of azoospermic and
severely oligospermic (< 5 million/mL) males have
microdeletions of their Y chromosome that can be
passed on to their male offspring (24, 25). There is
speculation that a deletion could potentially expand
2013 COMPENDIUM OF SELECTED PUBLICATIONS 334
 in successive generations; however, the reproductive
and nonreproductive health implications of this pos-
sibility are unknown (26). Some studies have sug-
gested a 1% increased risk for fetal sex chromosome
abnormalities following ICSI conception (27–29),
but others have yielded conflicting results (30).
Subfertile men, with a higher proportion of aneu-
ploid sperm, may have an increased risk of transmit-
ting chromosomal abnormalities to their children
(31). These men should be aware of the possible
reproductive consequences in their male offspring
and the options for prenatal diagnosis.
There is some concern that the micromanipula-
tion of the early embryonic environment in IVF may
result in imprinting errors. Genomic imprinting is an
epigenetic phenomenon in which one of the two
alleles of a subset of genes is expressed differen-
tially according to its parental origin. Imprinting is
established early in gametogenesis and maintained
in embryogenesis. Recent case series have reported
an overrepresentation of two syndromes associated
with abnormal imprinting in IVF offspring—
Beckwith–Wiedemann syndrome and Angelman’s
syndrome (32, 33). Both of these conditions may be
associated with severe learning disabilities, mental
retardation, and congenital malformations. Because
these conditions are so rare (1 in 100,000–1 in
300,000), large prospective studies of offspring con-
ceived with ART would be necessary to confirm an
increased risk (34). Currently, the risk of imprinting
disorders with offspring conceived with ART is
largely theoretical but warrants further investigation.
A growing body of evidence suggests an associ-
ation between ART pregnancies and perinatal mor-
bidity (possibly independent of multiple births),
although the absolute risk to children conceived with
IVF is low. There is observational evidence linking
ART and chromosomal abnormalities following
ICSI in severe male factor cases, and concerns have
been raised about a possible relationship to genomic
imprinting modifications. Given the large sample
sizes required to firmly answer these questions, par-
ticularly for rare genetic disorders, no causal rela-
tionship can be established at this time. It is still
unclear to what extent these associations are related
to the underlying cause(s) of infertility versus the
treatment. It would be prudent to acknowledge these
possibilities and to counsel patients accordingly. The
single most important health effect of ART for the
offspring remains iatrogenic multiple fetal preg-
nancy. The American College of Obstetricians and
ACOG Committee Opinion No. 324
COMMITTEE OPINIONS
Gynecologists supports the effort toward lowering
the risk of multiple gestation with ART.
References
1. Guidelines on the number of embryos transferred. Practice
Committee of the Society for Assisted Reproductive
Technology and the American Society for Reproductive
Medicine. Fertil Steril 2004;82 Suppl 1:S1–2.
2. Badawi N, Kurinczuk JJ, Keogh JM, Alessandri LM,
O’Sullivan F, Burton PR, et al. Antepartum risk factors for
newborn encephalopathy: the Western Australian case-
control study. BMJ 1998;317:1549–53.
3. Ozturk O, Bhattacharya S, Templeton A. Avoiding multi-
ple pregnancies in ART: evaluation and implementation of
new strategies. Hum Reprod 2001;16:1319–21.
4. Cetin I, Cozzi V, Antonazzo P. Fetal development after
assisted reproduction—a review. Placenta 2003;24 Suppl
B:S104–13.
5. Schieve LA, Ferre C, Peterson HB, Macaluso M,
Reynolds MA, Wright VC. Perinatal outcome among sin-
gleton infants conceived through assisted reproductive
technology in the United States. Obstet Gynecol 2004;
103:1144–53.
6. Jackson RA, Gibson KA, Wu YW, Croughan MS.
Perinatal outcomes in singletons following in vitro fertil-
ization: a meta-analysis. Obstet Gynecol 2004;103:
551–63.
7. Donovan EF, Ehrenkranz RA, Shankaran S, Stevenson
DK, Wright LL, Younes N, et al. Outcomes of very low
birth weight twins cared for in the National Institute of
Child Health and Human Development Neonatal
Research Network’s intensive care units. Am J Obstet
Gynecol 1998;179:742–9.
8. Martin JA, Hamilton BE, Sutton PD, Ventura SJ,
Menacker F, Munson ML. Births: final data for 2002. Natl
Vital Stat Rep 2003;52:1–113.
9. Powers WF, Kiely JL. The risks confronting twins: a
national perspective. Am J Obstet Gynecol 1994;170:
456–61.
10. Stevenson DK, Wright LL, Lemons JA, Oh W, Korones
SB, Papile LA, et al. Very low birth weight outcomes of
the National Institute of Child Health and Human
Development Neonatal Research Network, January 1993
through December 1994. Am J Obstet Gynecol 1998;
179:1632–9.
11. Lynch A, McDuffie R, Murphy J, Faber K, Leff M,
Orleans M. Assisted reproductive interventions and multi-
ple birth. Obstet Gynecol 2001;97:195–200.
12. Jain T, Missmer SA, Hornstein MD. Trends in embryo-
transfer practice and in outcomes of the use of assisted
reproductive technology in the United States. N Engl J
Med 2004;350:1639–45.
13. Gleicher N, Oleske DM, Tur-Kaspa I, Vidali A, Karande
V. Reducing the risk of high-order multiple pregnancy
after ovarian stimulation with gonadotropins. N Engl J
Med 2000;343:2–7.
14. Licciardi F, Berkeley AS, Krey L, Grifo J, Noyes N. A
two- versus three-embryo transfer: the oocyte donation
model. Fertil Steril 2001;75:510–3.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 335
 15. Staessen C, Janssenswillen C, Van den Abbeel E, Devroey
P, Van Steirteghem AC. Avoidance of triplet pregnancies
by elective transfer of two good quality embryos. Hum
Reprod 1993;8:1650–3.
16. Templeton A, Morris JK. Reducing the risk of multiple
births by transfer of two embryos after in vitro fertiliza-
tion. N Engl J Med 1998;339:573–7.
17. Grobman WA, Milad MP, Stout J, Klock SC. Patient per-
ceptions of multiple gestations: an assessment of knowl-
edge and risk aversion. Am J Obstet Gynecol 2001;185:
920–4.
18. Bergh T, Ericson A, Hillensjo T, Nygren KG, Wennerholm
UB. Deliveries and children born after in-vitro fertilisa-
tion in Sweden 1982–95: a retrospective cohort study.
Lancet 1999;354:1579–85.
19. Ericson A, Kallen B. Congenital malformations in infants
born after IVF: a population-based study. Hum Reprod
2001;16:504–9.
20. Wennerholm UB, Bergh C, Hamberger L, Lundin K,
Nilsson L, Wikland M. Incidence of congenital malfor-
mations in children born after ICSI. Hum Reprod
2000;15:944–8.
21. Hansen M, Kurinczuk JJ, Bower C, Webb S. The risk of
major birth defects after intracytoplasmic sperm injection
and in vitro fertilization. N Engl J Med 2002;346:725–30.
22. Chillon M, Casals T, Mercier B, Bassas L, Lissens W,
Silber S, et al. Mutations in the cystic fibrosis gene in
patients with congenital absence of the vas deferens. N
Engl J Med 1995;332:1475–80.
23. Dork T, Dworniczak B, Aulehla-Scholz C, Wieczorek D,
Bohm I, Mayerova A, et al. Distinct spectrum of CFTR
gene mutations in congenital absence of vas deferens.
Hum Genet 1997;100:365–77.
24. Dohle GR, Halley DJ, Van Hemel JO, van den Ouwel AM,
Pieters MH, Weber RF, et al. Genetic risk factors in infer-
tile men with severe oligozoospermia and azoospermia.
Hum Reprod 2002;17:13–6.
COMMITTEE OPINIONS
25. Feng HL. Molecular biology of male infertility. Arch
Androl 2003;49:19–27.
26. Tournaye H. ICSI: a technique too far? Int J Androl 2003;
26:63–9.
27. Bonduelle M, Aytoz A, Van Assche E, Devroey P,
Liebaers I, Van Steirteghem A. Incidence of chromosomal
aberrations in children born after assisted reproduction
through intracytoplasmic sperm injection. Hum Reprod
1998;13:781–2.
28. Bonduelle M, Ponjaert I, Van Steirteghem A, Derde MP,
Devroey P, Liebaers I. Developmental outcome at 2 years
of age for children born after ICSI compared with chil-
dren born after IVF. Hum Reprod 2003;18:342–50.
29. In’t Veld P, Brandenburg H, Verhoeff A, Dhont M, Los F.
Sex chromosomal abnormalities and intracytoplasmic
sperm injection. Lancet 1995;346:773.
30. Loft A, Petersen K, Erb K, Mikkelsen AL, Grinsted J,
Hald F, et al. A Danish national cohort of 730 infants born
after intracytoplasmic sperm injection (ICSI) 1994–1997.
Hum Reprod 1999;14:2143–8.
31. Calogero AE, Burrello N, De Palma A, Barone N,
D’Agata R, Vicari E. Sperm aneuploidy in infertile men.
Reprod Biomed Online 2003;6:310–7.
32. Cox GF, Burger J, Lip V, Mau UA, Sperling K, Wu BL,
et al. Intracytoplasmic sperm injection may increase the
risk of imprinting defects. Am J Hum Genet 2002;71:
162–4.
33. DeBaun MR, Niemitz EL, Feinberg AP. Association of in
vitro fertilization with Beckwith–Wiedemann syndrome
and epigenetic alterations of L1T1 and H19. Am J Hum
Genet 2003;72:156–60.
34. Niemitz EL, Feinberg AP. Epigenetics and assisted repro-
ductive technology: a call for investigation. Am J Hum
Genet 2004;74:599–609.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 336
 ACOG
Committee on
Gynecologic Practice
Reaffirmed 2008
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright © June 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, post-
ed on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photo-
copying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Tamoxifen and uterine cancer.
ACOG Committee Opinion No. 336.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;107:1475–8.
COMMITTEE OPINIONS
Committee
Opinion
Number 336, June 2006 (Replaces No. 232, April 2000)
Tamoxifen and Uterine Cancer
ABSTRACT: Tamoxifen may be associated with endometrial proliferation,
hyperplasia, polyp formation, invasive carcinoma, and uterine sarcoma. Any
symptoms of endometrial hyperplasia or cancer reported by a postmeno-
pausal woman taking tamoxifen should be evaluated. Premenopausal women
treated with tamoxifen have no known increased risk of uterine cancer and
as such require no additional monitoring beyond routine gynecologic care.
If atypical endometrial hyperplasia develops, appropriate gynecologic man-
agement should be instituted, and the use of tamoxifen should be reassessed.
Tamoxifen, a nonsteroidal antiestrogen agent, is used widely as adjunctive
therapy for women with breast cancer. It has been approved by the U.S.
Food and Drug Administration for the following indications:
• Adjuvant treatment of breast cancer
• Metastatic breast cancer
• Reduction in breast cancer incidence in high-risk women
Because obstetrician–gynecologists frequently treat women with breast
cancer and women at risk for the disease, they may be consulted for advice
on the proper follow-up of women receiving tamoxifen. The purpose of this
Committee Opinion is to review the risk and to recommend care to prevent
and detect uterine cancer in women receiving tamoxifen.
Tamoxifen is one of a class of agents known as selective estrogen recep-
tor modulators (SERMs). Although the primary therapeutic effect of tamoxi-
fen is derived from its antiestrogenic properties, this agent also has modest
estrogenic activity. In standard dosages, tamoxifen may be associated with
endometrial proliferation, hyperplasia, polyp formation, invasive carcinoma,
and uterine sarcoma.
Most studies have found that the increased relative risk of developing
endometrial cancer for women taking tamoxifen is two to three times higher
than that of an age-matched population (1–3). The level of risk of endome-
trial cancer in women treated with tamoxifen is dose and time dependent.
Studies suggest that the stage, grade, histology, and biology of tumors
that develop in individuals treated with tamoxifen (20 mg/d) are no differ-
ent from those that arise in the general population (3, 4). However, some
reports have indicated that women treated with a higher dosage of tamoxifen
2013 COMPENDIUM OF SELECTED PUBLICATIONS 337
 (40 mg/d) are more prone to develop more biologi-
cally aggressive tumors (5).
In one early study of the National Surgical
Adjuvant Breast and Bowel Project (NSABP), the
rate of endometrial cancer occurrence among tamox-
ifen users who were administered 20 mg/d was 1.6
per 1,000 patient years, compared with 0.2 per 1,000
patient years among control patients taking a placebo
(3). In this study, the 5-year disease-free survival rate
from breast cancer was 38% higher in the tamoxifen
group than in the placebo group, suggesting that the
small risk of developing endometrial cancer is out-
weighed by the significant survival benefit provided
by tamoxifen therapy for women with breast cancer
(3). The survival advantage with 5 years of tamoxi-
fen therapy continued with long-term follow-up,
but extending the duration of tamoxifen use to 10
years failed to improve the survival benefit gained
from 5 years of tamoxifen use (6). In a more recent
update of all NSABP trials of patients with breast
cancer, the rate of endometrial cancer was 1.26 per
1,000 patient years in women treated with tamoxifen
versus 0.58 per 1,000 patient years in the placebo
group (7).
Uterine sarcomas consisting of malignant mixed
müllerian tumors, leiomyosarcoma, and stroma cell
sarcomas are a rare form of uterine malignancy
occurring in 2–5% of all patients with uterine malig-
nancies (8). In a review of all NSABP breast cancer
treatment trials, the rate of sarcoma in women treat-
ed with tamoxifen was 17 per 100,000 patient years
versus none in the placebo group (7). Similarly, in
a separate trial of high-risk women without breast
cancer taking tamoxifen as part of a breast cancer
prevention trial with a median follow-up of 6.9
years, there were four sarcomas (17 per 100,000
patient years) in the tamoxifen group versus none
in the placebo group (7). This is compared with the
incidence of one to two per 100,000 patient years in
the general population (9).
The NSABP prevention trial (P-1) data sug-
gest that the risk for both invasive and noninvasive
breast cancer is reduced markedly with tamoxifen
prophylaxis. In this trial, however, the risk ratio for
developing endometrial cancer was 2.53 in women
using tamoxifen compared with women receiving a
placebo (10). In addition, the ability of tamoxifen
to induce endometrial malignancy as well as other
histopathologic conditions appears to differ between
premenopausal and postmenopausal women. In the
prevention trial of high-risk women, there was no
COMMITTEE OPINIONS
statistically significant difference in endometrial
cancer rates between women treated with tamoxifen
and those in the placebo group in the women aged
49 years and younger; however, in women aged
50 years and older, the risk ratio was 4.01 (95%
confidence interval, 1.70–10.90) for those treated
with tamoxifen versus those receiving placebo. The
annual rate was 3.05 malignancies per 1,000 women
treated with tamoxifen versus 0.76 malignancies per
1,000 women receiving placebo (10). Another study
of women with breast cancer found that premeno­
pausal women, treated or untreated, had no dif-
ferences in endometrial thickness on ultrasound
examination, uterine volume, or histopathologic find-
ings, whereas postmenopausal women treated with
tamox­i­­fen had significantly more abnormalities (11).
Several approaches have been explored for
screening asymptomatic women using tamoxifen
for abnormal endometrial proliferation or endome-
trial cancer. Correlation is poor between ultrasono­
graphic measurements of endometrial thickness and
abnormal pathology in asymptomatic tamoxifen
users because of tamoxifen-induced subepithelial
stromal hypertrophy (12). In asymptomatic women
using tamoxifen, screening for endometrial cancer
with routine transvaginal ultrasonography, endo-
metrial biopsy, or both has not been shown to be
effective (13–15). Although asymptomatic post-
menopausal tamoxifen-treated women should not
have routine testing to diagnose endometrial pathol-
ogy, sonohysterography has improved the accuracy
of ultrasonography in excluding or detecting ana-
tomical changes, when necessary (16).
Other data suggest that low- and high-risk
groups of postmenopausal patients may be identified
before the initiation of tamoxifen therapy for breast
cancer (17–19). Pretreatment screening identified
85 asymptomatic patients with benign polyps in
510 postmenopausal patients with newly diagnosed
breast cancer (16.7%). All polyps were removed. At
the time of polypectomy, two patients had atypical
hyperplasias and subsequently underwent hyster-
ectomies. The rest were treated with tamoxifen, 20
mg/d, for up to 5 years. The incidence of atypical
hyperplasia was 11.7% in the group with initial
lesions versus 0.7% in the group without lesions
(P <.0001), an 18-fold increase in risk. In addition,
polyps developed in 17.6% of the group with initial
lesions versus 12.9% in the group without.
Although the concurrent use of progestin reduces
the risk of endometrial hyperplasia and cancer in
2013 COMPENDIUM OF SELECTED PUBLICATIONS 338
 patients receiving unopposed estrogen, the effect of
progestin on the course of breast cancer and on the
endometrium of women receiving tamoxifen is not
known. Therefore, such use cannot be advocated as a
means of lowering risk in women taking tamoxifen.
On the basis of these data, the committee recom-
mends the following:
• Postmenopausal women taking tamoxifen
should be monitored closely for symptoms of
endometrial hyperplasia or cancer.
• Premenopausal women treated with tamoxifen
have no known increased risk of uterine cancer
and as such require no additional monitoring
beyond routine gynecologic care.
• Women taking tamoxifen should be informed
about the risks of endometrial proliferation,
endometrial hyperplasia, endometrial cancer,
and uterine sarcomas. Women should be encour-
aged to promptly report any abnormal vaginal
symptoms, including bloody discharge, spotting,
staining, or leukorrhea.
• Any abnormal vaginal bleeding, bloody vaginal
discharge, staining, or spotting should be inves-
tigated.
• Emerging evidence suggests the presence of
high- and low-risk groups for development of
atypical hyperplasias with tamoxifen treatment
in postmenopausal women based on the pres-
ence or absence of benign endometrial polyps
before therapy. Thus there may be a role for pre-
treatment screening of postmenopausal women
with transvaginal ultrasonography, and sono-
hysterography when needed, or office hysteros-
copy before initiation of tamoxifen therapy.
• Unless the patient has been identified to be at
high risk for endometrial cancer, routine endo-
metrial surveillance has not been effective in
increasing the early detection of endometrial
cancer in women using tamoxifen. Such sur-
veillance may lead to more invasive and costly
diagnostic procedures and, therefore, is not rec-
ommended.
• Tamoxifen use should be limited to 5 years’
duration because a benefit beyond this time has
not been documented.
• If atypical endometrial hyperplasia develops,
appropriate gynecologic management should be
instituted, and the use of tamoxifen should be
reassessed. If tamoxifen therapy must be con-
COMMITTEE OPINIONS
tinued, hysterectomy should be considered in
women with atypical endometrial hyperplasia.
Tamoxifen use may be reinstituted following
hysterectomy for endometrial carcinoma in con-
sultation with the physician responsible for the
woman’s breast care.
References
1. Sismondi P, Biglia N, Volpi E, Giai M, de Grandis T.
Tamoxifen and endometrial cancer. Ann N Y Acad Sci
1994;734:310–21.
2. Bissett D, Davis JA, George WD. Gynaecological moni-
toring during tamoxifen therapy. Lancet 1994;344:1244.
3. Fisher B, Costantino JP, Redmond CK, Fisher ER,
Wickerham DL, Cronin WM. Endometrial cancer in
tamoxifen-treated breast cancer patients: findings from
the National Surgical Adjuvant Breast and Bowel Project
(NSABP) B-14. J Natl Cancer Inst 1994;86:527–37.
4. Barakat RR, Wong G, Curtin JP, Vlamis V, Hoskins WJ.
Tamoxifen use in breast cancer patients who subsequently
develop corpus cancer is not associated with a higher
incidence of adverse histologic features. Gynecol Oncol
1994;55:164–8.
5. Magriples U, Naftolin F, Schwartz PE, Carcangiu ML.
High-grade endometrial carcinoma in tamoxifen-treated
breast cancer patients. J Clin Oncol 1993;11:485–90.
6. Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham
DL, Wolmark N, et al. Five versus more than five years
of tamoxifen therapy for breast cancer patients with nega-
tive lymph nodes and estrogen receptor-positive tumors. J
Natl Cancer Inst 1996;88:1529–42.
7. Wickerham DL, Fisher B, Wolmark N, Bryant J,
Costantino J, Bernstein L, et al. Association of tamoxifen
and uterine sarcoma. J Clin Oncol 2002;20:2758–60.
8. Averette HE, Nguyen H. Gynecologic cancer. In: Murphy
GP, Lawrence W Jr, Lenhard RE Jr, editors. American
Cancer Society textbook of clinical oncology. 2nd ed.
Atlanta (GA): American Cancer Society; 1995. p. 552–
79.
9. Mouridsen H, Palshof T, Patterson J, Battersby L.
Tamoxifen in advanced breast cancer. Cancer Treat Rev
1978;5:131–41.
10. Fisher B, Costantino JP, Wickerham DL, Redmond CK,
Kavanah M, Cronin WM, et al. Tamoxifen for prevention
of breast cancer: report of the National Surgical Adjuvant
Breast and Bowel Project P-1 Study. J Natl Cancer Inst
1998;90:1371–88.
11. Cheng WF, Lin HH, Torng PL, Huang SC. Comparison
of endometrial changes among symptomatic tamoxifen-
treated and nontreated premenopausal and postmenopaus-
al breast cancer patients. Gynecol Oncol 1997;66:233–7.
12. Achiron R, Lipitz S, Sivan E, Goldenberg M, Horovitz
A, Frenkel Y, et al. Changes mimicking endometrial neo-
plasia in postmenopausal, tamoxifen-treated women with
breast cancer: a transvaginal Doppler study. Ultrasound
Obstet Gynecol 1995;6:116–20.
13. Bertelli G, Venturini M, Del Mastro L, Garrone O, Cosso
M, Gustavino C, et al. Tamoxifen and the endometrium:
2013 COMPENDIUM OF SELECTED PUBLICATIONS 339
 findings of pelvic ultrasound examination and endome­
trial biopsy in asymptomatic breast cancer patients. Breast
Cancer Res Treat 1998;47:41–6.
14. Fung MF, Reid A, Faught W, Le T, Chenier C, Verma S,
et al. Prospective longitudinal study of ultrasound screen-
ing for endometrial abnormalities in women with breast
cancer receiving tamoxifen. Gynecol Oncol 2003;91:154–
9.
15. Love CD, Muir BB, Scrimgeour JB, Leonard RC, Dillon
P, Dixon JM. Investigation of endometrial abnormalities
in asymptomatic women treated with tamoxifen and an
evaluation of the role of endometrial screening. J Clin
Oncol 1999;17:2050–4.
16. Markovitch O, Tepper R, Aviram R, Fishman A, Shapira
J, Cohen I. The value of sonohysterography in the
COMMITTEE OPINIONS
prediction of endometrial pathologies in asymptomatic
postmenopausal breast cancer tamoxifen-treated patients.
Gynecol Oncol 2004;94:754–9.
17. Berliere M, Charles A, Galant C, Donnez J. Uterine side
effects of tamoxifen: a need for systematic pretreatment
screening. Obstet Gynecol 1998;91:40–4.
18. Berliere M, Radikov G, Galant C, Piette P, Marbaix E,
Donnez J. Identification of women at high risk of devel-
oping endometrial cancer on tamoxifen. Eur J Cancer
2000;36(suppl 4):S35–6.
19. Vosse M, Renard F, Coibion M, Neven P, Nogaret JM,
Hertens D. Endometrial disorders in 406 breast cancer
patients on tamoxifen: the case for less intensive monitor-
ing. Eur J Obstet Gynecol Reprod Biol 2002;101:58–63.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 340
 ACOG
Committee on
Gynecologic Practice
Reaffirmed 2008
American Society
for Colposcopy and
Cervical Pathology
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
The Committee and Society wish
to thank Hope K. Haefner, MD,
and Mark Spitzer, MD, for their
assistance in the development of
this document.
Copyright © October 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or trans-
mitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or oth-
erwise, without prior written per-
mission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Vulvodynia. ACOG Committee
Opinion No. 345. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:1049–52.
COMMITTEE OPINIONS
Committee
Opinion
Number 345, October 2006
Vulvodynia
ABSTRACT: Vulvodynia is a complex disorder that can be difficult to treat.
It is described by most patients as burning, stinging, irritation, or rawness.
Many treatment options have been used, including vulvar care measures,
medication, biofeedback training, physical therapy, dietary modifications,
sexual counseling, and surgery. A cotton swab test is used to distinguish
generalized disease from localized disease. No one treatment is effective for
all patients. A number of measures can be taken to prevent irritation, and
several medications can be used to treat the condition.
Vulvodynia is a complex disorder that can be difficult to treat. This
Committee Opinion provides an introduction to the diagnosis and treatment
of vulvodynia for the generalist obstetrician–gynecologist. It is adapted with
permission from the 2005 American Society for Colposcopy and Cervical
Pathology publication, “The Vulvodynia Guideline” (1).
Terminology and Classification
Many women experience vulvar pain and discomfort that affects the quality
of their lives. Vulvodynia is described by most patients as burning, stinging,
irritation, or rawness. It is a condition in which pain is present although the
vulva appears normal (other than erythema).
The most recent terminology and classification of vulvar pain by
the International Society for the Study of Vulvovaginal Disease defines
vulvodynia as “vulvar discomfort, most often described as burning pain,
occurring in the absence of relevant visible findings or a specific, clinically
identifiable, neurologic disorder” (2). It is not caused by commonly identi-
fied infection (eg, candidiasis, human papillomavirus, herpes), inflammation
(eg, lichen planus, immunobullous disorder), neoplasia (eg, Paget’s disease,
squamous cell carcinoma), or a neurologic disorder (eg, herpes neuralgia,
spinal nerve compression). The classification of vulvodynia is based on
the site of the pain, whether it is generalized or localized, and whether it is
provoked, unprovoked, or mixed. Although the term vulvar dysesthesia has
been used in the past, there is now consensus to use the term vulvodynia and
subcategorize it as localized or generalized.
Several causes have been proposed for vulvodynia, including embryo-
logic abnormalities, increased urinary oxalates, genetic or immune factors,
2013 COMPENDIUM OF SELECTED PUBLICATIONS 341
 hormonal factors, inflammation, infection, and neu-
ropathic changes. Most likely, there is not a single
cause.
Because the etiology of vulvodynia is unknown,
it is difficult to say whether localized vulvodynia
(previously referred to as vestibulitis) and gener-
alized vulvodynia are different manifestations of
the same disease process. Distinguishing localized
disease from generalized disease is fairly straight-
forward and is done with the cotton swab test as
described in the following section. Early classifi-
cation to localized or generalized vulvodynia can
facilitate more timely and appropriate treatment.
Diagnosis and Evaluation
Vulvodynia is a diagnosis of exclusion, a pain syn-
drome with no other identified cause. A thorough
history should identify the patient’s duration of pain,
previous treatments, allergies, medical and surgical
history, and sexual history.
Cotton swab testing (Fig. 1) is used to identify
areas of localized pain and to classify the areas where
there is mild, moderate, or severe pain. A diagram of
pain locations may be helpful in assessing the pain
over time. The vagina should be examined, and tests,
including wet mount, vaginal pH, fungal culture,
Figure 1. Cotton swab testing for vestibulodynia. The
vestibule is tested at the 2-, 4-, 6-, 8-, and 10-o’clock
positions. When pain is present, the patient is asked to
quantify it as mild, moderate, or severe. (Haefner HK.
Critique of new gynecologic surgical procedures: sur­-
gery for vulvar vestibulitis. Clin Obstet Gynecol 2000;
43:689–700.)
COMMITTEE OPINIONS
and Gram stain, should be performed as indicated.
Fungal culture may identify resistant strains, but
sensitivity testing usually is not required. Testing
for human papillomavirus infection is unnecessary.
Treatment
Most of the available evidence for treatment of
vulvodynia is based on clinical experience, descrip-
tive studies, or reports of expert committees. There
are few randomized trials of vulvodynia treatments.
Outlined here are treatments used by clinicians with
an interest in vulvodynia. Multiple treatments have
been used (Fig. 2), including vulvar care measures;
topical, oral, and injectable medications; biofeedback
training; physical therapy; dietary modifications;
cognitive behavioral therapy; sexual counseling;
and surgery. Newer treatments being used include
acupuncture, hypnotherapy, nitroglycerin, and botu-
linum toxin.
Gentle care of the vulva is advised. The fol-
lowing vulvar care measures can minimize vulvar
irritation:
• Wearing 100% cotton underwear (no underwear
at night)
• Avoiding vulvar irritants (perfumes, dyes,
shampoos, detergents) and douching
• Using mild soaps for bathing, with none applied
to the vulva
• Cleaning the vulva with water only
• Avoiding the use of hair dryers on the vulvar
area
• Patting the area dry after bathing, and applying
a preservative-free emollient (such as vegetable
oil or plain petrolatum) topically to hold mois-
ture in the skin and improve the barrier function
• Switching to 100% cotton menstrual pads (if
regular pads are irritating)
• Using adequate lubrication for intercourse
• Applying cool gel packs to the vulvar area
• Rinsing and patting dry the vulva after urination
Different medications have been tried as treat-
ments for vulvar pain. These include topical, oral,
and intralesional medications, as well as pudendal
nerve blocks. Many of these medications are known
to interact with other drugs, and many patients with
vulvodynia may be taking multiple medications.
Clinicians should check for any potential drug inter-
actions before prescribing a new medication. Before
2013 COMPENDIUM OF SELECTED PUBLICATIONS 342
 Physical examination
Cutaneous or mucosal surface disease present

No Yes

Cotton swab test Treat abnormal visible condition present (infections,

dermatoses, premalignant or malignant conditions)

Not tender, no area of vulva Tender, or patient describes

touched described as area
of burning
Alternative diagno-
sis (incorrect belief
that vulvodynia is
present)
Antifungal
area touched as area of
burning
Treatment Options
1. Vulvar care measures
Yeast culture 2. Topical medications
3. Oral medications
4. Injections
Positive Negative
5. Biofeedback/physical therapy
6. Dietary modifications
7. Cognitive behavioral therapy
Inadequate 8. Sexual counseling
therapy relief

Adequate relief Good relief

Inadequate relief Inadequate relief and
and pain localized pain generalized
to vestibule
No additional treatment;
stop treatment when indicated
High-dose and
Surgery multiple
(Vestibulectomy) medications for
neuropathic pain;
consider referral
to pain specialist;
consider
neuromodulation

Figure 2. Vulvodynia treatment algorithm. (Adapted from Haefner HK, Collins ME, Davis GD, Edwards L, Foster DC,
Hartmann EH, et al. The vulvodynia guideline. J Low Genit Tract Dis 2005;9:40–51.)

prescribing a new course of therapy, clinicians may
stop use of all topical medication.
Commonly prescribed topical medications
include a variety of local anesthetics (which can
be applied immediately before intercourse or in
extended use), estrogen cream, and tricyclic antide­
pressants compounded into topical form. Although
topical steroids generally do not help patients with
vulvodynia, trigger-point injections of a combina-
tion of steroid and bupivacaine have been successful
for some patients with localized vulvodynia (3).
Tricyclic antidepressants and anticonvulsants
can be used for vulvodynia pain control. When first
prescribing drugs, clinicians should avoid poly-
pharmacy. One drug should be prescribed at a time.
Before prescribing antidepressants or anticonvul-
sants for a patient of reproductive age, the clini-
cian should emphasize the need for contraception.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 343

 Antidepressants have been found to have a 60%
response rate for various pain conditions; how-
ever, no randomized, controlled studies have been
published regarding the use of antidepressants for
vulvodynia. Both tricyclic antidepressants and anti-
convulsants take time to achieve adequate pain con-
trol, which may take up to 3 weeks. Patients usually
develop tolerance to the side effects of these medica-
tions (particularly sedation, dry mouth, and dizziness).
Biofeedback and physical therapy also are used
in the treatment of both localized and generalized
vulvodynia (4). Physical therapy techniques include
internal (vaginal and rectal) and external soft tissue
mobilization and myofascial release; trigger-point
pressure; visceral, urogenital, and joint manipula-
tion; electrical stimulation; therapeutic exercises;
active pelvic floor retraining; biofeedback; bladder
and bowel retraining; instruction in dietary revi-
sions; therapeutic ultrasonography; and home vagi-
nal dilation.
Vestibulectomy has been helpful for many
patients with localized pain that has not responded
to previous treatments (5). Patients should be evalu-
ated for vaginismus and, if present, treated before a
vestibulectomy is performed. For generalized vulvar
burning unresponsive to previous behavioral and
medical treatments, referral to a pain specialist may
be helpful.
Conclusion
Vulvodynia is a complex disorder that frequently
is frustrating to both clinician and patient. It can
be difficult to treat, and rapid resolution is unusual,
even with appropriate therapy. Decreases in pain
may take weeks to months and may not be complete.
No single treatment is successful in all women.
Expectations for improvement need to be realisti-
COMMITTEE OPINIONS
cally addressed with the patient. Emotional and
psychologic support is important for many patients,
and sex therapy and counseling may be beneficial.
Resources
Haefner HK, Collins ME, Davis GD, Edwards L,
Foster DC, Hartman ED, et al. The vulvodynia guide-
line. J Low Genit Tract Dis 2005;9:40–51. Avail-
able at: http://www.jlgtd.com/pt/re/jlgtd/pdfhandler.
00128360-200501000-00009.pdf. Retrieved March
15, 2006.
National Vulvodynia Association
http://www.nva.org
PO Box 4491
Silver Spring, MD 20914-4491
301-299-0775
References
1. Haefner HK, Collins ME, Davis GD, Edwards L, Foster
DC, Hartmann EH, et al. The vulvodynia guideline. J Low
Genit Tract Dis 2005;9:40–51.
2. Moyal-Barracco M, Lynch PJ. 2003 ISSVD terminology
and classification of vulvodynia: a historical perspective.
J Reprod Med 2004;49:772–7.
3. Segal D, Tifheret H, Lazer S. Submucous infiltration of
betamethasone and lidocaine in the treatment of vulvar
vestibulitis. Eur J Obstet Gynecol Reprod Biol 2003;
107:105–6.
4. Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer
HI, Meana M, et al. A randomized comparison of group
cognitive-behavioral therapy, surface electromyographic
biofeedback, and vestibulectomy in the treatment of
dyspareunia resulting from vulvar vestibulitis. Pain 2001;
91:297–306.
5. Haefner HK. Critique of new gynecologic surgical proce-
dures: surgery for vulvar vestibulitis. Clin Obstet Gynecol
2000;43:689–700.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 344
 ACOG COMMITTEE OPINION
Number 372 • July 2007

The Role of Cystourethroscopy in the

Generalist Obstetrician–Gynecologist
Practice
Committee on ABSTRACT: Cystourethroscopy can be performed for diagnostic and a few opera-
Gynecologic tive indications by obstetrician–gynecologists to help improve patient care. Perhaps the
Practice most important indications for cystourethroscopy are to rule out cystotomy and intra­
Reaffirmed 2010 vesical or intraurethral suture or mesh placement and to verify bilateral ureteral patency
This document reflects during or after certain gynecologic surgical procedures. The granting of privileges for
emerging clinical and sci- cystourethroscopy and other urogynecologic procedures should be based on training,
entific advances as of the
date issued and is subject experience, and demonstrated competence. Postgraduate education, including resi-
to change. The information dency training programs in obstetrics and gynecology and continuing medical education,
should not be construed
as dictating an exclusive should include education in the instrumentation, technique, and evaluation of findings
course of treatment or of cystourethroscopy, and in the pathophysiology of diseases of the lower urinary tract.
procedure to be followed.

Although many of the pioneers of cysto-
urethroscopy, most notably Howard Kelly,
were gynecologists, for decades the proce-
dure has been performed mainly by urolo-
gists. However, cystourethroscopy can be
performed for diagnostic and a few operative
indications by obstetrician–gynecologists to
help improve patient care. This document
reviews the definition and indications for
cystourethroscopy and discusses the evidence
and recommendations for its use in the gen-
eralist obstetrician–gynecologist practice.
Cystoscopy
Cystoscopy is a surgical procedure in which
a rigid or flexible fiberoptic endoscope is
used to examine the lumen of the bladder.
Urethroscopy, in which the urethral lumen is
examined for urethral diseases or abnormali-
ties, is a related procedure. For cystoscopy,
the endoscope is introduced through the
urethra, allowing the surgeon to visualize
both the bladder and urethra, thus the term
cystourethroscopy.
The American College Operative Technique
of Obstetricians When performing cystourethroscopy for
and Gynecologists diagnostic indications, the surgeon should
Women’s Health Care follow a technical routine in which the
Physicians entire lumen of the urethra and bladder
are examined systematically. The instru-
mentation, surgical technique, and typical
findings (normal and abnormal) have been
reviewed in most textbooks on urogynecol-
ogy and female urology. Briefly, diagnostic
cysto­urethroscopy is performed using sterile
techniques, usually with local anesthesia,
while the patient is awake and in the supine
lithotomy position. It also can be performed
during or after gynecologic surgery with the
patient under general or regional anesthesia.
The urine should be free of infection before
the procedure. After sterile preparation of
the urethral meatus and surrounding vulvar
vestibule, 2% lidocaine jelly can be intro-
duced into the urethra and then used as
lubrication for the endoscope. Sterile water
or saline is used to fill the bladder by gravity
during the procedure. If electrocautery is to
be performed, a nonconducting solution,
such as glycine, should be used.
Depending on the indication for the cys-
tourethroscopy, the surgeon generally starts
with a 30-degree endoscope and, with the
solution running, introduces it through the
urethra under direct vision with or without
video assistance. After partial distention of
the bladder, the trigone is examined for
mucosal abnormalities, lesions, or foreign
bodies, as indicated. The interureteric ridge

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 345

 is noted above the trigone, and both ureteral orifices are
visualized. If the goal is to examine for ureteral patency,
5 mL of indigo carmine can be given intravenously 10–15
minutes before the cystoscopy, followed by observation
of blue-stained urine from the ureteral orifices. An in–out
technique is used to circumferentially examine sections of
the bladder surface, usually starting at the trigone at the
6-o’clock position, progressing clockwise around the right
bladder surface to the dome at the 12-o’clock position,
and then back to the trigone on the left side of the bladder
(1). After the entire bladder examination is accomplished,
the urethra is reexamined with removal of the endoscope.
If the specific goal is to examine for lesions or for suture
or mesh material in the lateral edges of the bladder, a
70-degree rigid or flexible endoscope can be reintroduced
to reexamine the bladder. If the specific goal is to examine
the urethra, a 0-degree or 25-degree endoscope can be
used. The findings should be documented carefully, not-
ing the systematic nature of the procedure.
Shortly before the procedure, a single dose of pro-
phylactic antibiotics is recommended to prevent urinary
tract infection or septicemia for patients at moderate or
high risk of endocarditis, those who are neutropenic,
and those with preoperative bacteriuria or an indwelling
catheter (2, 3).
Indications and Complications
The indications for cystourethroscopy, like hysteroscopy,
are both diagnostic and operative and are for symptoms
and diseases related to the lower urinary tract. Diagnostic
cystourethroscopy can be performed as part of an eval-
uation of abnormal symptoms, signs, or laboratory
findings; intraoperatively during gynecologic or uro­
gynecologic surgery to rule out bladder, urethral, or
ureteral trauma; and as part of staging or surgery for
gynecologic malignancy. A list of possible indications for
diagnostic cystourethroscopy during gynecologic sur-
gery is shown in the box. Operative cystoscopy usually
involves the introduction of additional instruments, such
as biopsy forceps or scissors, through an operating chan-
Possible Indications for
Diagnostic Cystourethroscopy
During Gynecologic Surgery
• During or after surgery for pelvic organ prolapse or
stress urinary incontinence to rule out cystotomy and
intravesical or intraurethral suture or mesh placement
• Verification of bilateral ureteral flow during or after
obstetric, gynecologic, urogynecologic, or gyneco-
logic oncologic surgery
• Evaluation of suspected urine leak during or after
laparotomy, laparoscopy, or vaginal surgery
• Verification of suprapubic catheter placement, if desired
COMMITTEE OPINIONS
nel in the cystoscope to perform procedures or interven-
tions. It also can be done as part of a reparative procedure
to the bladder or urethra, such as vesicovaginal fistula
or urethral diverticulum repair. Operative procedures
generally are performed by urologists and selectively by
urogynecologists and gynecologic oncologists. However,
generalist obstetrician–gynecologists with special exper-
tise and experience may perform minor operative proce-
dures such as passage of ureteral stents and injection of
urethral bulking agents.
Complications after cystourethroscopy are few.
These generally involve minor pain related to the pro-
cedure and the small risk of postoperative urinary tract
infection. These risks usually are negligible with use of
local anesthesia and single-dose prophylactic antibiot-
ics in patients at moderate or high risk for endocarditis.
Other rare complications include perforation of the ure-
thra or bladder or ureteral perforation if instruments or
stents are placed into the ureter.
There is a small risk that the surgeon will not rec-
ognize abnormalities that are present, such as bladder
lesions or mesh or sutures in the bladder. For example,
in one study, urologists had less than perfect agree-
ment between cystoscopic and histologic diagnoses when
biopsies were performed for suspicious bladder lesions
(4). Because routine intraoperative cystourethroscopy
examines only the bladder and urethral mucosal surfaces
and ureteral orifices, it does not guarantee recognition
of all lower urinary tract injuries (5). Nonobstructive,
partially obstructive, or late ureteral injuries may not be
recognized or prevented (6–8). When cystourethroscopy
is performed, there are minimal additional costs and time
spent in the operating room.
Recommendations for the Generalist
Obstetrician–Gynecologist
Few studies have been conducted that provide evidence-
based recommendations for the use of cystourethroscopy
in a general obstetric and gynecologic practice. Typically,
recommendations for the use of cystourethroscopy in
general obstetric and gynecologic practice imply that
the physician has knowledge and competency in the
instrumentation and surgical technique; can recognize
normal and abnormal bladder and urethral findings; and
has knowledge of pathology, diagnosis, and treatment
of specific diseases of the female lower urinary tract.
Specialists in female pelvic medicine and reconstructive
surgery and gynecologic oncology have an expanded use
of cysto­urethroscopy based on their additional training
and resulting greater level of expertise and experience.
The granting of privileges for cystourethroscopy
and other urogynecologic procedures should be based
on training, experience, and demonstrated competence.
Obstetrician–gynecologists who are appropriately trained
in a technique, have sufficient experience performing
it, and have demonstrated current clinical competence
should be granted privileges accordingly.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 346
 In 1996, the Agency for Healthcare Research and
Quality (then known as the Agency for Healthcare Policy
and Research) provided recommendations for cystoscopy
(regardless of specialty), but none of the recommenda-
tions were supported by scientific evidence from properly
designed and implemented controlled trials and are no
longer considered current (9). In that document, cys-
toscopy was recommended for the evaluation of patients
who have sterile hematuria or pyuria; new-onset irrita-
tive voiding symptoms such as frequency, urgency, and
urge incontinence in the absence of any reversible causes;
bladder pain; recurrent cystitis; suspected presence of
a foreign body; or when urodynamic testing failed to
duplicate symptoms of urinary incontinence. Cystoscopy
was not recommended in the basic evaluation of urinary
incontinence. Likewise, routine cystoscopy in women
with urinary incontinence to exclude neoplasia was not
indicated because the risk of bladder lesions is less than
2% (9, 10).
Cystourethroscopy is indicated during or after some
surgical procedures performed 1) to treat stress urinary
incontinence and anterior vaginal prolapse, such as Burch
colposuspension, paravaginal defect repair, pubovaginal
sling procedure, and tension-free vaginal tape procedure;
2) to rule out intravesical placement of sutures or mesh;
and 3) to verify ureteral patency. Tension-free vaginal
tape and related mid-urethral sling procedures that pass
through the retropubic space especially require rou-
tine cystourethroscopy to detect intraoperative bladder
perforation, which occurs in 3–9% of cases (11, 12). As
noted earlier, certain other surgical procedures usually
performed by specialists, such as repair of vesicovaginal
fistula or urethral diverticulum, routinely require cysto­
urethroscopy to aid the surgical repair.
The issue of whether cystourethroscopy should be
performed during and after gynecologic surgery to evalu-
ate for bladder integrity and for ureteral patency remains
unresolved. Intraoperative cystotomies usually are noted
at the time of the injury, especially if retrograde blad-
der filling is used to aid recognition. However, sutures
or mesh placed in the bladder or urethral lumen during
surgical procedures usually are not recognized unless
cysto­urethroscopy is performed.
Ureteral injuries are of particular concern to practic-
ing obstetrician–gynecologists. Although the incidence of
bladder and ureteral injury during common gynecologic
procedures is low, wide ranges have been reported in the
literature making estimation of risk difficult for indi-
vidual surgical procedures. A recent systematic review of
urinary tract injuries during gynecologic surgery with
routine intraoperative cystourethroscopy for benign dis-
ease reported crude ureteral injury rates for laparoscopic
hysterectomy with bilateral salpingo-oophorectomy of
17.3 per 1,000 procedures (95% confidence interval [CI],
0.3–66.3); for other gynecologic and urogynecologic sur-
gical procedures, including other types of hysterectomy,
COMMITTEE OPINIONS
the overall ureteral injury rate was 8.8 per 1,000 proce-
dures (95% CI, 2.3–12.6) (13). The overall bladder injury
rate per 1,000 laparoscopic hysterectomies with bilateral
salpingo-oophorectomy was 29.2 (95% CI, 7.5–148.0);
after other gynecologic and urogynecologic surgical pro-
cedures, the rate was 16.3 (95% CI, 4.3–26.6) (13).
Factors that should be considered when deciding
when to perform diagnostic cystourethroscopy include
complication rates associated with the procedure and the
difficulty of the individual surgical case. Cystourethro­s­
copy is indicated during or after tension-free vaginal tape
procedure, Burch colposuspension, and high uterosacral
ligament vaginal vault suspension. Surgical procedures
such as McCall culdoplasty, colpocleisis, and perhaps
certain advanced and difficult vaginal and laparoscopic
procedures and hysterectomies may be indications for
intraoperative diagnostic cystoure­throscopy.
Conclusions
Cystourethroscopy is a low-risk operative procedure used
to examine the lumen of the bladder and urethra. Perhaps
the most important indications for cystourethroscopy are
to rule out cystotomy and intravesical or intraurethral
suture or mesh placement and to verify bilateral ureteral
patency during or after certain gynecologic surgical pro-
cedures. The procedures that have a relatively high risk
for these complications (at least 1–2%) may benefit
from cystourethroscopy to help avoid additional surgery,
permanent loss of renal function, fistulas, and other
abnormalities. Because intraoperative cystourethroscopy
examines only the bladder and urethral mucosal surfaces
and ureteral orifices, it does not guarantee recognition of
all lower urinary tract injuries. Nonobstructive, partially
obstructive, or late ureteral or bladder injuries may not
be recognized or prevented. Whether the routine use of
intraoperative cystourethroscopy during hysterectomy
and other gynecologic surgical procedures with a lower
risk of urinary tract injury is advisable requires further
study.
Postgraduate education, including residency train-
ing programs in obstetrics and gynecology and continu-
ing medical education, should include education in the
instrumentation, technique, and evaluation of findings
of cystourethroscopy, and in the pathophysiology of dis-
eases of the lower urinary tract.
References
1. Cundiff GW, Bent AE. Endoscopic evaluation of the lower
urinary tract. In: Walters MD, Karram MM, editors.
Urogynecology and reconstructive pelvic surgery. 3rd ed.
Philadelphia (PA): Mosby Elsevier; 2007. p. 114–23.
2. Dajani AS, Taubert KA, Wilson W, Bolger AF, Bayer
A, Ferrieri P, et al. Prevention of bacterial endocarditis.
Recommendations by the American Heart Association.
JAMA 1997;277:1794–801.
3. Olson ES, Cookson BD. Do antimicrobials have a role in
preventing septicemia following instrumentation of the
urinary tract? J Hosp Infect 2000;45:85–97.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 347
 4. Mitropoulos D, Kiroudi-Voulgari A, Nikolopoulos P,
Manousakas T, Zervas A. Accuracy of cystoscopy in pre­
dicting histologic features of bladder lesions. J Endourol
2005;19:861–4.
5. Dwyer PL, Carey MP, Rosamilia A. Suture injury to the
urinary tract in urethral suspension procedures for stress
incontinence. Int Urogynecol J Pelvic Floor Dysfunct
1999;10:15–21.
6. Councell RB, Thorp JM Jr, Sandridge DA, Hill ST.
Assessments of laparoscopic-assisted vaginal hysterectomy.
J Am Assoc Gynecol Laparosc 1994;2:49–56.
7. Dandolu V, Mathai E, Chatwani A, Harmanli O, Pontari
M, Hernandez E. Accuracy of cystoscopy in the diagno-
sis of ureteral injury in benign gynecologic surgery. Int
Urogynecol J Pelvic Floor Dysfunct 2003;14:427–31.
8. Gustilo-Ashby AM, Jelovsek JE, Barber MD, Yoo EH,
Paraiso MF, Walters MD. The incidence of ureteral
obstruction and the value of intraoperative cystoscopy dur-
ing vaginal surgery for pelvic organ prolapse. Am J Obstet
Gynecol 2006;194:1478–85.
9. Agency for Health Care Policy and Research. Urinary
incontinence in adults: acute and chronic management.
Clinical Practice Guideline, No. 2, 1996 update. AHCPR
Publication No. 96-0682. Rockville (MD): AHCPR; 1996.
10. Ouslander J, Leach G, Staskin D, Abelson S, Blaustein J,
Morishita L, et al. Prospective evaluation of an assessment
strategy for geriatric urinary incontinence. J Am Geriatr Soc
1989;37:715–24.
COMMITTEE OPINIONS
11. Ward K, Hilton P. Prospective multicentre randomised
trial of tension-free vaginal tape and colposuspension
as primary treatment for stress incontinence. United
Kingdom and Ireland Tension-Free Vaginal Tape Trial
Group. BMJ 2002;325:67–70.
12. Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA.
Tension-free vaginal tape operation: results of the Austrian
registry. Austrian Urogynecology Working Group. Obstet
Gynecol 2001;98:732–6.
13. Gilmour DT, Das S, Flowerdew G. Rates of urinary tract
injury from gynecologic surgery and the role of intraopera-
tive cystoscopy. Obstet Gynecol 2006;107:1366–72.
Copyright © July 2007 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photo­
copying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
The role of cystourethroscopy in the generalist obstetrician–gynecol-
ogist practice. ACOG Committee Opinion No. 372. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;110:221–4.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 348
 ACOG COMMITTEE OPINION
Number 375 • August 2007

Brand Versus Generic Oral Contraceptives

Committee on ABSTRACT: The U.S. Food and Drug Administration considers generic and brand
Gynecologic name oral contraceptive (OC) products clinically equivalent and interchangeable. The
Practice American College of Obstetricians and Gynecologists supports patient or clinician
Reaffirmed 2010 requests for branded OCs or continuation of the same generic or branded OCs if the
This document reflects request is based on clinical experience or concerns regarding packaging or compliance,
emerging clinical and sci- or if the branded product is considered a better choice for that individual patient.
entific advances as of the
date issued and is subject
to change. The information
should not be construed To control pharmaceutical costs and standard- with the branded product. No clinical trial
as dictating an exclusive ize national practice, the U.S. Food and Drug is needed given that the safety and efficacy
course of treatment or
procedure to be followed. Administration (FDA) was given the author­ of the generic product is expected to be that
ity to approve generic versions of branded of the clinically tested and FDA-approved
pharmaceutical products by the Drug Price branded product. Brand name and generic
Competition and Patent Term Restoration drug facilities are required to meet the same
Act. Before 1984, manufacturers of generic standards of good manufacturing practices.
products had to submit clinical safety and Patients and clinicians have ques-
efficacy data for their products just as the tioned whether generic and brand name OC
innovator drug manufacturer had to do for products are clinically equivalent and inter-
initial approval. Since 1984, generic products, changeable, as effective in preventing preg-
including generic oral contraceptive (OC) nancy, and have similar occurrences of side
products, must demonstrate pharmaceutical effects, such as breakthrough bleeding. The
equivalence, meaning that this new generic FDA considers generic and brand name OC
product contains the same active ingredi- products clinically equivalent and inter-
ents, identical in strength and dosage, as the changeable; however, others imply that this
branded product. This generic product also may not be true (2). The statistical meth-
must be bioequivalent, meaning that blood ods used by the FDA to determine bio-
levels obtained in clinical trials demonstrate equivalence have been challenged. The FDA
a rate and extent of absorption not substan­ Center for Drug Evaluation and Research has
tially different from the branded product (1). taken a firm stand upholding the therapeutic
Studies demonstrating bioequivalence equivalence and interchangeability of generic
of generic OC products are submitted by and branded products (3).
the generic pharmaceutical company after Oral contraceptive pills are the most
a crossover study of adequate power (usu- commonly used form of reversible contra-
ally of 20–24 women) with pharmacokinetic ception in the United States. Overall, the
calculations of serial blood levels of the pro­ FDA lists more than 90 combination hor-
gestin or its active metabolite and ethinyl monal contraceptives containing ethinyl
estradiol, plasma concentration time curves estradiol. Most OCs are no longer patent
(AUC), peak concentration, and the time to protected and are available for the develop-
peak concentration. The average blood level ment of generic pharmaceutical copies. The
deviation from the brand must be in the 2007 27th edition of Approved Drug Products
range of 80–125%. If these criteria are met, With Thera­ peutic Equivalence Evaluations,
The American College the FDA Office of Generic Drugs does not the so-called “Orange Book,” lists only seven
of Obstetricians
request or recommend clinical efficacy or combination OCs that do not have a generic
and Gynecologists
safety studies for the generic product before alternative (4). Although new OC formula-
Women’s Health Care
Physicians
granting marketing approval, and it consid- tions are protected by patent for 20 years
ers the generic product to be interchangeable from initial patent filing, in practice there is a

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 349

 much shorter interval from final approval and marketing
to loss of patent protection.
Although considered clinically equivalent by the
FDA, branded and generic OCs may differ in shape, pack-
aging, color, flavor, and shelf life. In addition, nonactive
ingredients such as preservatives and labeling and storage
requirements also may differ. Products are considered
bioequivalent if they fall within the required parameters;
the mean bioequivalence cannot be more than 20%
lower or 25% higher, with 95% certainty. In practice, the
reported ranges of generics are much narrower. Given
the range of acceptable generic bioequivalence, switching
between generic OCs or from branded to generic OCs
might be associated with increased side effects or other
problems, but similar problems theoretically might occur
when switching between two batches made by the same
manufacturer. Additionally, some firms package their
own branded drugs and sell them under a generic or
other brand label.
When taken correctly and consistently, combina-
tion OCs and other hormonal contraceptives have failure
rates of less than one pregnancy per 100 couples over 1
year. Published studies report different failure rates for
various brands, but few head-to-head studies have been
performed, and there is no evidence that with perfect
use different combination products have different failure
rates (5).
Although there are no clinical data on any differ-
ence in compliance between different branded OCs or
between generic and branded OCs, patients and clinicians
anecdotally report problems when switching occurs. It is
possible that side effects or pregnancy occur as a result
of poor compliance because patients are confused by
new packaging, they fear that they received the wrong
pill, or they lack confidence in generics. Although this
likely affects compliance and effectiveness, there are no
evidence-based data addressing these issues. Even though
some patients may perceive generic products to be less
effective, there are no clinical data on how this perception
affects continuation rates.
Given an individual’s variations in metabolism, it is
probably impossible to improve our knowledge of OCs
by completing larger studies; effectiveness and side effects
will tend to be overwhelmed by other nonpharmaceutical
effects. Breakthrough bleeding, which is a common cause
of OC discontinuation, is related to missed pills, smoking,
infection, and possibly drug interactions, which will tend
to overwhelm subtle variations between already confirmed
bioequivalent and pharmaceutically equivalent products.
As the FDA has pointed out, patients may be more likely to
be aware of symptoms when substitutions occur or if they
have been told they are taking a generic brand.
Oral contraceptive pills are obtained by patients in
a variety of settings and with different reimbursement
plans, and cost clearly influences access and use. For a
patient whose insurance will pay only for a generic prod-
uct on formulary or in cases where a patient is paying
COMMITTEE OPINIONS
out of pocket, the difference in price can be as much as
70% less for a generic, especially when multiple generic
choices for a specific branded product are available.
Often, the difference is much less. Cost has been shown
to be among the most important factors in OC continu-
ation, and less expensive generic OCs may have better
continuation rates than more expensive alternatives (6).
Generic OCs approved by the FDA have been shown
to be bioequivalent and pharmaceutically equivalent
to the branded product and are interchangeable. There
are no evidence-based data to challenge this conclu-
sion. However, because of possible effects on patient
compliance, the American College of Obstetricians and
Gyne­cologists supports patient or clinician requests for
branded OCs or continuation of the same generic or
branded OC if the request is based on clinical experience
or concerns regarding packaging or compliance, or if the
branded product is considered a better choice for that
individual patient. Women should be informed when a
different OC is substituted for a previously prescribed OC.
References
1. Welage LS, Kirking DM, Ascione FJ, Gaither CA.
Understanding the scientific issues embedded in the gen-
eric drug approval process. J Am Pharm Assoc 2001;41:
856–67.
2. Bioequivalence between brand-name and generic OCs.
Contracept Rep 2002;13(2):6–9.
3. U.S. Food and Drug Administration. Therapeutic equiva-
lence of generic drugs. Letter to health practitioners.
Rockville (MD): FDA; 1998. Available at: http://www.fda.
gov/cder/news/nightgenlett.htm. Retrieved April 3, 2007.
4. U.S. Food and Drug Administration. Approved drug prod-
ucts with therapeutic equivalence evaluations. 27th ed.
Rockville (MD): FDA; 2007. Available at: http://www.fda.
gov/cder/ob. Retrieved April 3, 2007.
5. Rosenberg MJ, Waugh MS. Oral contraceptive discontinu­
ation: a prospective evaluation of frequency and reasons.
Am J Obstet Gynecol 1998;179:577–82.
6. Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K,
DeLapp D, et al. The implications of choice: prescribing
generic or preferred pharmaceuticals improves medication
adherence for chronic conditions. Arch Intern Med 2006;
166:332–7.
Copyright © August 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Brand versus generic oral contraceptives. ACOG Committee Opinion
No. 375. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2007;110:447–8.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 350
 ACOG COMMITTEE OPINION
Number 378 • September 2007

Vaginal “Rejuvenation” and Cosmetic

Vaginal Procedures
Committee on
Gynecologic ABSTRACT: So-called “vaginal rejuvenation,” “designer vaginoplasty,” “revirgin-
Practice ation,” and “G-spot amplification” are vaginal surgical procedures being offered by some
practitioners. These procedures are not medically indicated, and the safety and effective-
This document reflects
emerging clinical and sci- ness of these procedures have not been documented. Clinicians who receive requests
entific advances as of the from patients for such procedures should discuss with the patient the reason for her
date issued and is subject
to change. The information request and perform an evaluation for any physical signs or symptoms that may indicate
should not be construed the need for surgical intervention. Women should be informed about the lack of data
as dictating an exclusive
course of treatment or supporting the efficacy of these procedures and their potential complications, including
procedure to be followed. infection, altered sensation, dyspareunia, adhesions, and scarring.

There have been an increasing number of
practitioners offering various types of vagi-
nal surgeries marketed as ways to enhance
appearance or sexual gratification. Among
the types of procedures being promoted are
so-called “vaginal rejuvenation,” “designer
vaginoplasty,” “revirgination,” and “G-spot
amplification.” Often the exact procedure
performed is not clear because standard
medical nomenclature is not used. Some
procedures, such as vaginal rejuvenation,
appear to be modifications of traditional vag-
inal surgical procedures. Other procedures
are performed to alter the size or shape of the
labia majora or labia minora. Revirgination
involves hymenal repair in an attempt to
approximate the virginal state. G-spot ampli-
fication involves the injection of collagen
into the anterior wall of the vagina.
Medically indicated surgical procedures
may include reversal or repair of female geni-
tal cutting and treatment for labial hypertro-
phy or asymmetrical labial growth secondary
to congenital conditions, chronic irritation,
or excessive androgenic hormones. Other
procedures, including vaginal rejuvenation,
designer vaginoplasty, revirgination, and
G-spot amplification, are not medically indi-
The American College cated, and the safety and effectiveness of these
of Obstetricians procedures have not been documented. No
and Gynecologists adequate studies have been published assess-
Women’s Health Care ing the long-term satisfaction, safety, and
Physicians complication rates for these procedures.
Also of concern are ethical issues asso-
ciated with the marketing of these proce-
dures and the national franchising in this
field. Such a business model that controls
the dissemination of scientific knowledge is
troubling.
Clinicians who receive requests from
patients for such procedures should discuss
with the patient the reason for her request
and perform an evaluation for any physical
signs or symptoms that may indicate the
need for surgical intervention. A patient’s
concern regarding the appearance of her
genitalia may be alleviated by a frank discus-
sion of the wide range of normal genitalia
and reassurance that the appearance of the
external genitalia varies significantly from
woman to woman (1). Concerns regarding
sexual gratification may be addressed by
careful evaluation for any sexual dysfunction
and an exploration of nonsurgical interven-
tions, including counseling.
It is deceptive to give the impression that
vaginal rejuvenation, designer vaginoplasty,
revirgination, G-spot amplification, or any
such procedures are accepted and routine
surgical practices. Absence of data support-
ing the safety and efficacy of these procedures
makes their recommendation untenable.
Patients who are anxious or insecure about
their genital appearance or sexual function
may be further traumatized by undergoing
an unproven surgical procedure with obvi-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 351

 ous risks. Women should be informed about the lack of
data supporting the efficacy of these procedures and their
potential complications, including infection, altered sen-
sation, dyspareunia, adhesions, and scarring.
Reference
1. Lloyd J, Crouch NS, Minto CL, Liao LM, Creighton SM.
Female genital appearance: “normality” unfolds. BJOG
2005;112:643–6.
COMMITTEE OPINIONS
Copyright © September 2007 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Vaginal “rejuvenation” and cosmetic vaginal procedures. ACOG
Committee Opinion No. 378. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:737–8.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 352
 ACOG COMMITTEE OPINION
Number 388 • November 2007

Supracervical Hysterectomy
Committee on ABSTRACT: Women with known or suspected gynecologic cancer, current or
Gynecologic recent cervical dysplasia, or endometrial hyperplasia are not candidates for a supracervi-
Practice cal procedure. Patients electing supracervical hysterectomy should be carefully screened
Reaffirmed 2010 preoperatively to exclude cervical or uterine neoplasm and should be counseled about the
This document reflects need for long-term follow-up, the possibility of future trachelectomy, and the lack of data
emerging clinical and demonstrating clear benefits over total hysterectomy. The supracervical approach should
scientific advances as of
the date issued and is not be recommended by the surgeon as a superior technique for hysterectomy for benign
subject to change. The
information should not
disease.
be construed as dictat-
ing an exclusive course Hysterectomy remains one of the most com- Women with known or suspected gyne-
of treatment or proce-
dure to be followed. monly performed surgical procedures in cologic cancer, current or recent cervical
the United States, with the most frequent dysplasia, or endometrial hyperplasia are
indications being abnormal uterine bleed- not candidates for a supracervical procedure
ing and symptomatic uterine leiomyomata. (3–5). Candidates for elective supracervi-
Variations in surgical technique have been cal hysterectomy must have normal results
described in an attempt to reduce opera- from a recent cytologic cervical examination
tive morbidity and reduce the effects of and normal gross appearance of the cervix
hysterectomy on urinary and sexual func- documented before surgery (3–5). Clinicians
tion. Supracervical hysterectomy is one such also should consider testing for high-risk
technique in which there has been renewed human papillomavirus to identify patients
interest among patients and some gyneco- who could be at risk for future cervical neo-
logic surgeons. Historically, the supracervi- plasia. Amputation of the uterine corpus in
cal hysterectomy was abandoned in favor the abdominal approach and morcellation
of total hysterectomy because of problems of the corpus in the laparoscopic approach
related to the retained cervix. The purpose require adequate preoperative assessment of
of this document is to review the scientific the endometrial cavity to exclude neoplasm
data for elective supracervical hysterectomy (3–5).
in which it is the preference of the patient or Possible benefits of supracervical hys-
physician to preserve the cervix at the time terectomy with regard to perioperative mor-
of hysterectomy unrelated to the indications bidity are not supported by recent evidence.
for surgery. In three prospective randomized controlled
Techniques for supracervical hysterec- trials that did not include laparoscopic pro-
tomy, defined as removal of the uterine cedures, no difference in complications,
corpus with preservation of the cervix, are including infection; blood loss requiring
well described for both the abdominal and transfusion; or urinary tract, bowel, or vas-
laparoscopic approaches (1, 2). Features cular injury, was seen between women ran-
common to both the laparoscopic and open domized to total abdominal hysterectomy
techniques of supracervical hysterectomy are (TAH) and supracervical abdominal hyster-
removal of the corpus at or below the level ectomy (3–5). Length of hospital stay (5.2
of the internal os and attempted ablation of versus 6 days, P = .04) and duration of surgi-
the endocervical canal after removal of the cal procedure (59.5 versus 71.1 minutes P
The American College <.001) were significantly shorter for women
corpus (1). In laparoscopic supracervical
of Obstetricians randomized to supracervical hysterectomy
and Gynecologists hysterectomy, morcellation of the uterine
fundus is performed to facilitate its removal in European studies, but no significant dif-
Women’s Health Care ference was seen in any outcome measured
Physicians through the port site incisions (1).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 353

 in the only prospective randomized trial of TAH versus
supracervical hysterectomy conducted in the United
States (3–5). Reported rates of postoperative cyclical
vaginal bleeding in women randomized to supracervical
hysterectomy were 5–20% in these three prospective tri-
als. Of the two trials that reported reoperation rates, 1.5%
of the participants had a second operation to remove the
cervix less than 3 months from the time of hysterectomy.
Choosing to preserve the cervix to reduce adverse
effects of hysterectomy on sexual and urinary function
also is not supported by data from prospective ran-
domized trials. Differences in preoperative and postop-
erative stress or urge incontinence, urinary frequency,
and incomplete bladder emptying were not statistically
significant between women randomized to supracervi-
cal hysterectomy or TAH in either the U.S. or British
trials (3, 4). The Danish Hysterectomy Group found a
higher incidence of urinary incontinence in women ran-
domized to supracervical hysterectomy (P = .043) (5).
Sexual satisfaction was reported with similar frequency
preoperatively and 1 year postoperatively by women in
the Danish study, irrespective of type of hysterectomy
performed (5). Frequency of intercourse, frequency of
orgasm, and rating of sexual relationship with a partner
measured preoperatively and postoperatively were simi-
lar for the supracervical hysterectomy and TAH groups
in the British study (4). In the U.S. study, there were
no differences between the supracervical hysterectomy
and the TAH groups in sexual functioning and measure
of health-related quality of life, including sexual desire,
orgasm frequency and quality, and body image, measured
2 years after surgery (6).
Because there have been no randomized, controlled
trials of laparoscopic supracervical hysterectomy com-
pared with either TAH or laparoscopically assisted vagi-
nal hysterectomy (LAVH), evidence regarding the poten-
tial benefits of this technique is limited to retrospective
series. In a retrospective comparison of laparoscopic
supracervical hysterectomy with LAVH, less blood loss,
shorter operating time, and fewer complications were
found in the patients who had supracervical hysterec-
tomy (7). In contrast, the recent experience of a large
managed care organization was documented, indicating
longer operating time for laparoscopic supracervical
hysterectomy compared with TAH but less blood loss,
shorter hospital stay, and fewer major complications for
laparoscopic supracervical hysterectomy compared with
TAH (8). Although only reported in series with small
numbers of patients, the long-term complications of
laparoscopic supracervical hysterectomy include cyclical
vaginal bleeding in 11–17% of cases and the need for
trachelectomy because of symptoms in 23% of cases at
a mean of 14 months from the time of hysterectomy (9,
10). The potential risks as well as benefits of laparoscopic
supracervical hysterectomy should be carefully consid-
ered by the individual surgeon and patient until data
from prospective randomized controlled trials compar-
ing this technique with LAVH or TAH are available.
COMMITTEE OPINIONS
An additional risk of supracervical hysterectomy
relates to the development of benign or neoplastic condi-
tions that require future removal of the cervical stump.
Complications of trachelectomy reported in the largest
published series (310 cases) include a 9% incidence of
infection and perioperative bleeding and a 2% incidence
of intraoperative bowel injury. Fewer complications were
seen with vaginal trachelectomy than with abdominal
trachelectomy (11).
Although data from uncontrolled series may suggest
a benefit from preserving the cervix, review of recently
published Level I evidence reveals no advantage to the
supracervical abdominal technique with regard to surgi-
cal complications, urinary symptoms, or sexual function
in women undergoing hysterectomy for symptomatic
uterine leiomyomata or abnormal uterine bleeding (3–5).
Despite the potential advantages of shorter hospital stay
and less blood loss afforded by the laparoscopic supra-
cervical approach, there are no prospective data compar-
ing laparoscopic supracervical hysterectomy with either
LAVH or TAH.
Patients electing supracervical hysterectomy should
be carefully screened preoperatively to exclude cervi-
cal or uterine neoplasm and should be counseled about
the need for long-term follow-up, the possibility of
future trachelectomy, and the lack of data demonstrating
clear benefits over total hysterectomy. The supracervical
approach should not be recommended by the surgeon as
a superior technique for hysterectomy for benign disease.
References
1 Jenkins TR. Laparoscopic supracervical hysterectomy. Am J
Obstet Gynecol 2004;191:1875–84.
2. Parker WH. Total laparoscopic hysterectomy and laparo-
scopic supracervical hysterectomy. Obstet Gynecol Clin
North Am 2004;31:523–37, viii.
3. Learman LA, Summitt RL Jr, Varner RE, McNeeley SG,
Goodman-Gruen D, Richter HE, et al. A randomized
comparison of total or supracervical hysterectomy: surgical
complications and clinical outcomes. Total or Supracervical
Hysterectomy (TOSH) Research Group. Obstet Gynecol
2003;102:453–62.
4. Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I.
Outcomes after total versus subtotal abdominal hysterec-
tomy. N Engl J Med 2002;347:1318–25.
5. Gimbel H, Zobbe V, Andersen BM, Filtenborg T, Gluud
C, Tabor A. Randomised controlled trial of total compared
with subtotal hysterectomy with one-year follow up results.
BJOG 2003;110:1088–98.
6. Kuppermann M, Summitt RL Jr, Varner RE, McNeeley SG,
Goodman-Gruen D, Learman LA, et al. Sexual function-
ing after total compared with supracervical hysterectomy:
a randomized trial. Total or Supracervical Hysterectomy
Research Group. Obstet Gynecol 2005;105:1309–18.
7. El-Mowafi D, Madkour W, Lall C, Wenger JM. Laparoscopic
supracervical hysterectomy versus laparoscopic-assisted
vaginal hysterectomy. J Am Assoc Gynecol Laparosc 2004;
11:175–80.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 354
 8. Hoffman CP, Kennedy J, Borschel L, Burchette R, Kidd
A. Laparoscopic hysterectomy: the Kaiser Permanente San
Diego experience. J Minim Invasive Gynecol 2005;12:16–24.
9. Okaro EO, Jones KD, Sutton C. Long term outcome fol-
lowing laparoscopic supracervical hysterectomy. BJOG
2001; 108:1017–20.
10. Ghomi A, Hantes J, Lotze EC. Incidence of cyclical bleed-
ing after laparoscopic supracervical hysterectomy. J Minim
Invasive Gynecol 2005;12:201–5.
11. Hilger WS, Pizarro AR, Magrina JF. Removal of the retained
cervical stump. Am J Obstet Gynecol 2005;193:2117–21.
COMMITTEE OPINIONS
Copyright © November 2007 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Supracervical hysterectomy. ACOG Committee Opinion No. 388.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2007;110:1215–7.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 355
 ACOG COMMITTEE OPINION
Number 396 • January 2008

Intraperitoneal Chemotherapy
for Ovarian Cancer
Committee on ABSTRACT: Postoperative intravenous (IV) chemotherapy for advanced stage ovar-
Gynecologic ian cancer has been the standard treatment. Recent studies have found significant sur-
Practice vival advantages with the use of adjuvant intraperitoneal (IP) chemotherapy. Combination
Reaffirmed 2010 IV/IP chemotherapy may be an option for well counseled, carefully selected patients with
This document reflects optimally debulked stage III ovarian cancer. However, IV/IP treatment also has increased
emerging clinical and
scientific advances as of rates of pain, fatigue, and hematologic, gastrointestinal, metabolic, and neurologic tox-
the date issued and is icities. Given the balance of efficacy, quality of life, and toxicity, the decision to use IP
subject to change. The
information should not chemotherapy must be individualized.
be construed as dictat-
ing an exclusive course
of treatment or proce- Epithelial ovarian cancer is the second most Intraperitoneal chemotherapy as a ther-
dure to be followed.
common gynecologic malignancy, but is the apeutic strategy for patients with ovarian
leading cause of death from gynecologic cancer was based on pharmacologic model-
cancer in the United States. In 2007, an esti- ing studies performed in the late 1970s (2).
mated 22,430 new cases of ovarian cancer The rationale was based on the findings of
and 15,280 deaths from ovarian cancer will high intraperitoneal concentration of drugs
occur in the United States (1). Most patients and longer half-life of the drug in the peri-
with ovarian cancer present with either stage toneal cavity, which resulted in a prolonged
III or stage IV disease. exposure of the chemotherapy agents. One of
Patients with early stage disease need the concerns of the use of IP chemotherapy
to have comprehensive surgical staging to has been uniform distribution of the drug,
assess risks and to direct adjuvant chemo- which may not occur because of adhesions
therapy. In addition, for advanced ovarian that result from surgery.
cancer, primary surgical cytoreduction plays To study these concerns, randomized
an important role. The goal of cytoreductive clinical trials of IV chemotherapy versus IP
surgery is to achieve optimal tumor reduc- chemotherapy began approximately 20 years
tion, ideally with individual aggregates of ago. The results of Gynecologic Oncology
residual disease less than 1 cm. Postoperative Group (GOG) Protocol 172 were published
intravenous (IV) chemotherapy in advanced in early 2006 (3). This trial compared IV
stage ovarian cancer has been the standard chemotherapy with an experimental regimen
treatment. Recent trials have suggested that containing both IV and IP chemotherapy in
patients with optimally debulked stage III women with optimally debulked stage III
ovarian cancer may be candidates to receive ovarian cancer. The treatment regimen was
part of their chemotherapy intraperitone- administered every 3 weeks for six cycles (see
ally. Patients with newly diagnosed ovar- box). The results of this trial are summarized
ian cancer may solicit input from their in Table 1.
generalist obstetrician–gynecologist regard- The survival advantage of approximately
ing treatment options. The purpose of this 16 months in GOG Protocol 172 was consid-
Committee Opinion is to provide the gen- ered to be a significant advance. The results
The American College eralist obstetrician–gynecologist with infor- of this trial and six other randomized tri-
of Obstetricians mation regarding the use of intraperitoneal als prompted the National Cancer Institute
and Gynecologists (IP) chemotherapy in the treatment of ovar- (NCI) to issue a Clinical Announcement
Women’s Health Care ian cancer and a summary of recent trial pertaining to IP chemotherapy for epithelial
Physicians results. ovarian cancer (4). Seven randomized trials

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 356


Gynecologic Oncology Group
Protocol 172 Treatment Schedules
Standard Therapy Experimental Arm
IV administration of IV administration of
paclitaxel, 135 mg/m2 paclitaxel, 135 mg/m2
over 24 h over 24 h
plus plus
IV administration of IP administration of
cisplatin, 75 mg mg/m2 cisplatin, 100 mg/m2
every 3 wk × 6 plus
IP administration of
paclitaxel, 60 mg/m2
on d 8 every 3 wk × 6
Table 1. Gynecologic Oncology Group Protocol 172 Results
Therapy
Standard Experimental P Value
Progression-free survival 18.3 mos 23.8 mo .05
Survival 49.7 mos 65.8 mo .03 nation of drugs for IV/IP therapy had not been identified.
found that women who received adjuvant IP chemo-
therapy had greater overall survival rates than women
who did not receive such treatment.
However, in GOG Protocol 172, the complication
rate of the experimental IV/IP regimen was significantly
greater than the complication rate of IV therapy alone.
The IV/IP chemotherapy group had more severe tox-
icities, which included pain and fatigue and hematologic,
gastrointestinal, metabolic, and neurologic toxicities.
Quality of life was lower in the IV/IP chemotherapy
group during the first year after initial treatment. In addi-
tion, only 42% of the patients randomized to IV/IP che-
motherapy completed the recommended six cycles. The
most common reason for discontinuation of IP therapy
was catheter-related problems (34%) (5). Nine percent of
patients refused additional IP treatment.
There has not been widespread acceptance of IV/
IP therapy because of toxicities, catheter problems, and
a complicated treatment regimen. Acceptance of the IV/
IP regimen is further complicated because the IV-only
regimen used in GOG Protocol 172 was not the cur-
rent preferred treatment of IV administration of pacli-
taxel, 175 mg/m2 over 3 hours, and IV administration
of carboplatin (area under the curve, 7.5). Intravenous
administration of paclitaxel, 175 mg/m2 over 3 hours,
and IV administration of carboplatin (area under the
curve, 7.5) was one of the treatments compared with
24-hour IV administration of paclitaxel and cisplatin in
GOG Protocol 158. The paclitaxel (given over 3 hours)
COMMITTEE OPINIONS
and carboplatin treatment arm of GOG Protocol 158
demonstrated improved survival compared with 24-hour
IV administration of paclitaxel and cisplatin, which was
the IV-only regimen used in GOG Protocol 172 (6).
Women in GOG Protocol 172 and GOG Protocol 158
had optimally debulked stage III ovarian cancer. Robust
exploratory cross-trial comparisons of IV administration
of carboplatin and IV administration of paclitaxel com-
pared with IV/IP regimens suggest similar efficacy (7). A
recent international consensus conference recommended
IV administration of carboplatin and paclitaxel as the
standard regimen against which new treatments should
be compared (8).
Patients with optimally debulked stage III epithelial
ovarian cancer who would be potential candidates for
IP chemotherapy should be well counseled regarding the
risks and benefits of IV plus IP chemotherapy versus IV
chemotherapy alone. Clinically, many patients are being
treated with IP chemotherapy, but probably are not using
the GOG Protocol 172 dosing regimen. Consequently,
women may be treated with IV/IP chemotherapy regi-
mens that have no scientific evidence of better outcomes.
The NCI Clinical Announcement summary stated that
despite the positive findings of the trials, the ideal combi-
The NCI Clinical Announcement suggested consideration
of IP cisplatin therapy, 100 mg/m2, and IV-only taxane
administration or by IV plus IP administration. The
Gynecology Oncology Group is currently evaluating other
IV/IP chemotherapy regimens to identify a less toxic,
more tolerable, and less complicated treatment regimen.
In summary, combination IV/IP chemotherapy
may be an option for well counseled, carefully selected
patients with optimally debulked stage III ovarian cancer
when provided by a physician with the requisite training
and experience in administering this treatment. How-
ever, given the balance of efficacy, quality of life, and
toxicity, the decision to use IP chemotherapy must be
individualized.
References
1. American Cancer Society. Cancer facts and figures 2007.
Atlanta (GA): ACS; 2007. Available at: http://www.cancer.
org/downloads/STT/CAFF2007PWSecured.pdf. Retrieved
August 22, 2007.
2. Dedrick RL, Myers CE, Bungay PM, DeVita VT Jr.
Pharmacokinetic rationale for peritoneal drug administra-
tion in the treatment of ovarian cancer. Cancer Treat Rep
1978;62:1–11.
3. Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen
R, Lele S, et al. Intraperitoneal cisplatin and paclitaxel in
ovarian cancer. Gynecologic Oncology Group. N Engl J
Med 2006;354:34–43.
4. National Cancer Institute. Clinical announcement on
intraperitoneal chemotherapy in ovarian cancer. Cancer
Therapy Evaluation Program. Bethesda (MD): NCI; 2006.
Available at: http://ctep.cancer.gov/highlights/clin_annc_
010506.pdf. Retrieved September 28, 2007.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 357
 5. Walker JL, Armstrong DK, Huang HQ, Fowler J, Webster
K, Burger RA, et al. Intraperitoneal catheter outcomes in a
phase III trial of intravenous versus intraperitoneal chemo-
therapy in optimal stage III ovarian and primary peritoneal
cancer: a Gynecologic Oncology Group Study. Gynecol
Oncol 2006;100:27–32.
6. Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson
D, Burger RA, et al. Phase III trial of carboplatin and pacli-
taxel compared with cisplatin and paclitaxel in patients with
optimally resected stage III ovarian cancer: a Gynecologic
Oncology Group study. Gynecologic Oncology Group. J
Clin Oncol 2003;21:3194–200.
7. Ozols RF, Bookman MA, du Bois A, Pfisterer J, Reuss A,
Young RC. Intraperitoneal cisplatin therapy in ovarian
cancer: comparison with standard intravenous carboplatin
and paclitaxel. Gynecol Oncol 2006;103:1–6.
8. du Bois A, Quinn M, Thigpen T, Vermorken J, Avall-
Lundqvist E, Bookman M, et al. 2004 consensus statements
on the management of ovarian cancer: final document of the
3rd International Gynecologic Cancer Intergroup Ovarian
COMMITTEE OPINIONS
Cancer Consensus Conference (GCIG OCCC 2004).
Gynecologic Cancer Intergroup; AGO-OVAR; ANZGOG;
EORTC; GEICO; GINECO; GOG; JGOG; MRC/NCRI;
NCIC-CTG; NCI-US; NSGO; RTOG; SGCTG; IGCS;
Organizational team of the two prior International OCCC.
Ann Oncol 2005;16(suppl 8):viii7–viii12.
Copyright © January 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Intraperitoneal chemotherapy for ovarian cancer. ACOG Committee
Opinion No. 396. American College of Obstetricians and Gyne-
cologists. Obstet Gynecol 2008;111:249–51.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 358
 ACOG COMMITTEE OPINION
Number 408 • June 2008 (Replaces No. 288, October 2003)

Professional Liability and Gynecology-Only

Practice
Committee on ABSTRACT: Fellows of the American College of Obstetricians and Gynecologists
Gynecologic may choose to limit the scope of their practices to gynecology. The College considers
Practice early pregnancy care (often up to 12–14 weeks of gestation) to be within the scope of
Committee on gynecology and gynecologic practice. Liability insurers who provide coverage for “gyne-
Obstetric Practice cology-only” practices should provide coverage for clinical practice activities that involve
the management of early pregnancy and its complications.
Committee on
Professional Liability
Reaffirmed 2012 Fellows of the American College of Obstetricians and Gynecologists may choose to limit the
scope of their practices to gynecology and, accordingly, may choose not to request profes-
sional liability coverage for obstetrics. However, the College considers early pregnancy care
(often up to 12–14 weeks of gestation) to be within the scope of gynecology and gynecologic
practice. Management of conditions such as ectopic pregnancy as well as spontaneous and
elective abortion, including early midtrimester abortion, may be properly undertaken in such
practices. Liability insurers who provide coverage for “gynecology-only” practices should pro-
vide coverage for clinical practice activities that involve the management of early pregnancy
and its complications.

Copyright © June 2008 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO
Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced,
stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher.
Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Professional liability and gynecology-only practice. ACOG Committee Opinion No. 408. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2008;111:1491.

The American College

of Obstetricians
and Gynecologists
Women’s Health Care
Physicians

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 359

 ACOG COMMITTEE OPINION
Number 411 • August 2008

Routine Human Immunodeficiency

Virus Screening
Committee on ABSTRACT: The American College of Obstetricians and Gynecologists recom-
Gynecologic mends routine human immunodeficiency virus (HIV) screening for women aged 19–64
Practice years and targeted screening for women with risk factors outside of that age range.
Reaffirmed 2010 Ideally, opt-out HIV screening should be performed, in which the patient is notified that
This document reflects HIV testing will be performed as a routine part of gynecologic and obstetric care, unless
emerging clinical and sci- the patient declines testing (1). The American College of Obstetricians and Gynecologists
entific advances as of the
date issued and is subject recommends that obstetrician–gynecologists annually review patients’ risk factors for
to change. The information HIV and assess the need for retesting.
should not be construed
as dictating an exclusive
course of treatment or
procedure to be followed. An estimated one quarter of all individuals and targeted screening for women with risk
infected with the human immunodeficiency factors outside of that age range, for example,
virus (HIV) in the United States are unaware sexually active adolescents younger than 19
of their HIV status. In order to identify years.
individuals with undiagnosed HIV infection, Ideally, opt-out HIV screening should
the U.S. Centers for Disease Control and be performed, in which the patient is noti-
Prevention (CDC) recommends HIV screen- fied that HIV testing will be performed as a
ing for all patients aged 13–64 years in health routine part of gynecologic and obstetric care,
care settings (1). Because obstetrician–gyne- unless the patient declines testing (1). In opt-
cologists provide primary and preventive out screening, neither specific signed consent
care for women, they are ideally suited to nor prevention counseling is required. How-
play an important role in promoting HIV ever, women should be provided with oral
screening for their patients. Although most or written information about HIV and the
obstetrician­–gynecologists are familiar with meaning of positive and negative test results
routine HIV testing of their pregnant and given the opportunity to ask questions
patients, physicians should incorporate rou- and decline testing. If a patient declines HIV
tine HIV testing into their gynecologic prac- testing, this should be documented in the
tices as well. medical record and should not affect access
There are a number of reasons why it to care (4). Although ACOG recommends
is critical that women, who represent an opt-out screening where legally possible, state
increasing proportion of overall HIV and and local laws may have specific requirements
acquired immunodeficiency syndrome for HIV testing that are not consistent with
(AIDS) cases, know their HIV status. Early such an approach. Therefore, obstetrician–
diagnosis and treatment of HIV can improve gynecologists should be aware of and comply
survival and reduce morbidity (2). In addi- with legal requirements regarding HIV test-
tion, women who are infected with HIV can ing in their jurisdictions. Legal requirements
take steps to avoid unintended pregnancy, for HIV testing may be verified by contact-
protect their sexual partners, and reduce ing state or local health departments. The
The American College the likelihood of mother-to-child transmis- National HIV/AIDS Clinicians’ Consultation
of Obstetricians sion should pregnancy occur (3). Therefore, Center at the University of California San
and Gynecologists the American College of Obstetricians and Francisco maintains an online compendium
Women’s Health Care Gynecologists (ACOG) recommends routine of state HIV testing laws that can be a useful
Physicians HIV screening for women aged 19–64 years resource (www. nccc.ucsf.edu).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 360

 The use of rapid HIV tests may provide test results
to women in a more timely manner and may reduce the
resources necessary to follow-up with patients regarding
their test results. Although a positive rapid test result
is preliminary and must be confirmed with additional
testing, a negative rapid test result does not require any
additional testing. Therefore, rapid testing may be a fea-
sible and acceptable approach for an HIV screening pro-
gram in an obstetric–gynecologic practice (5). To code for
rapid testing, the modifier 92 is added to the basic
HIV testing Current Procedural Terminology* (CPT) codes
(86701–86703).
Although CDC and ACOG both recommend that
reproductive-aged women be tested at least once in
their lifetime, there is no consensus regarding how
often women should be retested. The American College
of Obstetricians and Gynecologist recommends that
obstetrician­–gynecologists annually review patients’ risk
factors for HIV and assess the need for retesting. Repeat
HIV testing should be offered at least annually to women
who:
• Are injection drug users
• Have sex partners who are injection drug users or are
infected with HIV
• Exchange sex for drugs or money
• Have received a diagnosis of another sexually trans-
mitted disease in the past year
• Have had more than one sex partner since their most
recent HIV test
Obstetrician–gynecologists also should encourage women
and their prospective sex partners to be tested before ini-
tiating a new sexual relationship. In addition, periodic
retesting could be considered even in the absence of risk
factors depending on clinical judgment and the patient’s
wishes because patients may be concerned about their
status but not know about or want to disclose risk-taking
behavior to their physicians.
Although HIV-negative test results may be conveyed
without direct personal contact, HIV-positive test results
should be communicated confidentially and in person by
a physician, nurse, or other skilled staff member. Women
who are infected with HIV should receive or be referred
for appropriate clinical and supportive care.
Rapid test results usually will be available during
the same clinical visit that the specimen (eg, blood or
oral swab sample) is collected. Obstetrician–gynecologists
who use these tests must be prepared to provide coun-
seling to women who receive positive rapid test results
the same day that the specimen is collected (ie, women
*Current Procedural Terminology (CPT) is copyright 2008 by American
Medical Association. All rights reserved. No fee schedules, basic units,
relative values, or related listings are included in CPT . The AMA
assumes no liability for the data contained herein. CPT  is a trademark
of the American Medical Association.
COMMITTEE OPINIONS
with positive rapid test results should be counseled
regarding the meaning of these preliminarily positive
test results and the need for confirmatory testing) (4).
Obstetrician–gynecologists should develop links with
individuals who can provide these counseling services
on an emergent basis or train their own staff to handle
the initial encounter and, thereafter, transition infected
individuals to professionals who can serve as ongoing
resources to them. Women whose confirmatory testing
yields positive results and, therefore, are infected with
HIV should receive or be referred to appropriate clinical
and supportive care.
Resources
American College of Obstetricians and Gynecologists
409 12th Street SW, PO Box 96920
Washington, DC 20090-6920
202-638-5577
ACOG HIV resources: www.acog.org/goto/HIV
National HIV/AIDS Clinicians’ Consultation Center
UCSF Department of Family and Community Medicine at
San Francisco General Hospital
1001 Potrero Ave., Bldg. 20, Ward 22
San Francisco, CA 94110
415-206-8700
National HIV Telephone Consultation Service:
1-800-933-3413 (M–F, 8 am–8 pm [EST])
www.nccc.ucsf.edu
American Academy of HIV Medicine, American Medical
Association. Coding guidelines for routine HIV testing in
health care settings. Washington, DC: AAHIVM; Chicago
(IL): AMA; 2008. Available at: http://aahivm.org/images/
stories/ pdfs/brochure_reimburse_guide_routinehivtest.pdf.
Retrieved May 6, 2008.
References
1. Branson BM, Handsfield HH, Lampe MA, Janssen RS,
Taylor AW, Lyss SB, et al. Revised recommendations for
HIV testing of adults, adolescents, and pregnant women
in health-care settings. Centers for Disease Control and
Prevention (CDC). MMWR Recomm Rep 2006;55(RR-
14):1–17; quiz CE1–4.
2. Palella FJ Jr, Deloria-Knoll M, Chmiel JS, Moorman AC,
Wood KC, Greenberg AE, et al. Survival benefit of initiating
antiretroviral therapy in HIV-infected persons in different
CD4+ cell strata. HIV Outpatient Study Investigators. Ann
Intern Med 2003;138:620–6.
3. U.S. Public Health Service Task Force. Recommendations
for use of antiretroviral drugs in pregnant HIV-infected
women for maternal health and interventions to reduce
perinatal HIV transmission in the United States. Rockville
(MD): USPHSTF; 2007. Available at: http://www.aidsinfo.
nih.gov/contentfiles/PerinatalGL.pdf. Retrieved March 7,
2008.
4. Human immunodeficiency virus. ACOG Committee
Opinion No. 389. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1473–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 361
 5. Jamieson DJ, Cohen MH, Maupin R, Nesheim S, Danner
SP, Lampe MA, et al. Rapid human immunodeficiency
virus-1 testing on labor and delivery in 17 US hospitals: the
MIRIAD experience. Am J Obstet Gynecol 2007;197(suppl
1):S72–S82.
COMMITTEE OPINIONS
Copyright © August 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Routine human immunodeficiency virus screening. ACOG Committee
Opinion No. 411. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2008;112:401–3.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 362
 ACOG COMMITTEE OPINION
Number 412 • August 2008

Aromatase Inhibitors in Gynecologic

Practice
Committee on
Gynecologic ABSTRACT: Aromatase inhibitors appear to be effective as an adjuvant treatment
Practice for early-stage and late-stage breast cancer. Their role in chemoprevention of breast
cancer in high-risk patients remains to be defined. Side effects of aromatase inhibitors
Reaffirmed 2010 in postmenopausal women are due to estrogen-lowering action at the target tissues and
This document reflects include hot flushes, vaginal dryness, arthralgias, and decreased bone mineral density. In
emerging clinical and sci-
entific advances as of the reproductive-aged women, aromatase inhibitors stimulate gonadotropin secretion and
date issued and is subject increase ovarian follicular activity. The role of aromatase inhibitors in the treatment of
to change. The information
should not be construed endometriosis and in ovulation induction is still being investigated.
as dictating an exclusive
course of treatment or
procedure to be followed.
The pharmacologic manipulation of hor- similar clinical efficacy despite these differ-
mone levels has been very successful in the ences in pharmacologic properties.
treatment of estrogen-dependent disease In postmenopausal women, aromatase
processes such as breast cancer, endome- inhibitors were first introduced for the treat-
triosis, and uterine leiomyomas. As part ment of advanced breast cancer. Although
of this approach, aromatase inhibitors have these compounds did not increase overall
been introduced for the treatment of breast survival, they appeared to be similar or bet-
cancer and, more recently, endometriosis. ter than megestrol when objective responses
Aromatase inhibitors also have been used as were the endpoint (1). The early success of
ovulation induction agents. these studies led to clinical trials of aroma-
The aromatase enzyme is a cytochrome tase inhibitors in breast cancer patients with
P-450 complex encoded by a single gene, resectable, estrogen receptor-positive tumors.
and it is widely expressed in tissues, such as The largest of these trials compared anastro-
brain, breast, placenta, ovary, testes, endo- zole with tamoxifen, alone or in combina-
metrium, skin, bone, and fat. Within these tion, as adjuvant treatment in women with
tissues, aromatase mediates the conversion early breast cancer following surgical resec-
of andros-tenedione to estrone and testoster- tion. The study results demonstrated a small
one to estradiol in situ. Thus, for tissues that but significantly improved 3-year disease-
express this enzyme, conversion of circulat- free survival in postmenopausal women with
ing androgens from an adrenal or ovarian invasive, operable breast cancer who received
source will significantly increase the in situ anastrazole alone compared with tamoxifen
estrogen concentrations and provide these (89.4% versus 87.4%, hazard ratio 0.83 [95%
tissues with a proliferative advantage. confidence interval, 0.71–0.96]) (2). Subse-
Three aromatase inhibitors are currently quent trials have been initiated to examine
available in the United States. Exemestane is the effectiveness of aromatase inhibitors in
a steroid-derived aromatase inhibitor that other breast cancer clinical scenarios, includ-
binds irreversibly to aromatase and per- ing the use of aromatase inhibitors as a
The American College manently inactivates the available enzyme. sequential therapy following tamoxifen, aro-
of Obstetricians Letrozole and anastrozole are reversible matase inhibitors for the treatment of ductal
and Gynecologists inhibitors of aromatase that compete with carcinoma in situ, and aromatase inhibitors
Women’s Health Care androgens for aromatase binding sites. All for the prevention of breast cancer in high-
Physicians three aromatase inhibitors appear to have risk patients (3). Although data from these

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 363

 trials are not complete, it appears that aromatase inhibi-
tors will play a significant role in therapy for estrogen
receptor-positive breast cancer.
The short-term and long-term adverse effects of
aromatase inhibitors in postmenopausal women are
related to lack of estrogen action at aromatase-targeted
tissue sites. These side effects include hot flushes, vaginal
dryness, arthralgias, decreased bone mineral density, and
an increased fracture rate (4). The American Society of
Clinical Oncologists recommends that bone mineral
density screening be repeated annually in all patients
receiving aromatase inhibitor adjuvant therapy, and
bisphosphonate therapy should be initiated when T
scores are –2.5
­­ or lower (5). To reduce the risk of osteo-
porosis in high-risk patients, bisphosphonates may be
co-administered to patients during long-term treatment
with aromatase inhibitors.
In contrast to tamoxifen, aromatase inhibitors are
associated with a reduced incidence of thrombosis (6)
and endometrial cancer (7), and a reduction in vaginal
bleeding. Although the results of early studies suggest
that aromatase inhibitors have adverse effects on the
cardiovascular system and lipid profiles compared with
tamoxifen, these effects are milder or have not been seen
when comparing aromatase inhibitors with placebo. This
suggests that aromatase inhibitors lack the protective
effects found with tamoxifen rather than exhibit true tox-
icity (8). Increased cardiovascular morbidity or mortality
through poor lipid profiles or other mechanisms has not
been clearly established in patients treated with aroma-
tase inhibitors compared with tamoxifen or placebo (9).
More rigorous study is required in this area because most
of the trials were not designed to address cardiac disease.
Aromatase inhibitors also have been used as treat-
ment for premenopausal women with early breast cancer
who have chemotherapy-induced amenorrhea. This off-
label use should be prescribed with caution because case
series have described the resumption of ovarian function
following initiation of an aromatase inhibitor regimen
(10, 11). Serial monitoring of estradiol and gonadotropin
levels to identify women who experience a return of ovar-
ian function may be indicated (10).
In premenopausal women, aromatase inhibitors
reduce hypothalamic–pituitary estrogen feedback that
leads to increased gonadotropin-releasing hormone
(GnRH) secretion, concomitant elevations in luteini-
zing hormone and follicle-stimulating hormone, and
increased ovarian follicular development. The gonado-
tropin-stimulating action of letrozole has been used
off-label in the treatment of patients with ovulatory
dysfunction, such as polycystic ovary syndrome, and for
increasing the number of ovarian follicles recruited for
ovulation in women who are already ovulatory (12, 13).
In a meta-analysis of four published trials, including 662
women with polycystic ovary syndrome, pregnancy rates
were similar between women treated with clomiphene
and women treated with letrozole (relative risk, 1.02; 95%
COMMITTEE OPINIONS
confidence interval, 0.83–1.26) (14). Some have raised
concerns about this off-label use because letrozole may
disrupt the normal aromatase activity in tissues during
early fetal development and can be potentially teratogenic
if administered inadvertently during early pregnancy.
However, a large study of 911 newborns conceived using
letrozole for ovulation induction showed no difference
in rates of congenital malformations (15). In addition,
the half-life of letrozole (approximately 30–60 hours)
is shorter than that of clomiphene citrate (5–7 days)
and, thus, should be effectively cleared from the body
by the time of embryo implantation, likely preventing a
teratogenic effect when used in ovulation induction (14).
Possible advantages of letrozole over clomiphene citrate
include reduced multiple pregnancies, lower estradiol
levels, and an absence of antiestrogenic adverse effects
on the endometrium. However, there is no evidence that
letrozole is more effective than clomiphene for ovulation
induction. Letrozole may have a role in the treatment of
clomiphene-resistant patients (16).
The recent demonstration that aromatase is expressed
at higher levels in endometriosis implants than in normal
endometrium has led to pilot studies using anastrozole
co-administered with progestins in patients with endo-
metriosis resistant to conventional medical and surgical
therapies (17). These small studies suggest that aromatase
inhibitors could reduce endometriosis-associated pelvic
pain, whereas the progestin could effectively suppress
gonadotropins and reduce ovarian activity. Results of
subsequent trials have shown similar efficacy for relief of
pelvic pain when aromatase inhibitors were combined
with combination oral contraceptives (18), or when
aromatase inhibitors were given concomitantly with a
GnRH agonist (19). There are no randomized controlled
trials comparing aromatase inhibitors with traditional
medical treatment for endometriosis. Side effect profiles
of aromatase inhibitor regimens (including a progestin
or oral contraceptive as add-back therapy) are favorable
compared with regimens containing GnRH agonists or
danazol. These aromatase inhibitor regimens with add-
back progestin or oral contraceptives do not appear to
be associated with significant bone loss after 6 months
of treatment and may be suitable for long-term use (20).
Randomized controlled trials are needed to establish the
efficacy and side effects of these regimens.
Aromatase inhibitors appear to be effective as an
adjuvant treatment for early-stage and late-stage breast
cancer. Their role in chemoprevention of breast cancer
in high-risk patients remains to be defined. Side effects
of aromatase inhibitors in postmenopausal women are
due to estrogen-lowering action at the target tissues and
include hot flushes, vaginal dryness, arthralgias, and
decreased bone mineral density. Although there are no
long-term data with regard to side effects and complica-
tions associated with the use of aromatase inhibitors in
breast cancer patients, the overall safety profile of aroma-
tase inhibitors is good, with less endometrial and throm-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 364
 boembolic toxicity than tamoxifen. In reproductive-aged
women, aromatase inhibitors stimulate gonadotropin
secretion and increase ovarian follicular activity. The role
of aromatase inhibitors in the treatment of endometriosis
and in ovulation induction is still being investigated.
References
1. Buzdar AU, Jonat W, Howell A, Jones SE, Blomqvist CP,
Vogel CL, et al. Anastrozole versus megestrol acetate in
the treatment of postmenopausal women with advanced
breast carcinoma: results of a survival update based on a
combined analysis of data from two mature phase III trials.
Arimidex Study Group. Cancer 1998;83:1142–52.
2. Baum M, Budzar AU, Cuzick J, Forbes J, Houghton JH,
Klijn JG, et al. Anastrozole alone or in combination with
tamoxifen versus tamoxifen alone for adjuvant treatment
of postmenopausal women with early breast cancer: first
results of the ATAC randomised trial. Lancet 2002;359:
2131–9.
3. Bickenbach KA, Jaskowiak N. Aromatase inhibitors: an
overview for surgeons. J Am Coll Surg 2006;203:376–89.
4. Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes
JF, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone
or in Combination) trial after completion of 5 years’ adju-
vant treatment for breast cancer. Lancet 2005;365:60–2.
5. Hillner BE, Ingle JN, Chlebowski RT, Gralow J, Yee GC,
Janjan NA, et al. American Society of Clinical Oncology 2003
update on the role of bisphosphonates and bone health
issues in women with breast cancer. J Clin Oncol 2003;21:
4042–57.
6. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J,
Delozier T, et al. A randomized trial of exemestane after
two to three years of tamoxifen therapy in postmenopausal
women with primary breast cancer. N Engl J Med 2004;
350:1081–92.
7. Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch
C, et al. Switching of postmenopausal women with endo-
crine-responsive early breast cancer to anastrozole after 2
years’ adjuvant tamoxifen: combined results of ABCSG trial
8 and ARNO 95 trial. Lancet 2005;366:455–62.
8. Conte P, Frassoldati A. Aromatase inhibitors in the adju-
vant treatment of postmenopausal women with early breast
cancer: Putting safety issues into perspective. Breast J 2007;
13:28–35.
9. Gandhi S, Verma S. Aromatase inhibitors and cardiac tox-
icity: getting to the heart of the matter. Breast Cancer Res
Treat 2007;106:1–9.
10. Smith IE, Dowsett M, Yap YS, Walsh G, Lonning PE, Santen
RJ, et al. Adjuvant aromatase inhibitors for early breast can-
cer after chemotherapy-induced amenorrhoea: caution and
suggested guidelines. J Clin Oncol 2006;24:2444–7.
11. Burstein HJ, Mayer E, Patridge AH, O’Kane H, Litsas G,
Come SE, et al. Inadvertent use of aromatase inhibitors in
COMMITTEE OPINIONS
patients with breast cancer with residual ovarian function:
cases and lessons. Clin Breast Cancer 2006;7:158–61.
12. Fisher SA, Reid RL, Van Vugt DA, Casper RF. A random-
ized double-blind comparison of the effects of clomiphene
citrate and the aromatase inhibitor letrozole on ovulatory
function in normal women. Fertil Steril 2002;78:280–5.
13. Bedaiwy MA, Forman R, Mousa NA, Al Inany HG, Casper
RF. Cost-effectiveness of aromatase inhibitor co-treatment
for controlled ovarian stimulation. Hum Reprod 2006;
21:2838–44.
14. Casper RF. Letrozole versus clomiphene citrate: which is
better for ovulation induction? Fertil Steril 2007 June 21.
DOI: 10.1016/j.fertnstert.2007.03.094.
15. Tulandi T, Martin J, Al-Fadhli R, Kabli N, Forman R,
Hitkari J, et al. Congenital malformations among 911 new-
borns conceived after infertility treatment with letrozole or
clomiphene citrate. Fertil Steril 2006;85:1761–5.
16. Badawy A, Abdel Aal I, Abulatta M. Clomiphene citrate or
letrozole for ovulation induction in women with polycystic
ovarian syndrome: a prospective randomized trial. Fertil
Steril 2007 Jun 18. DOI: 10.1016/j.fertnstert.2007.02.062.
17. Ailawadi RK, Jobanputra S, Kataria M, Gurates B, Bulun
SE. Treatment of endometriosis and chronic pelvic pain
with letrozole and norethindrone acetate: a pilot study.
Fertil Steril 2004;81:290–6.
18. Amsterdam LL, Gentry W, Jobanputra S, Wolf M, Rubin
SD, Bulun SE. Anastrazole and oral contraceptives: a novel
treatment for endometriosis. Fertil Steril 2005;84:300–4.
19. Soysal S, Soysal ME, Ozer S, Gul N, Gezgin T. The effects of
post-surgical administration of goserelin plus anastrozole
compared to goserelin alone in patients with severe endo-
metriosis: a prospective randomized trial. Hum Reprod
2004;19:160–7.
20. Attar E, Bulun SE. Aromatase inhibitors: the next genera-
tion of therapeutics for endometriosis? Fertil Steril 2006;85:
1307–18.
Copyright © August 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Aromatase inhibitors in gynecologic practice. ACOG Committee
Opinion No. 412. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2008;112:405–7.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 365
 ACOG COMMITTEE OPINION
Number 413 • August 2008

Age-Related Fertility Decline

Committee on
Gynecologic Practice
Reaffirmed 2010
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
American Society
for Reproductive
Medicine
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
ABSTRACT: Age is a significant factor influencing a woman’s ability to conceive.
Social trends have led to deferred childbearing, and an increasing number of women
are experiencing age-related infertility and pregnancy loss. Women older than 35 years
should receive expedited evaluation and treatment after 6 months of failed attempts to
conceive, or earlier if clinically indicated.
The number of oocytes in the ovaries
declines naturally and progressively through
the process of atresia. The maximum
complement of oocytes is 6–7 million and
exists at 20 weeks of gestation in the female
fetus. The number of oocytes decreases to
approximately 1–2 million oocytes at birth;
300,000–500,000 at puberty; 25,000 at age
37 years; and 1,000 at age 51 years, the aver-
age age of menopause in the United States
(1–3). Fecundity declines gradually but sig-
nificantly beginning approximately at age
32 years, and decreases more rapidly after
age 37 years, reflecting primarily a decrease
in egg quality in association with a gradual
increase in the circulating level of follicle-
stimulating hormone (3). The mechanisms
involved are poorly understood, but appear
to include multiple factors encoded by genes
on both the X chromosome and the auto-
somes (4).
Age alone has an impact on fertility.
Historical data suggest that among popula-
tions that do not use contraception, fertility
rates decrease with increasing age of women
(Fig. 1). Because sexual activity also declines
with age, it is difficult to separate out the
effects of sexual behavior from age. However,
a classic French study was able to sepa-
rate behavioral and age effects by studying
normal women with azoospermic husbands
undergoing donor insemination. The study
found that pregnancy rates decreased pro-
gressively with increasing age of the recipient
female (5). The cumulative pregnancy rate
observed across up to 12 insemination cycles
was 74% for women younger than 31 years
and decreased to 62% for women aged 31–35
years and to 54% for women older than 35
years (5). A similar trend has been observed
in analyses of data derived from in vitro fer-
tilization (IVF) embryo transfer programs in
the United States. For the year 2006, the per-
centage of embryo transfers resulting in live
births decreased progressively from 44.9%
in women younger than 35 years to 37.3%
for women aged 35–37 years, 26.6% for
women aged 38–40 years, 15.2% for women
aged 41–42 years, and 6.7% for women aged
43–44 years (6). By contrast, in cycles using
eggs obtained from healthy, young donors,
54% of transfers resulted in a live birth,
regardless of the age of the recipient (6).
As age increases, the risks of other disorders
that may adversely affect fertility, such as
fibroids, tubal disease, and endometriosis,
also increase. Women with a history of prior
ovarian surgery, chemotherapy, radiation
therapy, severe endometriosis, smoking, pel-
vic infection, or a strong family history of
early menopause may be at increased risk
for having a premature decline in the size of
their follicular pool and their fertility.
The age-related decline in fertility is
accompanied by a significant increase in the
rates of aneuploidy and spontaneous abor-
tion (7). Autosomal trisomy is the most fre-
quent finding and is related, at least in part,
to changes in the meiotic spindle (8) that
predispose to nondisjunction (9). Even for
morphologically normal embryos selected
for transfer in IVF cycles, the prevalence of
aneuploidy is high in women of advanced
maternal age (10). The fetal loss rate also is
significantly higher, even after fetal heart rate
motion is detected by transvaginal ultraso-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 366

 nography (11). Whereas 9.9% of women younger than
33 years who conceive during IVF with a fresh embryo
transfer experience a pregnancy loss after fetal heart
activity is observed, the rate of miscarriage progressively
increases to 11.4% for women aged 33–34 years, 13.7%
for women aged 35–37 years, 19.8% for women aged
38–40 years, 29.9% for women aged 41–42 years, and
36.6% for women older than age 42 years (11). Therefore,
given the anticipated age-related decline in fertility, the
increased incidence of disorders that impair fertility, and
the higher risk of pregnancy loss, women older than 35
years should receive expedited evaluation and treatment
after 6 months of failed attempts to conceive, or earlier if
clinically indicated.
In conclusion, fertility in women is closely related
to reproductive age and becomes significantly compro-
mised before the onset of perimenopausal menstrual
irregularity. Education and enhanced awareness of the
impact of age on fertility is essential in counseling the
patient who desires pregnancy. Women older than 35
years should receive expedited evaluation and treatment
after 6 months of failed attempts to conceive, or earlier if
clinically indicated.
COMMITTEE OPINIONS
References
1. Baker TG. A quantitative and cytological study of germ cells
in human ovaries. Proc R Soc Lond B Biol Sci 1963;158:
417–33.
2. Block E. Quantitative morphological investigations of the
follicular system in women; variations at different ages.
Acta Anat (Basel) 1952;14:108–23.
3. Faddy MJ, Gosden RG, Gougeon A, Richardson SJ, Nelson
JF. Accelerated disappearance of ovarian follicles in mid-
life: implications for forecasting menopause. Hum Reprod
1992;7:1342–6.
4. Simpson JL. Genetic programming in ovarian development
and oogenesis. In: Lobo RA, Kelsey J, Marcus R, editors.
Menopause: biology and pathobiology. San Diego (CA):
Academic Press; 2000. p. 77–94.
5. Schwartz D, Mayaux MJ. Female fecundity as a function of
age: results of artificial insemination in 2193 nulliparous
women with azoospermic husbands. Federation CECOS.
N Engl J Med 1982;306:404–6.
6. Society for Assisted Reproductive Technology. Clinic sum-
mary report: all SART member clinics. Birmingham (AL):
SART; 2007. Available at: https://www.sartcorsonline.com/
rptCSR_PublicMultYear.aspx?ClinicPKID=0. Retrieved
March 18, 2008.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 367
 7. Newcomb WW, Rodriguez M, Johnson JW. Reproduction Copyright © August 2008 by the American College of Obstetricians
in the older gravida. A literature review. J Reprod Med and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
1991;36:839–45. DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
8. Battaglia DE, Goodwin P, Klein NA, Soules MR. Influence or transmitted, in any form or by any means, electronic, mechani-
of maternal age on meiotic spindle assembly in oocytes cal, photocopying, recording, or otherwise, without prior written
from naturally cycling women. Hum Reprod 1996;11: permission from the publisher. Requests for authorization to make
2217–22. photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
9. Pellestor F, Andreo B, Arnal F, Humeau C, Demaille J.
Maternal aging and chromosomal abnormalities: new data Age-related fertility decline. ACOG Committee Opinion No. 413.
drawn from in vitro unfertilized human oocytes. Hum American College of Obstetricians and Gynecologists. Obstet
Gynecol 2008;112:409–11.
Genet 2003;112:195–203.
ISSN 1074-861X
10. Munne S, Alikani M, Tomkin G, Grifo J, Cohen J. Embryo
morphology, developmental rates, and maternal age are
correlated with chromosome abnormalities. Fertil Steril
1995;64:382–91.
11. Farr SL, Schieve LA, Jamieson DJ. Pregnancy loss among
pregnancies conceived through assisted reproductive
technology, United States, 1999-2002. Am J Epidemiol
2007;165: 1380–8.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 368

 ACOG COMMITTEE OPINION
Number 420 • November 2008

Hormone Therapy and Heart Disease

Committee on ABSTRACT: The effect of menopausal hormone therapy on coronary heart disease
Gynecologic has been the subject of much concern. The Heart and Estrogen/Progestin Replacement
Practice
Study (HERS) and Women’s Health Initiative studies found an increased risk of cardio-
This document reflects
emerging clinical and vascular events with conjugated equine estrogen and medroxyprogesterone acetate
scientific advances as use. However, recent evidence suggests that women in early menopause who are in
of the date issued and
is subject to change. The good cardiovascular health are at low risk of adverse cardiovascular outcomes and as
information should not be such should be considered candidates for the use of conjugated equine estrogen or
construed as dictating an
exclusive course of treat-
conjugated equine estrogen and medroxyprogesterone acetate for relief of menopausal
ment or procedure to be vasomotor symptoms. Hormone therapy use should be limited to the treatment of
followed.
menopausal symptoms at the lowest effective dosage over the shortest duration pos-
sible, and continued use should be reevaluated on a periodic basis.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
More than two decades of accumulated evi-
dence suggested that women taking estrogen
plus progesterone hormone therapy (HT)
and estrogen therapy (ET) alone gained pro-
tection against coronary heart disease (CHD).
Notably criticized, these largely observational
studies were confounded by superior cardio-
vascular health profiles among participants
electing to use HT or ET. To assess fully
the role of HT and ET for CHD protec-
tion among menopausal women, large-scale
randomized, controlled clinical trials were
begun. Recent evidence suggesting cardio-
protective effects of HT and ET has sparked
debate regarding the possibility of a “tim-
ing hypothesis” (ie, women who recently
experienced menopause may be more likely
to benefit from HT than women who have
been menopausal for a longer period) (1, 2).
Among menopausal women with
known CHD, the Heart and Estrogen/Pro-
gestin Replacement Study (HERS) examined
whether conjugated equine estrogen and
medroxyprogesterone acetate altered CHD
risk (3). After 4 years of follow-up, the study
did not demonstrate an overall reduction
in CHD risk. Those receiving conjugated
equine estrogen and medroxyprogesterone
acetate exhibited a 52% increase in CHD
and a 3–4-fold increase in venous thrombo-
embolic events during the first and second
years of use.
In 2002, the Women’s Health Initiative
(WHI), a CHD prevention trial among pre-
dominantly healthy menopausal women,
published its initial results after 5.2 years of
follow-up (4). The study was prematurely
terminated because of reports of adverse
cardiovascular effects and a worsened global
index. Not only did conjugated equine estro-
gen and medroxyprogesterone acetate not
provide protection against CHD, but its use
also imparted a 29% increase in CHD-related
events (37 versus 30 per 10,000 woman-years)
that developed soon after randomization.
Notably, most CHD events attributed to con-
jugated equine estrogen and medroxyproges-
terone acetate use were nonfatal myocardial
infarctions, and there were no significant dif-
ferences in overall CHD deaths (hazard ratio
(HR): 1.18; 95% CI, 0.70–1.97). Unlike prior
randomized studies (5, 6), WHI associated
conjugated equine estrogen and medroxy-
progesterone acetate use with a 41%
increased stroke risk, mostly nonfatal events
(29 versus 21 per 10,000 woman-years) that
became apparent between the first and sec-
ond year of use. Consistent with the HERS
trial, WHI provided further evidence that
conjugated equine estrogen and medroxy-
progesterone acetate increased venous
throm-boembolism and pulmonary embo-
lism risks twofold (venous thromboem-
bolism: 34 versus 16 per 10,000 woman-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 369

 years; pulmonary embolism: 16 versus 8 per 10,000
woman-years). Time-trend analyses suggested that the
risk of CHD and pulmonary embolism began to occur
immediately following the initiation of HT. Similar to
HERS, the conjugated equine estrogen and medroxy-
progesterone acetate arm of the WHI indicated that there
was a 26% increase in invasive breast cancer (38 versus
30 per 10,000 woman-years). Benefits associated with
conjugated equine estrogen and medroxyprogesterone
acetate use in the WHI trial included a 37% reduction
in colorectal carcinoma rates (10 versus 16 per 10,000
woman-years) and reduced incidence of hip (10 versus
15 per 10,000 woman-years) and vertebral fractures (9
versus 15 per 10,000 woman-years).
Nearly 2 years later, the conjugated equine estrogen
alone study of the WHI was published after a mean of 6.8
years of follow-up, in advance of its designed observation
period because of a lack of improvement in CHD risk
(the primary outcome) and an increased rate of stroke
(7). This conjugated equine estrogen alone trial revealed
several notable differences from the initial WHI study
publications. No differences in CHD incidence were
observed among those receiving conjugated equine estro-
gen compared with placebo. Although not statistically sig-
nificant, another notable finding was that invasive breast
cancer occurred 23% less frequently in the conjugated
equine estrogen alone group compared with the control
group (HR=0.77; 95% CI, 0.59–1.01; P=.06). Moreover,
no differences were seen in colorectal carcinoma rates. In
line with the conjugated equine estrogen and medroxy-
progesterone acetate arm of the WHI trial, conjugated
equine estrogen alone increased stroke rates by 39%
and reduced both hip and vertebral fractures. Although
deep vein thrombosis risk was increased (21 versus 15
per 10,000 woman-years), increases in venous thrombo-
embolism and pulmonary embolism risk failed to reach
statistical significance. Time-trend analyses demonstrated
an increased stroke risk immediately after randomiza-
tion, but no risk differences could be elucidated for pul-
monary embolism or CHD.
Subsequent to the aforementioned studies, the WHI
investigators have published several follow-up studies.
Consistent with previous reports, analysis directed at
extricating the HT effect on CHD risk found superior
lipid, insulin, and glucose profiles with conjugated equine
estrogen and medroxyprogesterone acetate (8). Subse-
quent data from the conjugated equine estrogen alone
arm suggested an attenuation of venous thromboembo-
lism risk by the exclusion of progestin, yet venous throm-
boembolism risks were increased with HT use in both the
conjugated equine estrogen and conjugated equine estro-
gen and medroxyprogesterone acetate arms of the study
after a longer mean follow-up period (conjugated equine
estrogen: 7.1 years; conjugated equine estrogen and
medroxyprogesterone acetate: 5.6 years) (9, 10). Likewise,
HT increased the risk of ischemic stroke in both the con-
jugated equine estrogen and conjugated equine estrogen
and medroxyprogesterone acetate arms (11, 12). Overall,
COMMITTEE OPINIONS
the risks associated with long-term primary preventive
therapy appeared to outweigh the beneficial effects.
The mean participant age of the WHI trial exceeded
60 years and it has been suggested that the results may not
apply to women who recently experienced menopause
and for whom treatment would likely be initiated. In an
attempt to delineate the impact of age on CHD risk with
HT use, WHI data was stratified according to participant
age and duration of menopause (13). This study found
that the effects of either conjugated equine estrogen or
conjugated equine estrogen and medroxyprogesterone
acetate on CHD risk might depend, in part, on age at the
start of treatment. When analyzed according to treatment
type, a trend toward reduced total mortality with conju-
gated equine estrogen or conjugated equine estrogen and
medroxyprogesterone acetate use was noted among those
women aged 50–59 years (see Table 1). When individual
treatment type data were pooled, total mortality decreased
by 30% with conjugated equine estrogen or conjugated
equine estrogen and medroxyprogesterone acetate use
(95% CI, 0.51–0.96). Whether conjugated equine estrogen
or conjugated equine estrogen and medroxyprogesterone
acetate administration improves the cardiovascular health
of women who recently experienced menopause remains
to be determined. Presently, there is insufficient evidence
to suggest that long-term conjugated equine estrogen
or conjugated equine estrogen and medroxyprogester-
one acetate use improves cardiovascular outcomes (1).
Nevertheless, recent evidence suggests that women in
early menopause who are in good cardiovascular health
are at low risk of adverse cardiovascular outcomes and
as such should be considered candidates for the use
of conjugated equine estrogen or conjugated equine
estrogen and medroxyprogesterone acetate for relief of
menopausal vasomotor symptoms (2). Ongoing studies,
including the Kronos Early Estrogen Prevention Study
(KEEPS) are evaluating alterations in surrogate CHD
risk markers, including carotid intimal thickness and the
accrual of coronary calcium deposition induced by HT,
in this case conjugated equine estrogen or transdermal
estradiol patches combined with cyclic oral, micronized
progesterone.
The WHI Coronary-Artery Calcium Study (WHI-
CACS) recently evaluated 1,064 women aged 50–59 years
who were previously enrolled in the conjugated equine
estrogen arm of WHI (14). Because coronary athero-
sclerotic plaques have been associated with future CHD
risk, the investigators used computed tomography heart
imaging to determine the degree of coronary-artery cal-
cium burden. The study results indicated that the overall
distribution of coronary-artery calcification scores were
lower among those receiving conjugated equine estro-
gen compared with those receiving placebo (P=.03).
Furthermore, for those who adhered to the study medica-
tion regimen (80% medication adherence for 5 or more
years), conjugated equine estrogen use was associated
with a significant reduction in the coronary-artery cal-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 370
 Table 1. Cardiovascular and Global Index Events by Age at Baseline

Abbreviations: CEE, conjugated equine estrogens; CHD, coronary heart disease; CI, confidence interval; HR, hazard ratio; MPA, medroxyprogesterone acetate.
*Cox regression models stratified according to prior cardiovascular disease and randomization status in the Dietary Modification Trial.
†
Test for trend (interaction) using age as continuous (linear) form of categorical coded values. Cox regression models stratified according to active vs placebo and trial,
including terms for age and the interaction between trials and age.
Defined as CHD death, nonfatal myocardial infarction, or definite silent myocardial infarction (Novacode 5.1 or 5.2).
‡

Defined as CHD, stroke, pulmonary embolism, breast cancer, colorectal cancer, endometrial cancer for CEE plus MPA trial only, hip fracture, or death from other causes.
§

Rossouw JE, Prentice RL, Manson JE, Wu L, Barad D, Barnabei VM, et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since
menopause. JAMA 2007;297:1465–77. April 4. Copyright © 2007 American Medical Association. All rights reserved.

cification (OR=0.64; 95% CI, 0.46-0.91; P=.01). This
preliminary evidence, using surrogate outcome markers,
needs confirmation of its clinical significance and cor-
relation with clinical outcomes. Nevertheless, it suggests
that conjugated equine estrogen therapy may reduce
CHD risk factors and may provide cardiovascular protec-
tion for select populations of women who experienced
menopause recently.
Conclusion
Menopausal HT should not be used for the primary or
secondary prevention of CHD at the present. Recent
analyses suggest that HT may not increase CHD risk
for select populations of women who have experienced
menopause recently. Hormone therapy use should be
limited to the treatment of menopausal symptoms at the
lowest effective dosage over the shortest duration pos-
sible and continued use should be reevaluated on a peri-
odic basis. Some women may require extended therapy
because of persistent symptoms.
References
1. Barrett-Connor E. Hormones and heart disease in women:
the timing hypothesis. Am J Epidemiol 2007;166:506–10.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 371

 2. Manson JE, Bassuk SS. Invited commentary: hormone
therapy and risk of coronary heart disease why renew the
focus on the early years of menopause? Am J Epidemiol
2007;166:511–7.
3. Hulley S, Grady D, Bush T, Furberg C, Herrington D,
Riggs B, et al. Randomized trial of estrogen plus progestin
for secondary prevention of coronary heart disease in
postmenopausal women. Heart and Estrogen/progestin
Replacement Study (HERS) Research Group. JAMA 1998;
280(7):605–13.
4. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ,
Kooperberg C, Stefanick ML, et al. Risks and benefits of
estrogen plus progestin in healthy postmenopausal women:
principal results From the Women’s Health Initiative
randomized controlled trial. Writing Group for Women’s
Health Initiative Investigators. JAMA 2002;288(3):321–33.
5. Simon JA, Hsia J, Cauley JA, Richards C, Harris F, Fong J,
et al. Postmenopausal hormone therapy and risk of stroke:
The Heart and Estrogen-progestin Replacement Study
(HERS). Circulation 2001;103:638–42.
6. Grady D, Herrington D, Bittner V, Blumenthal R, Davidson
M, Hlatky M, et al. Cardiovascular disease outcomes dur-
ing 6.8 years of hormone therapy: Heart and Estrogen/
progestin Replacement Study follow-up (HERS II). HERS
Research Group. JAMA 2002;288:49–57.
7. Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford
SA, Black H, et al. Effects of conjugated equine estrogen in
postmenopausal women with hysterectomy: the Women’s
Health Initiative randomized controlled trial. Women’s
Health Initiative Steering Committee. JAMA 2004;291:
1701–12.
8. Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR,
Lasser NL, et al. Estrogen plus progestin and the risk
of coronary heart disease. Women’s Health Initiative
Investigators. N Engl J Med 2003;349:523–34.
9. Curb JD, Prentice RL, Bray PF, Langer RD, Van Horn L,
Barnabei VM, et al. Venous thrombosis and conjugated
equine estrogen in women without a uterus. Arch Intern
Med 2006;166:772–80.
COMMITTEE OPINIONS
10. Cushman M, Kuller LH, Prentice R, Rodabough RJ, Psaty
BM, Stafford RS, et al. Estrogen plus progestin and risk of
venous thrombosis. Women’s Health Initiative Investiga-
tors. JAMA 2004;292:1573–80.
11. Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G,
Kooperberg C, Baird A, et al. Effect of estrogen plus pro-
gestin on stroke in postmenopausal women: the Women’s
Health Initiative: a randomized trial. WHI Investigators.
JAMA 2003 May;289:2673–84.
12. Hendrix SL, Wassertheil-Smoller S, Johnson KC, Howard
BV, Kooperberg C, Rossouw JE, et al. Effects of conjugated
equine estrogen on stroke in the Women’s Health Initiative.
WHI Investigators. Circulation 2006;113:2425–34.
13. Rossouw JE, Prentice RL, Manson JE, Wu L, Barad D,
Barnabei VM, et al. Postmenopausal hormone therapy and
risk of cardiovascular disease by age and years since meno-
pause. JAMA 2007;297:1465–77.
14. Manson JE, Allison MA, Rossouw JE, Carr JJ, Langer RD,
Hsia J, et al. Estrogen therapy and coronary-artery calcifi-
cation. WHI and WHI-CACS Investigators. N Engl J Med
2007;356:2591–602.
Copyright © November 2008 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Hormone therapy and heart disease. ACOG Committee Opinion No.
420. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2008;112:1189–92.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 372
 ACOG COMMITTEE OPINION
Number 434 • June 2009 (Replaces No. 285, August 2003)

Induced Abortion and Breast Cancer Risk

Committee on Abstract: The relationship between induced abortion and the subsequent develop-
Gynecologic ment of breast cancer has been the subject of a substantial amount of epidemiologic
Practice study. Early studies of the relationship between prior induced abortion and breast cancer
Reaffirmed 2011 risk were methodologically flawed. More rigorous recent studies demonstrate no causal
This document reflects relationship between induced abortion and a subsequent increase in breast cancer risk.
emerging clinical and sci-
entific advances as of the
date issued and is subject The relationship between induced abortion
to change. The information and the subsequent development of breast
should not be construed
as dictating an exclusive cancer has been the subject of a substantial
course of treatment or amount of epidemiologic study. Early case–
procedure to be followed. control studies that reported an association
between induced abortion and subsequent
development of breast cancer had significant
methodological problems, most notably reli-
ance on retrospective reporting of abortion
history. A key methodological consideration
in interpreting the evidence for any relation-
ship between abortion and breast cancer risk
is the sensitive nature of abortion, which
could affect the accuracy in retrospective
studies that rely on participant reports of
having had an abortion.
In contrast to retrospective studies,
prospective studies conclude there is no
association between induced abortion and
breast cancer. A world-wide meta-analysis
of 83,000 women examined the relationship
between induced abortion and breast cancer
and found a significant difference between
the overall estimate of relative risk (RR)
from studies that had recorded informa-
tion on induced abortion prospectively (RR,
0.93; 95% confidence interval, 0.89–0.96)
and the overall estimate of RR from studies
that had recorded such information retro-
spectively (RR, 1.11; 95% confidence interval,
1.09–1.14), suggesting that reporting bias was
probably present in studies using retrospec-
tive reporting of abortion history (1).
The American College
In 2003, the National Cancer Institute
of Obstetricians convened the Early Reproductive Events and
Breast Cancer Workshop to evaluate the cur-
and Gynecologists
Women’s Health Care
rent strength of evidence of epidemiologic,
Physicians clinical, and animal studies addressing the
association between reproductive events and
the risk of breast cancer (2). The workshop
participants concluded that induced abor-
tion is not associated with an increase in
breast cancer risk. Studies published since
2003 continue to support this conclusion
(3–7).
Early studies of the relationship between
prior induced abortion and breast cancer risk
were methodologically flawed. More rigor-
ous recent studies demonstrate no causal
relationship between induced abortion and
a subsequent increase in breast cancer risk.
References
1. Beral V, Bull D, Doll R, Peto R, Reeves
G. Breast cancer and abortion: collaborative
reanalysis of data from 53 epidemiological
studies, including 83,000 women with breast
cancer from 16 countries. Collaborative
Group on Hormonal Factors in Breast Cancer.
Lancet 2004;363:1007–16.
2. National Cancer Institute. Summary report:
early reproductive events and breast cancer
workshop. Bethesda (MD): NCI; 2003. Avail-
able at: http://www.cancer.gov/cancertopics/
ere-workshop-report. Retrieved November 6,
2008.
3. Rosenblatt KA, Gao DL, Ray RM, Rowland
MR, Nelson ZC, Wernli KJ, et al. Induced
abortions and the risk of all cancers com-
bined and site-specific cancers in Shanghai.
Cancer Causes Control 2006;17:1275–80.
4. Reeves GK, Kan SW, Key T, Tjonneland A,
Olsen A, Overvad K, et al. Breast cancer risk
in relation to abortion: results from the EPIC
study. Int J Cancer 2006;119:1741–5.
5. Michels KB, Xue F, Colditz GA, Willett WC.
Induced and spontaneous abortion and inci-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 373

 dence of breast cancer among young women: a prospective
cohort study. Arch Intern Med 2007;167:814–20.
6. Lash TL, Fink AK. Null association between pregnancy
termination and breast cancer in a registry-based study of
parous women. Int J Cancer 2004;110:443–8.
7. Henderson KD, Sullivan-Halley J, Reynolds P, Horn-Ross
PL, Clarke CA, Chang ET, et al. Incomplete pregnancy
is not associated with breast cancer risk: the California
Teachers Study. Contraception 2008;77:391–6.
COMMITTEE OPINIONS
Copyright © June 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Induced abortion and breast cancer risk. ACOG Committee Opinion
No. 434. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:1417–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 374
 ACOG COMMITTEE OPINION
Number 440 • August 2009

The Role of Transvaginal Ultrasonography

in the Evaluation of Postmenopausal
Bleeding
Committee on ABSTRACT: The clinical approach to postmenopausal bleeding requires prompt
Gynecologic and efficient evaluation to exclude or diagnose carcinoma. Women with postmeno-
Practice pausal bleeding may be assessed initially with either endometrial biopsy or transvaginal
Reaffirmed 2011 ultrasonography; this initial evaluation does not require performance of both tests.
This document reflects Transvaginal ultrasonography can be useful in the triage of patients in whom endo-
emerging clinical and sci-
entific advances as of the metrial sampling was performed but tissue was insufficient for diagnosis. When trans-
date issued and is subject vaginal ultrasonography is performed for patients with postmenopausal bleeding and an
to change. The information
should not be construed endometrial thickness of less than or equal to 4 mm is found, endometrial sampling is
as dictating an exclusive not required. Meaningful assessment of the endometrium by ultrasonography is not pos-
course of treatment or
procedure to be followed. sible in all patients. In such cases, alternative assessment should be completed. When
bleeding persists despite negative initial evaluations, additional assessment usually is
indicated.
Cancer of the endometrium is the most com- to 4–5 mm in patients with postmenopausal
mon type of gynecologic cancer in the United bleeding reliably excluded endometrial cancer
States. In 2008, an estimated 40,100 cases of (7–9). Since that time, a number of confirma-
cancer of the endometrium will occur and an tory multicenter trials have been completed
estimated 7,470 deaths (1). Vaginal bleeding (see Table 1). Because transvaginal ultraso-
is the presenting sign in more than 90% of nography in postmenopausal patients with
postmenopausal patients with endometrial bleeding has an extremely high negative pre-
carcinoma (2). The majority of patients with dictive value, it is a reasonable first approach.
postmenopausal vaginal bleeding experience An endometrial thickness of greater than
bleeding secondary to atrophic changes of the 4 mm is not diagnostic of any particular
vagina or endometrium. However, depend- pathology and cannot be relied on to exclude
ing on age and risk factors, 1–14% will have disease.
endometrial cancer (3–6). Thus, the clini-
cal approach to postmenopausal bleeding Biopsy Findings of Tissue
requires prompt and efficient evaluation to Insufficient for Diagnosis
exclude or diagnose carcinoma. Endometrial tissue sampling resulting in
findings insufficient for diagnosis is com-
Transvaginal Ultrasonography mon. In a study of 97 consecutive patients
Transvaginal ultrasonography has been with postmenopausal bleeding evaluated by
explored as an alternative technique to indi- transvaginal ultrasonography and endome-
rectly visualize the endometrium. Endome- trial biopsy, in only 82% of the patients
trial thickness is measured as the maximum with an endometrial thickness of less than 5
anterior–posterior thickness of the endome- mm (n=45) was a Pipelle biopsy able to be
The American College trial echo on a long-axis transvaginal view of performed (10). Of these patients, a sample
of Obstetricians the uterus. The earliest reports comparing adequate for diagnosis was obtained in only
and Gynecologists transvaginal ultrasonography with endome- 27%. There was no correlation with parity
Women’s Health Care trial sampling consistently found that an or cavity length. In other studies of patients
Physicians endometrial thickness of less than or equal with postmenopausal bleeding, the range of

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 375

 Table 1. Endometrial Thickness and Cancer Findings in Postmenopausal Women With Bleeding
Endometrial Number of Number of Negative
Reference Thickness* Women Cases of Cancer Predictive Value

Karlsson 1995 † ≤4 mm 1,168 0 100%

Ferrazzi 1996 ‡ ≤4 mm 930 2 99.8%
≤5 mm 4 99.6%
Gull 2000 § ≤4 mm 163 1 99.4%
Epstein 2001|| ≤5 mm 97 0 100%
Gull 2003¶ ≤4 mm 394 0 100%
*Determined by transvaginal ultrasonography
Karlsson B, Granberg S, Wikland M, Ylostalo P, Torvid K, Marsal K, et al. Transvaginal ultrasonography of the endometrium in women with post-
†

menopausal bleeding—a Nordic multicenter study. Am J Obstet Gynecol 1995;172:1488–94.

‡
Ferrazzi E, Torri V, Trio D, Zannoni E, Filiberto S, Dordoni D. Sonographic endometrial thickness: a useful test to predict atrophy in patients with
postmenopausal bleeding. An Italian multicenter study. Ultrasound Obstet Gynecol 1996;7:315–21.
§
Gull B, Carlsson S, Karlsson B, Ylostalo P, Milsom I, Granberg S. Transvaginal ultrasonography of the endometrium in women with postmenopausal
bleeding: is it always necessary to perform an endometrial biopsy? Am J Obstet Gynecol 2000;182:509–15.
Epstein E, Valentin L. Rebleeding and endometrial growth in women with postmenopausal bleeding and endometrial thickness < 5 mm managed by
||

dilatation and curettage or ultrasound follow-up: a randomized controlled study. Ultrasound Obstet Gynecol 2001;18:499–504.
¶
Gull B, Karlsson B, Milsom I, Granberg S. Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal bleeding and
transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol 2003;188:401–8.

sampling failure (ie, inadequate sample or inability to
perform the biopsy) with Pipelle biopsy was 0–54% (11).
Transvaginal ultrasonography can be useful in the
triage of patients in whom endometrial sampling was
performed but tissue was insufficient for diagnosis (12).
No further evaluation is necessary following an insuf-
ficient endometrial biopsy if subsequent transvaginal
ultrasonography demonstrates an endometrial thickness
of less than or equal to 4 mm in a woman with post-
menopausal bleeding because the incidence of malig-
nancy is rare in these cases (Table 1). However, if
bleeding recurs or persists, additional evaluation usually
is indicated.
Postmenopausal Patients Without
Bleeding
Whereas several studies have evaluated transvaginal
ultrasonography in postmenopausal women with bleed-
ing, there are fewer data on transvaginal ultrasonography
endometrial findings in patients without bleeding. In
1,750 postmenopausal women without bleeding being
screened for a selective estrogen receptor modulator
study, an endometrial thickness of less than or equal to 6
mm had a negative predictive value of 99.94% for exclud-
ing malignancy (only 1 case of cancer in 1,750 women)
and a 99.77% negative predictive value for complex
hyperplasia (only 4 cases in 1,750 women) (13). Among
42 patients with endometrial thickness of greater than 6
mm, there was 1 case of adenocarcinoma and no cases of
hyperplasia (positive predictive value = 2.4%).
In another study, 82 asymptomatic postmenopausal
women had an incidental ultrasonographic finding suspect-
ed to be an intrauterine polyp (14). All underwent operative
hysteroscopy. Of these patients, a benign polyp was found
in 68, submucosal myoma in 7, atrophic endometrium in 6,
and proliferative endometrium in 1. One polyp contained
simple hyperplasia. There were no cases of endometrial
carcinoma or complex hyperplasia. The total complication
rate was 3.6% (two perforations, one difficult intubation).
The significance of an endometrial measurement
greater than 4 mm incidentally discovered in a post-
menopausal patient without bleeding has not been estab-
lished. This finding need not routinely trigger evaluation,
although an individualized assessment based on patient
characteristics and risk factors is appropriate. Transvagi-
nal ultrasonography is not an appropriate screening tool
for cancer in postmenopausal women without bleeding.
Limitations
It is not possible to complete a meaningful transvaginal
ultrasound examination with a reliable measurement of
endometrial thickness in all patients (15). An axial uterus,
marked obesity, coexisting myomas, or previous uterine
surgery all can contribute to difficulty in obtaining reli-
able transvaginal ultrasound assessment of endometrial
thickness and texture. Failure to adequately identify a
thin, distinct endometrial thickness in a postmenopausal
patient with bleeding should trigger some alternative
method of evaluation. In addition, when endometrial
fluid is present, it should not be included in measuring
endometrial thickness.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 376

 Recommendations
• Any vaginal bleeding in a postmenopausal woman
requires assessment to exclude malignancy.
• Women with postmenopausal uterine bleeding may
be assessed initially with either endometrial biopsy
or transvaginal ultrasonography; this initial evalua-
tion does not require performance of both tests.
• When endometrial biopsy is performed and tissue is
reported as insufficient for diagnosis, some further
investigation is necessary and transvaginal ultraso-
nography may be performed.
• When transvaginal ultrasonography is performed
for patients with postmenopausal bleeding and an
endometrial thickness of less than or equal to 4 mm
is found, endometrial sampling is not required.
• Endometrial thickness of greater than 4 mm in a
patient with postmenopausal bleeding should trig-
ger alternative evaluation (such as sonohysterogra-
phy, office hysteroscopy, or endometrial biopsy), as
should an inability to adequately visualize thickness.
• Meaningful assessment of the endometrium by
ultrasonography is not possible in all patients. In such
cases, alternative assessment should be completed.
• When bleeding persists despite negative initial evalu-
ations, additional assessment usually is indicated.
• The significance of an endometrial thickness of
greater than 4 mm in an asymptomatic, postmeno-
pausal patient has not been established, and this
finding need not routinely trigger evaluation.
References
1. American Cancer Society. Cancer facts and figures 2008.
Atlanta (GA): ACS; 2008. Available at: http://www.cancer.
org/downloads/STT/2008CAFFfinalsecured.pdf. Retrieved
June 20, 2008.
2. Goldstein RB, Bree RL, Benson CB, Benacerraf BR, Bloss
JD, Carlos R, et al. Evaluation of the woman with postmen-
opausal bleeding: Society of Radiologists in Ultrasound-
Sponsored Consensus Conference statement. J Ultrasound
Med 2001;20:1025–36.
3. Smith-Bindman R, Kerlikowske K, Feldstein VA, Subak
L, Scheidler J, Segal M, et al. Endovaginal ultrasound to
exclude endometrial cancer and other endometrial abnor-
malities. JAMA 1998;280:1510–7.
4. Tabor A, Watt HC, Wald NJ. Endometrial thickness as a
test for endometrial cancer in women with postmenopausal
vaginal bleeding. Obstet Gynecol 2002;99:663–70.
5. Gupta JK, Chien PF, Voit D, Clark TJ, Khan KS.
Ultrasonographic endometrial thickness for diagnosing
endometrial pathology in women with postmenopausal
bleeding: a meta-analysis. Acta Obstet Gynecol Scand 2002;
81:799–816.
COMMITTEE OPINIONS
6. Smith-Bindman R, Weiss E, Feldstein V. How thick is
too thick? When endometrial thickness should prompt
biopsy in postmenopausal women without vaginal bleed-
ing. Ultrasound Obstet Gynecol 2004;24:558–65.
7. Goldstein SR, Nachtigall M, Snyder JR, Nachtigall L.
Endometrial assessment by vaginal ultrasonography before
endometrial sampling in patients with postmenopausal
bleeding. Am J Obstet Gynecol 1990;163:119–23.
8. Varner RE, Sparks JM, Cameron CD, Roberts LL, Soong
SJ. Transvaginal sonography of the endometrium in post-
menopausal women. Obstet Gynecol 1991;78:195–9.
9. Granberg S, Wikland M, Karlsson B, Norstrom A, Friberg
LG. Endometrial thickness as measured by endovaginal
ultrasonography for identifying endometrial abnormality.
Am J Obstet Gynecol 1991;164:47–52.
10. Elsandabesee D, Greenwood P. The performance of Pipelle
endometrial sampling in a dedicated postmenopausal
bleeding clinic. J Obstet Gynaecol 2005;25:32–4.
11. Dijkhuizen FP, Mol BW, Brolmann HA, Heintz AP. The
accuracy of endometrial sampling in the diagnosis of
patients with endometrial carcinoma and hyperplasia: a
meta-analysis. Cancer 2000;89:1765–72.
12. Bakour SH, Khan KS, Gupta JK. Controlled analysis of
factors associated with insufficient sample on outpatient
endometrial biopsy. BJOG 2000;107:1312–4.
13. Fleischer AC, Wheeler JE, Lindsay I, Hendrix SL, Grabill
S, Kravitz B, et al. An assessment of the value of ultraso-
nographic screening for endometrial disease in postmeno-
pausal women without symptoms. Am J Obstet Gynecol
2001;184:70–5.
14. Lev-Sagie A, Hamani Y, Imbar T, Hurwitz A, Lavy Y. The
significance of intrauterine lesions detected by ultrasound
in asymptomatic postmenopausal patients. BJOG 2005;112:
379–81.
15. Sit AS, Modugno F, Hill LM, Martin J, Weissfeld JL.
Transvaginal ultrasound measurement of endometrial
thickness as a biomarker for estrogen exposure. Cancer
Epidemiol Biomarkers Prev 2004;13:1459–65.
Copyright © August 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
The role of transvaginal ultrasonography in the evaluation of post-
menopausal bleeding. ACOG Committee Opinion No. 440. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2009;
114:409–11.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 377
 ACOG COMMITTEE OPINION
Number 444 • November 2009

Choosing the Route of Hysterectomy for

Benign Disease
Committee on Abstract: Hysterectomies are performed vaginally, abdominally, or with laparoscopic
Gynecologic or robotic assistance. When choosing the route and method of hysterectomy, the physi-
Practice cian should take into consideration how the procedure may be performed most safely
Reaffirmed 2011 and cost-effectively to fulfill the medical needs of the patient. Evidence demonstrates
This document reflects that, in general, vaginal hysterectomy is associated with better outcomes and fewer
emerging clinical and sci- complications than laparoscopic or abdominal hysterectomy. When it is not feasible to
entific advances as of the
date issued and is subject perform a vaginal hysterectomy, the surgeon must choose between laparoscopic hys-
to change. The information terectomy, robot-assisted hysterectomy, or abdominal hysterectomy. Experience with
should not be construed
as dictating an exclusive robot-assisted hysterectomy is limited at this time; more data are necessary to deter-
course of treatment or mine its role in the performance of hysterectomy. The decision to electively perform a
procedure to be followed.
salpingoophorectomy should not be influenced by the chosen route of hysterectomy and
is not a contraindication to performing a vaginal hysterectomy.

Hysterectomy is one of the most frequently
performed surgical procedures in the United
States. During 2000–2004, approximately
3.1 million hysterectomies were performed
(approximately 600,000 per year). The most
common indications for hysterectomy are
symptomatic uterine leiomyomas (40.7%),
endometriosis (17.7%), and prolapse (14.5%)
(1).
Hysterectomies are performed vaginally,
abdominally, or with laparoscopic or robot-
ic assistance. When choosing the route and
method of hysterectomy, the physician should
take into consideration how the procedure
may be performed most safely and cost-effec-
tively to fulfill the medical needs of the patient.
Most literature supports the opinion that,
when feasible, vaginal hysterectomy is the
safest and most cost-effective route by which
to remove the uterus (2). However, analysis
of U.S. surgical data shows that abdominal
hysterectomy is performed in 66% of cases,
vaginal hysterectomy in 22% of cases, and lap-
aroscopic hysterectomy in 12% of cases (3).
The American College
of Obstetricians Factors That Influence the
and Gynecologists Route of Hysterectomy
Women’s Health Care Factors that may influence the route of hys-
Physicians terectomy for benign causes include the size
and shape of the vagina and uterus; acces-
sibility to the uterus; extent of extrauterine
disease; the need for concurrent procedures;
surgeon training and experience; available
hospital technology, devices, and support;
emergency or scheduled cases; and prefer-
ence of the informed patient.
A narrow pubic arch (less than 90
degrees), a narrow vagina, an undescended
immobile uterus, nulliparity, prior cesarean
delivery, and enlarged uterus have been pro-
posed by some authors as contraindications
for vaginal hysterectomy. However, many
nulliparous women and women who have
not given birth vaginally have adequate vagi-
nal caliber to allow successful completion of
the vaginal hysterectomy (4). If the vagina
will allow access to divide the uterosacral and
cardinal ligaments, uterine mobility usually
is improved enough to allow vaginal hyster-
ectomy, even in cases where there is mini-
mal uterine descent (5). When the uterus
is enlarged, vaginal hysterectomy often can
be accomplished safely by using uterine size
reduction techniques such as wedge morcel-
lation, uterine bisection, and intramyometrial
coring.
Guidelines incorporating uterine size,
mobility, accessibility, and pathology con-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 378

 fined to the uterus (no adnexal pathology or known or
suspected adhesions) have been proposed as selection cri-
teria for vaginal hysterectomy (6). In a randomized trial,
when residents followed specific guidelines for selection
and performance of hysterectomy, the percentage of vagi-
nal hysterectomies for benign conditions was more than
90%. Uterine morcellation and other uterine size reduc-
tion techniques were only necessary in 11% of cases (7).
Extrauterine disease such as adnexal pathology,
severe endometriosis, or adhesions may preclude vaginal
hysterectomy. However, in these cases, it may be prudent
to visualize the pelvis with a laparoscope before deciding
on the route of hysterectomy.
The decision to electively perform a salpingoopho-
rectomy should not be influenced by the chosen route of
hysterectomy and is not a contraindication to performing
a vaginal hysterectomy. The success of removing the ova-
ries vaginally varies greatly and is reported to range from
65–97.5% (8–10). In a randomized trial that compared
vaginal hysterectomy with bilateral salpingoophorectomy
to laparoscopically assisted vaginal hysterectomy with
bilateral salpingoophorectomy, there were more com-
plications and increased operating time with the laparo-
scopic approach (11).
Outcomes and Complication Rates
Evidence demonstrates that, in general, vaginal hysterec-
tomy is associated with better outcomes and fewer com-
plications. A Cochrane review of 34 randomized trials
of abdominal hysterectomy, laparoscopic hysterectomy,
and vaginal hysterectomy, including 4,495 patients, con-
cluded that vaginal hysterectomy has the best outcomes
of these three routes. The review also found that when a
vaginal hysterectomy is not possible, laparoscopic hyster-
ectomy has advantages (including faster return to normal
activity, shorter duration of hospital stays, lower intra-
operative blood loss, and fewer wound infections) over
abdominal hysterectomy; however, laparoscopic surgery
also is associated with longer operating time and higher
rates of urinary tract injury (2) (see Box 1).
The authors of one study compared vaginal and
abdominal hysterectomy and found that abdominal
hysterectomy was associated with 1.7 times more compli-
cations, 1.9 times more febrile morbidity, and 2.1 times
more blood transfusions than vaginal hysterectomy (12).
In another study, when women with enlarged uteri (200–
1,300 gm) were randomly assigned surgery by the vag-
inal or abdominal route, the vaginal procedure resulted in
decreased operative time, less febrile morbidity, reduced
postoperative narcotic use, and shorter hospital stay (13).
When it is not feasible to perform a vaginal hyster-
ectomy, the surgeon must choose between laparoscopic
hysterectomy, robot-assisted hysterectomy, or abdominal
hysterectomy. Experience with robot-assisted hysterec-
tomy for benign conditions is currently limited (14).
Abdominal hysterectomy is also an important surgical
procedure, especially when the vaginal or laparoscopic
COMMITTEE OPINIONS
Box 1. Comparison of Different
Approaches to Hysterectomy
Vaginal Hysterectomy Compared With Abdominal
Hysterectomy
• Shorter duration of hospital stay
• Faster return to normal activity
• Fewer febrile episodes or unspecified infections
Vaginal Hysterectomy Compared With Laparoscopic
Hysterectomy
• Shorter operating time
Laparoscopic Hysterectomy Compared With Abdominal
Hysterectomy
• Faster return to normal activity
• Shorter duration of hospital stay
• Smaller drop in hemoglobin
• Lower intraoperative blood loss
• Fewer wound or abdominal wall infections
• Longer operating time
• Higher rate of lower urinary tract (bladder and ureter)
injuries
Data from Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr
E, Garry R, et al. Surgical approach to hysterectomy for benign
gynaecological disease. Cochrane Database of Systematic
Reviews 2009, Issue 3. Art. No.: CD003677. DOI: 10.1002/14651858.
CD003677.pub4.
approach is not appropriate to manage the patient’s clini-
cal situation or when facilities cannot support a specific
procedure.
Other Considerations
Cost analysis has consistently demonstrated that vaginal
hysterectomy is the most cost-effective route (15, 16).
Patient preference may influence the route by which the
hysterectomy is performed (17). For example, despite the
evidence that there is no significant difference in outcome
between a supracervical hysterectomy and a total hyster-
ectomy (18), some patients may choose a supracervical
hysterectomy. In these cases, a laparoscopic or open
abdominal approach is most appropriate.
Conclusions
Listed as follows are the conclusions of the ACOG Com-
mittee on Gynecologic Practice:
• Vaginal hysterectomy is the approach of choice
whenever feasible, based on its well-documented
advantages and lower complication rates.
• The choice of when to perform prophylactic ooph-
orectomy at the time of hysterectomy is based on the
patient’s age, risk factors, and informed wishes, but
not on the route of hysterectomy.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 379
 • Laparoscopic hysterectomy is an alternative to abdom-
inal hysterectomy for those patients in whom a vagi-
nal hysterectomy is not indicated or feasible.
• Experience with robot-assisted hysterectomy is limit-
ed at this time; more data are necessary to determine
its role in the performance of hysterectomy.
References
1. Whiteman MK, Hillis SD, Jamieson DJ, Morrow B,
Podgornik MN, Brett KM, et al. Inpatient hysterectomy
surveillance in the United States, 2000–2004. Am J Obstet
Gynecol 2008;198:34.e1–34.e7.
2. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr
E, Garry R, et al. Surgical approach to hysterectomy
for benign gynaecological disease. Cochrane Database of
Systematic Reviews 2009, Issue 3. Art. No.: CD003677.
DOI: 10.1002/ 14651858.CD003677.pub4.
3. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG.
Hysterectomy rates in the United States, 2003. Obstet
Gynecol 2007;110:1091–5.
4. Tohic AL, Dhainaut C, Yazbeck C, Hallais C, Levin I,
Madelenat P. Hysterectomy for benign uterine pathology
among women without previous vaginal delivery. Obstet
Gynecol 2008;111:829–37.
5. Doucette RC, Sharp HT, Alder SC. Challenging gener-
ally accepted contraindications to vaginal hysterectomy.
Am J Obstet Gynecol 2001;184:1386–9; discussion 1390–1.
6. Kovac SR. Decision-directed hysterectomy: a possible
approach to improve medical and economic outcomes. Int
J Gynaecol Obstet 2000;71:159–69.
7. Kovac SR, Barhan S, Lister M, Tucker L, Bishop M, Das A.
Guidelines for the selection of the route of hysterectomy:
application in a resident clinic population. Am J Obstet
Gynecol 2002;187:1521–7.
8. Ballard LA, Walters MD. Transvaginal mobilization and
removal of ovaries and fallopian tubes after vaginal hyster-
ectomy. Obstet Gynecol 1996;87:35–9.
9. Davies A, O’Connor H, Magos AL. A prospective study to
evaluate oophorectomy at the time of vaginal hysterectomy.
Br J Obstet Gynaecol 1996;103:915–20.
10. Sheth SS. The place of oophorectomy at vaginal hysterec-
tomy. Br J Obstet Gynaecol 1991;98:662–6.
COMMITTEE OPINIONS
11. Agostini A, Vejux N, Bretelle F, Collette E, De Lapparent T,
Cravello L, et al. Value of laparoscopic assistance for vaginal
hysterectomy with prophylactic bilateral oophorectomy.
Am J Obstet Gynecol 2006;194:351–4.
12. Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally
MJ, Peterson HB, et al. Complications of abdominal and
vaginal hysterectomy among women of reproductive age in
the United States. The Collaborative Review of Sterilization.
Am J Obstet Gynecol 1982;144:841–8.
13. Benassi L, Rossi T, Kaihura CT, Ricci L, Bedocchi L, Galanti
B, et al. Abdominal or vaginal hysterectomy for enlarged
uteri: a randomized clinical trial. Am J Obstet Gynecol
2002;187: 1561–5.
14. ACOG Technology Assessment: Robot-Assisted Surgery (in
publication for November 2009)
15. Dorsey JH, Holtz PM, Griffiths RI, McGrath MM, Steinberg
EP. Costs and charges associated with three alternative tech-
niques of hysterectomy. N Engl J Med 1996;335:476–82.
16. Sculpher M, Manca A, Abbott J, Fountain J, Mason S, Garry
R. Cost effectiveness analysis of laparoscopic hysterectomy
compared with standard hysterectomy: results from a ran-
domised trial. BMJ 2004;328:134.
17. Surgery and patient choice. ACOG Committee Opinion
No. 395. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2008;111:243–7.
18. Supracervical hysterectomy. ACOG Committee Opinion
No. 388. American College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2007;110:1215–7.
Copyright © November 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Choosing the route of hysterectomy for benign disease. ACOG
Committee Opinion No. 444. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2009;114:1156–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 380
 ACOG COMMITTEE OPINION
Committee on
Gynecologic
Practice
Long-Acting
Reversible
Contraception
Working Group
Reaffirmed 2011
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 450 • December 2009
Increasing Use of Contraceptive Implants
and Intrauterine Devices To Reduce
Unintended Pregnancy
ABSTRACT: High unintended pregnancy rates in the United States may in part be
the result of relatively low use of long-acting reversible contraceptive (LARC) methods,
specifically the contraceptive implant and intrauterine devices. Top-tier reversible meth-
ods share the characteristic of requiring a single act of motivation for long-term use, elim-
inating adherence and user-dependence from the effectiveness equation. According to
the World Health Organization’s evidence-based Medical Eligibility Criteria for contracep-
tive use, LARC methods have few contraindications, and almost all women are eligible
for implants and intrauterine devices. Because of these advantages and the potential to
reduce unintended pregnancy rates, LARC methods should be offered as first-line contra-
ceptive methods and encouraged as options for most women. To increase use of LARC
methods, barriers such as lack of health care provider knowledge or skills, low patient
awareness, and high upfront costs must be addressed.
Unintended pregnancy persists as a major (7). The United States has higher unintended
public health problem in the United States. pregnancy rates than other countries (8).
Over the past 20 years, overall rates in the
United States have not changed and remain Long-Acting Reversible
unacceptably high at approximately 50% Contraception and
of all pregnancies (1). Although the rate Unintended Pregnancy
for unintended pregnancy has decreased
somewhat for higher income women, rates In part, high-unintended pregnancy rates in
have increased for lower income women (1). the United States may be the result of relatively
Unwanted births to women aged 15–24 years low use of long-acting reversible contraceptive
nearly doubled between 1995 and 2002 (2). (LARC) methods, specifically the contracep-
Many factors, including contraceptive tive implant and intrauterine devices (IUDs).
method choice and continuation patterns, Use of LARC methods is much less common
contribute to the lack of progress in reduc- in the United States than in countries such as
ing unintended pregnancies. Combined oral France, where unintended pregnancy rates are
contraceptives and condoms, the predomi- much lower (7). According to the most recent
nant reversible contraceptive methods used cycle of the National Survey of Family Growth,
in the United States, are user dependent, fewer than 5% of women in the United States
have relatively low continuation rates, and reported ever using intrauterine contracep-
have relatively high failure rates with typi- tion or an implant (9). Increasing use of
cal use patterns (3). Interventions such as LARC methods in the United States could
enhanced counseling and same day start have lower unintended pregnancy rates (7), and
not consistently improved contraceptive use expanding access to LARC for young women
patterns, continuation rates, or unintended has been declared a national priority (10).
pregnancy rates (4–6). Further, the predicted Emerging evidence indicates that increas-
effect of emergency contraception to reduce ing the use of contraceptive implants and IUDs
unintended pregnancy has not been achieved also could reduce repeat pregnancy among
2013 COMPENDIUM OF SELECTED PUBLICATIONS 381
 adolescent mothers and repeat abortions among women
seeking induced abortion. In a U.S. study of adolescent
mothers, the factor most strongly associated with repeat
pregnancy prevention in the first 2 postpartum years
was initiation of the six-rod contraceptive implant (11).
Other studies have concluded that immediate posta-
bortion initiation of LARC methods is associated with
reduced repeat abortion rates. In a retrospective cohort
study conducted in the United States, women who
received immediate postabortion IUDs for contracep-
tion had a significantly lower rate of repeat abortions
than women who chose other non-IUD postabortion
contraception (34.6 versus 91.3 abortions per 1,000
woman-years of follow-up) (12). Similarly, in a prospec-
tive cohort study from Northern Europe, 1,269 women
undergoing early medical abortion were monitored for
49 months. Women who chose immediate IUD insertion
had the lowest repeat abortion risk, as compared with
those who chose other methods or postponed starting a
contraceptive method (13).
Long-Acting Reversible Contraceptive
Methods
The World Health Organization family planning coun-
seling guide lists all methods in tiers of effectiveness (see
Fig. 1). The top-tier reversible methods all share the
characteristic of requiring a single act of motivation for
long-term use, essentially eliminating adherence and user-
dependence from the effectiveness equation. These top-
tier methods also share the highest continuation rates
of all contraceptive methods, one of the most important
factors in contraceptive success (3).
Currently, three LARC methods are available in the
United States. The single-rod etonogestrel implant was
approved by the U.S. Food and Drug Administration
in July 2007 for use up to 3 years. Two IUDs are avail-
able, the Copper T380A for use up to 10 years, and the
levonorgestrel intrauterine system for use up to 5 years.
According to the World Health Organization’s evidence-
based Medical Eligibility Criteria for contraceptive use,
LARC methods have few contraindications, and almost all
women are eligible for implants and IUDs (14, 15).
Despite high up-front costs and the need for office
visits for insertion and removal, LARC methods share the
following advantages over other methods:
• Are independent from coitus and user motivation
and adherence
• Have the highest effectiveness, continuation rates,
and user satisfaction
• Do not require frequent visits for resupply
• Require no additional funding for consistent use
once they have been placed
• Are highly cost-effective
• Are reversible, with a rapid return to fertility after
removal
COMMITTEE OPINIONS
Because of these advantages and the potential to reduce
unintended pregnancy rates, LARC methods should be
offered as first-line contraceptive methods and encour-
aged as options for most women.
Barriers to Long-Acting Reversible
Contraception
To increase use of LARC methods, barriers such as lack
of health care provider knowledge or skills, low patient
awareness, and high upfront costs should be addressed.
Increasing familiarity with changes in practice guide-
lines and improvements associated with the newer LARC
devices may address some health care provider reluctance
to encourage LARC use. Although health care providers
generally have favorable attitudes about IUDs, they may
use overly restrictive criteria to identify IUD candidates
(16). For example, IUDs may be safely used by nullipar-
ous women and by adolescents (17, 18). Although there is
a slight increased risk of infection in the first 20 days after
IUD insertion, evidence indicates there is no increased
risk of pelvic inflammatory disease or infertility in IUD
users (18).
Immediate postpartum and postabortal insertion of an
IUD is safe and effective (19, 20). Although expulsion rates
may be higher, the convenience of postpartum or postabor-
tal placement may outweigh this disadvantage and increase
access and use of effective contraception (19, 20).
The single-rod contraceptive implant is relatively new
and many physicians may be unaware of its advantages,
including its ease of removal as compared with the older six-
rod system. In one study, mean removal time for the single-
rod implant was 3.5 minutes (21). In order to procure the
single-rod contraceptive implant, health care providers are
required by the U.S. Food and Drug Administration to par-
ticipate in manufacturer-sponsored training.
Lack of experience or comfort with implant or IUD
insertion may result in physician reluctance to recom-
mend LARC methods, and overly cumbersome insertion
protocols, multiple visits, and unnecessary testing could
discourage patient use. The American College of Obstet-
ricians and Gynecologists supports efforts to increase
educational and hands-on training opportunities for clini-
cians in implant and IUD insertion.
Patient barriers include a general lack of awareness
of LARC methods and their safety and effectiveness.
Women describe the ideal contraceptive as reversible
and not needing frequent thought (22). Yet, two recent
surveys found that most young women had not heard of
the IUD (23, 24). However, young women were likely to
report a positive attitude about intrauterine contracep-
tion after a brief, 3-minute educational intervention (23).
Cost may present a barrier to LARC method use
for many women. Implants and IUDs have high up-
front costs that often are not fully covered by insurance.
Instead, less effective but initially less expensive meth-
ods such as oral contraceptives are more often covered.
However, both the implant and IUDs are highly cost-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 382
 Fig. 1. Abbreviations: IUD, intrauterine device; LAM, lactational amenorrhea method.
effective even with relatively short-term (12–24 months)
use (25–27).
Recommendations
Although lowering unintended pregnancy rates requires
multiple approaches, individual obstetrician–gynecolo-
gists may contribute by increasing access to LARC meth-
ods for their patients. The following strategies can reduce
barriers and increase use of implants and IUDs:
• Provide counseling on all contraceptive options,
including implants and IUDs, even if the patient ini-
tially states a preference for a specific contraceptive
method.
• Encourage implants and IUDs for all appropriate
candidates, including nulliparous women and adoles-
cents.
COMMITTEE OPINIONS
• Adopt same-day insertion protocols. Screening for
chlamydia, gonorrhea, and cervical cancer should not
be required before implant or IUD insertion but may
be obtained on the day of insertion, if indicated.
• Avoid unnecessary delays, such as waiting to initiate
a method until after a postabortion or miscarriage
follow-up visit or to time insertion with menses.
• Support efforts to lower the up-front costs of LARC
methods.
• Advocate for coverage of all contraceptive methods
by all insurance plans, both private and public.
• Become familiar with and support local, state, fed-
eral (including Medicaid), and private programs that
improve affordability of all contraceptive methods,
including implants and IUDs.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 383
 Resources
American College of Obstetricians and Gynecologists
Long-Acting Reversible Contraception Program
409 12th Street, SW, PO Box 96920
Washington, DC 20090-6920
800-673-8444 or 202-638-5577
http://www.acog.org/goto/larc
American College of Obstetricians and Gynecologists
Patient Education Pamphlet AP014 (2007)
The intrauterine device
Available at: http://www.acog.org/publications/
patient_ education/bp014.cfm
Spanish language version (pamphlet SP014) available at:
http://www.acog.org/publications/patient_education/
sp014.cfm
American College of Obstetricians and Gynecologists
Patient Education Pamphlet AP159 (2007)
Hormonal contraception—Injections, implants, rings,
and patches.
Available at: http://www.acog.org/publications/
patient_education/bp159.cfm
Spanish language version (pamphlet SP159) available at:
http://www.acog.org/publications/patient_education/
sp159.cfm
World Health Organization
Promoting family planning
Available at: http://www.who.int/reproductivehealth/
topics/family_planning/en/index.html
References
1. Finer LB, Henshaw SK. Disparities in rates of unintended
pregnancy In the United States, 1994 and 2001. Perspect
Sex Reprod Health 2006;38(2):90–6.
2. Kissin DM, Anderson JE, Kraft JM, Warner L, Jamieson DJ.
Is there a trend of increased unwanted childbearing among
young women in the United States? J Adolesc Health 2008;
43:364–71.
3. Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F,
Kowal D, editors. Contraceptive technology. 19th rev. ed.
New York (NY): Ardent Media, Inc.; 2007.
4. Halpern V, Grimes DA, Lopez LM, Gallo MF. Strategies to
improve adherence and acceptability of hormonal methods
of contraception. Cochrane Database of Systematic Reviews
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5. Moos MK, Bartholomew NE, Lohr KN. Counseling in
the clinical setting to prevent unintended pregnancy: an
evidence-based research agenda. Contraception 2003;67:
115–32.
6. Lopez LM, Newmann SJ, Grimes DA, Nanda K, Schulz KF.
Immediate start of hormonal contraceptives for contracep-
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7. Trussell J, Schwarz EB, Guthrie K, Raymond E. No such
thing as an easy (or EC) fix. Contraception 2008;78:351–4.
COMMITTEE OPINIONS
8. Trussell J, Wynn LL. Reducing unintended pregnancy in
the United States. Contraception 2008;77:1–5.
9. Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J.
Fertility, family planning, and reproductive health of U.S.
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Growth. Vital Health Stat 23 2005;(25):1–160.
10. Institute of Medicine (US). Initial national priorities for
comparative effectiveness research. Washington, DC:
National Academies Press; 2009.
11. Stevens-Simon C, Kelly L, Kulick R. A village would be nice
but...it takes a long-acting contraceptive to prevent repeat
adolescent pregnancies. Am J Prev Med 2001;21:60–5.
12. Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A.
Impact of immediate postabortal insertion of intrauterine
contraception on repeat abortion. Contraception 2008;78:
143–8.
13. Heikinheimo O, Gissler M, Suhonen S. Age, parity, his-
tory of abortion and contraceptive choices affect the risk of
repeat abortion. Contraception 2008;78:149–54.
14. World Health Organization. Medical eligibility criteria for
contraceptive use. 3rd ed. Geneva: WHO; 2004. Available at:
http://whqlibdoc.who.int/publications/2004/9241562668.
pdf. Retrieved August 13, 2009.
15. World Health Organization. Medical eligibility criteria
for contraceptive use: 2008 update. Geneva: WHO; 2008.
Available at: http://whqlibdoc.who.int/hq/2008/WHO_
RHR_08.19_eng.pdf. Retrieved August 13, 2009.
16. Harper CC, Blum M, de Bocanegra HT, Darney PD,
Speidel JJ, Policar M, et al. Challenges in translating evi-
dence to practice: the provision of intrauterine contracep-
tion. Obstet Gynecol 2008;111:1359–69.
17. Intrauterine device and adolescents. ACOG Committee
Opinion No. 392. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1493–5.
18. Intrauterine device. ACOG Practice Bulletin No. 59.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;105:223–32.
19. Grimes DA, Lopez LM, Schulz KF, Stanwood NL.
Immediate postabortal insertion of intrauterine devices.
Cochrane Database of Systematic Reviews 2004, Issue 4.
Art. No.: CD001777. DOI: 10.1002/14651858.CD001777.
pub2.
20. Grimes DA, Schulz KF, Van Vliet HH, Stanwood NL,
Lopez LM. Immediate post-partum insertion of intra-
uterine devices. Cochrane Database of Systematic Reviews
2001, Issue 2. Art. No.: CD003036. DOI: 10.1002/14651858.
CD003036.
21. Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter
A, Schmidt J, et al. Safety and efficacy of Implanon, a single-
rod implantable contraceptive containing etonogestrel. The
Implanon US Study Group. Contraception 2005;71:319–
26.
22. Cwiak C, Gellasch T, Zieman M. Peripartum contraceptive
attitudes and practices. Contraception 2004;70:383–6.
23. Whitaker AK, Johnson LM, Harwood B, Chiappetta L,
Creinin MD, Gold MA. Adolescent and young adult wom-
en’s knowledge of and attitudes toward the intrauterine
device. Contraception 2008;78:211–7.
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 24. Stanwood NL, Bradley KA. Young pregnant women’s
knowledge of modern intrauterine devices. Obstet Gynecol
2006;108:1417–22.
25. Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J.
Cost effectiveness of contraceptives in the United States.
Contraception 2009;79:5–14.
26. Foster DG, Rostovtseva DP, Brindis CD, Biggs MA, Hulett
D, Darney PD. Cost savings from the provision of specific
methods of contraception in a publicly funded program.
Am J Public Health 2009;99:446–51.
27. Chiou CF, Trussell J, Reyes E, Knight K, Wallace J, Udani
J, et al. Economic analysis of contraceptives for women.
Contraception 2003;68:3–10.
COMMITTEE OPINIONS
Copyright December 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Increasing use of contraceptive implants and intrauterine devices to
reduce unintended pregnancy. ACOG Committee Opinion No. 450.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;114:1434–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 385
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 458 • June 2010

Committee on Gynecologic Practice

This document reflects emerging clinical and scientific advances as of the date issued and is
Reaffirmed 2012 subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Use of Hysterosalpingography After Tubal Sterilization

ABSTRACT: The U.S. Food and Drug Administration has approved two devices for hysteroscopic tubal steril-
ization. To minimize the failure rates of these effective methods, it is important for health care providers to under-
stand the important role hysterosalpingography (HSG) plays in any hysteroscopic tubal sterilization procedure. The
purpose of this Committee Opinion is to emphasize the necessity of performing HSG 3 months after hysteroscopic
tubal sterilization and to identify factors that may interfere with performance of an adequate HSG assessment.

The U.S. Food and Drug Administration (FDA) has
approved two devices for hysteroscopic tubal sterilization,
and in the future, more devices may be approved. These
methods are a welcome expansion of the contraceptive
options available to women. As minimally invasive meth-
ods, they can be performed without general anesthesia in
many cases and offer an in-office sterilization procedure
for selected patients. To minimize the failure rates of these
effective methods, it is important for health care provid-
ers to understand the important role hysterosalpingogra-
phy (HSG) plays in any hysteroscopic tubal sterilization
procedure. According to the U.S. device labeling, HSG
is the only method to be used for confirmation of tubal
occlusion. The purpose of this Committee Opinion is to
emphasize the necessity of performing HSG 3 months
after hysteroscopic tubal sterilization and to identify fac-
tors that may interfere with performance of an adequate
HSG assessment.
The Essure (intrauterine [intratubal] microinsert) sys-
tem (1) was approved by the FDA in 2002. In this proce-
dure, a microinsert made of a nickel titanium outer coil
and a stainless steel inner coil wrapped in polyethylene
terephthalate fibers is placed in the proximal portion of
the fallopian tube under hysteroscopic guidance. Chronic
inflammation induced by the polyethylene terephthalate
fibers leads to fibrotic ingrowth in and around the micro-
inserts culminating in tubal occlusion. According to the
manufacturer, an estimated 310,000 devices have been
placed to date (2). More recently, the Adiana (bipolar
radiofrequency and silicone) system (3) was approved
in July 2009. In this procedure, the delivery catheter is
placed in the tubal ostia. Bipolar radiofrequency energy is
delivered to create a superficial lesion within the fallopian
tube. A silicone matrix is then deployed into the proximal
tube in the area of the lesion. The tissue ingrowth causes
tubal occlusion along the length of the implanted matrix.
Both procedures have a number of important differences
from other sterilization procedures that must be consid-
ered when selecting and counseling patients.
The most important difference from other steriliza-
tion procedures is that patients undergoing hysteroscopic
sterilization must rely on another method of contracep-
tion for at least 3 months after the microinsert placement
(interim contraception). They also must undergo HSG
to confirm bilateral occlusion before relying on hystero-
scopic sterilization because the tissue ingrowth necessary
for occlusion typically takes 3 months after placement
of the microinsert or deployment of the silicone matrix.
In some patients, occlusion may take even longer. In the
original phase III trial for the nickel titanium and poly-
ethylene terephthalate system, 8% of women undergoing
HSG 3 months after hysteroscopic sterilization had per-
sistent tubal patency (4). Similar rates were noted in the
first large trial of the bipolar radiofrequency and silicone
system (5). If bilateral tubal occlusion is not confirmed on
the HSG performed at 3 months, patients must be coun-
seled to use interim contraception and have a repeat HSG
3 months later. If bilateral occlusion is still not confirmed
on the repeat study, patients must be counseled not to
rely on the hysteroscopic tubal sterilization and to use
alternative contraception.
The manufacturers have specific protocols for the
confirmatory HSG, which differ from the standard HSG
required for infertility evaluation (6). These protocols are
notable for requiring lower filling pressure, potentially
making the procedure less uncomfortable for the patient,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 386

 but requiring six specific separate images. Health care
providers performing confirmatory HSG should follow
these protocols.
Patients considering hysteroscopic sterilization need
careful counseling regarding the need for interim contra-
ception and the need to return for postoperative HSG.
Interim contraceptive plans should be finalized before
the placement procedure. Logistic difficulties poten-
tially preventing return for HSG such as scheduling and
verification of coverage by insurance should be dealt
with before the procedure whenever possible. Patient
insurance coverage may change in the interim, posing a
substantial barrier. In clinical practice, patient adherence
with HSG varies. In three studies specifically examining
rates of adherence with HSG, rates varied from as high as
86.4% to as low as 12.7% (7–9). Out of the 64 pregnan-
cies that occurred after the nickel titanium and polyethyl-
ene terephthalate procedure, which were reported to the
manufacturer between 1997 and 2005, 47% appeared to
result from nonadherence to use of interim contraception
or return for HSG (10). Failure to return for confirma-
tory HSG was the most frequent risk factor. Out of the
six pregnancies that occurred in the first 12 months of use
in the Evaluation of the Adiana System for Sterilization
Using Electrothermal Energy trial, three were attributed
by the manufacturer to improper interpretation of the
HSG (11).
Some health care providers have combined place-
ment of the nickel titanium and polyethylene tere-
phthalate system with same-day endometrial ablation
procedures. A single published study conducted outside
of the United States evaluated tubal occlusion in 23 par-
ticipants undergoing placement of the nickel titanium
and polyethylene terephthalate system and endometrial
ablation by a variety of techniques (12). Out of these 23
participants, 20 returned for confirmation of occlusion,
and all 20 had occlusion confirmed. However, in this
study, tubal occlusion was documented by three-dimen-
sional ultrasonogram and pelvic X-ray, not the HSG
required in the device labeling. In the Hopkins et al study
(13) sterilization was performed with the nickel titanium
and polyethylene terephthalate system after endometrial
ablation with an automated radiofrequency procedure
in 25 patients. Out of the 23 patients who eventually
returned for HSG, 21 had confirmed occlusion. Two of
the patients were unable to have adequate HSG assess-
ments, one because of cervical stenosis and one because
of intrauterine synechiae. In a study presented to the
FDA by the manufacturer, 10 out of 30 women undergo-
ing thermal balloon endometrial ablation followed by
sterilization with the nickel titanium and polyethylene
terephthalate system had intrauterine synechiae on the
day of HSG. Out of these 10 patients, five cases of syn-
echiae were so severe that confirmatory HSG could not
be performed (14). Based on this finding, the nickel
titanium and polyethylene terephthalate device labeling
was specifically changed to state “DO NOT perform the
2 Committee Opinion No. 458
COMMITTEE OPINIONS
Essure procedure concomitantly with endometrial abla-
tion. Ablation causes intrauterine synechiae, which can
compromise (ie, prevent) the 3-month Essure confirma-
tion test (HSG). Women who have inadequate 3-month
confirmation tests cannot rely on Essure for contracep-
tion” (1). Labeling for the bipolar radiofrequency and
silicone system contains similar warnings. Health care
providers should follow the manufacturers’ instructions
and not perform same-day endometrial ablation and
hysteroscopic sterilization.
References
1. Conceptus, Inc. Essure: instructions for use. Mountain
View (CA): Conceptus; 2009. Available at: http://www.
essuremd.com/portals/essuremd/PDFs/TopDownloads/
L3002%2009_09_09%20smaller.pdf. Retrieved January 28,
2010.
2. Conceptus, Inc. What is Essure? Mountain View (CA):
Conceptus; 2010. Available at: http://www.essuremd.com/
Home/AboutEssure/WhatisEssure/tabid/219/Default.aspx.
Retrieved January 28, 2010.
3. Hologic, Inc. Hysterosalpingography (HSG) for Adiana
permanent contraception. Marlborough (MA): Hologic; 2009.
Available at: http://training.adiana.com/Content/Adiana
HSGIFU.pdf. Retrieved January 28, 2010.
4. Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert
nonincisional hysteroscopic sterilization. Selective Tubal
Occlusion Procedure 2000 Investigators Group. Obstet
Gynecol 2003;102:59–67.
5. Vancaillie TG, Anderson TL, Johns DA. A 12-month
prospective evaluation of transcervical sterilization using
implantable polymer matrices. Obstet Gynecol 2008;112:
1270–7.
6. Conceptus, Inc. Essure: the alternative to incision. HSG
protocol. Mountain View (CA): Conceptus; 2003. Available
at: http://www.essuremd.com/Portals/0/Skins/Conceptus_
Skin/PDFs/TR-0671-101-HSG-Protocol.pdf. Retrieved
January 28, 2010.
7. Glazerman LR. Hysterosalpingogram after Essure steriliza-
tion in a private practice: patient compliance and results
[abstract]. J Minim Invasive Gynecol 2008;15:S76.
8. Guiahi M, Goldman KN, Olson CG. Retrospective analysis
of hysterosalpingogram confirmatory test follow-up after
Essure hysteroscopic sterilization; 4-year experience in a
community setting [abstract]. J Minim Invasive Gynecol
2008;15:S78–9.
9. ShavellVI,AbdallahME,DiamondMP,KmakDC,BermanJM.
Post-Essure hysterosalpingography compliance in a clinic
population. J Minim Invasive Gynecol 2008;15:431–4.
10. Levy B, Levie MD, Childers ME. A summary of reported
pregnancies after hysteroscopic sterilization. J Minim Invasive
Gynecol 2007;14:271–4.
11. Hologic, Inc. Adiana permanent contraception: instruc-
tions for use and radiofrequency (RF) generator operator’s
manual. Marlborough (MA): Hologic; 2009. Available at:
http://www.adiana.com/pdf/hcp/adiana-instructions-for-
use.pdf. Retrieved January 28, 2010.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 387
 12. Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R,
Fernandez H. Essure sterilization associated with endome-
trial ablation. Int J Gynaecol Obstet 2007;97:139–42.
13. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE,
Famuyide AO. Radiofrequency global endometrial ablation
followed by hysteroscopic sterilization. J Minim Invasive
Gynecol 2007;14:494–501.
14. Conceptus, Inc. Important information for physicians
on modifications to the Essure permanent birth control
system labeling related to concomitant use with Gynecare
Thermachoice uterine balloon therapy system. Mountain
View (CA): Conceptus; 2006. Available at: http://www.
essuremd.com/portals/essuremd/PDFs/TopDownloads/
CC-1411%2031Octo6F_on_lthd.pdf. Retrieved February 29,
2010.
Committee Opinion No. 458
COMMITTEE OPINIONS
Copyright June 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Use of hysterosalpingography after tubal sterilization. Committee
Opinion No. 458. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2010;115:1343–5.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 388
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 477 • March 2011 (Replaces No. 280, December 2002)
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

The Role of the Obstetrician–Gynecologist in the Early

Detection of Epithelial Ovarian Cancer
ABSTRACT: Epithelial ovarian cancer is most commonly detected in an advanced stage, when the overall
5-year survival rate is 20–30%. Detection of early-stage ovarian cancer results in improved survival. Currently, there
is no effective strategy for ovarian cancer screening. Women with persistent and progressive symptoms, such as
an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated, with
ovarian cancer being included in the differential diagnosis. Evaluation of the symptomatic patient includes physical
examination and may include transvaginal ultrasonography and measurement of levels of the serum tumor marker
CA 125. Patients suspected of having ovarian cancer should be managed by a gynecologic surgeon, such as a gyne-
cologic oncologist, who is trained to perform comprehensive surgical staging and cytoreductive (debulking) surgery.

Although ovarian cancer is the second most common
type of female reproductive cancer, more women die
from ovarian cancer than from cervical cancer and uter-
ine cancer combined. It is estimated that in the United
States in 2010, ovarian cancer was diagnosed in 21,880
women and 13,850 women died from this malignancy.
The principal reason for these poor outcomes is the
advanced stage of epithelial ovarian cancer at diagnosis
(70–75% of cases are stage III or stage IV and have an
overall 5-year survival rate of only 20–30%). However,
women with stage I disease have a 90–95% probability of
cure. The purpose of this Committee Opinion is to define
the role of the generalist obstetrician–gynecologist in the
early detection of epithelial ovarian cancer.
Screening of Low-Risk Women
The use of transvaginal ultrasonography and tumor
markers (such as CA 125) as potential screening strate-
gies have been evaluated. These methods, however, have
proved ineffective for screening low-risk asymptomatic
women because their sensitivity, specificity, positive pre-
dictive value (PPV), and negative predictive value all have
been modest at best (1). Because of the low prevalence of
epithelial ovarian cancer, reported to be approximately
1 case per 2,500 women per year, it has been estimated
that a test with even 100% sensitivity and 99% specific-
ity would have a PPV of only 4.8%, which means 20 of
21 women undergoing surgery would not have primary
ovarian cancer (2).
Transvaginal Ultrasonography
Transvaginal ultrasonography may detect changes in
ovarian size and morphology before signs or symptoms
of cancer develop. The upper limit of normal ovarian
volume has been defined as 20 cm3 in premenopausal
women who are not pregnant and 10 cm3 in post-
menopausal women (3). Adding cyst wall character-
istics and the presence of septae to the measurement
of ovarian volume resulted in a sensitivity of 86% and
a specificity of 99% for differentiating benign lesions
from malignant lesions (4). A finding of increased blood
flow in the ovary by Doppler ultrasonography also
has been suggested as a means of identifying malignant
lesions.
Some ovarian cancer screening trials involving the
use of transvaginal ultrasonography have demonstrated
a trend toward an early-stage ovarian cancer diagnosis
(5–12). The PPV of ultrasonography in these studies of
more than 136,000 women varied from 1.0% (10) to 27%
(8); however, the latter study included mostly women at
high risk because of a family history of breast cancer or
ovarian cancer, and because of its nonrandomized and
uncontrolled design, is insufficient to support claims that
screening results in an improved survival rate.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 389

 CA 125 Serum Tumor Marker
The potential advantages of measuring serum tumor
markers for ovarian cancer detection include availability
and repeatability, minimal invasiveness, operator indepen-
dence, and lower cost than ultrasonography. The tumor
marker CA 125, a monoclonal antibody that detects
ovarian cancer antigen OC 125, is the most extensively
evaluated serum marker for cancer screening and has been
evaluated alone and in combination with other markers.
Initial studies showed that the CA 125 levels were
elevated in approximately 80% of women with epithe-
lial ovarian cancer (13). However, subsequent studies
have demonstrated both poor sensitivity and specificity
for early-stage cancer detection (14, 15). Measuring the
CA 125 level may predict cancer more accurately in post-
menopausal women than in premenopausal women, with
specificity values reported as 98.5% for women older than
50 years and an unacceptable 94.5% for those younger
than 50 years (16). Measuring CA 125 levels over time
provides a more accurate assessment of ovarian cancer
risk than does a one-time measurement (17). In a pro-
spective study of postmenopausal women, such a serial
measure, called the Risk of Ovarian Cancer algorithm,
was found to have a PPV of 19% (18).
Combining CA 125 with other markers in tumor
marker panels has been shown to increase sensitivity
by 5–10%; however, specificity is decreased (19). Initial
analysis of a tumor marker panel that included CA 125,
leptin, prolactin, osteopontin, insulin-like growth fac-
tor II, and macrophage inhibitory factor was reported
to significantly improve sensitivity and specificity (20).
However, because of serious methodologic limitations of
the study, the results were greatly overestimated (21, 22),
and PPV was only 6.5% when recalculated at the true
prevalence of the disease (20). Tumor marker panels have
not been evaluated prospectively in large population-
based studies and have not been proved to improve early
detection and survival rates.
Studies on Combined Modality
Screening
Ultrasonography and measurement of tumor markers
alone have not demonstrated the sensitivity, specificity,
and PPV necessary to justify their use for ovarian cancer
screening in average-risk populations of postmenopausal
women. Large-scale prospective randomized trials in
both the United States and the United Kingdom have
been initiated to address the virtue of combined modality
assessment for screening.
The Prostate, Lung, Colorectal and Ovarian Cancer
Screening Trial is a U.S.-based randomized controlled
trial that has enrolled 34,261 healthy average-risk women
between the ages of 55 years and 74 years to receive either
annual CA 125 testing plus transvaginal ultrasonography
or “usual care,” which includes annual pelvic examina-
tion (10). Based on interim results from the screening
2 Committee Opinion No. 477
COMMITTEE OPINIONS
period, the PPV of this combination testing in the aver-
age-risk population was 1.3%. Long-term follow-up is
not yet complete, and final results are anticipated in 2014.
The United Kingdom Collaborative Trial of Ovarian
Cancer Screening has enrolled more than 202,000 post-
menopausal women between the ages of 50 years and 74
years. Women of average risk have been randomized to
receive either annual pelvic examination, annual ultraso-
nography, or CA 125 measurement (including the Risk
of Ovarian Cancer algorithm), with ultrasonography for
elevated CA 125 levels (23). Preliminary results suggest a
more favorable proportion of early-stage ovarian cancer
detection (48%) with either transvaginal ultrasonogra-
phy or CA 125 measurement (plus ultrasonography, as
indicated). Specificity of CA 125 measurement (plus indi-
cated ultrasonography) was 99.8% and that of ultrasonog-
raphy alone was 98.2%. The PPV of CA 125 measurement
and ultrasonography, as indicated, was 35.1%. However,
despite these promising results, it is important to await
the longer-term follow-up data with respect to survival.
Screening of High-Risk Women
Factors known to increase the risk of ovarian cancer
include an identified BRCA gene mutation and a fam-
ily history of cancer, which is suggestive of a hereditary
cancer syndrome. Women with these conditions should
be referred for formal genetic counseling to better assess
their cancer risk, including risk of ovarian cancer. If
appropriate, these women may be offered ovarian can-
cer screening. Screening with CA 125 measurement and
transvaginal ultrasonography every 6 months has been
recommended for high-risk women by the National Com-
prehensive Cancer Network (24), although evidence is
insufficient to demonstrate that current screening meth-
ods improve survival rates for these women (25–29). The
American College of Obstetricians and Gynecologists
recommends that risk-reducing salpingo-oophorectomy,
which includes removal of the ovaries and fallopian tubes
in their entirety, be offered by age 40 years for women
with BRCA1 or BRCA2 mutations (30).
Evaluation of Women With Signs or
Symptoms
Past descriptions of ovarian cancer as the “silent” cancer
are a misconception. Recent studies have shown that
women with ovarian cancer may develop symptoms sev-
eral months before the diagnosis, even with early-stage
disease. In a survey of 1,725 women with ovarian cancer,
70% recalled having symptoms for 3 months or longer
before the diagnosis, and 35% recalled having symptoms
for at least 6 months (31). Approximately three fourths
of these women had abdominal symptoms and one
half had pain or constitutional symptoms. This initial
research led to further studies to define which symp-
toms are most associated with ovarian cancer. In a case–
control study of women between the ages of 15 years and
90 years, researchers compared the frequency of symp-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 390
 toms typical in ovarian cancer reported by 1,709 women
being evaluated in a primary care clinic with those
reported by 128 women undergoing surgery for a pelvic
mass (32). Symptoms such as increased abdominal size,
bloating, urinary urgency, and pelvic pain were found
more frequently in women with ovarian cancer. Women
with cancer reported that their symptoms occurred
20–30 times per month as compared with two to three
times per month for the women seen in the primary
care clinics. The study pointed out that although these
symptoms experienced by women with ovarian cancer
and those presenting to primary care clinics are similar,
the frequency, severity, and duration of these symptoms
were greater in women with ovarian cancer. Although
this information is compelling, it is not from a prospec-
tive trial, and patient recall bias may have influenced the
results. However, based on this information, an ovarian
cancer symptom index was developed (33). Factors that
were most significantly associated with ovarian cancer, if
they occurred more than 12 days per month and for less
than 1 year, were pelvic or abdominal pain, increase in
abdominal size or bloating, and difficulty eating or feeling
full. When tested in a confirmatory sample, this ovarian
cancer index had a sensitivity of 56.7% for women with
early-stage disease and 79.5% for those with late-stage
disease, with a specificity of 86.7% for women younger
than 50 years and 90% for women older than 50 years.
Two other studies have disputed the value of the
symptom index to detect early ovarian cancer. In a study
that tested the symptom index in a group of patients
undergoing transvaginal ultrasonography as part of a
screening trial, only 20% of women with ovarian cancer
acknowledged that they had symptoms (34). In another
study, in-person interviews were conducted with 812
patients with ovarian cancer and 1,313 control partici-
pants. Symptoms were less likely to be present in women
with early-stage ovarian cancer. The estimated PPV of the
symptom index was 0.6% for late-stage disease and less
than 0.5% for early-stage disease (35).
Currently, it appears that the best way to detect
ovarian cancer is for both the patient and her clinician to
have a high index of suspicion of the diagnosis in symp-
tomatic women. This requires education of both as to
the symptoms commonly associated with ovarian cancer.
Persistent and progressive symptoms such as an increase
in bloating, pelvic or abdominal pain, or difficulty eating
or feeling full quickly, should be evaluated, with ovarian
cancer being included in the differential diagnosis.
In evaluating these symptoms, physicians should per-
form a physical examination, including a pelvic examina-
tion. A rectovaginal examination may provide additional
information. Imaging studies, especially transvaginal
ultrasonography, may be helpful in recognizing increased
ovarian size or morphologic changes associated with ovar-
ian cancer.
In premenopausal women with symptoms, a slightly
elevated CA 125 value may be misleading because
Committee Opinion No. 477
COMMITTEE OPINIONS
elevated levels of CA 125 are associated with a vari-
ety of common benign conditions, including uterine
leiomyomas, pelvic inflammatory disease, endometrio-
sis, adenomyosis, pregnancy, and even menstruation.
Nonetheless, extremely high levels of CA 125 may be
useful in the evaluation of premenopausal women. In
postmenopausal women with a pelvic mass, a CA 125
measurement may be helpful in predicting a higher like-
lihood of malignancy. This information may be useful
in making consultation or referral decisions. However,
a normal CA 125 measurement alone does not rule out
ovarian cancer because more than 50% of cases of early-
stage cancer and 20–25% of cases of advanced cancer are
associated with normal values.
The U.S. Food and Drug Administration has recently
cleared for marketing a qualitative serum test, which
appears to improve the predictability of ovarian can-
cer in women with pelvic masses (http://www.fda.gov/
NewsEvents/Newsroom/PressAnnouncements/2009/
ucm182057.htm). This is not a screening test, but it may
be useful for evaluating women with a pelvic mass. The
test evaluates five biomarkers: 1) transthyretin, 2) apoli-
poprotein A-1, 3) b2 microglobulin, 4) transferrin, and
5) CA 125 II (36). This test is cleared for use in women
older than 18 years, with an already detected ovarian
adnexal mass needing surgery. Clinical utility is not yet
established.
When physical examination and imaging techniques
have detected the presence of a pelvic mass that is suspi-
cious for a malignant ovarian neoplasm, the presence
of at least one of the following indicators warrants con-
sideration of referral to or consultation with a physician
trained to appropriately stage and debulk ovarian cancer,
such as a gynecologic oncologist:
• Postmenopausal women: elevated CA 125 level,
ascites, a nodular or fixed pelvic mass, or evidence of
abdominal or distant metastasis
• Premenopausal women: very elevated CA 125 level,
ascites, or evidence of abdominal or distant metastasis
When a patient with a suspicious or persistent complex
adnexal mass requires surgical evaluation, a physician
trained to appropriately stage and debulk ovarian can-
cer, such as a gynecologic oncologist, should perform
the operation. This should be done in a hospital facility
that has the necessary support and consultative services
(eg, frozen section pathology) to optimize the patient’s
outcome. When a malignant ovarian tumor is discov-
ered and the appropriate operation cannot be properly
performed, a gynecologic oncologist should be consulted
intraoperatively if possible.
Surgical Staging
Patients whose comprehensive surgical staging confirms
early-stage disease have a much better prognosis than
those patients who are thought to have early-stage dis-
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 391
 ease but do not undergo comprehensive surgical stag-
ing, presumably because occult metastatic disease was
missed. In the absence of clinically apparent malignant
disease, an intraoperative pathology consultation should
be obtained if cancer remains a concern. If an apparent
early-stage malignancy is present, comprehensive surgical
staging should be performed, preferably during the same
operation. The surgical procedure should include obtain-
ing peritoneal cytology when the abdomen is entered.
The adnexal mass should be removed intact through
an incision that permits thorough staging and surgical
management of the primary tumor and possible sites of
metastasis. The liver, spleen, and all peritoneal surfaces,
including both hemidiaphragms, should be inspected and
palpated. Further staging should include an omentec-
tomy, bilateral pelvic and paraaortic lymphadenectomy,
peritoneal biopsies, removal of the uterus and adnexa,
and removal of any suspicious lesions.
When the cancer appears to be confined to one
ovary, especially if it is low grade, it is appropriate to
modify the staging procedure by leaving the uterus and
the uninvolved ovary in place for younger women who
wish to preserve their fertility.
Conclusions
• Epithelial ovarian cancer is most commonly detected Obstet Gynecol 2009;113:775–82.
in an advanced stage, when the overall 5-year sur-
vival rate is 20–30%.
• Detection of early stage ovarian cancer results in women over 50 years old selected by ovarian cancer screen-
improved survival.
• There is currently no effective strategy for ovarian 12. Tabor A, Jensen FR, Bock JE, Hogdall CK. Feasibility study
cancer screening.
• The obstetrician–gynecologist should be aware that Screen 1994;1:215–9.
there may be symptoms (including increased abdom-
inal size or bloating, abdominal or pelvic pain, or feel-
ing full quickly or difficulty eating) associated with
ovarian cancer that should be investigated.
• Evaluation of the symptomatic patient includes
physical examination and may include transvaginal
ultrasonography and measurement of levels of the
serum tumor marker CA 125.
• When a patient with a suspicious or persistent com-
plex adnexal mass requires surgical evaluation, a
physician trained to appropriately stage and debulk
ovarian cancer, such as a gynecologic oncologist,
should perform the operation.
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17. Skates SJ, Menon U, MacDonald N, Rosenthal AN, Oram DH,
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et al. Diagnostic markers for early detection of ovar-
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21. Greene MH, Feng Z, Gail MH. The importance of test
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Sharma A, et al. Sensitivity and specificity of multimodal
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Screening (UKCTOCS). Lancet Oncol 2009;10:327–40.
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Davies AP, et al. Screening for ovarian cancer: a pilot ran-
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28. Gaarenstroom KN, van der Hiel B, Tollenaar RA, Vink GR,
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(suppl 1):54–9.
29. Olivier RI, Lubsen-Brandsma MA, Verhoef S, van Beurden
M. CA125 and transvaginal ultrasound monitoring in
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high-risk women cannot prevent the diagnosis of advanced
ovarian cancer. Gynecol Oncol 2006;100:20–6.
30. Hereditary breast and ovarian cancer syndrome. ACOG
Practice Bulletin No. 103. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2009;113:957–66.
31. Goff BA, Mandel L, Muntz HG, Melancon CH. Ovarian
carcinoma diagnosis. Cancer 2000;89:2068–75.
32. Goff BA, Mandel LS, Melancon CH, Muntz HG. Frequency
of symptoms of ovarian cancer in women presenting to
primary care clinics. JAMA 2004;291:2705–12.
33. Goff BA, Mandel LS, Drescher CW, Urban N, Gough S,
Schurman KM, et al. Development of an ovarian cancer
symptom index: possibilities for earlier detection. Cancer
2007;109:221–7.
34. Pavlik EJ, Saunders BA, Doran S, McHugh KW, Ueland FR,
Desimone CP, et al. The search for meaning-symptoms
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35. Rossing MA, Wicklund KG, Cushing-Haugen KL, Weiss NS.
Predictive value of symptoms for early detection of ovarian
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Newsroom/PressAnnouncements/ucm182057.htm.
Retrieved November 4, 2010.
Copyright March 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
The role of the obstetrician–gynecologist in the early detection of epi-
thelial ovarian cancer. Committee Opinion No. 477. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2011;117:742–6.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 393
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 482 • March 2011
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Colonoscopy and Colorectal Cancer Screening

Strategies
ABSTRACT: Each year colorectal cancer is diagnosed in more women than all types of gynecologic cancer
combined. There continues to be a significant need to increase the rate of screening. Obstetrician–gynecologists
have a unique opportunity to increase colorectal cancer screening rates among their patients and, thus, favorably
affect colorectal cancer morbidity and mortality. Health care providers should counsel patients about the benefits
of colorectal cancer screening and recommend colonoscopy every 10 years for either average-risk or high-risk
women 50 years and older. The advantages and limitations of other appropriate colorectal cancer screening meth-
ods also should be discussed so that women may choose to be tested by whichever method they are most likely
to accept and complete.

More than 70,000 women develop colorectal cancer in
the United States each year. Colorectal cancer is diag-
nosed in more women than all types of gynecologic
cancer combined. Each year, more than 24,000 women
die from colorectal cancer, making it the third leading
cause of cancer death in women, after lung cancer and
breast cancer (1). Despite consensus among health care
organizations about the value of screening for colorectal
cancer, a recent study reported that approximately 63%
of respondents (U.S. women older than 50 years) have
been screened by colonoscopy or sigmoidoscopy in the
past 10 years or fecal occult blood test within the past year
(2). The primary goal of colorectal cancer screening is to
reduce mortality through the reduction of advanced dis-
ease. The detection of early-stage adenocarcinomas and
the detection and removal of adenomatous polyps can be
achieved by colorectal cancer screening (3). The purpose
of this document is to review the available methods and
recommended screening guidelines to enable the obstetri-
cian–gynecologist to appropriately and adequately coun-
sel patients about colorectal cancer screening.
Prospective randomized trials have demonstrated
reductions in mortality associated with early detection of
colorectal cancer, as well as with removal of adenoma-
tous polyps. There continues to be a significant need to
increase the rate of screening, although the screening rates
in the target population of adults older than 50 years have
increased from 20–30% in 1997 to nearly 55% in 2008
(4). It is critical that physicians’ practices establish mecha-
nisms to ensure that every eligible patient will receive a
screening recommendation. It has been calculated that if
90% of the population were screened as recommended,
310,000 lifetime quality-adjusted life years would be saved
(5). However, screening tests are underused for many seg-
ments of the population. They also are ordered in a man-
ner inconsistent with guidelines because many physicians
continue to recommend that screening begin before 50
years of age or be repeated at too frequent intervals (6).
Screening Guidelines
The American College of Obstetricians and Gynecologists
(the College) recommends colonoscopy for colorectal
cancer screening for average-risk women beginning at
age 50 years. Other organizations recommend colorec-
tal cancer screening, but their recommendations may
differ slightly from College guidelines. For example,
the U.S. Preventive Services Task Force recommends
screening for colorectal cancer using serial fecal occult
blood testing, flexible sigmoidoscopy, or colonoscopy
in adults at age 50 years and continuing until age 75
years. The U.S. Preventive Services Task Force recom-
mends against screening for colorectal cancer in adults

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 394

 older than 85 years and recommends against routine
screening in adults 75–85 years; however, there may be
considerations that support colorectal cancer screening
in an individual patient (7). The American College of
Gastroenterology recommends that African Americans
begin screening at age 45 years with colonoscopy (8).
For women at increased risk, screening and surveillance
guidelines also have been published (see http://caonline.
amcancersoc.org/cgi/content-nw/full/58/3/130/T3). Like
the joint guideline from the American Cancer Society, the
U.S. Multi-Society Task Force on Colorectal Cancer, and
the American College of Radiology, the College’s recom-
mendations recognize “the complexity of offering mul-
tiple screening options and the degree to which the range
of screening options and their performance, costs, and
demands on individuals poses a significant challenge for
shared decisions” (3). The College has developed practi-
cal guidance for the generalist obstetrician–gynecologist
by recommending colonoscopy as the preferred method
of screening because it allows for a full examination of
both the colon and rectum in one session, and allows
the practitioner to perform a biopsy or polypectomy, if
indicated.
Colorectal cancer screening methods should be dis-
cussed with patients to identify the method they are most
likely to accept and complete. Understanding the advan-
tages and limitations of each screening method is neces-
sary to adequately counsel women. Tests that detect both
adenomatous polyps and early colorectal cancer, such as
colonoscopy, should be encouraged. However, all meth-
ods described in this Committee Opinion are acceptable
options to screen for colorectal cancer. Abnormalities
found with any other screening method necessitate refer-
ral for diagnostic colonoscopy. Every screening method
has advantages and limitations, which ultimately depends
on the quality of the screening test, patient adherence,
and access to timely and appropriate follow-up.
Additionally, increased sensitivity by health care pro-
viders to patients’ behaviors, feelings, cultural differences,
and attitudes can result in increased patient and health
care provider satisfaction.
Tests for the Detection of Adenomas
and Colorectal Polyps
Colonoscopy
Colonoscopy allows for the mucosal inspection of the
entire colon from the dentate line to the appendiceal
orifice and is recommended every 10 years beginning
at age 50 years. Colonoscopy gives access to right-sided
lesions, which comprise a considerable proportion (65%)
of advanced colorectal neoplasia in women that would be
missed by other screening methods, such as sigmoidos-
copy (9). Data indicate that colonoscopy seems to offer
lower protection for the proximal colon than for the
distal colon (10), although a recent population-based,
case–control study suggests that the procedure is associ-
2 Committee Opinion No. 482
COMMITTEE OPINIONS
ated with risk reduction in both the right and the left side
of the colon (11). In one study, it was shown that the
incidence of colorectal cancer was reduced by 76–90%
among individuals undergoing colonoscopy with polyp-
ectomy compared with individuals in a general popula-
tion registry (12).
Although colonoscopy remains the standard method
for detecting colorectal pathology, the miss rate for
adenomas measuring 10 mm or more is 6–12% (13) and
for cancer it is approximately 5% (14). Other limitations
of colonoscopy include cost, dietary preparation for
the procedure, inconvenience of the bowel preparation
required of the patient, the necessity of a chaperone for
transportation because of sedation, and the risk of serious
complications. One study found 2.8 serious complica-
tions (including perforations, hemorrhage, diverticulitis,
cardiovascular events, severe abdominal pain, and death)
per 1,000 procedures (confidence interval, 1.5–5.2 per
1,000 procedures; test for heterogeneity; P=0.13) (15).
The effectiveness of the colonoscopy is dependent
upon the thoroughness of the bowel preparation and the
skill of the endoscopist. The endoscopist should have the
ability to sample or remove precancerous lesions (16).
Quality indicators for colonoscopy have been established,
and include appropriate indication, informed consent,
use of recommended postpolypectomy and postcancer
resection surveillance intervals, the use of recommended
ulcerative colitis and Crohn colitis surveillance, and
preparation (17).
Flexible Sigmoidoscopy
Flexible sigmoidoscopy, a test involving the insertion of
a thin, flexible tube into the rectum, is associated with a
60–80% reduction in colorectal mortality for the area
of the colon within its reach. This protective effect of
a reduction in the incidence of distal colorectal cancer
persists for up to 16 years (18). The recommended inter-
val between normal flexible sigmoidoscopy with depth
of insertion to 40 cm or to the splenic flexure is every
5 years. Two large screening studies indicate that if a
patient has an adenoma of any size in the distal colon, she
has a twofold or higher risk of proximal advanced neo-
plasia compared with patients with hyperplasic polyps or
no polyps in the distal colon (19, 20). Flexible sigmoid-
oscopy is technically easier, requires less preparation, can
be performed without sedation, and has a lower risk of
complications compared with colonoscopy. However,
it is limited to examining the most distal portion of
the colon and will miss a significant number of right-
sided colonic lesions, particularly in women and African
Americans (21, 9). Positive findings usually will require
referral for colonoscopy. Because of these limitations, the
combination of yearly fecal occult blood testing or fecal
immunochemical testing (see “Tests for the Detection of
Colorectal Cancer”) with flexible sigmoidoscopy every 5
years with high-sensitivity fecal occult blood testing every
3 years may be preferable to either method alone (22).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 395
 Double Contrast Barium Enema
Double contrast barium enema enables examination of
the entire colon and is associated with low risk. Complete
bowel preparation is essential for an optimal examina-
tion. This test has substantially lower sensitivity than
other modern test strategies and is not recommended by
the U.S. Preventive Services Task Force. However, this
procedure remains an option in cases in which colonos-
copy resources are low or colonoscopy is contraindicated
or less likely to be successful (eg, prior incomplete colo-
noscopy or prior pelvic surgery). Any individuals with
a polyp measuring 6 mm or more on double contrast
barium enema should undergo a follow-up colonoscopy.
Tests for the Detection of Colorectal
Cancer
High-sensitivity guaiac fecal occult blood testing and fecal
immunochemical testing (FIT) are noninvasive tests that
detect occult blood in the stool from large polyps (greater
than 1 cm) or cancer disrupting the mucosal barrier (3).
Fecal immunochemical testing specifically detects lower-
tract bleeding (23). Three large prospective randomized
control trials have shown that screened patients have
cancer detected at an early and more curable stage than
unscreened patients (3). Colorectal cancer screening with
fecal occult blood testing or fecal immunochemical test-
ing should be performed on an annual basis. Fecal blood
testing requires three consecutive samples of stool. The
optimal number of fecal immunochemical testing sam-
ples is unclear, but two samples may be superior to one.
Fecal occult blood testing of a single stool sample from a
rectal examination performed during an office visit is not
adequate for the detection of colorectal cancer and should
not be performed. In one study, the sensitivity of a single
stool sample for fecal occult blood testing obtained dur-
ing an office visit by digital rectal examination was 4.9%,
compared with 23.9% for the recommended at-home
fecal occult blood testing series (24).
Before testing with guaiac fecal occult blood test-
ing, patients should be instructed on the appropriate
dietary restrictions (see Table 1) and to avoid the use of
all noncardioprotective nonsteroidal drugs. Fecal immu-
nochemical testing detects human globulin, which is a
protein that along with heme constitutes human hemo-
globin (3) and, therefore, does not require changes in diet
or medication before testing.
Although fecal occult blood testing and fecal immu-
nochemical testing are the least invasive colorectal cancer
screening methods, they have limitations. For example,
both of these methods require samples obtained by the
patient at home using a kit that must be returned for
analysis. Another limitation of these tests is poor-quality
screening practices, which may be affecting mortality
rates (25). These tests often are distributed sporadically

Table 1. Guidelines for Screening for the Early Detection of Colorectal Cancer and Adenomas for Average-Risk Women and
Men Aged 50 Years and Older*

Tests That Detect Adenomatous Polyps and Cancer

Test Interval Key Issues for Informed Decisions

Colonoscopy Every 10 years • Complete bowel preparation is required

Flexible sigmoidoscopy
with insertion to 40 cm or to
splenic flexure
Double contrast barium enema
• Conscious sedation is used in most centers; patients will miss a day of work
and will need a chaperone for transportation from the facility
• Risks include perforation, bleeding, and death, which are rare but potentially
serious; most of the risk is associated with polypectomy
Every 5 years • Complete or partial bowel preparation is required
• Sedation usually is not used, so there may be some discomfort during the
procedure
• The protective effect of sigmoidoscopy is primarily limited to the portion of the
colon examined
• Patients should understand that positive findings on sigmoidoscopy usually result
in a referral for colonoscopy
Every 5 years • Complete bowel preparation is required
• If patients have one or more polyps larger than 6 mm, colonoscopy will be
recommended; follow-up colonoscopy will require complete bowel preparation
• Risks of DCBE are very low; rare cases of perforation have been reported
• Use is dependent upon the availability of facilities with the expertise to perform
and interpret the study
(continued)

Committee Opinion No. 482 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 396

 Table 1. Guidelines for Screening for the Early Detection of Colorectal Cancer and Adenomas for Average-Risk Women and
Men Aged 50 Years and Older* (continued)

Tests That Detect Adenomatous Polyps and Cancer

Test Interval Key Issues for Informed Decisions

Computed tomography Every 5 years • Complete bowel preparation is required

colonography • If patients have one or more polyps larger than 6 mm, colonoscopy will be
recommended; if same day colonoscopy is not available, a second complete
bowel preparation will be required before colonoscopy
• Risks of CTC are very low; rare cases of perforation have been reported
• Significance of incidental extracolonic findings not clear
• Increased lifetime, cumulative radiation risk needs further evaluation

Tests That Primarily Detect Cancer

Test Interval Key Issues for Informed Decisions

gFOBT with high sensitivity Annual • Depending on manufacturer’s recommendations, two to three stool samples
for cancer collected at home are needed to complete testing; a single sample of stool
gathered during a digital exam in the clinical setting is not an acceptable stool
test and should not be done
FIT with high sensitivity for Annual • Positive test results are associated with an increased risk of colon cancer and
cancer advanced neoplasia; colonoscopy should be recommended if the test results
are positive
• If the test result is negative, the test should be repeated annually
• Patients should understand that one-time testing is likely to be ineffective
sDNA with high sensitivity Interval uncertain • An adequate stool sample must be obtained and packaged with appropriate
for cancer preservative agents for shipping to the laboratory
• The unit cost of the currently available test is significantly higher than other
forms of stool testing
• If the test result is positive, colonoscopy will be recommended
• If the test result is negative, the appropriate interval for a repeat test is uncertain
Abbreviations: CTC, computed tomography colonography; DCBE, double-contrast barium enema; FIT, fecal immunochemical test; gFOBT, guaiac-based fecal occult blood test;
sDNA, stool DNA test.
*These options are acceptable choices for colorectal cancer screening in average-risk adults beginning at age 50 years. Because each of these tests has inherent characteristics
related to prevention potential, accuracy, costs, and potential harms, individuals should have an opportunity to make an informed decision when choosing one of these options.
In the opinion of the Guidelines Development Committee (of the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College
of Radiology), colon cancer prevention should be the primary goal of colorectal cancer screening. Tests that are designed to detect both early cancer and adenomatous pol-
yps should be encouraged if resources are available and patients are willing to undergo an invasive test.
Modified from Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, et al. Screening and surveillance for the early detection of colorectal cancer and adeno-
matous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA
Cancer J Clin. 2008 May-Jun;58(3):130-60. This material is reproduced with permission of John Wiley & Sons, Inc.

and always in the context of a visit because a system or Developing Technologies

program of screening is not being used. Health care pro-
viders should understand that guaiac fecal occult blood
testing and fecal immunochemical testing are less likely
to detect cancer compared with the invasive tests, guaiac
fecal occult blood testing and fecal immunochemical test-
ing must be repeated at regular intervals to be effective,
and positive test results with guaiac fecal occult blood
testing or fecal immunochemical testing require a diag-
nostic workup with colonoscopy to examine the entire
colon.
Virtual Colonoscopy
A noninvasive method of colorectal cancer screening
currently being evaluated is computed tomography colo-
nography or virtual colonoscopy (see Table 1). Virtual
colonoscopy requires bowel preparation similar to colo-
noscopy. In randomized trials, virtual colonoscopy has
shown 39% sensitivity and 90.5% specificity in detect-
ing lesions of at least 6 mm. (26). The potential harm
from evaluation of incidental extracolonic findings and

4 Committee Opinion No. 482

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 397

 the lifetime cumulative radiation risk must be evalu-
ated. Because computed tomography colonography is
an imaging examination, screening programs should
consider offering same-day colonoscopy to eliminate a
second bowel preparation for the patient. Radiologists
experienced in the evaluation of this modality may not be
widely available. This test is not currently recommended
4.
by the U.S. Preventive Services Task Force.
Fecal DNA Testing
Fecal DNA testing detects genetic mutations associated
with colorectal cancer. Adenoma and carcinoma cells that 5.
contain neoplastic changes are shed into the lumen of
the large bowel and eliminated with feces. Because there
is no single gene mutation present in the cells of every
adenoma or adenocarcinoma, a multitargeted DNA assay 6.
is necessary. Because DNA is stable in stool, it can be
isolated from bacterial DNA found in feces. Fecal DNA
testing requires only a single stool sample. There is no
direct risk to the colon, no bowel preparation is neces- 7.
sary, there are no pretest dietary modifications, and the
sampling is performed at home. In a recent prospective
randomized trial, the fecal DNA test was found to be 8.
more sensitive than fecal occult blood testing in detect-
ing both precancerous and cancerous colonic lesions in
individuals at average risk of developing colorectal cancer
(27). Fecal DNA tests are evolving, and no test is widely
used; however, these tests have the potential to be highly
specific tests. This test is not currently recommended by 9.
the U.S. Preventive Services Task Force.
Conclusions and Recommendations
• Colorectal screening methods should be discussed 10.
with patients to identify the method they are most
likely to accept and complete.
11.
• Tests that detect both early colorectal cancer and Hoffmeister M. Protection from colorectal cancer after
adenomatous polyps should be encouraged.
• Abnormalities found with any other screening meth-
ods necessitate referral for diagnostic colonoscopy. 12.
• In-office single stool guaiac fecal occult blood testing Sternberg SS, et al. Prevention of colorectal cancer by
or digital rectal examination for colorectal cancer
screening should not be performed.
• Every screening method has advantages and limita- 13.
tions, which ultimately depends on the quality of
the screening test, patient adherence, and access to
timely and appropriate follow-up. 14.
References
15.
1. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA
Cancer J Clin 2010;60:277–300.
2. Vital signs: colorectal cancer screening among adults aged
50 –75 years—United States, 2008. Centers for Disease 16.
Control and Prevention (CDC). MMWR Morb Mortal
Wkly Rep 2010;59:808–12.
3. Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks
D, Bond J, et al. Screening and surveillance for the early
Committee Opinion No. 482
COMMITTEE OPINIONS
detection of colorectal cancer and adenomatous polyps,
2008: a joint guideline from the American Cancer Society,
the US Multi-Society Task Force on Colorectal Cancer,
and the American College of Radiology. American Cancer
Society Colorectal Cancer Advisory Group; US Multi-
Society Task Force; American College of Radiology Colon
Cancer Committee. Gastroenterology 2008;134:1570–95.
Steinwachs D, Allen JD, Barlow WE, Duncan RP, Egede LE
Friedman LS, et al. National Institutes of Health state-of-
the-science conference statement: Enhancing use and qual-
ity of colorectal cancer screening. Ann Intern Med 2010;
152:663–7.
Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ,
Goodman MJ, Solberg LI. Priorities among effective clini-
cal preventive services: results of a systematic review and
analysis. Am J Prev Med 2006;31:52–61.
Klabunde CN, Lanier D, Nadel MR, McLeod C, Yuan G,
Vernon SW. Colorectal cancer screening by primary care
physicians: recommendations and practices, 2006-2007.
Am J Prev Med 2009;37:8–16.
Screening for colorectal cancer: U.S. Preventive Services
Task Force recommendation statement. U.S. Preventive
Services Task Force. Ann Intern Med 2008;149:627–37.
Agrawal S, Bhupinderjit A, Bhutani MS, Boardman L,
Nguyen C, Romero Y, et al. Colorectal cancer in African
Americans. Committee of Minority Affairs and Cultural
Diversity, American College of Gastroenterology [published
erratum appears in Am J Gastroenterol 2005;100:1432]. Am
J Gastroenterol 2005;100:515–23; discussion 514.
Schoenfeld P, Cash B, Flood A, Dobhan R, Eastone J, Coyle W,
et al. Colonoscopic screening of average-risk women for
colorectal neoplasia. CONCeRN Study Investigators. N
Engl J Med 2005;352:2061–8.
Baxter NN, Rabeneck L. Is the effectiveness of colonos-
copy “good enough” for population-based screening? J Natl
Cancer Inst 2010;102:70–1.
Brenner H, Chang-Claude J, Seiler CM, Rickert A,
colonoscopy: a population-based, case–control study. Ann
Intern Med 2011;154:22–30.
Winawer SJ, Zauber AG, Ho MN, O’Brien MJ, Gottlieb LS,
colonoscopic polypectomy. The National Polyp Study
Workgroup. N Engl J Med 1993;329:1977–81.
Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR, Schindler
WR. Location of adenomas missed by optical colonoscopy.
Ann Intern Med 2004;141:352–9.
Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L.
Colonoscopic miss rates for right-sided colon cancer: a pop-
ulation-based analysis. Gastroenterology 2004;127:452–6.
Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for
colorectal cancer: a targeted, updated systematic review for
the U.S. Preventive Services Task Force. Ann Intern Med
2008;149:638–58.
Lieberman D, Nadel M, Smith RA, Atkin W, Duggirala SB,
Fletcher R, et al. Standardized colonoscopy reporting and
data system: report of the Quality Assurance Task Group
of the National Colorectal Cancer Roundtable. Gastrointest
Endosc 2007;65:757–66.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 398
 17. Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE,
et al. Quality indicators for colonoscopy. Gastrointest
Endosc 2006;63(4 suppl):S16–28.
18. Newcomb PA, Storer BE, Morimoto LM, Templeton A,
Potter JD. Long-term efficacy of sigmoidoscopy in the
reduction of colorectal cancer incidence. J Natl Cancer Inst
2003;95:622–5.
19. Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD,
Ransohoff DF. Risk of advanced proximal neoplasms in
asymptomatic adults according to the distal colorectal find-
ings. N Engl J Med 2000;343:169–74.
20. Lieberman DA, Weiss DG. One-time screening for
colorectal cancer with combined fecal occult-blood testing
and examination of the distal colon. Veterans Affairs Coop-
erative Study Group 380. N Engl J Med 2001;345:555–60.
21. Nelson RL, Dollear T, Freels S, Persky V. The relation of
age, race, and gender to the subsite location of colorectal
carcinoma. Cancer 1997;80:193–7.
22. Smith RA, Cokkinides V, Eyre HJ. American Cancer
Society guidelines for the early detection of cancer, 2006.
CA Cancer J Clin 2006;56:11–25; quiz 49–50.
23. Allison JE. Colon Cancer Screening Guidelines 2005: the
fecal occult blood test option has become a better FIT.
Gastroenterology 2005;129:745–8.
24. Collins JF, Lieberman DA, Durbin TE, Weiss DG. Accuracy
of screening for fecal occult blood on a single stool sam-
ple obtained by digital rectal examination: a comparison
with recommended sampling practice. Veterans Affairs
6 Committee Opinion No. 482
COMMITTEE OPINIONS
Cooperative Study #380 Group. Ann Intern Med 2005;
142:81–5.
25. Nadel MR, Shapiro JA, Klabunde CN, Seeff LC, Uhler R,
Smith RA, et al. A national survey of primary care physi-
cians’ methods for screening for fecal occult blood. Ann
Intern Med 2005;142:86–94.
26. Cotton PB, Durkalski VL, Pineau BC, Palesch YY, Mauldin
PD, Hoffman B, et al. Computed tomographic colonogra-
phy (virtual colonoscopy): a multicenter comparison with
standard colonoscopy for detection of colorectal neoplasia.
JAMA 2004;291:1713–9.
27. Imperiale TF, Ransohoff DF, Itzkowitz SH, Turnbull BA,
Ross ME. Fecal DNA versus fecal occult blood for colorectal-
cancer screening in an average-risk population. Colorectal
Cancer Study Group. N Engl J Med 2004;351:2704–14.
Copyright March 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Colonoscopy and colorectal cancer screening strategies. Committee
Opinion No. 482. American College of Obstetricians and Gynecologists.
Obstet Gyencol 2011;117:766–71.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 399
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 484 • April 2011
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Performance Enhancing Anabolic Steroid Abuse

in Women
ABSTRACT: Anabolic steroids are composed of testosterone and other substances related to testosterone that
promote growth of skeletal muscle, increase hemoglobin concentration, and mediate secondary sexual characteris-
tics. These substances have been in use since the 1930s to promote muscle growth, improve athletic performance,
and enhance cosmetic appearance. Although anabolic steroids are controlled substances, only to be prescribed by
a physician, it is currently possible to obtain anabolic steroids illegally without a prescription. There are significant
negative physical and psychologic effects of anabolic steroid use, which in women can cause significant cosmetic
and reproductive changes. Anabolic steroid use can be addictive and, therefore, difficult to stop. Treatment for
anabolic steroid abuse generally involves education, counseling, and management of withdrawal symptoms. Health
care providers are encouraged to address the use of these substances, encourage cessation, and refer patients
to substance abuse treatment centers to prevent the long-term irreversible consequences of anabolic steroid use.

History on Drug Abuse estimates that approximately 1 million

Anabolic steroids were first discovered to promote muscle
growth and enhance athletic performance in the 1930s.
Since the 1950s, these substances have been used by body
builders, athletes, and others to improve performance and
enhance cosmetic appearance. In 1975, the International
Olympic Committee first banned the use of anabolic ste-
roids. Now most athletic organizations prohibit the use
of these substances, and drug testing has become routine
in professional sports (1). A growing awareness of steroid
abuse also has led to federal regulation of these substances.
Anabolic steroids were first classified as schedule III con-
trolled substances in 1990, and in 2004, a new law expand-
ed the definition of anabolic steroids to include substances
that could be converted to testosterone, such as andro-
stenedione (2). Current clinical uses of these substances
in women include libido disorders, cachexia related to
chronic disease such as human immunodeficiency virus
(HIV), and anemia. Clinical use requires a prescription
from a licensed physician and close observation (3).
Prevalence
Although the exact prevalence of anabolic steroid use is
not known, data from the National Household Survey
individuals in the United States are current or former
anabolic steroid users, and that more than 300,000 indi-
viduals use these substances annually (4). The 2009 Youth
Risk Behavior Surveillance Study evaluated more than
16,400 high-school adolescents and reported a lifetime
prevalence of use of 2.2% in girls (5).
Risk Factors of Abuse
Pressure to perform well is pervasive throughout amateur
and professional athletics and can lead some individuals
to pursue unsafe and illegal means to enhance perfor-
mance. Anabolic steroids have been shown to improve
athletic performance by increasing muscle strength and
aggressiveness (1). Another motivation to take anabolic
steroids is to improve physical appearance because these
substances increase muscle size and reduce body fat.
Factors that predict anabolic steroid use in teenagers
include perceived social pressure to increase muscular-
ity, depression, and a negative body image. In addition,
steroid users are more likely to have participated in high-
school sports, used other illicit substances, and engaged
in other risky behaviors. Individuals are likely to begin
steroid use in their late teenaged years and 20s.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 400

 Types of Substances
Anabolic steroids are composed of testosterone and
other substances related to testosterone that promote
growth of skeletal muscle, increase hemoglobin concen-
tration, and mediate secondary sexual characteristics.
Supraphysiologic doses of testosterone, which result in
serum testosterone levels 10–100 times the normal level,
are required to have the desired cosmetic and athletic
effect (6, 7). Because oral and injectable testosterone is
inactive, testosterone esters and ethers have been devel-
oped to enhance bioavailability when administered intra-
muscularly, transdermally, and orally (Box 1).
Polypharmacy and drug cycling (starting and stop-
ping) and use of new preparations with very short half-lives
are common among steroid abusers to evade detection of
these substances during drug testing. Although anabolic
steroids are controlled substances, only to be prescribed
by a physician, it is currently possible to obtain anabolic
steroids illegally without a prescription. Some dietary and
body building supplements sold over the Internet are mis-
labeled and can contain anabolic steroids. Alternatively,
these substances are imported and sold illegally.
Other Drugs of Abuse
Other substances, not considered anabolic steroids,
are also inappropriately used for cosmetic and athletic
enhancement purposes. Some of these substances include
danazol, dehydroepiandrosterone sulfate, growth hor-
mone, human chorionic gonadotropin, insulin, and levo-
thyroxine. These medications are more easily obtained
because they are not considered controlled substances.
Some medications, such as dehydroepiandrosterone sul-
fate, are considered dietary supplements and can be
purchased over the counter. These preparations can have
serious risks when used for nonmedical purposes, some
of which may be similar to those of anabolic steroids.
As previously noted, many dietary supplements actually
contain anabolic steroids even though the labeling does
not reflect this. It is important to recognize and inform
patients that dietary supplements do not require close
government regulation (8). More information on ana-
bolic steroids is available at http://www.usada.org/.
Adverse Effects
There are significant negative physical and psychologic
effects of anabolic steroid use. Anabolic steroid use in
women can cause significant cosmetic and reproduc-
tive changes (see Box 2). In addition, these substances
can have a negative effect on serum lipid parameters,
liver function (particularly with 17-methylated steroids),
glucose tolerance, and they can significantly increase the
risk of cardiovascular disease and thrombotic events,
including venous thromboembolism, stroke, and myo-
cardial infarction (9). Anabolic steroid use during preg-
nancy may cause virilization of a female fetus. Psychologic
effects include irritability, hostility, mood changes, per-
2 Committee Opinion No. 484
COMMITTEE OPINIONS
Box 1. Types of Steroid Preparations to
Enhance Bioavailability
Oral Preparations
Fluoxymesterone
Mesterolone
Methandienone
Methyltestosterone
Mibolerone
Oxandrolone
Oxymetholone
Stanozolol
Dihydrotestosterone
Androstenedione
Intramuscular Preparations
Boldenone undecylenate
Methenolone enanthate
Nandrolone decanoate
Nandrolone phenpropionate
Testosterone cypionate
Testosterone enanthate
Testosterone propionate
Trenbolone acetate
sonality changes, and psychosis (2). Changes in the
biomechanics of limb movements caused by use of
anabolic steroids also can lead to tendon injuries. Use of
unsanitary needles and sharing needles puts users at risk
of infections such as hepatitis, HIV, and intramuscular
abscesses (10). Some of these health risks are irreversible.
Anabolic steroid use can be addictive and, therefore,
difficult to stop. There is evidence that more than 50%
of users develop psychologic dependence to these sub-
stances. Data show that anabolic steroid use in women is
accompanied by extreme dissatisfaction with body image
and a body dysmorphic syndrome similar to anorexia.
Such women engage in rigid eating and exercise sched-
ules that can impair social and occupational functioning
(11).
Drug Testing
Although most anabolic steroids can be detected with
urine testing kits available commercially, testing for natu-
rally occurring and novel compounds may be difficult.
Urine screening for drug use in adolescents without the
adolescent’s prior informed consent is not recommended
(12).
Treatment
Treatment for anabolic steroid abuse generally involves
education, counseling, and management of withdrawal
symptoms. Individuals suspected of abusing anabolic ste-
roids should be referred to physicians with experience in
this area or to drug treatment centers. Treatment centers
2013 COMPENDIUM OF SELECTED PUBLICATIONS 401
 4. Yesalis CE, Kennedy NJ, Kopstein AN, Bahrke MS.
Box 2. Signs of Anabolic Steroid Anabolic-androgenic steroid use in the United States. JAMA
Abuse in Women 1993;270:1217–21.
5. Eaton DK, Kann L, Kinchen S, Shanklin S, Ross J, Hawkins J,
Acne et al. Youth risk behavior surveillance – United States,
Hirsutism 2009. Centers for Disease Control and Prevention (CDC).
Deepening of the voice MMWR Surveill Summ 2010;59(SS-5):1–142.
Male pattern balding 6. Shahidi NT. A review of the chemistry, biological action,
Clitoromegaly and clinical applications of anabolic-androgenic steroids.
Breast atrophy Clin Ther 2001;23:1355–90.
Irregular menstrual cycles 7. Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B,
Infertility Phillips J, et al. The effects of supraphysiologic doses of
Significant muscle growth testosterone on muscle size and strength in normal men.
Depression N Engl J Med 1996;335:1–7.
Mood instability 8. U.S. Food and Drug Administration. Dietary supplements.
Available at http://www.fda.gov/Food/DietarySupplements/
default.htm. Retrieved December 20, 2010.
9. Parssinen M, Kujala U, Vartiainen E, Sarna S, Seppala T.
may be located through the National Institute on Drug Increased premature mortality of competitive powerlifters
Abuse at http://findtreatment.samhsa.gov. suspected to have used anabolic agents. Int J Sports Med
2000;21:225–7.
Recommendations 10. Rich JD, Dickinson BP, Feller A, Pugatch D, Mylonakis E.
• Have information about the risks and deleterious The infectious complications of anabolic-androgenic ste-
effects of abusing anabolic steroids available to roid injection. Int J Sports Med 1999;20:563–6.
patients, especially teenagers and athletes. 11. Gruber AJ, Pope HG Jr. Psychiatric and medical effects
• Address the use of these substances, encourage cessa- of anabolic-androgenic steroid use in women. Psychother
tion, and refer patients to substance abuse treatment Psychosom 2000;69:19–26.
centers to prevent the long-term irreversible conse- 12. American College of Obstetricians and Gynecologists.
quences of anabolic steroid use. Tool Kit for Teen Care, Second Edition. Washington, DC:
American College of Obstetricians and Gynecologists; 2010.
References
1. Franke WW, Berendonk B. Hormonal doping and andro-
genization of athletes: a secret program of the German Copyright April 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
Democratic Republic government. Clin Chem 1997;43: DC 20090-6920. All rights reserved. No part of this publication may
1262–79. be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
2. Kanayama G, Hudson JI, Pope HG Jr. Long-term psychiat- cal, photocopying, recording, or otherwise, without prior written per-
ric and medical consequences of anabolic-androgenic ste- mission from the publisher. Requests for authorization to make
roid abuse: a looming public health concern? Drug Alcohol photocopies should be directed to: Copyright Clearance Center, 222
Depend 2008;98:1–12. Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

3. Basaria S, Wahlstrom JT, Dobs AS. Clinical review 138: ISSN 1074-861X
Anabolic-androgenic steroid therapy in the treatment Performance enhancing anabolic steroid abuse in women. Com-
of chronic diseases. J Clin Endocrinol Metab 2001;86: mittee Opinion No. 484. American College of Obstetricians and Gyne-
5108–17. cologists. Obstet Gynecol 2011;117:1016–18.

Committee Opinion No. 484 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 402

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 489 • May 2011 (Replaces No. 332, May 2006)
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Hepatitis B, Hepatitis C, and Human Immunodeficiency

Virus Infections in Obstetrician–Gynecologists
ABSTRACT: In the health care setting, bloodborne pathogens such as the hepatitis B virus (HBV), hepatitis C
virus, and human immunodeficiency virus (HIV) may be transmitted from infected patients to health care workers
as well as from infected health care workers to patients. To reduce the risk of transmission, all practicing obste-
trician–gynecologists should receive the HBV vaccine. Obstetrician–gynecologists infected with HBV, hepatitis C
virus, or HIV are advised to follow the updated Society for Healthcare Epidemiology of America’s recommenda-
tions, regarding infection-control measures, supervision, and periodic testing. These recommendations provide
a framework within which to consider such cases; however, each case should be independently considered in
context by the expert review panel.

Experts agree that the risk of transmission of the hepati-
tis B virus (HBV), hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) from an infected health
care provider to a patient during the provision of routine
health care that does not involve invasive procedures, and
with the institution of universal precautions, is negligible
(1). With invasive procedures, these risks remain quite
small but are clearly increased when compared with rou-
tine patient care activities. Therefore, clinical activities of
infected health care providers should include risk assess-
ment based on these factors. To prevent transmission of
bloodborne pathogens, it is important that health care
workers adhere to standard precautions, follow funda-
mental infection control principles, and use appropri-
ate procedural techniques. The Society for Healthcare
Epidemiology of America has established guidelines for
the management of health care providers who are infected
with HBV, HCV, or HIV (1). This Committee Opinion
focuses on these recommendations as they may relate to
the practicing obstetrician–gynecologist. Categorization
of representative obstetric and gynecologic procedures
according to level of risk of bloodborne pathogen trans-
mission is shown in Box 1. Recommendations for health
care provider clinical activities, based on these categories
and viral burden, are summarized in Table 1. It is impor-
tant to note that when no restrictions are recommended,
careful supervision should be carried out as highlighted in
the footnoted section of Table 1. These recommendations
provide a framework within which to consider such cases;
however, each case should be independently considered
in context by the expert review panel.
Expert Review Panel
The creation of an expert review panel is an important
component of the Society for Healthcare Epidemiology
of America’s recommendations (1). The expert review
panel counsels infected clinicians about continued prac-
tice, advising health care providers under what circum-
stances, if any, they may continue to perform procedures.
According to the Society for Healthcare Epidemiology of
America’s guidelines, the expert review panel should be a
locally convened panel of experts representing a variety
of perspectives and may include the following: the obste-
trician–gynecologist’s personal physician, an infectious
disease specialist with expertise in disease transmission, a
health care professional with expertise in the procedures
performed by the obstetrician–gynecologist, state or local
public health official(s), and a hospital epidemiologist or
other member of the infection-control committee of the
hospital (1). The panel follows up on the health care pro-
vider’s clinical status, via sanctioned communication with
his or her personal physician; and outlines the health care

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 403

 Box 1. Categorization of Obstetric–Gynecologic Procedures According to
Level of Risk of Bloodborne Pathogen Transmission

Category I: Procedures with negligible (de minimis) risk of bloodborne virus transmission
• Regular history taking and physical examinations
• Routine rectal or vaginal examination
• Minor surface suturing
• Elective peripheral phlebotomy*
• Lower gastrointestinal tract endoscopic examinations and procedures, such as sigmoidoscopy
• Hands-off supervision during surgical procedures and computer-aided remote or robotic surgical procedures
Category II: Procedures for which bloodborne virus transmission is theoretically possible but unlikely
• Minor local procedures (eg, skin excision, abscess drainage, biopsy, and use of laser) under local anesthesia
(often under bloodless conditions)
• Insertion and maintenance of epidural and spinal anesthesia lines
• Minor gynecologic procedures (eg, dilation and curettage, suction abortion, colposcopy, insertion and removal of
contraceptive devices, and collection of ova)
• Minor vascular procedures (eg, vein stripping)
• Minimum-exposure plastic surgical procedures (eg, liposuction and minor skin resection for reshaping)
• Assistance with an anticipated uncomplicated vaginal delivery†
• Laparoscopic procedures‡
• Insertion of, maintenance of, and drug administration into arterial and central venous lines
• Endotracheal intubation and use of laryngeal mask
• Obtainment and use of venous and arterial access devices that occur under complete antiseptic technique, using universal
precautions, no-sharp technique, and newly gloved hands
Category III: Procedures for which there is a definite risk of bloodborne virus transmission or that have been classified
as exposure prone
• Nonelective procedures performed in the emergency department, including open resuscitation efforts and deep suturing to
arrest hemorrhage
• Obstetric–gynecologic surgery, including cesarean delivery, hysterectomy, forceps delivery, episiotomy, cone biopsy, and
ovarian cyst removal, and other transvaginal obstetric and gynecologic procedures involving hand-guided sharps
• Extensive plastic surgery, including extensive cosmetic procedures (eg, abdominoplasty)
• Interactions with patients in situations during which the risk of the patient biting the physician is significant (eg, interactions
with violent patients or patients experiencing an epileptic seizure)
• Any open surgical procedures with a duration of more than 3 hours, probably necessitating glove change
*If done emergently (eg, during acute trauma or resuscitation efforts), peripheral phlebotomy is classified as Category III.
†
Making and suturing an episiotomy is classified as Category III.
‡
If unexpected circumstances require moving to an open procedure (eg, laparotomy), some of these procedures will be classified as Category III.
Modified from Henderson DK, Dembry L, Fishman NO, Grady C, Lundstrom T, Palmore TN, et al. SHEA guideline for management of healthcare
workers who are infected with hepatitis B virus, hepatitis C virus, and/or human immunodeficiency virus. Society for Healthcare Epidemiology
of America. Infect Control Hosp Epidemiol 2010;31:203–32.

provider’s responsibilities in a contract or letter that is to
be signed by the health care provider (1). See Box 2 for
additional information on the establishment and func-
tions of the expert review panel.
Hepatitis B Virus
All obstetrician–gynecologists who provide clinical care
should receive the HBV vaccine series. Postvaccination
testing for the antibody to hepatitis B surface antigen 1–2
months after completing the vaccine series is recommend-
ed by the U.S. Centers for Disease Control and Prevention
(2). Individuals who do not respond to the primary vac-
cine series (anti-hepatitis B surface antigen titers of less
than 10 mIU/mL) should complete a second three-dose
series or be evaluated to determine if they test positive for
the hepatitis B surface antigen. Revaccinated individuals
should be retested at the completion of the second vaccine
series (3). Referral to a specialist may be necessary in cases

2 Committee Opinion No. 489

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 404

 TABLE 1. Summary Recommendations for Managing Health Care Providers Infected with Hepatitis B Virus, Hepatitis C Virus, or
Human Immunodeficiency Virus*
Circulating Viral Burden Categories of Clinical Activities† Recommendations Testing

HBV

Less than 10 GE/mL

4
Categories I, II, and III No restrictions‡ Twice per year
Greater than or equal to Categories I and II No restrictions ‡
NA
104 GE/mL
Greater than or equal to Categories III Restricted§ NA
104 GE/mL
HCV

Less than 104 GE/mL Categories I, II, and III No restrictions‡ Twice per year
Greater than or equal to Categories I and II No restrictions ‡
NA
104 GE/mL
Greater than or equal to Categories III Restricted§ NA
104 GE/mL
HIV

Less than five times 102 GE/mL Categories I, II, and III No restrictions‡ Twice per year
Greater than five times 10 GE/mL 2
Categories I and II No restrictions ‡
NA
Greater than or equal to Categories III Restricted|| NA
five times 102 GE/mL

Abbreviations: HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; GE, genome equivalents; NA, not applicable.
* Note these recommendations provide a framework within which to consider such cases; however, each case should be independently considered in context by the expert
review panel.
†
See Box 1 for the categorization of clinical activities.
‡
No restrictions recommended, so long as the infected health care provider 1) is not detected as having transmitted infection to patients; 2) obtains advice from an expert
review panel about continued practice; 3) undergoes follow-up routinely by occupational medicine staff (or an appropriate public health official), who test the health care
provider twice per year to demonstrate the maintenance of a viral burden of less than the recommended threshold; 4) also receives follow-up by a personal physician who
has expertise in the management of her or his infection and who is allowed by the health care provider to communicate with the expert review panel about the health care
provider’s clinical status; 5) consults with an expert about optimal infection control procedures (and strictly adheres to the recommended procedures, including the routine
use of double-gloving for Category II and Category III procedures and frequent glove changes during procedures, particularly if performing technical tasks known to compro-
mise glove integrity, and 6) agrees to the information and signs a contract or letter from the expert review panel that characterizes her or his responsibilities.
§
These procedures are permissible only when the viral burden is less than 10 4 GE/mL.
||
These procedures are permissible only when the viral burden is greater than five times 10 2 GE/mL.
Modified from Henderson DK, Dembry L, Fishman NO, Grady C, Lundstrom T, Palmore TN, et al. SHEA guideline for management of healthcare workers who are infected with
hepatitis B virus, hepatitis C virus, and/or human immunodeficiency virus. Society for Healthcare Epidemiology of America. Infect Control Hosp Epidemiol 2010;31:203–32.

involving individuals who do not respond serologically
after completing a second series of HBV vaccination.
Obstetrician–gynecologists who test positive for the
hepatitis B surface antigen also should know their hepa-
titis B e antigen status, which indicates the presence of
high-viral concentrations. If this latter test result is nega-
tive, viral load DNA testing should be done to establish
the viral genome equivalents per milliliter of blood.
Because high-viral load concentrations have been associ-
ated with an increased risk of transmission, obstetrician–
gynecologists whose test results are Hepatitis B e antigen
positive or who have a circulating Hepatits B viral load
of at least 104 genome equivalents per milliliter of blood
should not perform procedures with a high risk of blood-
borne pathogen transmission until they have sought
counsel from an expert review panel (see “Expert Review
Panel”) and have been advised under what circumstances,
if any, they may continue to perform these procedures
(see Box 1 and Table 1) (1).
Recent advances have been made in the develop-
ment of treatment strategies that offer some hope of
reducing viral load in patients chronically infected with
HBV(4). There are now a number of antiviral agents that
are approved by the U.S. Food and Drug Administration
or are under investigation for such interventions. Of
patients receiving monotherapy for 1 year, it can be
anticipated that between 14% and 30% will have a nega-
tive test result for hepatitis B e antigen, and 21–67% will

Committee Opinion No. 489 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 405

 therapy assuming there are no contraindications to such
Box 2. Additional Information on the antiviral therapeutic intervention. As with HBV-infected
Establishment and Functions of the individuals, health care providers with circulating HCV
Expert Review Panel viral loads of at least 104 genome equivalents per mil-
liliter should routinely use double gloving for all invasive
• The panel can be established at a state, regional, procedures, for all contact with mucous membranes or
county, city, or institutional level, dependent on the nonintact skin, and for all instances in patient care in
individual health care provider’s circumstance and which gloving is routinely recommended (1) (see Box 1).
state and local laws. As noted in Table 1, these infected individuals should not
• If the health care provider works only from an office, perform any Category III activities.
the functions on the panel should be fulfilled by the
city, county, or state health department. Human Immunodeficiency Virus
• The entity chartering the panel should indemnify panel Since the original publication in 1991 of guidelines for
members against any legal risk or costs or both.
the management of HIV-infected health care provid-
• The panel develops and executes a signed contract ers, much progress has been made in HIV detection,
between the infected health care provider and the
monitoring, and drug prophylaxis and treatment (7). The
panel or institution or both.
American College of Obstetricians and Gynecologists has
• If the contract between the infected health care pro- a more detailed Committee Opinion on general issues
vider and the panel or institution or both is breached,
the panel notifies Risk Management and the appropri-
pertaining to the approach to the HIV-infected patient
ate licensure board (if required by state regulations). and health care provider (8). In the most recent Society
for Healthcare Epidemiology of America’s guidelines,
Data from Henderson DK, Dembry L, Fishman NO, Grady C, specific viral load cutoffs have been recommended to
Lundstrom T, Palmore TN, et al. SHEA guideline for management
of healthcare workers who are infected with hepatitis B virus, determine health care provider practice activity (Table
hepatitis C virus, and/or human immunodeficiency virus. Society 1). These viral load parameters are different than those
for Healthcare Epidemiology of America. Infect Control Hosp for HBV and HCV. The same general recommendations
Epidemiol 2010;31:203–32. apply regarding infection-control measures, supervision,
and periodic testing.

References
have undetectable viral DNA levels (4). The use of combi-
nation therapies may be even more beneficial. However,
despite these advances, the role of therapy, its impact on
transmission, and its place in modifying practice restric-
tions have not been adequately investigated to make a
recommendation (1).
Hepatitis C Virus
Although there is currently no vaccine available to prevent
infection with HCV, the risk of acquiring HCV infection
appears lower than the risk of acquiring HBV (an average
of 1.8% after a percutaneous exposure to a source patient
who is infected with HCV compared with 20–60% after
percutaneous exposure to a source patient who is infected
with HBV and is hepatitis B e antigen positive) (3). This is
presumably because most individuals chronically infected
with HCV have circulating viral loads that are an order
of magnitude lower than those of HBV carriers. Routine
HCV testing is not recommended for health care work-
ers. However, after an occupational exposure, such as a
needle stick, the exposed health care worker, as well as the
source patient, should be tested for the antibody to HCV.
Postexposure prophylaxis against HCV is not effective
and not recommended. However, early antiviral therapy
of the infected individual may be effective in reducing
the risk of progression to chronic HCV infection (5, 6).
Individuals who are chronically infected and have detect-
able levels of HCV RNA in their serum should be offered
1. Henderson DK, Dembry L, Fishman NO, Grady C,
Lundstrom T, Palmore TN, et al. SHEA guideline for
management of healthcare workers who are infected with
hepatitis B virus, hepatitis C virus, and/or human immu-
nodeficiency virus. Society for Healthcare Epidemiology
of America. Infect Control Hosp Epidemiol 2010;31:
203–32.
2. Immunization of health-care workers: recommendations
of the Advisory Committee on Immunization Practices
(ACIP) and the Hospital Infection Control Practices
Advisory Committee (HICPAC). MMWR Recomm Rep
1997;46(RR-18):1–42.
3. Updated U.S. Public Health Service guidelines for the
management of occupational exposures to HBV, HCV,
and HIV and recommendations for postexposure prophy-
laxis. U.S. Public Health Service. MMWR Recomm Rep
2001;50:1–52.
4. Hoofnagle JH, Doo E, Liang TJ, Fleischer R, Lok AS.
Management of hepatitis B: summary of a clinical research
workshop. Hepatology 2007;45:1056–75.
5. Recommendations for follow-up of health-care workers
after occupational exposure to hepatitis C virus. Centers
for Disease Control and Prevention (CDC). MMWR Morb
Mortal Wkly Rep 1997;46:603–6.
6. Recommendations for prevention and control of hepatitis
C virus (HCV) infection and HCV-related chronic disease.
Centers for Disease Control and Prevention. MMWR
Recomm Rep 1998;47(RR-19):1–39.

4 Committee Opinion No. 489

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 406

 7. Recommendations for preventing transmission of human
immunodeficiency virus and hepatitis B virus to patients
during exposure-prone invasive procedures. MMWR
Recomm Rep 1991;40(RR-8):1– 9.
8. Human immunodeficiency virus. ACOG Committee
Opinion No. 389. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1473–8.
Committee Opinion No. 489
COMMITTEE OPINIONS
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Hepatitis B, hepatitis C, and human immunodeficiency virus infec-
tions in obstetrician–gynecologists. Committee Opinion No. 489.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2011;117:1242–6.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 407
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 505 • September 2011
Committee on Gynecologic Practice
Long-Acting Reversible Contraception Working Group
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Understanding and Using the U.S. Medical Eligibility

Criteria for Contraceptive Use, 2010
ABSTRACT: The 2010 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) issued by the Centers
for Disease Control and Prevention gives comprehensive, evidence-based guidance to clinicians providing family
planning services to women, especially women with medical conditions. The American College of Obstetricians
and Gynecologists endorses the U.S. MEC and encourages its use by Fellows.

In May 2010, the Centers for Disease Control and Pre-
vention (CDC) issued the U.S. Medical Eligibility Criteria
for Contraceptive Use, 2010 (U.S. MEC), which provides
comprehensive, evidence-based guidance on contraceptive
use (1). The U.S. MEC gives guidance to clinicians provid-
ing family planning services to women, especially women
with medical conditions. The U.S. MEC recommenda-
tions were adapted from guidance previously developed
by the World Health Organization (2). Revised recom-
mendations for the use of contraceptive methods during
the postpartum period were released in July 2011 (3). This
Committee Opinion serves as a guide to understanding
and using the 2010 U.S. MEC. The full recommendations
are available at http://www.cdc.gov/mmwr/pdf/rr/rr5904.
pdf.
In the U.S. MEC, contraceptive methods are clas-
sified using four categories based on the safety of the
method when used by women with certain characteristics
or medical conditions (Box 1). Clinicians can use these
categories when assessing the appropriateness of contra-
ceptive methods for women with specific medical condi-
tions or characteristics. In addition, clinicians should
consider the severity of a woman’s medical condition; her
personal preference; and the effectiveness, acceptability,
and availability of alternative methods.
Category 1 indicates that no restrictions exist for
use of a contraceptive method by women with a given
characteristic or medical condition, whereas Category 2
indicates that the method can be used but that individual-
ization and careful follow-up may be required. Category 3
indicates that use of a particular method is generally not
recommended unless other methods are unavailable or
unacceptable. Provision of a method to a woman with a
characteristic or condition for which the contraceptive is
classified as Category 3 requires clinical judgment. Cate-
gory 4 indicates that the method should not be used in
Box 1. Categories for Medical Eligibility
Criteria for Contraceptive Use
1 = A condition for which there is no restriction for the
use of the contraceptive method.
2 = A condition for which the advantages of using the
method generally outweigh the theoretical or proven
risks.
3 = A condition for which the theoretical or proven risks
usually outweigh the advantages of using the method.
4 = A condition that represents an unacceptable health
risk if the contraceptive method is used.
Farr S, Folger SG, Paulen M, Tepper N, Whiteman M, Zapata L,
et al. U S. Medical Eligibility Criteria for Contraceptive Use,
2010: adapted from the World Health Organization Medical
Eligibility Criteria for Contraceptive Use, 4th edition. Division
of Reproductive Health, National Center for Chronic Disease
Prevention and Health Promotion; Centers for Disease Control
and Prevention (CDC); MMWR Recomm Rep 2010;59(RR-4):
1–86. Available at: http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf.
Retrieved May 26, 2011.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 408

 women with a specific characteristic or condition because
it may confer an unacceptable health risk.
For example, the use of combined oral contracep-
tives (OCs) would be classified as Category 2 for smok-
ers younger than 35 years (Table 1). However, the use
of combined OCs by a woman aged 35 years or older
who smokes fewer than 15 cigarettes per day is classi-
fied as Category 3 and is not generally recommended
unless other methods are unavailable or unacceptable to
her. A woman aged 35 years or older who smokes 15 or
more cigarettes per day should not use combined OCs
because of unacceptable health risks, primarily the risk
of myocardial infarction and stroke (Category 4). The
full recommendations are available at http://www.cdc.
gov/mmwr/pdf/rr/rr5904.pdf. Updates and supporting
information for clinicians are available at http://www.cdc.
gov/reproductivehealth/UnintendedPregnancy/USMEC.
htm.

Table 1. Summary of Classifications for Hormonal Contraceptive Methods and Intrauterine Devices

Condition SubCondition Combined progeStin- injeCtion implant lng iud Copper iud
pill, patCh, only pill
ring

I C I C I C I C I C I C
Age Menarche Menarche Menarche Menarche Menarche Menarche
to <40=1 to <18=1 to <18=2 to <18=1 to <20=2 to <20=2
≥40=2 18–45=2 18–45=1 18–45=2 ≥20=1 ≥20=1
>45=1 >45=2 >45=1
Anatomic a) Distorted uterine cavity 4 4
abnormalities b) Other abnormalities 2 2
Anemias a) Thalassemia 1 1 1 1 1 2
b) Sickle cell disease* 2 1 1 1 1 2
c) Iron-deficiency anemia 1 1 1 1 1 2
Benign ovarian (including cysts) 1 1 1 1 1 1
tumors
Breast disease a) Undiagnosed mass 2† 2† 2† 2† 2† 1
b) Benign breast disease 1 1 1 1 1 1
c) Family history of cancer 1 1 1 1 1 1
d) Breast cancer*
i) current 4 4 4 4 4 1
ii) past and no evidence of 3 3 3 3 3 1
current disease for 5 years
Breastfeeding a) < 1 month postpartum 3† 2† 2† 2†
b) 1 month or more postpartum 2† 1† 1† 1†
Cervical cancer Awaiting treatment 2 1 2 2 4 2 4 2
Cervical 1 1 1 1 1 1
ectropion
Cervical 2 1 2 2 2 1
intraepithelial
neoplasia (CIN)
Cirrhosis a) Mild (compensated) 1 1 1 1 1 1
b) Severe* (decompensated) 4 3 3 3 3 1
DVT/PE a) History of DVT/PE, not on
anticoagulant therapy
i) higher risk for recurrent 4 2 2 2 2 1
DVT/PE
ii) lower risk for recurrent 3 2 2 2 2 1
DVT/PE
b) Acute DVT/PE 4 2 2 2 2 3
C) DVT/PE and established on
anticoagulant therapy for at
least 3 months
i) higher risk for recurrent 4† 2 2 2 2 2
DVT/PE
ii) lower risk for recurrent 3 †
2 2 2 2 2
DVT/PE
d) Family history (first-degree 2 1 1 1 1 1
relatives
e) major surgery
i) with prolonged 4 2 2 2 2 1
immobilization
ii) without prolonged 2 1 1 1 1 1
immobilization
f) Minor surgery without 1 1 1 1 1 1
immobilization
Depressive 1† 1† 1† 1† 1† 1†
disorders
DM a) History of gestational DM only 1 1 1 1 1 1

(continued)

2 Committee Opinion No. 505

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 409

 Table 1. Summary of Classifications for Hormonal Contraceptive Methods and Intrauterine Devices (continued)

Condition SubCondition Combined progeStin- injeCtion implant lng iud Copper iud
pill, patCh, only pill
ring

I C I C I C I C I C I C
DM (continued) b) Non-vascular disease
i) non-insulin dependent 2 2 2 2 2 1
ii) insulin dependent* 2 2 2 2 2 1
c) Nephropathy/retinopathy/ 3/4† 2 3 2 2 1
neuropathy*
d) Other vascular disease or 3/4 †
2 3 2 2 1
diabetes of >20 years’ duration*
Endometrial 1 1 1 1 4 2 4 2
cancer*
Endometrial 1 1 1 1 1 1
hyperplasia
Endometriosis 1 1 1 1 1 2
Epilepsy*§ See drug interactions 1† 1† 1† 1† 1 1
Gall-bladder a) Symptomatic
disease i) treated by 2 2 2 2 2 1
cholecystectomy
ii) medical treated 3 2 2 2 2 1
iii) current 3 2 2 2 2 1
b) Asymptomatic 2 2 2 2 2 1
Gestational a) Decreasing or undetectable 1 1 1 1 3 3
trophoblastic b-hCG levels
disease b) Persistenly elevated 1 1 1 1 4 4
b-hCG levels or
malignant disease
Headaches a) Non-migrainous 1† 2† 1† 1† 1† 1† 1† 1† 1† 1† 1†
b) Migraine
i) without aura, age <35 2† 3† 1† 2† 2† 2† 2† 2† 2† 2† 1†
ii) without aura, age ≥ 35 3† 4† 1† 2† 2† 2† 2† 2† 2† 2† 1†
iii) with aura, any age 4† 4† 2† 3† 2† 3† 2† 3† 2† 3† 1†
History of a) Restrictive procedures 1 1 1 1 1 1
bariatric
surgery* b) Malabsorptive procedures COCs:3 3 1 1 1 1
P/R:1
History of a) Pregnancy-related 2 1 1 1 1 1
cholestasis b) Past COC-related 1 1 1 1 3 3
History of high 2 1 1 1 1 1
blood pressure
during pregnancy

History of 2 1 1 1 1 1
pelvic
surgery
HIV High risk or HIV infected* 1 1 1 1 2 2 2 2
AIDS (see drug interactions)*‡ 1† 1† 1† 1† 3 2† 3 2
Clinically well on ARV therapy§ If on treatment see drug interactions 2 2 2 2

Hyperlipidemias 2/3† 2† 2† 2† 2† 1†
Hypertension a) Adequately controlled 3† 1† 2† 1† 1 1
hypertension
b) Elevated blood pressure levels
(properly taken measurements)
i) Systolic 140–159 or 3 1 2 1 1 1
diastolic 90–99 mm Hg

(continued)

Committee Opinion No. 505 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 410

 Table 1. Summary of Classifications for Hormonal Contraceptive Methods and Intrauterine Devices (continued)

Condition SubCondition Combined progeStin- injeCtion implant lng iud Copper iud
pill, patCh, only pill
ring

I C I C I C I C I C I C
Hypertension ii) Systolic ≥160 or diastolics
(continued) ≥100 mm Hg‡ 4 2 3 2 2 1
c) Vascular disease 4 2 3 2 2 1
Inflammatory (Ulcerative colitis, Crohn’s 2/3† 2 2 2 2 1
bowel disease disease)
Ischemic heart Current and history of 4 2 3 3 2 3 2 3 1
disease‡
Liver tumors a) Benign
i) Focal nodular hyperplasia 2 2 2 2 2 1
ii) Hepatocellular adenoma‡ 4 3 3 3 3 1
b) Malignant* 4 3 3 3 3 1
Malaria 1 1 1 1 1 1
Multiple risk (such as older age, smoking 3/4† 2† 3† 2† 2 1
factors for diabetes and hypertension)
arterial
cardiovascular
disease
Obesity a) ≥ 30 kg/m2 body mass index 2 1 1 1 1 1
(BMI)
b) Menarche to <18 years and 2 1 2 1 1 1
≥ 30 kg/m2 BMI
Ovarian cancer* 1 1 1 1 1 1
Parity a) Nulliparous 1 1 1 1 2 2
b) Parous 1 1 1 1 1 1
Past ectopic 1 2 1 1 1 1
pregnancy
Pelvic a) Past, (assuming no current risk
inflammatory factors of STIs)
disease (i) with subsequent pregnancy 1 1 1 1 1 1 1 1
(ii) without subsequent 1 1 1 1 2 2 2 2
pregnancy
b) Current 1 1 1 1 4 2† 4 2†
Peripartum a) Normal or mildly impaired
cardiomyopathy* cardiac function
(i) <6 mo 4 1 1 1 2 2
(ii) ≥6 mo 3 1 1 1 2 2
b) Moderately or severely 4 2 2 2 2 2
impaired cardiac function
Postabortion a) First trimester 1† 1† 1† 1† 1† 1†
b) Second trimester 1† 1† 1† 1† 2 2
c) Immediately post-septic 1† 1† 1† 1† 4 4
abortion
Postpartum (in a) <21 d 4 1 1 1
nonbreastfeeding b) >21 d to 42 d
women) § i. With other risk factors for 3|| 1 1 1
VTE (such as age ≥35 y,
previous VTE, thrombophilia,
immobility, transfusion at
delivery, BMI ≥30 kg/m2,
postpartum hemorrhage,
postcesarean delivery,
preeclampsia or smoking)
ii. Without other risk factors 2 1 1 1
for VTE
c. >42 d 1 1 1 1
Postpartum a. <21 d 4 2 2 2
(breastfeeding)§ b. ≥21 d to <30 d
i. With other risk factors for 3|| 2 2 2
VTE (such as age ≥35 y,
previous VTE, thrombophilia,
immobility, transfusion
at delivery, BMI ≥30 kg/m2,
postpartum hemorrhage,
postcesarean delivery,
preeclampsia or smoking)

(continued)

4 Committee Opinion No. 505

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 411

 Table 1. Summary of Classifications for Hormonal Contraceptive Methods and Intrauterine Devices (continued)

Condition SubCondition Combined progeStin- injeCtion implant lng iud Copper-iud

pill, patCh, only pill
ring

I C I C I C I C I C I C
Postpartum ii. Without other risk factors
(breastfeeding)§ for VTE 3|| 2 2 2
(continued) c. 30 d to 42 d
i. With other risk factors for 3 1 1 1
VTE (such as age ≥35 y,
previous VTE, thrombophilia,
immobility, transfusion at
delivery, BMI ≥30 kg/m2,
postpartum hemorrhage,
postcesarean delivery,
preeclampsia or smoking)
ii. Without other risk factors 2 1 1 1
for VTE
d. >42 d 2 1 1 1
Postpartum (in a) <10 min after delivery of the 2 1
breastfeeding or placenta
nonbreastfeeding b) 10 min after delivery of the 2 2
women, including placenta to <4 wk
postcesarean c) ≥4 wk 1 1
delivery) d) Puerperal sepsis 4 4
Pregnancy NA †
NA †
NA †
NA †
4† 4†
Rheumatoid a) On immunosuppressive 2 1 2/3† 1 2 1 2 1
arthritis therapy
b) Not on immunosuppressive 2 1 2 1 1 1
therapy
Schistosomiasis a) Uncomplicated 1 1 1 1 1 1
b) Fibrosis of the liver* 1 1 1 1 1 1
Severe 1 1 1 1 1 2
dysmenorrhea
STIs a) Current purulent cervicitis 1 1 1 1 4 2† 4 2†
or chlamydial infection or
gonorrhea
b) Other STIs (excluding HIV
1 1 1 1 2 2 2 2
and hepatitis)
c) Vaginitis (including
1 1 1 1 2 2 2 2
trichomonas vaginalis and
bacterial vaginosis)
d) Increased risk of STIs 1 1 1 1 2/3† 2 2/3* 2
Smoking a) Age <35 y 2 1 1 1 1 1
b) Age ≥35 y, <15 cigarettes/d 3 1 1 1 1 1
c) Age ≥35 y, >15 cigarettes/d 4 1 1 1 1 1
Solid organ a) Complicated 4 2 2 2 3 2 3 2
transplantation* b) Uncomplicated 2† 2 2 2 2 2
History of cerebrovascular 4 2 3 3 2 3 2 1
Stroke*
accident
Superficial venous a) Varicose veins 1 1 1 1 1 1
thrombosis b) Superficial thrombophlebitis 2 1 1 1 1 1
Systemic lupus a) Positive (or unknown) 4 3 3 3 3 3 1 1
erythematosus* antiphospholipid antibodies
b) Severe thrombocytopenia 2 2 3 2 2 2† 3† 2†
c) Immunosuppressive treatment 2 2 2 2 2 2 2 1
d) None of the above 2 2 2 2 2 2 1 1
Thrombogenic 4† 2† 2† 2† 2† 1†
mutations*
Thyroid disorders a) Simple goiter/hyperthyroid/ 1 1 1 1 1 1
hypothyroid
Tuberculosis* a) Nonpelvic 1† 1† 1† 1† 1 1
b) Pelvic 1† 1† 1† 1† 4 3 4 3
Unexplained (suspicious for serious condition) 2† 2† 3† 3† 4† 2† 4† 2†
vaginal bleeding before evaluation
Uterine fibroids 1 1 1 1 2 2

(continued)

Committee Opinion No. 505 5

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 412

 Table 1. Summary of Classifications for Hormonal Contraceptive Methods and Intrauterine Devices (continued)

Condition Sub-Condition Combined progeStin- injeCtion implant lng iud Copper iud
pill, patCh, only pill
ring

I C I C I C I C I C I C
Valvular heart a) Uncomplicated 2 1 1 1 1 1
disease b) Complicated* 4 1 1 1 1 1
Vaginal bleeding a) Irregular pattern without heavy 1 2 2 2 1 1 1
patterns bleeding
b) Heavy or prolonged bleeding 1† 2† 2† 2† 1† 2† 2†
Viral hepatitis a) Acute or flare 3/4† 2 1 1 1 1 1
b) Carrier/chronic 1 1 1 1 1 1 1
Drug Interactions
Antiretroviral a) Nucleoside reverse 1† 1 1 1 2/3† 2† 2/3† 2†
therapy transcriptase inhibitors
b) Non-nucleoside reverse 2† 2† 1 2† 2/3† 2† 2/3† 2†
transcriptase inhibitors
c) Ritonavir-boosted protease 3† 3† 1 2† 2/3† 2† 2/3† 2†
inhibitors
Anticonvulsant a) Certain anticonvulsants 3† 3† 1 2† 1 1
therapy (phenytoin, carbamazepine,
barbiturates, primidone,
topiramate, oxcarbazepine)
b) Lamotrigine 3† 1 1 1 1 1
Antimicrobial a) Broad spectrum antibiotics 1 1 1 1 1 1
therapy b) Antifungals 1 1 1 1 1 1
c) Antiparasitics 1 1 1 1 1 1
d) Rifampicin or rifabutin therapy 3† 3† 1 2† 1 1

Abbreviations: AIDS, acquired immunodeficiency syndrome; ARV, antiretroviral; BMI, body mass index; C, continuation of contraceptive
method; COC, combined oral contraceptive; DM, diabetes mellitus; DVT, deep venous thrombosis; b-hCG, beta-human chorionic gonadotro-
pin; HIV, human immunodeficiency virus; I, initiation of contraceptive method; IUD, intrauterine device; LNG IUD, levonorgestrel-releasing
IUD; NA, not applicable; P, combined hormonal contraceptive patch; PE, pulmonary embolism; R, combined hormonal vaginal ring; STI,
sexually transmitted infection; VTE, venous thromboembolism.
*Condition that exposes a woman to increased risk as a result of an unintended pregnancy.
†
Please see the complete guidance for a clarification to this classification. www.cdc.gov/reproductivehealth/usmec
‡
Please refer to the U.S. Medical Eligibility Criteria for Contraceptive Use guidance related to drug interactions at the end of this chart.
§
See Tepper N, Curtis KM, Jamieson DJ, Marchbanks PA. Update to CDC’s U.S. medical eligibility criteria for contraceptive use, 2010:
revised recommendations for the use of contraceptive methods during the postpartum period. Centers for Disease Control and Prevention
(CDC). MMWR Morb Mortal Wkly Rep 2011;60:878–83. Available at: http://www.cdc.gov/mmwr/pdf/wk/mm6026.pdf. Retrieved July 7,
2011.
||
Clarification: For women with other risk factors for venous thromboembolism, these risk factors may increase the classification to a “4”;
for example, see Smoking, DVT/PE, Thrombogenic Mutations, and Peripartum Cardiomyopathy.
Modified from Farr S, Folger SG, Paulen M, Tepper N, Whiteman M, Zapata L, et al. U. S. Medical Eligibility Criteria for Contraceptive Use,
2010: adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition. Division of Reproductive
Health, National Center for Chronic Disease Prevention and Health Promotion; Centers for Disease Control and Prevention (CDC); MMWR
Recomm Rep 2010;59(RR-4):1–86. Available at: http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf. Retrieved May 26, 2011.

The U.S. MEC recommendations also address the
initiation and continued use of methods. Continuation
criteria become relevant when a woman develops a medi-
cal condition while already using a contraceptive method.
When recommendation categories differ for initiation
and continuation of a given method, these differences are
noted (Table 1).
The American College of Obstetricians and Gyne-
cologists endorses the U.S. MEC and encourages its use
by Fellows. As the CDC notes, “…these recommenda-
tions are meant to be a source of clinical guidance; health
care providers should always consider the individual
clinical circumstances of each person seeking family plan-
ning services” (1).
References
1. Centers for Disease Control and Prevention. United States
medical eligibility criteria for contraceptive use. Available
at: http://www.cdc.gov/reproductivehealth/Unintended
Pregnancy/USMEC.htm. Retrieved May 26, 2011.
2. World Health Organization. Medical eligibility crite-
ria for contraceptive use. 4th ed. Geneva: WHO; 2009.

6 Committee Opinion No. 505

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 413

 Available at http://whqlibdoc.who.int/publications/2010/
9789241563888_eng.pdf. Retrieved May 26, 2011.
3. Tepper N, Curtis KM, Jamieson DJ, Marchbanks PA.
Update to CDC’s U.S. medical eligibility criteria for
contraceptive use, 2010: revised recommendations for
the use of contraceptive methods during the postpar-
tum period. Centers for Disease Control and Prevention
(CDC). MMWR Morb Mortal Wkly Rep 2011;60:
878–83. Available at: http://www.cdc.gov/mmwr/pdf/wk/
mm6026.pdf. Retrieved July 7, 2011.
Committee Opinion No. 505
COMMITTEE OPINIONS
Copyright September 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Understanding and using the U.S. Medical Eligibility Criteria for
Contraceptive Use, 2010. Committee Opinion No. 505. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2011;
118:754–60.
7
2013 COMPENDIUM OF SELECTED PUBLICATIONS 414
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 509 • November 2011
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Management of Vulvar Intraepithelial Neoplasia

ABSTRACT: Vulvar intraepithelial neoplasia (VIN) is an increasingly common problem, particularly among
women in their 40s. The term VIN is used to denote high-grade squamous lesions and is subdivided into usual-type
VIN (including warty, basaloid, and mixed VIN) and differentiated VIN. Usual-type VIN is commonly associated with
carcinogenic genotypes of human papillomavirus (HPV) and other HPV persistence risk factors, such as cigarette
smoking and immunocompromised status, whereas differentiated VIN usually is not associated with HPV and is
more often associated with vulvar dermatologic conditions, such as lichen sclerosus. Biopsy is indicated for any
pigmented vulvar lesion. Treatment is indicated for all cases of VIN. When occult invasion is not a concern, VIN can
be treated with surgical therapy, laser ablation, or medical therapy. After resolution, women should be monitored
at 6 and 12 months and annually thereafter.

Scope of the Problem thelial neoplasia classification. Subsequent studies deter-

Vulvar intraepithelial neoplasia (VIN) is an increasingly
common problem, particularly among women in their
40s. Data from the U.S. Surveillance, Epidemiology, and
End Results program show that VIN incidence increased
more than fourfold between 1973 and 2000 (1). Although
spontaneous regression has been reported, VIN should be
considered a premalignant condition, as shown by a case
series of 405 New Zealand women with VIN (2). Sixty-
three (16%) women received no treatment of whom 10
women experienced invasive cancer progression before
treatment (2). Although cancer regression has been
reported, especially among women in whom cancer was
diagnosed during pregnancy (3), the risk of cancer pro-
gression appears to outweigh the risks of treatment, and
prognostic factors are not sufficiently reliable to select
women for treatment. Occult invasive cancer has been
reported in 3% of women undergoing surgery for VIN,
although two thirds of cases of invasive cancer in women
receiving surgical treatment for VIN are superficial (3).
The focus of this Committee Opinion will be on the
management of high-grade squamous lesions recognized
as VIN under the International Society for the Study of
Vulvovaginal Disease (ISSVD) system.
mined that VIN 1 reflects a usually self-limited infection
caused by human papillomavirus (HPV). In 2004, the
ISSVD replaced the previous three-grade classification
system with the current single-grade system, in which
only high-grade disease is classified as VIN (4). In the
current system, VIN is subdivided into usual-type VIN
(including warty, basaloid, and mixed VIN) and dif-
ferentiated VIN. Usual-type VIN is commonly associ-
ated with carcinogenic genotypes of HPV and other HPV
persistence risk factors, such as cigarette smoking and
immunocompromised status, whereas differentiated VIN
usually is not associated with HPV and is more often
associated with vulvar dermatologic conditions, such as
lichen sclerosus. However, differentiated VIN associated
with lichen sclerosus is more likely to be associated with
a squamous cell carcinoma of the vulva than usual-type
VIN.
Flat lesions associated with basal atypia and koilo-
cytic changes (formerly termed VIN 1) are considered
condylomas in the current ISSVD classification system
and can be treated as such (4). Other intraepithelial vulvar
neoplasms, such as Paget disease and melanoma in situ,
are rare.

Classification Prevention
Traditionally, squamous VIN was classified into three Immunization with the quadrivalent HPV vaccine, which
grades, analogous to the three-grade cervical intraepi- is effective against HPV genotypes 6, 11, 16, and 18, has

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 415

 been shown to decrease the risk of VIN and should be
recommended for women in target populations (5). The
bivalent HPV vaccine is not approved for this indication,
because this endpoint was not assessed in clinical trials.
Cigarette smoking is strongly associated with usual-type
VIN, and cessation should be encouraged, although no
studies have shown a reduction in VIN incidence or
posttreatment recurrence after smoking-cessation efforts.
Differentiated VIN may be associated with vulvar der-
matoses, and treatment of vulvar dermatologic disorders
may reduce VIN and cancer risk.
Diagnosis
No screening strategies have been developed for the pre-
vention of vulvar cancer through early detection of VIN.
Vulvar cytologic testing is complicated by the keratiniza-
tion of vulvar skin, making performance and interpreta-
tion of test results problematic. Diagnosis is limited to
visual assessment. The appearance of VIN can vary. Most
women have visible lesions that are elevated, but flat
lesions occur. Color can vary from white to gray or from
red to brown to black. Biopsy is indicated for any pig-
mented vulvar lesion. Expert opinion is divided regard-
ing the need for biopsy of all warty lesions, but biopsy
should be performed in postmenopausal women with
apparent genital warts and in women in whom topical
therapies have failed. Colposcopy, or other forms of mag-
nification of the vulva, can be useful in determining the
extent of disease and should be performed after applying
3–5% acetic acid to the vulva for several minutes using
soaked gauze pads. Keratinization requires longer acetic
acid application for effect and often renders typical col-
poscopic grading criteria useless. Although toluidine blue
testing is often cited for use in the assessment of VIN, this
method is infrequently used and rarely beneficial in the
diagnosis of VIN.
Treatment
Treatment is recommended for all women with VIN.
Wide local excision is recommended when cancer is sus-
pected. When occult invasion is not a concern, VIN can
be treated with surgical therapy, laser ablation, or medical
therapy.
Surgical Therapy
Wide local excision is the preferred initial intervention
for women in whom clinical or pathologic findings sug-
gest invasive cancer, despite a biopsy diagnosis of only
VIN, to obtain a specimen for pathologic analysis. The
excision should be tailored to the lesion. Wide local
excision is also acceptable for women in whom cancer is
not suspected. Skinning vulvectomy, which removes all
vulvar skin, is rarely needed, although it may be useful
for cases of confluent multifocal lesions, which can occur
in women who are immunocompromised. Women with
pathologic clear margins have a lower, although still sig-
nificant, risk of recurrence compared with women with
2 Committee Opinion No. 509
COMMITTEE OPINIONS
involved margins (6); gross margins of 0.5–1 cm around
tissue with visible disease appear optimal but may be
altered to avoid injury to the clitoris, urethra, anus, or
other critical structures.
Laser Ablation
Laser ablation is acceptable for the treatment of VIN when
cancer is not suspected. It can be used for single, multi-
focal, or confluent lesions, although the risk of recur-
rence may be higher than with excision (7, 8). Appropriate
power density (750–1,250 W/cm2) is critical to avoid deep
coagulation injury. Colposcopy after application of 3–5%
acetic acid facilitates delineation of lesion margins, and
use of a micromanipulator or a hand piece with a depth
gauge allows application of high-power density without
inadvertent defocusing. As with excision, a margin of
normal-appearing skin should be treated. In contrast to
its application to genital warts, when superficial ablation
is acceptable, laser treatment of VIN requires destruction
of cells through the entire thickness of the epithelium.
In hair-bearing areas, laser procedures must ablate hair
follicles, which can contain VIN and extend into the
subcutaneous fat for 3 mm or more. Consequently, large
VIN lesions over hair-bearing areas may be preferentially
treated with other modalities. Ablation over skin that
does not bear hair should extend through the dermis (up
to 2 mm).
Medical Therapy
Randomized controlled trials have shown that the appli-
cation of topical imiquimod 5% is effective for the
treatment of VIN (9), although it is not approved by the
U.S. Food and Drug Administration for this purpose.
Published regimens include three times weekly applica-
tion to affected areas for 12–20 weeks, with colposcopic
assessment at 4–6-week intervals during treatment.
Residual lesions require surgical treatment. Erythema and
vulvar pain may limit adverse effects. Experience with
imiquimod in immunosuppressed patients is limited,
and because it is believed to act through local immuno-
modulators, it may have decreased effectiveness in women
who are immunocompromised. Sinecatechins are effec-
tive for the treatment of genital warts but have not
been tested as a therapy for VIN and so should not be
used for management of VIN outside of clinical trials.
Photodynamic therapy has been effective in some trials
but requires specialized equipment and training. Topical
cidofovir cream and 5-fluorouracil creams have been
tested in clinical trials with varying degrees of efficacy but
have more pronounced adverse effects on skin and have
fallen out of favor.
Surveillance
Posttreatment recurrence rates exceed 30–50% with all
treatment regimens and are higher with positive excision
margins. Follow-up has been limited in most studies,
and women with VIN should be considered to be at risk
of recurrent VIN and vulvar cancer throughout their
2013 COMPENDIUM OF SELECTED PUBLICATIONS 416
 lifetimes. The value of vulvar self-examination and serial
office visits in the detection of recurrence has not been
proved prospectively, but both appear prudent. Given the
relatively slow rate of progression, women with a com-
plete response to therapy and no new lesions at follow-up
visits scheduled 6 and 12 months after initial treatment
should be monitored annually thereafter.
Conclusions and Recommendations
The Committee on Gynecologic Practice of the American
College of Obstetricians and Gynecologists and the
American Society for Colposcopy and Cervical Pathology
make the following conclusions and recommendations:
• Immunization with the quadrivalent HPV vaccine genital diseases in young women. J Natl Cancer Inst 2010;
has been shown to decrease the risk of VIN and
should be recommended for women in target popu-
lations.
• No screening strategies have been developed for the 1998;92:962–6.
prevention of vulvar cancer through early detection
of VIN.
• Diagnosis is limited to visual assessment. Biopsy is of vulvar intraepithelial neoplasia. Gynecol Oncol 1999;
indicated for most pigmented vulvar lesions.
• Presumed genital warts should be biopsied in post-
menopausal women and in women in whom topical
treatments have failed.
• Treatment is indicated for all cases of VIN. Wide
local excision is recommended when cancer is sus-
pected, despite a biopsy diagnosis of only VIN, to
identify occult invasion.
• When occult invasion is not a concern, VIN can
be treated with excision, laser ablation, or topical
imiquimod (off-label use).
• Women with VIN should be considered at risk of be reproduced, stored in a retrieval system, posted on the Internet,
recurrent VIN and vulvar cancer throughout their
lifetimes. After resolution, women should be moni-
tored at 6 and 12 months and annually thereafter.
References
1. Judson PL, Habermann EB, Baxter NN, Durham SB, Virnig BA.
Trends in the incidence of invasive and in situ vulvar carci-
noma. Obstet Gynecol 2006;107:1018–22.
Committee Opinion No. 509
COMMITTEE OPINIONS
2. Jones RW, Rowan DM, Stewart AW. Vulvar intraepithelial
neoplasia: aspects of the natural history and outcome in
405 women. Obstet Gynecol 2005;106:1319–26.
3. van Seters M, van Beurden M, de Craen AJ. Is the assumed
natural history of vulvar intraepithelial neoplasia III based
on enough evidence? A systematic review of 3322 published
patients. Gynecol Oncol 2005;97:645–51.
4. Sideri M, Jones RW, Wilkinson EJ, Preti M, Heller DS,
Scurry J, et al. Squamous vulvar intraepithelial neopla-
sia: 2004 modified terminology, ISSVD Vulvar Oncology
Subcommittee. J Reprod Med 2005;50:807–10.
5. Munoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-
Avila M, Wheeler CM, et al. Impact of human papilloma-
virus (HPV)-6/11/16/18 vaccine on all HPV-associated
102:325–39.
6. Modesitt SC, Waters AB, Walton L, Fowler WC Jr, Van Le L.
Vulvar intraepithelial neoplasia III: occult cancer and the
impact of margin status on recurrence. Obstet Gynecol
7. Sideri M, Spinaci L, Spolti N, Schettino F. Evaluation of
CO(2) laser excision or vaporization for the treatment
75:277–81.
8. Reid R. Superficial laser vulvectomy. III. A new surgical
technique for appendage-conserving ablation of refrac-
tory condylomas and vulvar intraepithelial neoplasia. Am J
Obstet Gynecol 1985;152:504–9.
9. van Seters M, van Beurden M, ten Kate FJ, Beckmann I,
Ewing PC, Eijkemans MJ, et al. Treatment of vulvar intra-
epithelial neoplasia with topical imiquimod. N Engl J Med
2008;358:1465–73.
Copyright November 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Management of vulvar intraepithelial neoplasia. Committee Opinion
No. 509. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;118:1192–4.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 417
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 513 • December 2011
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Vaginal Placement of Synthetic Mesh for Pelvic

Organ Prolapse
ABSTRACT: Since 2004, use of synthetic mesh has increased in vaginal surgery for the treatment of pelvic
organ prolapse. However, concerns exist about the safety and efficacy of transvaginally placed mesh. Based on
the currently available limited data, although many patients undergoing mesh-augmented vaginal repairs heal well
without problems, there seems to be a small but significant group of patients who experience permanent and
life-altering sequelae, including pain and dyspareunia, from the use of vaginal mesh. The American College of
Obstetricians and Gynecologists and the American Urogynecologic Society provide background information on the
use of vaginally placed mesh for the treatment of pelvic organ prolapse and offer recommendations for practice.

Since 2004, use of synthetic mesh has increased in vaginal
surgery for the treatment of pelvic organ prolapse (POP).
However, concerns exist about the safety and efficacy
of transvaginally placed mesh. Surgeons who perform
these procedures may have many questions related to
a U.S. Food and Drug Administration (FDA) Safety
Communication released in July 2011 (1), which updates
a 2008 FDA Public Health Notification (2), as well as pub-
lished reports describing variable experience with mesh.
The purpose of this joint document developed by the
American College of Obstetricians and Gynecologists and
the American Urogynecologic Society is to provide back-
ground information on the use of vaginally placed mesh
for the treatment of POP and offer recommendations
for practice. This report does not address the subject of
synthetic mesh used for abdominal or minimally invasive
sacrocolpopexy or for midurethral slings to treat stress
urinary incontinence.
How does the U.S. Food and Drug
Administration currently regulate
surgical mesh products?
Surgical mesh is a medical device, currently regulated
by the FDA as Class II Special Controls. Instead of the
premarket approval review process reserved for Class III
devices, Class II devices are introduced to the market
by way of the regulatory pathway of Section 510(k)
of the Federal Food, Drug and Cosmetic Act. In the
510(k) Premarket Notification Program (http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/PremarketSubmissions/
PremarketNotification510k/default.htm), a manufacturer
attempts to demonstrate that a new device is “substan-
tially equivalent” to a predicate device (ie, a similar Class II
device already on the market). In making such a deter-
mination, the FDA reviews a comparison of the new
device and the predicate device in terms of intended
use and product design. This review typically addresses
labeling and performance data, including material safety,
mechanical performance, and animal testing, but, for
some devices, it may also include clinical data.
In 2001, the FDA reviewed the first surgical mesh
indicated for repair of POP and found it substantially
equivalent to surgical mesh indicated for hernia repair.
This finding was done without clinical data, and, since
then, many subsequent mesh products have been cleared
for the same indication without clinical data. Currently,
an estimated 100 synthetic mesh devices or kits have
been cleared by the FDA for use in surgery for POP,
but only approximately 20% are actively marketed and
sold. Modification of mesh devices continues. Compared
with existing mesh products and devices, new products
should not be assumed to have equal or improved safety
and efficacy unless clinical long-term data are available.
However, the FDA is currently re-evaluating the process it
uses to evaluate mesh intended for vaginal repair of POP
and is considering whether to reclassify it from Class II to

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 418

 Class III, which would allow the FDA to require clinical
trials comparing procedures with mesh with those in
which mesh is not used.
As with all medical devices, the adverse events asso-
ciated with use of surgical mesh should be reported in
the FDA’s Manufacturer and User Facility Device Exper-
ience database (http://www.fda.gov/MedicalDevices/
Safety/ReportaProblem/FormsandInstructions/default.
htm). This reporting is voluntary for physicians and man-
datory for manufacturers, but underreporting of compli-
cations is acknowledged. The complication rate related
to vaginally placed mesh is not fully known because of
incomplete knowledge of the total number of adverse
events and the total number of vaginal mesh delivery
systems that have been implanted.
What outcome data exist for vaginal
placement of synthetic mesh for
pelvic organ prolapse?
Vaginal mesh kits were first marketed to urologists and
gynecologists as a way to improve success rates for POP
repairs with native tissue, but without well-designed trials
to establish the safety and efficacy of these devices. The
body of literature is increasing for vaginal mesh, yet, case
series and prospective cohort studies greatly outnumber
randomized trials. These smaller series document good
short-term surgical success in the hands of individual
surgeons, but longer follow-up of procedures performed
by surgeons from multiple centers is lacking.
Several systematic reviews draw on a similar pool of
studies of vaginal mesh repairs, but these studies are based
on short-term follow-up and have variable outcome mea-
sures. Systematic reviews by the Society of Gynecologic
Surgeons and the World Health Organization-sponsored
International Consultation on Incontinence found weak
evidence for improved anterior anatomy when vaginal
prolapse repairs were performed with synthetic mesh
compared with native tissue (3–5). There are insufficient
data on the use of mesh for the posterior or apical com-
partments. Although the risk of mesh erosion varied, it
was a risk that did not exist for native tissue repairs.
One systematic review evaluated 30 studies totaling
2,653 patients who had undergone one of several apical
prolapse kit repairs (6). Success was defined variably and
ranged from 87% to 95%, with follow-up ranging from
26 weeks to 78 weeks. Another systematic review ana-
lyzed the complications and reoperation rates for surgical
procedures specifically performed to correct apical POP:
1) native tissue vaginal repairs, 2) abdominal sacrocolpo-
pexy, and 3) vaginal mesh kits (7). In this review, the rate
of reoperation to correct complications as well as the total
reoperation rate was highest for vaginal mesh kits com-
pared with vaginal native tissue and abdominal repairs,
despite shorter overall follow-up.
A 2010 Cochrane review evaluated 3,773 participants
in 40 trials of different surgical procedures for POP and
concluded that mesh grafts improved anterior anatomy
2 Committee Opinion No. 513
COMMITTEE OPINIONS
more than native tissue repairs, but the abdominal
approaches offered the best anatomic result (8). There
was a higher rate of complications associated with vaginal
mesh compared with native tissue vaginal repairs, includ-
ing a 10% mesh erosion rate.
In Canada, the Society of Obstetricians and Gyn-
aecologists of Canada (SOGC) reviewed 18 published
studies of vaginal mesh for POP, of which 9 were obser-
vational or case series with 3–12-month follow-up, and
only 1 was a randomized trial (9). Anatomic cure was
typically defined as less than stage II of the POP quanti-
fication system (leading edge of prolapse within 1 cm of
hymenal ring) and reported as 79–100%. The SOGC rec-
ommended that transvaginal mesh procedures be consid-
ered novel techniques that can demonstrate high rates of
anatomic cure in uncontrolled short-term case series. It
advocated surgeon training specific to each device before
vaginal mesh repair for POP is performed and called for
thorough individual patient counseling regarding the
risks and benefits of these surgical procedures.
In a recent randomized controlled trial (RCT) of 389
women assigned to anterior mesh or anterior colporrha-
phy, higher success rates based on a composite outcome
of subjective absence of a bulge and anatomic stage 0 or
stage I prolapse were seen with anterior mesh (60.8%)
compared with colporrhaphy (34.5%) at 1 year (10). Rates
of intraoperative bladder injury and hemorrhage were
higher in the mesh group, and de novo stress incontin-
ence also was higher (12.3% versus 6.3%). Surgical rein-
tervention for mesh exposure was 3.2%.
What are the complications of vaginal
mesh in surgery for pelvic organ
prolapse?
The complications of vaginal mesh in surgery for POP
range from transient pain and small mesh erosions to
larger vaginal mesh exposures or extrusions or perfora-
tions into the bladder or bowel (11). Some complications
can be managed in the office, but others that involve
bladder and bowel injury, fistulae, abscess formation,
and debilitating pain may require repeat surgery under
anesthesia. Table 1 is adapted from the SOGC review and
reports additional case studies and randomized trials of
mesh for POP published since the Canadian review that
analyzed literature published through May 2010. In the
previously described reviews, mesh erosion was the most
common complication, occurring in 5–19% of vaginal
repairs using mesh (2–11% in the SOGC report). Some
acknowledged risk factors for mesh erosion include uro-
genital atrophy and smoking, and vaginal or topical estro-
gen and smoking cessation may be helpful for affected
women (12). Overall, complication rates from vaginal
mesh range from less than 1% to 15%; however, because
most of the studies cited in the SOGC report were obser-
vational and of short follow-up, there is concern that the
complication rates could be higher than those estimated
from these reviews.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 419
 Table 1. Range of Percentage of Mesh-Related Complications
Range Based on
Range Based on Randomized
Reported Case Series Controlled Trials
Complication (%) (%)
Mesh erosion 1–18.8 5–19
(exposure)
Buttock, groin, 2.9–18.3 0–10
or pelvic pain
De novo dyspareunia 2.2–15 8–27.8
Reoperation* 1.3–7.6 3.2–22
*Does not include reoperation for stress urinary incontinence.
Data from Transvaginal mesh procedures for pelvic organ prolapse. SOGC Technical
Update No. 254. Society of Obstetricians and Gynaecologists of Canada. J Obstet
Gynaecol Can 2011;33:168–74; Carey M, Higgs P, Goh J, Lim J, Leong A, Krause H,
et al. Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised
controlled trial. BJOG 2009;116:1380–6; Nieminen K, Hiltunen R, Takala T,
Heiskanen E, Merikari M, Niemi K, et al. Outcomes after anterior vaginal wall
repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J
Obstet Gynecol 2010;203:235.e1–235.e8; Miller D, Lucente V, Babin E, Beach P,
Jones P, Robinson D. Prospective clinical assessment of the transvaginal mesh
technique for treatment of pelvic organ prolapse-5-year results. Female Pelvic
Med Reconstr Surg 2011;17:139–43; Jacquetin B, Fatton B, Rosenthal C, Clave H,
Debodinance P, Hinoul P, et al. Total transvaginal mesh (TVM) technique for treat-
ment of pelvic organ prolapse: a 3-year prospective follow-up study. Int Urogynecol
J Pelvic Floor Dysfunct 2010;21:1455–62; Nguyen JN, Burchette RJ. Outcome
after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol
2008;111:891–8; Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL,
et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol
2010;116:293–303; Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME.
Trocar-guided mesh compared with conventional vaginal repair in recurrent pro-
lapse: a randomized controlled trial. Obstet Gynecol 2011;117:242–50; Maher C,
Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse
in women. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.:
CD004014. DOI: 10.1002/14651858.CD004014.pub4; and Altman D, Vayrynen T,
Engh ME, Axelsen S, Falconer C. Anterior colporrhaphy versus transvaginal mesh
for pelvic-organ prolapse. Nordic Transvaginal Mesh Group. N Engl J Med 2011;364:
1826–36.
Several recent retrospective reports provide longer
follow-up. One reported that vaginal erosion rates for
anterior mesh repairs ranged from 7% to 20% (13) with
one half of the cases managed with vaginal estrogen and
antibiotics and the other half requiring surgical mesh
removal (partial or complete). Another reported 5-year
follow-up in a cohort of 85 women after vaginal mesh
surgery (14). The overall rate of mesh exposure was 18.8%
with 56% (9/16 patients) requiring reintervention for par-
tial mesh excision. Anatomic success rate (defined as less
than POP quantification system stage II) at 5 years was
66.7%. One report evaluated a cohort of 355 women after
vaginal mesh procedures (15). Eighteen percent of the
women developed pelvic muscle dysfunction and pain;
of these, one quarter continued to have symptoms after 6
months of therapy.
Pelvic pain, groin pain, and dyspareunia can occur
with pelvic reconstructive surgery regardless of the use or
nonuse of mesh. However, a complication unique to mesh
Committee Opinion No. 513
COMMITTEE OPINIONS
is erosion (also described as exposure or extrusion), which
seems to be the most common complication, and may
sometimes present several years after the index proce-
dure. There are increasing reports of vaginal pain associ-
ated with changes that can occur with mesh (contraction,
retraction, or shrinkage) that result in taut sections of
mesh; 11.7% of patients were found to have retracted
mesh in a large retrospective multicenter cohort (16).
Some of these women will require surgical intervention
to correct the condition, and some of the pain appears to
be intractable.
Risk factors for developing intractable pain after vagi-
nal mesh placement are not understood. Mesh grafts for
abdominal hernia repair, which are placed in clean surgi-
cal planes with intervening tissue layers, can cause pain in
one quarter of individuals 1 year after repair; in one half of
these cases there was functional impairment (17). Hernia
mesh also is known to undergo retraction (18), and pain
persists in patients at 5 years (19). Mesh grafts in the vagina
are placed in a clean–contaminated field with a single vag-
inal incision, and the “arms” of some mesh configurations
pass into the obturator internus and levator ani muscles.
Shrinkage or contraction of mesh around these structures
or excess tension on the mesh arms can cause vaginal pain
in some individuals. All vaginal surgery can potentially
affect vaginal length and function; however, the addition
of synthetic mesh could make the vagina, a cylindrical
organ that expands and contracts, less pliable and perhaps
more prone to pain or dyspareunia. One ultrasound study
evaluating women at 3 months after anterior vaginal mesh
placement found severe contraction or shrinkage, defined
as a decrease of more than 50% of the size of the mesh, in
9.3% of patients (20).
Based on the currently available limited data,
although many patients who undergo mesh-augmented
vaginal repairs heal well without problems, there seems
to be a small but significant group of patients who experi-
ence permanent and life-altering sequelae, including pain
and dyspareunia, from the use of vaginal mesh. These
problems emerge in studies with longer follow-up, simi-
lar to hernia literature. Large-scale registries are urgently
needed to understand the number of mesh-augmented
vaginal procedures that are being performed with POP
repair and how many of them are associated with vaginal
mesh complications as well as to balance the risks and
benefits of mesh-augmented vaginal procedures.
How effective and safe are native tissue
repairs for pelvic organ prolapse?
Native tissue repair may have better success rates than
previously thought. However, like repairs augmented
with mesh, native tissue repairs also may be associated
with complications, including pain, dyspareunia, granula-
tion tissue formation, and recurrences, all of which may
also require subsequent intervention. Older definitions
of surgical success from prolapse repairs were more ana-
tomically based (eg, no prolapse beyond -1 cm from the
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 420
 hymenal ring) and may not be the best assessment of
outcome compared with newer definitions of surgical
success, which include the absence of bulge symptoms
or rates of retreatment (21). Previous studies used defi-
nitions of success that may have been too stringent. A
2001 randomized trial of three methods of anterior wall
repair, including native tissue, ultralateral anterior col-
porrhaphy, and absorbable vaginal mesh, reported suc-
cess rates (based on anatomic success definitions) of only
30–46% (22). These low success rates were frequently
cited as a reason why innovations such as vaginal mesh
were needed to decrease failure rates. The original data
from this study were recently reanalyzed using modern
outcome measures (a composite of anatomic outcomes
and subjective success), and the revised success rates for
the three arms of this RCT were comparable, with 89% of
women having no objective prolapse beyond the hymen.
Overall, only 5% of those with 1-year follow-up data
were symptomatic, and there were no reoperations either
for recurrence or complications at 1 year (23). Patient
“success” is more than an anatomic outcome; subjective
patient-oriented success and quality of life outcomes need
to be considered as well. The ideal method for comparing
vaginal surgical procedures using native tissues and those
using vaginal mesh kits remains an RCT with an adequate
length of follow-up and blinded assessment of outcome
using several complementary outcome measures, includ-
ing cost–benefit analysis.
Who are the best patients for trans-
vaginally placed mesh?
Few data exist as to who are the best patients for trans-
vaginally placed mesh. Pelvic organ prolapse vaginal mesh
repair should be reserved for high-risk individuals in
whom the benefit of mesh placement may justify the risk,
such as individuals with recurrent prolapse (particularly
of the anterior compartment) or with medical comorbidi-
ties that preclude more invasive and lengthier open and
endoscopic procedures. The approach to the repair of
POP should take into account the patient’s medical and
surgical history, severity of prolapse, and patient prefer-
ence after education regarding the benefits and risks of the
surgical and nonsurgical alternatives.
How can patient safety be maximized
by physicians who perform pelvic
organ prolapse repairs with vaginal
mesh?
Surgeons performing complex pelvic floor reconstructive
surgery should have adequate experience and training in
native tissue repairs as well as repairs using mesh aug-
mentation specific to each device, should have a thorough
understanding of pelvic anatomy, and should be able to
counsel patients regarding the risk/benefit ratio on the
use of mesh compared with native tissue repairs. In its
2011 Safety Communication, the FDA identified trans-
4 Committee Opinion No. 513
COMMITTEE OPINIONS
vaginal placement of surgical mesh for POP repair as an
area of “continuing serious concern” (1). The FDA’s 2011
Safety Communication reaffirmed its 2008 recommenda-
tion that clinicians inform patients about the potential
for serious complications and the effect on quality of life,
including pain during sexual intercourse, scarring, and
narrowing of the vaginal wall in POP repair using surgi-
cal mesh, and provide a copy of the patient labeling from
the surgical mesh manufacturer if available. Clinicians
should be vigilant for possible adverse events from mesh.
Additionally, the FDA made several new recommenda-
tions for health care providers, including that they recog-
nize that in most cases, POP can be treated successfully
without mesh thus avoiding the risk of mesh-related com-
plications; that they choose mesh surgery only after weigh-
ing the risks and benefits of surgery with mesh versus all
surgical and nonsurgical alternatives; and that they consider
that the removal of mesh because of mesh complications
may involve multiple surgical procedures and significantly
impair the patient’s quality of life. Complete removal of
mesh may not be possible and may not result in complete
resolution of complications, including pain.
As a surgeon, one should have a thorough under-
standing of pelvic anatomy and have training in the
technique. Patients need to be counseled that there are
alternative native tissue repairs and that synthetic mesh
is permanent. Some patients may not realize that vaginal
bleeding, pain, and dyspareunia may be related to vaginal
mesh, and such reports should prompt a thorough vagi-
nal examination, and an examination under anesthesia if
needed.
Summary
Mesh kits for repair of POP were first marketed to urolo-
gists and gynecologists as a way to improve success rates
for POP repairs with native tissue, but without well-
designed trials to establish the safety and efficacy of these
devices. However, prolapse surgical procedures, with or
without mesh, are not always successful.
With the use of a composite of anatomic success,
patient-oriented improvement and satisfaction, and total
reoperation rates, success rates of native tissue repairs
may be higher than previously thought. Based on avail-
able data, transvaginally placed mesh may improve the
anatomic support of the anterior compartment compared
with native tissue repairs; however, there are insufficient
data on the use of mesh for the posterior or apical com-
partments. The risk/benefit ratio for mesh-augmented
vaginal repairs must balance improved anatomic sup-
port of the anterior vaginal wall against the cost of the
devices and increased complications such as mesh ero-
sion, exposure, or extrusion; pelvic pain; groin pain; and
dyspareunia.
Recommendations
The American College of Obstetricians and Gynecologists
and the American Urogynecologic Society make the fol-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 421
 lowing recommendations for the safe and effective use of
vaginal mesh for the repair of POP:
• Outcome reporting for prolapse surgical techniques mendations of the International Scientific Committee:
must clearly define success, both objectively (ana-
tomic results) and subjectively (patient satisfaction or
symptomatic return of bulge causing bother or requir-
ing reoperation). Complications and total reopera-
tion rates (for recurrence or complications) should
be reported as outcomes.
• Pelvic organ prolapse vaginal mesh repair should be et al. Graft use in transvaginal pelvic organ prolapse repair:
reserved for high-risk individuals in whom the ben-
efit of mesh placement may justify the risk, such as
individuals with recurrent prolapse (particularly of
the anterior compartment) or with medical comor-
bidities that preclude more invasive and lengthier
open and endoscopic procedures.
• Surgeons placing vaginal mesh should undergo train-
ing specific to each device and have experience with
reconstructive surgical procedures and a thorough
understanding of pelvic anatomy.
• Compared with existing mesh products and devices, agement of pelvic organ prolapse in women. Cochrane Data-
new products should not be assumed to have equal or
improved safety and efficacy unless clinical long-term
data are available.
• The American College of Obstetricians and Gyne-
cologists and the American Urogynecologic Society
strongly support continued audit and review of out-
comes, as well as the development of a registry for
surveillance for all current and future vaginal mesh
implants.
• Rigorous comparative effectiveness randomized trials 11. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila
of synthetic mesh and native tissue repair and long-
term follow-up are ideal.
• Patients should provide their informed consent after related directly to the insertion of prostheses (meshes,
reviewing the risks and benefits of the procedure, as
well as discussing alternative repairs.
References
1. Food and Drug Administration. FDA safety communica-
tion: UPDATE on serious complications associated with
transvaginal placement of surgical mesh for pelvic organ
prolapse. Silver Spring (MD): FDA; 2011. Available at: http://
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm262435.htm. Retrieved July 27, 2011.
2. Food and Drug Administration. FDA public health notifi-
cation: serious complications associated with transvaginal
placement of surgical mesh in repair of pelvic organ prolapse
and stress urinary incontinence. Silver Spring (MD): FDA;
2008. Available at: http://www.fda.gov/MedicalDevices/
Safety/AlertsandNotices/PublicHealthNotifications/
ucm061976.htm. Retrieved June 2, 2011.
3. Murphy M. Clinical practice guidelines on vaginal graft
use from the society of gynecologic surgeons. Society of
Gynecologic Surgeons Systematic Review Group. Obstet
Gynecol 2008;112:1123–30.
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COMMITTEE OPINIONS
4. Brubaker L, Glazener C, Jacquentin B, Maher C, Melgrem A,
Norton P, et al. Surgery for pelvic organ prolapse. In:
4th International Consultation on Incontinence. Recom-
evaluation and treatment of urinary incontinence, pelvic
organ prolapse and faecal incontinence; 2008 Jul 5–9; Paris,
France. p. 1273–320. Available at: http://www.icsoffice.org/
Publications/ICI_4/files-book/comite-15.pdf. Retrieved
June 2, 2011.
5. Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J,
a systematic review. Society of Gynecologic Surgeons Sys-
tematic Review Group. Obstet Gynecol 2008;112:1131–42.
6. Feiner B, Jelovsek JE, Maher C. Efficacy and safety of trans-
vaginal mesh kits in the treatment of prolapse of the vaginal
apex: a systematic review. BJOG 2009;116:15–24.
7. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE.
Complication and reoperation rates after apical vaginal pro-
lapse surgical repair: a systematic review [published erratum
appears in Obstet Gynecol 2009;113:1377]. Obstet Gynecol
2009;113:367–73.
8. Maher C, Feiner B, Baessler K, Glazener CM. Surgical man-
base of Systematic Reviews 2010, Issue 4. Art. No.: CD004014.
DOI: 10.1002/14651858.CD004014.pub4.
9. Transvaginal mesh procedures for pelvic organ prolapse.
SOGC Technical Update No. 254. Society of Obstetricians
and Gynaecologists of Canada. J Obstet Gynaecol Can 2011;
33:168–74.
10. Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C.
Anterior colporrhaphy versus transvaginal mesh for pelvic-
organ prolapse. Nordic Transvaginal Mesh Group. N Engl J
Med 2011;364:1826–36.
GW, Deprest J, et al. An International Urogynecological
Association (IUGA)/International Continence Society (ICS)
joint terminology and classification of the complications
implants, tapes) & grafts in female pelvic floor surgery. Int
Urogynecol J Pelvic Floor Dysfunct 2011;22:3–15.
12. Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW,
Norton PA, et al. Risk factors for mesh/suture erosion fol-
lowing sacral colpopexy. Am J Obstet Gynecol 2008;199:
688.e1–688.e5.
13. Rardin CR, Washington BB. New considerations in the
use of vaginal mesh for prolapse repair. J Minim Invasive
Gynecol 2009;16:360–4.
14. Miller D, Lucente V, Babin E, Beach P, Jones P, Robinson D.
Prospective clinical assessment of the transvaginal mesh
technique for treatment of pelvic organ prolapse-5-year
results. Female Pelvic Med Reconstr Surg 2011;17:139–43.
15. Aungst MJ, Friedman EB, von Pechmann WS, Horbach NS,
Welgoss JA. De novo stress incontinence and pelvic muscle
symptoms after transvaginal mesh repair. Am J Obstet
Gynecol 2009;201:73.e1–73.e7.
16. Caquant F, Collinet P, Debodinance P, Berrocal J, Garbin O,
Rosenthal C, et al. Safety of trans vaginal mesh procedure:
retrospective study of 684 patients. J Obstet Gynaecol Res
2008;34:449–56.
5
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 17. Bay-Nielsen M, Perkins FM, Kehlet H. Pain and functional
impairment 1 year after inguinal herniorrhaphy: a nation-
wide questionnaire study. Danish Hernia Database. Ann
Surg 2001;233:1–7.
18. Schoenmaeckers EJ, van der Valk SB, van den Hout HW,
Raymakers JF, Rakic S. Computed tomographic measure-
ments of mesh shrinkage after laparoscopic ventral incisional
hernia repair with an expanded polytetrafluoroethylene
mesh. Surg Endosc 2009;23:1620–3.
19. Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE,
Rudberg C, Smedberg S, et al. Discomfort five years after
laparoscopic and Shouldice inguinal hernia repair: a ran-
domised trial with 867 patients. A report from the SMIL
study group. SMIL Study Group. Hernia 2007;11:307–13.
20. Velemir L, Amblard J, Fatton B, Savary D, Jacquetin B.
Transvaginal mesh repair of anterior and posterior vagi-
nal wall prolapse: a clinical and ultrasonographic study.
Ultrasound Obstet Gynecol 2010;35:474–80.
21. Bradley CS, Nygaard IE. Vaginal wall descensus and pelvic
floor symptoms in older women. Obstet Gynecol 2005;
106:759–66.
6 Committee Opinion No. 513
COMMITTEE OPINIONS
22. Weber AM, Walters MD, Piedmonte MR, Ballard LA.
Anterior colporrhaphy: a randomized trial of three surgi-
cal techniques. Am J Obstet Gynecol 2001;185:1299–304;
discussion 1304–6.
23. Chmielewski L, Walters MD, Weber AM, Barber MD.
Reanalysis of a randomized trial of 3 techniques of anterior
colporrhaphy using clinically relevant definitions of success.
Am J Obstet Gynecol 2011;205:69.e1–69.e8.
Copyright December 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
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mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Vaginal placement of synthetic mesh for pelvic organ prolapse. Com-
mittee Opinion No. 513. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;118:1459–64.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 423
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 532 • August 2012 (Replaces No. 387, November 2007 and
No. 322, November 2005)
Committee on Gynecologic Practice and the
American Society for Reproductive Medicine Practice Committee
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Compounded Bioidentical Menopausal

Hormone Therapy
ABSTRACT: Although improvement in long-term health is no longer an indication for menopausal hormone
therapy, evidence supporting fewer adverse events in younger women, combined with its high overall effective-
ness, has reinforced its usefulness for short-term treatment of menopausal symptoms. Menopausal therapy
has been provided not only by commercially available products but also by compounding, or creation of an indi-
vidualized preparation in response to a health care provider’s prescription to create a medication tailored to the
specialized needs of an individual patient. The Women’s Health Initiative findings, coupled with an increase in
the direct-to-consumer marketing and media promotion of compounded bioidentical hormonal preparations as
safe and effective alternatives to conventional menopausal hormone therapy, have led to a recent increase in
the popularity of compounded bioidentical hormones as well as an increase in questions about the use of these
preparations. Not only is evidence lacking to support superiority claims of compounded bioidentical hormones over
conventional menopausal hormone therapy, but these claims also pose the additional risks of variable purity and
potency and lack efficacy and safety data. The Committee on Gynecologic Practice of the American College of
Obstetricians and Gynecologists and the Practice Committee of the American Society for Reproductive Medicine
provide an overview of the major issues of concern surrounding compounded bioidentical menopausal hormone
therapy and provide recommendations for patient counseling.

Case Study
A 50-year-old woman experiencing common menopausal
symptoms feels embarrassed to discuss these issues with
a health care provider and believes that the health care
provider’s response will be a prescription for risky hor-
mone therapy that will not address her symptoms (ie,
sleep disturbances, weight gain, knee and hip pain, hair
loss, low libido, and depression). She finds literature on
the Internet promising her that she can regain all of the
vigor and fitness of her youth. Furthermore, for the price
of a salivary hormone assay by a specialized laboratory,
she will be sent a printout of her test results along with a
customized list of the natural hormones she needs to feel
young again. Although many of these preparations are
not covered by insurance, she believes that the cost is less
than the cost of a doctor’s office visit. She reads that she
need only present this list to a health care provider willing
to prescribe it, and she will be able to take this safe form of
hormones. The given reason that these hormones are so
safe is that they are bioidentical to the natural hormones
produced by the body and have no reported risks. What
should a clinician tell this patient?
Background
Before the publication of the Women’s Health Initiative
(WHI) findings, it was believed that “replacing” lost ovar-
ian hormones would not only relieve menopausal symp-
toms but also improve overall health. This belief was
dispelled after the WHI reported a lack of cardioprotec-
tion and an increased risk of incident breast cancer (1),
venous thromboembolism (1), and stroke (2) associated
with the use of combined hormone therapy. These find-
ings dramatically changed the indications for menopausal
hormone therapy, and secondary analysis of WHI results
continues. Although improvement in long-term health is
no longer an indication for menopausal hormone therapy,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 424

 some evidence has supported fewer adverse events in
younger women (3). This, combined with its high overall
effectiveness, has reinforced its usefulness for short-term
treatment of menopausal symptoms.
Menopausal therapy has been provided not only by
commercially available products, as in the WHI, but also
by compounding. Compounding is the creation of an
individualized preparation in response to a health care
provider’s prescription to create a medication tailored to
the specialized needs of an individual patient. The WHI
findings, coupled with an increase in the direct-to-con-
sumer marketing and media promotion of compounded
bioidentical hormonal preparations as safe and effec-
tive alternatives to conventional menopausal hormone
therapy, have led to a recent increase in the popularity
of compounded bioidentical hormones as well as ques-
tions about the use of these preparations. In this joint
document, the Committee on Gynecologic Practice of
the American College of Obstetricians and Gynecologists
and the Practice Committee of the American Society for
Reproductive Medicine provide an overview of the major
issues of concern surrounding compounded bioidentical
menopausal hormone therapy and provide recommen-
dations for patient counseling.
Compounded Bioidentical Hormones
Bioidentical hormones are plant-derived hormones that
are chemically similar or structurally identical to those
produced by the body. Bioidentical hormones include
commercially available products approved by the U.S.
Food and Drug Administration (FDA), such as micron-
ized progesterone and estradiol, as well as compounded
preparations that are not regulated by the FDA. Many
compounding pharmacies use the term bioidentical hor-
mone to imply that these preparations are natural or the
same as endogenous substances and, thus, are safe. The
phrase bioidentical hormone therapy has been recog-
nized by the FDA and the Endocrine Society as a market-
ing term and not one based on scientific evidence (4).
Examples of compounded hormones include Biest
(biestrogen) and Triest (triestrogen) preparations. The
name Biest commonly refers to an estrogen preparation
based on a ratio of 20% estradiol and 80% estriol on a
milligram-per-milligram basis. A similar preparation,
Triest, usually contains a ratio of 10% estradiol, 10%
estrone, and 80% estriol. These ratios are not based on
each agent’s estrogenic potency but on the milligram
quantity of the different agents added together (5). Other
commonly compounded hormones include dehydro-
epiandrosterone, pregnenolone, testosterone, and pro-
gesterone (6). (See the FDA, “Compounded Menopausal
Hormone Therapy Questions and Answers,” in the
Resources section for additional information.)
Compounding
Compounded bioidentical hormones are made by a
compounding pharmacist from a health care provider’s
2 Committee Opinion No. 532
COMMITTEE OPINIONS
prescription and are available in various routes of admin-
istration, including oral, sublingual, and percutaneous
or as implants, injectables, and suppositories. Unlike
drugs that are approved by the FDA to be manufactured
and sold in standardized dosages, compounded prepa-
rations often are custom-made for a patient according
to a health care provider’s specifications. Traditionally,
compounding is used to provide treatment for patients
when the exact products needed are not commercially
available or different ingredients, preservatives, or routes
of administration are required because of patient intol-
erances. For example, in the case of menopausal hor-
mone therapy, there is an FDA-approved progesterone
product that contains peanut oil. A health care provi-
der’s prescription to compound progesterone to elimi-
nate the peanut oil can allow a patient with a peanut
allergy to safely use the drug. Far removed from the tra-
ditional uses of compounding is the practice of blending
commercially available drug products in proportions
tailored to individual patient information. Many com-
pounded bioidentical hormone preparations fall into
this category. Other potential advantages of compounded
hormone therapy compared with FDA-approved conven-
tional hormone therapy include greater dosage flexibil-
ity, availability of low-dose preparations, and potential
lower cost.
The practice of custom blending commercially avail-
able drug products may lack both a strong biological
rationale and medical evidence for effectiveness. More-
over, it introduces the possibility of multiple sources for
drug effects and adverse effects, making it difficult to
identify the active agent responsible. For these reasons,
compounded preparations generally are considered infe-
rior to FDA-approved agents, which have much better
characterized pharmacokinetic properties.
Lack of U.S. Food and Drug
Administration Regulation for
Compounded Preparations
Compounded preparations are not regulated by the FDA.
Although technically all compounded prescription drug
preparations could be considered unapproved new drugs,
the FDA has adopted a policy of enforcement discretion,
allowing legitimate preparation of compounded formula-
tions to be regulated by state boards of pharmacy, with a
provision of stepping in when dangerous practices must
be addressed and when drug manufacturing occurs under
the guise of compounding. There are currently no specific
regulations by the FDA on what constitutes a legitimate
claim for compounded drug preparations. In general,
states regard compounding to be part of the practice of
pharmacy. In addition, individual states’ pharmacy acts
usually permit other licensed practitioners (eg, physi-
cians, nurse practitioners, and others with prescriptive
authority) to engage in the practice of pharmacy com-
pounding for their own patients.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 425
 Regulatory Exemptions for Dietary
Supplements
Under the Dietary Supplement Health and Education Act
of 1994, compounded hormones applied to the skin are
considered to be supplements; the argument being that
the hormones came from natural sources and should
be considered in a category similar to herbs. Thus, the
potential for such agents to cause harm was considered
minimal. The Dietary Supplement Health and Education
Act exempted remedies that fell into the category of
supplements from regulation by the FDA, which requires
that, unless a drug is generally recognized as safe, its
safety and efficacy must be demonstrated before it can
be marketed. Dietary supplements are not required to
prove safety or efficacy; hence, there is no major bar-
rier to marketing them. However, the FDA can remove
these supplements from the market and subject them to
further testing if there is sufficient suspicion that they are
not safe.
Labeling Issues
The FDA requires manufacturers of FDA-approved prod-
ucts that contain estrogen and progesterone to use class
labeling (the black box warning indicating a drug with
special problems, particularly ones that may lead to death
or serious injury) reflective of the findings of the WHI.
However, because compounded preparations are not
approved by the FDA and have no official labeling (ie, a
package insert), they are exempt from including contra-
indications and warnings. They also may have additional
risks intrinsic to compounding. The lack of even rudi-
mentary pharmacokinetic data for the commonly pre-
scribed bioidentical hormone preparations should cause
considerable concern about the prudence of prescribing
such medications. In January 2008, the FDA warned seven
pharmacy operations that their claims about the safety
and efficacy of their bioidentical hormone replacement
therapy preparations were misleading and unsupported
by medical evidence because the mixtures were not tested
for purity, potency, efficacy, or safety (7).
Safety and Efficacy Issues
Because of a lack of FDA oversight, most compounded
preparations have not undergone any rigorous clinical
testing for either safety or efficacy, the purity, potency,
and quality of compounded preparations are a concern.
Over a 6-month period, the FDA performed repeat ana-
lytic testing of 29 Internet-ordered samples—including
estradiol and progesterone—from 12 compounding phar-
macies (8). Although none of the preparations failed iden-
tity testing, 10 of the 29 preparations (34%) failed one or
more standard quality tests performed, including potency
testing. In contrast, the analytical testing failure rate for
drug therapies approved by the FDA is less than 2%.
Because of variable bioavailability and bioactivity,
underdosage and overdosage are both possible. Certain
progestin preparations, such as that found in the Mexican
Committee Opinion No. 532
COMMITTEE OPINIONS
wild yam, are not bioavailable to humans and, therefore,
patients can believe that they are receiving endome-
trial protection against hyperplasia when they are not (9).
Similarly, underdosing of estrogen can lead a woman to
believe that she is protected against osteoporosis when,
in fact, bone resorption is progressing. Estriol is substan-
tially less bioactive than estradiol, and large quantities
must be used to achieve any biological effect. The poten-
tial for overdosage also exists, which can lead to increased
risks of endometrial hyperplasia, endometrial cancer, and
venous thromboembolism.
Hormone Level Testing and
Compounded Bioidentical
Hormone Use
Many advocates and compounders of bioidentical hor-
mones recommend the use of salivary hormone level
testing (and other proposed mechanisms, such as serum
and urine testing) as a means of offering individualized
therapy. However, individualized testing only is indicated
when a narrow therapeutic window exists for a drug or a
drug class. This includes drugs with nonlinear pharma-
cokinetics, that are eliminated by the kidney as the active
drug, that are not metabolized during first pass through
the liver, and that have clearly defined therapeutic and
toxic concentrations based on large-population phar-
macokinetic studies of serum concentrations. Steroid
hormones, such as estrogen and progesterone do not
meet these criteria and, thus, do not require individual-
ized testing.
There is no evidence that hormonal levels in saliva
are biologically meaningful. In addition, whereas saliva
is an ultrafiltrate of the blood and in theory should be
amenable to testing for “free” (unbound) concentrations
of hormones, salivary testing does not currently offer
an accurate or precise method of hormone testing (10,
11). There are several problems with salivary testing and
monitoring of free hormone levels. First, salivary levels do
not consistently provide a reasonable representation of
endogenous, circulating serum hormones (12). There is
large within-patient variability in salivary hormone con-
centrations, especially when exogenously administered
hormones are given (11, 13–16). Salivary hormone levels
vary depending on diet, time of testing, and the specific
hormone being tested (11, 14, 17–19). Second, because
the pharmacokinetics of exogenously administered com-
pounded hormones cannot be known, it is not possible
to estimate with reliability how and when to test saliva
to obtain a representative result. Third, saliva contains
far lower concentrations of hormone than serum and is
prone to contamination with blood, infectious agents,
and epithelial cells––all of which may affect the level of
hormone to be measured.
Although more sensitive testing is becoming avail-
able through the use of mass spectrometry, there are
few indications for the measurement of hormone
levels to ascertain success of therapy when treating a
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 426
 postmenopausal woman with hormones. If treatment is
initiated for symptom control, subjective improvement
in symptoms is the therapeutic end point, and there is
no need to assess hormone levels. Hormone therapy
should not be titrated to hormone levels (serum, uri-
nary, or salivary).
Patient Counseling
Patients should be counseled that menopausal hormonal
therapies that are proved to be safe and effective by the
FDA are more appropriate for their use than individual
pharmacy-compounded preparations. Patients should
be educated on the FDA approval status of compounded
preparations and their risks and benefits, including the
risks specific to compounding. Physicians should exer-
cise caution in prescribing compounded hormones when
FDA-approved alternatives exist.
The following preparations are naturally occurring
hormones that are ingredients in FDA-approved products:
Estrogens
• Estradiol-17b (transdermal or oral, micronized)
• Estrone (sodium estrone sulfate)––active ingredient References
in naturally occurring conjugated equine estrogen
preparations and in synthetic conjugated estrogen
preparations
Progesterone
• Progesterone (oral, micronized or vaginal gel or insert)
Regardless of the type of preparation, the varying for-
mulations available, pharmacodynamics, and individual
patient factors must be taken into consideration when
using menopausal hormone therapy.
Conclusions and Recommendations
The American College of Obstetricians and Gynecologists’
Committee on Gynecologic Practice and the Practice
Committee of the American Society for Reproductive
Medicine make the following conclusions and recom-
mendations:
• Evidence is lacking to support superiority claims of issues. Menopause 2008;15:1014–22. [PubMed] ^
compounded bioidentical hormones over conven-
tional menopausal hormone therapy.
• Customized compounded hormones pose additional [PubMed] ^
risks. These preparations have variable purity and
potency and lack efficacy and safety data.
• Because of variable bioavailability and bioactivity, Compounding 2000;4:414–20. ^
both underdosage and overdosage are possible.
• Conventional hormone therapy is preferred over
compounded hormone therapy given the available
data.
• Despite claims to the contrary, evidence is inad-
equate to support increased efficacy or safety for
individualized hormone therapy regimens based on
salivary, serum, or urinary testing.
4 Committee Opinion No. 532
COMMITTEE OPINIONS
Resources
U.S. Food and Drug Administration. Compounded meno-
pausal hormone therapy questions and answers. Avail-
able at: http://www.fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/PharmacyCompounding/ucm183
088.htm. Retrieved April 23, 2012. ^
U.S. Food and Drug Administration. The special risks
of pharmacy compounding. Silver Spring (MD): FDA;
2007. Available at: http://www.fda.gov/downloads/For
Consumers/ConsumerUpdates/ucm107839.pdf. Retrieved
April 23, 2012.
North American Menopause Society. Hormone products
for postmenopausal use in the United States and Canada.
Mayfield Heights (OH): NAMS; 2011. Available at: http://
www.menopause.org/htcharts.pdf. Retrieved April 23,
2012.
Marshall DD, Iglesia C. A guide to lotions and potions
for treating vaginal atrophy. OBG Manage 2009;21(12):
29–30, 32, 34–7.
1. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ,
Kooperberg C, Stefanick ML, et al. Risks and benefits of
estrogen plus progestin in healthy postmenopausal women:
principal results From the Women’s Health Initiative ran-
domized controlled trial. Writing Group for the Women’s
Health Initiative Investigators. JAMA 2002;288:321–33.
[PubMed] [Full Text] ^
2. Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G,
Kooperberg C, Baird A, et al. Effect of estrogen plus pro-
gestin on stroke in postmenopausal women: the Women’s
Health Initiative: a randomized trial. WHI Investigators.
JAMA 2003;289:2673–84. [PubMed] [Full Text] ^
3. Rossouw JE, Prentice RL, Manson JE, Wu L, Barad D,
Barnabei VM, et al. Postmenopausal hormone therapy and
risk of cardiovascular disease by age and years since meno-
pause [published erratum appears in JAMA 2008;299:
1426]. JAMA 2007;297:1465–77. [PubMed] [Full Text] ^
4. Rosenthal MS. The Wiley Protocol: an analysis of ethical
5. Boothby LA, Doering PL, Kipersztok S. Bioidentical hor-
mone therapy: a review. Menopause 2004;11:356–67.
6. Drisko JA. “Natural” isomolecular hormone replacement:
an evidence-based medicine approach. Int J Pharmaceut
7. U.S. Food and Drug Administration. FDA takes action
against compounded menopause hormone therapy drugs.
Silver Spring (MD): FDA; 2008. Available at: http://www.fda.
gov/NewsEvents/Newsroom/PressAnnouncements/2008/
ucm116832.htm. Retrieved February 15, 2012. ^
8. U.S. Food and Drug Administration. Report: limited FDA
survey of compounded drug products. Silver Spring
(MD): FDA; 2009. Available at: http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Pharmacy
2013 COMPENDIUM OF SELECTED PUBLICATIONS 427
 Compounding/ucm155725.htm. Retrieved February 15,
2012. ^
9. American College of Obstetricians and Gynecologists. Use
of botanicals for management of menopausal symptoms.
ACOG Practice Bulletin 28. Washington, DC: ACOG; 2001.
[PubMed] ^
10. Flyckt RL, Liu J, Frasure H, Wekselman K, Buch A,
Kingsberg SA. Comparison of salivary versus serum tes-
tosterone levels in postmenopausal women receiving
transdermal testosterone supplementation versus placebo.
Menopause 2009;16:680 –8. [PubMed] ^
11. Lewis JG, McGill H, Patton VM, Elder PA. Caution on
the use of saliva measurements to monitor absorption of
progesterone from transdermal creams in postmenopausal
women. Maturitas 2002;41:1–6. [PubMed] [Full Text] ^
12. Ellison PT. Human salivary steroids: methodological con-
siderations and applications in physical anthropology. Am
J Phys Anthropol 1988;31(suppl 9):115–42. ^
13. Hardiman P, Thomas M, Osgood V, Vlassopoulou V,
Ginsburg J. Are estrogen assays essential for monitor-
ing gonadotropin stimulant therapy? Gynecol Endocrinol
1990;4:261–9. [PubMed] ^
14. Klee GG, Heser DW. Techniques to measure testosterone
in the elderly. Mayo Clin Proc 2000;75(suppl):S19–25.
[PubMed] ^
15. Meulenberg PM, Ross HA, Swinkels LM, Benraad TJ. The
effect of oral contraceptives on plasma-free and salivary
cortisol and cortisone. Clin Chim Acta 1987;165:379–85.
[PubMed] ^
16. Wren BG, McFarland K, Edwards L, O’Shea P, Sufi S,
Gross B, et al. Effect of sequential transdermal progester-
Committee Opinion No. 532
COMMITTEE OPINIONS
one cream on endometrium, bleeding pattern, and plasma
progesterone and salivary progesterone levels in postmeno-
pausal women. Climacteric 2000;3:155–60. [PubMed] ^
17. Bolaji II, Tallon DF, O’Dwyer E, Fottrell PF. Assessment of
bioavailability of oral micronized progesterone using a sali-
vary progesterone enzymeimmunoassay. Gynecol Endo-
crinol 1993;7:101–10. [PubMed] ^
18. Raff H, Raff JL, Duthie EH, Wilson CR, Sasse EA, Rudman I,
et al. Elevated salivary cortisol in the evening in healthy
elderly men and women: correlation with bone mineral
density. J Gerontol A Biol Sci Med Sci 1999;54:M479–83.
[PubMed] ^
19. Zava DT, Dollbaum CM, Blen M. Estrogen and progestin
bioactivity of foods, herbs, and spices. Proc Soc Exp Biol
Med 1998;217:369–78. [PubMed] ^
Copyright August 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
This article is being published concurrently in the August 2012 issue
of Fertility and Sterility.
ISSN 1074-861X
Compounded bioidentical menopausal hormone therapy. Committee
Opinion No. 532. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2012;120:411–5.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 428
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 534 • August 2012
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Well-Woman Visit
Abstract: The annual health assessment (“annual examination”) is a fundamental part of medical care and is
valuable in promoting prevention practices, recognizing risk factors for disease, identifying medical problems, and
establishing the clinician–patient relationship. The annual health assessment should include screening, evaluation
and counseling, and immunizations based on age and risk factors. The interval for specific individual services and
the scope of services provided may vary in different ambulatory care settings. The performance of a physical
examination is a key part of an annual health assessment visit, and the components of that examination may vary
depending on the patient’s age, risk factors, and physician preference. The American College of Obstetricians
and Gynecologists explains the need for annual assessments and provides guidelines regarding some important
elements of the annual examination; specifically, when to perform pelvic examinations in asymptomatic women,
including when to start internal pelvic and speculum examinations, and when to initiate formal clinical breast
examinations.

The annual health assessment (“annual examination”)
is a fundamental part of medical care and is valuable in
promoting prevention practices, recognizing risk factors
for disease, identifying medical problems, and establish-
ing the clinician–patient relationship (1). New recom-
mendations and improving technologies continue to
influence guidelines and the necessary components of the
annual health assessment of women. The purpose of this
Committee Opinion is to explain the need for annual
assessments and to provide guidelines regarding some
important elements of the annual examination; specifi-
cally, when to perform pelvic examinations in asymptom-
atic women, including when to start internal pelvic and
speculum examinations, and when to initiate formal clini-
cal breast examinations. Recommendations regarding the
role of pelvic examination in the evaluation of symptoms
are published elsewhere (2).
The Importance of the Annual Visit
Obstetrician–gynecologists have a tradition of providing
preventive care to women. An annual visit provides an
excellent opportunity to counsel patients about main-
taining a healthy lifestyle and minimizing health risks.
The annual health assessment should include screening,
evaluation and counseling, and immunizations based on
age and risk factors. The interval for specific individual
services and the scope of services provided may vary in
different ambulatory care settings. The performance of a
physical examination is a key part of an annual visit, and
the components of that examination may vary depending
on the patient’s age, risk factors, and physician prefer-
ence. In general, the physical examination will include
obtaining standard vital signs, determining body mass
index, palpating the abdomen and inguinal lymph nodes,
and making an assessment of the patient’s overall health.
Many, but not all, women will have a pelvic examination
and a clinical breast examination as a part of the physical
examination. Information on these core elements of the
physical examination is provided in the following sections.
The American College of Obstetricians and Gynecologists
(the College) has comprehensive recommendations and
resources for the annual health assessment of women
available online at www.acog.org/wellwoman.
Pelvic Examination
The pelvic examination includes three elements: 1) in-
spection of the external genitalia, urethral meatus, vaginal
introitus, and perianal region (external examination); 2)
speculum examination of the vagina and cervix; and 3)
bimanual examination of the uterus, cervix, and adnexa

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 429

 (the latter two elements constitute the internal examina-
tion). When indicated, a rectovaginal examination also
should be performed.
Annual pelvic examination of patients 21 years of age
or older is recommended by the College. At this time, this
recommendation is based on expert opinion, and limita-
tions of the internal pelvic examination should be recog-
nized. Studies have shown that the bimanual examination
is better at evaluating the uterus than the adnexa and has
a low sensitivity for detecting adnexal masses (3). Data
do not support the necessity of performing an internal
pelvic examination before initiating oral contraceptives
in otherwise healthy, asymptomatic individuals or as a
screening examination for sexually transmitted infections
(STIs) (4). Cultures for STIs can be obtained from the
cervix during an internal pelvic examination. However,
current evidence shows that screening for STIs also can be
performed without an internal pelvic examination using
nucleic acid amplification testing from urine samples or
vaginal swab specimens.
Patients Younger Than 21 Years
Currently, the College recommends that the first visit
to the obstetrician–gynecologist for screening and the
provision of preventive services and guidance take place
between the ages of 13 years and 15 years. This visit
generally does not include pelvic examination. The focus
of this visit should be on patient education. During this
visit, the obstetrician–gynecologist can establish the clini-
cian–patient relationship and engage in age-appropriate
discussion of anatomical development, body image, self-
confidence, weight management, immunizations (includ-
ing the human papillomavirus vaccine), contraception,
and prevention of STIs (5).
The College recommends that pelvic examinations
be performed only when indicated by the medical his-
tory for patients younger than 21 years (6). An “external-
only” genital examination can provide the health care
provider with the opportunity to evaluate the patient
for normal external genital anatomy, issues of personal
hygiene, and abnormalities of the vulva, introitus, and
perineum that might require further investigation. The
external-only examination also provides the clinician
with the opportunity to educate the patient on the range
of normal female anatomy.
No evidence supports the routine internal exami-
nation of the healthy, asymptomatic patient before age
21 years, although it is recognized that pelvic pathology
sometimes is identified by a pelvic examination on an
asymptomatic patient. A pelvic examination always is an
appropriate component of a comprehensive evaluation of
any patient who reports or exhibits symptoms suggestive
of female genital tract, pelvic, urologic, or rectal prob-
lems. For patients younger than 21 years with problems,
such as menstrual disorders, vaginal discharge, or pelvic
pain, an internal examination may be necessary.
2 Committee Opinion No. 534
COMMITTEE OPINIONS
The College guidelines for cervical cytology screen-
ing published in May 2009 now recommend beginning
cervical cancer screening at age 21 years, irrespective of
sexual activity of the patient (6). This is based on the
current understanding of human papillomavirus infec-
tion in the adolescent patient and the pathophysiology of
invasive cervical cancer.
Testing for STIs is recommended for sexually active
adolescents. Nucleic acid amplification testing on urine
samples or vaginal swab specimens is now an acceptable
form of screening for gonorrhea and chlamydial infec-
tions (7, 8) obviating the need for cervical sampling.
Other options that do not require an internal examina-
tion include self-collected vaginal swabs for diagnosing
yeast infections, trichomoniasis, and bacterial vaginosis.
Patients Aged 21 Years and Older
The College guidelines recommend that a pelvic examina-
tion be performed on an annual basis in all patients aged
21 years and older (2). No evidence supports or refutes
the annual pelvic examination or speculum and bimanual
examination for the asymptomatic, low-risk patient. An
annual pelvic examination seems logical, but also lacks
data to support a specific time frame or frequency of such
examinations. The decision whether or not to perform a
complete pelvic examination at the time of the periodic
health examination for the asymptomatic patient should
be a shared decision after a discussion between the patient
and her health care provider.
A pelvic examination always is an appropriate com-
ponent of a comprehensive evaluation of any patient who
reports or exhibits symptoms suggestive of female genital
tract problems. Patients with menstrual disorders, vaginal
discharge, infertility, or pelvic pain should receive a pelvic
examination. Perimenopausal patients with abnormal
uterine bleeding, changes in bowel or bladder function,
or symptoms of vaginal discomfort should have a pelvic
examination. Pelvic symptoms related to later reproduc-
tive years and menopause, such as abnormal bleeding,
vaginal bulge, urinary or fecal incontinence, or vaginal
dryness, warrant a pelvic examination. Bimanual exami-
nation is indicated before procedures, such as an endo-
metrial biopsy, inserting an intrauterine device, or fitting
a diaphragm or pessary. A patient’s personal and family
medical history and known risk factors for gynecologic
malignancies can affect the decision regarding the indica-
tions for a pelvic examination. An exhaustive list of spe-
cific indications for a pelvic examination for all patients is
beyond the scope of this document. Sound clinical judg-
ment always must be the guiding factor in determining
when a pelvic examination is indicated.
The decision to receive an internal examination
can be left to the patient if she is asymptomatic and has
undergone a total hysterectomy and bilateral salpingo–
oophorectomy for benign indications and has no history
of vulvar intraepithelial neoplasia, cervical intraepithelial
neoplasia 2, cervical intraepithelial neoplasia 3, or cancer;
2013 COMPENDIUM OF SELECTED PUBLICATIONS 430
 is not infected with human immunodeficiency virus
(HIV); is not immunocompromised; and was not exposed
to diethylstilbestrol in utero. Cytology testing is not rec-
ommended in this select population. Annual examination
of the external genitalia should continue. Also, it would be
reasonable to stop performing pelvic examinations when
a woman’s age or other health issues reach a point where
the woman would not choose to intervene on conditions
detected during the routine examination, particularly if
she is discontinuing her other routine health care main-
tenance assessments. This conclusion can be documented
after a process of shared and ongoing communication and
decision making between the patient and physician (9).
Clinical Breast Examination
No data exist regarding the ideal age at which to begin
clinical breast examinations in the asymptomatic, low-
risk patient. Expert opinion suggests that the value of
clinical breast examination and the ideal time to start
such examinations is influenced by the patient’s age and
known risk factors for breast cancer. The occurrence of
breast cancer is rare before age 20 years and uncommon
before age 30 years (10). Based on available evidence, the
College, the American Cancer Society (ACS), and the
National Comprehensive Cancer Network recommend
that clinical breast examination be performed annually
in women aged 40 years and older. Although the value
of a screening clinical breast examination for women with
a low prevalence of breast cancer (eg, women aged 20–39
years) is not clear, the College, ACS, and the National
Comprehensive Cancer Network continue to recom-
mend clinical breast examination for these women every
1–3 years (11). All three organizations also recommend
the teaching of breast self-awareness and inquiry into
medical history and family history of risk factors for breast
disease. Breast self-awareness educates patients about the
normal feel and appearance of their breasts (12). For
many patients, breast self-awareness also may include per-
forming breast self-examinations. Both modalities have
the potential to alert the patient to changes in her breast
that should be reported immediately to her physician and
may lead to earlier detection of breast cancer.
Mammography is the primary tool for breast cancer
screening, and the roles of the clinical breast examina-
tions and breast self-examinations have been questioned
by some experts. The 2009 U.S. Preventive Services Task
Force report on breast cancer screening states that “cur-
rent evidence is insufficient to assess the additional ben-
efits and harms of clinical breast examinations beyond
screening mammography in women 40 years and older”
(13). The data evaluated by the U.S. Preventive Services
Task Force in its 2009 recommendation suggest that
teaching breast self-examination does not reduce the
mortality rate of breast cancer and it recommends against
clinicians teaching women how to perform breast self-
examination (13). However, 8–17% of cases of breast
cancer are missed by mammography (14). The clinical
Committee Opinion No. 534
COMMITTEE OPINIONS
breast examination and breast self-awareness, which may
include breast self-examination, have the potential to
detect a palpable cancer. Some studies show that clinical
breast examination and mammography together have a
better sensitivity than mammographic screening alone
for detecting breast cancer (15–17). Thus, the clinical
breast examination still is recommended as part of the
periodic health examination of women, especially those
with known risk factors for breast cancer.
Shared Communication and
Decision Making
The decision to perform an internal pelvic examina-
tion, breast examination, or both should be made by the
physician and the patient after shared communication
and decision making. Concerns, such as individual risk
factors, patient expectations, or medical–legal concerns
may influence the decision to perform an internal pel-
vic examination or clinical breast examination. In these
situations, the medical record should reflect the pertinent
details of the patient’s medical and family history and
overall condition, documentation of the physical exami-
nation, and the issues discussed between the patient and
physician. The decision to perform any type of pelvic or
breast examination should always be made with the con-
sent of the patient.
Conclusions and Recommendations
• An annual visit provides an excellent opportunity to
counsel patients about maintaining a healthy lifestyle
and minimizing health risks.
• The annual health assessment should include screen-
ing, evaluation and counseling, and immunizations
based on age and risk factors.
• Speculum examinations for cervical cancer screening
should begin at age 21 years, irrespective of sexual
activity of the patient.
• A pelvic examination always is an appropriate com-
ponent of a comprehensive evaluation of any patient
who reports or exhibits symptoms suggestive of female
genital tract, pelvic, urologic, or rectal problems.
• The decision to receive an internal examination can
be left to the patient if she is asymptomatic and has
undergone a total hysterectomy and bilateral sal-
pingo–oophorectomy for benign indications and has
no history of vulvar intraepithelial neoplasia, cervical
intraepithelial neoplasia 2, cervical intraepithelial
neoplasia 3, or cancer; is not infected with HIV; is
not immunocompromised; and was not exposed to
diethylstilbestrol in utero. Cytology testing is not rec-
ommended in this select population. Annual exami-
nation of the external genitalia should continue.
• Breast self-awareness, which for many patients also
may include performing breast self-examination,
is recommended. The patient should immediately
report changes in her breast to her physician.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 431
 • Based on available evidence, the College, ACS, and 9. End-of-life decision making. ACOG Committee Opinion
the National Comprehensive Cancer Network rec-
ommend that a clinical breast examination be per-
formed annually in women aged 40 years and older.
In women aged 20–39 years, the College, ACS, and
the National Comprehensive Cancer Network con-
tinue to recommend a clinical breast examination
every 1–3 years.
• The decision to perform any type of pelvic or breast College of Obstetricians and Gynecologists. Obstet Gynecol
examination should always be made with the consent
of the patient.
References
1. Boulware LE, Marinopoulos S, Phillips KA, Hwang CW,
Maynor K, Merenstein D, et al. Systematic review: the
value of the periodic health evaluation. Ann Intern Med
2007;146:289–300. [PubMed] [Full Text] ^
2. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual. 3rd
ed. Washington, DC: ACOG; 2007. ^
3. Padilla LA, Radosevich DM, Milad MP. Accuracy of
the pelvic examination in detecting adnexal masses.
Obstet Gynecol 2000;96:593–8. [PubMed] [Obstetrics &
Gynecology] ^
4. Stewart FH, Harper CC, Ellertson CE, Grimes DA, Sawaya
GF, Trussell J. Clinical breast and pelvic examination
requirements for hormonal contraception: current practice
vs evidence. JAMA 2001;285:2232–9. [PubMed] [Full Text]
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5. The initial reproductive health visit. Committee Opinion
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7. Screening for gonorrhea: U.S. Preventive Services Task
Force recommendation statement. U.S. Preventive Services
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8. Screening for chlamydial infection: U.S. Preventive Services
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[PubMed] [Full Text] ^
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No. 403. American College of Obstetricians and Gynecol-
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10. Pearlman MD, Griffin JL. Benign breast disease. Obstet
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11. Breast cancer screening. Practice Bulletin No. 122. American
2011;118:372–82. [PubMed] [Obstetrics & Gynecology] ^
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Atlanta (GA): ACS; 2011. Available at: http://www.cancer.
org/acs/groups/cid/documents/webcontent/003165.pdf.
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13. Screening for breast cancer: U.S. Preventive Services Task
Force recommendation statement. US Preventive Services
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Intern Med 2009;151:716–26, W-236. [PubMed] ^
14. Goodson WH 3rd, Hunt TK, Plotnik JN, Moore DH 2nd.
Optimization of clinical breast examination. Am J Med
2010;123:329–34. [PubMed] ^
15. Jatoi I. Screening clinical breast examination. Surg Clin
North Am 2003;83:789–801. [PubMed] ^
16. Oestreicher N, Lehman CD, Seger DJ, Buist DS, White
E. The incremental contribution of clinical breast exami-
nation to invasive cancer detection in a mammography
screening program. AJR Am J Roentgenol 2005;184:428–
17. Chiarelli AM, Majpruz V, Brown P, Theriault M, Shumak R,
Mai V. The contribution of clinical breast examination to
the accuracy of breast screening. J Natl Cancer Inst 2009;
101:1236 – 43. [PubMed] ^
Copyright August 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Well-woman visit. Committee Opinion No. 534. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2012;120:421–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 432
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 537 • October 2012
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Reprocessed Single-Use Devices

ABSTRACT: The reprocessing and reuse of single-use instruments has become increasingly common.
Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate
of physical defects, performance issues, or improper decontamination. There are currently no data in the medical
literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery.
The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is
the operating surgeon’s ethical responsibility to make a good faith effort to know whether reprocessed single-use
devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the
instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gyneco-
logic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or
reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-
use devices.

Reprocessing single-use devices involves reusing instru-
ments that were designed and sold for single-use only.
Single-use instruments have been reprocessed and reused
since the 1970s. Initially, hospitals widely accepted
single-use devices in an effort to avoid product aging,
overuse, and malfunction. Since the 1990s, efforts by hos-
pitals to contain costs have created incentives to reprocess
single-use devices. Today, the reprocessing market earns
nearly $40 million annually. The reuse of single-use
devices is a complex issue that requires consideration
of patient safety, wise allocation of health care dollars,
and informed consent. Due to the increase in the repro-
cessing of single-use devices, obstetrician–gynecologists
should be educated about this practice. This document
includes a discussion of the definition of reprocessed
single-use devices, the regulation of these instruments,
as well as issues of safety and quality, cost-effectiveness,
and ethics.
Reprocessed Single-Use Devices
Because of the variety of single-use devices, from simple
and inert to complex and electronic, it is challenging
to critique the process. Single-use devices range from
an external device designed to lie against the skin, such
as the plastic boots used for venous thromboembolism
prophylaxis (intermittent pneumatic compression), to
more invasive and complex electrothermal equipment
consisting of insulation, sharp blades, and crevices that
may become filled with blood or human tissue.
Regulation
Current law requires that the institutions or companies
that reprocess single-use devices for repeat use be held to
the original manufacturing specifications for the single-use
instrument. Testimony regarding the 1977 Compliance
Policy Guide issued by the U.S. Food and Drug Admin-
istration (FDA) clarified that hospitals that reprocess
single-use devices assume full liability and responsibility
for their reprocessing actions (1). This policy did not
provide for third-party reprocessors, so in 2000, the
FDA issued a new guidance document that included
descriptions of the regulations that the FDA would apply
to third-party and hospital reprocessors of single-use
devices (2). Under the Medical Device User Fee and
Modernization Act of 2002, a reprocessed medical device
is considered a product of the reprocessing company and
no longer a product of the original manufacturer; the
name of the manufacturer of the reprocessed device is
required to be placed in the space identifying the person
responsible for reprocessing (3). This 2002 congressional
act established new statutory requirements for repro-
cessed single-use devices, including labeling to identify
the devices as reprocessed, submission of validation data
for many reprocessed single-use devices, and submission

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 433

 of premarket notification (510[k]) with validation data
(3, 4).
Safety and Quality
In a 2008 report to the U.S. Congress, the Government
Accountability Office (GAO) stated that despite increased
use of reprocessed single-use devices, there appears to be
no increased health risk (5). However, this report may
not reflect the full spectrum of important safety issues
because it refers to all categories of devices and relies
only on voluntarily reported adverse events. The GAO
also stated that because of the limited number of identi-
fied peer-reviewed studies related to reprocessing, there
was insufficient evidence to support a comprehensive
conclusion on the relative safety of reprocessed single-
use devices compared with single-use devices on their
initial use.
As with any surgical device, reprocessed or not,
relying on voluntarily reported adverse events likely
underrepresents associated health risks. In the case of
reprocessed single-use devices, particularly in products
used for invasive procedures such as hysterectomy, it is
unlikely that a postoperative surgical site infection would
ever be linked to, or reported as related to, the use of a
reprocessed single-use device. Furthermore, if an adverse
event were to be reported, it may be attributed errone-
ously to the original manufacturer of the product. (For
more information, MedWatch, the FDA safety informa-
tion and adverse event reporting program can be accessed
at http://www.fda.gov/Safety/MedWatch/default.htm.)
Publications exist in the medical literature on ortho-
pedics and laparoscopic surgery that report on the quality
of reprocessed single-use devices, such as arthroscopic
shavers and harmonic scalpels (6–10). These studies have
largely been funded by the original device manufacturers,
and limited independent studies are available. However,
all studies found a significant rate of physical defects,
performance issues, or improper decontamination of
reprocessed single-use devices.
Cost-Effectiveness
There are currently no data in the medical literature of
studies evaluating the cost-effectiveness of reprocessed
single-use devices in gynecologic surgery. Each repro-
cessed device costs less to purchase than the original,
but no information is available regarding any change in
operative time or the need to use more than one device
if malfunction occurs. Reprocessed devices result in cost
savings for the hospital, but it is not apparent that there is
any financial benefit to the patient or third-party payers.
Existing Guidelines
The Association of periOperative Registered Nurses has
issued a guidance statement regarding reprocessed single-
use devices (11). This group’s recommendations include
that the sterility, integrity, and functionality of a repro-
2 Committee Opinion No. 537
COMMITTEE OPINIONS
cessed single-use device must be documented as safe for
patient care and/or equal to the original device specifica-
tions.
Ethical Issues
The use of a reprocessed single-use device provides
no direct benefit to an individual patient or her physi-
cian. Devices must be clearly labeled as manufactured
by the reprocessor. Physicians should be informed that
the instrument being used is a reprocessed single-use
device. The right of the patient to be informed is also
a consideration. It remains the operating surgeon’s ethi-
cal responsibility to make a good faith effort to know
whether reprocessed single use devices are to be used. If
the surgeon has concerns about the quality or safety of
the instrument(s), he or she has the ethical obligation to
not use the instrument(s).
Conclusion
Studies on the safety, quality, and cost-effectiveness of
reprocessed single-use devices in gynecologic surgery
are needed. Physicians should be informed whether the
instruments used in surgery are original or reprocessed.
Adverse events should be reported to improve the safety
information about reprocessed single-use devices.
References
1. Feigal DW. Reuse of medical devices labeled for single-
use. Statement of David W. Feigal, M.D. before the Senate
Committee on Health, Education, Labor, and Pensions, June
27, 2000. Silver Spring (MD): Food and Drug Administra-
tion; 2000. Available at: http://www.fda.gov/NewsEvents/
Testimony/ucm114926.htm. Retrieved April 30, 2012. ^
2. Food and Drug Administration. Guidance for industry
and for FDA staff: enforcement priorities for single-use
devices reprocessed by third parties and hospitals. Silver
Spring (MD): FDA; 2000. Available at: http://www.fda.
gov/downloads/MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ucm107172.pdf. Retrieved
April 30, 2012. ^
3. Medical device user fee and modernization act of 2002.
Pub L No. 107-250, 116 Stat 216 (2002). ^
4. Food and Drug Administration. Summary of the
Medical Device User Fee and Modernization Act of 2002:
including changes made by the Medical Devices Technical
Corrections Act. Silver Spring (MD): FDA; 2004. Available
at: http://www.fda.gov/downloads/MedicalDevices/Device
RegulationandGuidance/Overview/MedicalDeviceUser
FeeandModernizationActMDUFMA/ucm109123.pdf.
Retrieved April 30, 2012. ^
5. Government Accountability Office. Reprocessed single-use
medical devices. Report to the Committee on Oversight
and Government Reform, House of Representatives.
Washington, DC: GAO; 2008. Available at: http://www.gao.
gov/new.items/d08147.pdf. Retrieved April 30, 2012. ^
6. King JS, Pink MM, Jobe CM. Assessment of reprocessed
arthroscopic shaver blades. Arthroscopy 2006;22:1046–52.
[PubMed] ^
2013 COMPENDIUM OF SELECTED PUBLICATIONS 434
 7. Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R,
Matthews BD, et al. Comparison of mechanical and in vivo
performance of new and reprocessed harmonic scalpels.
Urology 2006;67:898–903. [PubMed] ^
8. Roth K, Heeg P, Reichl R. Specific hygiene issues relating
to reprocessing and reuse of single-use devices for laparo-
scopic surgery. Surg Endosc 2002;16:1091–7. [PubMed] ^
9. Granados DL, Jimenez A, Cuadrado TR. Assessment of
parameters associated to the risk of PVC catheter reuse.
J Biomed Mater Res 2001;58:505–10. [PubMed] ^
10. Hambrick D 3rd. Reprocessing of single-use endoscopic
biopsy forceps and snares. One hospital’s study. Gastro-
enterol Nurs 2001;24:112–5. [PubMed] ^
Committee Opinion No. 537
COMMITTEE OPINIONS
11. Association of periOperative Registered Nurses. AORN
Guidance Statement: reuse of single-use devices. In: Peri-
operative standards and recommended practices. Denver
(CO): AORN; 2012. p. 717–24. ^
Copyright October 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved.
ISSN 1074-861X
Reprocessed single-use devices. Committee Opinion No. 537.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012:120:974–6.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 435
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 540 • November 2012
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Risk of Venous Thromboembolism Among Users of

Drospirenone-Containing Oral Contraceptive Pills
ABSTRACT: Although the risk of venous thromboembolism is increased among oral contraceptive users
compared with nonusers who are not pregnant and not taking hormones, and some data have suggested that
use of drospirenone-containing pills has a higher risk of venous thromboembolism, this risk is still very low and is
much lower than the risk of venous thromboembolism during pregnancy and the immediate postpartum period.
When prescribing any oral contraceptive, clinicians should consider a woman’s risk factors for venous thrombo-
embolism and refer to the U.S. Medical Eligibility Criteria for Contraceptive Use issued by the Centers for Disease
Control and Prevention. Patient education materials, including product labeling, should place information regarding
oral contraceptive use and venous thromboembolism risks in context by also providing information about overall
venous thromboembolism risks and venous thromboembolism risks during pregnancy and the postpartum period.
Decisions regarding choice of oral contraceptive should be left to clinicians and their patients, taking into account
the possible minimally increased risk of venous thromboembolism, patient preference, and available alternatives.

Combined oral contraceptives (OCs) that contain dro-
spirenone have been widely used in the United States for
several years and in Europe for longer. Early safety reports
have suggested a higher risk of venous thromboembolism
associated with the use of OCs that contain drospire-
none compared with OCs that contain other progestins,
such as levonorgestrel (1, 2). Two large studies (one large
Dutch case–control study and one cohort study from
Denmark) also reported increased risks of venous throm-
boembolism with use of drospirenone-containing OCs
compared with levonorgestrel-containing OCs (3, 4).
However, these studies had several methodological limi-
tations, such as potential misclassification of venous
thromboembolism and the duration of use of the OCs,
inadequate control of confounding variables, and poten-
tial information and detection biases (5). Despite these
limitations, it is biologically plausible to consider an
increased risk of complications from venous throm-
boembolism with the use of drospirenone-containing
OCs as compared with other progestin-containing OCs.
Aldosterone may be involved with hemostasis, leading to
a decrease in coagulability. Therefore, the antimineralo-
corticoid properties of drospirenone could in turn lead to
hypercoagulability, creating a possible mechanism for the
increased risk of venous thromboembolism with the use
of drospirenone-containing OCs (6).
After reviewing the data in these as well as other stud-
ies, the U.S. Food and Drug Administration (FDA) issued
a Drug Safety Communication in which it concluded that
use of drospirenone-containing OCs may be associated
with a higher risk of blood clots than other progestin-
containing OCs (7). Because the studies did not provide
consistent estimates of the comparative risk of blood
clots between drospirenone-containing OCs and other
progestin-containing OCs and because the studies failed
to account for important patient characteristics, such as
smoking status and body mass index, that may influence
prescribing and likely affect the risk of blood clots, the
FDA was unable to conclude causality.
Two nested case–control studies that used United
States and United Kingdom clinical databases found the
risk of nonfatal idiopathic venous thromboembolism to
be two to three times higher among new current users
of drospirenone-containing OCs compared with users of
levonorgestrel-containing OCs (8, 9). Information regard-
ing OC use was ascertained from a pharmacy database

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 436

 recorded from drug claims in one study (8) and from
a research database in the other study (9). All ident-
ified patients with venous thromboembolism had to
have received long-term anticoagulation therapy. In con-
trast, a German case–control study found similar risks of
confirmed venous thromboembolism between users
of drospirenone-containing OCs and levonorgestrel-
containing OCs (10). Although some known potential
confounders were identified and adjusted for in these
studies, case–control studies remain susceptible to con-
founding by unknown variables, selection bias, and diag-
nostic referral bias, among other factors.
The European Active Surveillance Study prospec-
tively evaluated the risks of cardiovascular complica-
tions among 59,674 new users of OCs, including women
who were taking drospirenone-containing OCs, who
were actively observed for 142,475 woman-years (11).
Cases of venous thromboembolism were verified with
medical records; loss to follow-up was less than 2.5%.
In this 5-year multinational study, the risk of venous
thromboembolism among new users of drospirenone-
containing OCs was 9.1 per 10,000 woman-years com-
pared with 8 per 10,000 woman-years among new users
of levonorgestrel-containing OCs and 9.9 per 10,000
woman-years among new users of other progestin-con-
taining OCs. The adjusted hazard ratios (HRs) were 1
(95% confidence interval [CI], 0.6–1.8) for users of
drospirenone-containing OCs compared with users of
levonorgestrel-containing OCs and 0.9 (95% CI, 0.5–1.3)
for users of drospirenone-containing OCs compared with
users of other progestin-containing OCs. A U.S. study
of 67,000 new OC users, one third of whom were using
drospirenone-containing OCs, did not find significant
differences in the incidence of venous thromboembolism
among users of drospirenone-containing OCs (1.3/1,000
woman-years; 95% CI, 0.8–2) compared with users of
other progestin-containing OCs (1.4/1,000 woman-years;
95% CI, 1.–1.9) (12).
Another large multinational prospective cohort
study assessing the risk of drospirenone use and venous
thromboembolism, the International Active Surveillance
Study of Women Taking Oral Contraceptives, will con-
clude in 2012 (13). Preliminary safety data from this
study, based on 105,000 woman-years of observation,
showed that the risk of venous thromboembolism was
not significantly different among users of 24-day regi-
mens of drospirenone-containing OCs (8.7/10,000 wom-
an-years), 21-day regimens of drospirenone-containing
OCs (5.4/10,000 woman-years), and regimens of other
progestin-containing OCs (8/10,000 woman-years) (13).
Initial data from this study also showed that women who
took 24-day regimens of drospirenone-containing OCs
had lower pregnancy rates with typical use than users of
21-day regimens of other progestin-containing OCs (14).
In contrast with these studies, an FDA-funded
study released in October 2011 concluded that all use
(ie, new use, switching from another combined OC, or
2 Committee Opinion No. 540
COMMITTEE OPINIONS
continuing use of a current contraceptive) of the drospi-
renone–ethinyl estradiol pill (3 mg of drospirenone and
30 micrograms of ethinyl estradiol) was associated with
a 1.74-fold increased risk of venous thromboembolism
relative to the other low-dose combined OCs (0.1 mg of
levonorgestrel and 20 micrograms of ethinyl estradiol;
0.15 mg of levonorgestrel and 30 micrograms of ethinyl
estradiol; 1 mg of norethindrone acetate and 20 micro-
grams of ethinyl estradiol; and 0.18 – 0.25 mg of norges-
timate and 35 micrograms of ethinyl estradiol) (15). The
FDA study of more than 800,000 U.S. women reported an
increased age-adjusted incidence rate of venous throm-
boembolism of 10.22 per 10,000 women-years in users
of drospirenone-containing OCs versus 5.96 per 10,000
women-years in the comparison group of users of second-
generation combined OCs (15). However, this study is
limited by the lack of adjusting for confounders, such as
smoking and obesity. Furthermore, diagnoses of venous
thromboembolism were established based on computer-
ized data with partial verification from review of medical
records. Additionally, the increased risk of venous throm-
boembolism demonstrated in this study is seen within
the first 12 months of drospirenone-containing OC use
only. The elevated incidence ratio in the first 3 months is
1.93 (1.26–2.95) and from 7 months to 12 months is 2.9
(1.59–5.28). However, after 12 months of use, the risk of
venous thromboembolism in patients who use drospi-
renone-containing OCs is equivalent to that of users of
other second-generation combined OCs, with an inci-
dence rate ratio of 1.17 (0.63–2.18). The increased risk of
venous thromboembolism with all use of drospirenone-
containing OCs as compared with all use of other OCs is
found in women aged 10–34 years. The relative HR in this
age range is 1.86 (1.41–2.46) compared with the relative
HR of 1.35 (1–1.82) for women aged 35–55 years. Older
“new” users of the drospirenone-containing OCs are
less likely to be naïve users of combined OCs and are more
likely to have had previous hormonal exposure without
complications.
Conclusions
The risk of venous thromboembolism is increased among
OC users (3–9/10,000 woman-years) compared with
nonusers who are not pregnant and not taking hormones
(1–5/10,000 woman-years) (7), and some data have sug-
gested that the use of drospirenone-containing OC pills
has a higher risk (10.22/10,000) than the use of other
progestin-containing OCs (15). However this risk is still
very low and is much lower than the risk of thromboem-
bolism during pregnancy (approximately 5–20/10,000
woman-years) and the postpartum period (40–65/10,000
woman-years) (7) (Figure 1).
Recommendations
Based on recent reports regarding the increase of venous
thromboembolism in users of drospirenone-containing
OCs, the American College of Obstetricians and Gyne-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 437
 Nonpregnant nonusers of
1–5
combined OCs

Users of combined OCs 3–9

Per U. S. Food and Drug

Administration study, users of 10.22
drospirenone-containing OCs

Pregnant women 5–20

Women in the postpartum

period (12 weeks only) 40–65

0 10 20 30 40 50 60 70

Fig. 1. Likelihood of developing a blood clot (number of women with a blood clot per 10,000 women-years).
Abbreviation: OC indicates oral contraceptives. Adapted from Food and Drug Administration. FDA drug safety commu-
nication: updated information about the risk of blood clots in women taking birth control pills containing drospirenone.
Silver Spring (MD): FDA; 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm299305. Retrieved July 5, 2012.
Additional information from Food and Drug Administration. Combined hormonal contraceptives (CHCs) and the risk of
cardiovascular disease endpoints. Silver Spring (MD): FDA; 2011. Available at: http://www.fda.gov/downloads/Drugs/
DrugSafety/UCM277384.pdf. Retrieved July 5, 2012. ^

cologists’ Committee on Gynecologic Practice makes the

following recommendations:
• Decisions regarding the choice of OC should be left Combined Oral Contraceptives* ^
to clinicians and their patients, taking into account
the following factors:
— The possible minimally increased risk of venous
thromboembolism in new users of drospirenone-
containing OCs compared with users of combined
OCs (10.22/10,000 woman-years compared with
3–9/10,000 woman-years) (Fig. 1)
— Patient preference
— Available alternatives
• Women should have a wide range of contraceptive vitamin deficiencies, or fluid depletion
options, including drospirenone-containing OCs.
• If a patient is using a drospirenone-containing OC unknown) antiphospholipid antibodies
and is tolerating the regimen, there is no need to
discontinue that OC.
• When prescribing any OC, clinicians should consid-
er a woman’s risk factors for venous thromboembo-
lism (Box 1) and refer to the U.S. Medical Eligibility
Criteria for Contraceptive Use (16, 17).
• Patient education materials, including product label-
ing, should place information regarding risks of
venous thromboembolism in context by also provid-
ing information about overall venous thromboem-
bolism risks and venous thromboembolism risks
during pregnancy and the postpartum period.
Box 1. High-Risk Factors for
Venous Thromboembolism in Users of
• Smoking and age 35 years or older
• Less than 21 days postpartum or 21–42 days postpar-
tum with other risk factors
• Major surgery with prolonged immobilization
• History of deep vein thrombosis or pulmonary embolism
• Hereditary thrombophilia (including antiphospholipid
syndrome)
• Inflammatory bowel disease with active or extensive
disease, surgery, immobilization, corticosteroid use,
• Systemic lupus erythematosus with positive (or
*Oral contraceptive use in women with these conditions is clas-
sified as U.S. Medical Eligibility Criteria Category 3 (theoretical
or proven risks usually outweigh the advantages of using the
method) or Category 4 (condition that represents an unaccept-
able health risk if the contraceptive method is used).
Data from U.S. Medical Eligibility Criteria for Contraceptive Use,
2010. Centers for Disease Control and Prevention (CDC). MMWR
Recomm Rep 2010;59(RR-4):1–86 [PubMed] [Full Text] and Update
to CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use,
2010: revised recommendations for the use of contraceptive
methods during the postpartum period. Centers for Disease
Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep
2011;60:878–83. [PubMed] [Full Text]

Committee Opinion No. 540 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 438

 References
1. Sheldon T. Dutch GPs warned against new contraceptive
pill. BMJ 2002;324:869. [PubMed] [Full Text] ^
2. van Grootheest K, Vrieling T. Thromboembolism associat-
ed with the new contraceptive Yasmin. BMJ 2003;326:257.
[PubMed] [Full Text] ^
3. Lidegaard O, Lokkegaard E, Svendsen AL, Agger C. Hor-
monal contraception and risk of venous thromboem-
bolism: national follow-up study. BMJ 2009;339:b2890.
[PubMed] [Full Text] ^
4. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke
JP, Doggen CJ, Rosendaal FR. The venous thrombotic risk
of oral contraceptives, effects of oestrogen dose and proges-
togen type: results of the MEGA case-control study. BMJ
2009;339:b2921. [PubMed] [Full Text] ^
5. Shapiro S, Dinger J. Risk of venous thromboembolism
among users of oral contraceptives: a review of two recently
published studies. J Fam Plann Reprod Health Care 2010;
36:33–8. [PubMed] [Full Text] ^
6. Ducros E, Berthaut A, Mirshahi SS, Faussat AM, Soria J,
Agarwal MK, et al. Aldosterone modifies hemostasis via
upregulation of the protein-C receptor in human vascu-
lar endothelium. Biochem Biophys Res Commun 2008;
373:192–6. [PubMed] ^
7. Food and Drug Administration. FDA drug safety commu-
nication: updated information about the risk of blood clots
in women taking birth control pills containing drospire-
none. Silver Spring (MD): FDA; 2012. Available at: http://
www.fda.gov/Drugs/DrugSafety/ucm299305. Retrieved
July 5, 2012. ^
8. Jick SS, Hernandez RK. Risk of non-fatal venous thrombo-
embolism in women using oral contraceptives containing
drospirenone compared with women using oral contracep-
tives containing levonorgestrel: case-control study using
United States claims data. BMJ 2011;342:d2151. [PubMed]
[Full Text] ^
9. Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of
venous thromboembolism in users of oral contraceptives
containing drospirenone or levonorgestrel: nested case-
control study based on UK General Practice Research
Database. BMJ 2011;342:d2139. [PubMed] [Full Text] ^
10. Dinger J, Assmann A, Mohner S, Minh TD. Risk of
venous thromboembolism and the use of dienogest- and
drospirenone-containing oral contraceptives: results from
a German case-control study. J Fam Plann Reprod Health
Care 2010;36:123–9. [PubMed] [Full Text] ^
4 Committee Opinion No. 540
COMMITTEE OPINIONS
11. Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of
a drospirenone-containing oral contraceptive: final results
from the European Active Surveillance Study on oral con-
traceptives based on 142,475 women-years of observation.
Contraception 2007;75:344–54. [PubMed] [Full Text] ^
12. Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone
J, Walker AM. Risk of thromboembolism in women
taking ethinylestradiol/drospirenone and other oral con-
traceptives. Obstet Gynecol 2007;110:587–93. [PubMed]
[Obstetrics & Gynecology] ^
13. Dinger J, Bardenheuer K, Moehner S. The risk of venous
thromboembolism in users of a drospirenone-containing
oral contraceptive with a 24-day regimen – results from the
INAS-OC Study [abstract]. Fertil Steril 2010;94:S3. ^
14. Dinger J, Minh TD, Buttmann N, Bardenheuer K.
Effectiveness of oral contraceptive pills in a large U.S.
cohort comparing progestogen and regimen. Obstet
Gynecol 2011;117:33–40. [PubMed] [Obstetrics &
Gynecology] ^
15. Food and Drug Administration. Combined hormonal con-
traceptives (CHCs) and the risk of cardiovascular disease
endpoints. Silver Spring (MD): FDA; 2011. Available at:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM
277384.pdf. Retrieved July 5, 2012. ^
16. U. S. Medical Eligibility Criteria for Contraceptive Use,
2010. Centers for Disease Control and Prevention (CDC).
MMWR Recomm Rep 2010;59(RR-4):1–86. [PubMed]
[Full Text] ^
17. Update to CDC’s U.S. Medical Eligibility Criteria for
Contraceptive Use, 2010: revised recommendations for
the use of contraceptive methods during the postpar-
tum period. Centers for Disease Control and Prevention
(CDC). MMWR Morb Mortal Wkly Rep 2011;60:878–83.
[PubMed] [Full Text] ^
Copyright November 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Risk of venous thromboembolism among users of drospirenone-
containing oral contraceptive pills. Committee Opinion No. 540.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:1239 – 42.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 439
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 544 • December 2012
Committee on Gynecologic Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Over-the-Counter Access to Oral Contraceptives

ABSTRACT: Unintended pregnancy remains a major public health problem in the United States. Access and
cost issues are common reasons why women either do not use contraception or have gaps in use. A potential
way to improve contraceptive access and use, and possibly decrease unintended pregnancy rates, is to allow over-
the-counter access to oral contraceptives (OCs). Screening for cervical cancer or sexually transmitted infections is
not medically required to provide hormonal contraception. Concerns include payment for pharmacist services, pay-
ment for over-the-counter OCs by insurers, and the possibility of pharmacists inappropriately refusing to provide
OCs. Weighing the risks versus the benefits based on currently available data, OCs should be available over-the-
counter. Women should self-screen for most contraindications to OCs using checklists.

Unintended pregnancy remains a major public health
problem in the United States. Over the past 20 years, the
overall rate of unintended pregnancy has not changed and
remains unacceptably high, accounting for approximately
50% of all pregnancies (1). The economic burden of
unintended pregnancy has been recently estimated to cost
taxpayers $11.1 billion dollars each year (2). According
to the Institute of Medicine, women with unintended
pregnancy are more likely to smoke or drink alcohol dur-
ing pregnancy, have depression, experience domestic
violence, and are less likely to obtain prenatal care or
breastfeed. Short interpregnancy intervals have been asso-
ciated with adverse neonatal outcomes, including low
birth weight and prematurity, which increase the chances
of children’s health and developmental problems (3).
Many factors contribute to the high rate of unin-
tended pregnancy. Access and cost issues are common
reasons why women either do not use contraception or
have gaps in use (4). Although oral contraceptives (OCs)
are the most widely used reversible method of family plan-
ning in the United States (5), OC use is subject to problems
with adherence and continuation, often due to logistics or
practical issues (6, 7). A potential way to improve contra-
ceptive access and use, and possibly decrease the unin-
tended pregnancy rate, is to allow over-the-counter access
to OCs.
Interest in Over-the-Counter Access
A 2004 national telephone survey of 811 women aged
18–44 years found that 68% of women at risk of unin-
tended pregnancy would utilize pharmacy access for OCs,
the contraceptive patch, the contraceptive vaginal ring,
and emergency contraception. Also, 47% of uninsured
women and 40% of low-income women who were not
using OCs, the contraceptive patch, or the contraceptive
vaginal ring said they would start using those methods if
they were available from pharmacies without a prescrip-
tion (8). In another survey of 1,271 women aged 18–49
years, 60% of women not currently using a highly effec-
tive contraceptive method said they would be more likely
to use OCs if they were available over-the-counter (9). A
national survey of 2,725 pharmacists found that 85% were
interested in providing hormonal contraception, with
66% expressing concerns about reimbursement (10).
Safety of Over-the-Counter
Medications
No drug or intervention is completely without risk of
harm. For example, common nonsteroidal antiinflam-
matory drugs, such as aspirin, have documented adverse
effects, including gastrointestinal bleeding. These effects
may occur even at doses used for prophylaxis of car-
diovascular disease (11). Additionally, over-the-counter
use of acetaminophen is linked to serious liver dam-
age (12). Safety concerns about OCs frequently focus
on the increased risk of venous thromboembolism.
However, it is important to understand that the rate of
venous thromboembolism for OC users is extremely
low (3–10.22/10,000 women-years) (13, 14) and to put
this risk in context by recognizing the much greater

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 440

 risk of venous thromboembolism during pregnancy
(5–20/10,000 women-years) or in the postpartum period
(40–65/10,000 women-years) (14). Overall, the consen-
sus is that OC use is safe (15–17).
Ability of Nonphysicians to Screen for
Contraindications
Despite the safety of OC use, one frequently cited con-
cern regarding over-the-counter provision of OCs is the
potential harm that could result if women with contrain-
dications use them. However, several studies have shown
that women can self-screen for contraindications. In one
study that compared current family planning clients’ self-
assessment of contraindications with clinical assessment,
392 of the 399 participant (females aged 15–45 years) and
health care provider pairs obtained agreement on medi-
cal eligibility criteria (greater than 90%) (18). Similar find-
ings were seen in general populations of women, although
in one study approximately 6% of the 1,271 women
aged 18 –49 years had unrecognized hypertension (19).
Both studies showed that in cases of discrepancy, women
were more likely to report contraindications than were
health care providers. A study conducted in the United
Kingdom replicated the findings that women take a more
conservative approach compared with clinicians and
also demonstrated that none of the 328 women studied
would have incorrectly used OCs based on self-screening
(20). Another study found that women obtaining OCs
from pharmacies were no more likely to have contrain-
dications than those who got OCs from a clinic (21). A
study of women seeking to buy OCs online through a
special program for patients of a clinic found that online
participants (n=243) were as knowledgeable about con-
traindications and adverse events as women seen in the
clinic (n=161) (22). It is acknowledged that the women
with Internet access may not be comparable to the gen-
eral population.
In contrast to the aforementioned studies, one U.S.-
based cohort study found that women who obtained
OCs over-the-counter in Mexican pharmacies were more
likely to have relative contraindications rather than
absolute contraindications (23) (see Box 1). At least one
relative contraindication to OC use was found in 13% of
the over-the-counter group versus 9% of the prescribed
group (P =.006) but with similar frequencies of absolute
contraindications (7% versus 5%, P =.162). However,
women who purchased OCs over-the-counter in this
study were not self-screened using any standardized pro-
cess, and the demographics of patients (obese or lacking
access to health maintenance services) may have affected
the outcome.
Pharmacist provision (behind-the-counter access)
of hormonal contraceptive methods also has been evalu-
ated. In the Direct Access Study in Washington State,
several pharmacists received specialized education in
the provision of hormonal contraceptive methods and
were authorized to provide hormonal contraception
2 Committee Opinion No. 544
COMMITTEE OPINIONS
Box 1. Categories for Medical Eligibility
Criteria for Contraceptive Use ^
1 = A condition for which there is no restriction for the
use of the contraceptive method.
2 = A condition for which the advantages of using the
method generally outweigh the theoretical or proven
risks.
3 = A condition for which the theoretical or proven
risks usually outweigh the advantages of using the
method.
4 = A condition that represents an unacceptable health
risk if the contraceptive method is used.
U S. Medical Eligibility Criteria for Contraceptive Use, 2010. Cen-
ters for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR-4):1–86 [PubMed] [Full Text]
including, OCs, the contraceptive patch, and the contra-
ceptive vaginal ring (24). Pharmacists successfully used
checklists to identify women without contraindications
to OCs according to the World Health Organization’s
Medical Eligibility Criteria for Contraceptive Use; blood
pressure and body mass index also were measured (24).
Continuation of use through 12 months was fairly high
(70% of 127 women), although most women were con-
tinuing users (either currently using OCs or had used
hormonal contraceptives in the past), and only 65%
(127 of 195 women) completed the 12-month interview.
Acceptability also was high, although most women had to
pay out-of-pocket for the pharmacist evaluation because
most insurance providers did not cover that service (24).
Contraceptive Adherence and
Continuation
Other concerns about over-the-counter access include
that women who choose to purchase OCs over-the-
counter might be less adherent, less likely to continue
their method, or less likely to choose more effective
long-acting methods of contraception. However, efforts
to improve use of long-acting methods of contracep-
tion should not preclude efforts to increase access to
other methods. In one study, 68% of the women who
might avail themselves to over-the-counter OCs reported
not currently using any contraceptive method (8). Fur-
thermore, continuation may be increased with better
access. In a U.S. cohort study of approximately 1,000
women over 9 months, those who obtained OCs over-
the-counter in Mexican pharmacies had slightly higher
continuation rates (79.2%, P=.12) compared with those
who obtained OCs in U.S. public clinics (74.9%, P=.12),
although the increase was statistically insignificant (25).
Access to multiple pill packs at one time results in
higher rates of continuation. In a 2011 randomized trial,
investigators compared 6-month contraceptive continu-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 441
 ation rates among women who were dispensed three pill
packs or seven pill packs. Participants who received
seven pill packs had a higher 6-month rate continuation
than participants who received three pill packs (51%
compared with 35%, P<.001), and the effect was greater
among participants younger than 18 years (49% com-
pared with 12%, P<.001). Although not statistically sig-
nificant, participants who received a prescription were
less likely to continue OC use than those who received pill
packs over-the-counter (26).
Use of Preventive Services
Another theoretic concern is that women who choose
to purchase OCs over-the-counter will forgo screening
and other preventive services. However, cervical cancer
screening or sexually transmitted infection (STI) screen-
ing is not required for initiating OC use and should not
be used as barriers to access (27, 28). The American
College of Obstetricians and Gynecologists recommends
an annual health assessment for every woman as a funda-
mental part of medical care (29). This visit also includes
a discussion of a woman’s reproductive health plan. She
can review her health plan with her obstetrician–gyne-
cologist on a periodic basis (30). This review provides an
opportunity for the clinician to ask the patient what type
or types of birth control she uses and to educate her about
adverse effects of her chosen method and alternatives.
In a 2012 study, researchers compared the screening
habits of U.S. women who had obtained their OCs from
U.S. clinics with those who had obtained their OCs
from Mexican pharmacies (31). Both groups reported
high screening rates of Pap tests within the past 3 years
(greater than 88%), ever having received STI testing
(greater than 71%), and ever having had a clinical breast
examination (greater than 88%), all higher than national
screening proportions. Rates were slightly higher among
those receiving OCs from clinics. Among those receiv-
ing OCs over-the-counter, the reasons given for no Pap
testing included inconvenience, cost, and not knowing
where to go to get screened (31). Currently, there are no
long-term data of adverse health consequences for over-
the-counter OC users.
Cost
It is possible that some women might be adversely
affected by changing to over-the-counter OCs if they
lose insurance coverage for their preferred contraceptive
method. However, OCs are already a significant expense
for many women. In a recent national survey, women,
particularly young women and the uninsured, paid an
average of $16 per pill pack, and many reported limits
on the number of pill packs they could receive (32).
Regardless, any plans to improve access to OCs by
moving toward behind-the-counter or over-the-counter
access should address issues of cost. The recent U.S.
Department of Health and Human Services guidelines
regarding women’s preventive services will require new
Committee Opinion No. 544
COMMITTEE OPINIONS
private health plans to cover without cost sharing all U.S.
Food and Drug Administration-approved contraceptive
methods, sterilization procedures, and patient education
and counseling for women with reproductive capacity
(33). It remains to be seen how these guidelines will be
implemented, and it should be noted that they do not
apply to Medicaid. Pharmacy consultative services may
incur additional costs.
Data From Developing Countries
Although the results of studies from developing coun-
tries may not be generalizable to a U.S. population, this
information allows health care providers to examine the
potential benefits and challenges of over-the-counter
access to OCs in the United States. Some obstacles found
in these studies include pharmacist refusal and a lack of
counseling of patients on the proper use of OCs. (See
Table 1 for additional data from developing countries.)
Conclusions and Recommendations
In the interest of increasing access to contraception, and
based on the available data, the American College of
Obstetricians and Gynecologists’ Committee on Gyne-
cologic Practice makes the following conclusions and
recommendations:
• Weighing the risks versus the benefits based on cur-
rently available data, OCs should be available over-
the-counter.
• Women should self-screen for most contraindica-
tions to OCs using checklists.
• There are concerns about payment for pharma-
cist services, payment for over-the-counter OCs by
insurers, and the possibility of pharmacists inappro-
priately refusing to provide OCs.
• Screening for cervical cancer or STIs is not medically
required to provide hormonal contraception.
• Continuation rates of OCs are higher in women who
are provided with multiple pill packs at one time.
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pregnancy in the United States, 1994 and 2001. Perspect Sex
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2. Sonfield A, Kost K, Gold RB, Finer LB. The public costs
of births resulting from unintended pregnancies: national
and state-level estimates. Perspect Sex Reprod Health 2011;
43:94–102. [PubMed] [Full Text] ^
3. Institute of Medicine. The best intentions: unintended
pregnancy and the well-being of children and families.
Washington, DC: National Academy Press; 1995. ^
4. Frost JJ, Singh S, Finer LB. U.S. women’s one-year con-
traceptive use patterns, 2004. Perspect Sex Reprod Health
2007;39:48 –55. [PubMed] [Full Text] ^
5. Mosher WD, Jones J. Use of contraception in the United
States: 1982–2008. Vital Health Stat 23 2010;(29):1–44.
[PubMed] ^
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 442
 Table 1. Data From Developing Countries ^
Country Study
Jamaica Chin-Quee DS, Cuthbertson C, Janowitz B.
Over-the-counter pill provision: evidence from
Jamaica. Stud Fam Plann 2006;37:99–110.
[PubMed]
Kuwait Shah MA, Shah NM, Al-Rahmani E, Behbehani J,
Radovanovic Z. Over-the-counter use of oral
contraceptives in Kuwait. Int J Gynaecol Obstet
2001;73:243–51. [PubMed] [Full Text]
Mexico Bailey J, Jimenez RA, Warren CW. Effect of
supply source on oral contraceptive use in
Mexico. Stud Fam Plann 1982;13:343–9.
[PubMed]
Thailand Ratanajamit C, Chongsuvivatwong V. Survey of
knowledge and practice on oral contraceptive
and emergency contraceptive pills of drugstore
personnel in Hat Yai, Thailand. Pharmacoepidemiol
Drug Saf 2001;10:149–56. [PubMed]
Abbreviation: OC, oral contraceptive.
6. Smith JD, Oakley D. Why do women miss oral contracep-
tive pills? An analysis of women’s self-described reasons for
missed pills. J Midwifery Womens Health 2005;50:380–5.
[PubMed] ^
7. Prepregnancy contraceptive use among teens with unin-
tended pregnancies resulting in live births - Pregnancy
Risk Assessment Monitoring System (PRAMS), 2004–
2008. Centers for Disease Control and Prevention (CDC).
MMWR Morb Mortal Wkly Rep 2012;61:25–9. [PubMed]
[Full Text] ^
8. Landau SC, Tapias MP, McGhee BT. Birth control within
reach: a national survey on women’s attitudes toward and
interest in pharmacy access to hormonal contraception.
Contraception 2006;74:463–70. [PubMed] [Full Text] ^
9. Grossman D, Fernandez L, Hopkins K, Amastae J, Potter
JE. Perceptions of the safety of oral contraceptives among a
predominantly Latina population in Texas. Contraception
2010;81:254–60. [PubMed] [Full Text] ^
10. Landau S, Besinque K, Chung F, Dries-Daffner I, Maderas
NM, McGhee BT, et al. Pharmacist interest in and attitudes
toward direct pharmacy access to hormonal contraception
4 Committee Opinion No. 544
COMMITTEE OPINIONS
Conclusions
• Low-dose OCs have been available behind-the-
counter since 1998.
• Primary source of information of OCs was a
doctor, nurse, or member of the clinic staff, not
a pharmacist.
• Access was restricted because of contraindica-
tions or younger age.
• OCs were sold through pharmacies without
prescription.
• Few women were counseled about how to use
OCs and few were counseled regarding side
effects.
• OCs are available over-the-counter in many
pharmacies.
• Pharmacy users had slightly higher continuation
rates compared with other women but statistical
significance is not reported.
• Knowledge of how to obtain a proper medical
history and counseling on the proper use and side
effects of OCs was fair to good among both
pharmacists and nonpharmacists.
• Pharmacists were likely to have better knowledge
overall than nonpharmacist staff members.
• Secret shopper data reported that OCs were
usually dispensed with little or no medical history
or counseling.
in the United States. J Am Pharm Assoc (2003) 2009;49:
43–50. [PubMed] ^
11. Abbott FV, Fraser MI. Use and abuse of over-the-counter
analgesic agents. J Psychiatry Neurosci 1998;23:13–34.
[PubMed] [Full Text] ^
12. Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E,
Hynan LS, et al. Acetaminophen-induced acute liver fail-
ure: results of a United States multicenter, prospective
study. Acute Liver Failure Study Group. Hepatology 2005;
42:1364–72. [PubMed] [Full Text] ^
13. Food and Drug Administration. Combined hormonal con-
traceptives (CHCs) and the risk of cardiovascular disease
endpoints. Silver Spring (MD): FDA; 2011. Available at:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM
277384.pdf. Retrieved July 5, 2012. ^
14. Food and Drug Administration. FDA drug safety com-
munication: updated information about the risk of blood
clots in women taking birth control pills containing drospi-
renone. Silver Spring (MD): FDA; 2012. Available at: http:
//www.fda.gov/Drugs/DrugSafety/ucm299305. Retrieved
July 5, 2012. ^
2013 COMPENDIUM OF SELECTED PUBLICATIONS 443
 15. Kaunitz AM. Clinical practice. Hormonal contraception
in women of older reproductive age. N Engl J Med 2008;
358:1262–70. [PubMed] [Full Text] ^
16. Farley TM, Meirik O, Collins J. Cardiovascular disease and
combined oral contraceptives: reviewing the evidence and
balancing the risks. Hum Reprod Update 1999;5:721–35.
[PubMed] [Full Text] ^
17. Grimes DA. Over-the-counter oral contraceptives—an
immodest proposal? Am J Public Health 1993;83:1092– 4.
[PubMed] [Full Text] ^
18. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement
between women’s and providers’ assessment of hormonal
contraceptive risk factors. Contraception 2006;73:501–6.
[PubMed] [Full Text] ^
19. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia
SG, Potter JE. Accuracy of self-screening for contraindica-
tions to combined oral contraceptive use. Obstet Gynecol
2008;112:572–8. [PubMed] [Obstetrics & Gynecology] ^
20. Doshi JS, French RS, Evans HE, Wilkinson CL. Feasibility of
a self-completed history questionnaire in women request-
ing repeat combined hormonal contraception. J Fam Plann
Reprod Health Care 2008;34:51–4. [PubMed] [Full Text]
^ over-the-counter oral contraceptive users. Contraception
21. Yeatman SE, Potter JE, Grossman DA. Over-the-counter
access, changing WHO guidelines, and contraindicated
oral contraceptive use in Mexico. Stud Fam Plann 2006;37:
197–204. [PubMed] ^
22. Kaskowitz AP, Carlson N, Nichols M, Edelman A, Jensen J.
Online availability of hormonal contraceptives without a
health care examination: effect of knowledge and health
care screening. Contraception 2007;76:273–7. [PubMed]
[Full Text] ^
23. Grossman D, White K, Hopkins K, Amastae J, Shedlin M,
Potter JE. Contraindications to combined oral contracep-
tives among over-the-counter compared with prescrip-
tion users. Obstet Gynecol 2011;117:558–65. [PubMed]
[Obstetrics & Gynecology] ^
24. Gardner JS, Miller L, Downing DF, Le S, Blough D,
Shotorbani S. Pharmacist prescribing of hormonal con-
traceptives: results of the Direct Access study. J Am Pharm
Assoc (2003) 2008;48:212–26. [PubMed] ^
25. Potter JE, McKinnon S, Hopkins K, Amastae J, Shedlin MG,
Powers DA, et al. Continuation of prescribed compared
with over-the-counter oral contraceptives. Obstet Gynecol
2011;117:551–7. [PubMed] [Obstetrics & Gynecology] ^
Committee Opinion No. 544
COMMITTEE OPINIONS
26. White KO, Westhoff C. The effect of pack supply on
oral contraceptive pill continuation: a randomized con-
trolled trial. Obstet Gynecol 2011;118:615–22. [PubMed]
[Obstetrics & Gynecology] ^
27. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual.
3rd ed. Washington, DC: ACOG; 2007. ^
28. Stewart FH, Harper CC, Ellertson CE, Grimes DA, Sawaya
GF, Trussell J. Clinical breast and pelvic examination
requirements for hormonal contraception: Current practice
vs evidence. JAMA 2001;285:2232–9. [PubMed] [Full Text]
^
29. Well-woman visit. Committee Opinion No. 534. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:421–4. [PubMed] [Obstetrics & Gynecology] ^
30. The importance of preconception care in the continuum of
women’s health care. ACOG Committee Opinion No. 313.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:665–6. [PubMed] [Obstetrics &
Gynecology] ^
31. Hopkins K, Grossman D, White K, Amastae J, Potter JE.
Reproductive health preventive screening among clinic vs.
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[Full Text] ^
32. Liang SY, Grossman D, Phillips KA. Women’s out-of-
pocket expenditures and dispensing patterns for oral con-
traceptive pills between 1996 and 2006. Contraception
2011;83:528–36. [PubMed] [Full Text] ^
33. Health Resources and Services Administration. Women’s
preventive services: required health plan coverage guide-
lines. Available at: http://www.hrsa.gov/womensguidelines.
Retrieved August 10, 2012. ^
Copyright December 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Over-the-counter access to oral contraceptives. Committee Opinion
No. 544. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012:120;1527-31.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 444

technology assessment
in obstetrics and gynecology
This Technology Assessment
was developed by the ACOG
Committee on Gynecologic
Practice. This document reflects
emerging clinical and scientific
advances as of the date issued
and is subject to change. The
information should not be con-
strued as dictating an exclusive
course of treatment or proce-
dure to be followed. Variations in
practice may be warranted based
on the needs of the individual
patient, resources, and limita-
tions unique to the institution or
type of practice.
the american college
of obstetricians
and gynecologists
women’s health care physicians
COMMITTEE OPINIONS
ACOG
Number 6, November 2009
Robot-Assisted Surgery
ABSTRACT: The field of robotic surgery is developing rapidly, but experi-
ence with this technology is currently limited. In response to increasing
interest in robotics technology, the Committee on Gynecologic Practice’s
Technology Assessment was developed to describe the robotic surgical sys-
tem, potential advantages and disadvantages, gynecologic applications, and
the current state of the evidence. Randomized trials comparing robot-assisted
surgery with traditional laparoscopic, vaginal, or abdominal surgery are
needed to evaluate long-term clinical outcomes and cost-effectiveness, as
well as to identify the best applications of this technology.
Robot-assisted surgery evolved from the on-site needs of battlefield medicine
and from the technical limitations of traditional laparoscopy (1). Although a
number of precursors existed, the da Vinci Surgical System, introduced in 1999,
is the only commercially available system approved by the U.S. Food and Drug
Administration (FDA) for gynecologic surgery. Initial applications included
radical retropubic prostatectomy and cardiac surgery. Use in gynecologic surgery
was approved by the FDA in 2005. In response to increasing interest in robotics
technology, the Committee on Gynecologic Practice’s Technology Assessment
was developed to describe the robotic surgical system, potential advantages and
disadvantages, gynecologic applications, and the current state of the evidence.
Description of Robotic Instrumentation
The current robotic surgical system consists of four components: 1) a console
where the surgeon sits, views the screen, and controls the robotic instruments and
camera via finger graspers and foot pedals; 2) a robotic cart with three or four
interactive arms that hold instruments through trocars attached to the patient; 3)
a camera and vision system that allows for a three-dimensional image of the pel-
vis using image synchronizers and illuminators; and 4) wristed instruments with
computer interfaces that translate the mechanical movements of the surgeon’s
hands into computer algorithms directing the instrument use within the patient (2).
During robotic surgery, the primary surgeon sits unscrubbed at the console, and
at some distance from the patient, with fingers through graspers controlling the
instruments. Foot pedals and a clutch are used for camera control, activation of
energy sources, focusing, and robotic arm switching. Three or four robotic arms
are docked to trocars inserted through the patient’s abdomen. A 12-mm, three-
dimensional endoscope is placed at the midline and two or three instruments are
2013 COMPENDIUM OF SELECTED PUBLICATIONS 445
 passed through the lateral ports. Assistant surgical team
members pass robotic instruments and sutures through
these ports for use by the primary surgeon and also pro-
vide suction, irrigation, and countertraction. Instruments
for suturing, clamping, endosurgery, and tissue manipu-
lation are used with the robotic arms.
Potential Advantages and
Disadvantages
Potential advantages over traditional laparoscopic sur-
gery include 1) three-dimensional visualization with
improved depth perception, 2) improved dexterity and
instrument articulation secondary to increased freedom
of movement and elimination of tremor and coun-
terintuitive motions, and 3) the potential for use in
telesurgery. The improved visualization and dexterity
may offer some advantages over conventional laparos-
copy for complex procedures such as those required for
gynecologic malignancy or invasive endometriosis (3, 4).
Shorter hospital stays and decreased blood loss also may
be advantages over laparotomy (5, 6).
Disadvantages of robotic surgery include 1) the high
costs associated with the technology (more than $1 mil-
lion for the initial system, with additional costs of yearly
service contracts and disposable instrumentation), 2)
the increased operating time associated with equipment
setup and docking, 3) the lack of tactile feedback and sen-
sation (haptics), 4) the inability to reposition the patient
once the robotic arms are attached, and 5) the bulkiness
of the current robotic system making it difficult for assis-
tants to maneuver around it (eg, when applying uterine
manipulation for hysterectomy).
Robotic surgery has the potential to be a useful edu-
cational tool in resident and physician training. A cur-
rent concern is that its use may adversely affect surgical
training by decreasing residents’ overall surgical experi-
ence because only one surgeon can sit at the console.
Newer models that allow two surgeons to operate with
dual consoles are now available.
Gynecologic Applications
The field of robotic surgery is developing rapidly, but
experience with the technology is limited at this time.
Limited data, mostly from heterogeneous small retro-
spective case series and a few small nonrandomized,
mostly retrospective comparative studies (2, 3, 5–11)
have shown the safety and feasibility of robot-assist-
ed surgery for numerous procedures, including tubal
reanastomosis, hysterectomy, nodal sampling, and pro-
lapse suspension procedures. However, the comparative
studies frequently use historical controls, with different
COMMITTEE OPINIONS
surgeons, patient selection criteria, or settings (8). Large
prospective comparative studies evaluating long-term
clinical outcomes and costs are lacking. Few data exist on
how surgeon experience relates to overall complication
rates, operative time, or costs. Similarly, data are insuf-
ficient to demonstrate the specific patients or indications
where robot-assisted procedures might be advantageous
over vaginal surgery, laparotomy, or conventional lapar-
oscopy. Although randomized controlled trials comparing
robotic-assisted surgery to conventional approaches are
ongoing (7), results are currently unavailable. Additional
information on ongoing clinical trials is available at
ClinicalTrials.gov.
Credentialing
When surgeons adopt a new surgical technique, they
should be supervised or assisted by a more experienced
colleague, whenever feasible, until satisfactory com-
petency has been demonstrated (12). Credentialing for
robotic-assisted surgery within and across specialties is
based on training, experience, and documented current
competency.
Conclusion
The field of robotic surgery is developing rapidly, but
experience with this technology is currently limited.
Randomized trials comparing robot-assisted surgery with
traditional laparoscopic, vaginal, or abdominal surgery are
needed to evaluate long-term clinical outcomes and cost-
effectiveness, as well as to identify the best applications
of this technology.
References
1. Falcone T, Goldberg JM. Robotics in gynecology. Surg
Clin North Am 2003;83:1483–9, xii.
2. Visco AG, Advincula AP. Robotic gynecologic surgery.
Obstet Gynecol 2008;112:1369–84.
3. Veljovich DS, Paley PJ, Drescher CW, Everett EN, Shah
C, Peters WA 3rd. Robotic surgery in gynecologic oncol-
ogy: program initiation and outcomes after the first year
with comparison with laparotomy for endometrial cancer
staging. Am J Obstet Gynecol 2008;198:679.e1–9; discus-
sion 679.e9–10.
4. Advincula AP, Reynolds RK. The use of robot-assisted
laparoscopic hysterectomy in the patient with a scarred or
obliterated anterior cul-de-sac. JSLS 2005;9:287–91.
5. Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term out-
comes of robotic sacrocolpopexy compared with abdomi-
nal sacrocolpopexy. Obstet Gynecol 2008;112:1201–6.
6. Magrina JF, Kho RM, Weaver AL, Montero RP, Magtibay
PM. Robotic radical hysterectomy: comparison with lap-
aroscopy and laparotomy. Gynecol Oncol 2008;109:86–
91.
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 7. Obermair A, Gebski V, Frumovitz M, Soliman PT,
Schmeler KM, Levenback C, et al. A phase III random-
ized clinical trial comparing laparoscopic or robotic radi-
cal hysterectomy with abdominal radical hysterectomy in
patients with early stage cervical cancer. J Minim Invasive
Gynecol 2008;15:584–8.
8. Belgian Health Care Knowledge Center (KCE). Robot-
assisted surgery: health technology assessment. KCE reports
104C. Brussels: KCE; 2009. Available at: http://www.kce.
fgov.be/Download.aspx?ID=1462. Retrieved June 29, 2009.
9. Persson J, Reynisson P, Borgfeldt C, Kannisto P, Lindahl
B, Bossmar T. Robot assisted laparoscopic radical hyster-
ectomy and pelvic lymphadenectomy with short and long
term morbidity data. Gynecol Oncol 2009;113:185–90.
10. Seamon LG, Cohn DE, Henretta MS, Kim KH, Carlson
MJ, Phillips GS, et al. Minimally invasive comprehensive
surgical staging for endometrial cancer: robotics or lapa-
roscopy? Gynecol Oncol 2009;113:36–41.
11. Dharia Patel SP, Steinkampf MP, Whitten SJ, Malizia BA.
Robotic tubal anastomosis: surgical technique and cost
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12. Patient safety in the surgical environment. ACOG
Committee Opinion No. 328. American College of
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2006;107:429–33.
COMMITTEE OPINIONS
Copyright © November 2009 by the American College of
Ob­ste­tri­cians and Gynecologists. All rights reserved. No part
of this publication may be reproduced, stored in a re­triev­al
sys­tem, or transmitted, in any form or by any means, elec­tron­ic,
me­chan­i­cal, photocopying, recording, or oth­er­wise, without
prior written permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920
Washington, DC 20090-6920
Robot-assisted surgery. ACOG Technology Assessment in
Obstetrics and Gynecology No. 6. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2009;114:
1153–5.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 447
 technology assessment
in obstetrics and gynecology
(Replaces Technology Assessment Number 4, August 2005)
This Technology Assessment was
developed by the Committee on
Gynecologic Practice. This docu-
ment reflects emerging clinical
and scientific advances as of the
date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed. Varia-
tions in practice may be war-
ranted based on the needs of the
individual patient, resources, and
limitations unique to the institu-
tion or type of practice.
the american college
of obstetricians
and gynecologists
women’s health care physicians
COMMITTEE OPINIONS
number 7, June 2011
Hysteroscopy
ABSTRACT: Hysteroscopy is performed to view and treat pathology within
the uterine cavity and endocervix. Diagnostic hysteroscopy allows visual-
ization of the endocervical canal, endometrial cavity, and fallopian tube
ostia. Operative hysteroscopy incorporates the use of mechanical, electro-
surgical, or laser instruments to treat intracavitary pathology and perform
hysteroscopic sterilization procedures. Selection of a distending medium
requires consideration of the advantages, disadvantages, and risks asso-
ciated with various media as well as their compatibility with electrosurgical
or laser energy. A preoperative consultation allows the patient and physi-
cian to discuss the hysteroscopic procedure, weigh its inherent risks and
benefits, review the patient’s medical history for any comorbid conditions,
and exclude pregnancy. Known pregnancy, genital tract infections, and
active herpetic infection are contraindications to hysteroscopy. The most
common perioperative complications associated with operative hysteros-
copy are hemorrhage, uterine perforation, and cervical laceration. The pro-
cedure is minimally invasive and can be used with a high degree of safety.
Hysteroscopy is performed to view and treat pathology within the uter-
ine cavity and endocervix. Diagnostic hysteroscopy allows visualization
of the endocervical canal, endometrial cavity, and fallopian tube ostia.
Abnormal findings may include polyps, leiomyomas, intrauterine adhe-
sions, hyperplasia, malignancy, foreign bodies, retained products of con-
ception, and müllerian anomalies. Operative hysteroscopy incorporates
the use of mechanical, electrosurgical, or laser instruments to treat intra-
cavitary pathology and perform hysteroscopic sterilization procedures.
InstrumentatIon
Diagnostic hysteroscopes are available in both flexible and rigid models,
all of which contain a telescope consisting of light bundles. Flexible hys-
teroscopes range in diameter from 2.7 mm to 5 mm and have a bendable
tip that can be deflected in two directions ranging from 100 degrees to 180
degrees. Rigid hysteroscopes may consist of two or three pieces and range
from 1 mm to 5 mm in diameter. Their tips have varying viewing angles
(0 degrees, 12 degrees, 15 degrees, 30 degrees, and 70 degrees). An outer
sheath fits over the telescope to allow inflow of a distending medium into
the uterine cavity. This system allows fluid to return on the outside of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 448
 the outer sheath passively from the uterine cavity
through the cervix. Continuous flow hysteroscopes
consist of two channels to allow fluid to flow into
the intrauterine cavity while debris and cloudy
intrauterine fluid exit through perforations in the
outer sheath to the outflow port. Fluid exiting the
outflow port can be collected through tubing and
returned to a collection canister for the accurate
measurement of fluid volume. Flexible and rigid
hysteroscopes may contain an operative channel
for endometrial biopsy, tubal cannulation, or intra-
uterine surgery.
Operative hysteroscopes typically range from
8 mm to 10 mm in diameter and contain a retract-
able hand piece wherein electrosurgical tips (eg,
rollerballs, loops, and vaporizing tips), laser devices,
or mechanical instruments (eg, scissors or morcel-
lators) may be attached. Currently, there are three
types of operative hysteroscopes: the traditional
model contains a retractable hand piece and is
available as bipolar or monopolar device; a second
type consists of a hysteroscopic morcellator (this
type does not use electrosurgical energy to resect
tissue), uses saline as the distention media, and
resects tissue and suctions it to a canister; the third
type of hysteroscope contains a bipolar electrosur-
gical hand piece that resects and removes tissue
through the operative sheath, leaving few tissue
fragments within the operative site.
DIstenDIng meDIa
The uterine cavity requires distention for adequate
visualization. Several distending media are avail-
able and each has inherent advantages and disad-
vantages (see Table 1). It is critically important to
understand which media are compatible with elec-
trosurgical and laser energy. Furthermore, the risks
associated with various media must be understood.
High-viscosity media, such as dextran, have been
used in the past, but they are generally not used now
because of limitations, such as the fluid’s tendency
to harden and crystalize onto the equipment, as well
as an increased risk of anaphylaxis and disseminated
intravascular coagulation.
Carbon Dioxide Gas
Carbon dioxide (CO2), a colorless gas, is used in
outpatient settings for diagnostic purposes only.
The advantages of its use include the ease of clean-
ing and maintaining equipment and a clear view
of the cavity in the absence of active bleeding or
bubbles. To minimize the risk of gas embolization,
the flow of CO2 should be limited to 100 mL/min
with intrauterine pressure less than 100 mm Hg and
used with a hysteroscopic insufflator. Insufflators
designed for use in laparoscopy must not be used
for hysteroscopy.
Fluid Media
Fluid media have historically been divided into elec-
trolyte media and nonelectrolyte media, based on
compatibility with the electrosurgical device used.
However, it is now possible to use electrolyte media
with bipolar electrosurgical systems. It also is impor-
tant to understand which media are hypo-osmolar.
Electrolyte-Poor Fluid. Electrolyte-poor fluids in-
clude glycine, 1.5%; sorbitol, 3%; and mannitol,
5%. These fluids have been widely used for opera-

Table 1. Distending Media

Type
Carbon dioxide gas
Electrolyte-poor fluid
(eg, glycine, 1.5%; sorbitol, Monopolar devices require electrolyte-poor
3%; and mannitol, 5%)
Electrolyte-containing fluid
Advantages
Ease of cleaning and maintaining equipment
Clear view of cavity
Compatible with radiofrequency energy
fluids.
Readily available
Isotonic
Media of choice during diagnostic
hysteroscopy and in operative cases where
mechanical, laser, or bipolar energy is used
Disadvantages and Safety Precautions
To minimize the risk of gas embolization, the flow of
carbon dioxide should be limited to 100 mL/min with
intrauterine pressure of less than 100 mm Hg and used
with a hysteroscopic insufflator. Insufflators designed for
use in laparoscopy must not be used for hysteroscopy.
Excessive absorption of these fluids can cause
hyponatremia, hyperammonemia, and decreased
serum osmolality with the potential for seizures,
cerebral edema, and death.
Although the risk of hyponatremia and decreased
serum osmolality can be reduced by using these media,
pulmonary edema and congestive heart failure can still
occur. Careful attention should be paid to fluid input
and output, with particular attention to the fluid deficit.

2 Technology Assessment in Obstetrics and Gynecology No. 7

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 449

 tive hysteroscopy. They are compatible with radio-
frequency energy, which cuts, desiccates, and fulgu-
rates intrauterine tissue. Monopolar devices require
electrolyte-poor fluids. If electrolyte-containing fluid
is used, the electrical current will dissipate away
from the electrode, rendering it ineffective. Glycine,
1.5%, and sorbitol, 3%, are hypo-osmolar. Excessive
absorption of these fluids can cause hyponatremia,
hyperammonemia, and decreased serum osmolal-
ity, with the potential for seizures, cerebral edema,
and death (1). Some clinicians have recommended
mannitol, 5%, which is iso-osmolar and acts as its
own diuretic. It may cause hyponatremia, but not
decreased serum osmolality (2).
Electrolyte-Containing Fluid. Normal saline solu-
tion and lactated Ringer’s solution are electrolyte
fluids. The use of these fluids is advantageous
because they are readily available and are isotonic.
These solutions are the distending media of choice
during diagnostic hysteroscopy and in operative
cases where mechanical, laser, or bipolar energy
is used. Although the risk of hyponatremia and
decreased serum osmolality can be reduced by
using these media, pulmonary edema and conges-
tive heart failure can still occur. Careful attention
should be paid to fluid input and output, with par-
ticular attention to the fluid deficit.
PreoPeratIve consIDeratIons
A preoperative consultation allows the patient and
physician to discuss the hysteroscopic procedure,
weigh its inherent risks and benefits, review the
patient’s medical history for any comorbid condi-
tions, and exclude pregnancy. Appropriate analgesia
or anesthesia also should be considered depending
on the venue (ie, office versus operating room).
Preoperative placement of laminaria or osmotic dila-
tors or pretreatment with misoprostol for cervical
ripening may facilitate cervical dilation and decrease
operative time and pain (3–6). Antibiotic prophy-
laxis is not recommended for hysteroscopy (7).
In premenopausal women with regular men-
strual cycles, the optimal timing for diagnostic
hysteroscopy is during the follicular phase of the
menstrual cycle after menstruation. Hysteroscopy
during the secretory phase of the cycle can make
diagnosis more difficult because the endometrium
is thick and can mimic polyps. Some women with
unpredictable menses can be scheduled at any time
for operative hysteroscopy.
Technology Assessment in Obstetrics and Gynecology No. 7
COMMITTEE OPINIONS
offIce hysteroscoPy
Office hysteroscopy is becoming increasingly com-
mon because of smaller-diameter telescopes, excel-
lent analgesia protocols, and increased convenience
and cost-effectiveness compared with operating room
procedures (8, 9). Equipment generally needed to per-
form hysteroscopic procedures in the office includes
a hysteroscope with an outer sheath of less than 5
mm in outer diameter, distending media and infusion
system, operative instrumentation, and a light source.
Although it is possible for the surgeon to look directly
into the eyepiece, cameras and video monitoring sys-
tems make it possible to obtain photographs and video
and enable the patient to see images.
Major barriers to successful office hysteroscopy
include pain, cervical stenosis, and poor visualization
of the cervix (10). Therefore, preoperative patient
selection and counseling are very important. Poor
candidates for office hysteroscopy include patients
who have cervical stenosis, high levels of anxiety,
comorbidities, limited mobility, or significant uter-
ine pathology requiring operative procedures. Office
hysteroscopy should be brief and usually consists
of either diagnostic or minor operative procedures.
Off-label administration of oral or intravaginal pros-
taglandin (misoprostol, 200–400 micrograms) the
night before surgery, preoperative administration of
nonsteroidal antiinflammatory medications or anti-
anxiety medications, paracervical anesthetic block,
the use of narrow-caliber hysteroscopes (less than
5 mm in diameter) and flexible hysteroscopes, and
assistance of a dedicated office staff may facilitate
these procedures (4, 10). Although data on the use
of misoprostol with hysteroscopy are limited, buc-
cal or sublingual misoprostol has been found to be
more effective than vaginal misoprostol in other set-
tings, such as postmenopausal dilation and curettage
(D&C) or suction D&C associated with first-trimes-
ter pregnancy termination (11–14). When introduc-
ing any invasive technology, such as hysteroscopy,
into the office setting, it is imperative to institute
rigorous patient safety measures. See the American
College of Obstetricians and Gynecologists’ Patient
Safety Task Force report (15).
contraInDIcatIons
Known pregnancy, genital tract infections, and
active herpetic infection are contraindications to hys-
teroscopy. Hysteroscopy usually is not performed
in patients with advanced stage uterine or cervical
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 450
 cancer who are at risk of hemorrhage or dissemina-
tion of tumor cells. Hysteroscopy may cause reflux of
neoplastic cells into the peritoneal cavity, although it
is unclear if this adversely affects the prognosis (16,
17). However, hysteroscopy is acceptable as part of
the evaluation of abnormal uterine bleeding.
PreventIon anD management of
comPlIcatIons
The most common perioperative complications
associated with operative hysteroscopy are hemor-
rhage (2.4%), uterine perforation (1.5%) (18), and
cervical laceration (1–11%) (19). Complications
from fluid overload should be considered as well.
Other complications include visceral injury, infec-
tion, CO2 and air embolism, and, rarely, death.
Delayed complications may include intrauterine
adhesions and infertility.
Hemorrhage
Hemorrhage may occur during hysteroscopic resec-
tion of the endometrium, leiomyomas, uterine septa,
or synechiae and from cervical lacerations or uter-
ine perforation. Delayed hemorrhage may be seen
among patients with endometritis weeks after sur-
gery. For patients with continued intraoperative
bleeding, electrosurgical coagulation can be used
if a bleeding site can be visualized (1). Alternative
strategies, such as injection of vasopressin into the
cervical stroma, Foley catheter balloon tamponade
(20), or uterine compression, can be attempted. In
extreme cases, laparoscopic suturing of a perfora-
tion, hysterectomy, or uterine artery embolization
may be necessary.
Fluid Overload
Complications from fluid overload may best be
avoided by anticipation and preoperative evalua-
tion of size and number of lesions to be removed.
Fluid absorption is affected by size and number of
the lesions removed, the depth of myometrial resec-
tion, the number of myometrial sinuses opened,
and the intrauterine pressure. Complications may
be prevented by limiting excess fluid absorption,
recognizing and treating fluid overload promptly,
and selecting a distending medium that minimizes
risk. Vasopressin injection in the cervical stroma
may reduce the volume of fluid intravasation (21).
The best way to limit excess fluid intravasation is
to monitor the fluid deficit closely and frequently
throughout the procedure. During long and difficult
4 Technology Assessment in Obstetrics and Gynecology No. 7
COMMITTEE OPINIONS
cases, the surgeon may work with anesthesiologists
to maintain awareness of the deficit and manage the
rate and volume of intravenous fluid infusion from
the head of the operating table. Fluid absorption
should be carefully and frequently monitored by a
designated individual.
Newer methods, based on measurement of fluid
weight, have made fluid monitoring more accurate;
however, some of these systems can be expensive
and may not be available in all settings. One diffi-
culty in estimating fluid input and output is that com-
mercially purchased 3-liter bags may be overfilled
by up to 150–300 mL (22). Dilutional hyponatremia
can be rapidly evaluated by serum sodium analysis.
Guidelines for fluid monitoring and the limits
of fluid excess have been published (2) and adapted
by the American College of Obstetricians and Gyne-
cologists’ Committee on Gynecologic Practice as
follows:
• Intravenous hydration of patients undergoing
hysteroscopy should be closely monitored pre-
operatively and intraoperatively. Hysteroscopic
fluid absorption should be closely monitored
intraoperatively.
• The fluid deficit should be monitored at an
extremely close interval. With electrolyte-poor
fluids, a deficit of 750 mL implies excessive
intravasation. If this occurs, in elderly patients,
patients with comorbid conditions, and patients
with cardiovascular or renal compromise, con-
sideration should be given to terminating the
hysteroscopic procedure immediately.
• Depending on patient size and other factors, if
fluid deficit reaches 1,000–1,500 mL of a non-
electrolyte solution or 2,500 mL of an electrolyte
solution, further infusion should be stopped and
the procedure should be promptly concluded.
Electrolytes should be assessed, administration of
diuretics considered, and further diagnostic and
therapeutic intervention begun as indicated (2).
• In an outpatient setting with limited acute care
and laboratory services, consideration should
be given to discontinuing procedures at a lower
fluid deficit threshold than indicated earlier.
• An automated fluid monitoring system facili-
tates early recognition of excessive deficit in
real-time totals.
• An individual should be designated to frequently
measure intake and outflow and report the defi-
cit to the operative team.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 451
 The treatment of fluid overload from hypo-
tonic agents may require consultation and pos-
sibly a patient transfer to an urgent care facility.
Whereas most women recover, seizures, permanent
brain damage, and death have been reported with
serum sodium levels of 116 mmol/L plus or minus
2 mmol/L (23). Although the rate at which severe
hyponatremia should be corrected is controversial,
most authors agree that if acute hyponatremia has
existed for less than 24 hours, there are few long-
term complications from rapid correction. Therapy is
most often provided in the form of hypertonic saline
solution in conjunction with loop-acting diuretics,
such as furosemide. Serum sodium levels should
be increased by 1–2 mEq/L/h, but by no more than
12 mEq/L in the first 24 hours (24). When patients
present with hyponatremia of greater than 48 hours’
duration postoperatively, rapid correction should not
be undertaken because it can lead to neurologic com-
promise, seizures, and death. Consultation is strong-
ly encouraged in these situations and often requires
slower correction in an intensive care setting.
Perforation
Before performing hysteroscopy, the clinician
should perform a pelvic examination to determine
uterine position. Ultrasound guidance may be use-
ful in difficult cases. If resistance is encountered
during insertion of the hysteroscope, the cervix may
need further dilation. If a flexible hysteroscope is
available, it should be used before attempting force-
ful dilation with larger dilators or placement of a
hysteroscope. The flexible hysteroscope often can
be placed without need for cervical dilation and per-
mits a physician the ability to determine the angle of
inclination of the cervix and trajectory taken when
cervical dilation commences. Midline uterine per-
foration rarely leads to significant morbidity unless
a laser or electrosurgical device is used. Lateral
uterine perforations can lead to the development of a
retroperitoneal hematoma, and cervical perforations
can result in significant immediate or delayed bleed-
ing. Laparoscopy may be useful to determine the
extent of damage, including the existence of bowel
injury or bladder injury.
Embolization
Air and CO2 emboli are rare complications of hys-
teroscopy that may result in circulatory collapse.
Preventive strategies include flushing air from tub-
ing and making sure that the procedure is stopped
and tubing is purged of air when bags are changed.
For such emboli to occur, there must be both vas-
Technology Assessment in Obstetrics and Gynecology No. 7
COMMITTEE OPINIONS
cular access and a pressure gradient between the
site of access and the right side of the heart. In the
conscious patient, chest pain and dyspnea may be
noted. Other findings can include decreased oxygen
saturation, the presence of a “mill wheel” heart
murmur, hypotension, bradycardia, or tachycardia.
In the anesthetized patient, cardiopulmonary status
shows signs of collapse with sudden hypotension,
decrease in oxygenation or end-tidal CO2 or both, or
cardiac dysrhythmias (25).
Management of this emergency consists of
placing the patient in a left lateral decubitus posi-
tion with the head tilted downward 5 degrees. This
maneuver favors the movement of air in the right
ventricle and right ventricular outflow tract toward
the apex of the right ventricle (26). The air may be
aspirated by passing a catheter down the jugular
vein into the right ventricle, or possibly by perform-
ing cardiocentesis.
summary
Hysteroscopy is an effective procedure for the
diagnosis and treatment of intrauterine pathology. It
is minimally invasive and can be used with a high
degree of safety. Knowledge of potential risks relat-
ing to distending media and intraoperative compli-
cations will enhance its safety.
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Copyright June 2011 by the American College of Obstetricians
and Gynecologists. All rights reserved. No part of this publica-
tion may be reproduced, stored in a retrieval system, posted
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electronic, mechanical, photocopying, recording, or otherwise,
without prior written permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Hysteroscopy. Technology Assessment in Obstetrics and
Gynecology No. 7. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1486–91.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 453
 technology assessment
in obstetrics and gynecology
This Technology Assessment was
developed by the Committee on
Gynecologic Practice. This docu-
ment reflects emerging clinical and
scientific advances as of the date
issued and is subject to change.
The information should not be
construed as dictating an exclusive
course of treatment or procedure to
be followed. Variations in practice
may be warranted based on the
needs of the individual patient,
resources, and limitations unique to
the institution or type of practice.
COMMITTEE OPINIONS
Number 8, J uNe 2012
(Replaces Technology Assessment Number 5, December 2008)
Sonohysterography
ABSTRACT: The primary goal of sonohysterography is to visualize the
endometrial cavity in more detail than is possible with routine transvaginal
ultrasonography. The procedure consists of the transcervical injection of
sterile fluid under real-time ultrasound imaging. The indications for sono-
hysterography include, but are not limited to, the evaluation of abnormal
uterine bleeding; uterine cavity, especially with regard to uterine leiomyomas,
polyps, and synechiae; abnormalities detected on transvaginal ultrasonogra-
phy, including focal or diffuse endometrial or intracavitary abnormalities;
congenital abnormalities of the uterus; infertility; and recurrent pregnancy
loss. The procedure should not be performed in a woman who is pregnant or
who could be pregnant or who has an existing pelvic infection or unexplained
pelvic tenderness. Physicians who perform or supervise diagnostic sonohys-
terography should be skilled in vaginal ultrasonography and transcervical
placement of catheters; should have training, experience, and demonstrated
competence in gynecologic ultrasonography and sonohysterography; and
should keep careful records. Portions of this document were developed jointly
with the American College of Radiology, the American Institute of Ultrasound
in Medicine, and the Society of Radiologists in Ultrasound.
Sonohysterography is the evaluation of the endometrial cavity using the trans-
cervical injection of sterile fluid. The primary goal of sonohysterography is to
visualize the endometrial cavity in more detail than is possible with routine
transvaginal ultrasonography. Sonohysterography also can be used to assess
tubal patency. Adherence to the following recommendations serves to maxi-
mize the benefits and safety of sonohysterography. Additional imaging studies
may be necessary for a complete diagnosis.
The clinical aspects of this document include sections that address indica-
tions and contraindications, specifications of the examination, and equipment
specifications that were developed collaboratively by the American College
of Radiology (ACR), the American Institute of Ultrasound in Medicine, the
Society of Radiologists in Ultrasound, and the American College of Obstetri-
cians and Gynecologists (the College) and adapted by the College’s Commit-
tee on Gynecologic Practice. Sections of the document that address physician
qualifications and responsibilities, documentation, quality control, performance
improvement, safety, infection control, and patient education are recommenda-
tions of the College’s Committee on Gynecologic Practice.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 454
 Most clinical experience and medical literature to
date have focused on ultrasound imaging of the uterus
and, specifically, the endometrial cavity, using the trans-
cervical injection of sterile fluid. Thus, terms such as
saline infusion sonohysterography or simply sonohys-
terography have been used to describe this technique.
Sonohysterography can provide diagnostic information
about the uterus and endometrial cavity and also may
be used to assess tubal patency. Early studies involved
the use of sterile normal saline solution mixed with
small amounts of air that is agitated in the saline solu-
tion before instillation. The observation of fluid accu-
mulation in the peritoneal cavity after instillation of
saline solution indicates a minimum of unilateral tubal
patency. Advantages of sonohysterography include the
following (1):
• It can be performed in an office setting
• It eliminates radiation exposure
• It creates less patient discomfort than hysterosal-
pingography
Indications and Contraindications
The indications for sonohysterography include, but are
not limited to, evaluation of the following:
• Abnormal uterine bleeding
• Uterine cavity, especially with regard to uterine tenderness is present during the preliminary trans-
leiomyomas, polyps, and synechiae
• Abnormalities detected on transvaginal ultra-
sonography, including focal or diffuse endome-
trial or intracavitary abnormalities
• Congenital abnormalities of the uterus
• Infertility
• Recurrent pregnancy loss
Sonohysterography should not be performed in
a woman who is pregnant or who could be pregnant.
Usually, this is avoided by scheduling the examination
in the follicular phase of the menstrual cycle, after
the menstrual flow has essentially ceased, but before
the patient has ovulated. In a patient with regular
menstrual cycles, sonohysterography should, in most
cases, be performed by the 10th day of the menstrual
cycle. In cases of intermittent or prolonged abnormal
uterine bleeding, treatment with a short course of pro-
gestin may be considered to enable timing of the pro-
cedure. Sonohysterography should not be performed in
patients with existing pelvic infection or unexplained
pelvic tenderness. Active vaginal bleeding is not a
2 Technology Assessment in Obstetrics and Gynecology No. 8
COMMITTEE OPINIONS
contraindication to the procedure but may make the
interpretation more challenging.
Physician Qualifications and
Responsibilities
Physicians who perform or supervise diagnostic sono-
hysterography should be skilled in transvaginal ultra-
sonography and transcervical placement of catheters.
They should understand the indications, limitations,
and possible complications of the procedure. Physi-
cians should have training, experience, and demon-
strated competence in gynecologic ultrasonography
and sonohysterography. Physicians are responsible for
the documentation of the examination, quality control,
and patient safety.
Specifications of the Examination
Patient Preparation
The sonohysterography procedure should be fully
explained to the patient in advance. Transvaginal ultra-
sonography is a specialized form of a pelvic examina-
tion. Therefore, local policies regarding chaperone
or patient privacy issues during a pelvic examination
also apply during a transvaginal ultrasound examina-
tion. Caution is advised if unexpected pelvic organ
vaginal ultrasound examination or if pelvic infection
is suspected. If adnexal tenderness or pain indicative
of possible active pelvic infection is found before fluid
infusion, the examination should be deferred until after
an appropriate course of treatment. Although routine
use of antibiotic prophylaxis is not recommended, con-
sideration should be given to administering antibiotics
based on individual risk factors (eg, in the presence of
nontender hydrosalpinges or a past history of pelvic
inflammatory disease). A pregnancy test is advised
when clinically indicated. Patients should be ques-
tioned about latex allergy if a latex sheath is used to
cover the ultrasound transducer.
Procedure
Preliminary transvaginal ultrasonography with mea-
surements of the endometrium and evaluation of the
uterus, ovaries, and amount of pelvic free fluid should
be performed before sonohysterography. A speculum
is inserted into the vagina to allow visualization of
the cervix. The presence of unusual pain, lesions, or
purulent vaginal or cervical discharge may require
2013 COMPENDIUM OF SELECTED PUBLICATIONS 455
 rescheduling the procedure pending further evalua-
tion. Before insertion, the catheter should be flushed
with sterile fluid to avoid introducing air during
the study. After the external os is cleansed, a sterile
catheter is inserted into the cervical canal or uterine
cavity using aseptic technique. Once the speculum
is removed and the catheter is in position, the endo-
vaginal transducer is reinserted into the vagina. The
sterile fluid should be instilled slowly with the help of
real-time ultrasound imaging. Imaging should include
real-time scanning of the endometrium and cervical
canal.
Contrast Agent
Appropriate sterile fluid should be used for sonohys-
terography. Normal saline solution can be used for this
purpose.
Images
Precatheterization images should be obtained and
recorded in at least two planes to demonstrate normal
and abnormal findings. These images should include
the thickest bilayer endometrial measurement in the
sagittal plane, when possible.
Once the uterine cavity is filled with fluid, a com-
plete survey of the uterine cavity should be performed
and representative images obtained to document nor-
mal and abnormal findings. If a balloon catheter is
used for the examination, images should be obtained
at the end of the procedure with the balloon deflated
to fully evaluate the endometrial cavity, particularly
the cervical canal and lower portion of the endometrial
cavity. Additional techniques, such as color Doppler
and three-dimensional imaging, may be helpful in the
evaluation of normal and abnormal findings.
Documentation
Appropriate documentation of a sonohysterographic
examination is essential for clinical care and qual-
ity assessment and improvement. The written report
should include patient identification, procedural tech-
nique, measurements, morphologic descriptions, and
interpretation. Images of key findings and written
reports from ultrasound examinations are considered
part of the medical record and should be documented
and stored appropriately. Current Procedural Termi-
nology code 76831 is defined as “Saline infusion sono-
hysterography (SIS), including color flow Doppler,
when performed,” and is found in the Current Proce-
dural Terminology index as “Sonohysterography” (2).
Technology Assessment in Obstetrics and Gynecology No. 8
COMMITTEE OPINIONS
Equipment Specifications
Sonohysterography usually is conducted with a high-
frequency endovaginal transducer. If a patient has an
enlarged uterus, additional transabdominal images
during infusion may be required to fully evaluate the
endometrium. The transducer should be adjusted to
operate at the highest clinically appropriate frequency
under the ALARA (as low as reasonably achievable)
principle.
Quality and Infection Control
Quality control is accomplished through careful record
keeping, reliable archiving of reports and images,
and clinical correlation with outcomes. Endovaginal
transducers always should be covered with a single-
use disposable nonlatex or latex cover before inser-
tion. However, because no such disposable protective
cover is without risk of rupture or defect, endovaginal
transducers should undergo appropriate antimicro-
bial and antiviral reprocessing between patient uses.
Coupling gel should be used. After the examination,
the sheath should be disposed of and the transducer
cleaned in an antimicrobial solution. The type of solu-
tion and amount of time for cleaning should follow
manufacturer and infectious disease control recom-
mendations.
Policies and procedures related to quality, patient
education, infection control, and safety should be
developed and implemented in accordance with the
ACR Position Statement on Quality Control and
Improvement, Safety, Infection Control, and Patient
Education (3). Equipment performance monitoring
should be performed in accordance with the ACR
Technical Standard for Diagnostic Medical Physics
Performance Monitoring of Real Time Ultrasound
Equipment (4).
RefeRences
1. Saunders RD, Shwayder JM, Nakajima ST. Current meth-
ods of tubal patency assessment. Fertil Steril 2011;95:
2171–9. [PubMed] [Full Text] ^
2. Practice Management Information Corporation. CPT plus:
a comprehensive guide to current procedural terminology.
Los Angeles (CA): PMIC; 2011. ^
3. American College of Radiology. ACR position statement
on quality control and improvement, safety, infection
control, and patient education. Reston (VA): ACR; 2008.
Available at: http://www.acr.org/SecondaryMainMenu
Categories/quality_safety/guidelines/position_statement.
aspx. Retrieved January 31, 2012.^
4. American College of Radiology. ACR technical standard
for diagnostic medical physics performance monitoring
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 456
 of real time ultrasound equipment. Reston (VA): ACR;
2011. Available at: http://www.acr.org/SecondaryMain
MenuCategories/quality_safety/guidelines/med_phys/
us_equipment.aspx. Retrieved January 31, 2012. ^
ResouRces
American College of Radiology. ACR–ACOG–AIUM–SRU
practice guideline for the performance of sonohysterography.
Reston (VA): ACR; 2011. Available at: http://www.acr.org/
SecondaryMainMenuCategories/quality_safety/guidelines/us/
us_sonohysterography.aspx. Retrieved January 20, 2011.
Becker E Jr, Lev-Toaff AS, Kaufman EP, Halpern EJ, Edel-
weiss MI, Kurtz AB. The added value of transvaginal sono-
hysterography over transvaginal sonography alone in women
with known or suspected leiomyoma. J Ultrasound Med 2002;
21:237–47. [PubMed] [Full Text]
Benacerraf BR, Shipp TD, Bromley B. Improving the efficien-
cy of gynecologic sonography with 3-dimensional volumes:
a pilot study. J Ultrasound Med 2006;25:165–71. [PubMed]
[Full Text]
Bree RL, Bowerman RA, Bohm-Velez M, Benson CB, Doubi-
let PM, DeDreu S, et al. US evaluation of the uterus in patients
with postmenopausal bleeding: A positive effect on diagnostic
decision making. Radiology 2000;216:260–4. [PubMed] [Full
Text]
Breitkopf DM, Frederickson RA, Snyder RR. Detection of
benign endometrial masses by endometrial stripe measurement
in premenopausal women. Obstet Gynecol 2004;104:120–5.
[PubMed] [Obstetrics & Gynecology]
Connor V. Contrast infusion sonography in the post-Essure
setting. J Minim Invasive Gynecol 2008;15:56–61. [PubMed]
[Full Text]
Cullinan JA, Fleischer AC, Kepple DM, Arnold AL. Sono-
hysterography: a technique for endometrial evaluation. Radio-
graphics 1995;15:501–14; discussion 515–6. [PubMed] [Full
Text]
Doubilet PM. Society of Radiologists in Ultrasound Consensus
Conference statement on postmenopausal bleeding. J Ultra-
sound Med 2001;20:1037–42. [PubMed] [Full Text]
Dubinsky TJ, Stroehlein K, Abu-Ghazzeh Y, Parvey HR,
Maklad N. Prediction of benign and malignant endometrial
disease: hysterosonographic-pathologic correlation. Radiology
1999;210:393–7. [PubMed] [Full Text]
Fleischer AC, Vasquez JM, Cullinan JA, Eisenberg E. Sono-
hysterography combined with sonosalpingography: correlation
with endoscopic findings in infertility patients. J Ultrasound
Med 1997;16:381–4; quiz 385–6. [PubMed]
Ghate SV, Crockett MM, Boyd BK, Paulson EK. Sonohys-
terography: do 3D reconstructed images provide additional
value? AJR Am J Roentgenol 2008;190:W227–33. [PubMed]
[Full Text]
4 Technology Assessment in Obstetrics and Gynecology No. 8
COMMITTEE OPINIONS
Goldstein RB, Bree RL, Benson CB, Benacerraf BR, Bloss
JD, Carlos R, et al. Evaluation of the woman with postmeno-
pausal bleeding: Society of Radiologists in Ultrasound-Spon-
sored Consensus Conference statement. J Ultrasound Med
2001;20:1025– 36. [PubMed] [Full Text]
Goldstein SR. Use of ultrasonohysterography for triage of peri-
menopausal patients with unexplained uterine bleeding. Am J
Obstet Gynecol 1994;170:565–70. [PubMed]
Hajishafiha M, Zobairi T, Zanjani VR, Ghasemi-Rad M, Yekta
Z, Mladkova N. Diagnostic value of sonohysterography in
the determination of fallopian tube patency as an initial step
of routine infertility assessment. J Ultrasound Med 2009;28:
1671–7. [PubMed] [Full Text]
Laifer-Narin S, Ragavendra N, Parmenter EK, Grant EG.
False-normal appearance of the endometrium on conven-
tional transvaginal sonography: comparison with saline hys-
terosonography. AJR Am J Roentgenol 2002;178:129–33.
[PubMed] [Full Text]
Laifer-Narin SL, Ragavendra N, Lu DS, Sayre J, Perrella RR,
Grant EG. Transvaginal saline hysterosonography: character-
istics distinguishing malignant and various benign conditions.
AJR Am J Roentgenol 1999;172:1513–20. [PubMed] [Full
Text]
Lindheim SR, Sprague C, Winter TC 3rd. Hysterosalpingogra-
phy and sonohysterography: lessons in technique. AJR Am J
Roentgenol 2006;186:24–9. [PubMed] [Full Text]
Mihm LM, Quick VA, Brumfield JA, Connors AF Jr, Finnerty
JJ. The accuracy of endometrial biopsy and saline sonohys-
terography in the determination of the cause of abnormal
uterine bleeding. Am J Obstet Gynecol 2002;186:858–60.
[PubMed]
Copyright © June 2012 by the American College of Obstetri-
cians and Gynecologists. All rights reserved. No part of this
publication may be reproduced, stored in a retrieval system, or
transmitted, in any form or by any means, electronic, mechan-
ical, photocopying, recording, or otherwise, without prior writ-
ten permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920
Washington, DC 20090-6920
Sonohysterography. Technology Assessment in Obstetrics and
Gynecology No. 8. American College of Obstetricians and Gyne-
cologists. Obstet Gynecol 2012;119:1325–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 457
COMMITTEE OPINIONS
Committee on Health Care for
Underserved Women

2013 COMPENDIUM OF SELECTED PUBLICATIONS 458

 ACOG
Committee on
Health Care for
Underserved Women
Reaffirmed 2008
The in­for­ma­tion should not be
con­strued as dic­tat­ing an ex­clu­
sive course of treat­ment or pro­ce­
dure to be followed.
The Committee wishes to thank
Kurt Barnhart, MD, MSCE;
Jeffrey Ecker, MD; and Carol
Tauer, PhD; for their assistance in
the development of this document.
Copyright © December 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Partner consent for participation in
women’s reproductive health research.
ACOG Committee Opinion No. 307.
American College of Obstetricians and
Gynecologists. Obstet Gynecol 2004;
104:1467–9.
COMMITTEE OPINIONS
Committee
Opinion
Number 307, December 2004
Partner Consent for Participation
in Women’s Reproductive Health
Research
ABSTRACT: Recent advances in reproductive medicine include treatment
of subfertility as well as investigation of agents that may serve as both con-
traceptives and potential prophylaxis against sexually transmitted diseases,
including potential protection from human immunodeficiency virus (HIV).
Although there is no doubt regarding the need for informed consent by women
participating in trials evaluating the safety and effectiveness of these novel
agents and treatments, there has been some debate regarding the necessity
and propriety of requiring consent from the partners of women involved in
certain types of clinical trials involving reproductive health. Issues of partner
consent are unique to research surrounding women’s reproductive health as
opposed to research pertaining to women’s health, in general. This is due,
in part, to a valid concern about a potential effect of the research on the
partner. There are, therefore, legitimate reasons to obtain partner consent
for a woman’s participation in a clinical trial. In the absence of such reason,
partner consent should not be mandated.
Background
A large number of clinical trials are currently being conducted in nearly every
therapeutic area, including women’s health. Women may be motivated to
participate in clinical trials by altruism to further the care of women, by the
ability to receive novel and state-of-the-art medical care, or by the benefits
of highly supervised medical monitoring of treatment. Often women without
health insurance choose to participate in these trials because such trials may
provide enhanced access to care, the care provided is often rendered without
cost, and there is reimbursement for time and travel. The American College
of Obstetricians and Gynecologists supports the development of new devices
and medications to advance women’s health and reproductive options. The
American College of Obstetricians and Gynecologists also endorses the high-
est ethical and moral conduct of clinical research. All women, regardless of
socioeconomic status and race, should have access to enrollment in clinical
trials. The decision to enter a clinical trial should be autonomous, without
2013 COMPENDIUM OF SELECTED PUBLICATIONS 459
 coercion, and after informed consent. Informed
consent is the ability to understand the risks and
benefits of one’s participation in a research activity
and to authorize one’s participation in this activity
freely (1).
A research subject is defined as “An individual
who participates in a clinical trial, either as a recipi-
ent of the investigational product(s) or as a control.”
(2). In research on women’s reproductive health,
sometimes both the woman and her partner will
be the subjects. For example, in a study designed
to identify any risk or harm to a partner of a new
contraceptive method, both the woman and her
partner may be research subjects. If a partner is a
subject in the research, informed consent for both
participants is required. This Committee Opinion
primarily addresses the need for partner consent in
research for which the woman, and not a partner, is
the research subject. The respect for the autonomy
of research subjects to consent to participation is one
of the pillars of The Belmont Report, promulgated
by The National Commission for the Protection
of Human Subjects of Biomedical and Behavioral
Research in 1979 (3). The decision to reproduce or
use contraceptives should remain autonomous for a
woman even when enrolled in a clinical trial.
It also is important to note that the discussion
and recommendations that follow do not pertain
to research involving pregnant women. There are
specific regulations that apply to federally funded
research involving this population (4).
Partner Consent Requirement
Inconsistencies
Recent advances in reproductive medicine include
treatment of subfertility as well as investigation of
agents that may serve as both contraceptives and
potential prophylaxis against sexually transmit-
ted diseases, including potential protection from
human immunodeficiency virus (HIV). Although
there is no doubt regarding the need for informed
consent by women participating in trials evaluating
the safety and effectiveness of these novel agents
and treatments, there has been some debate regard-
ing the necessity and propriety of requiring consent
from the partners of women involved in certain
types of clinical trials involving reproductive health.
Some local institutional review boards (IRB) have
requested consent of a woman’s partner and at other
times a trial sponsor or an individual investigator has
COMMITTEE OPINIONS
made the decision unilaterally. Because of the lack
of guidance on this issue, there is great inconsistency
regarding requirements for partner consent and the
manner in which partner consent is obtained (see
box “Methods of Obtaining Partner Consent”).
When Is Partner Consent Needed?
Issues of partner consent are unique to research sur-
rounding women’s reproductive health as opposed
to research pertaining to women’s health, in general.
This is partly due to a valid concern about a potential
impact of the research on the partner. Therefore,
there are legitimate reasons to obtain partner consent
for a woman’s participation in a clinical trial. In the
absence of such reason, partner consent should not
be mandated. Partner consent should be obtained if:
• A sexual partner is a subject in the same clinical
trial as the woman.
• A partner will be exposed to a novel agent and
there is a potential for more than minimal risks*
of exposure to the investigational agent.
• Data will be collected regarding a partner’s
acceptance of the investigational agent, or the
impact of partner’s acceptance of the agent on
the female participant.
• Inclusion or exclusion criteria directly relate to
a partner, for example, if testing of a partner is
required for a woman to enroll in the trial (eg,
semen analysis or testing for a sexually trans-
mitted disease).
If, after careful consideration, it is determined that
none of the previous conditions apply, partner con-
sent is not warranted because it should not need-
lessly:
• Impose a barrier to participation for a woman
• Interfere with a woman’s choice of reproduc-
tive options
• Interfere with a woman’s right to make inde-
pendent decisions about her reproductive health
care due to an IRB’s or regulatory agency’s
paternalistic reasons for partner consent
*According to applicable federal regulations, “Minimal risk
means that the probability and magnitude of harm or discom-
fort anticipated in the research are not greater in and of them-
selves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examina-
tions or tests.” (45 C.F.R §46.102[I]).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 460

Methods of Obtaining Partner Consent
Several methods exist that may be used to obtain partner
consent regarding a woman’s participation in a clinical
trial. The suitability of these methods depends on the
particular research study. Some ways of obtaining part-
ner consent include:
• Having a partner attend the screening visit and sign
the consent at that time
• Giving a copy of the consent to the participant and
having a partner come in for a separate visit to con-
sent
• Mailing the consent and having it mailed back
• Performing the informed consent process over the
telephone
• Obtaining a single informed consent that is signed by
the woman and partner
Recommendations
Recognizing the complexities of the conduct and
consent requirements for trials in women’s repro-
ductive health, the following recommendations are
made:
References
• The partner consent requirements of each clini-
cal trial need to be individually evaluated and
based on the best available scientific and medi-
cal evidence and ethical principles.
• When partner consent is required, efforts
should be undertaken to decrease the likelihood
that receipt of such consent will be a barrier for
participation of a woman interested in enroll-
ing in such a trial. The addition of consent
adds complexity to all trials, often resulting in
additional visits for the participant and partner.
This can result in fewer women enrolling and a
decrease in compliance.
• Whenever possible, the choice of a woman to
enroll in a clinical trial regarding her reproduc-
tive function and health should be hers alone
when it does not also include a partner as a
research subject. In these instances, the woman,
not the IRB or the researcher(s), considering
the research study should determine the extent
to which a partner is to be involved in the pro-
cess of informed consent and the decision to
participate. For example:
—In the case of the study of a microbicide
or barrier contraception efficacy, the risk
COMMITTEE OPINIONS
to a partner is likely negligible (compared
with the female partner) because of minimal
contact time. If potential irritation to a male
partner is suspected, it should be ruled out in
the early stages of clinical investigation.
—In contraceptive research where the par-
ticipant may face an unintended pregnancy,
a partner may be a potential father with the
resultant legal and moral responsibilities for
the child. However, the principle of auton-
omy, allowing a woman to make a choice
to enter a trial regarding her reproductive
rights, should take precedence (5). The
American College of Obstetricians and
Gynecologists does not support recognition
of distinct paternal rights before the birth of
a child (6).
• Regardless of the requirement for partner con-
sent, communication with a partner about repro-
ductive health and contraception use should be
encouraged.
1. American College of Obstetricians and Gynecologists.
Informed consent. In: Ethics in obstetrics and gynecology.
2nd ed. Washington (DC): ACOG; 2004. p. 9–17.
2. International Conference On Harmonisation. Guideline for
good clinical practice. ICH Harmonised Tripartite Guideline
E6. London: ICH; 1997. Available at: http://www.proclinica.fr/
GCPICH.pdf. Retrieved August 26, 2004.
3. The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. The
Belmont report: ethical principles and guidelines for the
protection of human subjects of research. Washington,
DC: U.S Department of Health and Human Services;
1979. Available at: http://www.hhs.gov/ohrp/humansub
jects/guidance/belmont.htm. Retrieved August 26, 2004.
4. Protection of human subjects. 45 C.F.R §46 (2003). Available
at: http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfr46
_03.html. Retrieved August 27, 2004.
5. Holder AR. Contraceptive research: do sex partners have
rights? IRB 1982;4(2):6–7.
6. American College of Obstetricians and Gynecologists.
Research involving women. In: Ethics in obstetrics and
gynecology. 2nd ed. Washington (DC): ACOG; 2004.
p. 86–91.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 461
 ACOG
Committee on
Health Care for
Underserved Women
This in­for­ma­tion should not be
con­strued as dic­tat­ing an ex­clu­sive
course of treat­ment or pro­ce­dure
to be followed.
The Committee on Health Care
for Underserved Women wishes
to thank Raymond L. Cox, MD,
MBA, for his invaluable assis-
tance in the development of this
document.
Copyright © October 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Racial and ethnic disparities in
women’s health. ACOG Committee
Opinion No. 317. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:889–92
COMMITTEE OPINIONS
Committee
Opinion
Number 317, October 2005
Racial and Ethnic Disparities in
Women’s Health
ABSTRACT: Significant racial and ethnic disparities exist in women’s health.
These health disparities largely result from differences in socioeconomic
status and insurance status. Although many disparities diminish after taking
these factors into account, some remain because of health care system-level,
patient-level, and provider-level factors. The American College of Obste-
tricians and Gynecologists strongly supports the elimination of racial and
ethnic disparities in the health and the health care of women. Health profes-
sionals are encouraged to engage in activities to help achieve this goal.
Health disparities can be defined as “differences in the incidence, prevalence,
mortality, and burden of diseases and other adverse health conditions that
exist among specific population groups in the United States” (1). These dif-
ferences can be assessed according to a variety of factors including gender,
race or ethnicity, education, income, disability, geographic location, or sex-
ual orientation (2). Although significant health disparities occur between men
and women and among certain groups of women based on the factors men-
tioned previously, disparities are most likely to be experienced by women
who are members of racial and ethnic minority groups. For example, disease
and premature death occur disproportionately in minority women compared
with non-Hispanic white women (3).
Approximately 44 million women in the United States, nearly one third
of all women in this country, are members of racial and ethnic minority
groups. African-American women and women of Hispanic origin together
comprise roughly one quarter of the total population of U.S. women (4). The
Hispanic population accounted for 22% of the 4 million births in the United
States in 2003 (5). The largest segment of the immigrant population in the
United States is from Latin America (6).
It is important to note that race and ethnicity are primarily social charac-
teristics much more than they are biologic categories. However, race and eth-
nicity can provide useful information to women’s health care providers about
environmental, cultural, behavioral, and medical factors that may affect their
patients’ health. Also, the frequency of certain genetic variations may differ
between racial or ethnic groups. For instance, there is an increased frequency
2013 COMPENDIUM OF SELECTED PUBLICATIONS 462
 of mutations for certain genetic diseases, such as
Tay-Sachs disease, in individuals of Ashkenzic
Jewish descent. These differences in the frequency
of genetic variations generally are related to a com-
mon ancestral lineage (founder effect).
Genetic polymorphisms associated with in-
creased susceptibility to disease also may vary
in frequency in different racial and ethnic groups
(7). Another consideration is the issue of gene-
environment interaction. Genetic variations, even
those that do not vary in frequency among racial
or ethnic groups, may enhance susceptibility to an
environmental exposure that occurs more frequently
in a particular racial or ethnic group. Thus, although
race and ethnicity are primarily social constructs,
the impact of common ancestral lineage on the seg-
regation and frequency of genetic variations in com-
bination with the influence of cultural factors on
environmental exposures cannot be ignored. All of
these factors should be considered when trying to elu-
cidate the multifactorial causes of health disparities.
Examples of Racial and Ethnic Health
Disparities Among Women
• During 1991–1995, heart disease death rates
remained the highest for African-American
women, followed by white, American Indian/
Alaskan Native, and Asian/Pacific Islander
women, with more than a twofold difference
between the lowest and highest rates (8).
• Asian/Pacific Islander women, especially
those who are Vietnamese; black women; and
Hispanic white women have higher incidence
rates of invasive cervical cancer than non-
Hispanic white women (9, 10). Cervical cancer
mortality rates are higher among American
Indian/Alaskan Natives than among all racial
and ethnic populations (3.7 per 100,000 popu-
lation and 2.6 per 100,000 population, respec-
tively) despite lower incidence (11).
• When compared with white women, black
women have a higher mortality rate (34.7 per
100,000 compared with 25.9 per 100,000) for
breast cancer despite a lower breast cancer inci-
dence rate (10).
• Seventy-eight percent of the female popula-
tion with acquired immunodeficiency syn-
drome (AIDS) is African American or Hispanic.
Although American Indian/Alaskan Native
COMMITTEE OPINIONS
women have a lower annual rate of new AIDS
cases (4.8 per 100,000) than non-Hispanic black
(50.2 per 100,000) and Hispanic (12.4 per
100,000) women, the rate is still more than twice
the rate for non-Hispanic white women (2.0 per
100,000) (12).
• Non-Hispanic black and some Hispanic popu-
lations have preterm births at rates 60% and
27% higher, respectively, than the rate for non-
Hispanic white women (13).
• African-American women have higher infant,
fetal, and perinatal mortality rates than white
women (14) (see Table 1).
• Although maternal mortality ratios for all ethnic
groups have declined over the past half century,
racial and ethnic disparities in maternal mortal-
ity have actually increased (15, 16). African-
American women are three to six times more
likely to have a pregnancy-related death than
white women (16).
Understanding the Causes of Health
Disparities
Many health disparities are directly related to ineq-
uities in income, housing, safety, education, and
job opportunities; they largely result from differ-
ences in socioeconomic status and insurance status.
Although many disparities diminish after taking
these factors into account, some remain because of
health care system-level, patient-level, and provider-
level factors (17).
The current U.S. health care financing paradigm
inadvertently may contribute to disparities in health
outcomes. The United States is the only developed
country that does not extend health care as a right
of citizenship. In the United States, health care is
Table 1. Infant, Fetal, and Perinatal Mortality by Race
of Mother
Race of Infant Fetal Perinatal
Mother Mortality Rate Mortality Rate Mortality Rate
White 5.8 5.5 5.9
Black or 14.4 11.9 12.8
Africian
American
National Center for Health Statistics. Health, United States, 2004: with
chartbook on trends in the health of Americans. Hyattsville (MD):
NCHS; 2004. Available at: http://www.cdc.gov/nchs/data/hus/hus04.pdf.
Retrieved June 23, 2005.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 463
 driven by market forces; the ultimate goal of the
health care business is to maximize profit. For these
reasons, this health care system contributes to a lack
of access for citizens who are either uninsured or
underinsured. The varying geographic availability
of health care institutions also may contribute to
racial and ethnic disparities in health care.
Access to health insurance coverage and care
and utilization of care is significantly different for
minority women. The following examples illustrate
this point:
• Hispanic and African-American women are
more likely to be uninsured than white women.
In 2001, 16% of white women, 20% of African-
American women, and 37% of Hispanic women
18­–64 years of age were uninsured (18).
• Asian-American and Hispanic women are most
likely to have not received preventive care in
the past year. In 1998, 29% of Asian-American
women and 21% of Hispanic women received
no preventive services in the previous year
compared with 16% of white women and 7% of
African-American women. (19).
• The proportion of Asian-American women
obtaining Pap tests was considerably lower than
that for white women. Only approximately one
half (49%) of Asian-American women reported
receiving a Pap test in the previous year com-
pared with 64% of white women (19).
• Non-Hispanic black, Hispanic, and American
Indian women are more than twice as likely as
non-Hispanic white women to begin prenatal
care in the third trimester or not at all (5).
Evidence suggests that factors such as ste-
reotyping and prejudice on the part of health care
providers may contribute to racial and ethnic dis-
parities in health (17). Additionally, cultural differ-
ences between the health care provider and patient
can cause communication problems between the
patient and the provider and can lead to an inaccu-
rate understanding of the patient’s symptoms. Ambi-
guities between health care providers’ and patients’
understanding and interpretation of information
may contribute to disparities in care (17). For
example, language and literacy barriers interfere
with physician–patient communication and can
contribute to culturally derived mistrust of the
health care system and to reduced adherence to
health care provider recommendations. Use of
COMMITTEE OPINIONS
traditional or folk remedies can interfere with
science-based treatments. There also are lifestyle
risk factors, such as unhealthy diets, low levels
of physical activity, and alcohol and tobacco use,
which contribute to morbidity and mortality and are
more prevalent among certain populations (3).
ACOG Recommendations
The American College of Obstetricians and
Gynecologists strongly supports the elimination of
racial and ethnic disparities in women’s health and
health care as well as gender disparities in health
and health care. The elimination of disparities in
women’s health and health care requires a compre-
hensive, multilevel strategy that involves all mem-
bers of society. Our goal as health care providers
and leaders must be to optimize individuals’ health
status and the quality of health care. We encour-
age health professionals to engage in the following
activities:
1. Advocate for universal access to basic afford-
able health care (20).
2. Improve cultural competency in the physician–
patient relationship and engage in cross-cultural
educational activities to improve communica-
tion and language skills (21).
3. Use national best practice guidelines to reduce
unintended variation in health care outcomes by
gender, race, and ethnicity.
4. Provide high quality, compassionate, and ethi-
cally sound health care services to all. Engage
in dialogue with patients to determine their care
expectations, and counsel patients regarding
the benefits of preventive health care and early
screening, intervention, and treatment.
5. Advocate for increased public awareness of
the benefits of preventive health care and early
screening and intervention.
6. Encourage and become active in recruiting
minorities to the health professions.
7. Advocate for improved access to programs that
develop fluency in English among non-English
speaking populations.
8. Acquire team-building skills to help attract and
retain qualified nurses and other health pro-
fessionals for provision of quality services to
underserved women.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 464
 9. Conduct research to determine causes of health
disparities and develop and evaluate interven-
tions to address these causes.
10. Advocate for the continued collection of race-
based data which is important in understanding
disparities. Advocate for increased funding for
this research.
11. Increase training of health care providers about
racial, ethnic, and gender disparities in health
and health care.
12. Support safety net providers, including public
health systems, urban academic centers, and
other health care delivery systems that are more
likely to provide health care to minority popula-
tions.
References
1. Fauci AS. Slideshow: The NIH Strategic Plan to Address
Health Disparities. Bethesda (MD): National Institutes
of Allergy and Infectious Diseases; 2000. Available
at: http://www.niaid.nih.gov/director/healthdis.htm.
Retrieved June 23, 2005.
2. U.S. Department of Health and Human Services. Healthy
people 2010: understanding and improving health. 2nd ed.
Washington, DC: U.S. Government Printing Office; 2000.
Available at: http://www.healthypeople.gov/Document/
pdf/uih/2010uih.pdf. Retrieved June 23, 2005.
3. Clark A, Fong C, Romans M. Health disparities among
U.S. women of color: an overview. Washington, DC: The
Jacobs Institute of Women’s Health; 2002.
4. U.S. Bureau of the Census. Population by age, sex,
race, and Hispanic or Latino origin for the United
States: 2000(PHC-T-9). Washington, DC: The Bureau;
2001. Available at: http://www.census.gov/population/
www/cen2000/phc-t9.html. Retrieved June 23, 2005.
5. Hamilton BE, Martin JA, Sutton PD. Births: preliminary
data for 2003. Natl Vital Stat Rep 2004;53(9):1–17.
6. Larsen LJ. The foreign-born population in the United
States: 2003: population characteristics. Current Population
Reports, P20-539. Washington, DC: US Census Bureau;
2004. Available at: http://www.census.gov/prod/2004 pubs/
p20–551.pdf. Retrieved June 23, 2005.
7. Romero R, Kuivaniemi H, Tromp G, Olson J. The design,
execution, and interpretation of genetic association stud-
ies to decipher complex diseases. Am J Obstet Gynecol
2002;187:1299–312.
8. Casper ML, Barnett E, Halverson JA, Elmes GA, Braham
VE, Majeed ZA, et al. Racial and ethnic disparities in
heart disease among women. In: Women and heart dis-
ease: an atlas of racial and ethnic disparities in mortal-
ity. 2nd ed. Atlanta (GA): Centers for Disease Control
COMMITTEE OPINIONS
and Prevention; Morgantown (WV): West Virginia
University, Office for Social Environment and Health
Research; 2000. Available at: ftp://ftp.cdc.gov/pub/
Publications/ womens_atlas/00-atlas-all.pdf. Retrieved
June 22, 2005. p. 19–24.
9. Satcher D. American women and health disparities [edi-
torial]. J Am Med Womens Assoc 2001;56:131–2, 160.
10. Ries LA, Eisner MP, Kosary CL, Hankey BF, Miller BA,
Clegg L, et al., editors. SEER cancer statistics review,
1975–2002. Bethesda (MD): National Cancer Institute;
2005. Available at: http://seer.cancer.gov/csr/1975_2002.
Retrieved June 23, 2005.
11. Cancer mortality among American Indians and Alaska
Natives­­—United States, 1994–1998. Centers for Disease
Control and Prevention. MMWR Morb Mortal Wkly Rep
2003;52:704–7.
12. Centers for Disease Control and Prevention. HIV/AIDS
Surveillance Report, 2003;15:1–46. Available at: http://
www.cdc.gov/hiv/stats/2003SurveillanceReport.pdf. Retrieved
June 22, 2005.
13. Martin JA, Hamilton BE, Sutton PD, Ventura SJ,
Menacker F, Munson ML. Births: final data for 2002.
Natl Vital Stat Rep 2003;52(10):1–113.
14. National Center for Health Statistics. Health, United
States, 2004: with chartbook on trends in the health of
Americans. Hyattsville (MD): NCHS; 2004. Available at:
http://www.cdc.gov/nchs/data/hus/hus04.pdf. Retrieved
June 23, 2005.
15. Differences in maternal mortality among black and white
women—United States, 1990. MMWR Morb Mortal
Wkly Rep 1995;44:6–7, 13–4.
16. State-specific maternal mortality among black and white
women—United States, 1987–1996. MMWR Morb Mortal
Wkly Rep 1999;48:492–6.
17. Institute of Medicine (US). Unequal treatment: confront-
ing racial and ethnic disparities in healthcare. Washington,
DC: The Institutes 2002.
18. Kaiser Family Foundation. Racial and ethnic disparities
in women’s health coverage and access to care: findings
from the 2001 Kaiser Women’s Health Survey. Menlo
Park (CA): KFF; 2004. Available at: http://www.kff.org/
womenshealth/loader.cfm?url=/commonspot/security/
getfile.cfm&PageID=33087. Retrieved June 23, 2005.
19. Collins KS, Schoen C, Joseph S, Duchon L, Simantov E,
Yellowitz M. Health concerns across a woman’s lifespan:
The Commonwealth Fund 1998 Survey of Women’s
Health. New York (NY): The Commonwealth Fund;
1999.
20. The uninsured. ACOG Committee Opinion No. 308.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:1471–4.
21. American College of Obstetricians and Gynecologists.
Cultural competency, sensitivity and awareness in the
delivery of health care. In: Special issues in women’s
health. Washington, DC: ACOG; 2005. p. 11–20.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 465
 ACOG COMMITTEE OPINION
Number 361 • February 2007

Breastfeeding: Maternal and Infant

Aspects
Committee on ABSTRACT: Evidence continues to mount regarding the value of breastfeeding for
Health Care for both women and their infants. The American College of Obstetricians and Gynecologists
Underserved strongly supports breastfeeding and calls on its Fellows, other health care profession-
Women als caring for women and their infants, hospitals, and employers to support women in
Committee on choosing to breastfeed their infants. Obstetrician–gynecologists and other health care
Obstetric Practice pro­fessionals caring for pregnant women should provide accurate information about
The Committees breastfeeding to expectant mothers and be prepared to support them should any prob-
would like to thank lems arise while breastfeeding.
Sharon Mass, MD, for
her contributions to
Research in the United States and through- Breastfeeding is the preferred method
the development of
out the world indicates that breastfeeding of feeding for newborns and infants. Nearly
this document.
and human milk provide benefits to infants, every woman can breastfeed her child.
women, families, and society. In 1971, only Excep­tions are few and include those women
24.7% of mothers left the hospital breast- who take street drugs or do not control alco-
feeding. Since then, breastfeeding initiation hol use, have an infant with galactosemia,
rates have been increasing because of a grow- are infected with human immunodeficiency
ing awareness of the advantages of breast virus (HIV) or human T-cell lymphotropic
milk over formula, but they have not yet virus type I or type II, and have active
reached the goal set by the U.S. Public Health untreated tuberculosis or varicella or active
Service for Healthy People 2010 (1). In 2005, herpes simplex virus with breast lesions (3,
72.9% of new U.S. mothers initiated breast- 4).
feeding (2). Although this is close to the The American College of Obstetricians
target rate of 75% in the early postpartum and Gynecologists strongly supports breast-
period, there is still a long way to go to feeding and calls upon its Fellows, other
achieve target breastfeeding rates of 50% at health care professionals caring for women
6 months and 25% at 12 months (1). and their infants, hospitals, and employers
Improvement in breastfeeding initiation to support women in choosing to breastfeed
rates has been un­even as women attempt their infants. All should work to facilitate the
to overcome practical obstacles. Women continuation of breastfeeding in the work-
and infants who could benefit most from place and public facilities. Health care pro-
breastfeeding are often within population fessionals have a wide range of opportunities
groups (geographic, racial, economic, and to serve as a primary resource to the public
educational) with low rates of breastfeeding. and their patients regarding the benefits of
Education and support services can improve breastfeeding and the knowledge, skills, and
The American College rates among these as well as other women. support needed for successful breastfeed-
of Obstetricians Breastfeeding education and support are an ing (5). In addition to providing supportive
and Gynecologists economical investment for health plans and clinical care for their own patients, obstetri-
Women’s Health Care employers because there are lower rates of cian–gynecologists should be in the forefront
Physicians illness among infants who are breastfed. of fostering changes in the public environ-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 466

 ment that will support breastfeeding, whether through
change in hospital practices, through community efforts,
or through supportive legislation.
The advice and encouragement of the obstetrician–
gynecologist during preconception, prenatal, postpar-
tum, and interconception care are critical in making the
decision to breastfeed. Good hospital practices surround-
ing childbirth are significant factors in enabling women
to breastfeed. Health care providers should be aware
that the giving of gift packs with formula to breastfeed-
ing women is commonly a deterrent to continuation of
breastfeeding (4). A professional recommendation of
the care and feeding products in the gift pack is implied.
For this reason, physicians may conclude that noncom-
mercial educational alternatives or gift packs without
health-related items are preferable. After discharge, the
obstetrician–gynecologist’s office should be a resource
for 24-hour assistance, or provide links to other resources
in the community. Breastfeeding problems, including
breast and nipple pain, should be evaluated and treated
promptly. Clinical breast examinations are recommend-
ed for breastfeeding women. If any mass or abnormality
is detected, it should be fully evaluated.
Contraception is an important topic for early discus-
sion and follow-up for breastfeeding women. Women
should be encouraged to consider their future plans for
contraception and childbearing during prenatal care and
be given information and services that will help them
meet their goals. Options that should be explained in
detail include nonhormonal methods, hormonal meth-
ods, and the lactational amenorrhea method.
Women should be supported in integrating breast-
feeding into their daily lives in the community and in
the workplace to enable them to continue breastfeeding
as long as possible. Maintaining milk supply depends
largely on frequency and adequacy of maternal stimula-
tion through breastfeeding and through pumping when
mother and baby are separated. The American College
of Obstetricians and Gynecologists recommends that
exclusive breastfeeding be continued until the infant
is approximately 6 months old. A longer breastfeeding
experience is, of course, beneficial. The professional
objectives are to encourage and enable as many women as
possible to breastfeed and to help them continue as long
as possible (3, 4). Physicians’ offices can set the example
COMMITTEE OPINIONS
in encouraging and welcoming breastfeeding through
staff training, office environment, awareness and educa-
tional materials, and supportive policies (3, 4).
More detailed information on breastfeeding and
practical strategies for support can be found in the
ACOG Clinical Review “Special Report From ACOG,
Breastfeeding: Maternal and Infant Aspects” and in the
American Academy of Pediatrics and ACOG resource,
Breastfeeding Handbook for Physicians (3, 4).
References
1. U.S. Department of Health and Human Services. Increase
in the proportion of mothers who breastfeed their babies.
In: Healthy people 2010: objectives for improving health.
2nd ed. Washington, DC: U.S. Government Printing
Office; 2000. p. 16–46.
2. Centers for Disease Control and Prevention. Breastfeeding:
data and statistics: breastfeeding practices—results from
the 2005 National Immunization Survey. Atlanta (GA):
CDC. Available at: http://www.cdc.gov/breastfeeding/
data/NIS_data/data_2005.htm. Retrieved November 14,
2006.
3. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Breastfeeding handbook
for physicians. Elk Grove Village (IL): AAP; Washington,
DC: ACOG; 2006.
4. American College of Obstetricians and Gynecologists.
Breastfeeding: maternal and infant aspects. Special report
from ACOG. ACOG Clin Rev 2007;12(suppl):1S–16S.
5. American College of Obstetricians and Gynecologists.
Breastfeeding. ACOG Executive Board Statement.
Washington, DC; ACOG: 2003. Available at: http://www.
acog.org/departments/underserved/breastfeedingStatement.
pdf. Retrieved November 1, 2006.
Copyright © February 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400
Breastfeeding: maternal and infant aspects. ACOG Committee
Opinion No. 361. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2007;109:479–80.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 467
 ACOG COMMITTEE OPINION
Committee on Health
Care for Underserved
Women
The Committee on
Health Care for
Underserved Women
would like to thank
Kerry M. Lewis, MD,
and Virginia C. Leslie,
MD, for their assistance
in the development of
this document.
This information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 416 • September 2008 (Replaces No. 308, December 2004)
The Uninsured
ABSTRACT: The United States is one of the few industrialized nations in the world
that do not guarantee health care for their populations. Access to health care for all
women is of paramount concern to obstetrician–gynecologists and the American College
of Obstetricians and Gynecologists. Pregnant women and infants are among the most
vulnerable populations in the United States and the American College of Obstetricians
and Gynecologists believes that providing them with full insurance coverage and access
to health care must be a primary step in the process of providing coverage for all individu-
als within the U.S. borders. Health care professionals can play a pivotal role in improving
access to needed health care by helping society and our political representatives under-
stand the importance of broadening health insurance coverage.
The United States is one of the few industri- cially Latina women (2). Most low income
alized nations in the world that do not guar- uninsured women are not eligible for public
antee health insurance for their populations. programs but cannot afford private coverage
Of the 30 countries in the Organization of (5). This is a problem for both U.S and non-
Economic Cooperation and Development, U.S. citizens.
only Mexico and Turkey have a higher unin-
sured rate than the United States (1). There Effect of Lack of Insurance on
are more than 17 million uninsured women Women’s Reproductive Health
(aged 18–64 years) in the United States. This and Health Care
number has increased by 1.2 million since Having health insurance does not guaran-
2004, with one half of this growth occurring tee good health, but not having insurance
among low-income women (2). The num- is guaranteed to put Americans at higher
ber of women in the United States who are risk for poor health outcomes and eco-
uninsured grew three times faster than the nomic hardship. Acquiring health insurance
number of men without health insurance reduces mortality rates for the uninsured
during the late 1990s and early 2000s (3). by 10–15% (6). The uninsured receive less
In 2006, one in five women of childbear- preventive care, receive diagnoses at more
ing age—totaling 12.6 million women—was advanced disease stages, and, once diseases
uninsured, showing no improvement from are diagnosed, tend to receive less therapeu-
2005 and accounting for 27% of all unin- tic care (7). Lack of health insurance may
sured Americans (4). Nearly eight out of ten affect women’s health in the following ways:
uninsured women (79%) are in families with
at least one part-time or full-time worker (2). • Uninsured pregnant women receive
Most uninsured women do not qualify for fewer prenatal care services than their
Medicaid, do not have access to employer- insured counterparts (1) (a total of 18%
sponsored plans, and cannot afford indi- of uninsured pregnant women reported
vidual policies. Access to health care also is that they did not receive some needed
affected by other barriers, including health medical care versus 7.6% of privately
literacy and cultural differences along with insured and 8.1% of Medicaid-enrolled
proximity to health care facilities and lack of pregnant women [8]).
transportation. Women who are young and • Uninsured pregnant women are more
low-income are particularly at risk of being likely to experience an adverse maternal
uninsured, as are women of color, espe- outcome (1).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 468
 • Uninsured newborns are more likely to experience
adverse health outcomes and are more likely to die
than insured newborns (1).
• Uninsured women with breast cancer have a 30–50%
higher risk of dying than insured women with breast
cancer (1).
• Uninsured women’s options for contraception are
limited (9).
• Uninsured women aged 18–64 years are three times
less likely to have had a needed Pap test in the past
3 years (10). This contributes to a 60% greater risk
of late-stage diagnosis of cervical cancer among
uninsured women compared with insured women
(11).
Uninsured Non-U.S. Citizens
As efforts to expand coverage are pursued, assessing the
coverage needs of low-income non-citizen adults, who
have a high uninsured rate caused by limited access to
both private and public coverage, will be an important
consideration (12). Following the 1996 welfare reform
law, almost all legal immigrants became ineligible for
federally matched Medicaid coverage during their first 5
years of residence in the United States. Undocumented
immigrants and temporary immigrants generally are
ineligible for Medicaid regardless of their length of resi-
dence in the country, a restriction that has been in place
before welfare reform.
The Capacity of the Health Care
System to Serve the Uninsured
The cost of uncompensated care is staggering; in 2004, it
was estimated to be $40.7 billion. Most uncompensated
care expenses are incurred by hospitals, where services are
the most costly. In 2001, hospitals spent 63% of total costs
in uncompensated care. Office-based physicians and direct
care programs or clinics accounted for 18% and 19% of
uncompensated costs, respectively (13). A 2001 Common-
wealth Fund study found that the value of care provided by
academic health centers to those who were unable to pay
for their services increased as a percentage of gross patient
revenues by more than 40% in the past decade (14). The
number of patients treated at hospitals who are unable to
pay is increasing as the number of uninsured individuals
grows, threatening the financial viability of some institu-
tions.
The proportion of private physicians providing care
to the uninsured is decreasing and those who pro-
vide such care are spending less time doing so (15).
Specifically, the number of physicians providing any
care to individuals unable to pay decreased from 71.5%
in 2001 to 68.2% in 2005 (15). A combination of higher
office expenses, including professional liability insurance,
and stagnant insurance payments reduces the ability of
physicians to provide uncompensated care.
COMMITTEE OPINIONS
Covering the Uninsured
In recent years, there has been bipartisan interest in
broadening access to health coverage to the nearly 47
million uninsured Americans. Although there has been
relatively little activity at the federal level, a handful of
states have recently adopted or are considering adopting
proposals to expand coverage. States are using a combi-
nation of strategies, such as expanding public programs
to cover most children in a state, mandating employers to
cover all workers or contribute to a public financing pool,
and requiring all individuals to carry health insurance
with subsidies for those with lower incomes.
Massachusetts and Vermont passed laws in 2006 to
achieve nearly universal coverage as well as address cost
and quality. On April 12, 2006, Massachusetts enacted
legislation requiring that individuals have health insur-
ance and that the government provide subsidies to ensure
affordability (16). Vermont’s law, which includes access
to subsidized or low-cost insurance, relies on voluntary
participation. Approximately 21 states introduced uni-
versal coverage bills in 2007 (17).
Conclusion
Access to health care for all women is a paramount
concern of the American College of Obstetricians and
Gynecologists (see box). Pregnant women and infants
are among the most vulnerable populations in the United
States and the American College of Obstetricians and
Gynecologists believes that providing them with full
insurance coverage and access to care must be a prior-
ity. Lack of health care coverage creates access issues that
affect women, practitioners, and the health care system as
a whole. A change in our currently fragmented health care
system is warranted to expand coverage to the millions of
uninsured individuals within the U.S. borders. Health
Principles for Reform of the
U.S. Health Care System
January 2007
PREAMBLE: Health care coverage for all is needed to
facilitate access to quality health care, which will in turn
improve the individual and collective health of society.
1. Health care coverage for all is needed to ensure
quality of care and to improve the health status of
Americans.
2. The health care system in the U.S. must provide
appropriate health care to all people within the U.S.
borders, without unreasonable financial barriers to
care.
3. Individuals and families must have catastrophic health
coverage to provide protection from financial ruin.
4. Improvement of health care quality and safety must
be the goal of all health interventions, so that we can
assure optimal outcomes for the resources expended.
(continued)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 469

Principles for Reform of the
U.S. Health Care System
January 2007 (continued)
5. In reforming the health care system, we as a society
must respect the ethical imperative of providing
health care to individuals, responsible stewardship
of community resources, and the importance of per-
sonal health responsibility.
6. Access to and financing for appropriate health ser-
vices must be a shared public/private cooperative
effort, with a system which will allow individu-
als/ employers to purchase additional services or
insurance.
7. Cost management by all stakeholders, consistent
with achieving quality health care, is critical to
attaining a workable, affordable and sustainable
health care system.
8. Less complicated administrative systems are essen-
tial to reduce costs, and increase efficiency.
9. Sufficient funds must be available for research (basic,
clinical, translational, and health services), medical
education, and comprehensive health information
technology infrastructure and implementation.
10. Sufficient funds must be available for public health
and other essential medical services to include, but
not be limited to, preventive services, trauma care
and mental health services.
11. Comprehensive medical liability reform is essential
to ensure access to quality health care.
American Academy of Family Physicians, American Academy
of Orthopaedic Surgeons, American College of Cardiology,
American College of Emergency Physicians, American College
of Obstetricians and Gynecologists, American College of
Osteopathic Family Physicians, American College of Physicians,
American College of Surgeons, American Medical Association,
American Osteopathic Association. Principles for reform of the
U.S. health care system. Leawood (KS): AAFP; Rosemont (IL):
AAOS; Washington, DC: ACC; Irving (TX): ACEP; Washington,
DC: ACOG; Arlington Heights (IL): ACOFP; Philadelphia (PA):
ACP; Chicago (IL): ACS; Chicago (IL): AMA; Chicago (IL): AOA;
2007. Available at: http://www.acponline.org/pressroom/health_
reform.pdf. Retrieved June 10, 2008.
professionals can play a pivotal role in improving access
to needed health care by helping society understand the
importance of universal health care access. For a listing
of resources on the topic of the uninsured, go to www.
acog.org/goto/underserved.
References
1. Institute of Medicine. Insuring America’s health: principles
and recommendations. Washington, DC: National Acad-
emies Press; 2004.
2. Henry J. Kaiser Family Foundation.Women’s health
insurance coverage: December 2007. Menlo Park (CA):
KFF; 2007. Available at: http://www.kff.org/womenshealth/
upload/ 6000 _06.pdf. Retrieved June 10, 2008.
COMMITTEE OPINIONS
3. Lambrew JM. Diagnosing disparities in health insurance
for women: a prescription for change. New York (NY):
The Commonwealth Fund; 2001. Available at: http://www.
commonwealthfund.org/usr_doc/lambrew_disparities_
493.pdf?section=4039. Retrieved June 10, 2008.
4. March of Dimes. Census data on uninsured women and
children. Washington (DC): MOD; 2007. Available at:
http://www.marchofdimes.com/Census.pdf. Retrieved June
10, 2008.
5. Henry J. Kaiser Family Foundation. Characteristics of the
uninsured: who is eligible for public coverage and who
needs help affording coverage? Kaiser Commission on
Medicaid and the Uninsured. Washington, DC: KFF; 2007.
Available at: http://www.kff.org/uninsured/upload/7613.pdf.
Retrieved June 10, 2008.
6. Henry J. Kaiser Family Foundation. Sicker and poorer: the
consequences of being uninsured. A review of the research
on the relationship between health insurance, health, work,
income, and education. Kaiser Commission on Medicaid
and the Uninsured. Washington, DC: KFF; 2002. Available
at: http://www.kff.org/uninsured/upload/Full-Report.pdf.
Retrieved June 10, 2008.
7. American College of Physicians–American Society of
Internal Medicine. No health insurance? It’s enough to
make you sick. Philadelphia (PA): ACP-ASIM; 1999.
8. Bernstein AB. Insurance status and use of health services
by pregnant women. Washington, DC: Alpha Center;
1999. Available at: http://www.marchofdimes.com/files/
bernstein_paper.pdf. Retrieved June 10, 2008.
9. Sonfield A, Gold RB. New study documents major strides
in drive for contraceptive coverage. Guttmacher Rep Public
Policy 2004;7(2):4–5, 14.
10. Ayanian JZ, Weissman JS, Schneider EC, Ginsburg JA,
Zaslavsky AM. Unmet health needs of uninsured adults in
the United States. JAMA 2000;284:2061–9.
11. Ferrante JM, Gonzalez EC, Roetzheim RG, Pal N, Woodard
L. Clinical and demographic predictors of late-stage cervical
cancer. Arch Fam Med 2000;9:439–45.
12. Henry J. Kaiser Family Foundation. Health insurance cov-
erage and access to care for low-income non-citizen adults.
Kaiser Commission on Medicaid and the Uninsured.
Washington, DC: KFF; 2007. Available at: http://www.kff.
org/uninsured/upload/7651.pdf. Retrieved June 10, 2008.
13. Henry J. Kaiser Family Foundation. The cost of care for the
uninsured: what do we spend, who pays, and what would
full coverage add to medical spending? Issue update. Kaiser
Commission on Medicaid and the Uninsured. Washington,
DC: KFF; 2004. Available at: http://www.kff.org/uninsured/
upload/The-Cost-of-Care-for-the-Uninsured-What-Do-
We-Spend-Who-Pays-and-What-Would-Full-Coverage-
Add-to-Medical-Spending.pdf. Retrieved June 10, 2008.
14. The Commonwealth Fund. A shared responsibility: aca-
demic health centers and the provision of care to the poor
and uninsured. A report of The Commonwealth Fund
Task Force on Academic Health Centers. New York (NY):
Commonwealth Fund; 2001. Available at: http://www.
commonwealthfund.org/usr_doc/AHC_indigentcare_ 443.
pdf?section=4039. Retrieved June 10, 2008.
15. Center for Studying Health System Change. A growing
hole in the safety net: physician charity care declines again.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 470
 Tracking Report No. 13. Washington, DC: HSC; 2006.
Available at: http://www.hschange.com/CONTENT/826/
826. pdf. Retrieved June 10, 2008.
16. Henry J. Kaiser Family Foundation. Massachusetts
health care reform plan: an update. Kaiser Commission
on Medicaid and the Uninsured. Washington, DC:
KFF; 2007. Available at: http://www.kff.org/uninsured/
upload/7494-02.pdf. Retrieved June 10, 2008.
17. National Conference of State Legislatures. Health reform
bills. Denver (CO): NCSL; 2007. Available at: http://
www. ncsl.org/programs/health/universalhealth2007.htm.
Retrieved June 10, 2008.
COMMITTEE OPINIONS
Copyright © September 2008 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
The uninsured. ACOG Committee Opinion No. 416. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2008;112:
731–4.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 471
 ACOG COMMITTEE OPINION
Committee on
Health Care for
Underserved Women
Reaffirmed 2012
The Committee on
Health Care for
Underserved Women
would like to thank
Ann Honebrink, MD,
for her assistance in the
development of this
document.
This information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 423 • January 2009
Motivational Interviewing: A Tool for
Behavior Change
Abstract: Applying the principles of motivational interviewing to everyday patient
interactions has been proved effective in eliciting “behavior change” that contributes
to positive health outcomes and improved patient–physician communication. Current
Procedural Terminology codes are available to aid in obtaining reimbursement for time
spent engaging patients in motivational interviewing for some conditions.
Many common diseases affecting women’s tance and achieve behavior change within the
health can be moderated or controlled by constraints of an active clinical practice (4).
“behavior change.” However, promoting The American College of Obstetricians and
changes in a patient’s dietary habits, alcohol Gynecologists (ACOG) encourages the use
use, or sexual practices usually is daunting of motivational interviewing as one effective
to the obstetrician–gynecologist. The prac- approach to elicit behavior change.
tice of motivational interviewing is emerg-
ing as an effective and efficient catalyst for Definition of Motivational
behavior change. Motivational interviewing Interviewing
tactics have been successfully used within
Motivational interviewing is defined as, “a
the clinical setting to promote weight reduc- directive, client-centered counseling style for
tion, dietary modification, exercise, and eliciting behavior change by helping cli-
smoking cessation, thus having a potential ents explore and resolve ambivalence” (5).
profound impact on heart disease, hyper- Initially, it was used to motivate patients
tension, and diabetes mellitus. Prompting who abused alcohol to modify their drinking
patients to use safe sex practices and to use behaviors. The goal of motivational inter-
contraception more consistently also has viewing is to “help patients identify and
been achieved through motivational inter- change behaviors that place them at risk of
viewing techniques (1). developing health problems or that may be
Communication with patients that indi- preventing optimal management of a chronic
cates sensitivity and empathy is an approach condition” (6). Recognizing the dynamics of
used successfully by obstetrician–gynecolo- an individual patient’s readiness to change
gists (2). Whereas the traditional manner by behavior is integral to this approach (7). The
which physicians give advice often is enough to goal of using motivational interviewing is
motivate some patients to adopt more healthy to help patients move through the stages of
behaviors, advice alone has little impact for readiness for change in dealing with risky or
those engaged in risky health behaviors (3). unhealthy behavior (see the box).
This resistance to change may be associ-
ated with the patient’s misunderstanding of
CPT copyright © 2008 American Medical Association
the connection between the activity and the (AMA). All rights reserved. Fee schedules, relative value
health risk. The resistance also may be asso- units, conversion factors and/or related components are
ciated with minimizing the risk, valuing a not assigned by the AMA, are not part of CPT, and the
social connection associated with the behav- AMA is not recommending their use. The AMA does not
ior, or even addiction. Evidence suggests that directly or indirectly practice medicine or dispense medi-
cal services. The AMA assumes no liability for the data
motivational interviewing is one technique contained or not contained herein. CPT is a registered
that can be used to break through this resis- trademark of the AMA.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 472

Stages of Readiness for Change
• Precontemplation–The patient does not believe a prob-
lem exists. (“I won’t get pregnant!”)
• Contemplation—The patient recognizes a problem
exists and is considering treatment or behavior
change. (“Maybe I could get pregnant and there are
things I could do to prevent this.”)
• Action—The patient begins treatment or behavior
change. (“I’ll take that prescription for birth control
pills.”)
• Maintenance—The patient incorporates new behavior
into daily life. (“I’m taking the pill every day.”)
• Relapse—The patient returns to the undesired behav-
ior. (“The pill makes me sick, I think I’ll stop.”)
In motivational interviewing, the traditional
approach of “advice giving” gives way to one of “reflec-
tive listening.” Although a physician may give sound and
logical advice, the patient, often concurrently, experi-
ences resistance to that advice. Motivational interviewing
reframes the patient–physician interaction but does not
necessarily add time to the patient visit. Studies show
that when a patient is allowed to talk and the physician is
actively listening and reflecting back to the patient what
he or she has heard, no more than 3 minutes are added to
the encounter (8). Use of the reflective listening approach
helps to better define patient concerns and decreases
“late-arising concerns” at the end of the patient’s visit (9).
Principles and Practice of
Motivational Interviewing
Motivational interviewing helps the patient identify the
thoughts and feelings that cause her to continue “unhealthy”
behaviors and help her to develop new thought patterns to
aid in behavior change. This technique is implemented
most effectively after the physician has established a trust-
ing rapport with the patient. Once the desired outcome (eg,
weight loss, better compliance with contraception, smoking
cessation) is set, the health care provider then uses the fol-
lowing principles during the interview:
• Express empathy and avoid arguments—For exam-
ple, as part of a discussion about weight loss in a
patient with diabetes mellitus, the physician can
state, “I understand that is has been difficult for
you to exercise and lose weight in the past. Many of
my patients find this to be difficult. I think it is still
important for us to try to find ways for you to work
on this. What do you think you can do to exercise
more and eat less?”
• Develop discrepancies—The physician can help the
patient understand the difference between her behav-
CPT only © 2008 American Medical Association. All Rights Reserved.
COMMITTEE OPINIONS
ior and her goals. For example, consider stating, “You
have told me that you would like to feel better and
cut down on your medication. I think you know that
losing weight would help with this. Why do you think
it is hard for you to find more time to exercise?”
• Roll with resistance and provide personalized feed-
back. When patients express reasons for not achiev-
ing goals, the physician can help them find ways to
succeed. For example, consider stating, “I know you
are tired when you get home from work, but do you
think you could try walking up the stairs at work
instead of taking the elevator?”
• Support self-efficacy, elicit self-motivation—For
example, the physician can state, “Let’s talk about
what you can do to be more physically active.”
Effectiveness
Motivational interviewing techniques have been evalu-
ated and found to be effective in randomized clinical
trials. These trials have examined the impact of the use of
motivational interviewing to elicit behavior modification
such as smoking cessation, human immunodeficiency
virus (HIV) risk reduction, and increased diet and exer-
cise (4, 10). In a meta-analysis of 72 randomized clinical
trials on the effectiveness of motivational interviewing
in eliciting behavior change such as smoking cessation,
weight loss, decreased alcohol use, and cholesterol level
control, it was found that motivational interviewing had
a significant and clinically relevant effect in modifying
behaviors in approximately 75% of the studies, with an
approximate equal effect on those with physiologic and
psychologic diseases (11). More than one encounter
ensured greater effectiveness with the patient. Discussion
of behavior change to improve health outcomes is not
associated with diminished patient satisfaction. In fact,
tobacco use assessment and counseling by the physician
are associated with greater satisfaction (12).
Applications for the Obstetrician–
Gynecologist
The use of motivational interviewing has been shown
to help reduce alcohol consumption in heavy drinkers
during pregnancy and help drinkers who do not want
to become pregnant use contraception more effectively
(13). Other studies suggest that the use of motivational
interviewing may increase the duration of breast-feeding
and improve smoking cessation efforts. Some studies
support the use of motivational interviewing to reduce
risky behaviors in individuals with HIV infection as well
as improve adherence with medication regimens. The
use of motivational interviewing has been successful in
such diverse areas as reducing the fear of childbirth, and
thus decreasing the rate of cesarean delivery (14), and in
lifestyle intervention for women with polycystic ovary
syndrome. Studies have shown the effective application
of the use of motivational interviewing in changing “risk
2013 COMPENDIUM OF SELECTED PUBLICATIONS 473
 behavior” in adolescents (15, 16). The use of motivational
interviewing also has been used in the general popula-
tion to aid in counseling for effective contraception use
and to reduce the risk of sexually transmitted diseases.
Specific Current Procedural Terminology (CPT) codes
are available for billing for the counseling of patients
regarding smoking cessation and other substance abuse.
In addition, evaluation and management codes can be
selected, using the time component, when working with
patients to modify specific behaviors related to a medical
diagnosis. The use of motivational interviewing is one of
the strategies for structured brief intervention mentioned
within the coding requirements.
Training
Traditional medical training has not included the prin-
ciples of motivational interviewing, but curricula have
been developed and evaluated for both postgraduate and
medical student training (11). Several approaches, known
by their acronyms, have been developed for use in train-
ing. One such approach is FRAMES (17):
F Feedback—Compare the patient’s risk behavior with
nonrisk behavior patterns. She may not be aware that
what she considers normal is risky.
R Responsibility—Stress that it is her responsibility to
make the change.
A Advice—Give direct advice (not insistence) to
change the behavior.
M Menu—Identify “risk situations” and offer options
for coping.
E Empathy—Use a style of interaction that is under-
standing and involved.
S Self-efficacy—Elicit and reinforce self-motivating
statements such as “I am confident that I can stop
drinking.” Help the patient to develop strategies,
implement them, and commit to change.
An example of an intervention, using the FRAMES
approach, with a nonpregnant woman is listed as follows:
“Your drinking is in the range that we call ‘risky drink-
ing’ because it can cause health risks for you. These risks
include…It is important to reduce your drinking to no
more than seven drinks per week and no more than three
drinks on one occasion.” The health care provider should
ask for a response to this advice to ensure that the patient
understands the need to take action: “What do you think
about what I just said? How do you feel about reduc-
ing your drinking below risky levels? What about using
effective birth control?” If the patient agrees, consider
establishing goals and creating a “change plan” to reinforce
her behavior change.
Other successful motivational interviewing approaches
can be found within the ACOG “Drinking and Repro-
ductive Health Tool Kit” (17).
COMMITTEE OPINIONS
Training courses in motivational interviewing can
be brief. In one clinical trial, it was noted that obstetric
care clinicians who viewed a 20-minute motivational
interviewing training video showed greater empathy,
minimized patient defensiveness, and supported wom-
en’s beliefs in their ability to change (18). Presentation of
techniques used for motivational interviewing and case
examples are suitable for Grand Rounds or other con-
tinuing medical education activities.
Coding
As of 2008, new CPT codes have been developed for
patient counseling using motivational interviewing and
other structured counseling techniques for smoking
cessation and for screening and intervention in cases of
alcohol and substance abuse. Smoking cessation coding
information is available on the ACOG web site at www.
acog.org/departments/dept_web.cfm?recno=13.
For patients with positive screening results for sub-
stance use or alcohol abuse, a motivational discussion by
the physician or a qualified staff member that is focused
on increasing the patient’s understanding of the impact
of substance use and motivating behavior change can be
coded for reimbursement. Evaluation and Management
(E/M) service codes are listed as follows (both assessment
and intervention components must be documented):
99408—Alcohol and/or substance (other than tobac-
co) abuse structured assessment and brief interven-
tion services 15–30 minutes
99409—Screening and brief intervention services
greater than 30 minutes
These E/M services are separate from other E/M services
that are performed during the same clinical visit. Modifier
25, indicating an additional separate and distinct E/M ser-
vice, may be coded for some health plans.
G0396—Alcohol and/or substance (other than
tobacco) abuse structured assessment and brief
intervention services 15–30 minutes
G0397—Screening and brief intervention services
greater than 30 minutes
Conclusion
Applying principles of motivational interviewing to every-
day patient interactions has the potential to elicit behav-
ior change that contributes to positive health outcomes.
These changes could have an important impact on the
management of major diseases in women. In addition,
the principle of effective listening improves physician–
patient communication and patient satisfaction during all
types of physician–patient encounters. Motivational inter-
viewing principles should be incorporated into physician
and medical student training. Although the groundwork
CPT only © 2008 American Medical Association. All Rights Reserved.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 474
 for eliciting behavior change can be set during a brief
encounter, follow-up is helpful and often necessary to
aid in the achievement of long term, often incremen-
tal, results. Current Procedural Terminology codes are
available to aid in obtaining reimbursement for time
spent engaging patients in motivational interview-
ing. Incorporation of motivational interviewing tools
into everyday clinical encounters enhances the obstetri-
cian–gynecologist’s ability to serve patients.
Resources
Books
• Miller WR, Rollnick S. Motivational interviewing:
preparing people for change. 2nd ed. New York
(NY): Guilford Press; 2002
• Rollnick S, Miller WR, Butler C. Motivational inter-
viewing in health care: helping patients change
behavior. New York (NY): Guilford Press; 2008.
Videos
• Miller WR. Motivational interviewing. Albuquerque
(NM): University of New Mexico; 1989. Available
from the author at the Department of Psychology,
University of New Mexico, Albuquerque, NM 87131,
(505) 277-4121.
• Hester RK, Handmaker NS. Motivating pregnant
women to stop drinking. Albuquerque (NM):
Behavior Therapy Associates; 1997. Available from
Behavior Therapy Associates, 9426 Indian School
Road NE, Suite 1, Albuquerque, NM 87112, (505)
345-6100.
• Additional video training materials available at:
www.motivationalinterview.org/training/videos.html
References
1. Golin CE, Patel S, Tiller K, Quinlivan EB, Grodensky CA,
Boland M. Start talking about risks: development of a moti-
vational interviewing-based safer sex program for people
living with HIV. AIDS Behav 2007;11(suppl):S72–83.
2. American College of Obstetricians and Gynecologists.
Patient communication. In: Special issues in women’s
health. Washington, DC: ACOG; 2003. p. 3–9.
3. Steinbrook R. Imposing personal responsibility for health.
N Engl J Med 2006;355:753–6.
4. Dunn C, Deroo L, Rivara FP. The use of brief interventions
adapted from motivational interviewing across behavioral
domains: a systematic review. Addiction 2001;96:1725–42.
5. Hettema J, Steele J, Miller WR. Motivational interviewing.
Annu Rev Clin Psychol 2005;1:91–111.
6. Bundy C. Changing behaviour: using motivational inter-
viewing techniques. J R Soc Med 2004;97(suppl 44):43–7.
CPT only © 2008 American Medical Association. All Rights Reserved.
COMMITTEE OPINIONS
7. Prochaska JO, DiClemente CC, Norcross JC. In search of
how people change. Applications to addictive behaviors.
Am Psychol 1992;47:1102–14.
8. Beckman HB, Frankel RM. The effect of physician behavior
on the collection of data. Ann Intern Med 1984;101:692–6.
9. Marvel MK, Epstein RM, Flowers K, Beckman HB.
Soliciting the patient’s agenda: have we improved? JAMA
1999;281:283–7.
10. Burke BL, Arkowitz H, Menchola M. The efficacy of moti-
vational interviewing: a meta-analysis of controlled clinical
trials. J Consult Clin Psychol 2003;71:843–61.
11. Rubak S, Sandbaek A, Lauritzen T, Christensen B.
Motivational interviewing: a systematic review and meta-
analysis. Br J Gen Pract 2005;55:305–12.
12. Barzilai DA, Goodwin MA, Zyzanski SJ, Stange KC. Does
health habit counseling affect patient satisfaction? Prev
Med 2001;33:595–9.
13. Floyd RL, Sobell M, Velasquez MM, Ingersoll K, Nettleman
M, Sobell L, et al. Preventing alcohol-exposed pregnancies:
a randomized controlled trial. Project CHOICES Efficacy
Study Group [published erratum appears in Am J Prev Med
2007;32:360]. Am J Prev Med 2007;32:1–10.
14. Saisto T, Salmela-Aro K, Nurmi JE, Kononen T, Halmesmaki
E. A randomized controlled trial of intervention in fear of
childbirth. Obstet Gynecol 2001;98:820–6.
15. Knight JR, Sherritt L, Van Hook S, Gates EC, Levy S, Chang
G. Motivational interviewing for adolescent substance use:
a pilot study. J Adolesc Health 2005;37:167–9.
16. Erickson SJ, Gerstle M, Feldstein SW. Brief interventions
and motivational interviewing with children, adolescents,
and their parents in pediatric health care settings: a review.
Arch Pediatr Adolesc Med 2005;159:1173–80.
17. American College of Obstetricians and Gynecologists.
Drinking and reproductive health: a fetal alcohol spectrum
disorders prevention tool kit. Washington, DC: ACOG;
2006. Available at: http://www.acog.org/departments/
health issues/FASDToolKit.pdf. Retrieved September 19,
2008.
18. Handmaker NS, Hester RK, Delaney HD. Videotaped training
in alcohol counseling for obstetric care practitioners: a ran-
domized controlled trial. Obstet Gynecol 1999;93:213–8.
Copyright © January 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Motivational interviewing: a tool for behavior change. ACOG
Committee Opinion No. 423. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2009;113:243–6.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 475
 ACOG COMMITTEE OPINION
Committee on Health
Care for Underserved
Women
The Committee on
Health Care for Under-
served Women would like
to thank Eve Espey, MD,
for her assistance in the
development of this
document.
This information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 424 • January 2009
Abortion Access and Training
ABSTRACT: Despite a decrease in abortion rates over the past decade, numerous
political, social, and provider barriers limit access to abortion services. Barriers include
state restrictions and mandates limiting access, lack of public funding for abortion ser-
vices, and the decrease in abortion providers. Abortion education and training are limited
in medical schools and in residency programs. The American College of Obstetricians
and Gynecologists supports education in family planning and abortion for both medical
students and residents and abortion training among residents. In addition, the American
College of Obstetricians and Gynecologists supports availability of reproductive health
services for all women, including strategies to reduce unintended pregnancy and to
improve access to safe abortion services.
Abortion is one of the most common health Reducing the Need for
services performed in the United States and is Abortion
an integral component of women’s reproduc-
Reducing unintended pregnancy is the best
tive health services. In 2005, 1.2 million abor-
way to reduce abortion. Abortion rates have
tions were performed (1). Approximately
decreased over the past decade. Obtaining
50% of women in the United States will
experience an unintended pregnancy by age accurate statistics about abortion prevalence
45 years, and based on current abortion is difficult given underreporting of abortion
rates, nearly one in three women will have and lack of a national requirement for report-
an abortion by age 45 years (2). Since 1973 ing abortion. Some states require reporting
when the U.S. Supreme Court recognized the and others voluntarily report to the Centers
constitutional right to abortion in Roe v. for Disease Control and Prevention. Statistics
Wade, morbidity and mortality from the from the Centers for Disease Control and
performance of unsafe abortion have Prevention indicate that the number of abor-
decreased dramatically. Abortion-related tions in the United States has decreased dur-
deaths decreased from 40 per million live ing the 1990s and was at its lowest level in
births in 1970 to eight per million live births 2005 since 1974, at 19.4 abortions per 1,000
in 1976 (3). Although the majority of ter- reproductive-aged women (1). The decrease
minations are performed with aspiration, in abortions directly reflects the decrease in
medication abortion has provided an alter- unintended pregnancy over the same period
native for women seeking first trimester (1). Three quarters of the decrease in unin-
termination (up to 63 days) of pregnancy tended pregnancy is attributable to higher
since 2000, when the U.S. Food and Drug contraceptive prevalence and use of more
Administration approved mifepristone and effective contraceptive methods in repro-
misoprostol (4). In 2005, early medication ductive-aged women (5). Strategies that may
abortion accounted for 13% of abortions. contribute to higher contraceptive prevalence
Public health efforts have focused on include comprehensive sexuality education
reducing the frequency of unintended preg- and improved access to contraceptive meth-
nancy, but the demand for abortion contin- ods and emergency contraception.
ues. The availability of abortion services is in
jeopardy because of restricted access to the Reduced Access to Abortion
procedure and to limited training of physi- Numerous barriers limit access to abortion.
cians during residency. Federal funds may not be used for abortion
2013 COMPENDIUM OF SELECTED PUBLICATIONS 476
 except when the woman’s life is endangered or in the
case of rape or incest. Only 17 states allow state Medicaid
funds to be used for medically necessary abortions (6).
Private insurance varies in its coverage of abortion.
Some states specifically prohibit private insurance from
covering abortion except in cases where the woman’s
life would be endangered if she carried the pregnancy
to term (7). Lack of health insurance and other financial
concerns constitute a further barrier to access for the
economically disadvantaged women who require abor-
tion services.
State mandated restrictions on abortion reduce
access. Thirty five states require some parental notifica-
tion or consent or both for a minor seeking abortion
(8). A minor can be exempted from a state’s parental
notification or consent requirement or both through a
judicial bypass, by which a court grants approval instead
of a parent. However, some evidence suggests that these
procedures are frequently inadequate as well as medi-
cally and psychologically harmful to adolescents (9, 10).
Twenty-four states require delays of up to 24 hours
before an abortion may be performed as well as requir-
ing the provision of information about abortion that
may be misleading and sometimes not based on scientific
evidence (11). Parental notification and consent laws and
mandatory delays create obstacles for women, including
family problems, increased expense, and travel difficul-
ties. These restrictions may disproportionately affect low-
income women, particularly those in rural settings.
The number of abortion providers has decreased
over the past 2 decades. From 1996 to 2000, the number
of abortion providers decreased from 2,042 to 1,819, a
decrease of 11% (1). From 2000 to 2005, that number
decreased from 1,819 to 1,787, a further decrease of 2%
(1). Nearly 35% of women across 87% of U.S. counties
had no abortion provider in 2005 (1). The lack of pro-
viders and the lack of integration of the procedure into
routine practice may single out abortion as a reproduc-
tive health service that is much less accessible than others.
One third of women live in counties without an abortion
provider and more than 20% of women undergoing
abortion in 2000 traveled more than 50 miles to obtain
the procedure (12).
Abortion may take place in an atmosphere of con-
troversy, harassment, and sometimes violence (13). The
highly charged emotional and political debate stigmatizes
the women who undergo abortion and the providers who
offer abortion. In addition to creating a barrier for seeking
care, this negative atmosphere may be a deterrent to train-
ing providers and offering reproductive health services.
Abortion Training
Despite the high demand for abortion procedures, educa-
tion and training in abortion care are limited. Education
in medical school about abortion is limited. In a recent
survey of abortion education in medical school cur-
riculum, 17% of educators reported no formal education
COMMITTEE OPINIONS
about abortion either in the preclinical or clinical years
for medical students (14). Only 32% of schools have at
least one lecture specifically about abortion during the
clinical years (14). Although 45% of schools offer a clini-
cal experience in abortion care, participation is low (14).
Unlike most clinical experiences that are integrated into
the clerkship, clinical experience in abortion is often “opt
in”—students must discuss their interest with the clerk-
ship director and help arrange the clinical experience.
Approximately one half of the schools offered a fourth-
year elective in family planning and abortion, but few
students participated (14).
Obstetrics and gynecology residency training in
abortion care is similarly limited. Concerns about the lack
of abortion training led the Accreditation Council for
Graduate Medical Education (ACGME) to issue program
requirements in 1996 that were specific to abortion train-
ing (15). These standards, supported by the American
College of Obstetricians and Gynecologists, required
that “experience with induced abortion must be part of
residency training.” Although residency programs may
opt out of providing in-house training, they must provide
their residents the opportunity for abortion training at
an outside facility. Similarly, residents with religious or
moral objections may opt out of receiving abortion train-
ing. However, residents must receive training in manage-
ment of abortion complications.
Despite the institution of these standards, a survey
performed by the National Abortion Federation in 1998
of the 261 accredited obstetrics and gynecology residen-
cies revealed that although 81% of programs reported
that they offered first-trimester abortion training, only
46% offered it routinely. In 34% of programs, abortion
training was offered as an “elective,” outside the standard
curriculum (16). The nature of elective or opt in training
places the burden to create a clinical experience on the
residents, and prior data show that the majority of resi-
dents participate in training when it is integrated whereas
a minority of residents participate when it is elective (17).
Forty percent of programs responded that fewer than
one half of their residents received training and 14%
responded that no residents were trained. In a follow-up
survey, conducted in 2004, 51% of responding obstetrics
and gynecology residency program directors reported
their programs offered routine abortion training, 39%
offered elective training, and 10% did not offer training
at all (18). Residents who attended programs where abor-
tion training was integrated into the curriculum were
more likely to undergo training in all abortion modalities
and received more training.
A recent study supports high satisfaction with abor-
tion training (19). Obstetrics and gynecology residents
at the University of California at San Francisco were
asked to evaluate their rotations and, specifically, to com-
pare the value of their family planning rotation, which
includes abortion training, with others. The family plan-
ning rotation received the highest rating of the third-year
2013 COMPENDIUM OF SELECTED PUBLICATIONS 477
 resident rotations and was comparable to a high volume
surgical rotation. Training in abortion offers many skills
which are applicable for the obstetrics and gynecology
practice, including early gestational sizing through the
use of examination and ultrasonography, pain manage-
ment, and the use of manual vacuum aspiration for
incomplete and missed abortions. Furthermore, evidence
suggests that residents who receive more extensive abor-
tion training are more likely to provide abortions after
residency (20). Information on family planning and
abortion training opportunities is listed in the box.
ACOG supports the availability of comprehensive
reproductive health services for all women (21) and spe-
cifically supports:
1. Strategies that may reduce unintended pregnan-
cy, such as comprehensive sexuality education and
improved access to effective contraceptive methods
and emergency contraception for all women wishing
to avoid pregnancy.
2. Availability of safe, legal, and accessible abortion
services.
3. Education about family planning and abortion for all
medical students as an integral part of reproductive
health education.
4. Education about family planning and abortion as an
integrated component of the obstetrics and gynecol-
ogy residency training.
Family Planning and Abortion Training
Opportunities
The Fellowship in Family Planning–The objective of the
program is to develop specialists focused on research,
teaching, and clinical practice in contraception and abor-
tion by receiving training in clinical and epidemiologic
research, developing clinical and teaching skills, working
internationally, and connecting to a rapidly expanding
network of family planning experts. For more information,
go to: http://familyplanningfellowship.org/whatis.html.
The Kenneth J. Ryan Residency Training Program in
Abortion and Family Planning–A national program with
the goal of formally integrating and enhancing family
planning training for residents in obstetrics and gynecol-
ogy. It strives to create academic settings for didactic
education, clinical training, and research. For more
information, go to: http://bixbycenter.ucsf.edu/training/
training/ kenneth_j_ryan_training.html.
For additional information, please go to www.acog.org/
goto/underserved. Please note the American College
of Obstetricians and Gynecologists (ACOG) does not
necessarily endorse the views expressed or the facts
presented on these web sites. Further, ACOG does not
endorse any commercial products that may be adver-
tised or available on these web sites.
COMMITTEE OPINIONS
References
1. Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in
the United States: incidence and access to services, 2005.
Perspect Sex Reprod Health 2008;40:6–16.
2. Guttmacher Institute. In brief: facts on induced abortion
in the United States. New York (NY): GI; 2008. Available
at: http://www.guttmacher.org/pubs/fb_induced_abortion.
html. Retrieved July 17, 2008.
3. Cates W Jr, Grimes DA, Schulz KF. The public health
impact of legal abortion: 30 years later. Perspect Sex Reprod
Health 2003;35:25–8.
4. Medical management of abortion. ACOG practice bulletin
No. 67. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2005;106:871–82.
5. Santelli JS, Lindberg LD, Finer LB, Singh S. Explaining
recent declines in adolescent pregnancy in the United
States: the contribution of abstinence and improved con-
traceptive use. Am J Public Health 2007;97:150–6.
6. Guttmacher Institute. State funding of abortion under
Medicaid. State Policies in Brief. New York (NY): GI; 2008.
Available at: http://www.guttmacher.org/statecenter/spibs/
spib_SFAM.pdf. Retrieved December 19, 2007.
7. Guttmacher Institute. Restricting insurance coverage of
abortion. State Policies in Brief. New York (NY): GI; 2008.
Available at: http://www.guttmacher.org/statecenter/spibs/
spib_RICA.pdf. Retrieved July 22, 2008.
8. Guttmacher Institute. Parental involvement in minors’
abortions. State Policies in Brief. New York (NY): GI; 2008.
Available at: http://www.guttmacher.org/statecenter/spibs/
spib_PIMA.pdf. Retrieved July 22, 2008.
9. The adolescent’s right to confidential care when consider-
ing abortion. American Academy of Pediatrics. Pediatrics
1996; 97:746–51.
10. Dailard C, Richard CT. Teenagers’ access to confidential
reproductive health services. Guttmacher Rep Public Policy
2005;8(4):6–11.
11. Guttmacher Institute. Counseling and waiting periods for
abortion. State Policies in Brief. New York (NY): GI; 2008.
Available at: http://www.guttmacher.org/statecenter/spibs/
spib_MWPA.pdf. Retrieved July 16, 2008.
12. Henshaw SK, Finer LB. The accessibility of abortion servic-
es in the United States, 2001. Perspect Sex Reprod Health
2003;35:16–24.
13. Harper CC, Henderson JT, Darney PD. Abortion in the
United States. Annu Rev Public Health 2005;26:501–12.
14. Espey E, Ogburn T, Chavez A, Qualls C, Leyba M. Abortion
education in medical schools: a national survey. Am J
Obstet Gynecol 2005;192:640–3.
15. Accreditation Council for Graduate Medical Education.
ACGME program requirements for graduate medical edu-
cation in obstetrics and gynecology. Chicago (IL): ACGME;
2007. Available at: http://www.acgme.org/acWebsite/
downloads/RRC_progReq/220obstetricsandgynecolo
gy07012007.pdf. Retrieved December 19, 2007.
16. Almeling R, Tews L, Dudley S. Abortion training in U.S.
obstetrics and gynecology residency programs, 1998. Fam
Plann Perspect 2000;32:268–71, 320.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 478
 17. MacKay HT, MacKay AP. Abortion training in obstetrics
and gynecology residency programs in the United States,
1991-1992. Fam Plann Perspect 1995;27:112–5.
18. Eastwood KL, Kacmar JE, Steinauer J, Weitzen S, Boardman
LA. Abortion training in United States obstetrics and
gynecology residency programs. Obstet Gynecol 2006;108:
303–8.
19. Steinauer J, Drey EA, Lewis R, Landy U, Learman LA.
Obstetrics and gynecology resident satisfaction with an
integrated, comprehensive abortion rotation. Obstet
Gynecol 2005;105:1335–40.
20. Steinauer JE, Landy U, Jackson RA, Darney PD. The effect
of training on the provision of elective abortion: a survey
of five residency programs. Am J Obstet Gynecol 2003;
188:1161–3.
21. American College of Obstetricians and Gynecologists.
Abortion policy. ACOG Statement of Policy. Washington,
DC: ACOG; 2007.
COMMITTEE OPINIONS
Copyright © January 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Abortion access and training. ACOG Committee Opinion No. 424.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:247–50.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 479
 ACOG COMMITTEE OPINION
Committee on Health
Care for Underserved
Women
The Committee would
like to thank Alan
Waxman, MD, MPH,
and Raymond Cox, MD,
MBA, for their assistance
in the development of
this document.
This information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 425 • January 2009
Health Care for Undocumented
Immigrants
Abstract: Undocumented immigrants are less likely than other residents of the
United States to have health insurance. Their access to publicly funded health programs
has become increasingly limited since the passage of welfare reform in 1996 and varies
from state to state. This is reflected in less preventive health care, including prenatal
care, and poorer health outcomes, including those associated with childbirth. The U.S.-
born children of undocumented immigrant women are U.S. citizens, and the nation’s
public health is enhanced by assuring that all who reside in the United States, including
undocumented immigrants, have access to quality health care.
Scope of the Problem and Los Angeles County, found that 60%
The United States has been called a nation of and 65%, respectively, of adult undocument-
immigrants. Approximately 11% of the U.S. ed Latinos have resided in the United States
for more than 5 years (6). Most undocu-
population, more than 30 million people,
were born outside the United States (1). Two mented immigrants live in poverty and have
thirds of these immigrant residents are not low rates of health insurance coverage (5,
U.S. citizens (1). Approximately 29% of these 7, 8). Prenatal care coverage may be an
immigrant residents are undocumented (i.e. exception. A recent study examining prenatal
they either entered the country illegally or coverage among undocumented Hispanic
have expired visas) (2, 3). Over the past 30 women who gave birth in three U.S. cit-
years, the proportion of recent immigrants in ies, found that 79–99% had some coverage,
the United States without documentation has mostly from public sources (9).
increased almost 10-fold (4). A majority of Immigrants do not appear to use an
undocumented immigrants (57%) come from excess of health care resources. In Los
Mexico, and almost one quarter (24%) are Angeles County, undocumented immigrants
from elsewhere in Latin America. The remain- comprise 12% of the population, but the cost
der come from Asia (9%), Europe and Canada of their medical care represents only 6% of
(6%), or Africa and other locales (4%) (2, 3). medical expenditures in the county (4). In
The undocumented immigrant pop- a 1998 study, immigrants (documented and
ulation is spread throughout the United undocumented) used 55% fewer dollars than
States, with about one half concentrated in their U.S.-born counterparts on medical care
California, Texas, Florida, and New York and prescription drugs (10). Undocumented
(2). Thirty five percent of undocumented Latino immigrants are less likely to visit a
immigrants are women and 15% are chil- physician in an outpatient setting than the
dren. Because children born in the United general U.S. population, although their rate
States are granted citizenship by the 14th of childbirth-related hospitalization is sig-
amendment to the U.S. Constitution, many nificantly higher (5).
children living in families headed by undocu-
mented immigrants are U.S. citizens (3, 5).
Health Status of
Undocumented Immigrant
Undocumented immigrants frequently
remain in the United States for many years. Women
A survey by the Kaiser Family Foundation Studies in several areas of the country have
of undocumented Latinos in Fresno County found that undocumented immigrant women
2013 COMPENDIUM OF SELECTED PUBLICATIONS 480
 begin prenatal care later and have fewer prenatal visits
compared with the general population (9, 11). Use of
prenatal care varies, however, with the availability of pub-
licly funded prenatal programs (9). Looking at maternal
outcomes, a Colorado study found significantly lower
rates of primary cesarean deliveries and increased rates
of operative vaginal deliveries and vaginal birth after
cesarean in undocumented women when compared with
the general state population (11). Birth complications
were more common among the undocumented women,
including meconium staining, excessive bleeding, pre-
cipitous labor, malpresentation, cord prolapse, and fetal
distress. Neonatal morbidity, including fetal alcohol
syndrome, respiratory distress syndrome and seizures,
also was more common (11). Few studies of perinatal
morbidity distinguish undocumented from legal immi-
grant women.
Some investigators have found that Hispanic immi-
grants have lower rates of prematurity and low birth
weight infants than the general U.S. population (11–13).
These outcomes have been attributed to a “healthy
migrant effect” resulting from a bias toward younger and
healthier individuals coming to the United States. This
tendency toward better birth outcomes particularly in
Latina immigrants appears to last only one generation.
Some evidence indicates that immigrants have less
access to preventive services. For example, although the
incidence and mortality from cervical cancer is on the
decline among women born in the United States, it is
actually increasing among immigrant women (14, 15). A
1998 survey showed that U.S. and foreign-born Latinas
were less likely than whites to have had a recent mammo-
gram and more likely to have never had a mammogram
or Pap test (16). A retrospective study of patients with
cervical cancer in Chicago found recent immigrant status
to be a risk factor for never having had a Pap test (17).
Lack of health insurance was the strongest predictor of
no recent mammogram, clinical breast examination, or
Pap test (16).
Health Programs and Undocumented
Immigrants
Although some health care services are available to unin-
sured immigrants, the complexity of accessing care in
the face of ever-changing and conflicting laws, coupled
with a fear of harassment by immigration officials,
inhibit many legal and undocumented immigrants from
seeking care. The Personal Responsibility and Work
Opportunity Reconciliation Act, popularly known as
the 1996 Welfare Reform Act, widened the gap in health
insurance coverage between low-income U.S. citizens and
immigrants (18). The Act eliminated Medicaid and other
federal health program eligibility for indigent undocu-
mented immigrants, and restricted eligibility for legal
immigrants, allowing exceptions for emergency medical
conditions, immunization, and treatment for symptoms
of communicable diseases.
COMMITTEE OPINIONS
Welfare reform also made undocumented immi-
grants ineligible for many similar benefits previously
provided by state and local governments unless new state
legislation was enacted (19). A number of states have
passed legislation to continue use of state funds to pro-
vide care, especially prenatal care, to undocumented
immigrants based on residence and financial need (9, 20).
A number of federally funded public health programs are
still available to undocumented immigrants, including
those administered under Title V of the Social Security
Act (Maternal and Child Health Services Block Grant)
and Title X of the Public Health Service Act (Family
Planning). In addition, Federally Qualified Health
Centers, Healthcare for the Homeless, and Migrant
Health Clinics provide comprehensive primary care,
including prenatal care, without regard to income, insur-
ance, or immigration status.
State grantees in the National Breast and Cervical
Cancer Early Detection Program may elect to offer
screening without regard to immigration status. If cancer
or premalignant conditions are diagnosed via this pro-
gram, however, undocumented patients may not receive
care through its companion law, the Breast and Cervical
Cancer Prevention and Treatment Act (21). The Act
allows Medicaid eligibility for those who receive diagno-
ses through the program; as stated earlier, undocumented
immigrants cannot receive Medicaid benefits.
The State Children’s Health Insurance Program,
which provides health coverage for children in families
with incomes too high for Medicaid but too low to afford
private coverage, contains similar restrictions on care for
immigrant children. In 2002, the Centers for Medicare
and Medicaid Services permitted states to use the State
Children’s Health Insurance Program funds to provide
coverage for fetuses. Some states have used this option
as a way to finance coverage for legal and undocumented
pregnant women. This can be done because, although the
pregnant woman is ineligible, her child will be a U.S. citi-
zen and qualifies for the program. However, conferring
eligibility on the fetus, rather than the pregnant woman
herself, may lead to the exclusion of essential perinatal
services, including postpartum care.
Undocumented immigrants, who meet Medicaid
financial and categorical eligibility requirements but are
not eligible for Medicaid because of their immigration
status, can receive Emergency Medicaid to cover emer-
gency care, including labor and delivery (18). In addi-
tion, federal law requires provision of emergency care to
any individual regardless of insurance or ability to pay,
citizenship, or immigration status (22). Under the
Emergency Medical Treatment and Active Labor Act,
passed in 1986, hospital emergency departments must
provide an appropriate medical screening examination
to any patient who comes to an emergency department
requesting examination or treatment for a medical con-
dition. If the emergency department determines that
the patient is experiencing an emergency medical condi-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 481
 tion, the hospital must provide treatment until the patient
is stabilized (23). The Emergency Medical Treatment
and Active Labor Act was enacted to ensure that indi-
gent and uninsured patients receive necessary emer-
gency medical care, and the law specifically addresses
emergency medical conditions for pregnant women.
A pregnant woman in true labor who seeks care may not
be transferred to another facility if there is not adequate
time to effect a safe transfer and if the transfer would
pose a threat to the health or safety of the mother or the
fetus.
The Emergency Medical Treatment and Active Labor
Act requires hospitals to provide necessary treatment, but
does not require the federal government to reimburse
hospitals for the cost of this care. Funding was addressed
for the first time when Congress passed Section 1011
of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173), which pro-
vides $250 million each year for fiscal years 2005–2008
to reimburse hospitals, physicians, and ambulance com-
panies for emergency care provided to undocumented
immigrants under the Emergency Medical Treatment
and Active Labor Act (22). Health care providers can send
payment requests until March 30, 2009, when the pro-
gram’s fiscal year ends. Funds will remain available until
expended or otherwise revised. Updated information can
be found at: http://www. cms.hhs.gov/undocAliens/.
Recommendations
The American College of Obstetricians and Gynecologists
supports a basic health care package for all women. The
College has long promoted the elimination of the dispari-
ties in health status and health care access among women
and includes recent and undocumented immigrants in
its advocacy efforts. Immigrant women living within our
borders should have the same access to basic preven-
tive health care as U.S. citizens without regard to their
country of origin or documentation of their status. The
College can help to achieve this by promoting universal
access to health insurance for all individuals in the United
States and eliminating barriers to existing federal pro-
grams, such as Medicaid (24).
Health professionals can play a pivotal role in
improving access to needed health care for undocument-
ed immigrants by:
• Helping the larger society understand the impor-
tance of universal health care access
• Being advocates for the goal of securing quality,
affordable coverage for every woman with active
support of proposed local, state, and national legisla-
tion
• Continuing to support the safety net system and pro-
vision of care in the community and office setting for
the uninsured
• Providing a comfortable office atmosphere with trans-
lators and materials available in languages appropri-
ate for the patient population
COMMITTEE OPINIONS
• Becoming informed and involved in the American
College of Obstetricians and Gynecologists’ govern-
ment relations outreach activities. (For more infor-
mation go to: http://www.acog.org/departments/
dept_ web.cfm?recno=11.)
References
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Guttmacher Rep Public Policy 2003;6(2):6–9.
2. Pew Hispanic Center. Unauthorized migrants: numbers
and characteristics. Washington, DC: PHC; 2005.
Available at: http://pewhispanic.org/files/reports/46.pdf.
Retrieved January 31, 2008.
3. Pew Hispanic Center. The size and characteristics of the
unauthorized migrant population in the U.S. estimates
based on the March 2005 Current Population Survey.
Washington, DC; PHC; 2006. Available at: http://pewhis-
panic.org/files/reports/61.pdf. Retrieved January 31, 2008.
4. Goldman DP, Smith JP, Sood N. Immigrants and the cost
of medical care. Health Aff 2006;25:1700–11.
5. Berk ML, Shur CL, Chavez LR, Frankel M. Health care
use among undocumented Latino immigrants. Health Aff
2000; 19:51–64.
6. Henry J. Kaiser Family Foundation. California’s undocu-
mented Latino immigrants: a report on access to health
care services. Menlo Park (CA): KFF; 1999. Available
at: http://www.kff.org/statepolicy/upload/Californias-
Undocumented-Latino-Immigrants-A-Report-on-Access-
to-Health-Care-Services-Report.pdf. Retrieved January 31,
2008.
7. Prentice JC, Pebley AR, Sastry N. Immigration status and
health insurance coverage: who gains? Who loses? Am J
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8. Goldman DP, Smith JP, Sood N. Legal status and health
insurance among immigrants. Health Aff 2005;24:1640–53.
9. Fuentes-Afflick E, Hessol NA, Bauer T, O’Sullivan MJ,
Gomez-Lobo V, Holman S, et al. Use of prenatal care by
Hispanic women after welfare reform. Obstet Gynecol
2006; 107:151–60.
10. Mohanty SA, Woolhandler S, Himmelstein DU, Pati S,
Carrasquillo O, Bor DH. Health care expenditures of
immigrants in the United States: a nationally representative
analysis. Am J Public Health 2005;95:1431–8.
11. Reed MM, Westfall JM, Bublitz C, Battaglia C, Fickenscher
A. Birth outcomes in Colorado’s undocumented immigrant
population. BMC Public Health 2005;5:100.
12. Kelaher M, Jessop DJ. Differences in low-birthweight
among documented and undocumented foreign-born and
US-born Latinas. Soc Sci Med 2002;55:2171–5.
13. Leslie JC, Diehl SJ, Galvin SL. A comparison of birth out-
comes among US-born and non-US-born Hispanic women
in North Carolina. Matern Child Health J 2006;10:33–8.
14. Schleicher E. Immigrant women and cervical cancer preven-
tion in the United States. Baltimore (MD): Women’s and
Children’s Health Policy Center, Johns Hopkins Bloomberg
School of Public Health; 2007. Available at: http://www.
jhsph.edu/wchpc/publications/ImmigrantWomenCer
CancerPrevUS.pdf. Retrieved July 28, 2008.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 482
 15. Seeff LC, McKenna MT. Cervical cancer mortality among
foreign-born women living in the United States, 1985 to
1996. Cancer Detect Prev 2003;27:203–8.
16. Rodriguez MA, Ward LM, Perez-Stable EJ. Breast and cer-
vical cancer screening: impact of health insurance status,
ethnicity, and nativity of Latinas. Ann Fam Med 2005;
3:235–41.
17. Behbakht K, Lynch A, Teal S, Degeest K, Massad S. Social
and cultural barriers to Papanicolaou test screening in an
urban population. Obstet Gynecol 2004;104:1355–61.
18. Henry J. Kaiser Family Foundation. Key facts: Medicaid and
SCHIP eligibility for immigrants. Kaiser Commission on
Medicaid and the Uninsured. Washington, DC: KFF; 2006.
Available at: http://www.kff.org/medicaid/upload/7492.
pdf. Retrieved January 31, 2008.
19. Kullgren JT. Restrictions on undocumented immigrants’
access to health services: the public health implications of
welfare reform. Am J Public Health 2003;93:1630–3.
20. Henry J. Kaiser Family Foundation. Deficit Reduction Act
of 2005: implications for Medicaid. Kaiser Commission on
Medicaid and the Uninsured. Washington, DC: KFF; 2006.
Available at: http://www.kff.org/medicaid/upload/7465.
pdf. Retrieved January 31, 2008.
21. Centers for Disease Control and Prevention. National
breast and cervical cancer early detection program. Available
at: http://www.cdc.gov/cancer/nbccedp. Retrieved July 28,
2008.
22. Centers for Medicare and Medicaid Services. Emergency
health services for undocumented aliens: Section 1011 of
COMMITTEE OPINIONS
the Medicare Modernization Act. Baltimore (MD): CMS;
2005. Available at: http://www.cms.hhs.gov/apps/media/
press/release.asp?Counter=1452. Retrieved January 31,
2008.
23. Kaiser Commission on Medicaid and the Uninsured.
Covering new Americans: a review of federal and state
policies related to immigrants’ eligibility and access to
publicly funded health insurance. Washington, DC:
KCMU; 2004. Available at: http://www.kff.org/medicaid/
upload/Covering- New-Americans-A-Review-of-Federal-
and-State-Policies-Related-to-Immigrants-Eligibility-and-
Access-to-Publicly-Funded-Health-Insurance-Report.pdf.
Retrieved October 1, 2008.
24. The Uninsured. ACOG Committee Opinion No. 416.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2008;112:731–4.
Copyright © January 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Health care for undocumented immigrants. ACOG Committee Opinion
No. 425. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:251–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 483
 ACOG COMMITTEE OPINION
Committee on Health
Care for Underserved
Women
The Committee on
Health Care for
Underserved Women
would like to thank
Kirsten Smith, MD, and
Virginia Leslie, MD, for
their assistance in the
development of this
document.
The information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 428 • February 2009
Legal Status: Health Impact for
Lesbian Couples
ABSTRACT: Women in same-sex relationships encounter barriers to health care that
include concerns about confidentiality and disclosure, discriminatory attitudes and treat-
ment, limited access to health care and health insurance, and often a limited understand-
ing as to what their health risks may be. Lesbians and their families also are adversely
affected by the lack of legal recognition of their relationships. Tangible harm comes from
the lack of financial and health care protections that are granted to legal spouses, and
children are harmed by the lack of protections afforded married families. The American
College of Obstetricians and Gynecologists endorses equitable treatment for lesbians and
their families, not only for direct health care needs but also for indirect health care issues;
this should include the same legal protections afforded married couples.
Background legal status designed to confer to a same-sex
couple state-based benefits, protections, and
In the United States, civil marriage is a legal
status established through a license issued responsibilities similar to civil marriage. In
the United States, Vermont, New Jersey,
by a state government that grants both legal
rights and obligations to two individuals and New Hampshire have established civil
(1). Civil marriage currently is available to unions. Connecticut established civil unions
same-sex couples only in Connecticut (as of in 2005. This law remains in place along with
2008) and Massachusetts (as of 2004) (2). the newest civil marriage ruling in that state
Civil marriage, as recognized by the fed- in 2008. (2). These legal arrangements are
eral government, must be between a man not reciprocally recognized in most states,
and a woman (3). Civil marriage grants rights and are not recognized by the federal gov-
under 1,138 federal statutory provisions as ernment.
well as additional state protections, benefits, A domestic partnership is a legally rec-
and responsibilities designed to support and ognized partnership between two individu-
protect family life (4). als, who may or may not be of the same
Religious marriage is a sacrament or rite sex. Domestic partnership does not pro-
that provides recognition by a specific reli- vide the same rights, benefits, and protec-
gious group. These religious organizations tions as civil union and civil marriage and
have rules and requirements that are separate what is provided varies by jurisdiction (1).
from those established for civil marriage by Statewide domestic partner laws that provide
a state (1). In the United States, judges and the equivalent of state-level spousal rights to
other public officials have the authority to same-sex couples within the state have been
establish civil marriages. However, clergy implemented in California,  Oregon, and the
also have been given the authority to endorse District of Columbia. Statewide laws provid-
a civil marriage, leading to significant confu- ing some statewide spousal rights to same-sex
sion between the civil and religious aspects of couples within the state have been imple-
marriage. The legality of civil marriage comes mented in Hawaii, Maine, and  Washington
from the state not the religious group. (2). These legal relationships also are not rec-
A civil union has a more limited legal ognized by the federal government or most
scope than civil marriage. A civil union is a other jurisdictions.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 484
 In 44 states, laws have been passed prohibiting same
sex marriage or prohibiting recognition of such a mar-
riage from another state. Twenty-nine states have passed
constitutional amendments prohibiting civil marriages
between persons of the same sex (5).
In almost all states, same sex couples are currently
vulnerable and are left to piece together a patchwork of
legal and financial documents to protect themselves and
their families.
Health Considerations Related to
Legal Status
• Even with legal documents such as a medical power
of attorney, discriminatory practices can result in a
woman in a same-sex relationship being excluded
from seeing her partner in the hospital (1, 6–8).
• Individuals in same-sex relationships can be pre-
vented from providing consent for medical care or
authorizing emergency treatment and health care
decisions for nonbiological or not-jointly adopted
children (1).
• In many jurisdictions, even if a woman in a same-
sex relationship does have access to health insurance
through her employer and that employer offers
spouse and family coverage, she is not able to obtain
coverage for her partner (1, 9).
• Unless she is defined as a spouse or parent under
state law, a woman in a same-sex relationships does
not have access to the federal Family Medical Leave
Act, which allows those eligible to take up to 12
weeks of unpaid leave each year to care for immedi-
ate family members (spouse, child, or parent) (1, 10).
• Same-sex couples who are not defined as legal
spouses will not have protections and compensation
for families of crime victims in state and federal pro-
grams (1, 11).
• Even with prior legal arrangements for individuals
in same-sex relationships, the surviving partner may
not be able to sign for the release of the body from
the hospital for funeral/disposition arrangements
(12, 13).
Financial Considerations Related to
Legal Status
A multitude of financial protections are granted to legal
spouses but not to same-sex partners. These financial
protections include differences in taxation eligibility for
Social Security benefits and rights to shared property.
Financial security is intimately tied to access to health
care and the health and well being of women and their
families. Although these examples also apply to unmar-
ried heterosexual partners, they can overcome them by
becoming married. Same-sex partners do not have that
option. Even in states where civil marriage is available to
same-sex couples, the marriage is not recognized by the
COMMITTEE OPINIONS
federal government and does not grant the same protec-
tions provided to heterosexual married couples.
• When same-sex partners are able to arrange for
domestic partner benefits to cover health insurance,
the value of the benefit is considered taxable income
to the employee under federal law. The only excep-
tion is when a domestic partner qualifies as a depen-
dent of the employee under Internal Revenue Service
definitions. Because this amount is also considered
income, the employer must also pay payroll taxes,
such as Social Security on the amount. Additionally,
employees cannot use pretax dollars to pay for a
domestic partner’s coverage (9).
• Same-sex couples cannot file joint tax returns and
are not eligible for additional federal tax benefits and
claims (11).
• Same-sex couples are not eligible for the Social
Security and veteran’s survivor benefits of the
deceased partner (11). A surviving partner may not
have access to spousal benefits under worker’s com-
pensation. She cannot roll a deceased partner’s 401K
funds into an IRA without paying income tax and,
in many states, inheritance taxes on those funds. In
many states the surviving partner will be required to
pay inheritance taxes on the partner’s portion of any
shared assets (14, 15).
• For same-sex couples, if a house is titled in one name
only, upon that partner’s death, the house ownership
passes as designated in the will of the deceased or if
there is no will, to the legal next-of-kin.
• In only a few states, those with marriage and some
domestic partnership laws, can a same sex partner
sue for wrongful death of a deceased spouse (16).
• Individuals who are U.S. citizens in a same-sex cou-
ple cannot sponsor their partner or family members
for immigration and citizenship (1, 17, 18).
Positions of Health Organizations
on Legal Protections for Same-Sex
Couples
The American Psychiatric Association, the American
Psychological Association, and the American Psycho-
analytic Association have issued policy statements sup-
porting civil marriage for same-sex partners (19–21).
The American Medical Women’s Association issued a
position statement on lesbian health in 1993 encouraging
national, state, and local legislation to end discrimination
based on sexual orientation in housing, employment,
marriage, tax, and child custody and adoption laws (22).
The American Academy of Pediatrics recognizes the
advantages for children of having two legally recognized
parents and in 2002 published their technical report in
support of coparent/second parent adoption by same-sex
parents (23, 24). The American College of Obstetricians
2013 COMPENDIUM OF SELECTED PUBLICATIONS 485
 and Gynecologists has previously recognized that lesbians
should have equal access to coparenting and second par-
ent adoption rights (25).
Conclusion
The American College of Obstetricians and Gynecologists
is dedicated to the advancement of women’s health
through education, practice, research, and advocacy. The
American College of Obstetricians and Gynecologists
advocates for the health and well-being of all women
and believes that no woman should suffer discrimination
(26). This includes women in same-sex relationships. The
health and well-being of women in same-sex relationships
and their families are harmed by lack of legal recognition
(1, 27, 28). The American College of Obstetricians and
Gynecologists endorses equitable treatment for lesbians
and their families, not only for direct health care needs
but also for indirect health care issues, which includes the
same legal protections afforded married couples.
References
1. Pawelski JG, Perrin EC, Foy JM, Allen CE, Crawford JE, Del
Monte M, et al. The effects of marriage, civil union, and
domestic partnership laws on the health and well-being of
children. Pediatrics 2006;118:349–64.
2. Human Rights Campaign. Relationship recognition in the
U.S. Washington DC: HRC; 2008. Available at: http://www.
hrc.org/documents/Relationship_Recognition_Laws_Map.
pdf. Retrieved November 17, 2008.
3. Defense of Marriage Act, Pub L No. 104-199, 110 Stat 2419.
4. General Accounting Office (US). Defense of Marriage
Act: update to prior report. Washington, DC: GAO; 2004.
Available at: http://www.gao.gov/new.items/d04353r.pdf.
Retrieved September 30, 2008.
5. Human Rights Campaign. Statewide marriage prohibi-
tions. Washington, DC: HRC; 2008. Available at: http://
www. hrc.org/documents/marriage_prohibitions.pdf.
Retrieved November 17, 2008.
6. Human Rights Campaign. Healthcare laws: state by
state. Available at: http://www.hrc.org/issues/7935.htm.
Retrieved October 28, 2008.
7. Human Rights Campaign. Health care proxy. Available at:
http://www.hrc.org/issues/2725.htm. Retrieved October 28,
2008.
8. Gay and Lesbian Medical Association. Same-sex mar-
riage and health. Gay and Lesbian Medical Association
Marriage Equality Initiative. San Francisco (CA): GLMA;
2008. Available at: http://glma.org/document/docWindow.
cfm? fuseaction=document.viewDocument&documentid
=146&documentFormatId=236. Retrieved October 28,
2008.
9. Center for American Progress, The Williams Institute.
Unequal taxes on equal benefits: the taxation of domestic
partner benefits. Washington, DC: CAP; Los Angeles (CA):
WI; 2007. Available at: http://www.americanprogress.
org/issues/2007/12/pdf/domestic_partners.pdf. Retrieved
September 30, 2008.
COMMITTEE OPINIONS
10. What do “spouse,” “parent,” and “son or daughter” mean
for purposes of an employee qualifying to take FMLA leave?
29 C.F.R. § 825.113 (2007).
11. Government Accounting Office. Defense of Marriage
Act. GAO/OGC-97-16. Washington, DC: GAO; 1997.
Available at: http://www.gao.gov/archive/1997/og97016.pdf.
Retrieved October 14, 2008.
12. Equality Maryland. Marriage inequality in the state of
Maryland. Silver Spring (MD): EM; 2006.
13. Human Rights Campaign. To have and to hold? Maybe
not.  True stories from same-sex couples denied the pro-
tections of marriage in life and death. Washington (DC):
HRC; 2005. Available at: http://www.hrc.org/documents/
tohaveandhold.pdf. Retrieved October 29, 2008.
14. Human Rights Campaign. How do I cut the inheri-
tance taxes for my partner? Washington (DC): HRC;
2000. Available at: http://www.hrc.org/issues/4670.htm.
Retrieved October 28, 2008.
15. American Civil Liberties Union. Protect your relationship.
New York, NY: ACLU. Available at: http://www.aclu.org/
getequal/rela/protect.html. Retrieved October 20, 2008.
16. Lambda Legal. Relationship recognition for same-sex cou-
ples across the United States. Available at: http://data.lamb-
dalegal.org/pdf/690.pdf. Retrieved October 28, 2008.
17. Immigration Equality, Lambda Legal. Sexual orientation
and immigration: the basics. Available at: http://www.
immigrationequality.org/uploadedfiles/Sexual_Orientation_
and_Immigration_Lambda_Booklet.pdf. Retrieved October
29, 2008.
18. Human Rights Campaign. Rights and protections denied
same-sex partners. Available at: http://www.hrc.org/issues/
5478.htm. Retrieved October 28, 2008.
19. American Psychiatric Association. Support of legal rec-
ognition of same-sex civil marriage: position statement.
Arlington (VA): APA; 2005. Available at: http://archive.
psych.org/edu/other_res/lib_archives/archives/200502.pdf.
Retrieved September 30, 2008.
20. American Psychoanalytic Association. Marriage resolu-
tion. New York (NY): APsaA; 2008. Available at: http://
www.apsa.org/ABOUTAPSAA/POSITIONSTATEMENTS/
MARRIAGERESOLUTION/tabid/470/Default.aspx.
Retrieved September 30, 2008.
21. American Psychological Association. Resolution on sexual
orientation and marriage. Washington, DC: APA; 2004.
Available at: http://www.apa.org/pi/lgbc/policy/marriage.
pdf. Retrieved September 30, 2008.
22. Position paper on lesbian health. American Medical
Women’s Association. J Am Med Womens Assoc 1994;49:
86.
23. Coparent or second-parent adoption by same-sex parents.
American Academy of Pediatrics. Pediatrics 2002;109:
339–40.
24. Technical report: coparent or second-parent adoption
by same-sex parents. American Academy of Pediatrics.
Pediatrics 2002;109:341–4.
25. American College of Obstetricians and Gynecologists.
Primary care of lesbians and bisexual women in obstetric
2013 COMPENDIUM OF SELECTED PUBLICATIONS 486
 and gynecologic practice. In: Special issues in women’s
health. Washington, DC: ACOG; 2005. p. 61–73.
26. American College of Obstetricians and Gynecologists.
Access to women’s health care. ACOG Statement of Policy.
Washington, DC: ACOG; 2006.
27. Hammond CB. Time to change. Obstet Gynecol 2006;107:
549.
28. O’Hanlan KA. Health policy considerations for our sexual
minority patients. Obstet Gynecol 2006;107:709–14.
COMMITTEE OPINIONS
Copyright © February 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Legal status: health impact for lesbian couples. ACOG Committee
Opinion No. 428. American College of Obstetricians and
Gynecologists. Obstet Gynecol;113:469–72
2013 COMPENDIUM OF SELECTED PUBLICATIONS 487
 ACOG COMMITTEE OPINION
Committee on
Health Care for
Underserved Women
The Committee
would like to thank
Ann M. Koontz, DrPH,
and Eliza Buyers, MD,
for their assistance in
the development of this
document.
The information should
not be construed as dictat-
ing an exclusive course of
treatment or procedure to
be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 429 • March 2009
Health Disparities for Rural Women
ABSTRACT: Significant health disparities exist for rural women in all categories
of women’s health, including obstetric and gynecologic outcomes and access to care.
Minority women living in rural areas may face even greater risks based on their combined
characteristics. Many rural areas have limited numbers of health care providers, particu-
larly those who provide obstetric and gynecologic care. Generalizations regarding rural
America are difficult because of the heterogeneity of rural areas within the United States
and even within the borders of a single state. Health professionals are encouraged to
engage in activities to diminish health disparities for rural women.
Significant health disparities exist between (8). Whereas 82% of nonmetropolitan resi-
women living in rural and urban areas. For dents are non-Hispanic white, Hispanics and
most people, the term “rural” implies regions Asians are now the fastest growing rural
that are less populated and geographically subgroups (4). Well-documented racial and
distant compared with urban areas. Multiple ethnic health disparities (9) may be amplified
agencies, policy makers, and researchers have by additional barriers to care in rural areas.
included aspects of these notions in the
many definitions used to study and report Rural Health Disparities
population data, and to determine eligibil- Although national data on women’s health
ity and reimbursement levels for numerous and outcomes according to residence are
federal and state programs. Two commonly relatively sparse, disparities for rural women
used definitions are those generated by the are apparent. Rates of rural women’s health
Office of Management and Budget and the disparities presented as follows reflect com-
U.S. Census Bureau, which characterize ter- parisons with their urban counterparts unless
ritories or populations as metropolitan/non- otherwise noted. General health conditions
metropolitan and urban/rural respectively and behaviors for which U.S. rural women
(1–3).*488 In this document, because of experience higher rates include unintention-
definitional complexities, the term “rural” al injury and motor vehicle related deaths,
will be used interchangeably with “nonmet- suicide, cigarette smoking, obesity, limita-
ropolitan” and the term “urban” will be used tion of activities caused by chronic health
interchangeably with “metropolitan.” conditions (8), and incidence of cervical
Rural America represents 80% of the cancer (10). Other comparisons show that
national landmass and is home to 17% of the ischemic heart disease death rate in rural
U.S. females aged 15 years and older and women exceeds that for all U.S. women, and
approximately 18% of all live births per in some regions of the country, there are
year (4–7). Rural communities are extremely higher rates of heavy alcohol consumption
heterogeneous, with substantial regional dif- for women in nonmetropolitan areas (8).
ferences in ethnic and racial composition Proportionately fewer rural women receive
such recommended preventive services as a
*Both definitions identify populations of 50,000 or
greater as urbanized areas but differ in their geopolitical
recent mammogram, Pap test, or colorectal
unit of focus, county for metropolitan/nonmetropolitan screening; however, when income and other
area and census block for urban/rural area. In addition, sociodemographic variables are controlled,
some mid-range population areas are classified as met- only the difference for obtaining a mammo-
ropolitan by one scheme and rural by the other. gram is significant (11).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 488
 Other examples of less favorable outcomes for U.S.
rural women and their infants related to obstetric and
gynecologic practice include lower likelihood of receiving
at least one family planning service within the past year
(5); highest adolescent birth rates in the nation for rural
teenagers in the South (8); increased risk of inadequate
prenatal care (including late or no prenatal care) that
is especially apparent in rural counties nonadjacent to
metropolitan counties (6); higher overall adjusted risk of
low-birth weight that is significantly greater for residents
of rural counties with at least 20% of their population liv-
ing in poverty for three decades compared with residents
of all other rural counties (6); and a 17.4% higher risk of
neonatal mortality and a 19.3% higher risk of postneona-
tal mortality for rural infants after adjusting for maternal
age, parity, race, marital status, education, and inadequate
prenatal care (6). In rural hospitals, African-American
Medicaid beneficiaries are at greater risk of potentially
avoidable maternity complications than non-Hispanic
white Medicaid beneficiaries, despite lower potentially
avoidable maternity complications rates for all Medicaid
deliveries in rural hospitals compared with urban
hospitals (12).
Data in the 2001 Nationwide Inpatient Sample reveal
differences in rates of cesarean delivery in rural hospitals.
Although the total rate in rural hospitals was identical to
that in urban nonteaching hospitals, small rural hospitals
with an average daily census of less than 10, 25–49, or
100–249 had significantly higher cesarean delivery rates
than comparable urban hospitals (13).
Health Services Access and
Availability
Access to health care for rural residents is complicated
by patient factors as well as those related to the delivery
of care. Rural residents are more likely to be poor, lack
health insurance, or rely substantially on Medicaid and
Medicare; they also travel longer distances to receive care
or to access a range of medical, dental, and mental health
specialty services (1). Increasing closures of hospital-
based obstetric services and decreasing percentages of
all physicians doing deliveries, exacerbated by reluctance
to select rural practice, is disquieting. In 2002, only 56%
of women living in nonmetropolitan counties and 21%
of women in counties with no population made up of
2,500 or more individuals per square mile had access to
obstetric care in a local hospital. Reasons cited by hos-
pital administrators for closing obstetric units include
low volumes of deliveries, financial vulnerability because
of Medicaid patients, malpractice burden, and difficulty
finding staff for the obstetric unit (eg, obstetricians, anes-
thesiologists, family physicians) (14). Counties without
an obstetrician–gynecologist affect 5.8 million (29%)
rural women (7). In some rural areas, family physi-
cians provide 100% of obstetric care. Data show that an
increasing proportion of women are entering obstetrics
and family practice; however, substantially fewer females
COMMITTEE OPINIONS
compared with males in both specialties choose to prac-
tice in rural areas (15–17). This could contribute to a
potential decrease in the rural workforce.
Obstetric and gynecologic health services along with
family planning options are limited in some nonmetro-
politan areas. Counties without publicly funded family
planning clinics are typically the least populated (18).
Data in the 2001 Nationwide Inpatient Sample reveal that
the rate of vaginal birth after cesarean delivery in rural
hospitals (17.8%) was statistically lower than that for
urban nonteaching hospitals (20%) and for urban teach-
ing hospitals (25.5%) (13). Local availability of abortion
services is restricted. Ninety-seven percent of nonmetro-
politan counties have no abortion provider. Nonhospital
abortion providers estimate that 19% of their patients
travel 50–100 miles, and 8% travel more than 100 miles
(19). There also is concern about availability of emer-
gency contraception. Data on current over-the-counter
availability of emergency contraception in rural pharma-
cies are lacking.
Current Initiatives to Improve Services
for Rural Women
Regional organization of perinatal services is an impor-
tant strategy to improve outcomes for underserved
women and their infants in rural communities, although
implementation can be a challenge in these areas. One
indicator used to measure how the system is functioning
is the percentage of very low birth weight (less than 1,500
grams) deliveries that take place in subspecialty hospitals.
Twelve of the 15 states ranked the lowest in the country
on this indicator have relatively high proportions of
rural populations (20, 21). Some studies examining very
low birth weight deliveries suggest that residing in more
distant areas from a subspecialty facility, as well as inad-
equate prenatal care, increases the likelihood of delivery
in a lower level facility (22, 23).
A variety of initiatives have been established to
address the difficulties in providing care to rural women.
There are multiple sources of funding, such as a range of
state programs (eg, Medicaid) and medical school depart-
ment budgets. Examples of recent or current approaches
are listed as follows:
• Oregon enacted legislation to offer financial incen-
tives such as a state income tax credit for rural practi-
tioners and assistance with medical liability insurance
for obstetricians practicing in rural areas (24).
• The University of Missouri-Columbia Family
Practice Residency Program incorporated a rural
obstetric rotation to increase the practice of obstet-
rics among family physicians (25).
• Wyoming, a state with no tertiary care centers for
pregnant women or infants and few pediatric spe-
cialists, approves out-of-state providers and facilities
as state Medicaid providers. This allows the state to
reimburse transport to and care and delivery in an
2013 COMPENDIUM OF SELECTED PUBLICATIONS 489
 out-of-state subspecialty hospital when medically
necessary (26).
• The Department of Obstetrics and Gynecology at
the University of Texas Medical Branch in Galveston
developed its Regional Maternal & Child Health
Program to serve geographically underserved women
in 37 off-site clinics. The program addresses culturally
relevant services and transportation needs, and uses
an electronic medical record to facilitate continuity
of care. It also provides free housing in its Regional
Perinatal Residence for high-risk women (and family
members) living in distant locations to facilitate their
access to regional center care when hospitalization is
not necessary (27).
• The Arkansas Medicaid Program and the University
of Arkansas for Medical Sciences are collaborating
with the state’s medical community to enhance pri-
mary obstetric care in rural Arkansas and increase
risk-appropriate referrals to maternal–fetal medicine
subspecialists. Their system uses telemedicine and
clinic networks to facilitate access to maternal–fetal
medicine consultation services, and to provide con-
tinuing education for practitioners (28).
Recommendations
Obstetricians and gynecologists in every region of the
United States can work to reduce rural health dispari-
ties. The diversity of rural communities necessitates local
solutions to local problems. Suggestions are listed as
follows:
• Collaborate with maternal-child and rural health
agencies in your state to identify the health needs of
rural women and barriers to care. Share your profes-
sional expertise as a member of an advisory commit-
tee or task force focused on improving the health of
rural women.
• Partner with family physicians and other women’s
primary care providers to ensure that appropriate
consultation and training are available for practitio-
ners in rural areas.490†
• Promote state initiatives offering financial incentives
to rural practitioners and providers of rural obstetric
care and reproductive health services.
• Reinvigorate the implementation of regionalized
perinatal care in underserved, rural areas. Share and
network resources as well as clinical expertise.
• Encourage and participate in efforts to utilize
effective telemedicine technologies to expand and
improve services for rural women.
†
For more information see, American Academy of Family Physicians,
American College of Obstetricians and Gynecologists. AAFP-ACOG
joint statement on cooperative practice and hospital privileges. ACOG
Statement of Policy 73. Leawood (KS): AAFP; Washington, DC: ACOG;
1998.
COMMITTEE OPINIONS
• Advocate for comprehensive professional liability
reform to facilitate the practice of providers in rural
areas.
• Conduct further research to understand acceptable
conditions for performance of vaginal birth after
cesarean delivery in rural areas and to study the effect
of vaginal birth after cesarean delivery policies on
access to care for rural women.
• Advocate for increased access to contraceptive meth-
ods and emergency contraception.
• Advocate for availability of safe, legal, and accessible
abortion services.
• Include place of residence in the collection of data for
health-related databases and their analyses to ensure
improved understanding of rural–urban health dis-
parities among women.
• Rural health disparities are only partially due to lack
of health care services. Rural communities have dis-
parities in education, employment, and poverty that
also should be addressed.
References
1. Hart LG, Larson EH, Lishner DM. Rural definitions for
health policy and research. Am J Public Health 2005;
95:1149–55.
2. Rural Policy Research Institute. Choosing rural defini-
tions: implications for health policy. Rural Policy Research
Institute Health Panel Issue Brief No. 2. Columbia (MO):
RUPRI; 2007. Available at: http://www.rupri.org/Forms/
RuralDefinitionsBrief.pdf. Retrieved August 25, 2008.
3. Rural Assistance Center. What is rural? Grand Forks (ND):
RAC; 2008. Available at: http://www.raconline.org/info_
guides/ruraldef. Retrieved August 25, 2008.
4. United States Department of Agriculture Economic
Resource Service. Rural population and migration.
Washington, DC: USDA; 2007. Available at: http://ers.
usda.gov/briefing/population. Retrieved August 25, 2008.
5. Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J.
Fertility, family planning, and reproductive health of U.S.
women: data from the 2002 National Survey of Family
Growth. Vital Health Stat 23 2005;(25):1–160.
6. University of Washington Rural Health Research Center.
Poor birth outcome in the rural United States: 1985-1987 to
1995-1997. Final Report No. 119. Seattle (WA): UWRHRC;
2008. Available at: http://depts.washington.edu/uwrhrc/
uploads/RHRC_FR119_Larson.pdf. Retrieved August 25,
2008.
7. National Center for Health Statistics. Health, United States,
2007: with chartbook on trends in the health of Americans.
Hyattsville (MD): NCHS; 2007. Available at: http://www.
cdc.gov/nchs/data/hus/hus07.pdf. Retrieved August 25,
2008.
8. National Center for Health Statistics. Health, United States,
2001: with urban and rural health chartbook. Hyattsville
(MD): NCHS; 2001. Available at: http://www.cdc.gov/nchs/
data/hus/hus01.pdf. Retrieved August 25, 2008.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 490
 9. Racial and ethnic disparities in women’s health. ACOG
Committee Opinion No. 317. Obstet Gynecol 2005;
106:889–92.
10. Benard VB, Coughlin SS, Thompson T, Richardson LC.
Cervical cancer incidence in the United States by area of
residence, 1998 2001. Obstet Gynecol 2007;110:681–6.
11. Larson S, Correa-de-Araujo R. Preventive health exami-
nations: a comparison along the rural-urban continuum.
Womens Health Issues 2006;16:80–8.
12. Laditka SB, Laditka JN, Bennett KJ, Probst JC. Delivery
complications associated with prenatal care access for
Medicaid-insured mothers in rural and urban hospitals. J
Rural Health 2005;21:158–66.
13. Greene SB, Holmes GM, Slifkin R, Freeman V, Howard
HA. Cesarean section rates in rural hospitals. Findings
Brief. Chapel Hill (NC): North Carolina Rural Health
Research and Policy Analysis Center, Cecil G. Sheps Center
for Health Services Research; 2005. Available at: http://
www.sheps center.unc.edu/research_programs/rural_pro-
gram/FB79.pdf. Retrieved August 25, 2008.
14. Zhao L. Why are fewer hospitals in the delivery business?
NORC Walsh Center for Rural Health Analysis Working
Paper #2007-04. Rockville (MD): Office of Rural Health
Policy; 2007.
15. American College of Obstetricians and Gynecologists.
Profile of ob-gyn practice. Washington, DC: ACOG; 2004.
Available at: http: //www.acog.com/from_home/depart
ments/practice/ProfileofOb-gynPractice1991-2003.pdf.
Retrieved September 17, 2008.
16. Emmons SL, Nichols M, Schulkin J, James KE, Cain JM.
The influence of physician gender on practice satisfaction
among obstetrician gynecologists. Am J Obstet Gynecol
2006;194:1728–38; discussion 1739.
17. Colwill JM, Cultice JM. The future supply of fam-
ily physicians: implications for rural America. Health Aff
2003;22:190–8.
18. Frost JJ, Frohwirth L, Purcell A. The availability and use
of publicly funded family planning clinics: U.S. trends,
1994–2001. Perspect Sex Reprod Health 2004;36:206–15.
19. Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in
the United States: incidence and access to services, 2005.
Perspect Sex Reprod Health 2008;40:6–16.
20. Maternal and Child Health Bureau. Search TVIS national
performance measures: most recent year available. Available
at: https://perfdata.hrsa.gov/mchb/mchreports/Search/core/
corsch01p.asp. Retrieved September 2, 2008.
COMMITTEE OPINIONS
21. U.S. Census Bureau. Table A-2. States — population by
residence. In: State and metropolitan area data book: 2006.
Washington (DC): Census; 2006. p. 4. Available at: http://
www.census.gov/prod/2006pubs/smadb/smadb-06tablea.
pdf. Retrieved September 2, 2008.
22. Samuelson JL, Buehler JW, Norris D, Sadek R. Maternal
characteristics associated with place of delivery and neo-
natal mortality rates among very-low-birthweight infants,
Georgia. Paediatr Perinat Epidemiol 2002;16:305–13.
23. Gould JB, Sarnoff R, Liu H, Bell DR, Chavez G. Very low
birth weight births at non-NICU hospitals: the role of
sociodemographic, perinatal, and geographic factors. J
Perinatol 1999;19:197–205.
24. Oregon Office of Rural Health. Providers. Available at:
http://www.ohsu.edu/ohsuedu/outreach/oregonrural
health/providers/index.cfm. Retrieved September 2, 2008.
25. Delzell JE Jr, Ringdahl EN. The University of Missouri
Rural Obstetric Network: creating rural obstetric training
sites for a university-based residency program. Fam Med
2003; 35:243–5.
26. Maternal and Child Health Bureau. State narrative for
Wyoming: application for 2008 annual report for 2006.
Maternal and Child Health Services Title V Block Grant.
Rockville (MD): MCHB; 2007. Available at: https://perfda-
ta. hrsa.gov/mchb/mchreports/documents/2008/Narrative/
WY-Narratives.pdf. Retrieved October 1, 2008.
27. Anderson GD, Nelson-Becker C, Hannigan EV, Berenson
AB, Hankins GD. A patient-centered health care delivery
system by a university obstetrics and gynecology depart-
ment. Obstet Gynecol 2005;105:205–10.
28. Lowery C, Bronstein J, McGhee J, Ott R, Reece EA, Mays
GP. ANGELS and University of Arkansas for Medical
Sciences paradigm for distant obstetrical care delivery. Am
J Obstet Gynecol 2007;196:534.e1–534.e9.
Copyright © March 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health disparities for rural women. ACOG Committee Opinion No.
429. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:762–5.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 491
 ACOG COMMITTEE OPINION
Number 437 • July 2009

Community Involvement and Volunteerism

Committee on
Health Care for
Underserved Women
Reaffirmed 2012
Abstract: As professional and community leaders, obstetrician–gynecologists have
unlimited opportunities to become involved in and have a positive impact on local,
national, and international communities and organizations. Volunteering outside of daily
work routines often revitalizes a commitment to medicine while serving as a much
needed resource to the community.

The Committee
would like to thank
Maureen G. Phipps,
MD, MPH, for her assis-
tance with the develop-
ment of this document.
This information should
not be construed as dictat-
ing an exclusive course of
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
As practitioners, obstetrician–gynecologists
affect the lives of hundreds of women every
year. As community members, physicians
have the potential to influence thousands,
even millions, of lives. Although some phy-
sicians may be reluctant to get involved in
community organizations because of the per-
ceived time commitment, others ask them-
selves how they could make a difference
beyond their practice in the local community,
the national community, and globally. Most
obstetrician–gynecologists pursued their
profession because of a commitment and
passion for improving the lives of women,
children, and families. As community leaders,
obstetrician–gynecologists have the ability
to inspire other people to be involved in sup-
porting worthy causes and to truly make a
positive difference in the community. The
demands of training, clinical practice, and
home life may make it difficult to know how
to get involved in the community.
Volunteerism generally has been defined
as time and effort devoted to helping oth-
ers without regard for compensation (1)
for charitable, educational, social, or other
worth-while purposes. In the United States
between the years 2005 and 2007, the average
volunteer rate was 27.2% per year. To put
this in perspective, in 2007, approximately 61
million people dedicated 8 billion hours of
volunteer service (2).
Using skills as an obstetrician–gynecolo-
gist, volunteerism opportunities for ACOG
members are unlimited and some examples
include: participating in hospital or university
committees; participating in local, state, or
regional public health committees; teaching in
the community; serving on an advisory board
for a local health agency; serving on a board of
directors for a nonprofit health organization;
providing care at a free clinic; providing guid-
ance to students who want to pursue medi-
cine as a career; assisting in the design and
implementation of research projects; mentor-
ing; working to promote better state and local
health care services; providing expertise for
the development of a new school-based clinic
or sex education curriculum; and providing
expertise at a community health fair.
Great rewards can come to obstetrician–
gynecologists who volunteer at the hospital
where they deliver patients and operate.
Undertaking efforts to participate in hospital
committees that seek to improve the quality
of care for patients and streamline services to
improve efficiency can be beneficial. Improv-
ing care requires thoughtful input from
knowledgeable clinicians who are willing to
consider ways to enhance and change clinical
practice in the best interests of patient care.
Realizing the importance of participating
in hospital quality committees or executive
committees may increase the level of physi-
cian engagement and satisfaction.
Involvement in the community may
extend to nonmedical areas. Improving safe
walking paths; building safe housing; donat-
ing food, clothing, and shelter; or participat-
ing in other safety initiatives to help families
are ways to volunteer and make a significant
impact on the local community. All of these
efforts directly or indirectly improve wom-
en’s health.
Another form of volunteerism is philan-
thropy. Contributing to organizations that

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 492

 affect women’s health, such as a women’s shelter, may
come in the form of a financial contribution or in the
form of helping to organize or solicit donations.
Being involved in local chapters of national profes-
sional organizations may lead to opportunities for lead-
ership at the regional and national level. For example,
there are numerous ways to participate in activities of
the American College of Obstetricians and Gynecologists
(ACOG). Volunteering at the section and district level
may include seeking nomination to become an officer,
mentoring, or serving as a community liaison. At the
national level, opportunities exist for serving on an
ACOG committee or working on a specific project or
program such as the National Fetal and Infant Mortality
Review Program (www.nfimr.org).
Volunteering for international organizations also
can include donating time and expertise or needed sup-
plies, finances, and resources. Opportunities for vol-
unteering internationally are diverse. The ACOG web
site (http://www.acog.org/goto/international) and other
international volunteer web sites provide many resources
on volunteer opportunities.
The positive influence one could have in the com-
munity and nationally is a strong motivation for volun-
teering. The contributions of obstetrician–gynecologists
to promote women’s health or serve women’s health causes
are essential to the growth and development of many
organizations. Sharing medical knowledge will increase
their capacity to provide accurate information, thereby
increasing the credibility of the organization. In addition,
getting involved in nonprofit organizations often helps
physicians realize their value in the community and the
impact they can have on specific causes.
Making the commitment to get involved often is the
most difficult aspect initially because it seems impossible
to fit more into already overloaded schedules. However,
being involved in an organization that contributes to
the health of a community outside of daily professional
activities can help recharge the volunteer as much as it
helps the community. Working with committed volun-
teers and staff helps keep the energy and enthusiasm of
volunteering vital.
COMMITTEE OPINIONS
It is important for obstetrician–gynecologists to
consider the type of impact they would like to have on
their communities and likewise the type of organizations
or programs that might fit these goals. The next step is
to contact either the organization’s executive director or
program director to express interest in volunteering, such
as staffing an event, giving a lecture on a relevant topic,
or leading a discussion about a specific issue. These initial
encounters will lead to an understanding of the organiza-
tion’s mission and direction.
Volunteering outside of daily work routines often
revitalizes a commitment to medicine while serving as a
much needed resource to the community. The skills and
training of obstetrician–gynecologists extend well beyond
direct patient care. Obstetrician–gynecologists have the
potential to make a significant positive impact on women’s
health in local communities, professional organizations,
as well as the international community.
References
1. Sloan Work and Family Research Network. Community
as a context for the work-family interface. Boston (MA):
Boston College; 2002. Available at: http://wfnetwork.
bc. edu/encyclopedia_entry.php?id=223&area=academics.
Retrieved March 27, 2009.
2. Volunteering in America. How we volunteer. Available at:
http://www.volunteeringinamerica.gov/index.cfm.
Retrieved March 27, 2009.
Copyright © July 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Community involvement and volunteerism. ACOG Committee Opinion
No. 437. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2009:114:203–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 493
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee opinion
Number 454 • February 2010 (Replaces No. 312, August 2005)

Committee on Health Care for Underserved Women

This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Health Care for Homeless Women

Abstract: Homelessness continues to be a growing problem in the United States. With increasing unemploy-
ment and home foreclosures, the recent recession and current economic difficulties are estimated to result in
more than 1 million Americans experiencing homelessness through 2011. Women and families represent the
fastest growing segment of the homeless population. Health care for these women is a challenge but an issue
that needs to be addressed. Homeless women are at higher risk for injury and illness and are less likely to obtain
needed health care than women who are not homeless. It is essential to undertake efforts to prevent homeless-
ness, to expand community-based services for the homeless, and provide adequate health care for this under-
served population. Health care providers can help address the needs of homeless individuals by identifying their
own patients who may be homeless or at risk of becoming homeless, educating these patients about available
resources in the community, treating their health problems, and offering preventive care.

Background expands the definition to include those at risk of immedi-

It has been estimated that as many as 14% of the U.S.
population have been homeless at some time and as
many as 3.5 million people (1% of the U.S. population,
or 10% of the poor population) experience homelessness
in a given year (1, 2). Homeless women aged 18 years to
44 years are more likely to die than women in the general
population (3). Those in their mid-50s are as physiologi-
cally aged and as affected by chronic disease as women in
their 70s who are not homeless (4). Homeless individuals
have more morbidity, including higher rates of hyperten-
sion, arthritis, mental illness, tuberculosis, and substance
abuse, and are more likely to experience violence than the
general population (3, 4). These individuals who are at
high risk for health problems are less likely to have health
insurance, social support, steady income, and preventive
health services.
Definition of Homelessness
A commonly used definition describes a homeless person
as being “an individual who has a primary nighttime
residence that is a supervised shelter designed to provide
temporary living accommodations or a nighttime resi-
dence in a public or private place not designed for use as
a regular sleeping accommodation (eg, vehicle, street,
park bench, abandoned building)” (5). Recent legislation
ately becoming homeless (6).
Statistics and Demographics
Women and families make up the fastest growing segment
of the homeless population. The 2008 Annual Homeless
Assessment Report issued to Congress on July 9, 2009,
showed that 664,414 Americans experienced homelessness
on a single night with more than 252,000 (38%) being
persons in families. At some point during the 12-month
reporting period, 1,594,000 persons (1 in every 190 per-
sons in the United States) were in a homeless facility with
517,000 being persons in homeless families (7). The num-
ber of homeless families increased by 9% from 2007 to
2008 (7). Whereas 36% of all sheltered homeless persons
were women, 81% of adults in sheltered homeless fami-
lies were women, and more than one half of children in
sheltered homeless families were younger than 6 years (7).
Whereas 58% of all homeless persons were in emergency
shelter or transitional housing, 42% were sleeping on the
streets or in places not meant for human habitation (7).
Although the sheltered homeless population is concen-
trated in urban areas, the sheltered homeless population
in suburban and rural regions increased from 23% in 2007
to 32% in 2008 (7). It is estimated that 1.5 million more
Americans will experience homelessness through 2011 (8).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 494

 Risks for Homelessness
Although extreme poverty is a characteristic of the home-
less population, the shortage of affordable housing is a
major precipitating factor that can render individuals
homeless who are not extremely poor. Unemployment or
job loss, foreclosures, mortgage defaults, personal or fam-
ily crisis, an increase in rent disproportionate to income,
or reduction in public health benefits all increase the
likelihood of loss of a home (9). Other risk factors include
lack of job skills, inadequate social support, problems
with alcohol or illicit drugs, mental illness, experiences of
violence, and previous incarceration (9, 10).
Domestic and sexual violence is the leading cause
of homelessness for women and families, and 20–50%
of all homeless women and children become homeless
as a direct result of fleeing domestic violence (11, 12).
Homeless women are far more likely to experience
violence of all sorts compared with women who are not
homeless because of a lack of personal security when
living outdoors or in shelters (11). Many adolescents
become homeless after leaving home over conflicts with
parents regarding sexual orientation. Among lesbian,
gay, bisexual, and transgender persons who are victims
of domestic violence, 57% became homeless as a result
of domestic violence (13). Domestic violence shelter
providers are prohibited from reporting client informa-
tion; therefore, estimates likely undercount the number of
homeless women and families seeking shelter as a result
of domestic violence.
Health Issues
Most homeless people seek care in hospital emergency
rooms; only 27% go to an established ambulatory care
provider. Nearly 75% of homeless individuals who are
hospitalized have conditions that could have been pre-
vented if outpatient treatment was obtained (14). Cases
of posttraumatic stress disorder, substance abuse disor-
ders, major depression, sexually transmitted infections
(STIs), including HIV, unintended pregnancies, and
lack of condom use and other contraceptive methods are
disproportionately higher among homeless women com-
pared with other populations (9, 10, 15).
Adverse birth outcomes are substantially higher
in homeless women than in the general population. A
Canadian study found that compared with women who
are not homeless, homeless women were 2.9 times more
likely to have a preterm delivery, 6.9 times more likely to
give birth to an infant who weighed less than 2,000 grams,
and 3.3 times more likely to have a small for gestational
age newborn, even after adjustment for risk factors such
as maternal age, number of previous pregnancies, and
smoking (16). In the United States, preterm birth rates
and low birth weight rates in homeless women exceed
national averages (17). Homeless women are less likely to
receive prenatal care, mammograms, and Pap tests than
women who are not homeless (18).
2 Committee Opinion No. 454
COMMITTEE OPINIONS
Barriers to Health Care
Approximately one third of homeless individuals who
reported a need for medical attention in the previous
year were unable to obtain care (19). Fifty-seven percent
of homeless individuals lack a regular source of health
care compared with 24% of poor individuals and 19%
of the general population (19). The factors that contrib-
ute to homeless women being unable to obtain needed
health care include lack of health insurance, inability to
purchase or acquire medications, lack of knowledge of
where and when to obtain health care, long wait times,
and lack of transportation to and from medical facilities.
Health care for these individuals competes with needs
for food, clothing, and shelter. Mental illness, substance
abuse, and being too sick to seek care create additional
obstacles in obtaining needed services. Homeless persons
may not seek care because of denial of health problems
and fear of losing their children if found to be homeless.
Medical providers who do not want to care for home-
less individuals in their offices and the lack of available
treatment facilities result in limited access to health care.
Inadequate inpatient discharge planning and follow-up
care, as well as lack of referral to services available within
the community for homeless individuals also act as bar-
riers (19–22). Providing housing and case management
to homeless individuals with chronic medical conditions
can result in fewer days in a hospital and fewer emergency
department visits (23).
Prevention
Numerous studies indicate that increasing the availabil-
ity of affordable housing prevents homelessness more
effectively than anything else (8, 9). With increasing rates
of unemployment and foreclosures, increasing the avail-
ability of affordable subsidized housing and reducing the
number of home foreclosures are essential in preventing
homelessness. Expanded services for women and families
experiencing domestic violence are critical to decreasing
the high rate of homelessness in this population.
Recommendations for ACOG Fellows
Difficult economic times increase homelessness and
worsen its effects. It is especially during these times that
physicians must reach out to homeless women and fami-
lies and try to make a difference in their access to health
care and, thus, their quality of life. Recommendations for
accomplishing this follow:
• Identify patients within the practice who may be
homeless or at risk of becoming homeless (ie, ask
about living conditions, nutrition, substance abuse,
domestic violence) (24).
• Provide health care for these homeless women with-
out bias, including preventive care, and do not
withhold treatment based on concerns about lack of
adherence.
• Become familiar with and inform patients who are
(or at risk of becoming) homeless about appropri-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 495
 ate community resources, including local substance health centers to assist them in planning and delivering
abuse programs, domestic violence services, and social high-quality, accessible health care to people experiencing
service agencies. homelessness.
• Simplify medical regimens and address barriers, Web: http://bphc.hrsa.gov/policy/pal9912.htm
including transportation needs for follow-up health Phone: (888) ASK-HRSA (275-4772)
care visits. Health Care for the Homeless Information Resource Center—
• Advocate for initiatives to address homelessness such develops and disseminates information on best practices
as increased funding for housing, case management to address the housing and service needs of people who
services, substance abuse treatment, mental health are homeless.
services, and primary and preventive care for the Web: http://www.nhchc.org/hchirc/directory
homeless (see Box 1). Phone: (518) 439-7415
• Volunteer to provide health care services at homeless
National Health Care for the Homeless Council (NHCHC)—
shelters and other facilities that serve the homeless advocates for federal policy with regard to issues of health
(25). care for the homeless.
Web: http://www.nhchc.org/index.html
Phone: (615) 226-2292
Box 1. Efforts for Health Care National Coalition for the Homeless (NCH)—has exten-
Improvement for Homeless Women sive literature on the homeless.
Web: http://www.nationalhomeless.org
The American College of Obstetricians and Gynecol-
ogists supports the following efforts for improved health Phone: (202) 462-4822
care for homeless women: National Alliance to End Homelessness—promotes policy,
• A universal health care plan that provides for the capacity building, education, and research to prevent and
health needs of homeless women and families. end homelessness.
• Improved coordination between community programs Web: http://www.endhomelessness.org
and specific health care services such as prenatal Phone: (202) 638-1526
care, cervical cancer screening, immunizations, men- The United States Interagency Council on Homelessness—
tal health, and treatment for sexually transmitted infec- coordinates the federal response to homelessness.
tions and tuberculosis.
Web: http://www.usich.gov
• Donations of medications from pharmaceutical com- Phone: (202) 708-4663
panies for use in homeless clinics and shelters, being
mindful of influences on prescribing behaviors.
References
• Modified residency and medical student curricula to
1. Gelberg L, Arangua L. Homeless persons. In: Andersen RM,
increase awareness of health care issues of homeless
Rice TH, and Kominski GF, editors. Changing the U.S.
individuals and promote involvement in direct care.
health care system: key issues in health services, policy, and
• Indexing the minimum wage locally to the cost of management. 2nd ed. San Francisco (CA): Jossey-Bass;
housing. 2001. p. 332–86.
• Expanding the number of communities sampled in 2. Link BG, Susser E, Stueve A, Phelan J, Moore RE, Struening E.
the Homeless Assessment Reports issued by the U.S. Lifetime and five-year prevalence of homelessness in the
Department of Housing and Urban Development. United States. Am J Public Health 1994;84:1907–12.
• Adequate disability benefits for those who are unable 3. Cheung AM, Hwang SW. Risk of death among homeless
to work to prevent them from becoming homeless. women: a cohort study and review of the literature. CMAJ
2004;170:1243–7.
• Increased funding for comprehensive programs, such
4. National Coalition for the Homeless. Homelessness among
as the Health Care for the Homeless program, and
elderly persons. Washington, DC: NCH; 2009. Available
research directed to the prevention of homelessness.
at: http://www.nationalhomeless.org/factsheets/youth.pdf.
• Professional liability protections for physicians who Retrieved October 26, 2009.
volunteer their services to the homeless.
5. General definition of homeless individual, 42 U.S.C. § 11302
(2008).
6. National Alliance to End Homelessness. McKinney-Vento
reauthorization. Washington, DC: NAEH; 2009. Available
Resources for Health Care Providers at: http://www.endhomelessness.org/section/policy/legisla-
Health Care for the Homeless Program—a federal pro- ture/mckinney_vento. Retrieved October 14, 2009.
gram funded by the Health Resources and Services 7. Department of Housing and Urban Development (US).
Administration that makes grants to community-based The 2008 annual homeless assessment report to Congress.

Committee Opinion No. 454 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 496

 Washington, DC: HUD; 2009. Available at: http://www.
hudhre.info/documents/4thHomelessAssessmentReport.
pdf. Retrieved October 14, 2009.
8. National Alliance to End Homelessness. Homelessness
looms as potential outcome of recession. Washington, DC:
NAEH; 2009. Available at: http://www.endhomelessness.
org/files/2161_file_Projected_Increases_in_Homelessness.
pdf. Retrieved October 9, 2009.
9. National Coalition for the Homeless. Why are people
homeless? Washington, DC: The Coalition; 2009. Available
at: http://www.nationalhomeless.org/factsheets/Why.pdf.
Retrieved October 9, 2009.
10. Zlotnick C, Zerger S. Survey findings on characteristics and
health status of clients treated by the federally funded (US)
Health Care for the Homeless Programs. Health Soc Care
Community 2009;17:18–26.
11. Jasinski JL, Wesely JK, Mustaine E, Wright JD. The
experience of violence in the lives of homeless women: a
research report. Orlando (FL): University of Central Florida;
2005. Available at: http://www.ncjrs.gov/pdffiles1/nij/grants/
211976.pdf. Retrieved October 9, 2009.
12. Zorza J. Woman battering: a major cause of homelessness.
Clgh Rev 1991;25:421–7.
13. GLBT Domestic Violence Coalition, Jane Doe Inc. Shelter/
housing needs for gay, lesbian, bisexual and transgender
(GLBT) victims of domestic violence. Analysis of public
hearing testimony, October 27, 2005, Massachusetts State
House. Boston (MA): GLBT Domestic Violence Coalition;
Jane Doe Inc.; 2006. Available at: http://www.thenet
worklared.org/GLBTDVPublicHearingReport2006.pdf.
Retrieved October 9, 2009.
14. Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL.
Hospitalization costs associated with homelessness in New
York City. N Engl J Med 1998;338:1734–40.
15. Gelberg L, Lu MC, Leake BD, Andersen RM, Morgenstern H,
Nyamathi AM. Homeless women: who is really at risk for
unintended pregnancy? Matern Child Health J 2008;12:
52–60.
16. Little M, Shah R, Vermeulen MJ, Gorman A, Dzendoletas D,
Ray JG. Adverse perinatal outcomes associated with home-
lessness and substance use in pregnancy. CMAJ 2005;
173:615–8.
17. Stein JA, Lu MC, Gelberg L. Severity of homelessness and
adverse birth outcomes. Health Psychol 2000;19:524–34.
4 Committee Opinion No. 454
COMMITTEE OPINIONS
18. Chau S, Chin M, Chang J, Luecha A, Cheng E, Schlesinger J,
et al. Cancer risk behaviors and screening rates among
homeless adults in Los Angeles County. Cancer Epidemiol
Biomarkers Prev 2002;11:431–8.
19. Lewis JH, Andersen RM, Gelberg L. Health care for home-
less women. J Gen Intern Med 2003;18:921–8.
20. Nickasch B, Marnocha SK. Healthcare experiences of the
homeless. J Am Acad Nurse Pract 2009;21:39–46.
21. Gelberg L, Browner CH, Lejano E, Arangua L. Access to
women’s health care: a qualitative study of barriers per-
ceived by homeless women. Women Health 2004;40:
87–100.
22. Kushel MB, Vittinghoff E, Haas JS. Factors associated with
the health care utilization of homeless persons. JAMA
2001;285:200–6.
23. Sadowski LS, Kee RA, VanderWeele TJ, Buchanan D. Effect
of a housing and case management program on emergency
department visits and hospitalizations among chronically
ill homeless adults: a randomized trial. JAMA 2009;301:
1771–8.
24. Allen J, Bharel M, Brammer S, Centrone W, Morrison S,
Phillips C, et al. Adapting your practice: treatment and
recommendations on reproductive health care for homeless
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Inc., 2008.
25. Community Involvement and Volunteerism. ACOG Com-
mittee Opinion No. 437. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2009:114:203–4.
Copyright February 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care for homeless women. Committee Opinion No. 454.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2010;115:396–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 497
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 457 • June 2010

Committee on Health Care for Underserved Women

This information should not be construed as dictating an exclusive course of treatment or
Reaffirmed 2012 procedure to be followed.

Preparing for Disasters: Perspectives on Women

ABSTRACT: Emergency plans that specifically address the needs of women, infants, and children during
disasters are currently underdeveloped in the United States. Pregnant women, infants, and children are adversely
affected by disasters resulting in an increased number of infants with intrauterine growth restriction, low birth
weight, and a small head circumference. There is an increased incidence of preterm delivery. To provide for a
healthy pregnancy and delivery, pregnant women affected by disasters need to be assured of a continuation of
prenatal care. Those in the third trimester should be aware of established local health care facilities that can pro-
vide prenatal care and obstetric services during a disaster. Establishing and maintaining lactation before, during,
and after a disaster is important for infant nutrition. Decreasing the number of unintended pregnancies can be
achieved by providing both prophylactic and emergency contraception. Women involved in disasters are also at an
increased risk for sexual assault and should be provided a safe and secure environment in evacuation shelters. In
addition to emergency contraception, sexual assault forensic examiners or sexual assault nurse examiners should
be available for victims of sexual assault.

Catastrophic disasters can greatly affect the health care
system. Not only does the health care system become
overwhelmed with medical emergencies but it also can be
disrupted. Following the events of 9/11 and the anthrax
letters of 2001, the Hospital Preparedness Program, a
sector of the U.S. Department of Health and Human
Services, was developed to address hospital prepared-
ness for bioterrorism, natural disasters, and epidemics.
Although great strides have been made in improving
the health care system in preparation for disasters, the
Evaluation Report from the Hospital Preparedness
Program released in March 2009, reveals hospitals in
the United States are not currently prepared for a major
disaster (1). Additionally, the aftermath of Hurricane
Katrina revealed the vulnerability of women, infants, and
children during disasters. As a result, in 2005 and 2006 the
National Working Group for Women and Infant Needs
in Emergencies in the United States extensively reviewed
most U.S. preparedness plans and found that these plans
seldom included the needs of mothers and children dur-
ing the acute or recovery phases of a disaster (2). The
American College of Obstetricians and Gynecologists is
a member of the White Ribbon Alliance that supported
this working group. The obstetrician–gynecologist has a
unique role in developing and carrying out an emergency
preparedness plan that addresses the safety and medical
needs of women in the event of bioterrorism, natural
disasters, and epidemics.
Effect of Disasters on Pregnant
Women, Newborns, and Infants
Pregnant women, newborns, and infants may be dis-
proportionately harmed by natural disasters. The lack of
resources, such as food and clean water, lack of access to
health care and medications, as well as psychologic stress
in the aftermath of disasters increase pregnancy-related
morbidities. After Hurricane Katrina, the Centers for
Disease Control and Prevention found that the 14 Federal
Emergency Management Agency designated counties
and parishes affected by the hurricane had a significant
increase in the number of women who received late or no
prenatal care. In the designated counties in Mississippi,
the percentage of inadequate prenatal care increased
significantly from 2.3% to 3.3% (3). In Louisiana, among
Hispanic women, it increased from 2.3% to 3.9% (3).
Infants who were born to pregnant women living within
a 2-mile radius of the World Trade Center on 9/11
were found to have a higher rate of intrauterine growth
restriction, decreased birth weight, and a small head
circumference (4, 5). In a study that monitored birth

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 498

 outcomes following Hurricane Katrina, women who antepartum, intrapartum, and postpartum periods needs
experienced three or more severe traumatic situations to be safely managed. For women in the antepartum
during the hurricane, such as feeling as though one’s life period, maintaining prenatal care is of utmost impor-
was in danger, walking through flood waters, or having tance. Health care providers outside the perimeter of the
a loved one die, were found to have a higher rate of low disaster should be willing to accept evacuees in an effort
birth weight infants and an increase in preterm deliveries to ensure continuation of prenatal care. State and local
(6). Additionally, disruption of the health care system may governments should establish local facilities where pre-
result in the separation of mothers and infants. For exam- natal care and obstetric services can be provided for those
ple, during Hurricane Katrina, many critically ill hospital- women unable to evacuate. Accessing prenatal records
ized infants were transported to medical facilities outside is important in maintaining prenatal care. This will be
of New Orleans without their mothers. The separation of impossible if written records are destroyed because of
mothers and their infants can interfere with breastfeeding the disaster or if interruption in electricity prohibits
as well as create additional stress for the mothers. access to electronic medical records. In preparation,
These pregnancy morbidities can be prevented by clinicians should make patients aware of their specific
developing an emergency plan that addresses them. As prenatal issues as well as provide them with key portions
providers of women’s health care, the involvement of the of their medical records. This is especially true in areas
obstetrician–gynecologist in disaster response is essential where natural disasters are seasonal and may be likely to
(see box, “Physician Guide to Emergency Preparedness occur. Also, health care providers of prenatal care should
for Women and Infants”). This can be done at the local increase patients’ awareness of the signs of preterm labor
level through a hospital emergency preparedness com- and other obstetric emergencies and the action to take in
mittee or a community group attached to the fire depart- the event of these emergencies.
ment or police department and at the state level through Obstetric care at a designated facility is ideal, and it
the Department of Homeland Security. is the role of public health officials in an area to designate
and equip obstetric care facilities, publicize which facili-
Disaster Preparedness for the Health ties in a given area will offer obstetric services, identify
Care System and Providers Caring for alternative safe delivery sites, and arrange for the staffing
Pregnant Women of the facilities. Individual obstetric care providers are
Although a “one-size fits all” emergency plan is diffi- urged to assist public health officials and to practice with-
cult to apply to all disasters, there are common dis- in the obstetric care system that is established. However,
tresses experienced by all pregnant women regardless there are several factors that may contribute to diffi-
of the nature of the disaster. Pregnant women should culty in accessing obstetric health care facilities during a
be encouraged to develop evacuation plans in the event disaster. The health care system may become inundated
there is enough forewarning to allow for evacuation. The with other health emergencies, which could decrease the
American Red Cross provides emergency preparedness resources available to pregnant women. Also, physical
checklists for specific disasters (7). However, when evacu- barriers, such as impassible roads, demolished bridges
ation is not possible, the health care for women in the and fire lines, may serve as obstacles to accessing obstet-
ric care facilities. These hindrances may result in women
giving birth outside of health care facilities. To prepare,
Physician Guide to Emergency clinicians should make pregnant women who reside in
Preparedness for Women and Infants locations subject to seasonal or frequent environmental
emergencies aware of the availability of emergency birth
• Encourage patients to develop an evacuation plan in kits (see box, “Emergency Birth Kits for Patients”). These
the event of a disaster kits have all of the essential equipment necessary should
• Inform pregnant patients on the signs of preterm labor a birth occur outside of a birthing facility.
and other obstetric emergencies During a disaster, women who are not breastfeeding
• Work with public health officials to identify facilities may have difficulty in providing food for their new-
that can provide prenatal and obstetric services during borns. Some new mothers may plan to bottle-feed their
a disaster newborns. However, during a disaster, there may not be
• Encourage patients to develop an emergency birth kit access to clean water for sterilization of bottles or access
to formula. Encouraging and establishing breastfeed-
• Promote lactation and relactation during a disaster
ing as a part of routine care ensures that mothers are
• Encourage local and state governments to provide facil- able to feed their newborns in the event of a disaster.
ities that are safe and secure for women and children Additionally, health care providers should be educated in
• Inform patients and be aware of the signs of mental lactation to assist new mothers in initiating breastfeeding
distress. Promote prompt attention to mental health in the immediate phase of a disaster. For mothers who
needs are less than 6 months postpartum, even if they have not
previously established lactation, relactation can be estab-

2 Committee Opinion No. 457

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 499


Emergency Birth Kits for Patients
• 10 blue pads
• 1 plastic “peri-bottle”
• 1 newborn hat
• 6 packs of sterile lubricant
• 2 plastic newborn cord clamps
• Sterilized scissors
• 12 alcohol prep pads, individually wrapped
• 1 dozen sanitary pads
• 1 dozen sterile gauze pads
• 1 bulb syringe
• 1 bottle of peroxide
• Neonatal thermometer
• Battery powered radio with extra batteries
• Instructions for use
Adapted from Women and Infant Services Package, National
Working Group for Women and Infant Needs in Emergencies, in evacuation shelters. Establishing safety, order, and the
White Ribbon Alliance. Accessed March 24, 2008.
lished and should be encouraged (8). For those mothers
who choose not to begin relactation or are beyond the
6-month period, ready-to-feed infant formula in a single-
serving bottle should be provided.
Disaster Preparedness for the Health
Care System and Providers Caring for
Nonpregnant Women
Providing contraception for postpartum and nonpreg-
nant women during a disaster is also important to pre-
vent unintended pregnancies. Contraception should be
provided in the form of emergency contraception as well
as prophylactic contraception. Providing condoms allows
for the prevention of not only unintended pregnancies
but also decreases the transmission of sexually transmit-
ted diseases. For women who are using reversible contra-
ception in the form of pills, the ring, or the patch, these
prescription medications should be provided to enable
these women to maintain their current form of birth
control. When possible, emergency health care facili-
ties should stock and dispense a variety of contraceptive
products.
Mental Health Considerations
Involvement in a disaster situation causes and exacerbates
tremendous anxiety, depression, and grief. Postdisaster,
patients and health care providers need to be aware of the
signs of mental distress requiring medical attention. The
Centers for Disease Control and Prevention offers infor-
mation and resources for mental health care during and
after disasters. This can be accessed at http://www.bt.cdc.
gov/mentalhealth/.
Committee Opinion No. 457
COMMITTEE OPINIONS
Prevention of Violence Against
Women During a Disaster
Women are subjected to and vulnerable to intimate
partner violence and sexual assault during disasters (9,
10). Similar to the conditions found in refugee camps
where sexual violence also is increased, during the phases
of a disaster women are isolated from their families and
without physical protection. The United Nations Refugee
Agency, in developing guidelines for prevention and
response to sexual violence against refugees, has identified
some contributing circumstances: 1) male perpetrators’
dominance over female victims, 2) psychologic strains
in refugee camps, 3) absence of support systems for pro-
tection, 4) crowded facilities, 5) lack of physical protec-
tion, 6) general lawlessness, 7) alcohol and drug abuse,
8) politically motivated violence against refugees, and
9) single females separated from male family members
(5). Ironically, these same circumstances existed among
the Hurricane Katrina evacuees and were likely responsi-
ble for the many personal accounts of rape that occurred
rule of law in shelters for disaster survivors is paramount
to the protection of women from sexual assault. In the
event that sexual violence does occur, appropriate and
sensitive services should be available to victims, includ-
ing emergency contraception and sexual assault forensic
examiners or sexual assault nurse examiners.
Conclusion
Disasters are unplanned but can be anticipated. Emergency
preparedness is essential to maintaining healthy pregnan-
cies and ensuring good outcomes for pregnant women
and their infants who endure disasters. Developing an
evacuation plan is the first step. However, if evacuation
is not possible, identifying local health care facilities that
can provide obstetric care, discussing the availability of
emergency birth kits, and emphasizing the importance of
lactation are key steps to facing the many challenges of a
disaster that are unique to pregnant women. Postpartum
and nonpregnant women must have access to contracep-
tion. Women’s health care providers are needed to advise,
assist, and support public health authorities in planning
for and serving during a disaster. Clinicians also should
encourage local and state governments to provide shel-
ters that are safe and secure to prevent violence against
women.
References
1. Toner E, Waldhorn R, Franco C, Courtney B, Rambhia K,
Norwood A, Inglesby TV, O’Toole T. Hospitals Rising to
the Challenge: The First Five Years of the U.S. Hospital
Preparedness Program and Priorities Going Forward.
Prepared by the Center for Biosecurity of UPMC for the
U.S. Department of Health and Human Services under
Contract No. HHSO100200700038C. 2009.
2. Women and Infants Services Package (WISP), from the
National Working Group for Women and Infant Needs in
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 500
 Emergencies, White Ribbon Alliance. Accessed March 24,
2008 from http://www.whiteribbonalliance.org/Resources/
Documents/WISP.Final.07.27.07.pdf.
3. Hamilton B, Sutton P, Matthews TJ, Martin J, Ventura S.
The Effect of Hurricane Katrina: Births in the U.S. Gulf
Coast Region, Before and After the Storm. National Vital
Statistics Report. Vol 58, No 2.
4. Callaghan W, Rasmussen, S, Jamieson D, Ventura S, Farr S,
Sutton P, Mathews, T, Hamilton B, Shealy K, Brantley D,
Posner S. Health Concerns of Women and Infants in Times
of Natural Disasters: Lessons Learned from Hurricane
Katrina. Maternal and Child Health Journal. 2007; 11(4):
307–311.
5. Lederman SA, Rauh V, Weiss L, Stein JL, Hoepner LA,
Becker M, et al. The effects of the World Trade Center
event on birth outcomes among term deliveries at three
lower Manhattan hospitals. Environ Health Perspect 2004;
112:1772-8.
6. Xiong X, Harville E, Mattison D, Elkind-Hirsch K, Pridjian
G, Buekens P. Exposure to Hurricane Katrina, Post-
Traumatic Stress Disorder and Birth Outcomes. Am J
Med Sci 2008 August; 336(2): 111–115. doi: 10.1097/MAJ.
0b013e318180f21c.
7. American Red Cross, “Preparedness Fast Facts: Emergency-
Specific Preparedness Information”. Copyright 2009. The
American National Red Cross. http://www.redcross.org/
portal/site/en/menuitem.86f46a12f382290517a8f210b80f7
8a0/?vgnextoid=92d51a53f1c37110VgnVCM1000003481a
10aRCRD
4 Committee Opinion No. 457
COMMITTEE OPINIONS
8. La Leche League International, “When an Emergency
Strikes Breastfeeding Can Save Lives, Part 2,” media release,
September 1, 2005. Accessed October 3, 2006 from http://
www.lalecheleague.org/Release/emergency2.html
9. United Nations High Commissioner for Refugees
(UNHCR). Prevention and Response to Sexual and
Gender-Based Violence in Refugee Situations. Proceedings
of the Inter-Agency Lessons Learned Conference, Geneva
(March 27–29, 2001). Available at: http://action.web.ca/
home/cpcc/attach/prevention%20and%20responses.pdf
10. Thornton, W., Voigt, L. “Disaster Rape: Vulnerability of
Women to Sexual Assaults During Hurricane Katrina.”
Journal of Public Management & Social Policy. Fall 2007.
Copyright June 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Preparing for disasters: perspectives on women. Committee Opinion
No. 457. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2010;115:1339–42.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 501
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 470 • October 2010

Committee on Health Care for Underserved Women

The information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Challenges for Overweight and Obese Urban Women

ABSTRACT: Overweight and obesity are epidemic in the United States. Obesity is a risk factor for numerous
conditions, including diabetes, hypertension, high cholesterol, stroke, heart disease, certain types of cancer, and
arthritis (1). More than one fourth of U.S. women are overweight and more than one third are obese. Women living
in urban settings, irrespective of demographics or income, are particularly vulnerable to becoming overweight or
obese because of limited resources for physical activity and healthy food choices. Therefore, there is a need for
clinicians and public health officials to address not only individual behaviors but also environmental issues in their
efforts to reduce the epidemic of obesity in this particular group of the population.

Overweight and obesity are epidemic in the United States.
Obesity is a risk factor for numerous conditions, includ-
ing diabetes, hypertension, high cholesterol, stroke, heart
disease, certain types of cancer, and arthritis (1). More
than one fourth of U.S. women are overweight and more
than one third are obese (1). Although all women are
at high risk of obesity, minority women and women in
low-income and urban areas are particularly at risk (2). It
is estimated that 80% of females aged 15 years and older
lived in urban areas in 2008 (3). Each year, 83% of live
births occur in urban cities and regions across the United
States. The demographic characteristics of women living
in urban communities are diverse and complex. Racial
composition and poverty rates vary by both the level of
urbanization and parameters unique to the geographic
region. In the United States, 54% of women living in urban
areas are non-Hispanic whites and 45% are minorities
or women of color (4). Poverty rates are highest in large
urban areas, particularly in the Northeast and Midwest
regions (5). Despite the regional diversity in specific social
and economic characteristics, urban women across the
United States face some unique barriers to healthy living.
Overweight and obesity in urban women may be exacer-
bated by additional barriers to physical activity and healthy
eating, collectively referred to by social scientists and urban
and public health planners as the built environment (6, 7).
Identifying Women Who Are
Overweight and Obese
The World Health Organization and the National Heart
Lung and Blood Institute (NHLBI) classify overweight
and obesity based on body mass index (BMI), defined as
weight in kilograms divided by the square of height in
meters (kg/m2) (8, 9). A healthy or desirable BMI for
adults is between 18.9 and 24.9. An adult is consid-
ered overweight if the BMI is between 25.0 and 29.9
and obese if the BMI is greater than or equal to 30.
The term morbid obesity is still used by the International
Classification of Diseases, 9th Revision, Clinical Modifica-
tion, to refer to a BMI greater than 35, but the NHLBI
recommends more respectful alternatives such as “stage
III,” “extreme obesity,” or “clinically severe obesity” (10).
Clinicians can access an online BMI calculator at the
NHLBI web site (http://www.nhlbisupport.com/bmi/).
Overweight and Obese Women in
Urban Communities
National data on rates of overweight and obesity in
urban settings are limited. The Behavioral Risk Factor
Surveillance System and the Pregnancy Risk Assessment
Monitoring System are based on self-reported height and
weight and may underestimate the prevalence of over-
weight and obesity (11, 12). In addition, although the
National Health and Nutrition Examination Survey pro-
vides data based on actual measures of individuals’ height
and weight across regions, its data on urban or rural areas
within regions are limited (13).
A 2001 Centers for Disease Control and Prevention
(CDC) health report showed obesity rates as high as 24%
in the Midwest and 19–20% in the South and Northeast.
These data likely underestimate current trends, particu-
larly in low-income and minority communities because

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 502

 data were aggregated from broad geographic regions that
included cities and surrounding suburban areas (5). The
CDC data also show that physical inactivity, a primary
risk factor for overweight and obesity, varies substantially
among women in different geographic settings (5).
Challenges for Overweight and Obese
Urban Women
There is growing recognition that the built environment,
which encompasses a range of physical and social charac-
teristics that make up the structure of a community, influ-
ences lifestyle behaviors and obesity, particularly among
adult women (14, 15). Access to healthy foods and desig-
nated areas for walking and other physical activities can
substantially improve the health of urban communities.
The availability of large supermarket chains or grocery
stores within a designated area influences food choices
and healthy eating among urban-based women (16). Sev-
eral studies show that large supermarkets with a variety of
food choices often are located several miles outside of the
city, requiring a car or long bus rides (16–18). Among
women in low-income urban communities, there are mul-
tiple challenges to healthy food selections. The primary
food retailers in many urban neighborhoods are small,
individually owned, corner markets with limited selections
of fresh fruits, vegetables, or low-fat dairy products (19).
A high number of fast food restaurants and convenience
stores per square mile in low-income urban neighborhoods
is another challenge (20). These restaurants and stores offer
quick, low-cost meals, but the menu is composed primarily
of high-calorie, high-fat foods that further contribute to or
exacerbate obesity among urban women. The higher por-
tion sizes and high-fat content of fast foods can be related to
increasing obesity rates (20). The cost of healthier selections
also is contributory (ie, a bag of potato chips costs approxi-
mately 20% less than the same portion of raw carrots).
The limited availability of healthy food choices in
low-income urban communities is emphasized in a study
conducted in Baltimore, MD (21). Using the healthy food
availability index, a novel measure of food selection used
by social scientists, healthy food selections were mapped
across 159 census tracts and 226 food stores in Baltimore.
Forty-three percent of low-income communities were in
the bottom third of accessibility to healthy food compared
with 13% of high-income urban neighborhoods. Further
assessments of food distribution by census tracts and zip
codes are necessary to monitor improvements in acces-
sibility and modifications in dietary intake. Local and
state policies that encourage supermarkets to broaden the
availability of food choices in all communities is another
important step in supporting healthy eating habits.
Physicians may find it difficult to explain the disad-
vantages of consuming fast foods during a 10–15 minute
office visit, especially when other problems must be
addressed or the patient is not yet considering a lifestyle
change. Motivational interviewing is a useful technique
to improve patient–physician communication and elicit
positive changes in patient behavior. Information on
COMMITTEE OPINIONS
the principles and practice of motivational interviewing
can be found in the American College of Obstetricians
and Gynecologists (the College) Committee Opinion
Number 423, “Motivational Interviewing: A Tool for
Behavior Change” (22). Educating patients about the
calories consumed with fast food is an important step.
Assisting the patient in comparing the number of daily
calories she needs with the number of calories in conve-
nient food items may be helpful. Calorie information of
some fast food chains is listed on their web sites and in
some chain locations. Assisting the patient in identify-
ing healthy options at popular fast food chains such as
grilled or skinless chicken, a salad or other side vegetable
selection, along with alternate food sources, such as a
local farmers’ market, may be helpful in the motivational
process.
Achieving the recommended amount of daily physi-
cal exercise (30–60 minutes per day) is another aspect of
the built environment that challenges women in urban
settings (23, 24). Development of safe neighborhood
walking paths and maintenance of accessible sidewalks in
high traffic areas may increase physical activity. Research
results document a direct correlation between sidewalk
accessible streets and pedestrian activity in urban neigh-
borhoods. Limited access to public parks or recreational
centers within individual neighborhoods is another bar-
rier to physical activity. Personal safety may prohibit
outdoor activities. Some urban neighborhoods contain a
safe, one to two block area bordered by several blocks of
high crime activity. Although a park or walking trail may
be a short distance from their homes, women may be
reluctant to use such facilities if they are afraid of crime.
Community resources, such as the YMCA or community
swimming pools, are alternative, safe venues. Strategies to
improve viable, safe pedestrian activity in urban neigh-
borhoods are necessary for women to sustain a healthy
level of activity.
Current Initiatives to Reduce Obesity
in Urban Settings
Policy decisions about transportation options, land use
and development, and community design influence the
accessibility of healthy foods and the level of physi-
cal activity. These planning decisions may increase the
convenience of purchasing healthy foods and create safe
neighborhood venues for walking and leisure activities.
Examples of recent initiatives led by state governments,
academic centers, and community organizations include
the following:
• The Well-Integrated Screening and Evaluation for
Women Across the Nation (WISEWOMAN) Pro-
gram, a state-level initiative supported by the CDC,
equips low-income adult women, aged 45–64 years
and at risk of cardiovascular disease, with lifestyle
modification skills to improve dietary intake and phys-
ical activity in urban and rural communities in 21
states (http://www.cdc.gov/WISEWOMAN/brochure.
htm).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 503
 • The University of Colorado, in collaboration with
community organizations and neighborhood resi-
dents, has transformed unused land lots into com-
munity gardens and open space for physical activity.
• The Upper Falls Community of Rochester, New York,
developed collaborations to bring a full service super-
market to a neighborhood that previously had no gro-
cery store.
• New York City’s Health Department amended the city
Health Code to require the posting of calorie counts
by chain restaurants on menus, menu boards, and
item tags (http://www.nyc.gov/html/doh/downloads/
pdf/cdp/calorie_compliance_guide.pdf).
These along with other initiatives can be found at http://
www.preventioninstitute.org/builtenv.html.
Recommendations for the
Obstetrician–Gynecologist
Addressing obesity and lifestyle behaviors during a busy
clinical office session is challenging to the obstetrician–
gynecologist. The following steps can help initiate a dia-
logue about lifestyle modifications between the patient
and her physician:
• Discuss healthy lifestyle behaviors at each visit.
Multiple discussions can facilitate an open dialogue
and opportunities to develop weight loss strategies.
Additional information is available in the College’s
Committee Opinion Number 319, “The Role of the
Obstetrician–Gynecologist in the Assessment and
Management of Obesity” (25).
• Encourage discussions of physical activity and the
range of food choices available in local neighborhoods
during prenatal and postpartum visits. Information
on obstetric management of obesity during preg
nancy can be found in the College’s Committee
Opinion Number 315, “Obesity in Pregnancy” (26).
• Use motivational interviewing techniques to assist
women in developing a long-term commitment to
weight loss and healthy living. Additional informa-
tion is available in the College’s Committee Opinion
Number 423, “Motivational Interviewing: A Tool for
Behavior Change” (22).
• Advocate for the development of a free wellness pro-
gram at your hospital.
• Partner with your hospital’s community liaison office
to advocate for further construction of safe, accessible
outdoor recreational areas.
• Volunteer to represent your hospital at community
initiatives to increase supermarkets or improve rec-
reational venues in the city.
• Encourage patients to consider shopping at farmers’
markets, if few grocery stores are available to them.
• Support city and state health department efforts to
expand data collection and improve surveillance of
trends in obesity and other chronic conditions.
COMMITTEE OPINIONS
• Encourage your hospital administration to partner
with nutritionists, social workers and community-
based fitness clubs (eg, YMCA) to provide a multi-
faceted approach to lifestyle behavior change.
• Collaborate with other clinicians to encourage local
grocery store owners to expand the selection of fruits
and vegetables and to encourage development of
farmers’ markets.
• Display handouts, when possible, in examination
rooms or the reception area with recommendations
for daily calorie intake and physical activity.
• Provide materials on preparation of low calorie meals
(available free of charge from the National Institute of
Diabetes and Digestive and Kidney Diseases [www.
niddk.gov]).
References
1. Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence
and trends in obesity among US adults, 1999–2008. JAMA
2010;303:235–41.
2. Raghuwanshi M, Kirschner M, Xenachis C, Ediale K, Amir J.
Treatment of morbid obesity in inner-city women. Obes
Res 2001;9:342–7.
3. U.S. Census Bureau. Available at: http://www.census.gov.
Retrieved January 25, 2010.
4. National Center for Health Statistics. Health, United States,
2008: with special feature on the health of young adults.
Hyattsville (MD): NCHS; 2009. Available at: http://www.
cdc.gov/nchs/data/hus/hus08.pdf. Retrieved January 25,
2010.
5. National Center for Health Statistics. Health, United States,
2001: with urban and rural health chartbook. Hyattsville
(MD): NCHS; 2001. Available at: http://www.cdc.gov/nchs/
data/hus/hus01.pdf. Retrieved January 26, 2010.
6. Booth KM, Pinkston MM, Poston WS. Obesity and the
built environment. J Am Diet Assoc 2005;105:S110–7.
7. Lee RE, Cubbin C, Winkleby M. Contribution of neigh-
bourhood socioeconomic status and physical activity
resources to physical activity among women. J Epidemiol
Community Health 2007;61:882–90.
8. Obesity: preventing and managing the global epidemic.
Report of a WHO consultation. World Health Organ Tech
Rep Ser 2000;894:1–253.
9. Clinical guidelines on the identification, evaluation, and
treatment of overweight and obesity in adults--the evidence
report. National Institutes of Health [published erratum
appears in Obes Res 1998;6:464]. Obes Res 1998;6(suppl 2):
51S–209S.
10. Kushner RF, Roth JL. Medical evaluation of the obese indi-
vidual. Psychiatr Clin North Am 2005;28:89–103, viii.
11. Centers for Disease Control and Prevention. Behavioral
Risk Factor Surveillance System. Available at: http://www.
cdc.gov/brfss. Retrieved January 25, 2010.
12. Centers for Disease Control and Prevention. Pregnancy Risk
Assessment Monitoring System (PRAMS): home. Available
at: http://www.cdc.gov/prams. Retrieved January 25, 2010.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 504
 13. National Center for Health Statistics. National Health and
Nutrition Examination Survey. Available at: http://www.
cdc.gov/nchs/nhanes.htm. Retrieved January 25, 2010.
14. Papas MA, Alberg AJ, Ewing R, Helzlsouer KJ, Gary TL,
Klassen AC. The built environment and obesity. Epidemiol
Rev 2007;29:129–43.
15. Lopez RP. Neighborhood risk factors for obesity. Obesity
2007;15:2111–9.
16. Morland K, Wing S, Diez Roux A. The contextual effect
of the local food environment on residents’ diets: the ath-
erosclerosis risk in communities study. Am J Public Health
2002;92:1761–7.
17. Casagrande SS, Whitt-Glover MC, Lancaster KJ, Odoms-
Young AM, Gary TL. Built environment and health behav-
iors among African Americans: a systematic review. Am J
Prev Med 2009;36:174–81.
18. Moore LV, Diez Roux AV, Nettleton JA, Jacobs DR, Franco M.
Fast-food consumption, diet quality, and neighborhood
exposure to fast food: the multi-ethnic study of atheroscle-
rosis. Am J Epidemiol 2009;170:29–36.
19. Townsend MS, Aaron GJ, Monsivais P, Keim NL,
Drewnowski A. Less-energy-dense diets of low-income
women in California are associated with higher energy-
adjusted diet costs. Am J Clin Nutr 2009;89:1220–6.
20. Jacobs DR Jr. Fast food and sedentary lifestyle: a combina-
tion that leads to obesity. Am J Clin Nutr 2006;83:189–90.
21. Franco M, Diez Roux AV, Glass TA, Caballero B, Brancati FL.
Neighborhood characteristics and availability of healthy
foods in Baltimore. Am J Prev Med 2008;35:561–7.
22. Motivational interviewing: a tool for behavior change.
ACOG Committee Opinion No. 423. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2009;
113:243–6.
COMMITTEE OPINIONS
23. U.S. Department of Health and Human Services. Physical
activity and health: a report of the Surgeon General. Atlanta
(GA): U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, National Center
for Chronic Disease Prevention and Health Promotion; 1996.
Available at: http://www.cdc.gov/nccdphp/sgr/pdf/sgrfull.
pdf. Retrieved January 26, 2010.
24. Laraia B, Messer L, Evenson K, Kaufman JS. Neighborhood
factors associated with physical activity and adequacy of
weight gain during pregnancy. J Urban Health 2007;84:
793–806.
25. The role of the obstetrician–gynecologist in the assess-
ment and management of obesity. ACOG Committee
Opinion No. 319. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2005;106:895–9.
26. Obesity in pregnancy. ACOG Committee Opinion No.
315. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2005;106:671–5.
Copyright October 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Challenges for overweight and obese urban women. Committee
Opinion No. 470. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:1011–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 505
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 471 • November 2010 (Replaces No. 316, October 2005)
Committee on Health Care for Underserved Women
Committee on Obstetric Practice
Reaffirmed 2012 This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Smoking Cessation During Pregnancy

ABSTRACT: Smoking is the one of the most important modifiable causes of poor pregnancy outcomes in the
United States, and is associated with maternal, fetal, and infant morbidity and mortality. The physical and psycho-
logic addiction to cigarettes is powerful; however, the compassionate intervention of the obstetrician–gynecologist
can be the critical element in prenatal smoking cessation. An office-based protocol that systematically identifies
pregnant women who smoke and offers treatment or referral has been proved to increase quit rates. A short coun-
seling session with pregnancy-specific educational materials and a referral to the smokers’ quit line is an effective
smoking cessation strategy. The 5A’s is an office-based intervention developed to be used under the guidance of
trained practitioners to help pregnant women quit smoking. Knowledge of the use of the 5A’s, health care support
systems, and pharmacotherapy add to the techniques providers can use to support perinatal smoking cessation.

Epidemiology women who use smokeless tobacco during pregnancy

Increased public education measures and public health
campaigns in the United States have led to a decrease in
smoking by pregnant women and nonpregnant women
of reproductive age (1). Pregnancy appears to motivate
women to stop smoking; 46% of prepregnancy smokers
quit smoking directly before or during pregnancy (1).
Although the rate of reported smoking during pregnancy
has decreased from 18.4% in 1990 to 13.2% overall in
2006, for some populations, such as adolescent females
and less educated non-Hispanic white and American
Indian women, the decrease was less dramatic (2, 3).
Smoking during pregnancy is a public health problem
because of the many adverse effects associated with it.
These include intrauterine growth restriction, placenta
previa, abruptio placentae, decreased maternal thyroid
function (4, 5), preterm premature rupture of mem-
branes (6, 7), low birth weight, perinatal mortality (4),
and ectopic pregnancy (4). An estimated 5–8% of pre-
term deliveries, 13–19% of term deliveries of infants with
low birth weight, 23–34% cases of sudden infant death
syndrome (SIDS), and 5–7% of preterm-related infant
deaths can be attributed to prenatal maternal smok-
ing (8). The risks of smoking during pregnancy extend
beyond pregnancy-related complications. Children born
to mothers who smoke during pregnancy are at an
increased risk of asthma, infantile colic, and childhood
obesity (9–11). Researchers report that infants born to
have a high level of nicotine exposure, low birth weight,
and shortened gestational age as to mothers who smoke
during pregnancy (12, 13). Secondhand prenatal expo-
sure to tobacco smoke also increases the risk of having
an infant with low birth weight by as much as 20% (14).
Intervention
Cessation of tobacco use, prevention of secondhand smoke
exposure and prevention of relapse to smoking are key
clinical intervention strategies during pregnancy. Inquiry
into tobacco use and smoke exposure should be a routine
part of the prenatal visit. The U.S. Preventive Services
Task Force (USPSTF) recommends that clinicians ask
all pregnant women about tobacco use and provide aug-
mented, pregnancy-tailored counseling for those who
smoke (15). The U.S. Public Health Service recommends
that clinicians offer effective tobacco dependence inter-
ventions to pregnant smokers at the first prenatal visit as
well as throughout the course of pregnancy (16).
Addiction to and dependence on cigarettes is both
physiologic and psychologic, and cessation techniques
have included counseling, cognitive and behavioral ther-
apy, hypnosis, acupuncture, and pharmacologic therapy.
Women who indicate that they are not ready to quit
smoking can benefit from consistent motivational
approaches by their health care providers as outlined in
Committee Opinion No. 423, “Motivational Interview-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 506

 ing” published by the American College of Obstetricians
and Gynecologists (17). Patients who are willing to try
to quit smoking benefit from a brief counseling session,
such as the 5A’s intervention (Box 1), which has been
proved to be effective when initiated by health care
providers (16). With appropriate training, obstetrician–
gynecologists, other clinicians, or auxiliary health care
providers can perform these five steps with pregnant
women who smoke (16). Referral to a smoker’s quit line
may further benefit the patient. Quit lines offer informa-
tion, direct support, and ongoing counseling, and have
been very successful in helping pregnant smokers quit
and remain smoke free (18). Most states offer pregnancy-
specific services, focusing on the pregnant woman’s moti-
vation to quit and providing postpartum follow-up to
prevent relapse to smoking. By dialing the national quit
line network (1-800-QUIT NOW) a caller is immediately
routed to her state’s smokers’ quit line. Many states offer
fax referral access to their quit lines for prenatal health care
providers. Health care providers can call the national quit
line to learn about the services offered within their states.
Examples of effective smoking cessation interventions
delivered by a health care provider are listed in Box 2.
Although counseling and pregnancy-specific materials
are effective cessation aids for many pregnant women, some
women continue to smoke (15). These smokers often
are heavily addicted to nicotine and should be encour-
aged at every follow-up visit to seek help to stop smoking.
They also may benefit from screening and intervention
for alcohol use and other drug use because continued
smoking during pregnancy increases the likelihood of
other substance use (19). Clinicians also may consider
referring patients for additional psychosocial treatment
(16). There is insufficient evidence to support the use of
meditation, hypnosis, and acupuncture for smoking ces-
sation (16). Although quitting smoking before 15 weeks
of gestation yields the greatest benefits for the pregnant
woman and fetus, quitting at any point can be beneficial
(20). Successful smoking cessation before the third tri-
mester can eliminate much of the reduction in birth
weight caused by maternal smoking (20). The benefits
of reduced cigarette smoking are difficult to measure or
verify. The effort of women who reduce the amount they
smoke should be lauded, but these women also should be
reminded that quitting entirely brings the best results for
their health, the health of their fetuses, and ultimately that
of their infants (21). Pregnant women who are exposed
to the smoking of family members or coworkers should
be given advice on how to address these smokers or avoid
exposure.
Approximately 50–60% of women who quit smoking
during pregnancy return to smoking within 1 year post-
partum, putting at risk their health, that of their infants,
and the outcomes of future pregnancies (1). Determining
a woman’s intention to return to smoking during the
third trimester has proved useful at targeting smoking
relapse interventions (22). Most pregnant former smokers
2 Committee Opinion No. 471
COMMITTEE OPINIONS
Box 1. Five A’s of Smoking Cessation
1. ASK the patient about smoking status at the first pre-
natal visit and follow-up with her at subsequent visits.
The patient should choose the statement that best
describes her smoking status:
A. I have NEVER smoked or have smoked LESS THAN
100 cigarettes in my lifetime.
B. I stopped smoking BEFORE I found out I was preg-
nant, and I am not smoking now.
C. I stopped smoking AFTER I found out I was preg-
nant, and I am not smoking now.
D. I smoke some now, but I have cut down on the
number of cigarettes I smoke SINCE I found out I
was pregnant.
E. I smoke regularly now, about the same as BEFORE
I found out I was pregnant.
If the patient stopped smoking before or after she found
out she was pregnant (B or C), reinforce her decision to
quit, congratulate her on success in quitting, and encour-
age her to stay smoke free throughout pregnancy and
postpartum. If the patient is still smoking (D or E), docu-
ment smoking status in her medical record, and proceed
to Advise, Assess, Assist, and Arrange.
2. ADVISE the patient who smokes to stop by providing
advice to quit with information about the risks of con-
tinued smoking to the woman, fetus, and newborn.
3. ASSESS the patient’s willingness to attempt to quit
smoking at the time. Quitting advice, assessment, and
motivational assistance should be offered at subse-
quent prenatal care visits.
4. ASSIST the patient who is interested in quitting by
providing pregnancy-specific, self-help smoking ces-
sation materials. Support the importance of having
smoke-free space at home and seeking out a “quit-
ting buddy,” such as a former smoker or nonsmoker.
Encourage the patient to talk about the process of
quitting. Offer a direct referral to the smoker’s quit line
(1-800-QUIT NOW) to provide ongoing counseling and
support.
5. ARRANGE follow-up visits to track the progress of the
patient’s attempt to quit smoking. For current and for-
mer smokers, smoking status should be monitored and
recorded throughout pregnancy, providing opportuni-
ties to congratulate and support success, reinforce
steps taken towards quitting, and advise those still
considering a cessation attempt.
Modified from Fiore MC, Jaen CR, Baker TB, Bailey WC,
Benowitz NL, Curry SJ, et al. Treating tobacco use and depen-
dence: 2008 update. Clinical Practice Guideline. Rockville (MD):
U.S. Department of Health and Human Services, Public Health
Service; 2008. Available at: http://www.surgeongeneral.gov/
tobacco/treating_tobacco_use08.pdf. Retrieved July 6, 2010.
indicate that they do not intend to smoke. To strengthen
their resolve for continued smoking abstinence, a review
of tobacco use prevention strategies and identification of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 507

Box 2. Examples of Effective
Smoking Cessation Interventions
With Pregnant Patients
• Physician advice regarding smoking related risks (2–3 Coding
minutes)
• Video tape with information on risks, barriers, and tips may be billed, but not all payers reimburse for counseling
for quitting; provider counseling in one 10-minute ses-
sion; self-help manual; and follow-up letters
• Pregnancy-specific self-help guide and one 10-minute reform, physicians will be reimbursed for the provision
counseling session with a health educator.
• Provide counseling in one 90-minute session plus twice Medicaid and in new health plans with no cost sharing
monthly telephone follow-up calls during pregnancy
and monthly telephone calls after delivery
social support systems to remain smoke free in the third
trimester and postpartum is encouraged (22).
Pharmacotherapy
The U.S. Preventive Services Task Force has concluded
that the use of nicotine replacement products or other
pharmaceuticals for smoking cessation aids during preg-
nancy and lactation have not been sufficiently evaluated
to determine their efficacy or safety (15). There is con-
flicting evidence as to whether or not nicotine replace-
ment therapy increases abstinence rates in pregnant
smokers, and it does not appear to increase the likelihood
of permanent smoking cessation during postpartum fol-
low-up of these patients (23, 24). Trials studying the use
of nicotine replacement therapy in pregnancy have been
attempted, yet all of those conducted in the United States
have been stopped by data and safety monitoring com-
mittees for either demonstration of adverse pregnancy
effects or failure to demonstrate effectiveness (15, 25,
26). Therefore, the use of nicotine replacement therapy
should be undertaken with close supervision and after
careful consideration and discussion with the patient of
the known risks of continued smoking and the possible
risks of nicotine replacement therapy. If nicotine replace-
ment is used, it should be with the clear resolve of the
patient to quit smoking.
Alternative smoking cessation agents used in the non-
pregnant population include varenicline and bupropion.
Varenicline is a drug that acts on brain nicotine receptors,
but there is no knowledge as to the safety of varenicline use
in pregnancy (27). Bupropion is an antidepressant with
only limited data, but there is no known risk of fetal anom-
alies or adverse pregnancy effects (28). However, both of
these medications have recently added product warnings
mandated by the U.S. Food and Drug Administration
about the risk of psychiatric symptoms and suicide associ-
ated with their use (29, 30). Both bupropion and vareni-
cline are transmitted to breast milk. There is insufficient
evidence to evaluate the safety and efficacy of these treat-
ments in pregnancy and lactation (16). Furthermore, in
Committee Opinion No. 471
COMMITTEE OPINIONS
a population at risk of depression, medications that can
cause an increased risk of psychiatric symptoms and sui-
cide should be used with caution and considered in con-
sultation with experienced prescribers only.
Office visits specifically addressing smoking cessation
outside of the global pregnancy care package and some do
not cover preventive services at all. Under the health care
of smoking cessation counseling to pregnant women in
for the patient. Health care providers are encouraged to
consult coding manuals regarding billing and be aware
that reimbursements will vary by insurance carrier.
Resources
The American College of Obstetricians and
Gynecologists Resources
American College of Obstetricians and Gynecologists.
Smoking cessation during pregnancy: a clinician’s guide to
helping pregnant women quit smoking. Washington, DC:
ACOG; 2002. The guide, pocket reminder card, and slide
lecture can be ordered by writing to smoking@acog.org.
American College of Obstetricians and Gynecologists.
Need help putting out that cigarette? Washington, DC:
ACOG; 2008. This pregnancy-specific smoking cessa-
tion workbook for patients is available in English and
Spanish from the ACOG bookstore at http://www.acog.
org/bookstore.
Other Resources
Dartmouth Medical School. Smoking cessation for preg-
nancy and beyond: learn proven strategies to help your
patients quit. Available at: http://iml.dartmouth.edu/
education/cme/Smoking. Retrieved July 6, 2010.
National Alliance for Tobacco Cessation. BecomeAnEX.
org: if you’re pregnant, start here. Available at: http://
www.becomeanex.org/pregnant-smokers.php. Retrieved
July 6, 2010. All states offer free smoking cessation tele-
phone quit line services. Dialing 1-800-QUIT NOW will
connect the caller to their state quit line.
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tix) and bupropion (marketed as Zyban, Wellbutrin, and
generics). Rockville (MD): FDA; 2009. Available at: http://
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety
InformationforPatientsandProviders/DrugSafety
InformationforHeathcareProfessionals/ucm169986.htm.
Retrieved July 6, 2010.
30. Safety of smoking cessation drugs. Med Lett Drugs Ther
2009;51:65.
Copyright November 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Smoking cessation during pregnancy. Committee Opinion No. 471.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2010;116:1241–4.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 509
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 473 • January 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
Reaffirmed 2012 procedure to be followed.

Substance Abuse Reporting and Pregnancy: The Role

of the Obstetrician–Gynecologist
Abstract: Drug enforcement policies that deter women from seeking prenatal care are contrary to the welfare
of the mother and fetus. Incarceration and the threat of incarceration have proved to be ineffective in reducing
the incidence of alcohol or drug abuse. Obstetrician–gynecologists should be aware of the reporting requirements
related to alcohol and drug abuse within their states. They are encouraged to work with state legislators to retract
legislation that punishes women for substance abuse during pregnancy.

A disturbing trend in legal actions and policies is the
criminalization of substance abuse during pregnancy
when it is believed to be associated with fetal harm or
adverse perinatal outcomes. Although no state specifi-
cally criminalizes drug abuse during pregnancy, prosecu-
tors have relied on a host of established criminal laws
to punish a woman for prenatal substance abuse (1). As
of September 1, 2010, fifteen states consider substance
abuse during pregnancy to be child abuse under civil
child-welfare statutes, and three consider it grounds for
involuntary commitment to a mental health or substance
abuse treatment facility (1). States vary in their require-
ments for the evidence of drug exposure to the fetus or
newborn in order to report a case to the child welfare
system. Examples of the differences include the following:
South Carolina relies on a single positive drug test result,
Florida mandates reporting newborns that are “demon-
strably adversely affected” by prenatal drug exposure,
and in Texas, an infant must be “addicted” to an illegal
substance at birth. Most states focus only on the abuse of
some illegal drugs as cause for legal action. For instance,
in Maryland, the use of drugs such as methamphetamines
or marijuana may not be cause for reporting the pregnant
woman to authorities (2). Some states also include evi-
dence of alcohol use by a pregnant woman in their defini-
tions of child neglect.
Although legal action against women who abuse
drugs prenatally is taken with the intent to produce
healthy birth outcomes, negative results are frequently
cited. Incarceration and the threat of incarceration have
proved to be ineffective in reducing the incidence of
alcohol or drug abuse (3–5). Legally mandated testing
and reporting puts the therapeutic relationship between
the obstetrician–gynecologist and the patient at risk,
potentially placing the physician in an adversarial rela-
tionship with the patient (6, 7). In one study, women
who abused drugs did not trust health care providers
to protect them from the social and legal consequences
of identification and avoided or emotionally disengaged
from prenatal care (8). Studies indicate that prenatal care
greatly reduces the negative effects of substance abuse
during pregnancy, including decreased risks of low birth
weight and prematurity (9). Drug enforcement policies
that deter women from seeking prenatal care are contrary
to the welfare of the mother and fetus.
Seeking obstetric–gynecologic care should not expose
a woman to criminal or civil penalties, such as incar-
ceration, involuntary commitment, loss of custody of
her children, or loss of housing (6). These approaches
treat addiction as a moral failing. Addiction is a chronic,
relapsing biological and behavioral disorder with genetic
components. The disease of substance addiction is sub-
ject to medical and behavioral management in the same
fashion as hypertension and diabetes. Substance abuse
reporting during pregnancy may dissuade women from
seeking prenatal care and may unjustly single out the
most vulnerable, particularly women with low incomes
and women of color (10). Although the type of drug may
differ, individuals from all races and socioeconomic strata
have similar rates of substance abuse and addiction (11).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 510

 Pregnant women who do not receive treatment for
drug dependence cannot be assumed to have rejected
treatment (12). The few drug treatment facilities in the
United States accepting pregnant women often do not
provide child care, account for the woman’s family
responsibilities, or provide treatment that is affordable.
As of 2010, only 19 states have drug treatment programs
for pregnant women, and only nine give priority access to
pregnant women (1).
Obstetrician–gynecologists have important opportu-
nities for substance abuse intervention. Three of the key
areas in which they can have an effect are 1) adhering to
safe prescribing practices, 2) encouraging healthy behav-
iors by providing appropriate information and educa-
tion, and 3) identifying and referring patients already
abusing drugs to addiction treatment professionals (13).
Substance abuse treatment programs integrated with pre-
natal care have proved to be effective in reducing mater-
nal and fetal pregnancy complications and costs (14).
The use of the legal system to address perinatal alcohol
and substance abuse is inappropriate. Obstetrician–gyne-
cologists should be aware of the reporting requirements
related to alcohol and drug abuse within their states. In
states that mandate reporting, policy makers, legislators,
and physicians should work together to retract punitive
legislation and identify and implement evidence-based
strategies outside the legal system to address the needs
of women with addictions. These approaches should
include the development of safe, affordable, available,
efficacious, and comprehensive alcohol and drug treat-
ment services for all women, especially pregnant women,
and their families.
Resource
Guttmacher Institute. Substance abuse during pregnancy.
State Policies in Brief. New York (NY): GI; 2010. Avail-
able at: http://www.guttmacher.org/statecenter/spibs/
spib_SADP.pdf. Retrieved September 10, 2010.
This report lists policies regarding prosecution for sub-
stance abuse during pregnancy and drug abuse treatment
options for pregnant women for each state. It is updated
monthly.
References
1. Guttmacher Institute. Substance abuse during pregnancy.
State Policies in Brief. New York (NY): GI; 2010. Available at:
http://www.guttmacher.org/statecenter/spibs/spib_SADP.pdf.
Retrieved September 10, 2010.
2. Paltrow LM, Cohen DS, Carey CA. Governmental responses
to pregnant women who use alcohol or other drugs: year
2000 overview. New York (NY): National Advocates for
Pregnant Women; Philadelphia (PA): Women’s Law
Project; 2000.
2 Committee Opinion No. 473
COMMITTEE OPINIONS
3. Poland ML, Dombrowski MP, Ager JW, Sokol RJ. Punishing
pregnant drug users: enhancing the flight from care. Drug
Alcohol Depend 1993;31:199–203.
4. Chavkin W. Drug addiction and pregnancy: policy cross-
roads. Am J Public Health 1990;80:483–7.
5. Schempf AH, Strobino DM. Drug use and limited prenatal
care: an examination of responsible barriers. Am J Obstet
Gynecol 2009;200:412.e1–412.e10.
6. At-risk drinking and illicit drug use: ethical issues in
obstetric and gynecologic practice. ACOG Committee
Opinion No. 422. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2008;112:1449–60.
7. Legal interventions during pregnancy. Court-ordered med-
ical treatments and legal penalties for potentially harmful
behavior by pregnant women. JAMA 1990;264:2663–70.
8. Roberts SC, Nuru-Jeter A. Women’s perspectives on screen-
ing for alcohol and drug use in prenatal care. Womens
Health Issues 2010;20:193–200.
9. El-Mohandes A, Herman AA, Nabil El-Khorazaty M,
Katta PS, White D, Grylack L. Prenatal care reduces the
impact of illicit drug use on perinatal outcomes. J Perinatol
2003;23:354–60.
10. Maternal decision making, ethics, and the law. ACOG
Committee Opinion No. 321. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2005;106:
1127–37.
11. Chasnoff IJ, Landress HJ, Barrett ME. The prevalence of
illicit drug or alcohol use during pregnancy and discrepan-
cies in mandatory reporting in Pinellas County, Florida.
N Engl J Med 1990;322:1202–6.
12. Flavin J, Paltrow LM. Punishing pregnant drug-using
women: defying law, medicine, and common sense. J Addict
Dis 2010;29:231–44.
13. Safe use of medication. ACOG Committee Opinion No. 331.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:969–72.
14. Armstrong MA, Gonzales Osejo V, Lieberman L, Carpenter
DM, Pantoja PM, Escobar GJ. Perinatal substance abuse
intervention in obstetric clinics decreases adverse neonatal
outcomes. J Perinatol 2003;23:3–9.
Copyright January 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Substance abuse reporting and pregnancy: the role of the obstetri-
cian–gynecologist. Committee Opinion No. 473. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;117:200–1.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 511
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 479 • March 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Methamphetamine Abuse in Women of

Reproductive Age
ABSTRACT: Methamphetamine abuse has continued to increase in the United States since the late 1980s
with its use spreading from the West Coast to areas across the country. Methamphetamine use in pregnancy
endangers the health of the woman and increases the risk of low birth weight and small for gestational age babies
and such use may increase the risk of neurodevelopmental problems in children. All pregnant women should be
asked about their drug and alcohol use. Urine toxicology screening may be useful in detecting methamphetamine
and other substance abuse during pregnancy, but this screening should only be done with maternal consent after
counseling regarding the potential ramifications of a positive test result. Women reporting continuing use of meth-
amphetamine in pregnancy should be referred for treatment and followed up with serial ultrasound examinations
to assess fetal growth.

Trends in Use of Methamphetamine
The abuse of methamphetamine has been increasing
in the United States since the late 1980s. After alcohol
and marijuana, methamphetamine is the drug most fre-
quently abused in many western and midwestern states
(1). Methamphetamine is the only illegal drug that can
be easily made from legally obtained ingredients (2).
The availability is fueled by the low cost of metham-
phetamine compared with other illicit drugs of abuse,
its production in large and small clandestine laboratories
in the United States, and its importation from Mexico.
According to the 2008 National Survey on Drug Use and
Health, 5% of the U.S. population older than 12 years
have tried methamphetamine at some time in their lives,
with 0.3% (850,000) reporting use in the past year, and
0.2% (314,000) reporting use in the past month (3).
The Drug Abuse Warning Network reported a 126%
increase in the number of emergency department visits
related to methamphetamine abuse from 1995 to 2002
(4). The treatment admissions for methamphetamine
abuse have increased from approximately 1% in 1992 to
more than 9% of admissions in 2006 (5). Among preg-
nant women, admissions for the treatment of metham-
phetamine abuse increased from 8% of federally funded
treatment admissions in 1994 to 24% by 2006, with 73%
of these admissions occurring in the western states (6).
Obstetrician–gynecologists need to be aware of the preva-
lence of methamphetamine use to improve identification
of women who are using methamphetamine and to pro-
vide adequate care and referral for treatment.
Physiology of Use
Methamphetamine is a more potent stimulant drug than
its parent compound, amphetamine. Amphetamines were
widely prescribed in the 1950s and 1960s for depres-
sion and obesity, but were changed to Schedule II of the
Controlled Substances Act in 1971 after the potential for
abuse and addiction was recognized (1). Medical indica-
tions for methamphetamine are narcolepsy and attention
deficit disorder, but it should only be used when these
disorders are unresponsive to other treatments and at
much lower doses than those typical for recreational use
(7). Street names for methamphetamine include meth,
speed, ice, crystal, chalk, crank, glass, black beauties, and
bikers’ coffee.
Methamphetamine can be smoked, snorted, injected,
or ingested orally or anally (7, 9). When methamphet-
amine is smoked or injected, the user experiences an
intense rush that lasts only a few minutes. Snorting or
oral use of the drug produces euphoria but not the intense

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 512

 high that is experienced if it is smoked or injected. The
effects of snorting are felt within 3–5 minutes and within
15–20 minutes when ingested orally. Methamphetamine
has a longer half-life than cocaine and has additional
mechanisms of action in the central nervous system.
Both cocaine and methamphetamine block re-uptake of
dopamine at nerve endings, but methamphetamine also
increases the release of dopamine, leading to higher con-
centrations of dopamine in the synapse, which may be toxic
to nerve terminals. The half-life of methamphetamine is
approximately 12 hours compared with approximately 1
hour for cocaine (7). Besides the euphoria, the short-term
effects of methamphetamine use include increased wake-
fulness and energy and decreased appetite. Potential com-
plications of methamphetamine use include arrhythmias,
hypertension, seizures, and hyperthermia. Increased sexual
activity related to methamphetamine use may increase the
risk of human immunodeficiency virus (HIV) and other
sexually transmitted infections. Consequences of long-
term use include addiction, a chronic, relapsing disease
characterized by compulsive drug seeking, anxiety, confu-
sion, insomnia, memory loss, weight loss, severe dental
problems (“meth mouth”), depression, and violent behav-
ior (8). Long-term users may display psychotic symptoms,
including paranoia, visual and auditory hallucinations,
and delusions, including the sensation of insects crawl-
ing under the skin (formication). Psychotic symptoms
may persist for months or years after stopping use and
may recur over time. Brain imaging studies of long-term
methamphetamine users have shown severe structural
and functional changes in areas of the brain associated
with emotion and memory, which may be reversible over
months to years after stopping use. Withdrawal symptoms
from methamphetamine use include depression, anxiety,
fatigue, and intense drug cravings.
Effects on Pregnancy and Infant
Outcome
The effects of methamphetamine use on pregnancy and
the infant have been less well-studied than those of opi-
ates, alcohol, and cocaine. In addition, women who use
methamphetamine frequently use tobacco, alcohol, and
other drugs, which may confound the birth outcomes
(9). Because of unrestricted manufacturing processes
and chemical additives used by dealers to expand drug
volume, a potential risk of illicit drug use is teratogenicity.
Case reports and retrospective analyses have suggested
that maternal methamphetamine use may be associated
with a possible increase of defects of the fetal central
nervous system, cardiovascular system, gastrointestinal
system, as well as oral cleft and limb defects (10–12).
However, case–control and prospective studies have
not confirmed these findings (13–15). The Teratogen
Information System database has assessed the risk of
teratogenicity after exposure to amphetamines during
pregnancy as unlikely based on fair to good data (16).
2 Committee Opinion No. 479
COMMITTEE OPINIONS
The risk of small for gestational age (SGA) and low
birth weight babies is consistently increased with meth-
amphetamine use in pregnancy. In follow-up studies of
a cohort of 65 children born to Swedish women who
used amphetamines during pregnancy, their weight,
height, and head circumference were all below those of an
unselected sample at birth, 1 year, and 4 years of age (17).
However, the women used many other substances and
the control group was not matched for these exposures.
More recent studies have been consistent in finding lower
birth weights and increased rates of SGA infants in meth-
amphetamine exposed pregnancies compared with con-
trols (18, 19). In a prospective study specifically designed
to enroll methamphetamine users and appropriate con-
trols, the rate of SGA infants was 3.5 times higher with
methamphetamine exposure, even after adjustment for
such factors as alcohol and tobacco use and maternal
weight gain (20). Whether or not methamphetamine use
increases the risk of other pregnancy complications, such
as hypertension, preterm birth, or placental abruption, is
unclear (21).
In an ongoing prospective study of a cohort of
children born to women who used methamphetamine
during pregnancy and matched controls, prenatal meth-
amphetamine exposure was associated with decreased
arousal, increased stress, and poor quality of movement
in the newborn (9). In a small study of 13 children with
in utero methamphetamine exposure and 15 unexposed
children aged 3–16 years, children with methamphet-
amine exposure scored lower on tests of attention, visual
motor integration, verbal memory, and long-term spa-
tial memory, but were similar in motor skills, short
delay spatial memory, and nonverbal intelligence (22).
Reductions in volumes in the putamen, globus palli-
dus, and hippocampus on magnetic resonance imaging
among methamphetamine exposed children correlated
with poorer performance on attention and memory tasks.
Functional magnetic resonance imaging studies in meth-
amphetamine-exposed and alcohol-exposed, alcohol-
only exposed, and control children found more diffuse
activation in the brains of the methamphetamine group
during verbal memory tasks, suggesting recruitment of
compensatory systems. These changes were not seen with
alcohol only groups or control groups (23). In a recent
study of 276 women who reported or tested positive for
methamphetamine use during pregnancy, multiple risks
of pregnancy complications were disclosed. Of the 276
women in the study, 78% were active tobacco smokers,
14% consumed alcohol regularly during the pregnancy,
and 24% tested positive for multiple illicit substances at
the time of presentation to the hospital (2). In comparing
birth outcome for this cohort with controls, their babies
had lower Apgar scores at 1 minute and 5 minutes, and
higher neonatal mortality and maternal intensive care
unit admissions (2).
Taken together, findings to date do not support an
increase in birth defects with use of methamphetamine
2013 COMPENDIUM OF SELECTED PUBLICATIONS 513
 in pregnancy, but methamphetamine use is consistently
associated with SGA infants and appears to be associ-
ated with neonatal and childhood neurodevelopmental
abnormalities. Continued surveillance of these children is
indicated, especially considering the potential for multi-
ple contaminants in the drug and concomitant substance
exposure, but as stated, further follow-up and evaluation
are required.
Breastfeeding and Amphetamines
Amphetamine use inhibits prolactin release and can
reduce breast milk supply (24). The concentration of
amphetamines found in breast milk is 2.8–7.5 times
higher than those found in maternal plasma (25). It is
reported that infants who ingest the breast milk of women
using amphetamines exhibit increased irritability, agita-
tion, and crying (26). Amphetamines purchased illegally
often contain a mixture of substances with unpredictable
harmful effects on the woman and her infant. Therefore,
women who are actively using methamphetamine should
not breastfeed.
Identification of Methamphetamine
Use
Given the potential risks to maternal, fetal, and infant
health with methamphetamine use in pregnancy, identi-
fication of use is important. All pregnant women should
be asked about past and recent smoking, alcohol, and
other drug use as part of the prenatal history. Asking
about partner substance use may aid patient disclosure
of personal drug use (27). Studies have shown that preg-
nant methamphetamine users are more likely to be white,
young, and unmarried (28, 29). Women using metham-
phetamine often seek prenatal care late in pregnancy and
experience poor weight gain. Signs of methamphetamine
use include track marks from intravenous injection, mal-
nutrition, severe dental decay, and skin abscesses from
skin picking secondary to formication (8). Urine toxicol-
ogy screening is an adjunct to detect or confirm suspected
substance abuse. However, screening should only be
done with consent, and the pregnant woman must be
informed of the potential ramifications of a positive test
result, including any mandated reporting requirements
(30, 31). Screening for substance abuse should be seen
as part of complete obstetric care but should be done in
partnership with women to maintain care and allow for
appropriate referral to treatment. Obstetricians should be
aware of laws and regulations in their practice locations
regarding reporting of maternal toxicology testing (31).
Meconium testing for methamphetamine use also may
be used after parental consent, but immunoassay positive
test results should be confirmed by methods such as gas
chromatography-mass spectrometry because false posi-
tive test results are frequent (32). Testing of infant hair or
umbilical cord specimens has been evaluated but is not
routinely available (33).
Committee Opinion No. 479
COMMITTEE OPINIONS
Treatment
All women reporting methamphetamine use should be
counseled and offered help to discontinue use. An excel-
lent model of screening and brief intervention strategies
for the clinician can be found in the American College
of Obstetricians and Gynecologists’ Committee Opinion
No. 422 “At-Risk Drinking and Illicit Drug Use: Ethical
Issues in Obstetric and Gynecologic Practice” (30).
Women who are unable to stop using methamphetamine
or other drugs during pregnancy or who desire treatment
when they are not pregnant should be referred for treat-
ment. Given the intensity of treatment required and the
urgency of treatment in pregnancy, it is highly recom-
mended that pregnant women seek care voluntarily at a
residential treatment center whenever possible. If outpa-
tient treatment is used, intensive schedules of three to five
visits per week are needed for the first several weeks with
two to three sessions per week continuing for at least 90
days after initiation (34). Cognitive–behavioral therapy,
such as the Matrix Model, which includes behavioral
therapy, family education, individual counseling, 12-step
support, and drug testing is recommended (35, 36).
Contingency management interventions, which provide
tangible incentives in exchange for engaging in treatment
and maintaining abstinence, also have been shown to be
effective (37). No pharmacologic treatments have been
shown to be effective thus far.
Pregnant women using methamphetamine should
receive comprehensive prenatal care, including nutrition-
al assessment and social support services. They should be
tested for sexually transmitted infections and HIV. Given
the increased rate of fetal growth restriction with meth-
amphetamine use, baseline ultrasonography for clinical
dating should be obtained early in pregnancy with follow-
up ultrasound examinations for growth determination
in the third trimester. Additional assessments such as
fetal surveillance should be done as clinically indicated.
Appropriate follow-up and support of the woman and
her infant after delivery are important because the stresses
of the postpartum period may increase the risk of relapse.
Resources
The following resources are listed for information pur-
poses only. Listing of these resources and web sites does
not imply the endorsement of the American College of
Obstetricians and Gynecologists. This list is not meant to
be comprehensive. The inclusion or exclusion of a source
or web sites does not reflect the quality of that source or
web site. Please note that web sites are subject to change
without notice.
American Society of Addiction Medicine (ASAM). Talk to
an addiction’s medicine expert in your state. ASAM state
officer directory. Available at http://www.asam.org/pdf/
Web%20–%20Chapter%20Listing.pdf. Retrieved August
16, 2010.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 514
 Substance Abuse and Mental Health Services Admin-
istration. The online substance abuse treatment loca-
tor identifies treatment facilities within a set radius of
a locality. Data searches can be modified to identify
facilities for pregnant women, source of payment, and
language needs. Available at http://dasis3.samhsa.gov/.
Retrieved August 16, 2010.
References
1. U.S. Drug Enforcement Administration. Methamphetamine.
Washington, DC: DEA; 2010. Available at: http://www.
justice.gov/dea/concern/meth.html. Retrieved October 4,
2010.
2. Good MM, Solt I, Acuna JG, Rotmensch S, Kim MJ.
Methamphetamine use during pregnancy: maternal and
neonatal implications. Obstet Gynecol 2010;116:330–4.
3. Substance Abuse and Mental Health Services Adminis-
tration, Office of Applied Studies. Table 1.1A—Types
of Illicit drug use in lifetime, past year, and past month
among persons aged 12 or older: numbers in thousands,
2008 and 2009. In: Results from the 2009 National Survey
on Drug Use and Health: detailed tables. Rockville (MD):
SAMHSA; 2010. Available at: http://www.oas.samhsa.
gov/NSDUH/2k9NSDUH/tabs/Sect1peTabs1to10.pdf.
Retrieved October 4, 2010.
4. Substance Abuse and Mental Health Services Adminis-
tration, Office of Applied Studies. Drug Abuse Warning
Network, 2007: national estimates of drug-related emer-
gency department visits. Rockville (MD): SAMHSA; 2010.
Available at: https://dawninfo.samhsa.gov/files/ED2007/
DAWN2k7ED.pdf. Retrieved October 4, 2010.
5. Substance Abuse and Mental Health Services Adminis-
tration, Office of Applied Studies. Treatment Episode
Data Set (TEDS): 1996-2006. National admissions to
substance abuse treatment services, DASIS Series: S-43,
DHHS Publication No. (SMA) 08–4347. Rockville (MD):
SAMHSA; 2008. Available at: http://wwwdasis.samhsa.gov/
teds06/teds2k6aweb508.pdf. Retrieved October 4, 2010.
6. Terplan M, Smith EJ, Kozloski MJ, Pollack HA. Meth-
amphetamine use among pregnant women. Obstet Gynecol
2009;113:1285–91.
7. National Institute on Drug Abuse. Methamphetamine
abuse and addiction. NIDA Research Report Series. NIH
Publication No. 06-4210. Bethesda (MD): NIDA; 2006.
Available at: http://www.drugabuse.gov/PDF/RRMetham.
pdf. Retrieved October 4, 2010.
8. Winslow BT, Voorhees KI, Pehl KA. Methamphetamine
abuse. Am Fam Physician 2007;76:1169–74.
9. Della Grotta S, LaGasse LL, Arria AM, Derauf C, Grant P,
Smith LM, et al. Patterns of methamphetamine use dur-
ing pregnancy: results from the Infant Development,
Environment, and Lifestyle (IDEAL) Study. Matern Child
Health J 2010;14:519–27.
10. Forrester MB, Merz RD. Risk of selected birth defects
with prenatal illicit drug use, Hawaii, 1986-2002. J Toxicol
Environ Health A 2007;70:7–18.
11. Golub M, Costa L, Crofton K, Frank D, Fried P, Gladen B,
et al. NTP-CERHR Expert Panel Report on the reproduc-
tive and developmental toxicity of amphetamine and meth-
4 Committee Opinion No. 479
COMMITTEE OPINIONS
amphetamine. Birth Defects Res B Dev Reprod Toxicol
2005;74:471–584.
12. Elliott L, Loomis D, Lottritz L, Slotnick RN, Oki E, Todd R
Case-control study of a gastroschisis cluster in Nevada.
Arch Pediatr Adolesc Med 2009;163:1000–6.
13. Nora JJ, Mcnamara DG, Fraser FC. Dexamphetamine sul-
phate and human malformations Lancet 1967;289:570–1.
14. Little BB, Snell LM, Gilstrap LC 3rd. Methamphetamine
abuse during pregnancy: outcome and fetal effects. Obstet
Gynecol 1988;72:541–4.
15. Felix RJ, Chambers CD, Dick LM, Johnson KA, Jones KL.
Prospective pregnancy outcome in women exposed to
amphetamines [abstract]. Teratology 2000;61:441.
16. University of Washington. TERIS: Teratogen Information
System and the on-line version of Shepard’s Catalog of
Teratogenic Agents. Available at http://depts.washington.
edu/terisweb/teris/index.html. Retrieved November 29,
2010.
17. Eriksson M, Jonsson B, Steneroth G, Zetterstrom R. Cross-
sectional growth of children whose mothers abused amphet-
amines during pregnancy. Acta Paediatr 1994;83:612–7.
18. Smith L, Yonekura ML, Wallace T, Berman N, Kuo J,
Berkowitz C. Effects of prenatal methamphetamine expo-
sure on fetal growth and drug withdrawal symptoms in
infants born at term. J Dev Behav Pediatr 2003;24:17–23.
19. Smith LM, Lagasse LL, Derauf C, Grant P, Shah R, Arria A,
et al. Prenatal methamphetamine use and neonatal neu-
robehavioral outcome. Neurotoxicol Teratol 2008;30:20–8.
20. Smith LM, LaGasse LL, Derauf C, Grant P, Shah R, Arria A,
et al. The infant development, environment, and lifestyle
study: effects of prenatal methamphetamine exposure,
polydrug exposure, and poverty on intrauterine growth.
Pediatrics 2006;118:1149–56.
21. Oro AS, Dixon SD. Perinatal cocaine and methamphet-
amine exposure: maternal and neonatal correlates. J Pediatr
1987;111:571–8.
22. Chang L, Smith LM, LoPresti C, Yonekura ML, Kuo J,
Walot I, et al. Smaller subcortical volumes and cognitive
deficits in children with prenatal methamphetamine expo-
sure. Psychiatry Res 2004;132:95–106.
23. Lu LH, Johnson A, O’Hare ED, Bookheimer SY, Smith
LM, O’Connor MJ, et al. Effects of prenatal methamphet-
amine exposure on verbal memory revealed with functional
magnetic resonance imaging. J Dev Behav Pediatr 2009;30:
185–92.
24. Anderson PO. Drugs and breastfeeding. In: Smith KM,
Riche DM, Henyan NN, editors. Clinical drug data. 11th ed
Stamford (CT): McGraw-Hill; 2010. p. 1080–110.
25. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy
and lactation: a reference guide to fetal and neonatal risk.
8th ed. Philadelphia (PA): Lippincott Williams & Wilkins;
2008.
26. Transfer of drugs and other chemicals into human milk.
American Academy of Pediatrics Committee on Drugs.
Pediatrics 2001;108:776–89.
27. Derauf C, LaGasse LL, Smith LM, Grant P, Shah R, Arria A,
et al. Demographic and psychosocial characteristics of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 515
 mothers using methamphetamine during pregnancy: pre-
liminary results of the infant development, environment,
and lifestyle study (IDEAL). Am J Drug Alcohol Abuse
2007;33:281–9.
28. Ho E, Karimi-Tabesh L, Koren G. Characteristics of preg-
nant women who use ecstasy (3, 4-methylenedioxymeth-
amphetamine). Neurotoxicol Teratol 2001;23:561–7.
29. Arria AM, Derauf C, Lagasse LL, Grant P, Shah R, Smith L,
et al. Methamphetamine and other substance use during
pregnancy: preliminary estimates from the Infant Devel-
opment, Environment, and Lifestyle (IDEAL) study.
Matern Child Health J 2006;10:293–302.
30. At-risk drinking and illicit drug use: ethical issues in
obstetric and gynecologic practice. ACOG Committee
Opinion No. 422. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2008;112:1449–60.
31. Substance abuse reporting and pregnancy: the role of the
obstetrician-gynecologist. ACOG Committee Opinion No.
274. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;117:200–1.
32. ElSohly MA, Stanford DF, Murphy TP, Lester BM, Wright
LL, Smeriglio VL, et al. Immunoassay and GC-MS proce-
dures for the analysis of drugs of abuse in meconium. J Anal
Toxicol 1999;23:436–45.
33. Garcia-Bournissen F, Rokach B, Karaskov T, Koren G.
Methamphetamine detection in maternal and neonatal
hair: implications for fetal safety. Arch Dis Child Fetal
Neonatal Ed 2007;92:F351–5.
34. Montgomery DP, Plate CA, Jones M, Jones J, Rios R,
Lambert DK, et al. Using umbilical cord tissue to detect
Committee Opinion No. 479
COMMITTEE OPINIONS
fetal exposure to illicit drugs: a multicentered study in Utah
and New Jersey. J Perinatol 2008;28:750–3.
35. Rawson R. The matrix model. In: National Institute on
Drug Abuse. Behavioral therapies development program:
effective drug abuse treatment approaches. Bethesda (MD):
NIDA; 1998. Available at: http://archives.drugabuse.gov/
BTDP/Effective/Rawson.html. Retrieved September 27,
2010.
36. Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A,
Frazier Y, Gallagher C, et al. A multi-site comparison of
psychosocial approaches for the treatment of methamphet-
amine dependence. Methamphetamine Treatment Project
Corporate Authors. Addiction 2004;99:708–17.
37. Roll JM, Petry NM, Stitzer ML, Brecht ML, Peirce JM,
McCann MJ, et al. Contingency management for the treat-
ment of methamphetamine use disorders. Am J Psychiatry
2006;163:1993–9.
Copyright March 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Methamphetamine abuse in women of reproductive age. Committee
Opinion No. 479. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2011;117:751–5.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 516
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 491 • May 2011 (Replaces No. 391, December 2007)
Committee on Health Care for Underserved Women
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The infor-
mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Health Literacy
ABSTRACT: According to the Institute of Medicine of the National Academies, health literacy is defined as
the degree to which individuals have the capacity to obtain, process, and understand basic health information and
services needed to make appropriate health decisions. The American College of Obstetricians and Gynecologists
is committed to the promotion of health literacy for all. Responsibility for recognizing and addressing the problem
of limited health literacy lies with all entities in the health care profession.

Each day, patients encounter the challenges of interpret-
ing health information presented by health care providers
and making decisions based on their understanding of
that information. According to the Institute of Medicine
of the National Academies’ report, Health Literacy, nearly
one half of all Americans have difficulty understanding
health information (1). Engaging patients in difficult
health care decisions requires that patients listen, under-
stand, read, and analyze information about their health;
in essence, patients are expected to be health literate.
Health literacy is defined as the degree to which individu-
als have the capacity to obtain, process, and understand
basic health information and services needed to make
appropriate health decisions, and to use such informa-
tion and services in ways that are health enhancing (1,
2). Because situations regarding an individual’s health
are often complex and the language used to explain them
is often specialized, years of education or reading ability
do not necessarily translate into adequate health literacy.
Health care professionals often use technical language
specific to their areas of expertise with the expectation
that people who are not familiar with the professional
jargon will understand the meaning of complex ideas and
terms. Even individuals highly trained in other fields may
have difficulty understanding health information and
instructions about their care.
The problem of limited health literacy is widespread.
Whereas approximately 10% of Americans have low
general literacy (skills necessary to perform simple and
everyday literacy activities), 50% of adults are estimated
to have marginal health literacy skills to low health lit-
eracy skills (3, 4). Multiple studies have demonstrated the
seriousness of the problem. Adults with low health lit-
eracy are at increased risk of hospitalization, encounter
more barriers to receiving necessary health care services,
and are less likely to understand medical advice that can
affect their disease progression (5–8). Given the scope of
the problem, the U.S. Department of Health and Human
Services identified several target areas in the Healthy
People 2010 objectives to improve health communica-
tion, which incorporated goals related to health literacy
and cultural competency (9). These target areas also are
included in the goals and objectives for Healthy People
2020.
Our current health care delivery system assumes a
high level of health literacy. Individuals are expected to
understand and apply verbal information pertaining to
consent, diagnosis, medical advice, and treatment; have
access to and use a computer and the Internet; calculate
and interpret numerical data; and interpret graphs and
visual information. Patients are expected to be articulate
and accurate about their conditions and symptoms, as
well as to have sophisticated decision-making skills. Often
those individuals with the greatest health care needs have
limited skills to synthesize and interpret health informa-
tion (10).
Patients with specific educational or linguistic chal-
lenges also may have limited health literacy. Nonadherence
to therapeutic and medication recommendations, often
pejoratively labeled “noncompliance,” can lead to poor
outcomes and may be more related to limited health
literacy than to patients’ indifference toward their health.
It may be that nonadherent patients are not following
recommendations because they do not understand what

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 517

 is expected of them. This is often the case with older
patients and those with limited English proficiency or
no English proficiency. In the United States, people
65 years and older consume 30% of prescriptions and
40% of over-the-counter drugs (11). Senior citizens
often have low health literacy skills and, therefore, poor
comprehension of information on medication labels
(3, 12). Low health literacy also may be a problem for
immigrant populations for whom English is a second
language (13). According to a project conducted by the
American College of Obstetricians and Gynecologists,
which focused on language access solutions in California,
25% of Fellows reported that one quarter of their patients
have limited English proficiency and 38% reported an
increase in patients with limited English proficiency dur-
ing the past 5 years (14).
When the concept of health literacy is taken into
consideration, all facets of the medical encounter, includ-
ing patient education and the informed consent process,
are important to improving the patient’s and the public’s
health. Individuals with low health literacy are vulnerable
to receiving poor-quality care and to being exposed to
medical errors because of communication barriers (15).
Patient health literacy includes the ability to understand
instructions on prescription drug bottles, appointment
slips, patient education brochures, and consent forms,
as well as the ability to negotiate complex health care
systems.
Multiple factors affect a patient’s understanding
of health information, including the physician’s health
knowledge and communication skills, the demands of
the situation in which the health information is being
conveyed, and time constraints for delivering the infor-
mation. Other factors include the patient’s ability to
communicate effectively with the health care team, to
manage and commit to her own health care, and to com-
prehend complex concepts such as probability and risk.
Understanding the unique capabilities of the individual
patient will make the information provided by the health
care team more accessible for both the patient and her
family members. When patients can obtain, process, and
understand basic health information, they are more likely
to make the most appropriate health decisions.
Responsibility for recognizing and addressing the
problem of limited health literacy lies with all entities in
the health care profession, from the primary health care
team to public health care systems. Making information
understandable and accessible to all patients involves a
systematic approach toward health literacy in physicians’
offices, hospitals, clinics, national organizations, local
health organizations, advocacy organizations, medical
and allied health professional schools, residency training
programs, and continuing medical education programs.
Because nursing and support staff are often the ones
identifying the level of health literacy among patients,
it is extremely important to also provide them with the
appropriate training and resources so they can help
2 Committee Opinion No. 491
COMMITTEE OPINIONS
navigate these patients through the health care system.
Community-based partnerships to help understand and
address the needs of the local community and consumer
health information organizations to focus on the issue of
health literacy are needed in the effort to improve health
literacy.
The American College of Obstetricians and Gyne-
cologists supports the following guidelines (adapted from
the U.S. Department of Health and Human Services’
Office of Disease Prevention and Health Promotion’s
Quick Guide to Health Literacy [16]):
1. Tailor speaking and listening skills to individual
patients.
• Ask open-ended questions using the words “what”
or “how” to start the sentence. (For example:
“What questions do you have for me?” rather than
“Do you have any questions?”)
• Use medically trained interpreters, when neces-
sary.
• Check for comprehension by asking patients to
restate the health information given in their own
words. (For example: “Tell me how you are going
to take this medication.”) This is particularly use-
ful during the informed consent process (15).
• Encourage staff and colleagues to use plain lan-
guage that is culturally sensitive and to obtain
training in improving communication with
patients (17). (For more information please refer
to the American College of Obstetricians and
Gynecologists’ Committee Opinion on “Effective
Patient–Physician Communication” [18]).
2. Tailor health information to the intended user.
• When developing health information, make sure
it reflects the target group’s age, social and cultural
diversity, language, and literacy skills.
• When developing information and services,
include the target group in the development (pre-
test) and implementation (posttest) phases of the
process to ensure the program is effective.
• In preparing health information, consider cul-
tural factors and the influence of culture on health,
including race, ethnicity, language, nationality,
religion, age, gender, sexual orientation, income
level, and occupation (17).
3. Develop written materials.
• Keep the messages simple.
• Limit the number of messages (general guideline is
four main messages).
• Focus on action. Give specific recommendations
based on behavior rather than the medical prin-
ciple. (For example, “Take a warm water bath
2013 COMPENDIUM OF SELECTED PUBLICATIONS 518
 two times a day” instead of “Sitz baths may help
healing.”)
• Use the active voice instead of the passive voice.
(For example, “These pills can make you sick to
your stomach” instead of “Nausea may be caused
by this medication.”)
• Use familiar language and avoid jargon. (For PDF/2006470.PDF. Retrieved November 5, 2010.
example, “You may have itching” instead of “You
may experience pruritus on your genitalia.”)
• Use visual aids such as drawings or models for key literacy. J Gen Intern Med 2005;20:175–84.
points. Make sure the visual messages are cultur-
ally relevant.
• Use at least a 12-point type size to make the mes-
sages easy to read.
• Leave plenty of white space around margins and among patients at two public hospitals. JAMA 1995;274:
between sections.
ACOG Resource
The following online resource may be helpful to physi-
cians in finding resources for patients:
American College of Obstetricians and Gynecologists
www.acog.org/goto/patients
Resources
The resources listed here are for information purposes
only. Referral to these resources and web sites does
not imply the endorsement of the American College of
Obstetricians and Gynecologists. Further, the American
College of Obstetricians and Gynecologists does not
endorse any commercial products that may be advertised
or available from these organizations or on these web
sites. This list is not meant to be comprehensive. The
exclusion of a source or web site does not reflect the qual-
ity of that source or web site. Please note that web sites
and URLs are subject to change without notice.
American Academy of Family Physicians
http://www.familydoctor.org
National Center for Farmworker Health, Inc.
http://www.ncfh.org/?sid=40
Oregon Health and Science University: Low-literacy
handouts in English
http://www.ohsu.edu/library/patiented/links.shtml#lowlit
U.S. Department of Health and Human Services, Office
on Women’s Health: Womenshealth.gov in Spanish
http://www.womenshealth.gov/espanol
University of Washington, Harborview Medical Center:
Ethnomed
http://ethnomed.org
References
1. Institute of Medicine (US). Health literacy: a prescription
to end confusion. Washington, DC: National Academies
Press; 2004.
Committee Opinion No. 491
COMMITTEE OPINIONS
2. Joint Committee on National Health Education Standards.
National Health Education Standards: achieving excellence.
2nd ed. Atlanta (GA): American Cancer Society; 2007.
3. National Center for Education Statistics. National
Assessment of Adult Literacy (NAAL): a first look at the lit-
eracy of America’s adults in the 21st century. Washington,
DC: NCES; 2005. Available at: http://nces.ed.gov/NAAL/
4. Paasche-Orlow MK, Parker RM, Gazmararian JA, Nielsen-
Bohlman LT, Rudd RR. The prevalence of limited health
5. Baker DW, Parker RM, Williams MV, Clark WS. Health
literacy and the risk of hospital admission. J Gen Intern
Med 1998;13:791– 8.
6. Williams MV, Parker RM, Baker DW, Parikh NS, Pitkin K,
Coates WC, et al. Inadequate functional health literacy
1677–82.
7. Williams MV, Baker DW, Parker RM, Nurss JR. Relationship
of functional health literacy to patients’ knowledge of their
chronic disease. A study of patients with hypertension and
diabetes. Arch Intern Med 1998;158:166–72.
8. Gazmararian JA, Baker DW, Williams MV, Parker RM,
Scott TL, Green DC, et al. Health literacy among Medicare
enrollees in a managed care organization. JAMA 1999;281:
545–51.
9. U.S. Department of Health and Human Services. Health
communication. In: Healthy People 2010. 2nd ed. With
understanding and improving health and objectives for
improving health. Washington, DC: U.S. Government
Printing Office; 2000. p. 11-3–11-25. Available at http://
www.healthypeople.gov/Document/pdf/Volume1/
11HealthCom.pdf. Retrieved January 25, 2011.
10. Parker RM, Gazmararian JA. Health literacy: essential for
health communication. J Health Commun 2003;8 Suppl
1:116–8.
11. Salom IL, Davis K. Prescribing for older patients: how to
avoid toxic drug reactions. Geriatrics 1995;50:37, 40, 43;
discussion 44–5.
12. Morrell RW, Park DC, Poon LW. Effects of labeling
techniques on memory and comprehension of prescrip-
tion information in young and old adults. J Gerontol
1990;45:P166–72.
13. Guerra CE, Krumholz M, Shea JA. Literacy and knowledge,
attitudes and behavior about mammography in Latinas. J
Health Care Poor Underserved 2005;16:152–66.
14. American College of Obstetricians and Gynecologists.
Strengthening communication capacity: California’s OB/
GYNs enhance language access for limited English profi-
cient patients. Sacramento (CA): ACOG District IX; 2006.
Available at: http://www.acog.org/acog_districts/dist9/2006
LanguageAccessSolutionsReport.pdf. Retrieved January 25,
2011.
15. National Quality Forum. Improving patient safety through
informed consent for patients with limited health literacy:
an implementation report. Washington, DC: NQF; 2005.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 519
 Available at: http://www.qualityforum.org/WorkArea/linkit.
aspx?LinkIdentifier=id&ItemID=22090. Retrieved January
25, 2011.
16. U.S. Department of Health and Human Services. Quick
guide to health literacy. Washington, DC: HHS; 2006. Avail-
able at: http://www.health.gov/communication/literacy/
quickguide/Quickguide.pdf. Retrieved January 25, 2011.
17. Cultural sensitivity and awareness in the delivery of health
care. Committee Opinion No. 493. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;
117:1258–61.
18. Effective patient–physician communication. Committee
Opinion No. 492. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011:117:1254–7.
4 Committee Opinion No. 491
COMMITTEE OPINIONS
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health literacy. Committee Opinion No. 491. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;117:1250–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 520
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 492 • May 2011
Committee on Health Care for Underserved Women
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The infor-
mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Effective Patient–Physician Communication

ABSTRACT: Perhaps the greatest contemporary challenge in implementing the principles of effective com-
munication lies in our current health care environment that demands increasing physician productivity and less
time with each patient. Effective patient–physician communication with the use of patient-centered interviewing,
caring communication skills, and shared decision making will help. The use of physician extenders and, in select
situations, e-mail communication with established patients also can be beneficial.

In medicine, the ability to compassionately communicate
information in a fashion that can be understood and
considered by the patient is key to an effective patient–
physician relationship. The Accreditation Council for
Graduate Medical Education identified interpersonal
and communication skills as one of six areas in which
physicians need to demonstrate competence (1). In
this Committee Opinion, interviewing techniques and
communication skills are emphasized that will help the
obstetrician–gynecologist to effectively elicit patient prob-
lems and communicate reasonable treatment plans in a
busy office practice.
The benefits of skilled, successful communication in
medicine are many. A physician who encourages open
communication often will obtain more complete infor-
mation, which enables a more accurate diagnosis and
appropriate counseling. This, in turn, leads to improved
patient adherence and enhancement of long-term health.
This model of patient–physician communication, often
termed the “partnership model,” increases patient involve-
ment in care through negotiation and consensus building
between the patient and physician (2, 3). In the partner-
ship model of communication, physicians use a par-
ticipatory style of conversation (3), where the amount of
time spent talking by physicians compared with patients
is fairly equal. The partnership model is one of several
communication models shown to improve patient care
and reduce the likelihood of litigation. Other models
cited in educational materials of the American College
of Obstetricians and Gynecologists include the GATHER
(4) and RESPECT (5) models. The GATHER model,
which is composed of six elements of counseling (1] greet,
2] ask, 3] tell, 4] help, 5] explain, and 6] return), is used to
help physicians maximize communication as well as con-
fidentiality. Advocated widely for use in communicating
with adolescents and in family planning discussions, the
GATHER model encourages physicians to greet patients
in a friendly and respectful manner and to provide a sum-
mary of what will occur during the visit. It also encourages
physicians to actively listen and help patients discuss their
concerns without judgment, tell patients about all of their
choices for treatment, explain the next steps in treatment,
and arrange a return visit for follow-up. The RESPECT
model includes seven core principles (1] rapport,
2] empathy, 3] support, 4] partnership, 5] explanations,
6] cultural competence, and 7] trust) to allow patients to
speak freely and physicians to tailor treatment plans to an
individual’s norms and beliefs. The RESPECT model has
been widely used to promote physician awareness of their
own cultural biases and to develop the rapport necessary
to assist patients from different cultural backgrounds.
Culture and Gender in Patient
Communication
Regardless of any discordance that may exist between a
patient’s and practitioner’s backgrounds, cultural beliefs,
or sexual orientation, increased sensitivity by a health care
provider to the patient’s behaviors, feelings, and attitudes
can increase patient and health care provider satisfaction.
Two seminal studies have documented differences in how
race and gender can affect care. Cooper and colleagues (6)
found that African American patients were substantially
less likely to report having equal speaking time (ie, partic-
ipatory decision making) compared with white patients.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 521

 Schulman and colleagues (7) reported gender and racial
differences in how physicians communicated about car-
diac catheterization. The Institute of Medicine issued a
report detailing the importance of patient-centered care
and cross-cultural communication as a means of improv-
ing health care quality across patient groups (8).
Developing Effective Communication
Developing effective patient–physician communication
requires that physicians are skilled in the conduct of
patient-centered interviewing, able to converse in a car-
ing, communicative fashion, and have the capability to
engage in shared decision making with their patients (9).
Physicians may wish to consider five steps for effective
patient-centered interviewing. A brief description of each
step and the actions to be taken to effectively accomplish
patient-centered interviewing are presented in Table 1 (10).
The following four qualities are important components
of caring communication skills: 1) comfort, 2) accep-
tance, 3) responsiveness, and 4) empathy (11). Comfort
and acceptance refer to the physician’s ability to deal
with difficult topics without displaying uneasiness and
accepting the attitudes a patient brings to the interview
without showing irritation or intolerance. Responsiveness
and empathy refer to the quality of reacting to indirect
messages expressed by a patient. Using this system, the
physician can gain an understanding of the patient’s
point of view and incorporate it into treatment (12).
Table 1. The Five Steps for Patient-Centered Interviewing
Steps Description
1 Set the stage for the interview
2 Elicit the chief problem and set an agenda
for the visit
3 Open the history of the present illness
(nonfocused portion of the interview)
4 Continue the patient-centered history of
present illness (focused portion of the interview)
5 Transition to the physician-centered process
(medical-centered process)
Data from Smith RC. Patient-centered interviewing: an evidence based method. 2nd ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2002.
2 Committee Opinion No. 492
COMMITTEE OPINIONS
The following scenarios and responses represent clinical
situations where these qualities can be applied.
• Scenario 1: An adolescent girl, accompanied by her
mother, comes to you to discuss birth control op-
tions. During the discussion, the mother continues
to express disagreement with her daughter’s decision
to become sexually active and proceeds to the door in
order to leave the examination room.
Effective response: You ask the mother to remain in
the room briefly so that you can explain to her and
her daughter what will take place during this visit.
After obtaining a general history from both mother
and daughter, the physician requests that the mother
allow private time for discussion with her daugh-
ter. Later, a member of the office staff escorts the
mother back to the examination room. The physician
encourages open communication between the moth-
er and daughter and answers any further questions.
• Scenario 2: A physician enters the examination room
and greets a long-term patient, noticing that she
appears tearful. On further questioning, she states,
“I’m just having a bad day.” The physician completes
the routine history and examination without further
discussion of her affect.
Effective response: The physician shakes the patient’s
hand, stating, “I’m sorry you’re having a hard time.
Actions to Ensure Patient-Centered Interaction
Welcome the patient and introduce yourself
Ensure patient readiness and privacy
Remove communication barriers
Ensure patient comfort and put patient at ease
Indicate time available
Obtain a list of all issues the patient wants to discuss
Summarize and finalize the agenda; negotiate
specifics if there are too many items
Ask open-ended questions using attentive listening,
including silence and nonverbal encouragement, to
elicit problems
Use focused, yet open-ended questions to obtain a
description of the physical symptoms, and explore
the emotional context of the personal and physical
symptom information
Summarize conversation and confirm accuracy of
information
Inform the patient that the style of questioning will
now change (eg, “I am going to ask you several
specific medical questions about your symptoms”)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 522
 Perhaps it will help to talk about it.” The physician is
then able to detect signs of depression and to offer or
refer her for treatment.
Shared decision making has been defined as a process
where both patients and physicians share information,
express treatment preferences, and agree on a treatment
plan (13). The process is applicable when there are two
or more reasonable medical options (14). The physi-
cian shares with the patient all relevant risk and benefit
information on all reasonable treatment alternatives and
the patient shares with the physician all relevant personal
information that might make one treatment or side effect
more or less tolerable than others (15). This relatively
new paradigm of communication is a marked departure
from the traditional doctor-centered model. A recent
example of a national recommendation that emphasizes
shared decision making, which also garnered much public
attention, is the National Institutes of Health Consensus
Panel on vaginal birth after cesarean delivery (16). The
Consensus Panel recommended that the decision for
vaginal birth after cesarean delivery or repeat cesarean
delivery should occur only after a conversation between
the patient and her physician, incorporating the risks and
benefits and the patient’s preferences. Shared decision
making can increase both patient engagement and reduce
risk with resultant improved outcomes, satisfaction, and
treatment adherence (17).
Recommendations for the
Obstetrician–Gynecologist
The competing demands of clinical productivity (18),
mounting paperwork, and the delivery of care to mul-
tiple patients, often with complex diagnoses (19, 20),
can inhibit effective communication. Developing effec-
tive patient–physician communication skills requires a
substantial commitment in an increasingly challenging
environment with lower clinical reimbursements and
higher expenses. In the long run, effective communica-
tion skills will save time by increasing patient adherence,
thereby reducing the need for follow-up calls and visits.
The obstetrician–gynecologist can take the following steps
to improve communication:
• Use patient-centered interviewing and caring com-
munication skills in daily practice.
• Encourage patients to write down their questions in ing patient-centered care. San Francisco (CA): Jossey-
preparation for appointments. An organized list of
questions can help to facilitate an effective conversa-
tion on topics important to the patient.
• If possible, hire a communications consultant to con-
duct a workshop on cultural and gender sensitivity
for you and your office staff.
• Hire physician extenders with patient-centered inter-
viewing skills to assist with established patients.
• E-mail has been slowly integrated into some sion of information and patient effects. Md State Med J
medical practices. If possible, consider the use
Committee Opinion No. 492
COMMITTEE OPINIONS
of e-mail as an alternative method for estab-
lished patients to communicate with their physi-
cians or nurses for follow-up questions (21, 22).
E-mail should be used in accordance with the Ameri-
can Medical Association Guidelines for Physician–
Patient Electronic Communications (http://www.
ama-assn.org/ama/pub/about-ama/our-people/
member-groups-sections/young-physicians-section/
advocacy-resources/guidelines-physician-patient-
electronic-communications.shtml).
• Advocate for sustainable practice models that allow
for visits of sufficient duration to provide an oppor-
tunity to address multiple patient concerns.
ACOG Resources
Cultural sensitivity and awareness in the delivery of
health care. Committee Opinion No. 493. American Col-
lege of Obstetricians and Gynecologists. Obstet Gynecol
2011;117:1258–61.
Health literacy. Committee Opinion No. 491. American
College of Obstetricians and Gynecologists. Obstet Gyne-
col 2011;117:1250–3.
Partnering with patients to improve safety. Committee
Opinion No. 490. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1247–9.
Other Resources
The resources listed are for information purposes only.
Referral to these resources and web sites does not imply
the endorsement of the American College of Obstetricians
and Gynecologists. This list is not meant to be compre-
hensive. The exclusion of a source or web site does not
reflect the quality of that source or web site. Please note
that web sites and URLs are subject to change without
notice.
Institute for Healthcare Communication
http://www.healthcarecomm.org
Massachusetts General Hospital, Disparities
Solutions Center
http://www2.massgeneral.org/disparitiessolutions
Walker JD. Enhancing physical comfort. In: Gerteis M,
Edgman-Levitan S, Daley J and Delblanco TL, editors.
Through the patient’s eyes: understanding and promot-
Bass; 1993. p. 119–53.
References
1. Accreditation Council for Graduate Medical Education.
Common program requirements: general competencies.
Chicago (IL): ACGME; 2007. Available at: http://www.acgme.
org/outcome/comp/GeneralCompetenciesStandards21307.
pdf. Retrieved January 18, 2011.
2. Roter DL. Physician/patient communication: transmis-
1983;32:260–5.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 523
 3. Roter DL. Patient question asking in physician-patient
interaction. Health Psychol 1984;3:395–409.
4. American College of Obstetricians and Gynecologists.
Talking with teens. In: Tool kit for teen care. 2nd ed.
Washington, DC: ACOG; 2009.
5. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual. 3rd
ed. Washington, DC: ACOG; 2007.
6. Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR,
Nelson C, et al. Race, gender, and partnership in the
patient-physician relationship. JAMA 1999;282:583–9.
7. Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S,
Gersh BJ, et al. The effect of race and sex on physicians’
recommendations for cardiac catheterization [published
erratum appears in N Engl J Med 1999;340:1130]. N Engl J
Med 1999;340:618–26.
8. Institute of Medicine (US). Unequal treatment: confront-
ing racial and ethnic disparities in health care. Washington,
DC: National Academies Press; 2003.
9. Simpson M, Buckman R, Stewart M, Maguire P, Lipkin M,
Novack D, et al. Doctor-patient communication: the
Toronto consensus statement. BMJ 1991;303:1385–7.
10. Smith RC. Patient-centered interviewing: an evidence based
method. 2nd ed. Philadelphia (PA): Lippincott Williams &
Wilkins; 2002.
11. Myerscough PR, Ford MJ. Talking with patients: keys to
good communication. 3rd ed. New York (NY): Oxford
University Press; 1996.
12. Suchman AL, Markakis K, Beckman HB, Frankel R. A
model of empathic communication in the medical inter-
view. JAMA 1997;277:678–82.
13. Peek ME, Wilson SC, Gorawara-Bhat R, Odoms-Young A,
Quinn MT, Chin MH. Barriers and facilitators to shared
decision-making among African-Americans with diabetes.
J Gen Intern Med 2009;24:1135–9.
14. Whitney SN, McGuire AL, McCullough LB. A typology
of shared decision making, informed consent, and simple
consent. Ann Intern Med 2004;140:5–9.
4 Committee Opinion No. 492
COMMITTEE OPINIONS
15. Kaplan RM. Shared medical decision making. A new tool
for preventive medicine. Am J Prev Med 2004;26:81–3.
16. National Institutes of Health Consensus Development
conference statement: vaginal birth after cesarean: new
insights March 8-10, 2010. National Institutes of Health
Consensus Development Conference Panel. Obstet Gynecol
2010;115:1279–95.
17. de Haes H. Dilemmas in patient centeredness and shared
decision making: a case for vulnerability. Patient Educ
Couns 2006;62:291–8.
18. Mechanic D, McAlpine DD, Rosenthal M. Are patients’
office visits with physicians getting shorter? N Engl J Med
2001;344:198–204.
19. Nutting PA, Rost K, Smith J, Werner JJ, Elliot C. Competing
demands from physical problems: effect on initiating and
completing depression care over 6 months. Arch Fam Med
2000;9:1059–64.
20. Haas LJ, Leiser JP, Magill MK, Sanyer ON. Management of
the difficult patient. Am Fam Physician 2005;72:2063–8.
21. Ye J, Rust G, Fry-Johnson Y, Strothers H. E-mail in patient-
provider communication: a systematic review. Patient Educ
Couns 2010;80:266–73.
22. Neill RA, Mainous AG 3rd, Clark JR, Hagen MD. The util-
ity of electronic mail as a medium for patient-physician
communication. Arch Fam Med 1994;3:268–71.
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Effective patient–physician communication. Committee Opinion No.
492. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;117:1254–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 524
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 493 • May 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Cultural Sensitivity and Awareness in the Delivery of

Health Care
ABSTRACT: Communication with patients can be improved and patient care enhanced if health care provid-
ers can bridge the divide between the culture of medicine and the beliefs and practices that make up patients’
value systems. These may be based on ethnic heritage, nationality of family origin, age, religion, sexual orientation,
disability, or socioeconomic status. Every health care encounter provides an opportunity to have a positive effect
on patient health. Health care providers can maximize this potential by learning more about patients’ cultures.

Obstetrician–gynecologists often come upon cul-
tural issues in all aspects of their care, including the
labor suite, office, and during preoperative encoun-
ters. Understanding the cultural context of a particular
patient’s health-related behavior can improve patient
communication and care (1). This Committee Opinion
contains several clinical vignettes pertinent to the obste-
trician–gynecologist, but many other situations can be
encountered in daily practice. When an individual’s cul-
ture is at odds with that of the prevailing medical estab-
lishment, the patient’s culture generally will prevail, often
straining physician–patient relationships. Physicians can
minimize such situations by increasing their understand-
ing and awareness of the cultures they serve or by being
open minded and educating themselves regarding those
that they do not know.
Culture is defined as the dynamic and multidimen-
sional context of many aspects of the life of an individual
(2). It includes gender, faith, sexual orientation, profes-
sion, tastes, age, socioeconomic status, disability, ethnic-
ity, and race. Cultural competency, or cultural awareness
and sensitivity, is defined as, “the knowledge and interper-
sonal skills that allow providers to understand, appreciate,
and work with individuals from cultures other than their
own. It involves an awareness and acceptance of cultural
differences, self awareness, knowledge of a patient’s cul-
ture, and adaptation of skills” (3).
Many cultural groups, including gay and lesbian
individuals; individuals with disabilities; individuals with
faiths unfamiliar to a practitioner; lower socioeconomic
groups; ethnic minorities, such as African Americans and
Hispanics; and immigrant groups receive no medical care
or are grossly underserved for multiple reasons. Lack of
cultural competence of health care providers is one of the
reasons these groups receive inadequate medical care.
Changing Demographics
For centuries, the United States has incorporated diverse
immigrant and cultural groups and continues to attract
people from around the globe. From 2000 to 2009,
there was a 32% increase in the Asian population, a
37% increase in individuals of Hispanic origin, an 18%
increase in American Indians and Alaskan Natives, and
a 13% increase in the African American population. The
white non-Hispanic population increased by only 2%. In
2009, non-Hispanic whites represented 65.1%, Hispanics
(of any race) represented 15.8%; African Americans rep-
resented 13.6%; Asians represented 4.6%; and American
Indians, Alaskan Natives, Native Hawaiians, and other
Pacific Islanders represented 1.2% of the total 307 million
inhabitants of the United States (4). Currently, however,
minorities outnumber whites in some communities in the
United States.
Selected Examples in Clinical Practice
The cases in Table 1 are intended to highlight the impor-
tance of cultural sensitivity in clinical practice. Although
these examples represent dramatic situations, the tradi-
tional approach can fail to gather the most crucial infor-
mation for providing appropriate medical care. These
examples are clearly not all encompassing, but can serve
as useful teaching tools for those in practice as well as
medical students and ob-gyn residents who may not be
aware of these issues.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 525

 Table 1. Cultural Sensitivity in Practice
Original Scenario—Insurance
An Amish woman undergoes a cesarean delivery. After surgery,
the woman and her husband are interviewed by a social worker
who was called by a nurse to see the couple because they had no
health insurance. The social worker immediately begins to tell them
how to enroll in Medicaid. They are visibly upset and will no longer
talk to the social worker. They refuse to complete any paperwork
for Medicaid. They ask to leave the hospital as soon as possible.
Original Scenario—Respect*
A 30-year-old physician enters the examination room to see his
next patient who is a 50-year-old African American woman; he
introduces himself, addresses her by her first name, and asks why
she has come to the office today. The patient becomes visually
upset and gets up to leave. She tells the office staff as she leaves
that she will never return to that doctor.
Original Scenario—Informed Consent and Medical
Decision Making*
A 17-year-old Hispanic woman has an arrest of labor for several
hours and it is decided that a cesarean delivery needs to be per-
formed. Labor and delivery is extremely busy, and a nurse brings
in the standard surgical consent form, hands the patient a pen,
and insists that the patient sign it. She and her family are clearly
uncomfortable.
Original Scenario––Concerns Over Medical Tests*
An elderly Chinese woman is asked by her physician to go to the
laboratory to have blood drawn for tests. She takes the laboratory
slip but does not get the tests, nor does she return to see that
physician.
Original Scenario—Sexual Orientation*
A lesbian sees a gynecologist for the first time. The patient has
marked “sexually active” and “not married” on the intake form,
and the physician asks what type of birth control she is using.
The patient shrugs, and the physician spends several minutes
discussing available options. She is sensitive to her needs but
keeps insisting that she consider using birth control. As the woman
leaves the office, she is upset and refuses to see this gynecologist
again.
*Modified with permission from Leppert, PC. Cultural competency. In: Leppert PC, Howard FM, editors. Primary care for women.
Philadelphia (PA): Lippincott-Raven; 1997p. 939–42. Copyright Lippincott Williams & Wilkins (http://lww.com).
2 Committee Opinion No. 493
COMMITTEE OPINIONS
Culturally Sensitive Approach
The social worker is called by a nurse because the couple does not
have health insurance. The social worker is aware that this is an
Amish couple and knows that generally Amish people do not believe
in or accept what they consider to be welfare. When the social
worker meets with the couple, she confirms that they are not seeking
assistance in acquiring health insurance; she helps them plan trans-
portation home, and she assists them in reaching other members of
their Amish community who, by tradition, provide financial and other
assistance to their own people.
Culturally Sensitive Approach
The clinician is aware that addressing patients by their first names
may be perceived as disrespectful, especially for certain minority
groups. Every patient can be asked an open-ended question about
how she would like to be addressed (Miss, Ms., Mrs., Dr., Professor)
by the health care provider. The name by which she wishes to be
addressed may vary by many factors, including whether the patient
resides in a rural or urban setting, whether she knows the health
care provider or is a stranger, and what her age is. The patient in this
example should be addressed by all members of the health care team
by her preferred mode of address. This preference can be noted in the
medical record to remind everyone how she wishes to be addressed.
Culturally Sensitive Approach
The nurse realizes that there are many members of the family crowd-
ed in the patient’s room and also understands that for many women
of Hispanic heritage, it is customary to involve family members in
medical and personal decisions. The nurse and resident caring for the
patient explain to the entire family the reason that a cesarean deliv-
ery is needed and the family understands. The patient is then asked
to sign the surgical consent form.
Culturally Sensitive Approach
The primary care physician orders laboratory tests on his patient, but
notes the woman’s hesitation and asks her why she is worried. She
tells the physician that she believes that blood taken from her body
will never be replenished and she is weak already. The physician
spends time explaining how blood is replaced and the importance of
the tests. The patient has the blood tests as the physician requested.
Culturally Sensitive Approach
The physician uses intake forms that do not assume heterosexuality.
The form asks if the patient is sexually active and then asks with
men, women, or both. The form asks if the patient is single or has a
partner. The physician takes her time in asking about the patient’s
sexual history, and takes time to assure confidentiality because
many patients will not disclose sexual behaviors, especially on forms
that can be viewed by the entire office staff. The physician then
learns that the patient is in a lesbian, long-term, committed relation-
ship, and currently has no need for birth control.
(continued)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 526
 Table 1. Cultural Sensitivity in Practice (continued)
Original Scenario—Interpretive Services*
A couple has newly arrived in the United States from Afghanistan.
The wife is uncomfortable. They do not speak English well, so an
interpreter is found. The interpreter appears to be having difficulty
interpreting the woman’s symptoms; the history that is obtained
is nonspecific. The physician cannot find any abnormalities on
physical examination and discharges the patient home. Later, she
returns with a ruptured ectopic pregnancy and is immediately
admitted to the operating room.
Original Scenario—Social Context*
A young white woman has recently moved to the city from a rural
area. She is 4 months pregnant and has four children, whom she
brings with her to her prenatal visits. She is always an hour late
for her appointments and the office policy is that she must wait
until everyone else is seen before she is seen. She refuses to fill
out her medical history forms and states that she requested her
previous records to be transferred. Her children are impatient in
the waiting room. The office staff members complain about this
situation and make disparaging comments on days when she is
scheduled for a visit.
Original Scenario––Birth Rituals
A Chinese couple experiences the birth of their first child. The
nurse on the postpartum floor is alarmed to find the room very
hot and the couple refuses to have the baby bathed. The mother
refuses to eat any hospital food or bathe. In addition, the nurse
complains to the physician that the body odor is overwhelming in
the patient’s room.
Original Scenario––Faith
A Latina presents for the fifth time to labor and delivery for hyper-
emesis gravidarum. Her English is limited. She is 14 weeks preg-
nant and through an ad hoc interpreter (her son) reports that she
cannot stop vomiting and that the medicines are not working. The
patient is admitted for routine hyperemesis treatment and vomits
little. She is discharged home after 24 hours only to return again
the next day with the same symptoms. The residents and staff
members are frustrated and label her as a “frequent flyer.”
*Modified with permission from Leppert, PC. Cultural competency. In: Leppert PC, Howard FM, editors. Primary care for women. Philadelphia (PA): Lippincott-Raven; 1997.
p. 939–42. Copyright Lippincott Williams & Wilkins (http://lww.com).
Committee Opinion No. 493
COMMITTEE OPINIONS
Culturally Sensitive Approach
The physician notices that the interpreter is not able to communicate
well with the couple. He asks the interpreter why the history is so
difficult to obtain. It takes a few moments to discover that the couple
speaks Dari and the interpreter speaks Pashto. The physician seeks
an appropriate interpreter and finds the patient has mild pelvic pain
and vaginal bleeding; a pelvic ultrasound reveals an unruptured
ectopic pregnancy that is treated appropriately.
Culturally Sensitive Approach
When the patient is an hour late for her first appointment, a staff
member takes some time to inquire about why she is so late. She
explains that she is new to the city, has no reliable transportation,
and she has to take two buses to get to the clinic. She explains her
living situation and that she has no one to watch her children. She
also reveals that she is unable to read. A peer counselor arranges
for help with learning the bus route and planning her trips. She also
is referred to a literacy program for help. One of her first triumphs is
learning to recognize the signs on the buses. Over the course of her
pregnancy, she learns to read the bus route map and schedule.
Culturally Sensitive Approach
The physician ensures that all personnel involved during the birth
and postpartum time understand that many Chinese people believe
that cold liquids and baths will harm the mother and baby. Special
foods are believed to be of paramount importance for the proper cul-
tural initiation of the baby and mother.
Culturally Sensitive Approach
The staff member and resident obtain the assistance of a certified
interpreter to interview the patient on her fifth admission to the hos-
pital. During this interview, the staff member asks if there is anything
happening at home that might be contributing to her illness, such as
lack of food, inability to purchase the nausea medicines, or lack of
social support. The staff member also asks what the patient thinks
is making her ill. The patient then relates that her neighbor has told
the patient she has cursed her and her pregnancy. This is why the
patient says she is vomiting. She says she gets better in the hospi-
tal because she is away from the neighbor. When asked if there is
anything she believes can be done, the patient states that a Spiritual
Healer could lift the curse. After such a healer is located in a nearby
community and performs the ritual, the patient’s vomiting ceases.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 527
 Suggestions for Coping With Cultural
Issues in the Office
As can be seen from the preceding examples, not all
cultural competency issues relate to foreign languages
or cultures. Cultural competency encompasses gender,
sexual orientation, socioeconomic status, faith, profes-
sion, tastes, disability, age, as well as race and ethnicity.
Physicians should be sensitive to the unique needs of
women in the communities they serve. Sensitivity to
patients’ reactions and possible behavioral differences
will alert clinicians to ask appropriate questions and take
appropriate actions. Using open-ended questions and
active listening with patients is important.
Language and cultural barriers should be examined
and addressed. Reaching out to community cultural lead-
ers can be enormously beneficial in understanding cul-
tural practices and accessing language services. For those
who do not speak English, efforts should be made to
provide assistance, such as offering appropriately trained
interpreters and written translations of forms and patient
education materials (5). In some circumstances, federal
and state laws and regulations impose responsibilities on
health care providers to accommodate individuals with
limited English proficiency. Appropriate measures for
overcoming communication barriers will depend on the
circumstances of the individual practice and patient pop-
ulation. Various options may be available, including hir-
ing bilingual staff for clerical or medical positions, using
appropriate community resources, or using translation
telephone services. Cosponsoring health fairs or infor-
mation sessions in the local cultural community center
can engender good relations with health care providers
while being informative as well. Being known as the phy-
sician in the community who understands a particular
culture can increase patient volume and the practice’s
net earnings. Reaching out to a particular segment of the
community, such as gay and lesbian groups, and asking
for information as well as offering to provide preventive
medical talks can prove beneficial for the community and
the practice (6). It is important to consider that not all sit-
uations require traditional allopathic solutions. Because
patients interact with many individuals in the office and
hospital, it is important to educate the front desk, billing,
nursing, and ancillary medical staff in cultural sensitivity.
4 Committee Opinion No. 493
COMMITTEE OPINIONS
Resources and web sites can be found on the Ameri-
can College of Obstetricians and Gynecologists’ web site
at www.acog.org/goto/underserved.
References
1. Effective patient–physician communication. Committee
Opinion No. 492. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1254–7.
2. Wells MI. Beyond cultural competence: a model for individ-
ual and institutional cultural development. J Community
Health Nurs 2000;17:189–99.
3. Fleming M, Towey K. Delivering culturally effective health
care to adolescents. Chicago (IL): American Medical
Association; 2001. Available at: http://www.ama-assn.org/
ama1/pub/upload/mm/39/culturallyeffective.pdf. Retrieved
September 20, 2010.
4. U.S. Census Bureau. Table 6. Resident population by
sex, race, and Hispanic-origin status: 2000 to 2009. In:
Statistical abstract of the United States: 2011. 130th ed.
Washington, DC: USCB; 2010. Available at: http://www.
census.gov/compendia/statab/2011/tables/11s0006.pdf.
Retrieved February 22, 2011.
5. U.S. Department of Health and Human Services, Office
of Minority Health. National standards for culturally and
linguistically appropriate services in health care. Final
report. Washington, DC: DHHS; 2001. Available at: http://
minorityhealth.hhs.gov/assets/pdf/checked/finalreport.pdf.
Retrieved September 24, 2010.
6. Kahn E, Sullivan T. Expanding your gay and lesbian patient
base: what savvy medical practices know. J Med Pract
Manage 2008;24:36–8.
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Cultural sensitivity and awareness in the delivery of health care.
Committee Opinion No. 493. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1258–61.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 528
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 496 • August 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

At-Risk Drinking and Alcohol Dependence: Obstetric

and Gynecologic Implications
ABSTRACT: Compared with men, at-risk alcohol use by women has a disproportionate effect on their health
and lives, including reproductive function and pregnancy outcomes. Obstetrician–gynecologists have a key role in
screening and providing brief intervention, patient education, and treatment referral for their patients who drink
alcohol at risk levels. For women who are not physically addicted to alcohol, tools such as brief intervention and
motivational interviewing can be used effectively by the clinician and incorporated into an office visit. For pregnant
women and those at risk of pregnancy, it is important for the obstetrician–gynecologist to give compelling and
clear advice to avoid alcohol use, provide assistance for achieving abstinence, or provide effective contraception
to women who require help. Health care providers should advise women that low-level consumption of alcohol in
early pregnancy is not an indication for pregnancy termination.

The National Institute on Alcohol Abuse and Alcoholism
defines at-risk alcohol use for healthy women as more than
three drinks per occasion or more than seven drinks per
week and any amount of drinking for women who are
pregnant or at risk of pregnancy. Binge drinking is defined
as more than three drinks per occasion. Almost 50% of
binge drinking occurs among otherwise moderate drink-
ers (1). Moderate drinking is defined as one drink per
day (2). When evaluating a patient’s drinking habits, it is
important to verify the description of “a drink” to deter-
mine the actual amount of alcohol consumed (Box 1).
National surveys indicate that American Indian and
Alaska Native women (13.7%) were the most likely race
to have an alcohol use disorder. This is compared with
Box 1. What Is a Drink?
One standard drink is equal to 15 mL of pure ethanol
• Beer or wine cooler – 12 oz physical and psychosocial health risks of at-risk alcohol
• Table wine – 5 oz (25-oz bottle = 5 drinks)
• Malt liquor – 8–9 oz (12-oz can = 1.5 drink)
• 80-Proof spirits – 1.5 oz (a mixed drink may contain 1–3 States (8). As indicated in Box 2, at-risk alcohol use results
or more drinks)
white non-Hispanic women (5.6%), black non-Hispanic
women (3.5%), and Hispanic or Latino women (3.8%)
(3). In 2009, 25.6% of individuals aged 18–24 years
reported binge drinking (4). Of those individuals, the
majority were white non-Hispanic, college graduates who
had an average household income greater than $50,000
per year (4). Among women aged 18–34 years who binge
drink, approximately one third (31.4%) report drink-
ing eight or more drinks per occasion (5). In 2008, 61%
of full-time college students were current drinkers and
40.5% reported binge drinking (3). Binge drinking is
associated with a sudden peak in the level of alcohol in the
blood, resulting in unsafe behavior and the risk of more
reproductive and organ damage than sustained high levels
of alcohol consumption (6).
For many people, alcohol use can be a pleasant
experience as a method of relaxation and social connec-
tion. It also offers some beneficial cardiovascular effects
(7). However, women are particularly vulnerable to the
use. Alcohol-related mortality represents the third lead-
ing cause of preventable death for women in the United
in multiple adverse health effects. Of note, data indicate
that women who drink between two and five drinks

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 529

 per day have up to a 41% increased incidence of breast Obstetrician–gynecologists have important oppor-
cancer, and the risk increases linearly with consumption tunities for at-risk alcohol use intervention in three key
throughout this range (9, 10). areas: 1) identifying women who drink at risk levels, 2)
encouraging healthy behaviors through brief intervention
and education, and 3) referring patients who are alcohol
dependent for professional treatment.
Box 2. At-Risk Alcohol Use: Secondary
Consequences Affecting Women Identification of At-Risk Drinking
Increased medical and physical risks The U.S. Preventive Services Task Force recommends
• Unplanned pregnancy that all adult patients in a primary care setting be
• Sexually transmitted diseases*
screened for alcohol misuse and provided counseling
for identified risky or harmful drinking. Referral for
• Altered fertility †, ‡
specialist treatment may be appropriate for those with
• Menstrual disorders§ alcohol abuse or dependence (11). All women seeking
• Injuries obstetric–gynecologic care should be screened for alcohol
• Seizures§ use at least yearly and within the first trimester of preg-
• Malnutrition§, || nancy. It should be noted that women who drink at risk
• Cardiomyopathies¶
levels are less likely to maintain routine annual visits, and
screening should be considered for episodic visits if not
• Cancer of the breast, liver, rectum, mouth, throat, and
completed within the past 12 months. Screening can be
esophagus§, #, **
accomplished using a variety of simple validated tools,
Increased risk of psychosocial problems like TACE with additional questions about the quantity
• Loss of primary relationships and frequency of alcohol use, within the context of the
• Sexual assault routine visit (Box 3). Although the CAGE mnemonic
• Loss of income screening tool has been taught in most medical schools
• Child neglect or abuse and loss of child custody and residency programs, it has not proved to be sensi-
tive for women and minorities (12). Using a validated
• Domestic violence
screening tool decreases false-positive and false-negative
• Driving under the influence responses. Women may fear disclosure of their alcohol
• Altered judgement use will result in the loss of employment, their children,
• Bartering sex for drugs or their relationships. Therefore, it is crucial that the cli-
• Depression and suicide nician assure the patient before screening that the infor-
mation disclosed is privileged and confidential. Seeking
*Nicoletti A. The STD/alcohol connection. J Pediatr Adolesc obstetric–gynecologic care should not expose a woman
Gynecol 2010;23:53–4.
to criminal or civil penalties or the loss of custody of her
†
Rossi BV, Berry KF, Hornstein MD, Cramer DW, Ehrlich S,
Missmer SA. Effect of alcohol consumption on in vitro fertiliza- children (13).
tion. Obstet Gynecol 2011;117:136–42. Women who develop alcohol or substance use
‡
Grodstein F, Goldman MB, Cramer DW. Infertility in women dependence are often more likely than men to deny
and moderate alcohol use. Am J Public Health 1994;84:1429–32. that they have a problem and to minimize the problems
§
Corrao G, Bagnardi V, Zambon A, La Vecchia C. A meta-anal- associated with their use. However, when they do seek
ysis of alcohol consumption and the risk of 15 diseases. Prev help for the problem, it often is from their primary care
Med 2004;38:613–9.
providers (14). Importantly, most women who use alco-
||
National Institute on Alcohol Abuse and Alcoholism. Alcohol
and nutrition. Alcohol Alert No. 22 PH 346. Bethesda (MD): hol at risk levels have no signs on physical examination.
NIAAA; 1993. Available at: http://pubs.niaaa.nih.gov/publica- A detailed medical history obtained by a trusted clinician
tions/aa22.htm. Retrieved April 18, 2011. remains the most sensitive means of detecting alcohol
¶
Urbano-Marquez A, Estruch R, Fernandez-Sola J, Nicolas JM, abuse (15).
Pare JC, Rubin E. The greater risk of alcoholic cardiomyopathy
and myopathy in women compared with men. JAMA 1995;274: Encouraging Healthy Behaviors and
149–54.
#
Ferrari P, Jenab M, Norat T, Moskal A, Slimani N, Olsen A, et al.
Early Intervention Strategies
Lifetime and baseline alcohol intake and risk of colon and rectal Many women may be surprised to learn that their drink-
cancers in the European prospective investigation into cancer ing exceeds a safe level of alcohol consumption. They may
and nutrition (EPIC). Int J Cancer 2007;121:2065–72.
live or associate with others who drink similar amounts
**
Kuper H, Tzonou A, Kaklamani E, Hsieh CC, Lagiou P, Adami HO,
et al. Tobacco smoking, alcohol consumption and their interac- of alcohol and consider their alcohol use as “normal.”
tion in the causation of hepatocellular carcinoma. Int J Cancer Offering compassionate education, exploring practical
2000;85:498–502. strategies to reduce use, and requesting a follow-up
appointment is a successful strategy for many women

2 Committee Opinion No. 496

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 530

 “As your obstetrician–gynecologist, I am con-
Box 3. Alcohol Use Screening Tools cerned that your menstrual irregularities or
other clinical findings may be associated with
TACE your drinking. This level of drinking also puts
you at risk of unplanned pregnancy and inju-
• T – Tolerance ries. Are you willing to try and reduce your
How many drinks does it take to make you feel high? drinking? I can offer you resources to help.”
(More than 2 drinks = 2 points)
(Wait for her response.)
• A – Annoyed
Have people annoyed you by criticizing your drinking? “Getting pregnant at this time could be very
(Yes = 1 point)
harmful for you and your baby. I want you to
consider using a more effective contraception
• C – Cut down method while you are working on reducing
Have you ever felt you ought to cut down on your your alcohol intake.”
drinking?
(Yes = 1 point) (Wait for her response.)
• E – Eye-opener At the conclusion of the brief intervention, it is
Have you ever had a drink first thing in the morning to important to assist the patient in setting a goal (eg, “I
steady your nerves or get rid of a hangover? will not have more than three drinks at the Friday happy
(Yes = 1 point) hour”), record the goal, and let her know that there will
be a follow-up discussion at the next visit. If she does not
A total score of 2 points or more indicates a positive consistently meet her goal, restate the advice to quit or cut
screening for at-risk drinking back on drinking, review her plan, and encourage her to
Alcohol Quantity and Drinking Frequency Questions seek additional support. A failed attempt is a motivating
moment toward seeking help.
• In a typical week, how many drinks do you have that
contain alcohol? Referral
(Positive for at-risk drinking if more than 7 drinks) Women who continue to drink or use alcohol at risk
• In the past 90 days, how many times have you had levels and women who exhibit signs of alcohol depen-
more than 3 drinks on any one occasion? dence require referral to a substance abuse specialist. This
(Positive for at-risk drinking if more than one time) referral is best made while the patient is in the clinician’s
office so that she is involved in making the appointment
Data from Sokol RJ, Martier SS, Ager JW. The T-ACE ques-
tions: practical prenatal detection of risk-drinking. Am J Obstet with the encouragement of her health care provider.
Gynecol 1989;160:863–8; discussion 868–70 and National Local substance abuse treatment programs can be found
Institute on Alcohol Abuse and Alcoholism. Helping patients through the Substance Abuse and Mental Health Services
who drink too much: a clinician’s guide. Updated 2005 edition. Administration treatment locater (19). If the patient
Bethesda (MD): NIAAA; 2005. Available at: http://pubs.niaaa.
nih.gov/publications/practitioner/CliniciansGuide2005/Guide_
refuses treatment, the health care provider should respect
Slideshow.htm. Retrieved April 18, 2011. her decision, make a short-term follow-up appointment
with her, and assure her that she will be welcomed back
in the clinician’s office. It may take a number of offers
before the patient is ready to accept a treatment referral.
The patient’s trust in her medical provider may be key in
who are not physically or psychologically dependent on taking the step toward treatment.
alcohol. There are effective alcohol educational materials
available for patients that are free or offered at a very low Alcohol Use and Pregnancy and
cost (see Resources). Breastfeeding
Brief, motivation-enhancing interventions are asso- Alcohol is a teratogen. Fetal alcohol syndrome is the most
ciated with a sustained reduction in alcohol consumption severe result of prenatal drinking. Fetal alcohol syndrome
(16–18). Following is an example of a brief intervention: is associated with central nervous system abnormalities,
“You indicated that you are drinking five or six growth defects, and facial dysmorphia. However, for
drinks one evening a week and that you often every child born with fetal alcohol syndrome, many more
do not feel drunk when you drink that amount. are born with neurobehavioral defects caused by prenatal
This is considered at-risk drinking. What do alcohol exposure. Alcohol-related birth defects include
you think about that?” growth deformities, facial abnormalities, central nervous
system impairment, behavioral disorders, and impaired
(Wait for her response.) intellectual development. Alcohol can affect a fetus at any

Committee Opinion No. 496 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 531

 stage of pregnancy, and the cognitive defects and behav-
ioral problems that result from prenatal alcohol exposure
are lifelong. In early pregnancy during organogenesis and
perhaps before the patient’s recognition of pregnancy,
the fetus may be particularly vulnerable to maternal
binge or heavy alcohol use. Alcohol-related birth defects
are completely preventable (20). Even moderate alcohol
consumption during pregnancy may alter psychomo-
tor development, contribute to cognitive defects, and
produce emotional and behavioral problems in children,
although patient denial and underreporting make it dif-
ficult to quantify these effects (21). There is evidence of
varying susceptibility to alcohol’s effect on the developing
fetus. Although alcohol consumption may have negative
consequences for any pregnant woman, the effects of
alcohol may be more potent in mothers who are older, in
poor health, or who also smoke or use drugs (22).
The U.S. Surgeon General advises that pregnant
women should not drink any alcohol. Women who have
already consumed alcohol during a current pregnancy
should stop in order to minimize further risk, and those
who are considering becoming pregnant should abstain
from drinking alcohol. Recognizing that nearly one half
of all births in the United States are unintended, women
of childbearing age should discuss with their clinicians
steps to reduce the possibility of prenatal alcohol expo-
sure (20). Health care providers should advise women
that low-level consumption of alcohol in early pregnancy
is not an indication for pregnancy termination.
A recent study indicated that the highest prevalence
of late-pregnancy alcohol use was reported by women
who were white non-Hispanic, college graduates, and
aged 35 years or older (23). However, these same women
were those who reported the least screening and counsel-
ing for alcohol use by their health care providers. There
is strong evidence that brief behavioral counseling inter-
ventions with women who engage in at-risk drinking
reduce the incidence of alcohol-exposed pregnancy (24,
25). Pregnant women are generally motivated to change
their drinking behavior, and alcohol dependence is rela-
tively rare (24). In one multicenter project, nearly 70% of
women who were drinking at risky levels and not using
effective contraception reduced their risk of alcohol-
exposed pregnancy 6 months after a brief intervention
because they stopped or reduced their drinking below
risky levels or they started using effective contraception
(26). Randomized studies report significant reductions
in alcohol use and improved newborn outcomes after
interventions with women who are already pregnant.
Women who are alcohol dependent need intense special-
ized counseling and medical support during the process
of withdrawal. They should be given priority access to
withdrawal management and treatment (24). If a woman
continues to use alcohol during pregnancy, harm reduc-
tion strategies should be encouraged (24). Postpartum,
many women who were abstinent during pregnancy
rapidly resume at-risk levels of alcohol use and should
4 Committee Opinion No. 496
COMMITTEE OPINIONS
be monitored at the postpartum and follow-up visits
(27). It is important to educate the at-risk patient about
pregnancy prevention and offer and provide effective,
long-term reversible contraception until at-risk alcohol
use has been curtailed.
Contrary to cultural folklore, alcohol consump-
tion does not enhance lactational performance. There is
consistent evidence showing that when lactating mothers
consume alcohol, there is reduced milk consumption by
the infant (28). Alcohol consumption during lactation
is associated with altered postnatal growth, sleep pat-
terns, and psychomotor patterns of the offspring (29).
After breastfeeding is well established, a mother should
be encouraged by her health care provider to wait 3–4
hours after a single drink before breastfeeding her infant.
By doing so, the infant’s exposure to alcohol would be
negligible (30).
Coding for Screening and Assessment
and Brief Intervention
There are two Current Procedural Terminology codes
to report for alcohol abuse structured screening and
brief intervention services. Report Current Procedural
Terminology codes 99408 (alcohol abuse structured
screening and brief intervention services; 15 to 30 min-
utes) and 99409 (greater than 30 minutes) for screen-
ing and brief intervention services for patients without
Medicare. These codes are only reportable for structured
screening using a validated screening tool, such as TACE,
and brief intervention. They are not reportable when
physicians ask patients about their alcohol use as part
of a comprehensive medical history. The services under
these new codes may be conducted as part of a periodic,
scheduled, preventive care office visit or in an acute
setting.
Resources
American College of Obstetricians and Gynecologists. Alco-
hol, tobacco, and other substance use and abuse. Guide-
lines for Adolescent Health Care [CD-ROM]. 2nd ed.
Washington, DC: ACOG; 2011.
National Institute on Alcohol Abuse and Alcoholism
(NIAAA), has free brochures on women and alcohol
as well as pregnancy and drinking available in English,
Spanish and for American Indians. They also have video-
taped screening and brief intervention interviews to guide
physician–patient interaction.
National Institute on Alcohol Abuse and Alcoholism. Help-
ing patients who drink too much: a clinician’s guide and
related professional support resources. Available at: http://
www.niaaa.nih.gov/Publications/EducationTraining
Materials/Pages/guide.aspx. Retrieved April 18, 2011
Substance Abuse and Mental Health Services Admin-
istration. Substance abuse treatment locator. Available at:
http://dasis3.samhsa.gov. Retrieved May 18, 2011.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 532
 References
1. Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge
drinking in the preconception period and the risk of
unintended pregnancy: implications for women and their
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2. US Department of Agriculture, US Department of Health
and Human Services. Dietary guidelines for Americans,
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Office; 2010. Available at: http://www.cnpp.usda.gov/
Publications/DietaryGuidelines/2010/PolicyDoc/Policy
Doc.pdf. Retrieved April 18, 2011.
3. Substance Abuse and Mental Health Services Admin-
istration. Results from the 2009 National Survey on Drug
Use and Health: Volume I. summary of national find-
ings (Office of Applied Studies, NSDUH Series H-38A,
HHS Publication No. SMA 10-4586Findings). Rockville
(MD): SAMHSA; 2010. Available at: http://oas.samhsa.gov/
NSDUH/2k9NSDUH/2k9ResultsP.pdf. Retrieved April 18,
2010.
4. Kanny D, Liu Y, Brewer RD. Binge drinking - United States,
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MMWR Surveill Summ 2011;60(suppl):101–4.
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alcohol consumption among U.S. adults. Am J Prev Med
2010;38:201–7.
6. Mann K, Batra A, Gunthner A, Schroth G. Do women
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7. Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA.
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8. Alcohol-attributable deaths and years of potential life
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2004;53:866–70.
9. Hamajima N, Hirose K, Tajima K, Rohan T, Calle EE,
Heath CW Jr, et al. Alcohol, tobacco and breast can-
cer--collaborative reanalysis of individual data from 53
epidemiological studies, including 58,515 women with
breast cancer and 95,067 women without the disease.
Collaborative Group on Hormonal Factors in Breast
Cancer. Br J Cancer 2002;87:1234–45.
10. Zhang SM, Lee IM, Manson JE, Cook NR, Willett WC,
Buring JE. Alcohol consumption and breast cancer risk
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667–76.
11. Screening and behavioral counseling interventions in pri-
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ment. U.S. Preventive Services Task Force. Ann Intern Med
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12. Volk RJ, Cantor SB, Steinbauer JR, Cass AR. Item bias in
the CAGE screening test for alcohol use disorders. J Gen
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13. Substance abuse reporting and pregnancy: the role of the
obstetrician-gynecologist. Committee Opinion No. 473.
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14. Becker KL, Walton-Moss B. Detecting and addressing
alcohol abuse in women. Nurse Pract 2001;26:13–6, 19–23;
quiz 24–5.
15. At-risk drinking and illicit drug use: ethical issues in
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Barry KL. Treatment of problem alcohol use in women
of childbearing age: results of a brief intervention trial.
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17. Burke BL, Arkowitz H, Menchola M. The efficacy of moti-
vational interviewing: a meta-analysis of controlled clinical
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18. Motivational interviewing: a tool for behavioral change.
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19. Substance Abuse and Mental Health Services Admin-
istration. Substance abuse treatment facility locator.
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20. U.S. Surgeon General. A 2005 message to women from
the U.S. Surgeon General: advisory on alcohol use in
pregnancy. Rockville (MD): US Surgeon General; 2005.
Available at: http://www.cdc.gov/ncbddd/fasd/documents/
SurgeonGenbookmark.pdf. Retrieved April 18, 2011.
21. Welch-Carre E. The neurodevelopmental consequences
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217–29.
22. Chiodo LM, da Costa DE, Hannigan JH, Covington CY,
Sokol RJ, Janisse J, et al. The impact of maternal age on the
effects of prenatal alcohol exposure on attention. Alcohol
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use by pregnant women. Am J Public Health 2007;97:
252–8.
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the risk of alcohol-exposed pregnancies: a study of a
motivational intervention in community settings. Project
CHOICES Intervention Research Group. Pediatrics 2003;
111:1131–5.
27. Substance Abuse and Mental Health Services Admin-
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substance use among women during pregnancy and follow-
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28. Mennella JA, Pepino MY. Biphasic effects of moderate
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6 Committee Opinion No. 496
COMMITTEE OPINIONS
Copyright August 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
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mission from the publisher. Requests for authorization to make
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Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
At-risk drinking and alcohol dependence: obstetric and gyneco-
logic implications. Committee Opinion No. 496. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;118:383–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 534
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 498 • August 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Adult Manifestations of Childhood Sexual Abuse

ABSTRACT: Long-term effects of childhood sexual abuse are varied, complex, and often devastating. Many
obstetrician–gynecologists knowingly or unknowingly provide care to abuse survivors and should screen all
women for a history of such abuse. Depression, anxiety, and anger are the most commonly reported emotional
responses to childhood sexual abuse. Gynecologic problems, including chronic pelvic pain, dyspareunia, vaginis-
mus, nonspecific vaginitis, and gastrointestinal disorders are common diagnoses among survivors. Survivors may
be less likely to have regular Pap tests and may seek little or no prenatal care. Obstetrician–gynecologists can
offer support to abuse survivors by giving them empowering messages, counseling referrals, and empathic care
during sensitive examinations.

Women who are survivors of childhood sexual abuse
often present with a wide array of symptoms. Frequently,
the underlying cause of these symptoms is unrecognized
by both the physician and patient. The obstetrician–gyne-
cologist should have the knowledge to screen for child-
hood sexual abuse, diagnose disorders that are a result
of abuse, and provide support with interventions. Adult
childhood sexual abuse survivors disproportionately use
health care services and incur greater health care costs
compared with adults who did not experience abuse (1).
Definitions
Child sexual abuse is defined as any sexual activity with
a child where consent is not or cannot be given. This
includes sexual contact that is accomplished by force or
threat of force, regardless of the age of the participants,
and all sexual contact between an adult and a child,
regardless of whether there is deception or the child
understands the sexual nature of the activity. Sexual
contact between an older child and a younger child also
can be abusive if there is a significant disparity in age,
development, or size, rendering the younger child inca-
pable of giving informed consent. The sexually abusive
acts may include sexual penetration, sexual touching, or
noncontact sexual acts such as exposure or voyeurism
(2). Legal definitions vary by state; however, state guide-
lines are available by using the Child Welfare Informa-
tion Gateway (www.childwelfare.gov/systemwide/laws_
policies/state).
Prevalence
Although the exact prevalence is unknown, it is estimated
that 12–40% of children in the United States experi-
ence some form of childhood sexual abuse. Shame and
stigma prevent many survivors from disclosing abuse.
Incest, once thought to be rare, occurs with alarming
frequency (3). Survivors come from all cultural, racial,
and economic groups (4). Approximately one in five
women has experienced childhood sexual abuse (4).
From 2006 to 2008, among females aged 18–24 years
who had sex for the first time before age 20 years, 7%
experienced nonvoluntary first sex (5). Twelve percent
of girls in grades 9–12 reported they had been sexu-
ally abused; 7% of girls in grades 5–8 reported sexual
abuse. Of all girls who experienced sexual abuse, 65%
reported that the abuse occurred more than once,
57% reported that the abuser was a family member,
and 53% reported that the abuse occurred at home (6).
Sequelae
Symptoms or behavioral sequelae are common and
varied. More extreme symptoms can be associated with
abuse onset at an early age, extended or frequent abuse,
incest by a parent, or use of force. Common life events,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 535

 like death, birth, marriage, or divorce may trigger the
return of symptoms for a childhood sexual abuse survi-
vor. The primary aftereffects of childhood sexual abuse
include the following:
• Emotional reactions
Emotions such as fear, shame, humiliation, guilt, and • Normalize the experience. Physicians may offer
self–blame are common and lead to depression and
anxiety.
• Symptoms of posttraumatic stress
Survivors may experience intrusive or recurring
thoughts of the abuse as well as nightmares or flash-
backs.
• Distorted self-perception
Survivors often develop a belief that they caused the
sexual abuse and that they deserved it. These beliefs
may result in self-destructive relationships.
Physical Effects
Chronic and diffuse pain, especially abdominal or pelvic
pain (1), lower pain threshold (7), anxiety and depres-
sion, self-neglect, and eating disorders have been attrib-
uted to childhood sexual abuse. Adults abused as children
are four to five times more likely to have abused alcohol
and illicit drugs (8). They are also twice as likely to smoke,
be physically inactive, and be severely obese (8).
Sexual Effects
Disturbances of desire, arousal, and orgasm may result If the physician suspects abuse, but the patient
from the association between sexual activity, violation,
and pain. Survivors are more likely to have had 50 or
more intercourse partners, have had a sexually transmit-
ted infection, and engage in risk-taking behaviors that
place them at risk of contracting human immunodefi-
ciency virus (HIV) (8, 9). Early adolescent or unintended does not matter or does not have medical relevance and
pregnancy and prostitution are associated with sexual
abuse (10, 11). Gynecologic problems, including chronic
pelvic pain, dyspareunia, vaginismus, and nonspecific
vaginitis, are common diagnoses among survivors (12–14).
Survivors may be less likely to have regular Pap tests and
may seek little or no prenatal care (15).
Interpersonal Effects
Adult survivors of sexual abuse may be less skilled at
self-protection. They are more apt to accept being vic-
timized by others (15, 16). This tendency to be victim-
ized repeatedly may be the result of general vulnerability
in dangerous situations and exploitation by untrust-
worthy people.
Obstetrician–Gynecologist Screening
for Sexual Violence
With recognition of the extent of family violence, it is
strongly recommended that all women be screened for a
history of sexual abuse (15, 17). Patients overwhelmingly
favor universal inquiry about sexual assault because they
2 Committee Opinion No. 498
COMMITTEE OPINIONS
report a reluctance to initiate a discussion of this subject
(18). Following are some guidelines:
• Make the question “natural.” When physicians rou-
tinely incorporate questions about possible sexual
abuse, they will develop increased comfort (19).
explanatory statements, such as: “About one woman
in five was sexually abused as a child. Because these
experiences can affect health, I ask all my patients
about unwanted sexual experiences in childhood”
(19).
• Give the patient control over disclosure. Ask every
patient about childhood abuse and rape trauma, but
let her control what she says and when she says it in
order to keep her emotional defenses intact (19).
• If the patient reports childhood sexual abuse, ask
whether she has disclosed this in the past or sought
professional help. Revelations may be traumatic for
the patient. Listening attentively is important because
excessive reassurance may negate the patient’s pain.
The obstetrician–gynecologist should consider refer-
ral to a therapist.
• The examination may be postponed until another
visit. Once the patient is ready for an examination,
questions about whether any parts of the breast or
pelvic examination cause emotional or physical dis-
comfort should be asked.
does not disclose it, the obstetrician–gynecologist should
remain open and reassuring. Patients may bring up the
subject at a later visit if they have developed trust in the
obstetrician–gynecologist. Not asking about sexual abuse
may give tacit support to the survivor’s belief that abuse
the opportunity for intervention is lost (20).
Obstetrician–Gynecologist
Intervention for Sexual Violence
Once identified, there are a number of ways that the
obstetrician–gynecologists can offer support. These
include sensitivity with the gynecologic or obstetric visit
and examination in abuse survivors, the use of empower-
ing messages, and counseling referrals.
Obstetric and Gynecologic Visits and
Examinations in Abuse Survivors
Pelvic examinations may be associated with terror and
pain for survivors. Feelings of vulnerability in the lithot-
omy position and being examined by relative strangers
may cause the survivor to re-experience past feelings of
powerlessness, violation, and fear. Many survivors may
be traumatized by the visit and pelvic examination, but
may not express discomfort or fear and may silently expe-
rience distress (20). All procedures should be explained
in advance, and whenever possible, the patient should be
2013 COMPENDIUM OF SELECTED PUBLICATIONS 536
 allowed to suggest ways to lessen her fear. For example,
the patient may desire the presence of friends or fam-
ily during the examination and she has the right to stop
the examination at any time. Techniques to increase the
patient’s comfort include talking her through the steps,
maintaining eye contact, allowing her to control the pace,
allowing her to see more (eg, use of a mirror in pelvic
examinations), or having her assist during her examina-
tion (eg, putting her hand over the physician’s to guide
the examination) (20). It is important to ask permission
to touch the patient.
Pregnancy and childbirth may be an especially dif-
ficult time for survivors. The physical pain of labor and
delivery may trigger memories of past abuse (21–23).
Women with no prior conscious memories of their abuse
may begin to experience emotions, dreams, or partial
memories. Pregnant women who are abuse survivors are
significantly more likely to report suicidal ideation and
depression (7, 24). There are no consistent data regarding
adverse pregnancy outcomes for women with histories of
childhood sexual abuse.
Positive Messages
Some positive and healing responses to the disclosure of
abuse include discussing with the patient that she is the
victim of abuse and is not to blame. She should be reas-
sured that it took courage for her to disclose the abuse,
and she has been heard and believed (19, 20).
Counseling Referrals
Traumatized patients generally benefit from mental
health care. The obstetrician–gynecologist can be a pow-
erful ally in the patient’s healing by offering support and
referral. Efforts should be made to refer survivors to bearing, National Survey of Family Growth 2006–2008.
professionals with significant experience in abuse-related
issues.
Physicians should compile a list of experts with
experience in abuse and have a list of appropriate crisis
hotlines that operate in their communities. Contacting
state boards of psychology or medicine can be beneficial
in locating therapists who are skilled in treating victims
of such trauma. Veterans’ centers, battered women’s shel-
ters, and rape crisis centers often are familiar with thera-
pists and programs that treat various types of trauma, as
are many university-based counseling programs. Because
of the relationship between trauma histories and alcohol
and drug abuse, therapists should be skilled in working
with individuals who have dual diagnoses (25).
When discussing with a patient referral to a mental
health professional, it is helpful to identify a specific
purpose for the referral. For example, “I would like Dr. household dysfunction to many of the leading causes of
Hill to assess you to determine if your past abuse is con-
tributing to your current health problems” is more effec-
tive than telling the survivor that her symptoms are all
psychological and that she should see a therapist (26). It
is important to secure the patient’s express authorization
before referring her to a mental health specialist, as well
Committee Opinion No. 498
COMMITTEE OPINIONS
as helping the patient to not feel abandoned or rejected
when a counseling referral is made.
Conclusion
For some survivors of childhood sexual abuse, there is
minimal compromise to their adult functioning. Others
will experience psychologic, physical, and behavioral
symptoms as a result of their abuse. An understanding
of the magnitude and effects of childhood sexual abuse,
along with knowledge about screening and interven-
tion methods, can help obstetrician–gynecologists offer
appropriate care and support to patients with such his-
tories.
References
1. Leserman J. Sexual abuse history: prevalence, health effects,
mediators, and psychological treatment. Psychosom Med
2005;67:906–15.
2. Saul J, Audage NC. Preventing child sexual abuse within
youth-serving organizations: getting started on policies
and procedures. Atlanta (GA): Centers for Disease Control
and Prevention, National Center for Injury Prevention and
Control; 2007.
3. Hendricks-Matthews M. Caring for victims of childhood
sexual abuse. J Fam Pract 1992;35:501–2.
4. Tjaden P, Thoennes N. Prevalence, incidence, and con-
sequences of violence against women: findings from the
National Violence Against Women Survey. Research in
brief. Washington, DC: U.S. Department of Justice, Office
of Justice Programs; 1998. Available at: http://www.ncjrs.
gov/pdffiles/172837.pdf. Retrieved May 5, 2011.
5. Abma JC, Martinez GM, Copen CE. Teenagers in the
United States: sexual activity, contraceptive use, and child-
National Center for Health Statistics. Vital Health Stat 23
2010;(30):1–79. Available at http://www.cdc.gov/nchs/data/
series/sr_23/sr23_030.pdf. Retrieved May 5, 2011.
6. Schoen C, Davis K, Collins KS, Greenberg L, Des Roches C,
Abrams M. The Commonwealth Fund survey of the health
of adolescent girls. New York (NY): Commonwealth Fund;
1997. Available at: http://www.commonwealthfund.org/~/
media/Files/Publications/Fund%20Report/1997/Nov/
The%20Commonwealth%20Fund%20Survey%20of%20
the%20Health%20of%20Adolescent%20Girls/Schoen_
adolescentgirls%20pdf.pdf. Retrieved May 5, 2011.
7. Scarinci IC, McDonald-Haile J, Bradley LA, Richter JE.
Altered pain perception and psychosocial features among
women with gastrointestinal disorders and history of abuse:
a preliminary model. Am J Med 1994;97:108–18.
8. Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM,
Edwards V, et al. Relationship of childhood abuse and
death in adults. The Adverse Childhood Experiences (ACE)
Study. Am J Prev Med 1998;14:245–58.
9. Bensley LS, Van Eenwyk J, Simmons KW. Self-reported
childhood sexual and physical abuse and adult HIV-risk
behaviors and heavy drinking. Am J Prev Med 2000;18:
151–8.
3
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 10. Noll JG, Shenk CE, Putnam KT. Childhood sexual abuse toward a solution. Kansas City (MO): Society of Teachers
and adolescent pregnancy: a meta-analytic update. J Pediatr of Family Medicine; 1992. p. 89–102.
Psychol 2009;34:366–78. 20. Holz KA. A practical approach to clients who are survivors
11. Wilson HW, Widom CS. The role of youth problem of childhood sexual abuse. J Nurse Midwifery 1994;39:
behaviors in the path from child abuse and neglect to pros- 13–8.
titution: a prospective examination. J Res Adolesc 2010; 21. Grant LJ. Effects of childhood sexual abuse: issues for
20:210–36. obstetric caregivers. Birth 1992;19:220–1.
12. Britton H, Hansen K. Sexual abuse. Clin Obstet Gynecol 22. Waymire V. A triggering time. Childbirth may recall sexual
1997;40:226–40. abuse memories. AWHONN Lifelines 1997;1:47–50.
13. Paras ML, Murad MH, Chen LP, Goranson EN, Sattler AL, 23. Rhodes N, Hutchinson S. Labor experiences of childhood
Colbenson KM, et al. Sexual abuse and lifetime diagnosis of sexual abuse survivors. Birth 1994;21:213–20.
somatic disorders: a systematic review and meta-analysis.
JAMA 2009;302:550–61. 24. Anderson G, Yasenik L, Ross CA. Dissociative experiences
and disorders among women who identify themselves as
14. Reissing ED, Binik YM, Khalife S, Cohen D, Amsel R. sexual abuse survivors. Child Abuse Negl 1993;17:677–86.
Etiological correlates of vaginismus: sexual and physical
abuse, sexual knowledge, sexual self-schema, and relation- 25. Hendricks-Matthews M. Recognition of sexual abuse. J Am
ship adjustment. J Sex Marital Ther 2003;29:47–59. Board Fam Pract 1993;6:511–3.
15. Baram DA, Basson R. Sexuality, sexual dysfunction, and 26. Laws A. Sexual abuse history and women’s medical prob-
sexual assault. In: Berek JS, editor. Berek & Novak’s gyne- lems. J Gen Intern Med 1993;8:441–3.
cology. 14th ed. Philadelphia (PA): Lippincott Williams &
Wilkins; 2007. p. 313–49.
16. Rieker PP, Carmen EH. The victim-to-patient process:
the disconfirmation and transformation of abuse. Am J Copyright August 2011 by the American College of Obstetricians and
Orthopsychiatry 1986;56:360–70. Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
17. American College of Obstetricians and Gynecologists. be reproduced, stored in a retrieval system, posted on the Internet,
Guidelines for women’s health care: a resource manual. or transmitted, in any form or by any means, electronic, mechani-
3rd ed. Washington, DC: ACOG; 2007. cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
18. Friedman LS, Samet JH, Roberts MS, Hudlin M, Hans P. photocopies should be directed to: Copyright Clearance Center, 222
Inquiry about victimization experiences. A survey of Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
patient preferences and physician practices. Arch Intern ISSN 1074-861X
Med 1992;152:1186– 90.
Adult manifestations of childhood sexual abuse. Committee Opinion
19. Wahlen SD. Adult survivors of childhood sexual abuse. No. 498. American College of Obstetricians and Gynecologists.
In: Hendricks-Matthews M, editor. Violence education: Obstet Gynecol 2011;118:392–5.

4 Committee Opinion No. 498

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 538

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 499 • August 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Sexual Assault
ABSTRACT: Victims of sexual assault who are of reproductive age are at risk of unintended pregnancy as
well as sexually transmitted diseases. Therefore, emergency contraception and prophylaxis for sexually transmit-
ted diseases should be available and provided to these women. Sexual assault victims are also at risk of mental
health conditions such as posttraumatic stress disorder. Health care providers should screen routinely for a history
of sexual assault. The physician who examines victims of sexual assault has a responsibility to be aware of state
and local statutory or policy requirements that may involve the use of assessment kits for gathering evidence.

Definitions prostitution, or other form of sexual exploitation of chil-

Sexual assault is a crime of violence and aggression, not
passion, and encompasses a continuum of sexual activ-
ity that ranges from sexual coercion to contact abuse
(unwanted kissing, touching, or fondling) to forcible rape
(1). Because definitions vary among states, sexual assault
is sometimes used interchangeably with rape. Rape is
defined as forced sexual intercourse, including vaginal,
anal, or oral penetration by a body part or object (2).
Sexual assault, or rape, often is further characterized to
include acquaintance rape, date rape, statutory rape, child
sexual abuse, and incest. These terms generally relate to
the age of the victim and her relationship to the abuser.
Acquaintance and date rape refer to sexual assaults
committed by someone known to the victim. Instances
in which the perpetrator has a close familial relationship
to the victim generally are defined as incest. Statutory
rape refers to consensual sexual intercourse with a female
younger than a specified age. The age at which an adoles-
cent may consent to sexual intercourse varies by state and
ranges from 14 years to 18 years. Sexual assault occurring
in childhood also is defined by most states as child abuse.
Childhood sexual abuse is further defined by the Child
Abuse and Prevention Act as “the employment, use,
persuasion, inducement, enticement, or coercion of any
child to engage in, or assist any other person to engage
in, any sexually explicit conduct or simulation of such
conduct for the purpose of producing a visual depiction
of such conduct; or the rape, and in cases of caretaker or
interfamilial relationships, statutory rape, molestation,
dren, or incest with children” (3).
Incidence and Prevalence
The method of obtaining data influences the estimates of
the incidence and prevalence of rape and sexual assault.
Data compiled from reports to law enforcement officials
will always underestimate the incidence of sexual assault.
Key findings of the National Violence Against Women
survey reveal that there are more than 300,000 rape-
related physical assaults against women annually (4).
Approximately 18% of women surveyed reported that
they had been the victim of a completed or attempted
rape during their lifetime. Of these women, 54% were
younger than 18 years. Among children and adolescents,
most cases of sexual assault are in the form of acquain-
tance rape. Of the children and adolescents who reported
rape, 14.3% of women younger than 18 years reported
that they were assaulted by a stranger.
Medical Consequences of Sexual
Assault
Acute traumatic injuries reported can be relatively minor,
including scratches, bruises, and welts; but some women
will sustain fractures, head and facial trauma, lacerations,
bullet wounds, or even death. The risk of injury increases
for adult female rape victims in the following situations:
the perpetrator is a current or former intimate partner;
the rape occurs in the victim’s or perpetrator’s home; the
rape is completed; harm to the victim or another is threat-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 539

 ened by the perpetrator; a gun, knife, or other weapon is
used during the assault; or the perpetrator is using drugs
or alcohol at the time of the assault (4).
Sexual assault is associated with a risk of pregnancy
and contributes to unintended pregnancy in the United
States. The national rape-related pregnancy rate is calcu-
lated to be 5% per rape among females aged 12–45 years
(5). This would be equivalent to approximately 32,000
pregnancies as a result of rape each year. This is especially
true among adolescent assault victims because they are
more likely to be repeatedly assaulted because of the pre-
dominance of incestuous relationships with perpetrators
in this age group and their relatively low use of ongoing
contraception. Rape-related sexually transmitted dis-
eases (STDs), including human immunodeficiency virus
(HIV), are a major concern. Additional conditions that
are diagnostic or suspicious for childhood sexual abuse
include syphilis, human papillomavirus, and herpes sim-
plex infection (6). Additional information on sexual
assault in this population is available elsewhere (7).
Various long-term health effects have been associated
with female sexual assault. Increases in patient-reported
symptoms, diminished levels of functional capacity, alter-
ations in health perceptions, and decreased positivity of
overall quality of life have all been reported as sequelae
of childhood and adult sexual abuse (8, 9). Many women
will not be forthright with a history of sexual assault but
are more likely to present with chronic pelvic pain, dys-
menorrhea, and sexual dysfunction than those without
such a history (10). Additional information on adult
manifestations of childhood sexual abuse is available
elsewhere (11).
Psychologic and Mental Health
Consequences of Sexual Assault
A woman who is sexually assaulted loses control over her
life during the period of the assault. After the assault, a
rape-trauma syndrome often occurs. The acute phase,
or disorganization phase, may last for days to weeks and
is characterized by physical reactions such as generalized
pain throughout the body, eating and sleep disturbances,
and emotional reactions such as anger, fear, anxiety,
guilt, humiliation, embarrassment, self-blame, and mood
swings (1, 12). The next phase, the delayed (or organiza-
tion) phase, is characterized by flashbacks, nightmares,
and phobias as well as somatic and gynecologic symp-
toms. This phase often occurs in the weeks and months
after the event and may involve major life adjustments
(1, 12).
Posttraumatic stress disorder may be a long-term
consequence of sexual assault. Posttraumatic stress disor-
der is characterized by a cluster of symptoms involving re-
experiencing the trauma, avoidance, and being in a state
of hyperarousal (13). These symptoms may not appear for
months or even years after a traumatic experience.
Alcohol abuse, including binge drinking, and illicit
drug use and dependence have a long-term association
2 Committee Opinion No. 499
COMMITTEE OPINIONS
with sexual assault. A survey of women seeking substance
abuse treatment found that prevalence rates of com-
pleted rape or other type of sexual assault were 64.2% and
44.8%, respectively (14).
Roles and Responsibilities of Health
Care Providers
Physicians can encourage primary prevention of sexual
assault by being involved in advocacy in professional,
community, and educational arenas. In addition, the
American College of Obstetricians and Gynecologists rec-
ommends that health care providers routinely screen all
patients for a history of sexual assault, paying particular
attention to those who report pelvic pain, dysmenorrhea,
or sexual dysfunction (15). Health care providers who
routinely screen for a history of sexual assault are better
able to identify victims of sexual assault and thereby pro-
vide tertiary prevention of long-term and persistent phys-
ical and mental health consequences of sexual assault. If
a history of sexual abuse has been obtained, the clinician
needs to be aware that various health care procedures can
be triggers for panic and anxiety reactions such as pelvic,
rectal, breast, and endovaginal ultrasound examinations.
When these reactions are seen in clinical practice, it is
important to consider that they may be caused by post-
traumatic stress disorder and may have a connection with
more remote events rather than the immediate practice
situation. Clinicians should screen for substance abuse
in patients with a history of sexual assault. Conversely,
clinicians should screen for a history of sexual assault in
patients with a history of substance abuse. Counseling
can help the patient to understand her psychologic and
physical responses, thereby diminishing the associated
symptoms (12).
In recent years, there has been a trend toward the
implementation of hospital-based programs to provide
acute medical and evidentiary examinations by sexual
assault nurse examiners or sexual assault forensic exam-
iners. In some parts of the country, however, obstetri-
cian–gynecologists will still be the first point of contact
for the evaluation and care of patients after a sexual
assault. Often obstetrician–gynecologists will be called
on to perform evaluations and, if conducting screening
for a history of sexual assault, will realize the importance
of this information in providing comprehensive health
care. Therefore, all physicians should be familiar with the
forensic examination procedure. If a physician is called
to perform this examination and he or she has no experi-
ence or limited experience, it may be judicious to request
assistance because any break in the technique in collect-
ing evidence, or break in the chain of custody of evidence,
including improper handling of samples or mislabeling,
will virtually eliminate any effort to prosecute a case in
the future.
The health care provider conducting an evidentiary
evaluation of a victim of sexual assault has a number of
responsibilities, both medical and legal, and should be
2013 COMPENDIUM OF SELECTED PUBLICATIONS 540
 aware of state and local statutory or policy requirements
that may involve the use of assessment kits for gathering
evidence. The health care provider’s role in the evalua-
tion of sexual assault victims is summarized in Box 1. If a
sexual assault victim communicates with the health care
provider’s office, emergency department, or clinic before
evaluation, she should be encouraged to come immedi-
ately to a medical facility and be advised not to bathe,
change her clothes, douche, urinate, defecate, wash out
her mouth, clean her fingernails, smoke, eat, or drink.
A history of previous obstetric and gynecologic condi-
tions should be recorded, and it is necessary to determine
whether the patient may have a preexisting pregnancy or
be at risk of pregnancy (1). A detailed examination of the
entire body should be performed and the injuries should
be photographed or drawn. Rape and sexual assault are
legal terms that should not be used in medical records.
Rather, the health care provider should report findings
Box 1. Health Care Provider’s Role in the
Evaluation of Sexual Assault Victims
Medical Issues
• Obtain informed consent
• Assess and treat physical injuries
• Obtain past gynecologic history
• Perform physical examination, including pelvic exami-
nation with appropriate chaperone transmission if the perpetrator is infected, including
• Obtain appropriate specimens and serologic tests for genital or rectal trauma leading to bleeding, multiple
sexually transmitted disease testing
• Provide appropriate infectious disease prophylaxis as and the presence of pre-existing genital infection in the
indicated
• Provide or arrange for provision of emergency contra-
ception as indicated
• Provide counseling regarding findings, recommenda-
tions, and prognosis
• Arrange follow-up medical care and referrals for psy-
chosocial needs
Legal Issues*
• Provide accurate recording of events
• Document injuries
• Collect samples as indicated by local protocol or regu-
lation
• Identify the presence or absence of sperm in the vagi-
nal fluids and make appropriate slides
• Report to authorities as required
• Ensure security of chain of evidence
*Many jurisdictions have prepackaged kits for the initial foren-
sic examination of a rape that provide specific containers and
instructions for the collection of physical evidence and for writ-
ten and pictorial documentation of the victim’s subjective and urged to assemble and maintain a list of these individuals
objective findings. See www.rainn.org/get-information/sexual-
assault-recovery/rape-kit for more information on rape kits.
Committee Opinion No. 499
COMMITTEE OPINIONS
as being consistent with whatever aspect of the reported
assault is being evaluated.
The health care provider should document the emo-
tional condition of the patient as judged by direct obser-
vation and examination (1). If the patient is a minor, the
health care provider should report the incident to the
appropriate authorities as required by state law. An effort
should be made to involve a parent or parental figure
unless such an individual represents a security threat to
the patient.
When the physical and medical–legal needs of the
patient have been addressed, the health care provider
should discuss with the patient the degree of injury and
the probability of infection or pregnancy. Emergency
contraception should be provided. Emergency contracep-
tion should be available in hospitals and facilities where
victims of sexual assault at risk of pregnancy are treated.
The most common STDs reported in sexual assault vic-
tims are those most common in the general community
and include trichomoniasis, gonorrhea, and Chlamydia
trachomatis infection (16). Prophylaxis for these STDs
is recommended. The Centers for Disease Control and
Prevention recommendations for prophylaxis for these
STDs can be found at http://www.cdc.gov/std/treatment
(17).
An STD of particular concern among victims of
sexual assault is HIV. The HIV status of the assailant in
a sexual assault is often unknown or unavailable. There
are multiple characteristics that increase the risk of HIV
traumatic sites involving lacerations or deep abrasions,
victim (18). The U.S. Department of Health and Human
Services recommends that an individual seeking care
within 72 hours after nonoccupational exposure to blood,
genital secretions, or other potentially infective body flu-
ids of an individual known to have HIV receive a 28-day
course of highly active antiretroviral therapy, initiated as
soon as possible after exposure. If the assailant’s HIV sta-
tus is unknown, clinicians should evaluate the risks and
benefits of nonoccupational postexposure prophylaxis on
a case-by-case basis. For individuals initiating care more
than 72 hours after exposure, clinicians might consider
prescribing nonoccupational postexposure prophylaxis
for exposures conferring a serious risk of transmission
if, in their judgment, the diminished potential benefit of
treatment outweighs the potential risk of adverse events
from antiretroviral medications (19).
Other health personnel, particularly those trained to
respond to rape-trauma victims, should be consulted to
provide immediate intervention if necessary and to facili-
tate counseling and follow-up. Health care providers are
and other resources for patient referral.
Because of the emotional intensity of the experience,
a woman may not recall all of what is said during an
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 541
 office visit. Therefore, it is helpful to provide all instruc-
tions and plans in writing. Generally, a visit for clinical
and psychologic follow-up should take place within 1–2
weeks and be scheduled thereafter as indicated by results
and assessments at that time.
References
1. Baram DA, Basson R. Sexuality, sexual dysfunction, and
sexual assault. In: Berek JS, editor. Berek & Novak’s gyne-
cology. 14th ed. Philadelphia (PA): Lippincott Williams &
Wilkins; 2007. p. 313–49.
2. Rape, Abuse and Incest National Network. Sexual assault.
Available at: http://www.rainn.org/get-information/types-
of-sexual-assault/sexual-assault. Retrieved May 5, 2011.
3. Administration for Children and Families, Child Welfare
Information Gateway. Definitions of child abuse and
neglect. Available at: http://www.childwelfare.gov/can/
defining. Retrieved May 5, 2011.
4. Tjaden P, Thoennes N. Full report of the prevalence, inci-
dence, and consequences of violence against women: find-
ings from the National Violence Against Women Survey.
NCJ 183781. Washington, DC: U.S. Department of Justice,
Office of Justice Programs; 2000. Available at: http://www.
ncjrs.gov/pdffiles1/nij/183781.pdf. Retrieved May 5, 2010.
5. Holmes MM, Resnick HS, Kilpatrick DG, Best CL. Rape-
related pregnancy: estimates and descriptive characteristics
from a national sample of women. Am J Obstet Gynecol
1996;175:320–4; discussion, 324–5.
6. Kellogg N. American Academy of Pediatrics Committee on
Child Abuse and Neglect. The evaluation of sexual abuse in
children. Pediatrics 2005;116:506–12.
7. American College of Obstetricians and Gynecologists.
Guidelines for adolescent health care [CD-ROM]. 2nd ed.
Washington, DC: American College of Obstetricians and
Gynecologists; 2011.
8. Plichta SB, Falik M. Prevalence of violence and its impli-
cations for women’s health. Womens Health Issues
2001;11:244–58.
9. Dickinson LM, de Gruy FV 3rd, Dickinson WP, Candib LM.
Health-related quality of life and symptom profiles of
female survivors of sexual abuse. Arch Fam Med 1999;8:
35–43.
10. Golding JM, Wilsnack SC, Learman LA. Prevalence of
sexual assault history among women with common gyne-
cologic symptoms [published erratum appears in Am J
Obstet Gynecol 1999;180:255]. Am J Obstet Gynecol 1998;
179:1013.
4 Committee Opinion No. 499
COMMITTEE OPINIONS
11. Adult manifestations of childhood sexual abuse. Committee
Opinion No. 498. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011:118:392–5.
12. Burgess AW, Holmstrom LL. Rape trauma syndrome. In:
Burgess AW, Holmstrom LL, editors. Rape: victims of crisis.
Bowie (MD): Robert J. Brady; 1974. p. 37–50.
13. Nakell L. Adult post-traumatic stress disorder: screening and
treating in primary care. Prim Care 2007;34:593–610, vii.
14. Dansky BS, Saladin ME, Coffey SF, Brady KT. Use of self-
report measures of crime-related posttraumatic stress dis-
order with substance use disordered patients. J Subst Abuse
Treat 1997;14:431–7.
15. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual.
3rd ed. Washington, DC: ACOG; 2007.
16. Lamba H, Murphy SM. Sexual assault and sexually trans-
mitted infections: an updated review. Int J STD AIDS 2000;
11:487–91.
17. Workowski KA, Berman S. Sexually transmitted diseases
treatment guidelines, 2010. Centers for Disease Control
and Prevention (CDC) [published erratum appears in
MMWR Recomm Rep 2011;60:18]. MMWR Recomm Rep
2010(RR-12);59:1–110. Available at: http://www.cdc.gov/
std/treatment/2010/default.htm. Retrieved March 4, 2011.
18. Fong C. Post-exposure prophylaxis for HIV infection after
sexual assault: when is it indicated? Emerg Med J 2001;
18:242–5.
19. Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F,
Struble KA, et al. Antiretroviral postexposure prophylaxis
after sexual, injection-drug use, or other nonoccupational
exposure to HIV in the United States: recommendations
from the U.S. Department of Health and Human Services.
U.S. Department of Health and Human Services. MMWR
Recomm Rep 2005;54:1–20.
Copyright August 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Sexual assault. Committee Opinion No. 499. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;118:396–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 542
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 503 • September 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Tobacco Use and Women’s Health

ABSTRACT. Tobacco use negatively affects every organ system and is the most prevalent cause of prema-
ture death for adults within the United States. Compared with women who are nonsmokers, women who smoke
cigarettes have greater risks of reproductive health problems, many forms of gynecologic cancer and other types
of cancer, coronary and vascular disease, chronic obstructive lung disease, and osteoporosis. Brief behavioral
counseling and the use of evidence-based smoking cessation aids are effective strategies for achieving smoking
cessation even for very heavy smokers. The trained obstetrician–gynecologist is well positioned to screen and
counsel all patients on tobacco use and to advocate for smoke-free environments. Smoking cessation counseling
is often reimbursed by health insurers. Tobacco use has deleterious effects on women through all stages of life.
Tools are available for obstetrician–gynecologists to screen for and treat tobacco abuse and give the appropriate
coding for smoking cessation counseling.

Epidemiology cult, particularly for some African Americans who believe

Despite the evidence of the negative effects of tobacco use,
the Centers for Disease Control and Prevention reports
18% of women older than 18 years smoked cigarettes in
2009 (1). This rate of smoking has remained essentially
unchanged over the past 5 years, thus falling short of the
Healthy People 2010 goal of a smoking rate of 12% or
less (2). More than 80% of current smokers began their
addiction to tobacco before age 18 years (3). Tobacco use
by women is most prevalent among women who have
attained lower levels of education, are poor, and are white
or of mixed race (1).
From 2000 to 2004, the United States spent $193
billion on annual tobacco use health-related economic
losses with one half dedicated to direct medical costs and
the other half to lost productivity (4). The money spent
by U.S. private and public entities on the adverse effects
of tobacco use is twice the amount of tobacco sales (4).
Forms of Tobacco
In recent years, tobacco products have changed and oth-
ers have been developed or gained popularity. There are
many flavors of cigarettes, cigars, and other forms of
tobacco that are available for sale and marketed primarily
to young and minority users. In fact, menthol cigarettes
increase the likelihood and degree of nicotine addiction
in new smokers and makes smoking cessation more diffi-
health benefits are associated with smoking menthol
cigarettes (5). Smokeless tobacco products are mistak-
enly believed to be a safer and may be a more convenient
alternative to cigarettes when smoking is prohibited. One
form of smokeless tobacco popular with young women
is “snus,” a flavored self-contained tobacco pouch that is
placed between the cheek and gum and does not require
spitting. Other smoking alternatives include a gel strip
impregnated with nicotine that melts on the tongue and
an electronic or e-cigarette, a battery powered device that
heats cartridges of liquid containing nicotine to create
a mist, which users inhale. Hookahs, or tobacco water
pipes, have become popular among youth and young
adults. Inhalation when using a hookah is deeper and
smoking sessions are longer than with a typical cigarette,
resulting in higher concentration of toxins after hookah
smoking compared with cigarette smoking (6). Evidence
indicates that changing tobacco delivery devices and
cigarette designs, including low-tar and light variations,
have not reduced overall disease risk among smokers (7).
Although the U.S. Food and Drug Administration is mov-
ing toward requiring disclosure and regulation, currently
tobacco companies are not required to divulge the addi-
tive content of tobacco products. It is widely known that
alkaloids are added to tobacco to increase the absorption
of nicotine and, therefore, add to the addictive nature of
the product (8).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 543

 Health Effects of Tobacco Use on
Women
Because of the negative effects of tobacco use on fertility
and fetal development, there is a focus on smoking ces-
sation in consideration of women’s reproductive health.
However, the sequelae of tobacco use have negative
health effects on a woman through all stages of her life.
Approximately 90% of cases of lung cancer are caused by
smoking or exposure to tobacco smoke. Lung cancer has
surpassed breast cancer as the leading cause of cancer
death in women (9). Colon cancer is the third leading
cause of cancer deaths in women, and there is a dose-
related increased risk of colon cancer in smokers (10).
Women who smoke are also at an increased risk of gyne-
cologic cancer. Cigarette smoking has been identified as
a risk factor in the development of mucinous epithelial
ovarian cancer (11). There is a linear relationship between
premenopausal tobacco use and breast cancer, particu-
larly if smoking is initiated before the birth of the first
child (12). Smoking also contributes to the progression
of cervical intraepithelial neoplasia, and both active and
passive smoking have been linked to squamous cell car-
cinoma of the cervix in women seropositive for HPV-16
or HPV-18 (13, 14). Smoking also has been linked to
cancer of the bladder, kidney, and pancreas (15).
Tobacco is the single greatest modifiable risk factor
for cardiovascular disease and the leading cause of death
in women in the United States (9). Women who smoke
have a sixfold increased risk of myocardial infarction
when compared with nonsmoking women (16). Tobacco
use causes endothelial damage and platelet aggregation,
contributing to thrombosis in smokers (17). The anties-
trogen effect of tobacco use accelerates menopause. This
premature menopause increases the risk of cardiovascu-
lar disease and increases the risk of osteoporotic fracture
independent of bone mineral density score (17–19).
Furthermore, the risk of stroke is almost doubled in indi-
viduals who smoke (17).
Role of the Obstetrician–Gynecologist
Screening and Intervention
Tobacco use screening and cessation counseling is rated
among the three most effective and efficacious preventive
health actions that can be undertaken in a clinical set-
ting, receiving a Grade A rating from the U.S. Preventive
Services Task Force (20, 21). Each visit to the obstetri-
cian–gynecologist is an opportunity for intervention.
The clinician can make a difference with minimal (less
than 3 minutes) intervention. Even when patients are not
willing to make a quit attempt, clinician-delivered brief
interventions enhance motivation and increase the likeli-
hood of future attempts (22). In addition, tobacco users
are being primed to consider quitting by a wide range of
societal and environmental factors as well as through the
availability of effective tobacco cessation aids.
2 Committee Opinion No. 503
COMMITTEE OPINIONS
The nicotine in tobacco products is highly addictive.
Symptoms of physical dependence can result after less
than 1 week of smoking initiation, especially in youth
(23). When smoked or ingested through oral mucosa,
nicotine rapidly increases blood levels of dopamine,
thereby affecting the channels controlling reward and
pleasure. Tobacco cessation for those dependent on nico-
tine is often uncomfortable causing one to experience
vasomotor, gastrointestinal, and mood altering symp-
toms. It takes an average of seven quit attempts for the
average smoker to quit smoking and stay abstinent for 1
year. However, patient adherence to physician smoking
cessation advice is better than that for diet change and
increasing physical activity (24).
The “5 A’s” intervention model is an evidence-based
model successfully used by the busy clinician to address
patient smoking. The 5 A’s are: Ask, Advise, Assess,
Assist, and Arrange.
1. ASK about tobacco use in any form or amount and
document this in the patient record. This can be accom-
plished through questions on the patient visit intake
form with a question such as: “Circle the tobacco prod-
ucts (cigarettes, cigars, smokeless tobacco, hookah, or
electronic cigarettes) used during the past year.” Any
use would require a further question on amount and
frequency of use.
2. ADVISE patients who smoke to quit in a clear, strong,
and personalized manner. It is best to incorporate in the
advice any clinical findings that may be influenced by
the patient’s tobacco use. All of the elements of the 5A’s
need not be delivered by one individual or during a single
office visit; however, it is important that the primary cli-
nician give the personalized advice to quit smoking. For
example:
I see that you are smoking two or three ciga-
rettes a day. As your obstetrician–gynecologist,
I want you to know that your smoking, even in
small amounts, increases your risk of cervical
and breast cancer, and may be contributing to
your menstrual irregularities. You don’t have to
stop on your own. If you are willing, I can help
you stop smoking. What do you think about
that?
3. ASSESS the patient’s willingness to make a quit
attempt. Ask if she is willing at this time to set a date to
stop using tobacco. Reducing smoking or switching to
another form of tobacco should not be considered a goal.
4. ASSIST in the quit attempt for those who are willing.
As a health care provider, you may offer medication and
provide or refer a patient for counseling or additional
treatment. The woman who is willing to try to quit smok-
ing needs to develop a quit plan. A direct referral to the
Smokers’ Quitline (1-800-QUIT NOW) is a great place
to start. In addition, there are excellent materials avail-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 544
 able from the American College of Obstetricians and
Gynecologists as well as the American Cancer Society
(www.acs.org) that will help her set a quit date, encour-
age her to tell her friends and family about her quit intent
to garner support, counsel her to anticipate challenges to
her quit attempt, and encourage her to remove tobacco
products from her environment.
For those who are unwilling or not ready to quit
at this time provide motivational messages to increase
future attempts to quit and explore their possible fears
and concerns with smoking cessation or demoralization
caused by a past relapse (25). Continue to ask and advise
about smoking status at every encounter and assess their
willingness to make an attempt to quit.
5. ARRANGE follow-up. If the patient is willing to
attempt to stop smoking, have someone from the office
staff call her within a week of the date she chooses to quit
to support and encourage her in her attempt. Flag her
record and make sure to verbally ask her about smok-
ing at subsequent visits. If she has been successful with
smoking cessation, praise her progress. If she slips back to
tobacco use, encourage her to quit immediately, review-
ing her personalized rationale for staying smoke-free and
offering additional smoking cessation aids.
Medications and Other Evidence-Based
Smoking Cessation Aids
In addition to counseling, all smokers making a quit
attempt should be offered medication to improve quit suc-
cess and reduce withdrawal symptoms (Table 1) (22).
Those who should not routinely use medication for
smoking cessation are pregnant women, adolescents,
smokeless tobacco users, and light smokers. The medica-
tions can be used individually or combined, and they can

Table 1. Smoking Cessation Aids

6-Month
Abstinence
Method Rate (%) Cost*/Duration Where Available

Patient desire 8
Physician advice 10.2
Group or individual counseling 14–17 Low to very high cost Health centers
depending on provider Public health programs
Private counselor
Telephone counseling 16 Free 1-800-QUIT NOW
(Smokers’ Quitline)
Nicotine gum, patch, or lozenge 19–26 $150–$300 Over-the-counter
6–14 weeks
Nicotine inhaler or nasal spray 25 –27 $150–$300 Requires prescription
Up to 6 months
Combined nicotine replacement 24–36 $150–$400 Over-the-counter
therapies Up to 6 months Requires prescription
Bupropion 24 $150–$300 Requires prescription
Up to 14 weeks
Varenicline 33 $250–$400 Requires prescription
Up to 14 weeks
Clonidine 25 Less than $150 Requires prescription
Up to 12 weeks
Nortriptyline 22.5 Less than $150 Requires prescription
Up to 12 weeks
Combined counseling and medication 28–32 $150 and up
Hypnosis Insufficient evidence Greater than $300 Not covered by insurance
Acupuncture 9 Greater than $300 Not covered by insurance

*Cost of a course of treatment. This may be covered by insurance unless otherwise indicated in the patient’s health insurance policy.
Data from Fiore MC, Jean CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, et al. Treating tobacco use and dependence: 2008 update. Clinical Practice Guideline, Rockville
(MD); U.S. Department of Health and Human Services. Public Health Service; 2008.

Committee Opinion No. 503 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 545

 be used as an addition to cognitive behavioral counsel-
ing. Medications include nicotine replacement therapy
products such as gum, patches, lozenges, inhalers, and
nasal sprays. Some of the nicotine replacement therapy
products are sold over-the-counter, whereas the inhaler
and nasal spray require a prescription. Other effective
prescription medications include the antidepressant,
bupropion, and varenicline, which block the pleasant
effects of smoking from the brain. A combination of nic-
otine replacement therapy products or nicotine replace-
ment therapy plus bupropion may be used to prevent
physical withdrawal from nicotine and to quell sudden
urges to smoke. The prescribing obstetrician–gynecologist
needs to be aware of the black box label warning on
bupropion and varenicline in regard to suicide ideation.
Patients should be counseled and monitored for abrupt
mood changes. The U.S. Food and Drug Administration
has issued a warning concerning an increase in cardio-
vascular events for those individuals with cardiovascular
disease who use varenicline. Nortriptyline and clonidine
are used as second-line smoking cessation aids. Both
have adverse effects that often prove to be undesirable.
A downloadable, comprehensive, and patient-centered
chart of evidence-based smoking cessation interven-
tions with effectiveness ratings can be found at http://
whatworkstoquit.tobacco-cessation.org/NTCCguide.pdf.
Hypnotherapy, acupuncture, and the use of herbal rem-
edies have not proved to be effective for achieving smok-
ing cessation (22).
Addressing Roadblocks to Smoking Cessation
As with other behavioral health issues, there are road-
blocks to smoking cessation. Many are particularly rel-
evant to women, including fear of weight gain, inability
to deal with negative mood and anxiety, the influence
of other tobacco users, difficulty in concentration, and
other withdrawal symptoms. Smoking cessation medica-
tions greatly decrease withdrawal symptoms and reduce
anxiety and mood swings. Approximately one half of
those who stop smoking gain weight and most will gain
fewer than 10 pounds (22). Those who use bupropion
tend to not gain weight rapidly following cessation. For
others who do gain weight, the health care provider must
stress the benefits of cessation and offer advice on physi-
cal activity and a modified eating plan. To reduce the
urge of smoking, temporary changes in routine such as
brushing teeth directly after eating, taking a walk instead
of a smoke, wearing mittens, or buffing fingernails when
talking on the phone, are simple effective strategies. In
addition, the Smokers’ Quitline offers free supportive
counseling at timed intervals during a quit attempt.
Developing Systems for Addressing
Tobacco Use
Training for smoking cessation and other behavioral
counseling greatly enhances clinician confidence, effi-
ciency, and the effectiveness of the intervention. Active
4 Committee Opinion No. 503
COMMITTEE OPINIONS
training is particularly helpful in working with patients
on denial, ambivalence, and relapse. Adding tobacco use
questions and a brief intervention screen to the electronic
medical record enhances the performance of screening
and counseling across a practice. Offices instituting or
revising their electronic medical records should include a
template on tobacco use.
An important office improvement in addressing
tobacco use is requiring a smoke-free office environ-
ment. This smoke-free zone should extend around the
building to discourage staff and patients from smoking at
the entrance. In addition, the obstetrician–gynecologist
can advocate at the state and community level for the
institution of ordinances that reduce smoking and smoke
exposure such as imposing clean air acts and increasing
tobacco taxes; the cost of tobacco products is inversely
proportional to the uptake of use by adolescents.
Coding and Reimbursement
As of October 2010, the Affordable Care Act requires
all new health plans to cover smoking cessation coun-
seling as a U.S. Preventive Services Task Force Grade
A preventive service. In January 2011, all Medicare
patients became covered and it is expected that all per-
sons will be covered in 2014. Also in January 2011, the
International Classification of Diseases, 9th Revision, and
Current Procedural Terminology codes for reimbursement
for smoking cessation counseling went into effect. Under
the new codes, counseling can be provided for all patients
who smoke. Reimbursement is based on the amount of
time spent counseling patients. Counseling that takes
3–10 minutes is considered intermediate and counseling
lasting longer than 10 minutes is considered intensive.
References
1. MMWR Morbidity and Mortality Weekly Report. “Vital
Signs: Current Cigarette Smoking Among Adults Aged ≥
18 Years – United States, 2009. Available at: http://www.
cdc.gov/mmwr. Retrieved April 13, 2011.
2. Healthy People.gov: 2020 Topics & Objectives: Tobacco.
Available at: http://healthypeople.gov/2020/topicsobjectives
2020/objectiveslist.aspx?topicid=41. Retrieved April 13, 2011.
3. Smoking and Tobacco Use: Youth and Tobacco Use.
Office on Smoking and Health. National Center for Chronic
Disease Prevention and Health Promotion. November 30,
2010.
4. Economic Facts About U.S. Tobacco Production and
Use. Office on Smoking and Health. National Center
for Chronic Disease Prevention and Health Promotion.
Available at: http://www.cdc.gov/tobacco/data_statistics/
fact_sheets/economics/econ_facts/index.htm. Retrieved
July 14, 2010.
5. Benowitz NL, Samet JM. The threat of menthol cigarettes
to U.S. public health [published online ahead of print
May 4, 2011]. N Engl J Med 2011;364:2179–81.
6. Knishkowy B, Amitai Y. Water-pipe (narghile) smoking: an
emerging health risk behavior. Pediatrics 2005;116:113–9.
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 7. Chen J. Toxicological analysis of low-nicotine and nicotine-
free cigarettes. Toxicology 2008;249:194–203.
8. Center for Tobacco Products, United States Food and
Drug Administration. Guidance, compliance & regulatory
information. United States Food and Drug Administration.
Available at: http://www.fda.gov/TobaccoProducts/Guidance
ComplianceRegulatoryInformation/default.htm. Retrieved
April 13, 2011.
9. U.S. Department of Health and Human Services. Women
and smoking: a report of the Surgeon General. Rockville
(MD); DHHS; 2001. p. 7.
10. Botteri E, Iodice S, Bagnardi V, Raimondi S, Lowenfels AB,
Maisonneuve P. Smoking and colorectal cancer: a meta-
analysis. JAMA 2008;300:2765–78.
11. Marchbanks PA, Wilson H, Bastos E, Cramer D, Schildkraut
JM, Peterson HB. Cigarette smoking and epithelial ovarian
cancer by histologic type. Obstet Gynecol 2000;95:255–60.
12. Xue F, Willett WC, Rosner BA, Hankinson SE, Michels KB.
Cigarette smoking and the incidence of breast cancer.
Archives of Internal Medicine 2011;171:125–133.
13. Kapeu AS, Luostarinen T, Jellum E, Dillner J, Hakama M,
Koskela P, et al. Is smoking an independent risk factor for
invasive cervical cancer? A nested case-control study within
Nordic biobanks. Am J Epidemiology 2009;169:480–8.
14. Trimble CL, Genkinger JM, Burke AE, Hoffman SC,
Helzlsouer KJ, Diener-West M, et al. Active and passing
smoking and the risk of cervical neoplasia. Obstet Gynecol
2005;105:174–81.
15. Reichert VC, Seltzer V, Efferen LS, Kohn N. Women and
tobacco dependence. Obstet Gynecol Clin North America
2009;36;877–90.
16. Njølstad I, Arnesen E, Lund-Larsen PG. Smoking, serum
lipids, blood pressure, and sex differences in myocar-
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Circulation 1996;93:450–6.
17. U.S. Department of Health and Human Services. The
Health Consequences of Smoking: A Report of the Surgeon
General. Washington, DC; HHS; 2004.
18. Shuster LT, Rhodes DJ, Gostout BS, Grossardt BR, Rocca WA.
Premature menopause or early menopause: long term
health consequences. Maturitas 2010;65:161–6.
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COMMITTEE OPINIONS
19. Kanis JA, Johnell O, Oden A, Johansson H, De Laet C,
Eisman JA, et al. Smoking and fracture risk: meta-analysis.
Osteoporosis International 2004;16:155–62.
20. Solberg LI, Maciosek MV, Edwards NM, Khanchandari HS,
Goodman MJ. Repeated tobacco-use screening and inter-
vention in clinical practice. Am J Prev Med 2006;31;62–71.
21. Counseling to Prevent Tobacco Use and Tobacco-Caused
Disease: USPSTF Recommendations. AHRQ Pub. No. 04-
0526. November 2003.
22. Fiore MC, Jean CR, Baker TB, Bailey WC, Benowitz NL,
Curry SJ, et al. Treating Tobacco Use and Dependence:
2008 update. Clinical Practice Guideline, Rockville (MD);
U.S. Department of Health and Human Services. Public
Health Service; 2008.
23. DiFranza J, Savageau JA, Fletcher K, O’Loughlin J, Pbert L,
Ockene JK, et al. Symptoms of tobacco dependence after
brief intermittent use: the development and assessment
of Nicotine Dependence in Youth-2 Study. Arch Pediatr
Adolesc Med 2007;161:704–10.
24. Thorogood M, Hillsdon M, Summerbell C. Changing
behavior. Clinical Evidence (online) August 1, 2006.
Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2907629. Retrieved April 11, 2011.
25. Motivational interviewing: a tool for behavior change.
ACOG Committee Opinion No. 423. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2009;113:
243–6.
Copyright September 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Tobacco use and women’s health. Committee Opinion No. 503.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2011;118:746–50.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 547
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 507 • September 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Human Trafficking
ABSTRACT: Human trafficking is a widespread problem with estimates ranging from 14,000 to 50,000 indi-
viduals trafficked into the United States annually. This hidden population involves the commercial sex industry,
agriculture, factories, hotel and restaurant businesses, domestic workers, marriage brokers, and some adoption
firms. Because 80% of trafficked individuals are women and girls, women’s health care providers may better
serve their diverse patient population by increasing their awareness of this problem. The exploitation of people of
any race, gender, sexual orientation, or ethnicity is unacceptable at any time, in any place. The members of the
American College of Obstetricians and Gynecologists should be aware of this problem and strive to recognize and
assist their patients who are victims or who have been victims of human trafficking.

Background individuals can afford legal representation (1, 3). From

Human trafficking is defined as “the recruitment, harbor-
ing, transportation, provision, or obtaining of a person
for labor or services, through the use of force, fraud, or
coercion for the purpose of subjection to involuntary
servitude, peonage, debt bondage, or slavery” (1). Largely
unrecognized, annual trafficking estimates have ranged
from 14,000 to 50,000 individuals in the United States
(2). Many experts think current reported statistics vastly
underestimate the scope of the problem. Although states
that border Canada and Mexico and states with major
ports are points of entry, the problem exists in all states
because trafficking networks quickly move people across
the country. Trafficked individuals have been reported in
all states in the United States; however, accurate data are
not available because of the difficulty in identifying traf-
ficked individuals.
Trafficked individuals fear identification. In addi-
tion, the networks responsible for trafficking are adept
at eluding law enforcement. Traffickers and those being
trafficked have complex relationships with each other. In
some cases those trafficked may be related to their cap-
tors, fear for their safety, or feel they would not survive
without the assistance of the trafficker.
Federal legislation, passed in 2000 and reauthorized
in 2003, 2005, and 2008, aimed to punish traffickers, pro-
tect and free victims, and eliminate human trafficking,
is not well known or well enforced, and few trafficked
2001 to 2009 only 2,076 foreign national victims of
human trafficking have been certified by the Department
of Health and Human Services (4). This significant lack
of victim identification underscores the need to better
educate the public and governmental officials about this
ubiquitous problem.
Characteristics of Individuals Being
Trafficked
Individuals who are trafficked have many faces. No racial
or ethnic group is spared; however, vulnerable people,
such as those of war-torn areas or economically poor
areas are more commonly subjected to human traffick-
ing. Some are unwittingly ensnared by human traffickers,
whereas others are desperate to escape their circumstances
and then find themselves enslaved in a worse situation. No
community is immune to this problem. Eighty percent of
trafficked individuals are female and 50% of victims are
minors (2, 5). Many are paid little or nothing for their
services and fear deportation because they often do not
have any identification papers. Rates of sexually transmit-
ted infections and human immunodeficiency virus (HIV)
infection are prevalent among these victims (6).
One million children, most of whom are girls, are
exploited in the global commercial sex trade every year (7).
Many of these children are violated by sexual acts
100–1,500 times per year (8). The United States has

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 548

 federal laws against individuals engaging in sexual acts
with individuals younger than 18 years, which are the
Mann Act, the Child Sexual Abuse Prevention Act of 1994,
and the PROTECT Act of 2003. States vary in their defini-
tion of underaged sex as well as their definition of a minor
regarding prostitution laws. In addition, the Department
of Homeland Security and U.S. Immigration and Cus-
toms Enforcement have a program called Operation
Predator, which aims to identify and prevent child preda-
tors from traveling in and out of the United States. Refer
to the Resources section for contact numbers to report
Americans suspected of engaging in sex tourism and to
report suspected cases of child sexual abuse.
Forms of Human Trafficking
Trafficking involves the commercial sex industry, agricul-
ture, factories, hotel and restaurant businesses, domestic
help, marriage brokers, and some adoption firms. Any
form of human trafficking may be operated by organized
crime, individuals, or both. Forced bondage involves
placing the victim at the mercy of their employer as can
be seen in migrant workers. Migrant workers are sepa-
rated from their social support and their families at home
who often are counting on their wages and are forced
to tolerate inhumane working and living conditions,
usually earning less than what was originally promised.
Involuntary servitude poses a unique challenge because
it is especially difficult to identify these cases, most of
which occur in private homes. Many of these victims,
mostly women, are abused physically, emotionally, and
sexually (9).
Challenges of Human Trafficking
The most challenging aspect of addressing human traf-
ficking is identifying the victims, which is problematic
for several reasons. Victims may not perceive themselves
as trafficked individuals. They may fear retaliation by the
trafficker; lack knowledge of resources to help themselves;
and face many cultural, social, and language barriers.
Some of these aspects are analogous to the difficulties in
identifying victims of domestic violence or prostitution.
Identifying victims is the first step in an effective strategy
to combat trafficking.
Although recognizing trafficked individuals is dif-
ficult, having some knowledge of its existence allows for
the possibility of recognition. Many service providers and
community members are on the frontline of contact with
victims of human trafficking. Health clinics, hospitals,
social welfare offices, and police frequently and unknow-
ingly experience face-to-face contact with trafficked indi-
viduals. Obstetrician–gynecologists may be key to the
identification of trafficked individuals. Because 80% of
trafficked people are women and girls who may be at risk
of gynecologic and obstetric issues due to their circum-
stances, they may go to practitioners’ offices or emer-
gency departments for their first medical contact. The
Polaris Project, a national organization working to address
2 Committee Opinion No. 507
COMMITTEE OPINIONS
human trafficking by advocating for stronger federal and
state laws, operating the National Human Trafficking
Resource Center hotline and providing services to help
victims of human trafficking (see Resources), provides a
set of general and health indicators that can alert a health
care practitioner to the signs of a patient who is a possible
victim of human trafficking. Following are some of these
indicators:
• Lack of any official identification papers or cards
(driver’s license, passport, green card)
• Vague answers about their situation (“I’m just visit-
ing” but has no passport)
• Many inconsistencies to their stories
• No eye contact
• No control of their money (someone else pays cash
for their health care visit)
• Malnourishment
• Signs of physical abuse (bruises, burns, cuts, broken
bones or teeth)
• Signs of depression or posttraumatic stress disorder
• Drug or alcohol addiction
Signs of being a victim of sex industry trafficking may
include the following:
• Known age younger than 18 years (along with some
combination of the following signs)
• Multiple sexual partners reported
• Multiple episodes of sexually transmitted infections
• Inappropriate attire for a health care visit (eg, lingerie)
• Tattoos or other types of branding for which the
patient offers a vague explanation
• Evidence of sexual abuse or trauma
Asking open-ended questions of the patient regard-
ing mental and physical health can sometimes reveal
abusive situations. Being alert to an unusual dynamic
between the patient and her partner often can lead a
health care provider to suspect abuse. Finding a way to
speak to the patient in the presence of a chaperone and
away from the partner is extremely important. If the
patient relates a history of abuse in addition to being
the victim of human trafficking, the National Human
Trafficking Resource Center Hotline (1-888-373-7888)
can be contacted to help determine the next steps to
help the victim. It is useful to have a list of local shelters,
safe homes for abused women and children, and contact
information ready to give to women in need. Literature
such as posters, brochures, or small pocket cards (trans-
lated as necessary) can be left in bathrooms or waiting
areas where women can more discreetly obtain infor-
mation and resources. If a child is suspected of being
involved in abuse, Child Protective Services should be
contacted as well as the National Center for Missing and
Exploited Children (see Resources).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 549
 If you think you have a victim of human trafficking
in your office, the following is important:
• Be sensitive (every situation is different)
• Make sure you are not putting yourself or your staff health care providers and staff working with victims is
in danger (10)
• Contact the police if you suspect immediate danger (10) (please note the following list includes some general
to the victim or yourself
• Offer assistance—Give the patient outreach infor-
mation, hotline numbers, or both for local services
(only when patient is alone)
• Give the patient the National Human Trafficking and other security personnel.
Resource Center (NHTRC) hotline number (only
when the patient is alone): 1-888-373-7888
• Call the NHTRC to report the incident or to locate
local victims’ services: 1-888-373-7888
Only when enough victims are assured of safety can
another great challenge be met: identifying and prosecut-
ing the traffickers. Although organized crime is signifi-
cantly involved in human trafficking, there are plenty of
individuals, sometimes family members of the victims,
and small groups running their own exploitation enter-
prises. Human traffickers are very adept at using modern
technology to operate their enterprises—cell phones, web
sites, and other electronic devices (eg, personal digital
assistants and smartphones). It is often very difficult to
keep track of the intended use of myriad web sites on the
Internet.
Eliminating Human Trafficking
One solution to address human trafficking is eliminat-
ing the demand for trafficked individuals. Strategies
in the United States to help achieve this goal include
workplace regulation and increasing public awareness
and consciousness (11). Legislation should focus on the
individuals and agencies that condone the trafficking of
human beings, rather than criminalizing the victims of
such activities. More global goals include improving the
livelihoods of communities where residents are targeted
for trafficking, and eliminating warfare that causes tragic
disruption and exposes large numbers of refugees to the
risks of being trafficked. A unified approach from local,
national, and global leadership can result in the changes
necessary to decrease the exploitation of victims of
human trafficking.
Costs of Human Trafficking
Human trafficking takes an immense toll on the quality
of human life as well as costs to society. This includes
degradation of human rights, poor public health, dis-
rupted families and communities, decreased governance,
and diminished social and economic development (3).
Victims of human trafficking require rescue, rehabilita-
tion, and reintegration into society.
Committee Opinion No. 507
COMMITTEE OPINIONS
Safety for Health Care Providers
Because traffickers may be involved in organized crime,
local gangs, or other trafficking networks, protecting
imperative. See the following suggestions for enhanc-
ing the safety practices of physicians, staff, and patients
safety measures along with measures that apply to health
care providers who may frequently help victims of abuse
or human trafficking):
• Establish a relationship with the local police force
• Obtain a security audit of the office or institution.
• Review emergency plans periodically.
• Restrict after-hours access.
• Improve lighting at entrances and in parking areas.
• Install security cameras, mirrors, and panic buzzers.
• Install deadbolt or electronic locks.
• Restrict access to all doors except the main entrance.
• Preprogram 911 (emergency telephone number)
into all telephones.
• Enclose and secure reception areas.
• Develop an emergency notification system.
Conclusion
The exploitation of people of any race, gender, sexual ori-
entation, or ethnicity is unacceptable at any time, in any
place. It is costly both to the people and the nation and
will take the concerted efforts of government agencies,
nongovernmental agencies, law enforcement, and the
public to defeat this problem. Barriers to accurately assess
the scope of the problem include the hidden nature of the
problem, fear and cultural barriers, lack of awareness on
the part of the public and public officials, the limited legal
language related specifically to human trafficking, and the
lack of adequate funding and training for those capable
of identifying and assisting victims of human traffick-
ing (3). As health care providers to women and girls,
the members of the American College of Obstetricians
and Gynecologists should be aware of this problem
and strive to recognize and assist their patients who are
victims or who have been victims of human trafficking.
This Committee Opinion is not the definitive resource of
information for identifying and helping trafficked women
seek care, but is an important tool that should be used
by obstetrician–gynecologists to start the dialogue with
these patients.
Resources
Child Exploitation/Operation Predator
http://www.ice.gov/predator/
Coalition Against Trafficking in Women
http://www.catwinternational.org
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 550
 CyberTipline: http://www.missingkids.com/missingkids/
servlet/PageServlet?LanguageCountry=en_US&PageId=169
1-800-843-5678
Human Rights Watch
http://www.hrw.org
National Center for Missing and Exploited Children
http://www.missingkids.com
National Human Trafficking Resource Center
http://www.polarisproject.org/what-we-do/national-
human-trafficking-hotline/the-nhtrc/overview
1-888-373-7888
Polaris Project
http://www.polarisproject.org/index.php
Safe Horizon Anti-Trafficking Program and Hotline
http://www.safehorizon.org/index/what-we-do-2/anti-
trafficking-program-13.html
1-800-621-HOPE (4673)
The Rebecca Project
http://www.rebeccaproject.org
United Nation
http://www.un.org/en
U.S. Department of Justice
http://ctip.defense.gov
U.S. Department of State: Office to Monitor and
Combat Trafficking in Person
http://www.state.gov/g/tip
U.S. Immigration and Customs Enforcement
http://www.ice.gov
1-866-DHS-2ICE
World Health Organization
http://www.who.int/en
References
1. Office to Monitor and Combat Trafficking in Persons, US
Department of State. Trafficking in persons report. 10th ed.
Washington, DC: US Department of State; 2010. Available
at: http://www.state.gov/documents/organization/142979.
pdf. Retrieved March 14, 2011.
2. Office of the Assistant Secretary for Planning and Evaluation,
US Department of Health and Human Services. Human
trafficking into and within the United States: a review of
the literature. Washington, DC: HHS; 2009. Available
at: http://aspe.hhs.gov/hsp/07/HumanTrafficking/LitRev/
index.pdf. Retrieved April 5, 2011.
3. Jackson School of International Studies, University of
Washington. Human trafficking: a spotlight on Washington
State. 2006 Task Force on Human Trafficking. Seattle
(WA): University of Washington; 2006. Available at: http://
csde.washington.edu/~scurran/files/HumanTrafficking
SpotlightonWashingtonState.pdf. Retrieved March 14,
2011.
4 Committee Opinion No. 507
COMMITTEE OPINIONS
4. Office of the Attorney General, US Department of Justice.
Attorney General’s annual report to Congress and assess-
ment of U.S. government activities to combat trafficking
in persons: fiscal year 2009. Washington, DC: USDOJ;
2010. Available at: http://www.justice.gov/ag/annualre
ports/tr2009/agreporthumantrafficking2009.pdf. Retrieved
April 5, 2011.
5. Polaris Project. Human trafficking statistics. Washington, DC:
Polaris Project; 2009. Available at: http://www.polarispro
ject.org/resources/resources-by-topic/human-trafficking.
Retrieved April 5, 2011.
6. Administration for Children and Families, US Department
of Health and Human Services. Resources: common health
issues seen in victims of human trafficking. Available at:
http://www.acf.hhs.gov/trafficking/campaign_kits/tool_
kit_health/health_problems.pdf. Retrieved April 5, 2011.
7. Office to Monitor and Combat Trafficking in Persons,
US Department of State. The facts about child sex tour-
ism. Washington, DC: US Department of State; 2005.
Available at: http://2001-2009.state.gov/documents/organi
zation/51459.pdf. Retrieved April 5, 2011.
8. Office to Monitor and Combat Trafficking in Persons,
US Department of State. Trafficking in persons report.
Washington, DC: US Department of State; 2008. Available
at: http://www.state.gov/documents/organization/105501.
pdf. Retrieved March 14, 2011.
9. Human Rights Watch. Hidden in the home: abuse of
domestic workers with special visas in the United States.
New York (NY): HRW; 2001. Available at: http://www.
hrw.org/legacy/reports/2001/usadom. Retrieved March 14,
2011.
10. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual.
3rd ed. Washington, DC: ACOG; 2007.
11. Office to Monitor and Combat Trafficking in Persons,
US Department of State. Assessment of U.S. government
activities to combat trafficking in persons. Washington,
DC: US Department of State; 2009. Available at: http://
www.state.gov/documents/organization/126789.pdf.
Retrieved March 14, 2011.
Copyright September 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Human trafficking. Committee Opinion No. 507. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;118:767–70.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 551
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 511 • November 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Health Care for Pregnant and Postpartum Incarcerated

Women and Adolescent Females
ABSTRACT. Clinicians who provide care for incarcerated women should be aware of the special health care
needs of pregnant incarcerated women and the specific issues related to the use of restraints during pregnancy
and the postpartum period. The use of restraints on pregnant incarcerated women and adolescents may not only
compromise health care but is demeaning and rarely necessary.

Between 1990 and 2009, the number of incarcerated

women increased 153% (1). Most women are incarcer-
ated for nonviolent crimes, including drug and property
offenses (2). On average, 6–10% of incarcerated women
are pregnant, with the highest rates in local jails (3). Data
on rates of pregnancy in juvenile facilities are limited, but
indicate higher rates than in adult facilities (4, 5).
The women in the criminal justice system are among
the most vulnerable in our society. Pregnancies among
incarcerated women are often unplanned and high-risk
and are compromised by a lack of prenatal care, poor
nutrition, domestic violence, mental illness, and drug and
alcohol abuse (6). Upon entry into a prison or jail,
every woman of childbearing age should be assessed for
pregnancy risk by inquiring about menstrual history,
heterosexual activity, and contraceptive use and tested
for pregnancy, as appropriate, to enable the provision of
adequate perinatal care and abortion services. Incarcerated
women who wish to continue their pregnancies should
have access to readily available and regularly scheduled
obstetric care, beginning in early pregnancy and continu-
ing through the postpartum period. Incarcerated pregnant
women also should have access to unscheduled or emer-
gency obstetric visits on a 24-hour basis. The medical care
provided should follow the guidelines of the American
College of Obstetricians and Gynecologists (see Box 1) (7).
Special Clinical Considerations
Because of high rates of substance abuse (8) and human
immunodeficiency virus (HIV) infection (9) among
incarcerated women, prompt screening for these condi-
tions in pregnant women is important. All pregnant
Box 1. Recommended Care
Intake
• Assess for pregnancy risk by inquiring about men-
strual history, heterosexual activity, and contraceptive
use and test for pregnancy as appropriate
During Pregnancy
• Provide pregnancy counseling and abortion services
• Provide perinatal care following guidelines of the
American Academy of Pediatrics and the American
College of Obstetricians and Gynecologists*
• Assess for substance abuse and initiate treatment;
prompt initiation of opioid-assisted therapy with meth-
adone or buprenorphine is critical for pregnant women
who are opioid-dependent
• Test for and treat human immunodeficiency virus (HIV)
to prevent perinatal HIV transmission
• Screen for depression or mental stress during preg-
nancy and for postpartum depression after delivery
and treat as needed
• Provide dietary supplements to incarcerated pregnant
and breastfeeding women
• Deliver services in a licensed hospital that has facili-
ties for high-risk pregnancies when available
• Provide postpartum contraceptive methods during
incarceration
*American Academy of Pediatrics, American College of Obstet-
ricians and Gynecologists. Guidelines for perinatal care. 6th ed.
Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 552

 women should be questioned about their past and pres-
ent use of alcohol, nicotine, and other drugs, including
the recreational use of prescription and over-the-counter
medication (7). Identification of pregnant women who
are addicted to opioids facilitates provision of opioid-
assisted therapy with methadone or buprenorphine.
Maintenance of opioid-assisted therapy can reduce the
risk of withdrawal, which can precipitate preterm labor
or fetal distress (10). In addition, substance abuse can
continue during incarceration despite efforts to prevent
drugs from entering correctional facilities. Effective drug
and alcohol treatment programs are essential. Pregnant
women universally should be tested for HIV infection
with patient notification unless they decline the test as
permitted by local and state regulations (7). Screening for
HIV infection allows for the initiation of essential treat-
ment to optimize maternal health and to prevent perina-
tal HIV transmission for HIV-positive pregnant women.
Incarcerated pregnant women should be screened for
depression or mental stress and for postpartum depres-
sion after delivery and be appropriately treated.
Good maternal nutrition can contribute positively to
the delivery of a healthy, full-term newborn of an appro-
priate weight. The recommended dietary allowances for
most vitamins and minerals increase during pregnancy
(7). Therefore, provision of dietary supplements to incar-
cerated pregnant and breastfeeding women is recom-
mended, as is access to a nutritious diet and timely and
regular meals.
Pregnant women who are required to stand or par-
ticipate in repetitive, strenuous, physical lifting are at risk
of preterm birth and small for gestational age infants.
In addition, a recovery period of 4–6 weeks generally is
required after delivery for resumption of normal activity
(7). This should be taken into consideration when assign-
ing work to incarcerated pregnant women and during the
postpartum period.
Pregnant women are at high risk of falls. Activities
with a high risk of falling should be avoided (7). Specif-
ically, incarcerated women should be given a bottom
bunk during pregnancy and the postpartum period.
Although maintaining adequate safety is critical,
correctional officers do not need to routinely be present
in the room while a pregnant woman is being examined
or in the hospital room during labor and delivery unless
requested by medical staff or the situation poses a danger
to the safety of the medical staff or others. Delivery services
for incarcerated pregnant women should be provided in
a licensed hospital with facilities for high-risk pregnan-
cies when available. Incarcerated pregnant women often
have short jail or prison stays and may not give birth
while incarcerated. Postpartum contraceptive options
should be discussed and provided during incarceration
to decrease the likelihood of an unintended pregnancy
during and after release from incarceration (11).
It is important to avoid separating the mother from
the infant. Prison nurseries or alternative sentencing of
2 Committee Opinion No. 511
COMMITTEE OPINIONS
women to community-based noninstitutional settings
should be considered for women during the postpartum
period. Correctional facilities should have provisions for
visiting infants for women in facilities without prison
nurseries. When adequate resources are available for
prison nursery programs, women who participate show
lower rates of recidivism, and their children show no
adverse effects as a result of their participation. In fact,
by keeping mothers and infants together, prison nursery
programs have been shown to prevent foster care place-
ment and allow for the formation of maternal–child
bonds during a critical period of infant development (12).
The American College of Obstetricians and Gyne-
cologists strongly supports breastfeeding as the preferred
method of feeding for newborns and infants (13). Given
the benefits of breastfeeding to both the mother and the
infant, incarcerated mothers wishing to breastfeed should
be allowed to either breastfeed their infants or express
milk for delivery to the infant. If the mother is to express
her milk, accommodations should be made for freezing,
storing, and transporting the milk. This can be difficult
to facilitate and is another argument for prison nurseries
or alternative sentencing of women to community-based
noninstitutional settings.
Barriers to Care
Barriers currently exist to the provision of recommended
care for incarcerated pregnant women and adolescents.
Thirty-eight states have failed to institute adequate poli-
cies, or any policies, requiring that incarcerated pregnant
women receive adequate prenatal care. Forty-one states
do not require prenatal nutrition counseling or the pro-
vision of appropriate nutrition to incarcerated pregnant
women, and 48 states do not offer pregnant women HIV
screening (14).
Limiting Use of Restraints
Use of restraints, often called shackling, is defined as using
any physical restraint or mechanical device to control
the movement of a prisoner’s body or limbs, including
handcuffs, leg shackles, and belly chains. In 2007, the U.S.
Marshals Service established policies and procedures for
the use of authorized restraining devices, indicating that
restraints should not be used when a pregnant prisoner
is in labor, delivery, or in immediate postdelivery recu-
peration (15). In 2008, the Federal Bureau of Prisons
ended the practice of shackling pregnant inmates as a
matter of routine in all federal correctional facilities (16).
That same year, the American Correctional Association
approved standards opposing the use of restraints on
female inmates during active labor and the delivery
of a child. The standards also state that before active
labor and delivery, restraints used on a pregnant inmate
should not put the woman or the fetus at risk (17). More
recently, in October 2010, the National Commission on
Correctional Health Care, which accredits correctional
facilities, adopted a position statement that opposes the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 553
 use of restraints on pregnant inmates (18). These stan-
dards serve as guidelines and are voluntary, not manda-
tory. State and local prisons and jails are not required
to abide by either the Federal Bureau of Prisons policy
or the National Commission on Correctional Health
Care standards, but several state legislatures and depart-
ments of corrections have enacted antishackling policies
recently. Despite progress, 36 states and the Immigration
and Customs Enforcement agency of the Department of
Homeland Security, which detains individuals who are in
violation of civil immigration laws pending deportation,
fail to limit the use of restraints on pregnant women dur-
ing transportation, labor and delivery, and postpartum
recuperation (14).
The use of restraints on pregnant incarcerated
women and adolescents may not only compromise health
care but is demeaning and rarely necessary. The apparent
purpose of shackling is to keep incarcerated women from
escaping or harming themselves or others. There are no
data to support this rationale because most incarcerated
women are nonviolent offenders. In addition, no escape
attempts have been reported among pregnant incarcer-
ated women who were not shackled during childbirth
(19). This demonstrates the feasibility of preserving the
dignity of incarcerated pregnant women and adolescents
and providing them with compassionate care. The safety
of health care personnel is paramount and for this reason,
adequate correctional staff must be available to monitor
incarcerated women, both during transport to and from
the correctional facility and during receipt of medical
care.
Physical restraints interfere with the ability of health
care providers to safely practice medicine by reducing
their ability to assess and evaluate the mother and the
fetus and making labor and delivery more difficult.
Shackling may put the health of the woman and fetus
at risk (see Box 2). Shackling during transportation to
medical care facilities and during the receipt of health
services should occur only in exceptional circumstances
for pregnant women and women within 6 weeks post-
partum after a strong consideration of the health effects
of restraints by the clinician providing care. Exceptions
include when there is imminent risk of escape or harm. If
restraint is needed, it should be the least restrictive pos-
sible to ensure safety and should never include restraints
that interfere with leg movement or the ability of the
woman to break a fall. The woman should be allowed to
lie on her side, not flat on her back or stomach. Pressure
should not be applied either directly or indirectly to
the abdomen. Correctional officers should be available
and required to remove the shackles immediately upon
request of medical personnel. Women should never be
shackled during evaluation for labor or labor and deliv-
ery. If restraint is used, a report should be filed by the
Department of Corrections and reviewed by an indepen-
dent body. There should be consequences for individuals
and institutions when use of restraints was unjustified.
Committee Opinion No. 511
COMMITTEE OPINIONS
Box 2. Examples of the Health Effects
of Restraints
• Nausea and vomiting are common symptoms of early
pregnancy. Adding the discomfort of shackles to a
woman already suffering is cruel and inhumane.
• It is important for women to have the ability to break
their falls. Shackling increases the risk of falls and
decreases the woman’s ability to protect herself and
the fetus if she does fall.
• If a woman has abdominal pain during pregnancy, a
number of tests to evaluate for conditions such as
appendicitis, preterm labor, or kidney infection may not
be performed while a woman is shackled.
• Prompt and uninhibited assessment for vaginal bleed-
ing during pregnancy is important. Shackling can delay
diagnosis, which may pose a threat to the health of the
woman or the fetus.
• Hypertensive disease occurs in approximately 12–22%
of pregnancies, and is directly responsible for 17.6% of
maternal deaths in the United States*. Preeclampsia
can result in seizures, which may not be safely treated
in a shackled patient.
• Women are at increased risk of venous thrombosis
during pregnancy and the postpartum period†. Limited
mobility caused by shackling may increase this risk
and may compromise the health of the woman and
fetus.
• Shackling interferes with normal labor and delivery:
— The ability to ambulate during labor increases the
likelihood for adequate pain management, suc-
cessful cervical dilation, and a successful vaginal
delivery.
— Women need to be able to move or be moved in
preparation for emergencies of labor and deliv-
ery, including shoulder dystocia, hemorrhage, or
abnormalities of the fetal heart rate requiring
intervention, including urgent cesarean delivery.
• After delivery, a healthy baby should remain with the
mother to facilitate mother–child bonding. Shackles
may prevent or inhibit this bonding and interfere with
the mother’s safe handling of her infant.
• As the infant grows, mothers should be part of the
child’s care (ie, take the baby to child wellness visits
and immunizations) to enhance their bond. Shackling
while attending to the child’s health care needs may
interfere with her ability to be involved in these activi-
ties.
*Diagnosis and management of preeclampsia and eclampsia.
ACOG Practice Bulletin No. 33. American College of Obstet-
ricians and Gynecologists. Obstet Gynecol 2002;99:159–67.
†
Thromboembolism in pregnancy. Practice Bulletin No. 123.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;118:718–29.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 554
 Recommendations
• Federal and state governments should adopt policies system. San Francisco (CA): National Council on Crime
to support provision of perinatal care for pregnant
and postpartum incarcerated women and adoles-
cents that follow the guidelines of the American
College of Obstetricians and Gynecologists. Mechan-
isms to ensure implementation of these policies and
adequate funding to provide this care need to be put
in place.
• Educational efforts are needed to increase the knowl-
edge of health care providers and correctional offi-
cers about issues specific to incarcerated pregnant
and postpartum women and adolescents.
• Obstetrician–gynecologists should support efforts 2005. Available at: http://bjs.ojp.usdoj.gov/content/pub/pdf/
to improve the health care of incarcerated pregnant
and postpartum women and adolescents at the local,
state, and national levels. Activities may include the
following:
— Advocating at the state and federal levels to restrict
shackling of incarcerated women and adolescents
during pregnancy and the postpartum period.
— Partnering with other organizations in the medi-
cal community opposed to shackling incarcerated
pregnant women such as the American Medical
Association and the Association of Women’s
Health, Obstetric and Neonatal Nurses (20, 21).
— Gaining representation on the boards of correc-
tional health organizations.
— Working in correctional facilities to provide ser-
vices to incarcerated pregnant and postpartum
women and adolescents and continuing care after
the woman’s release, when feasible.
— Undertaking efforts to ensure that medical needs
of pregnant and postpartum incarcerated women
and adolescents are being addressed appropriately,
such as by providing training or consultation to
health care providers and correctional officers in
prison settings.
References
1. Glaze LE. Correctional populations in the United States,
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ojp.usdoj.gov/content/pub/pdf/cpus09.pdf. Retrieved July
29, 2011.
2. West HC, Sabol WJ, Greenman SJ. Prisoners in 2009. Bureau
of Justice Statistics Bulletin. Washington, DC: Department of
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96:834–9.
4. Breuner CC, Farrow JA. Pregnant teens in prison. Prevalence,
management, and consequences. West J Med 1995;162:
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4 Committee Opinion No. 511
COMMITTEE OPINIONS
5. Acoca L, Dedel K. No place to hide: understanding and
meeting the needs of girls in the California juvenile justice
and Delinquency; 1998.
6. Clarke JG, Adashi EY. Perinatal care for incarcerated
patients: a 25-year-old woman pregnant in jail. JAMA 2011;
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7. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Guidelines for perinatal
care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC:
ACOG; 2007.
8. Karberg JC, James DJ. Substance dependence, abuse, and
treatment of jail inmates, 2002. Bureau of Justice Statistics
special report. Washington, DC: Department of Justice;
sdatji02.pdf. Retrieved July 29, 2011.
9. Maruschak LM. HIV in prisons, 2007–08. Bureau of Justice
Statistics bulletin. Washington, DC: Department of Justice;
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hivp08.pdf. Retrieved July 29, 2011.
10. Center for Substance Abuse Treatment. Medication-
assisted treatment for opioid addiction during pregnancy.
In: Medication-assisted treatment for opioid addiction
in opioid treatment programs. Treatment Improvement
Protocol (TIP) Series 43. DHHS Publication No. (SMA)
05-4048. Rockville (MD): Substance Abuse and Mental
Health Services Administration; 2005. Available at: http://
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11. Clarke JG, Phipps M, Tong I, Rose J, Gold M. Timing of
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alternatives. New York (NY): WPA; 2009. Available at:
http://www.wpaonline.org/pdf/Mothers%20Infants%20
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14. Rebecca Project for Human Rights, National Women’s Law
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DC: USMS; 2010. Available at: http://www.usmarshals.gov/
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 17. American Correctional Association. Public correctional
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COMMITTEE OPINIONS
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HnE%2fH-420.957.HTM. Retrieved July 29, 2011.
21. Shackling incarcerated pregnant women. AWHONN
Position Statement. Association of Women’s Health,
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Nurs 2011;40. DOI: 10.1111/j.1552-6909.2011.01300.x.
Copyright November 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care for pregnant and postpartum incarcerated women and
adolescent females. Committee Opinion No. 511. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;118:1198–1202.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 556
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 512 • December 2011
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or
procedure to be followed.

Health Care for Transgender Individuals

ABSTRACT: Transgender individuals face harassment, discrimination, and rejection within our society. Lack
of awareness, knowledge, and sensitivity in health care communities eventually leads to inadequate access to,
underutilization of, and disparities within the health care system for this population. Although the care for these
patients is often managed by a specialty team, obstetrician–gynecologists should be prepared to assist or refer
transgender individuals with routine treatment and screening as well as hormonal and surgical therapies. The
American College of Obstetricians and Gynecologists opposes discrimination on the basis of gender identity and
urges public and private health insurance plans to cover the treatment of gender identity disorder.

The Spectrum of Transgender Identity
Transgender is a broad term used for people whose gender
identity or gender expression differs from their assigned
sex at birth (Box 1) (1). However, there is no universally
accepted definition of the word “transgender” because of
the lack of agreement regarding what groups of people
are considered “transgender.” In addition, definitions
often vary by geographic region and by individual (2).
The American Psychiatric Association Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition,
Text Revision, considers transgender individuals to be
individuals with a disturbance in sexual or gender iden-
tity. Any combination of sexual and gender identity is
possible for transgender individuals (Box 2). The diag-
nosis of gender identity disorder is only established for
individuals with clinically significant distress and func-
tional impairment caused by the persistent discomfort
with one’s assigned sex and primary and secondary sex
characteristics. If untreated, gender identity disorder can
result in psychologic dysfunction, depression, suicidal
ideation, and even death (3).
Prevalence rates of transgender populations are not
clearly established; however, studies suggest that trans-
gender individuals constitute a small but substantial
population (4). Additional research is needed among this
population as outlined by the Institute of Medicine Report,
The Health of Lesbian, Gay, Bisexual, and Transgender
People: Building a Foundation for Better Understanding (2).
The social and economic marginalization of trans-
gender individuals is widespread. Harassment, discrim-
ination, and rejection occur frequently within an indi-
vidual’s own family and affect educational, employment,
and housing opportunities.
Transgender individuals, particularly young trans-
gender individuals, are disproportionately represented in
the homeless population (5). Once homeless, individuals
may be denied access to shelters because of their gender
or are placed in inappropriate housing. Subsequently,
many homeless transgender individuals turn to survival
sex (the exchange of sex for food, clothing, shelter, or
other basic needs), which increases the risk of exposure to
sexually transmitted infections and becoming victims of
violence (6). In one small study, 35% of male-to-female
transgender individuals tested positive for human immu-
nodeficiency virus (HIV), 20% were homeless, and 37%
reported physical abuse (7).
Barriers to Health Care
Within the medical community, transgender individuals
face significant barriers to health care. This includes the
failure of most health insurance plans to cover the cost
of mental health services, cross-sex hormone therapy,
or gender affirmation surgery. This barrier exists despite
evidence that such treatments are safe and effective and
that cross-gender behavior and gender identity issues are
not an issue of choice for the individual and cannot be
reversed with psychiatric treatment (8). With medical
and psychiatric care that affirms transgender identity, the
transgender individual can lead an enhanced, functional
life (9).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 557

 Box 1. Transgender Definitions
Transsexual—an individual who strongly identifies with
the other sex and seeks hormones or gender-affirmation
surgery or both to feminize or masculinize the body; may
live full-time in the crossgender role.*
Crossdresser—an individual who dresses in the cloth-
ing of the opposite sex for reasons that include a need
to express femininity or masculinity, artistic expression,
performance, or erotic pleasure, but do not identify as
that gender. The term “transvestite” was previously used
to describe a crossdresser, but it is now considered pejo-
rative and should not be used.†
Bigendered—individuals who identify as both or alter-
natively male and female, as no gender, or as a gender
outside the male or female binary.†
Intersex—individuals with a set of congenital varia-
tions of the reproductive system that are not considered
typical for either male or female. This includes newborns
with ambiguous genitalia, a condition that affects 1 in
2,000 newborns in the United States each year.‡
Female-to-male—refers to someone who was identified
as female at birth but who identifies and portrays his gen-
der as male. This term is often used after the individual
has taken some steps to express his gender as male, or
after medically transitioning through hormones or sur-
gery. Also known as FTM or transman.†
Male-to-female—refers to someone who was identified
as male at birth but who identifies and portrays her gen-
der as female. This term is often used after the individual
has taken some steps to express her gender as female,
or after medically transitioning through hormones or sur-
gery. Also known as MTF or transwoman.†
* The health of lesbian, gay, bisexual, and transgender people:
building a foundation for better understanding. Committee on
Lesbian, Gay, Bisexual, and Transgender Health Issues and
Research Gaps and Opportunities, Board on the Health of Select
Populations, Institute of Medicine of the National Academies.
Washington, DC: National Academies Press; 2011. Available at:
http://www.nap.edu/openbook.php?record_id=13128&page=R1.
Retrieved August 8, 2011.
†
Fenway Health. Glossary of gender and transgender terms. Boston
(MA): Fenway Health; 2010. Available at: http://www.fenwayhealth.
org/site/DocServer/Handout_7-C_Glossary_of_Gender_and_
Transgender_Terms__fi.pdf. Retrieved July 22, 2011.
‡
Dreger AD. “Ambiguous sex”--or ambivalent medicine? Ethical
issues in the treatment of intersexuality. Hastings Cent Rep 1998;
28:24–35.
The consequences of inadequate treatment are stag-
gering. Fifty-four percent of transgender youth have
attempted suicide and 21% resort to self-mutilation. More
than 50% of persons identified as transgender have used
injected hormones that were obtained illegally or used
outside of conventional medical settings. Additionally,
such individuals frequently resort to the illegal and dan-
gerous use of self-administered silicone injections to
2 Committee Opinion No. 512
COMMITTEE OPINIONS
Box 2. Sexual Identity and Gender
Identity Definitions
Sex—designation of a person at birth as male or female
based on anatomy and biology.*
Gender identity—a person’s innate identification as a
man, woman, or something else that may or may not
correspond to the person’s external body or assigned
sex at birth.*
Gender expression—how individuals present themselves
socially, including clothing, hairstyle, jewelry, and physi-
cal characteristics, including speech and mannerisms.
This may not be the same gender in all settings.*
Sexual orientation—a person’s physical, romantic, emo-
tional, and/or spiritual attraction to individuals of the
same (lesbian or gay), different (heterosexual), or both
(bisexual) biologic sexes. Sexual orientation does not
define the real-life sexual practices and behaviors of an
individual.*
Sexual behavior—the sexual encounters and behaviors
of the individual. This is likely to be the most important
factor in assessing the risk of sexually transmitted infec-
tions. Sexual behavior differs from sexual orientation;
for example, not all individuals who engage in same-sex
behaviors view themselves as gay, lesbian, or bisexual.
Legal sex—sex as stated on legal identifications, forms,
and documents. Transgender individuals may adopt a
second name other than their legal name with which
they may prefer to be addressed. Transgender persons
should be asked for their preferred name, even if it dif-
fers from their legal name and sex. State regulations vary
and it may be difficult or impossible for a transgender
individual to meet that state’s requirements to change
their legal sex.†
*Fenway Health. Glossary of gender and transgender terms. Boston
(MA): Fenway Health; 2010. Available at: http://www.fenwayhealth.
org/site/DocServer/Handout_7-C_Glossary_of_Gender_and_
Transgender_Terms__fi.pdf. Retrieved July 22, 2011.
†
This is a significant issue for transgender individuals. Some
states have adopted progressive laws that do not require gen-
der-affirmation surgery or an original birth certificate; instead,
these laws allow individuals to change their legal sex with
a letter from their health care providers stating that the indi-
viduals live their lives as this gender. See the National Center
for Transgender Equality (www.transequality.org) and the
Transgender Law and Policy Institute (www.transgenderlaw.
org) for more information, including descriptions of state laws.
spur masculine or feminine physiologic changes (5). The
American College of Obstetricians and Gynecologists,
therefore, urges public and private health insurance plans
to cover the treatment of gender identity disorder.
Caring for Transgender Individuals
Obstetrician–gynecologists should be prepared to assist
or refer transgender individuals for routine treatment
2013 COMPENDIUM OF SELECTED PUBLICATIONS 558
 and screening as well as hormonal and surgical thera-
pies. Basic preventive services, like sexually transmitted
infection testing and cancer screening, can be provided
without specific expertise in transgender care. Hormonal
and surgical therapies for transgender patients may be
requested, but should be managed in consultation with
health care providers with expertise in specialized care
and treatment of transgender patients (see Resources).
Physical and emotional issues for transgender individu-
als and the effects of aging, as in all other individuals,
affect the health status of this population and should
be addressed. Health care providers who are morally
opposed to providing care to this population should
refer them elsewhere for care. For more information, a
resource guide on health care for transgender individuals
is available at www.acog.org/departments/dept_notice.
cfm?recno=18&bulletin=5825.
Creating a Welcoming Environment
Health care providers’ discomfort when treating trans-
gender individuals may alienate patients and result in
lower quality or inappropriate care as well as deter them
from seeking future medical care (10). Excellent resources
exist to facilitate the provision of culturally competent
care for transgender patients (10). Adding a “transgender”
option to check boxes on patient visit records can help to
better capture information about transgender patients,
and could be a sign of acceptance to that person (10).
Questions should be framed in ways that do not make
assumptions about gender identity, sexual orientation, or
behavior. It is more appropriate for clinicians to ask their
patients which terms they prefer (1). Language should be
inclusive, allowing the patient to decide when and what
to disclose. The adoption and posting of a nondiscrimi-
nation policy can also signal health care providers and
patients alike that all persons will be treated with dignity
and respect. Assurance of confidentiality can allow for
a more open discussion, and confidentiality must be
ensured if a patient is being referred to a different health
care provider. Training staff to increase their knowledge
and sensitivity toward transgender patients will also
help facilitate a positive experience for the patient (10).
It is important to prepare now to treat a future trans-
gender patient. Additional guidelines for creating a wel-
coming office environment for transgender patients
have been developed by the Gay and Lesbian Medical
Association and can be found at http://www.glma.org/_
data/n_0001/resources/live/GLMA%20guidelines%20
2006%20FINAL.pdf.
Gender Transition: World Professional
Association for Transgender Health
Guidelines
The World Professional Association for Transgender
Health is a multidisciplinary professional society rep-
resenting the specialties of medicine, psychology, social
Committee Opinion No. 512
COMMITTEE OPINIONS
sciences, and law. Their published clinical guidelines
about the psychiatric, psychologic, medical, and surgical
management of gender identity disorders are widely used
by specialists in transgender health care (11), but are not
universally accepted by all members of the transgender
health community because critics consider them to be
overly restrictive and inflexible.
The World Professional Association for Transgender
Health guidelines describe the transition from one gender
to another in three stages: 1) living in the gender role
consistent with gender identity; 2) the use of cross-sex
hormone therapy after living in the new gender role for at
least 3 months; 3) gender-affirmation surgery after living
in the new gender role and using hormonal therapy for at
least 12 months. Additional clinical guidelines have been
published by the Endocrine Society (12).
Female-to-Male Transgender Individuals
Hormones
Methyltestosterone injections every 2 weeks are usually
sufficient to suppress menses and induce masculine sec-
ondary sex characteristics (13). Before receiving androgen
therapy, patients should be screened for medical contrain-
dications and have periodic laboratory testing, including
hemoglobin and hematocrit to evaluate for polycythemia,
liver function tests, and serum testosterone level assess-
ments (goal is a mid normal male range of 500 micro-
gram/dL), while receiving the treatment.
Surgery
Hysterectomy, with or without salpingo-oophorectomy,
is commonly part of the surgical process. An obstetri-
cian–gynecologist who has no specialized expertise in
transgender care may be asked to perform this surgery,
and also may be consulted for routine reasons such as
dysfunctional bleeding or pelvic pain. Reconstructive
surgery should be performed by a urologist, gynecologist,
plastic surgeon, or general surgeon who has specialized
competence and training in this field.
Screening
Age-appropriate screening for breast cancer and cervical
cancer should be continued unless mastectomy or removal
of the cervix has occurred. For patients using androgen
therapy who have not had a complete hysterectomy, there
may be an increased risk of endometrial cancer and ovar-
ian cancer (13).
Male-to-Female Transgender Individuals
Hormones
Estrogen therapy results in gynecomastia, reduced hair
growth, redistribution of fat, and reduced testicular vol-
ume. All patients considering therapy should be screened
for medical contraindications. After surgery, doses of estra-
diol, 2–4 mg/d, or conjugated equine estrogen, 2.5 mg/d,
are often sufficient to keep total testosterone levels to nor-
mal female levels of less than 25 ng/dL. Nonoral therapy
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 559
 also can be offered. It is recommended that male-to-female
transgender patients receiving estrogen therapy have an
annual prolactin level assessment and visual field exami-
nation to screen for prolactinoma (13).
Surgery
Surgery usually involves penile and testicular excision
and the creation of a neovagina (14). Reported complica-
tions of surgery include vaginal and urethral stenosis, fis-
tula formation, problems with remnants of erectile tissue,
and pain. Vaginal dilation of the neovagina is required to
maintain patency. Other surgical procedures that may be
performed include breast implants and nongenital sur-
gery, such as facial feminization surgery.
Screening
Age-appropriate screening for breast and prostate cancer
is appropriate for male-to-female transgender patients.
Opinion varies regarding the need for Pap testing in this
population. In patients who have a neocervix created
from the glans penis, routine cytologic examination of
the neocervix may be indicated (15). The glans are more
prone to cancerous changes than the skin of the penile
shaft, and intraepithelial neoplasia of the glans is more
likely to progress to invasive carcinoma than is intraepi-
thelial neoplasia of other penile skin (14).
Conclusion
Obstetrician–gynecologists should be prepared to assist
or refer transgender individuals. Physicians are urged to
eliminate barriers to access to care for this population
through their own individual efforts. An important step
is to identify the sexual orientation and gender identity
status of all patients as a routine part of clinical encoun-
ters and recognize that many transgender individuals
may not identify themselves. The American College of
Obstetricians and Gynecologists urges health care pro-
viders to foster nondiscriminatory practices and policies
to increase identification and to facilitate quality health
care for transgender individuals, both in assisting with
the transition if desired as well as providing long-term
preventive health care.
Resources
Select clinics with expertise in treating transgender
individuals:
Fenway Community Health
www.fenwayhealth.org
University of Minnesota, Center for Sexual Health
www.phs.umn.edu/clinic/home.html
Callen-Lorde Community Health Center
www.callen-lorde.org
Tom Waddell Health Center
www.sfdph.org/dph/comupg/oservices/medSvs/hlthCtrs/
TransgenderHlthCtr.asp
4 Committee Opinion No. 512
COMMITTEE OPINIONS
References
1. Fenway Health. Glossary of gender and transgender terms.
Boston (MA): Fenway Health; 2010. Available at: http://
www.fenwayhealth.org/site/DocServer/Handout_7-C_
Glossary_of_Gender_and_Transgender_Terms__fi.pdf.
Retrieved July 22, 2011.
2. The health of lesbian, gay, bisexual, and transgender people:
building a foundation for better understanding. Committee
on Lesbian, Gay, Bisexual, and Transgender Health Issues
and Research Gaps and Opportunities, Board on the
Health of Select Populations, Institute of Medicine of the
National Academies. Washington, DC: National Academies
Press; 2011. Available at: http://www.nap.edu/openbook.
php?record_id=13128&page=R1. Retrieved August 8, 2011.
3. American Psychiatric Association. Gender identity disor-
der. In: Diagnostic and statistical manual of mental dis-
orders. 4th ed. text revision. Washington, DC: APA; 2000.
p. 576–82.
4. Olyslager F, Conway L. On the calculation of the prevalence
of transsexualism. Paper presented at the WPATH 20th
International Symposium, Chicago, Illinois, September 5–8,
2007. Available at: http://ai.eecs.umich.edu/people/conway/
TS/Prevalence/Reports/Prevalence%20of%20Transsexual-
ism.pdf. Retrieved July 12, 2011.
5. Ray N. Lesbian, gay, bisexual and transgender youth: an
epidemic of homelessness. New York (NY): National Gay
and Lesbian Task Force Policy Institute; National Coali-
tion for the Homeless; 2006. Available at: http://www.the
taskforce.org/downloads/HomelessYouth.pdf. Retrieved
July 22, 2011.
6. Crossing to safety: transgender health and homelessness.
Health Care for the Homeless Clinicians’ Network. Healing
Hands 2002;6(4):1–2. Available at: http://www.nhchc.org/
Network/HealingHands/2002/June2002HealingHands.pdf.
Retrieved July 22, 2011.
7. San Francisco Department of Public Health. The Trans-
gender Community Health Project: descriptive results.
San Francisco (CA): SFDPH; 1999. Available at: http://
hivinsite.ucsf.edu/InSite?page=cftg-02-02. Retrieved July
22, 2011.
8. National Coalition for LGBT Health. An overview of
U.S. trans health priorities: a report by the Eliminating
Disparities Working Group. Washington, DC: National
Coalition for LGBT Health; 2004. Available at: http://tran-
sequality.org/PDFs/HealthPriorities.pdf. Retrieved July 22,
2011.
9. American Medical Association. Patient-physician relation-
ship: respect for law and human rights. In: Code of medical
ethics of the American Medical Association: current opinions
with annotations. 2010–2011 ed. Chicago (IL): AMA; 2010.
p. 349–51.
10. Gay and Lesbian Medical Association. Guidelines for
care of lesbian, gay, bisexual, and transgender patients.
Washington, DC: GLMA; 2006. Available at: http://www.
glma.org/_data/n_0001/resources/live/GLMA%20guide-
lines%202006%20FINAL.pdf. Retrieved July 22, 2011.
11. World Professional Association for Transgender Health.
The Harry Benjamin International Gender Dysphoria
Association’s standards of care for gender identity dis-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 560
 orders. 6th version. Minneapolis (MN): WPATH; 2001.
Available at: http://www.wpath.org/documents2/socv6.pdf.
Retrieved July 22, 2011.
12. Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA,
Gooren LJ, Meyer WJ 3rd, Spack NP, et al. Endocrine treat-
ment of transsexual persons: an Endocrine Society clini-
cal practice guideline. J Clin Endocrinol Metab 2009;94:
3132–54.
13. Moore E, Wisniewski A, Dobs A. Endocrine treatment of
transsexual people: a review of treatment regimens, out-
comes, and adverse effects. J Clin Endocrinol Metab 2003;
88:3467–73.
14. Lawrence AA. Vaginal neoplasia in a male-to-female trans-
sexual: case report, review of the literature, and recom-
mendations for cytological screening. Int J Transgender
2001;5(1). Available at: http://www.wpath.org/journal/www.
iiav.nl/ezines/web/IJT/97-03/numbers/symposion/ijtvo-
05no01_01.htm. Retrieved July 22, 2011.
Committee Opinion No. 512
COMMITTEE OPINIONS
15. Feldman JL, Goldberg J. Transgender primary medical care:
suggested guidelines for clinicians in British Columbia.
Vancouver (BC): Transgender Health Program; 2006.
Available at: http://transhealth.vch.ca/resources/library/
tcpdocs/guidelines-primcare.pdf. Retrieved July 22, 2011.
Copyright December 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care for transgender individuals. Committee Opinion No. 512.
American College of Obstetricians and Gynecologists. Obstet Gyne-
col 2011;118:1454–8.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 561
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 516 • January 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Health Care Systems for Underserved Women

ABSTRACT: Underserved women are those who are unable to obtain quality health care by virtue of barriers
created by poverty, cultural differences, race or ethnicity, geography, sexual orientation, gender identity, or other
factors that contribute to health care inequities. With passage of the Patient Protection and Affordable Care Act
Public Law 111–148 and 152, there is promise for increased health insurance coverage for underserved women.
There is concern, however, that specific populations of underserved women may be left out. These women must
continue to have access to existing safety net health care providers and to new models of care with systems that
support integrated service delivery and improved care coordination.

Health Care Systems
A health system is the sum total of all the organizations,
institutions, and resources whose primary purpose is to
improve health (1). The U.S. health care system is a large
and complex system with many components (eg, clinics,
hospitals, pharmacies, and laboratories). These compo-
nents are interconnected through the flow of patients and
information with the aim of maintaining and improving
health (2). Understanding a health care system perspec-
tive is critical to improving the delivery of care to women.
Poorly structured health care systems disproportionately
affect the delivery of care to underserved populations. A
goal of the Patient Protection and Affordable Care Act
(ACA) is to ensure effective system strategies to permit
access for all, including underserved women.
Underserved women are those who are unable to
obtain quality health care by virtue of barriers created by
poverty, cultural differences, race or ethnicity, geography,
sexual orientation, gender identity, or other factors that
contribute to health care inequities. Underserved women
are typically in need of more health services because of
high rates of chronic conditions and unmet reproductive
health care needs (3). Moreover, underserved women are
at an increased risk of health problems related to limited
access to quality health care in addition to elevated levels
of poverty and geographic and social isolation. For exam-
ple, Asian and Pacific Islander women, especially those
who are Vietnamese; black women; American Indian and
Alaska Native women; and Hispanic women have higher
incidence rates of invasive cervical cancer than non-
Hispanic white women (4, 5). Cervical cancer mortality
rates are higher among black women (4.4 per 100,000)
than among all racial and ethnic populations combined
(2.4 per 100,000) (4). Cervical cancer rates for Hispanic
women are nearly twice those of non-Hispanic white
women and death rates are 48% greater (4). A compre-
hensive study indicates that inequities in mortality rates
are due in large part to inequities in access to health care
services (6).
Key Issues Important to Underserved
Populations
Women have much at stake with the ACA. Currently,
increasing health care costs disproportionately affect
women with low incomes and minority women. More
than one half of women report delaying or avoiding
needed care because of cost (7). Additionally, some
women experience challenges in receiving coverage for
critical services, such as maternity care (8). For many,
the challenges are due to their lack of insurance or inade-
quate coverage, but educational, cultural, and logistical
factors also can compromise access to care. In 2010,
there were approximately 19 million uninsured women,
aged 18–64 years (9). These women face risks, including
lack of access to care, low quality of care, and poor health
outcomes (10). Moreover, uninsured women are more
likely than their insured counterparts to postpone obtain-
ing necessary prescriptions and preventive services, such
as screening for cervical cancer and breast cancer (3).
Preventive care services, preconception care, well-
woman care, family planning, and subspecialty care are
all critical to women’s health. The scope of care varies

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 562

 across the lifespan and specific aspects are of particular
importance to underserved women. Local and national
policies should ensure the delivery of culturally sensitive
services to vulnerable populations, such as minorities and
individuals with disabilities, and ensure the existence of
a safety net. Safety net programs provide health care for
individuals, regardless of their ability to pay. Moreover,
coordination with other key services, including mental
health care, results in the delivery of high-quality care.
There are several mandated benefits in the ACA spe-
cific to women (Box 1). The ACA also encourages state
expanded coverage of family planning (11). Health insur-
ance coverage is a critical aspect of ensuring that health
care is accessible to women. Additional strategies that
must be incorporated locally to ensure that the health
care system is responsive to the needs of women include
timely identification of patient risk factors, effective coor-
dination of care to allow linkages to appropriate levels
of care (eg, specialty care), and the provision of oppor-
tunities to ensure comprehensive care (12). These addi-
tional strategies are especially important for underserved
women.
Patient Protection and Affordable
Care Act
The ACA has the potential to improve access to care
for millions of underserved women across the nation.
Generally, health insurance coverage will be granted
to very low-income women, and insurers will be pro-
hibited from denying coverage because of pre-existing
conditions. Women will no longer face varying premium
rates because of gender or health status (3). Through
expansion of coverage, women up to age 26 years can
be covered under their parents’ insurance policies.
Additionally, the ACA allows direct access to obstetrician–
gynecologists, which will facilitate women’s health care
service delivery, including access to maternity care and
preconception care. At present, several aspects of the law
have been implemented, whereas others have yet to be
determined (11).
Workforce and Health Systems
A key aspect of a well-designed health system is a well-
trained workforce (13). Women must have access to a
multidisciplinary, culturally competent health care pro-
vider workforce that includes professional specialty and
primary health care providers for women (eg, obstetri-
cian–gynecologists) and certified, trained, and qualified
allied health care providers. Accredited education, profes-
sional certification, and licensure are essential to ensure
skilled health care providers at all levels of care.
Because of geographic maldistribution, there is a
relative shortage of obstetrician–gynecologists for the
U.S. population (14). Under the ACA, more women
will have access to health care, creating increasing pres-
sure for the provision of care by a wide range of trained
health care providers. These changing needs will require
2 Committee Opinion No. 516
COMMITTEE OPINIONS
seamless integrated health care provider relationships
across specialties.
Obstetrician–gynecologists provide women’s health
care throughout the lifespan, often functioning as pri-
mary health care providers in a collaborative team. The
American College of Obstetricians and Gynecologists has
long supported collaborative practice in an integrated,
patient-focused health care delivery system to help ensure
high-quality care. Such high-quality care depends on
appropriately trained and certified health care providers,
open communication and transparency, ongoing health
care provider performance evaluation, use of evidence-
based guidelines, and patient education. Exemplary sys-
tems of care with these characteristics should be identified
and replicated.
Health System Models
Currently, a number of health care systems provide for
underserved women. These include hospitals, publicly
funded clinics, community health centers, federally quali-
fied health centers, Title X Family Planning centers, man-
aged care delivery systems, and accredited free-standing
birth centers. Emergency departments also serve as a
vital component of the health care system by providing
care 24 hours a day, seven days a week to all who seek
care, thereby addressing logistical and financial barriers
faced by underserved women attempting to access care
(15, 16). Under health reform, underserved women must
continue to have access to these existing sites of care and
also to new models of care that improve continuity of
care and incorporate health information systems that
support integrated service delivery and improved care
coordination.
Conclusion
Health systems should be designed to achieve the funda-
mental goal of improving the health of the population
served with an emphasis on fairness and responsiveness
(17). Underserved women have a disproportionate share
of adverse outcomes, such as higher breast cancer mor-
tality rates among black populations than among any
other racial or ethnic group (4). Underserved women
also encounter challenges in interactions with the health
care system that pertain to cultural, educational, and logis-
tical factors. As implementation of the ACA moves for-
ward, stakeholders must advocate for expansion of access
for underserved women. Key areas include the following:
• Provision of culturally competent care
• Tracking of outcomes with attention to racial and
ethnic minorities and other populations who experi-
ence health inequities
• Coordination of key services, such as mental health
care and reproductive health care
• Funding of comparative effectiveness research to
develop effective interventions for underserved
women
2013 COMPENDIUM OF SELECTED PUBLICATIONS 563
 Box 1. Mandated Benefits in the Affordable Care Act Specific to Women* ^
• Access to women’s preventive health services without cost sharing, including the following:
Comprehensive lactation support and counseling from trained health care providers and renting breastfeeding equipment
Counseling for a healthy diet
Counseling for tobacco use
Counseling for sexually transmitted infections in sexually active women
Counseling and screening for human immunodeficiency virus (HIV) in sexually active women
Full range of U.S. Food and Drug Administration approved contraceptive methods and contraceptive counseling
Mammography
Screening for cervical cancer, including high-risk human papillomavirus DNA testing in women older than 30 years with
normal cytology results
Screening and counseling for interpersonal and domestic violence
Screening and counseling for obesity
Screening and counseling to reduce alcohol misuse
Screening for depression
Screening for gestational diabetes in pregnant women between 24 weeks and 28 weeks of gestation and at the first
prenatal visit for pregnant women identified to be at high risk of diabetes
Screening for gonorrhea and chlamydial infection in certain populations of sexually active women
Well-woman visits, including preconception care and prenatal care, for adult women to obtain recommended preven-
tive services, allowing for additional visits, depending on the women’s health status, needs, and other risk factors
• Maternity coverage
• Medicaid coverage of accredited free-standing birth center services
• Medicaid coverage of smoking cessation
*Catastrophic plans will be able to be offered through the exchanges for individuals younger than 30 years or if other plans are deemed
to be unaffordable. These plans are exempt from having to meet the essential health benefits standard, which includes maternity care.
Department of Health and Human Services. Affordable Care Act rules on expanding access to preventive services for women.
Washington, DC: DHHS; 2011. Available at: http://www.healthcare.gov/news/factsheets/womensprevention08012011a.html. Retrieved
September 21, 2011.
Department of Health and Human Services. U.S. Preventive Services Task Force recommendations: grade A and B recommendations
of the United States Preventive Services Task Force. Available at: http://www.healthcare.gov/law/resources/regulations/prevention/
taskforce.html. Retrieved September 27, 2011.
Department of Health and Human Services. Affordable Care Act expands prevention coverage for women’s health and well-being.
Washington, DC: DHHS; 2011. Available at: http://www.healthcare.gov/law/resources/regulations/womensprevention.html. Retrieved
September 27, 2011.
Department of Health and Human Services. Recommended preventive services. Washington, DC: DHHS; 2011. Available at: http://www.
healthcare.gov/law/resources/regulations/prevention/recommendations.html. Retrieved September 27, 2011.
Patient Protection and Affordable Care Act, Pub. L. No. 111–148, § 1302, 124 Stat. 119 (2010).
Patient Protection and Affordable Care Act, Pub. L. No. 111–148, § 2301, 124 Stat. 119 (2010).
Patient Protection and Affordable Care Act, Pub. L. No. 111–148, § 4107, 124 Stat. 119 (2010).

Despite the promise of the ACA to improve health
insurance coverage, some populations may be left out.
It is estimated that with full implementation of the ACA
in 2014, the rate of uninsured Americans younger than
65 years will decrease from 18.9% to 8.7%. Of the remain-
ing Americans younger than 65 years, approximately
25% will be undocumented immigrants and 16.2%
will be legal residents who qualify for the affordability
exemption (18). Safety net health care providers, includ-
ing Federally Qualified Health Centers and emergency
departments, must continue to offer care to populations
who may not benefit from the ACA.
Even if the ACA is never fully implemented, the
benefits expected to be achieved by its passage should
still be sought. We have an obligation to address the issue
of underserved women with or without the ACA. A well
functioning health care system responds in a balanced
way to a population’s needs and expectations by (19)
• improving the health status of individuals, families,
and communities
• defending the population against health threats
• protecting the population against the financial conse-
quences of ill-health

Committee Opinion No. 516 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 564

 • providing equitable access to patient-centered care 10. Henry J. Kaiser Family Foundation. The uninsured: a primer.
• ensuring patient participation in decision making Key facts about Americans without health insurance. Menlo
regarding health
These health system characteristics are important ele-
ments of ensuring quality care to all women, including
underserved women.
References
1. World Health Organization. What is a health system?
Geneva: WHO; 2005. Available at: http://www.who.int/
features/qa/28/en/index.html. Retrieved September 21,
2011. ^
2. Institute of Medicine. Crossing the quality chasm: a new
health system for the 21st century. Washington, DC:
National Academy Press; 2001. ^
3. Henry J. Kaiser Family Foundation. Women’s health insur-
ance coverage. Menlo Park (CA): KFF; 2010. Available
at: http://www.kff.org/womenshealth/upload/6000-09.pdf.
Retrieved September 21, 2011. ^
4. Altekruse SF, Kosary CL, Krapcho M, Neyman N, Aminou R,
Waldron W et al, editors. SEER cancer statistics review,
1975-2007. Bethesda (MD): National Cancer Institute; 2010.
Available at: http://seer.cancer.gov/csr/1975_2007. Retrieved
September 27, 2011. ^
5. Satcher D. American women and health disparities. J Am
Med Womens Assoc 2001;56:131–2, 160. [PubMed] ^
6. Freeman HP, Wingrove BK. Excess cervical cancer mor-
tality: a marker for low access to health care in poor
communities. NIH Pub. No. 05–5282. Rockville (MD):
National Cancer Institute, Center to Reduce Cancer Health
Disparities; 2005. Available at: http://crchd.cancer.gov/
attachments/excess-cervcanmort.pdf. Retrieved September
19, 2011. ^
7. Rustgi SD, Doty MM, Collins SR. Women at risk: why
many women are forgoing needed health care. An analysis
of the Commonwealth Fund 2007 biennial health insur-
ance survey. New York (NY): The Commonwealth Fund;
2009. Available at: http://www.commonwealthfund.org/~/
media/Files/Publications/Issue%20Brief/2009/May/
Women%20at%20Risk/PDF_1262_Rustgi_women_at_
risk_issue_brief_Final.pdf. Retrieved September 21, 2011.
^ Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
8. National Women’s Law Center. Still nowhere to turn:
insurance companies treat women like a pre-existing con-
dition. Washington, DC: NWLC; 2009. Available at: http://
www.nwlc.org/sites/default/files/pdfs/stillnowheretoturn.
pdf. Retrieved September 27, 2011. ^
9. Henry J. Kaiser Family Foundation. The uninsured: a primer.
Supplemental data tables. Menlo Park, CA: KFF; 2011.
Available at: http://www.kff.org/uninsured/upload/7451-
07-Data-Tables.pdf. Retrieved October 20, 2011. ^
4 Committee Opinion No. 516
COMMITTEE OPINIONS
Park (CA): KFF; 2010. Available at: http://www.kff.org/
uninsured/upload/7451-06.pdf. Retrieved September 21,
2011. ^
11. Henry J. Kaiser Family Foundation. Impact of health
reform on women’s access to coverage and care. Menlo
Park (CA): KFF; 2010. Available at: http://www.kff.org/
womenshealth/upload/7987.pdf. Retrieved September 21,
2011. ^
12. American Academy of Pediatrics, American College of
Obstetricians and Gynecologists. Guidelines for perinatal
care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC:
ACOG; 2007. ^
13. World Health Organization. Health systems. Available at:
http://www.who.int/topics/health_systems/en. Retrieved
September 21, 2011. ^
14. Rayburn WF. The obstetrician–gynecologist workforce in
the United States: facts, figures, and implications. Washing-
ton, DC: American Congress of Obstetricians and Gyne-
cologists; 2011. ^
15. Richardson LD, Hwang U. Access to care: a review of the
emergency medicine literature. Acad Emerg Med 2001;8:
1030–6. [PubMed] [Full Text] ^
16. Lowe RA, Schull M. On easy solutions. Ann Emerg Med
2011;58:235–8. [PubMed] ^
17. World Health Organization. Health systems: improv-
ing performance. The world health report 2000. Geneva:
WHO; 2000. Available at: http://www.who.int/whr/2000/
en/whr00_en.pdf. Retrieved September 21, 2011. ^
18. Buettgens M, Hall MA. Who will be uninsured after health
insurance reform? Princeton (NJ): Robert Wood Johnson
Foundation; 2011. Available at: http://www.rwjf.org/files/
research/71998.pdf. Retrieved September 21, 2011. ^
19. World Health Organization. Key components of a well
functioning health system. Geneva: WHO; 2010. Available at:
http://www.who.int/healthsystems/EN_HSSkey
components.pdf. Retrieved September 21, 2011. ^
Copyright January 2012 by the American College of Obstetricians and
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care systems for underserved women. Committee Opinion
No. 516. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;119:206–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 565
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 518 • February 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Intimate Partner Violence

ABSTRACT: Intimate partner violence (IPV) is a significant yet preventable public health problem that affects
millions of women regardless of age, economic status, race, religion, ethnicity, sexual orientation, or educational
background. Individuals who are subjected to IPV may have lifelong consequences, including emotional trauma,
lasting physical impairment, chronic health problems, and even death. Although women of all ages may experience
IPV, it is most prevalent among women of reproductive age and contributes to gynecologic disorders, pregnancy
complications, unintended pregnancy, and sexually transmitted infections, including human immunodeficiency
virus (HIV). Obstetrician–gynecologists are in a unique position to assess and provide support for women who
experience IPV because of the nature of the patient–physician relationship and the many opportunities for interven-
tion that occur during the course of pregnancy, family planning, annual examinations, and other women’s health
visits. The U.S. Department of Health and Human Services has recommended that IPV screening and counseling
should be a core part of women’s preventive health visits. Physicians should screen all women for IPV at periodic
intervals, including during obstetric care (at the first prenatal visit, at least once per trimester, and at the postpar-
tum checkup), offer ongoing support, and review available prevention and referral options. Resources are available
in many communities to assist women who experience IPV.

Intimate partner violence (IPV) is a pattern of assaultive
behavior and coercive behavior that may include physical
injury, psychologic abuse, sexual assault, progressive iso-
lation, stalking, deprivation, intimidation, and reproduc-
tive coercion (1). These types of behavior are perpetrated
by someone who is, was, or wishes to be involved in an
intimate or dating relationship with an adult or adoles-
cent, and is aimed at establishing control of one partner
over the other (1). It can occur among heterosexual or
same-sex couples and can be experienced by both men
and women in every community regardless of age, eco-
nomic status, race, religion, ethnicity, sexual orientation,
or educational background. Individuals who are subjec-
ted to IPV may have lifelong consequences, including
emotional trauma, lasting physical impairment, chronic
health problems, and even death.
More than one in three women in the United States
have experienced rape, physical violence, or stalking by an
intimate partner in their lifetime (2). In the United States,
women experience 4.8 million incidents of physical or
sexual assault annually (3). However, the true prevalence
of IPV is unknown because many victims are afraid to
disclose their personal experiences of violence. Intimate
partner violence caused 2,340 deaths in 2007; of this
number, 1,640 were female and 700 were male (4).
Patterns of Intimate Partner Violence
Intimate partner violence encompasses subjection of a
partner to physical abuse, psychologic abuse, sexual vio-
lence, and reproductive coercion. Physical abuse can
include throwing objects, pushing, kicking, biting, slap-
ping, strangling, hitting, beating, threatening with any
form of weapon, or using a weapon. Psychologic abuse
erodes a woman’s sense of self-worth and can include
harassment; verbal abuse such as name calling, degrada-
tion, and blaming; threats; stalking; and isolation. Often,
the abuser progressively isolates the woman from fam-
ily and friends and may deprive her of food, money,
transportation, and access to health care (5). Sexual vio-
lence includes a continuum of sexual activity that covers
unwanted kissing, touching, or fondling; sexual coercion;
and rape (6). Reproductive coercion involves behavior used
to maintain power and control in a relationship related
to reproductive health and can occur in the absence of
physical or sexual violence. A partner may sabotage efforts
at contraception, refuse to practice safe sex, intentionally

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 566

 expose a partner to a sexually transmitted infection (STI)
or human immunodeficiency virus (HIV), control the
outcome of a pregnancy (by forcing the woman to con-
tinue the pregnancy or to have an abortion or to injure
her in a way to cause a miscarriage), forbid sterilization,
or control access to other reproductive health services
(1).
Approximately 20% of women seeking care in family
planning clinics who had a history of abuse also experi-
enced pregnancy coercion and 15% reported birth con-
trol sabotage (7). In addition to unintended pregnancy
risk, there are also risks specific to partner notification
of an STI, which should be taken into account especially
when considering expedited partner treatment. Women
experiencing physical or sexual IPV are more likely to be
afraid to notify their partners of an STI. In a study with a
culturally diverse sample of women seeking care at family
planning clinics, clients exposed to IPV were more likely
to have partners who responded to partner notification
by saying that the STI was not from them or accusing her
of cheating (8). Some women reported threats of harm
or actual harm in response to notifying their partners
of an STI (9). Expedited partner therapy is only recom-
mended after a health care provider has assessed for and
confirmed that there is no risk of IPV associated with
partner notification. It is also not intended for child
abuse, sexual assault, or any situation where there is a
question of safety.
Consequences of Intimate Partner
Violence
Some women subjected to IPV present with acute injuries
to the head, face, breasts, abdomen, genitalia, or repro-
ductive system, whereas others have nonacute presenta-
tions of abuse such as reports of chronic headaches, sleep
and appetite disturbances, palpitations, chronic pelvic
pain, urinary frequency or urgency, irritable bowel syn-
drome, sexual dysfunction, abdominal symptoms, and
recurrent vaginal infections. These nonacute symptoms
often represent clinical manifestations of internalized
stress (ie, somatization). This stress can lead to post-
traumatic stress disorder, which is often associated with
depression, anxiety disorders, substance abuse, and sui-
cide. Research confirms the long-term physical and psy-
chologic consequences of ongoing or past violence (10).
Approximately 324,000 pregnant women are abused
each year in the United States (11). Although more
research is needed, IPV has been associated with poor
pregnancy weight gain, infection, anemia, tobacco use,
stillbirth, pelvic fracture, placental abruption, fetal injury,
preterm delivery, and low birth weight (11–14). In addi-
tion, the severity of violence may sometimes escalate
during pregnancy or the postpartum period (15, 16).
Homicide has been reported as a leading cause of mater-
nal mortality, with the majority perpetrated by a current
or former intimate partner (14). High rates of birth
2 Committee Opinion No. 518
COMMITTEE OPINIONS
control sabotage and pregnancy pressure and coercion
in abusive relationships are correlated with unintended
pregnancies (1, 7).
The societal and economic effects of IPV are pro-
found. Approximately one quarter of a million hospital
visits occur as a result of IPV annually (17). The cost of
intimate partner rape, physical assault, and stalking totals
more than $8.3 billion each year for direct medical and
mental health care services and lost productivity from
paid work and household chores (17, 18). Additional
medical costs are associated with ongoing treatment of
alcoholism, attempted suicide, mental health symptoms,
pregnancy, and pediatric-related problems associated with
concomitant child abuse and witnessing abuse. Intangible
costs include women’s decreased quality of life, undiag-
nosed depression, and lowered self-esteem. Destruction of
the family unit often results in loss of financial stability or
lack of economic resources for independent living, leading
to increased populations of homeless women and chil-
dren (19). Efforts to control health care costs should focus
on early detection and prevention of IPV (18).
Special Populations
Adolescents
Approximately one out of ten female high-school stu-
dents in the United States reported experiencing physical
violence from their dating partners in the previous year
(20). Of those who reported ever having had sexual inter-
course, one out of five girls experienced dating violence.
These girls were also more likely to have experienced
pregnancy and STIs, including HIV, and to report tobacco
use and mental health problems, including suicide
attempts (20). It is important for adolescents to be aware
of behavior that aims to maintain power and control in a
relationship such as monitoring cell phone usage, digital
dating abuse (including posting nude pictures against her
will, stalking her through social networks, and humiliat-
ing her through social networks), telling a partner what to
wear, controlling whether the partner goes to school that
day, as well as manipulating contraceptive use (1). Early
recognition is critical in this population because adoles-
cent violence can be associated with partner violence in
adult life.
Immigrant Women
Women from different backgrounds may have different
perceptions about IPV and need culturally relevant care
that is sensitive to language barriers, acculturation, acces-
sibility issues, and racism. Immigrant women may be
hesitant to report IPV because of fears of deportation. It is
important to increase awareness that a U Nonimmigrant
Visa allows immigrants who have been subjected to sub-
stantial physical or mental abuse caused by IPV or other
crimes to legally remain in the United States if it is justi-
fied on humanitarian grounds, ensures family unity, or is
otherwise in the public interest (21).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 567
 Women With Disabilities
Women with physical and developmental disabilities usu-
ally are less able to care for themselves and are more reli-
ant on their partners or caregivers for help. This sets up a
dangerous dynamic where abusers may be in a position to
physically abuse their victims by withholding medication,
preventing use of assistive equipment such as canes or
wheelchairs, and sabotaging other personal service needs
such as help with bathing, bathroom functions, or eating.
Also, many violence shelters do not accept women with
disabilities or are not trained to respond adequately to the
needs of women with disabilities.
Older Women
An estimated 1–2 million U.S. citizens aged 65 years
or older have been injured, exploited, or mistreated by
someone caring for them (22). For the obstetrician–
gynecologist, the importance of elder abuse relates to
the increasing number of older women in the popula-
tion (23). Older women seek care for pelvic floor relax-
ation, sexual dysfunction, breast and reproductive tract
cancer, and other problems. Elder abuse can occur in
the patient’s home, the home of the caregiver, or in a
residential facility in which the patient is residing. There
is no typical victim of elder abuse. Elder abuse occurs
in all racial, social, educational, economic, and cultural
settings. Victims of elder abuse know their perpetra-
tor 90% of the time (24). Approximately two thirds of
abusers are adult children or partners (24). Abuse can
be physical, sexual, and psychologic and includes neglect
(refusal or failure to fulfill caregiving obligations), aban-
donment, and financial exploitation (illegal or improper
exploitation of funds or other assets through undue
influence or misuse of power of attorney). For more
information go to: http://www.acog.org/About_ACOG/
ACOG_Departments/Violence_Against_Women/Elder_
Abuse__An_Introduction_for_the_Clinician.aspx.
Role of Health Care Providers
The medical community can play a vital role in identifying
women who are experiencing IPV and halting the cycle
of abuse through screening, offering ongoing support,
and reviewing available prevention and referral options.
Health care providers are often the first professionals to
offer care to women who are abused. The U.S. Department
of Health and Human Services has endorsed the Institute
of Medicine’s recommendation that IPV screening and
counseling be a core part of women’s health visits (25).
Adequate training and education among health care pro-
viders will provide the skills and confidence they need to
work with patients, colleagues, and health care systems to
combat violence and abuse (26). Obstetrician–gynecolo-
gists are in the unique position to provide assistance for
women who experience IPV because of the nature of the
patient–physician relationship and the many opportu-
nities for intervention that occur during the course of
annual examinations, family planning, pregnancy, and
Committee Opinion No. 518
COMMITTEE OPINIONS
follow-up visits for ongoing care. Screening all patients
at various times is also important because some women
do not disclose abuse the first time they are asked. Health
care providers should screen all women for IPV at peri-
odic intervals, such as annual examinations and new
patient visits. Signs of depression, substance abuse, mental
health problems, requests for repeat pregnancy tests when
the patient does not wish to be pregnant, new or recur-
rent STIs, asking to be tested for an STI, or expressing
fear when negotiating condom use with a partner should
prompt an assessment for IPV. Screening for IPV during
obstetric care should occur at the first prenatal visit, at
least once per trimester, and at the postpartum checkup.
Studies have shown that patient self-administered or
computerized screenings are as effective as clinician inter-
viewing in terms of disclosure, comfort, and time spent
screening (27, 28). Screening for IPV should be done
privately. Health care providers should avoid questions
that use stigmatizing terms such as “abuse,” “rape,” “bat-
tered,” or “violence” (see sample questions in Box 1) and
use culturally relevant language instead. They should use
a strategy that does not convey judgment and one with
which they are comfortable. Written protocols will facili-
tate the routine assessment process:
• Screen for IPV in a private and safe setting with the
woman alone and not with her partner, friends, fam-
ily, or caregiver.
• Use professional language interpreters and not some-
one associated with the patient.
• At the beginning of the assessment, offer a framing
statement to show that screening is done univer-
sally and not because IPV is suspected. Also, inform
patients of the confidentiality of the discussion and
exactly what state law mandates that a physician must
disclose.
• Incorporate screening for IPV into the routine medi-
cal history by integrating questions into intake forms
so that all patients are screened whether or not abuse
is suspected.
• Establish and maintain relationships with commu-
nity resources for women affected by IPV.
• Keep printed take-home resource materials such
as safety procedures, hotline numbers, and refer-
ral information in privately accessible areas such as
restrooms and examination rooms. Posters and other
educational materials displayed in the office also can
be helpful.
• Ensure that staff receives training about IPV and that
training is regularly offered.
Even if abuse is not acknowledged, simply discussing
IPV in a caring manner and having educational materials
readily accessible may be of tremendous help. Providing
all patients with educational materials is a useful strategy
that normalizes the conversation, making it acceptable
for them to take the information without disclosure.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 568
 Box 1. Sample Intimate Partner Violence Screening Questions ^
While providing privacy, screen for intimate partner violence during new patient visits,
annual examinations, initial prenatal visits, each trimester of pregnancy, and the postpartum
checkup.
Framing Statement
“We’ve started talking to all of our patients about safe and healthy relationships because it
can have such a large impact on your health.”*
Confidentiality
“Before we get started, I want you to know that everything here is confidential, meaning that
I won’t talk to anyone else about what is said unless you tell me that…(insert the laws in your
state about what is necessary to disclose).”*
Sample Questions
“Has your current partner ever threatened you or made you feel afraid?”
(Threatened to hurt you or your children if you did or did not do something, controlled who
you talked to or where you went, or gone into rages)†
“Has your partner ever hit, choked, or physically hurt you?”
(“Hurt” includes being hit, slapped, kicked, bitten, pushed, or shoved.)†
For women of reproductive age:
“Has your partner ever forced you to do something sexually that you did not want to do, or
refused your request to use condoms?”*
“Does your partner support your decision about when or if you want to become pregnant?”*
“Has your partner ever tampered with your birth control or tried to get you pregnant when
you didn’t want to be?”*
For women with disabilities:
“Has your partner prevented you from using a wheelchair, cane, respirator, or other assis-
tive device?”‡
“Has your partner refused to help you with an important personal need such as taking your
medicine, getting to the bathroom, getting out of bed, bathing, getting dressed, or getting
food or drink or threatened not to help you with these personal needs?”‡

*Family Violence Prevention Fund. Reproductive health and partner violence guidelines: an inte-
grated response to intimate partner violence and reproductive coercion. San Francisco (CA): FVPF;
2010. Available at: http://www.futureswithoutviolence.org/userfiles/file/HealthCare/Repro_Guide.pdf.
Retrieved October 12, 2011. Modified and reprinted with permission.
†
Family Violence Prevention Fund. National consensus guidelines on identifying and responding to
domestic violence victimization in health care settings. San Francisco (CA): FVPF; 2004. Available
at: http://www.futureswithoutviolence.org/userfiles/file/Consensus.pdf. Retrieved October 12, 2011.
Modified and reprinted with permission.
‡
Center for Research on Women with Disabilities. Development of the abuse assessment screen-
disability (AAS-D). In: Violence against women with physical disabilities: final report submitted to
the Centers for Disease Control and Prevention. Houston (TX): Baylor College of Medicine; 2002.
p. II-1–II-16. Available at http://www.bcm.edu/crowd/index.cfm?pmid=2137. Retrieved October 18, 2011.
Modified and reprinted with permission.

Futures Without Violence and the American College of
Obstetricians and Gynecologists have developed patient
education cards about IPV and reproductive coercion for
adults and teens that are available in English and Spanish.
For more information visit http://fvpfstore.stores.yahoo.
net/safetycards1.html.
If the clinician ascertains that a patient is involved
in a violent relationship, he or she should acknowl-
edge the trauma and assess the immediate safety of the
patient and her children while assisting the patient in the
development of a safety plan. Risk factors for intimate
partner homicide include having experienced previous
acts of violence, estrangement from partner, threats to
life, threats with a weapon, previous nonfatal strangula-
tion, and partner access to a gun (29). Patients should be
offered information that includes community resources
(mental health services, crisis hotlines, rape relief centers,
shelters, legal aid, and police contact information) and
appropriate referrals. Clinicians should not try to force
patients to accept assistance or secretly place informa-
tion in her purse or carrying case because the perpetrator
may find the material and increase aggression. To assist

4 Committee Opinion No. 518

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 569

 clinicians in responding to IPV, a local domestic violence
agency is often the best resource. It is important to note
that when abuse is identified, it is very useful to offer a
private phone for the patient to use to call a domestic
violence agency. Controlling partners often monitor cell
phone call logs and Internet usage. Offering a private
phone to call the National Domestic Violence hotline
is a simple but important part of supporting a victim of
violence. The National Domestic Violence hotline is a
multilingual resource that can connect a patient to local
domestic violence programs, help with safety planning,
and provide support. A protocol with all the information
needed to perform an IPV assessment should be kept on
site. Futures Without Violence also provides educational
materials, IPV assessment and safety assessment tools
(including scripts for clinical assessment of IPV and
reproductive coercion), and free technical assistance spe-
cifically for health care providers and settings. For more
information, visit www.futureswithoutviolence.org/sec-
tion/our_work/health.
Reporting of the abuse of children is mandatory;
however, reporting IPV, particularly mandatory report-
ing, is controversial. Although the intent of mandatory
reporting is to identify and protect individuals before
the next act of violence, the individual’s safety, in fact,
may be jeopardized (30). Most states do not mandate
reporting of IPV or only mandate reporting in certain
circumstances (31). To ensure compliance with state
laws and federal regulations, it is important to contact
the local law enforcement or domestic violence agency
to become familiar with the laws in a specific jurisdic-
tion. A summary of state laws can be found at: www.
futureswithoutviolence.org/userfiles/file/HealthCare/
MandReport2007FINALMMS.pdf. All fifty states and the
District of Columbia have laws in effect authorizing
the provision of adult protective services in cases of
elder abuse or the abuse of individuals with disabili-
ties, although the laws vary significantly between states.
Physicians generally are mandated to report abuse in
these instances. A current listing of state laws on elder
abuse can be found at: www.ncea.aoa.gov/NCEAroot/
Main_Site/Find_Help/State_Resources.aspx.
Documentation of the clinical interaction provides
important evidence for any future legal proceedings.
Accurate reflection of the patient’s condition, includ-
ing any pertinent photographs or body maps, should be
included with direct and specific quotations. The health
care provider should review with the patient in advance
what form of future communication is best because
medical bills and follow-up phone calls may prompt
retaliation from the abuser. Despite encountering vio-
lence, a patient may deny her circumstances based on fear
of retaliation from her partner, fear of involvement with
law enforcement and the justice system, embarrassment,
or shame. Even if women do not reveal violence to their
physicians, hearing validating messages and knowing
that options and resources may be available could help
prompt them to seek help on their own in the future.
Committee Opinion No. 518
COMMITTEE OPINIONS
Conclusion
Based on the prevalence and health burden of IPV among
women, education about IPV; screening at periodic inter-
vals, including during obstetric visits; and ongoing clini-
cal care can improve the lives of women who experience
IPV. Preventing the lifelong consequences associated
with IPV can have a positive effect on the reproductive,
perinatal, and overall health of all women.
Intimate Partner Violence National
Resources
Hotlines
• National Domestic Violence Hotline
1-800-799-SAFE (7233)
• Rape Abuse & Incest National Network (RAINN)
Hotline
1-800-656-HOPE (4673)
Web Sites
• Futures Without Violence (previously known as
Family Violence Prevention Fund)
www.futureswithoutviolence.org
• National Coalition Against Domestic Violence
www.ncadv.org
• National Network to End Domestic Violence
www.nnedv.org
• National Resource Center on Domestic Violence
www.nrcdv.org
• Office on Violence Against Women
(U.S. Department of Justice)
www.usdoj.gov/ovw
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31. Futures Without Violence. State codes on intimate part-
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Copyright February 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Intimate partner violence. Committee Opinion No. 518. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2012;
119:412–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 571
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 524 • May 2012
Committee on Health Care for Underserved Women
and the American Society of Addiction Medicine
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Opioid Abuse, Dependence, and Addiction

in Pregnancy
ABSTRACT: Opioid use in pregnancy is not uncommon, and the use of illicit opioids during pregnancy is
associated with an increased risk of adverse outcomes. The current standard of care for pregnant women with
opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that
buprenorphine also should be considered. Medically supervised tapered doses of opioids during pregnancy often
result in relapse to former use. Abrupt discontinuation of opioids in an opioid-dependent pregnant woman can
result in preterm labor, fetal distress, or fetal demise. During the intrapartum and postpartum period, special con-
siderations are needed for women who are opioid dependent to ensure appropriate pain management, to prevent
postpartum relapse and a risk of overdose, and to ensure adequate contraception to prevent unintended preg-
nancies. Patient stabilization with opioid-assisted therapy is compatible with breastfeeding. Neonatal abstinence
syndrome is an expected and treatable condition that follows prenatal exposure to opioid agonists.

Opioid abuse in pregnancy includes the use of heroin
and the misuse of prescription opioid analgesic medica-
tions. According to the 2010 National Survey on Drug
Use and Health, an estimated 4.4% of pregnant women
reported illicit drug use in the past 30 days (1). A second
study showed that whereas 0.1% of pregnant women were
estimated to have used heroin in the past 30 days, 1% of
pregnant women reported nonmedical use of opioid-
containing pain medication (2). In this study, the rates
of use varied by setting and by mode of assessment. The
urine screening of pregnant women in an urban teaching
hospital resulted in a detection rate for opioids of 2.6%
(2). The prevalence of opioid abuse during pregnancy
requires that practicing obstetrician–gynecologists be
aware of the implications of opioid abuse by pregnant
women and of appropriate management strategies.
Pharmacology and Physiology of
Opioid Addiction
Opioid addiction may develop with repetitive use of
either prescription opioid analgesics or heroin. Heroin
is the most rapidly acting of the opioids and is highly
addictive (3). Heroin may be injected, smoked, or nasally
inhaled. Heroin has a short half-life, and a heroin user
may need to take multiple doses daily to maintain the
drug’s effects. Prescribed opioids that may be abused
include codeine, fentanyl, morphine, opium, methadone,
oxycodone, meperidine, hydromorphone, hydrocodone,
propoxyphene, and buprenorphine (the partial agonist).
These products may variously be swallowed, injected,
nasally inhaled, smoked, chewed, or used as suppositories
(4). The onset and intensity of euphoria will vary based
on how the drug was taken and the formulation; however,
all have the potential for overdose, physical dependence,
abuse, and addiction. Injection of opioids also carries the
risk of cellulitis and abscess formation at the injection site,
sepsis, endocarditis, osteomyelitis, hepatitis B, hepatitis C,
and human immunodeficiency virus (HIV) infection.
Opioids bind to opioid receptors in the brain and
produce a pleasurable sensation (3). Opioids also depress
respiration, potentially resulting in respiratory arrest and
death. Opioid addiction is associated with compulsive
drug-seeking behavior, physical dependence, and tol-
erance that lead to the need for ever higher doses (4).
Once physical dependence to an opioid has developed, a
withdrawal syndrome occurs if use is discontinued. With
short-acting opioids, such as heroin, withdrawal symp-
toms may develop within 4–6 hours of use, may prog-
ress up to 72 hours, and usually subside within a week.
For long-acting opioids, such as methadone, withdrawal

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 572

 symptoms are usually experienced between 24 hours and
36 hours of use and may last for several weeks. Obsessive
thinking and drug cravings may persist for years, thus
leading to relapse. Although heroin withdrawal is not
fatal to healthy adults, fetal death is a risk in pregnant
women who are not treated for opioid addiction because
their offspring experience acute opioid abstinence syn-
drome (5).
Effects on Pregnancy and Pregnancy
Outcome
An association between first-trimester use of codeine and
congenital heart defects has been found in three of four
case–control studies (6–9). Previous reports have not
shown an increase in risks of birth defects after prenatal
exposure to oxycodone, propoxyphene, or meperidine
(10, 11). The authors of one retrospective study observed
an increased risk of some birth defects with the use of
prescribed opioids by women in the month before or
during the first trimester of pregnancy (12). However,
methodological problems with this study exist, and such
an association has not been previously reported. The
observed birth defects remain rare with a minute increase
in absolute risk. Although none of these studies investi-
gated methadone or buprenorphine specifically, concern
about a potential small increased risk of birth defects
associated with opioid-assisted therapy during pregnancy
must be weighed against the clear risks associated with
the ongoing use of illicit opioids by a pregnant woman.
During pregnancy, chronic untreated heroin use is
associated with an increased risk of fetal growth restric-
tion, abruptio placentae, fetal death, preterm labor, and
intrauterine passage of meconium (13). These effects may
be related to the repeated exposure of the fetus to opioid
withdrawal as well as the effects of withdrawal on placen-
tal function. Additionally, the lifestyle issues associated
with illicit drug use put the pregnant woman at risk of
engaging in activities, such as prostitution, theft, and
violence, to support herself or her addiction. Such activi-
ties expose women to sexually transmitted infections,
becoming victims of violence, and legal consequences,
including loss of child custody, criminal proceedings, or
incarceration.
Screening for Opioid Use, Abuse, and
Addiction
Screening for substance abuse is a part of complete
obstetric care and should be done in partnership with
the pregnant woman. Both before pregnancy and in early
pregnancy, all women should be routinely asked about
their use of alcohol and drugs, including prescription
opioids and other medications used for nonmedical
reasons. To begin the conversation, the patient should
be informed that these questions are asked of all preg-
nant women to ensure they receive the care they require
for themselves and their fetuses and that the informa-
2 Committee Opinion No. 524
COMMITTEE OPINIONS
tion will be kept confidential. Maintaining a caring and
nonjudgmental approach is important and will yield
the most inclusive disclosure. Routine screening should
rely on validated screening tools, such as questionnaires
including 4P’s and CRAFFT (for women aged 26 years or
younger) (Box 1) (14, 15).
In addition to the use of screening tools, certain signs
and symptoms may suggest a substance use disorder in a
Box 1. Clinical Screening Tools for
Prenatal Substance Use and Abuse ^
4 P’s
Parents: Did any of your parents have a problem with
alcohol or other drug use?
Partner: Does your partner have a problem with alcohol
or drug use?
Past: In the past, have you had difficulties in your life
because of alcohol or other drugs, including prescription
medications?
Present: In the past month have you drunk any alcohol
or used other drugs?
Scoring: Any “yes” should trigger further questions.
Ewing H. A practical guide to intervention in health and social
services with pregnant and postpartum addicts and alcohol-
ics: theoretical framework, brief screening tool, key interview
questions, and strategies for referral to recovery resources.
Martinez (CA): The Born Free Project, Contra Costa County
Department of Health Services; 1990.
CRAFFT—Substance Abuse Screen for Adolescents
and Young Adults
C Have you ever ridden in a CAR driven by someone
(including yourself) who was high or had been using
alcohol or drugs?
R Do you ever use alcohol or drugs to RELAX, feel
better about yourself, or fit in?
A Do you ever use alcohol or drugs while you are by
yourself or ALONE?
F Do you ever FORGET things you did while using
alcohol or drugs?
F Do your FAMILY or friends ever tell you that you
should cut down on your drinking or drug use?
T Have you ever gotten in TROUBLE while you were
using alcohol or drugs?
Scoring: Two or more positive items indicate the need
for further assessment.
Center for Adolescent Substance Abuse Research, Children’s
Hospital Boston. The CRAFFT screening interview. Boston (MA):
CeASAR; 2009. Available at: http://www.ceasar.org/CRAFFT/pdf/
CRAFFT_English.pdf. Retrieved February 10, 2012.
Copyright  Children’s Hospital Boston, 2011. All rights
reserved. Reproduced with permission from the Center for
Adolescent Substance Abuse Research, CeASAR, Children’s
Hospital Boston, 617-355-5133, or www.ceasar.org.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 573
 pregnant woman. Pregnant women with opioid addic-
tion often seek prenatal care late in pregnancy; exhibit
poor adherence to their appointments; experience poor
weight gain; or exhibit sedation, intoxication, withdrawal,
or erratic behavior. On physical examination, some signs
of drug use may be present, such as track marks from
intravenous injection, lesions from interdermal injec-
tions or “skin popping,” abscesses, or cellulitis. Positive
results of serologic tests for HIV, hepatitis B, or hepatitis
C also may indicate substance abuse. Urine drug testing is
an adjunct to detect or confirm suspected substance use,
but should be performed only with the patient’s consent
and in compliance with state laws. Pregnant women must
be informed of the potential ramifications of a positive
test result, including any mandatory reporting require-
ments (16). Laboratory testing for HIV, hepatitis B, and
hepatitis C should be repeated in the third trimester, if
indicated (17).
The use of an antagonist, such as naloxone, to diag-
nose opioid dependence in pregnant women is contra-
indicated because induced withdrawal may precipitate
preterm labor or fetal distress (13). Naloxone should be
used only in the case of maternal overdose to save the
woman’s life.
Treatment
Since the 1970s, maintenance therapy with methadone
has been the standard treatment of heroin addiction dur-
ing pregnancy (13). Recently, this treatment also has been
used for nonheroin opioid addiction (13) although the
benefits are less well documented than for the treatment
of heroin dependence.
The rationale for opioid-assisted therapy during
pregnancy is to prevent complications of illicit opioid
use and narcotic withdrawal, encourage prenatal care
and drug treatment, reduce criminal activity, and avoid
risks to the patient of associating with a drug culture.
Comprehensive opioid-assisted therapy that includes pre-
natal care reduces the risk of obstetric complications (13).
Neonatal abstinence syndrome is an expected and treat-
able condition that follows prenatal exposure to opioid
agonists and requires collaboration with the pediatric
care team. Methadone has significant pharmacokinetic
interactions with many other drugs, including antiretro-
viral agents.
Methadone maintenance, as prescribed and dis-
pensed on a daily basis by a registered substance abuse
treatment program, is part of a comprehensive package
of prenatal care, chemical dependency counseling, family
therapy, nutritional education, and other medical and
psychosocial services as indicated for pregnant women
with opioid dependence. Perinatal methadone dosages
are managed by addiction treatment specialists within
registered methadone treatment programs. A list of local
treatment programs for opioid addiction can be found at
the Substance Abuse and Mental Health Services Admin-
istration’s web site (http://dpt2.samhsa.gov/treatment/
Committee Opinion No. 524
COMMITTEE OPINIONS
directory.aspx). Obstetricians should communicate with
the addiction treatment program whenever there are
concerns about the patient’s care and methadone dosage.
The dosage should be adjusted throughout the pregnancy
to avoid withdrawal symptoms, which include drug crav-
ings, abdominal cramps, nausea, insomnia, irritability,
and anxiety. If a woman is treated with a stable metha-
done dosage before pregnancy, pharmacokinetic changes
may require dosage adjustments, especially in the third
trimester (18). Some women develop rapid metabolism
to the extent that it becomes difficult to control with-
drawal symptoms for 24 hours on a single daily dose; in
these cases, split dosages may be optimal. Not all women
require dose increases during pregnancy and any dosage
adjustments should be made on clinical grounds by the
addiction specialist. Methadone dosages usually are initi-
ated at 10–30 mg/d (13). If a woman begins treatment
with methadone while pregnant, her dosage should be
titrated until she is asymptomatic in accordance with safe
induction protocols. An inadequate maternal methadone
dosage may result in mild to moderate opioid withdrawal
signs and symptoms and cause fetal stress and increased
likelihood for the maternal use of illicit drugs. Separate
studies examined the extent to which the maternal
methadone dosage is related to the severity of neonatal
abstinence syndrome. The results are inconclusive and
conflicting (19, 20). One systematic literature review and
meta-analysis concluded that the severity of neonatal
abstinence syndrome does not appear to differ based
on the maternal dosage of methadone treatment (21).
These maternal, fetal, and neonatal findings all under-
score the need to provide pregnant women with an
adequate methadone dosage that relieves and prevents
opioid withdrawal signs and symptoms and also blocks
the euphoric effect of misused opioids.
In most situations, it is advisable for pregnant women
to initiate methadone induction in a licensed out-
patient methadone program. In situations when a preg-
nant woman requires hospitalization for initiation of
methadone treatment, an arrangement must be made
before discharge for next day admission to an outpatient
program. With the exception of buprenorphine, it is
illegal for a physician to write a prescription for any other
opioid for the treatment of opioid dependence, includ-
ing methadone, outside of a licensed treatment program
(22). Buprenorphine, when prescribed by accredited
physicians who have undergone specific credentialing,
is the only opioid approved for the treatment of opioid
dependence in an office-based setting (23). Physicians
should be familiar with federal and state regulations
regarding prescribing of medications for the treatment of
opioid dependence.
Emerging evidence supports the use of buprenor-
phine for opioid-assisted treatment during pregnancy.
Buprenorphine acts on the same receptors as heroin
and morphine (24). With appropriate informed consent,
including disclosure of the lack of evidence from long-
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 574
 term neurodevelopmental studies, buprenorphine also
may be offered to patients in need of opioid-assist-
ed therapy during pregnancy (25). The advantages of
buprenorphine over methadone include a lower risk of
overdose, fewer drug interactions, the ability to be treated
on an outpatient basis without the need for daily visits to
a licensed treatment program, and evidence of less severe
neonatal abstinence syndrome (25). The disadvantages
compared with methadone include reports of hepatic
dysfunction, the lack of long-term data on infant and
child effects, a clinically important patient dropout rate
due to dissatisfaction with the drug, a more difficult
induction with the potential risk of precipitated with-
drawal, and an increased risk of diversion (ie, sharing or
sale) of prescribed buprenorphine (25). Buprenorphine is
available as a single-agent product or in a combined for-
mulation with naloxone, an opioid antagonist used to
reduce diversion. Buprenorphine with naloxone is formu-
lated to prevent injected use because naloxone causes
severe withdrawal symptoms when injected. However,
because of poor naloxone absorption, the formulation
has rare adverse effects when used sublingually as direct-
ed (24). The single-agent product is recommended dur-
ing pregnancy to avoid any potential prenatal exposure
to naloxone, especially if injected (25). The single-agent
buprenorphine product has a higher potential to lead to
abuse as well as a higher street value than the combina-
tion product. Thus, all patients should be monitored for
the risk of diversion of their medication, especially if the
single product is prescribed. Unlike methadone, which
may be administered only through very tightly controlled
programs, buprenorphine may be prescribed by trained
and approved physicians in a medical office setting,
which potentially increases the availability of treatment
and decreases the stigma (24). The Substance Abuse and
Mental Health Services Administration publishes a direc-
tory of physicians licensed to dispense buprenorphine
(http://buprenorphine.samhsa.gov/bwns_locator).
Patients considered for using buprenorphine need to
be able to self-administer the drug safely and maintain
adherence with their treatment regimen. Compared
with methadone clinics, the less stringent structure of
buprenorphine treatment may make it inappropriate for
some patients who require more intensive structure and
supervision (17).
Until recently, data on use of buprenorphine in preg-
nancy were relatively limited (25). A 2010 multicenter,
randomized clinical trial compared the neonatal effects of
buprenorphine and methadone in 175 opioid-dependent
gravid women (26). In that study, the buprenorphine-
exposed neonates required, on average, 89% less mor-
phine to treat neonatal abstinence syndrome, a 43%
shorter hospital stay, and a 58% shorter duration of
medical treatment for neonatal abstinence syndrome
(26). These results support the use of buprenorphine
as a potential first-line medication for pregnant opioid-
dependent women who are new to treatment. It is
4 Committee Opinion No. 524
COMMITTEE OPINIONS
important to understand that buprenorphine will not be
effective for all patients.
Women who become pregnant while already under-
going a treatment with a stable co-formulated buprenor-
phine dosage generally are advised to continue the same
dosage but to transition to the single-agent product.
The indications for the use of buprenorphine during
pregnancy are in flux currently. Previous recommenda-
tions have limited use of buprenorphine to women who
have refused to use methadone, have been unable to take
methadone, or those for whom methadone treatment was
unavailable. The current trend is moving toward con-
sidering a patient as a potential candidate for buprenor-
phine if she prefers buprenorphine to methadone, gives
informed consent after a thorough discussion of relative
risks and benefits, and is capable of adherence and safe
self-administration of the medication. If the pregnant
woman is receiving methadone therapy, she should not
consider transitioning to buprenorphine because of the
significant risk of precipitated withdrawal. The potential
risk of unrecognized adverse long-term outcomes, which
is inherent with widespread use of relatively new medi-
cations during pregnancy, should always be taken into
consideration.
Medically supervised withdrawal from opioids in
opioid-dependent women is not recommended during
pregnancy because the withdrawal is associated with high
relapse rates (27). However, if methadone maintenance is
unavailable or if women refuse to undergo methadone or
buprenorphine maintenance, medically supervised with-
drawal should ideally be undertaken during the second
trimester and under the supervision of a physician expe-
rienced in perinatal addiction treatment (13). If the alter-
native to medically supervised withdrawal is continued
illicit drug use, then a medically supervised withdrawal in
the first trimester is preferable to waiting until the second
trimester.
It is important that frequent communication be
maintained between the patient’s obstetric care provider
and the addiction medicine provider to coordinate care.
The federal confidentiality law 42 CFR Part 2 applies
to addiction treatment providers. Patient information
release forms with specific language regarding substance
use are required (28).
Intrapartum and Postpartum
Management
Women receiving opioid-assisted therapy who are under-
going labor should receive pain relief as if they were not
taking opioids because the maintenance dosage does not
provide adequate analgesia for labor (29, 30). Epidural
or spinal anesthesia should be offered where appropriate
for management of pain in labor or for delivery. Narcotic
agonist–antagonist drugs, such as butorphanol, nalbu-
phine, and pentazocine, should be avoided because they
may precipitate acute withdrawal. Buprenorphine should
not be administered to a patient who takes methadone.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 575
 Pediatric staff should be notified of all narcotic-exposed
infants.
In general, patients undergoing opioid maintenance
treatment will require higher doses of opioids to achieve
analgesia than other patients. One study showed that
after cesarean delivery, women who used buprenorphine
required 47% more opioid analgesic than women who
did not use buprenorphine treatment, but adequate pain
relief was achieved with short-acting opioids and anti-
inflammatory medication (31). Injectable nonsteroidal
antiinflammatory agents, such as ketorolac, also are highly
effective in postpartum and postcesarean delivery pain
control. Daily doses of methadone or buprenorphine
should be maintained during labor to prevent with-
drawal, and patients should be reassured of this plan in
order to reduce anxiety. Dividing the usual daily main-
tenance dose of buprenorphine or methadone into three
or four doses every 6–8 hours may provide partial pain
relief; however, additional analgesia will be required (29).
Women should be counseled that minimal levels of
methadone and buprenorphine are found in breast milk
regardless of the maternal dose. Breastfeeding should be
encouraged in patients without HIV who are not using
additional drugs and who have no other contraindica-
tions (32). The current buprenorphine package insert
advises against breastfeeding; however, a consensus panel
stated that the effects on the breastfed infant are likely
to be minimal and that breastfeeding is not contraindi-
cated (33). Swaddling associated with breastfeeding may
reduce neonatal abstinence syndrome symptoms, and
breastfeeding contributes to bonding between mother
and infant as well as providing immunity to the infant.
Although most pregnant women who receive metha-
done will experience dosage increases during pregnancy,
and a need for dosage reduction might be expected, one
study demonstrated little need for immediate postpartum
methadone dosage reduction (34). Most women who
undergo buprenorphine maintenance therapy will not
experience large dosage adjustments during their preg-
nancies and may continue the same dosages after delivery
(34). However, the postpartum patient who receives opi-
oid therapy should be closely monitored for symptoms of
oversedation with dosages titrated as indicated. Women
should continue in their treatment and addiction support
postpartum. Discussions of contraceptive options should
begin during pregnancy and contraception, including
long-acting reversible contraceptive methods, should be
provided or prescribed before hospital discharge. Access
to adequate postpartum psychosocial support services,
including chemical dependency treatment and relapse
prevention programs, should be ensured (33).
Neonatal Abstinence Syndrome
Although maternal methadone or buprenorphine therapy
improves pregnancy outcomes and reduces risky behav-
ior, its use puts the neonate at risk of neonatal abstinence
syndrome, which is characterized by hyperactivity of the
Committee Opinion No. 524
COMMITTEE OPINIONS
central and autonomic nervous systems (13). Infants with
neonatal abstinence syndrome may have uncoordinated
sucking reflexes leading to poor feeding, become irri-
table, and produce a high-pitched cry. In infants exposed
to methadone, symptoms of withdrawal may begin at
anytime in the first 2 weeks of life, but usually appear
within 72 hours of birth and may last several days to
weeks (13). Infants exposed to buprenorphine who
develop neonatal abstinence syndrome generally develop
symptoms within 12–48 hours of birth that peak at 72–96
hours and resolve by 7 days (35). Close communication
between the obstetrician and pediatrician is necessary for
optimal management of the neonate.
All infants born to women who use opioids during
pregnancy should be monitored for neonatal abstinence
syndrome and treated if indicated (13). Treatment is
adequate if the infant has rhythmic feeding and sleep
cycles and optimal weight gain (13).
Long-Term Infant Outcome
Recent data on long-term outcomes of infants with in
utero opioid exposure are limited. For the most part,
earlier studies have not found significant differences in
cognitive development between children up to 5 years
of age exposed to methadone in utero and control
groups matched for age, race, and socioeconomic status,
although scores were often lower in both groups com-
pared with population data (36). Preventive interventions
that focus on enriching the early experiences of such chil-
dren and improving the quality of the home environment
are likely to be beneficial (37).
Summary
Early identification of opioid-dependent pregnant women
improves maternal and infant outcomes. Contraceptive
counseling should be a routine part of substance use
treatment among women of reproductive age to mini-
mize the risk of unplanned pregnancy. Pregnancy in the
opioid-dependent woman should be co-managed by the
obstetrician–gynecologist and addiction medicine spe-
cialist with appropriate 42 CFR Part 2-compliant release
of information forms. This collaboration is particularly
important when the woman receives opioid maintenance
treatment or is at high risk of relapse. When opioid
maintenance treatment is available, medically supervised
withdrawal should be discouraged during pregnancy. It is
essential for hospitalized pregnant women who initiated
opioid-assisted therapy to make a next-day appointment
with a treatment program before discharge. Infants born
to women who used opioids during pregnancy should
be closely monitored for neonatal abstinence syndrome
and other effects of opioid use by a pediatric health care
provider.
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2013 COMPENDIUM OF SELECTED PUBLICATIONS 576
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at https://www.drugabuse.gov/sites/default/files/rx_drugs_
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9. Shaw GM, Malcoe LH, Swan SH, Cummins SK, Schulman J.
Congenital cardiac anomalies relative to selected maternal
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12. Broussard CS, Rasmussen SA, Reefhuis J, Friedman JM,
Jann MW, Riehle-Colarusso T, et al. Maternal treatment
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assisted treatment for opioid addiction during pregnancy.
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15. Chang G, Orav EJ, Jones JA, Buynitsky T, Gonzalez S,
Wilkins-Haug L. Self-reported alcohol and drug use in
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18. Pond SM, Kreek MJ, Tong TG, Raghunath J, Benowitz NL.
Altered methadone pharmacokinetics in methadone-main-
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19. Dryden C, Young D, Hepburn M, Mactier H. Maternal
methadone use in pregnancy: factors associated with the
development of neonatal abstinence syndrome and impli-
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[PubMed] [Full Text] ^
20. Velez ML, Jansson LM, Schroeder J, Williams E. Prenatal
methadone exposure and neonatal neurobehavioral func-
tioning. Pediatr Res 2009;66:704–9. [PubMed] [Full Text]
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21. Cleary BJ, Donnelly J, Strawbridge J, Gallagher PJ, Fahey T,
Clarke M, et al. Methadone dose and neonatal abstinence
syndrome-systemic review and meta-analysis. Addiction
2010;105:2071–84. [PubMed] ^
22. Institute of Medicine. Federal regulation of methadone
treatment. Washington DC: National Academy Press; 1995.
^
23. Drug addiction treatment act of 2000, Pub. L. No. 106-310
§ 3502, 114 Stat. 1223–7. (2000). ^
24. Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN,
Jones K, et al. Office-based treatment of opiate addiction
with a sublingual-tablet formulation of buprenorphine and
naloxone. Buprenorphine/Naloxone Collaborative Study
Group. N Engl J Med 2003;349:949–58. [PubMed] [Full
Text] ^
25. Johnson RE, Jones HE, Fisher G. Use of buprenorphine in
pregnancy: patient management and effects on the neonate.
Drug Alcohol Depend 2003;70:S87–101. [PubMed] ^
26. Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG,
Arria AM, et al. Neonatal abstinence syndrome after meth-
adone or buprenorphine exposure. N Engl J Med 2010;
363:2320–31. [PubMed] [Full Text] ^
27. Jones HE, O’Grady KE, Malfi D, Tuten M. Methadone
maintenance vs. methadone taper during pregnancy: mater-
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28. Substance Abuse and Mental Health Services Adminis-
tration. Frequently asked questions: applying the substance
abuse confidentiality regulations to health information
exchange (HIE). Rockville (MD): SAHMSA; 2010. Available
at: http://www.samhsa.gov/healthprivacy/docs/EHR-FAQs.
pdf. Retrieved February 12, 2012. ^
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 29. Meyer M, Wagner K, Benvenuto A, Plante D, Howard D.
Intrapartum and postpartum analgesia for women main-
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2007;110:261–6. [PubMed] [Obstetrics & Gynecology] ^
30. Jones HE, O’Grady K, Dahne J, Johnson R, Lemoine L,
Milio L, et al. Management of acute postpartum pain in
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ing pregnancy. Am J Drug Alcohol Abuse 2009;35:151–6.
[PubMed] [Full Text] ^
31. Jones HE, Johnson RE, Milio L. Post-cesarean pain manage-
ment of patients maintained on methadone or buprenor-
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Copyright May 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Opioid abuse, dependence, and addiction in pregnancy. Committee
Opinion No. 524. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2012;119:1070–6.

32. Wojnar-Horton RE, Kristensen JH, Yapp P, Ilett KF, Dusci

LJ, Hackett LP. Methadone distribution and excretion into
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33. Johnson RE, Jones HE, Jasinski DR, Svikis DS, Haug NA,
Jansson LM, et al. Buprenorphine treatment of pregnant
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comes. Drug Alcohol Depend 2001;63:97–103. [PubMed]
^
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Milio L. Dosing adjustments in postpartum patients main-
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2:103–7. [PubMed] ^
35. Johnson RE, Jones HE, Fischer G. Use of buprenorphine in
pregnancy: patient management and effects on the neonate.
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36. Kaltenbach K, Finnegan LP. Developmental outcome of
children born to methadone maintained women: a review
of longitudinal studies. Neurobehav Toxicol Teratol 1984;
6:271–5. [PubMed] ^
37. Hans SL. Developmental consequences of prenatal expo-
sure to methadone. Ann N Y Acad Sci 1989;562:195–207.
[PubMed] ^

Committee Opinion No. 524 7

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 578

 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 525 • May 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Health Care for Lesbians and Bisexual Women

ABSTRACT: Lesbians and bisexual women encounter barriers to health care that include concerns about
confidentiality and disclosure, discriminatory attitudes and treatment, limited access to health care and health
insurance, and often a limited understanding as to what their health risks may be. Health care providers should
offer quality care to all women regardless of sexual orientation. The American College of Obstetricians and
Gynecologists endorses equitable treatment for lesbians and bisexual women and their families, not only for direct
health care needs, but also for indirect health care issues.

Definition and Prevalence Barriers to Health Care

Sexual orientation is an enduring emotional, romantic,
or sexual attraction that one feels toward men or women
or both (1). Although there is no standard definition of
a lesbian, common characteristics may include same-sex
attraction, same-sex sexual behavior, or self-identification
as a lesbian. For many women, sexual orientation falls
along a continuum where a woman may not be exclu-
sively heterosexual or homosexual, or she may develop
a lesbian orientation over her lifetime. A bisexual woman
is attracted to or engages in sexual behavior with both
sexes or identifies herself as bisexual. Sexual orientation
has not been conclusively found to be determined by
any particular factor or factors, and the timing of the
emergence, recognition, and expression of one’s sexual
orientation varies among individuals (1).
Although prevalence statistics vary in the United
States, data from the National Survey of Family Growth
suggest that 1.1% and 3.5% of women identify as les-
bian or bisexual, respectively (2). Lesbians and bisexual
women are as diverse a population as the population of
all women and are represented among all racial, ethnic,
and socioeconomic groups. All obstetrician–gynecologists
encounter lesbian or bisexual patients, although not all
women will disclose their sexual orientation to their
health care providers. Additional research is needed to
assess the current state of knowledge about the health of
this population as well as to identify research gaps and
formulate a research agenda as outlined by the Institute
of Medicine (3).
Women who identify as lesbian or bisexual encounter
barriers to health care that include concerns about con-
fidentiality and disclosure, discriminatory attitudes and
treatment, limited access to health care and health insur-
ance, and often a limited understanding as to what their
health risks may be (4). Lesbians who are unemployed or
work in a setting that does not offer health insurance are
not allowed to participate in their partners’ employment
benefits package in most circumstances (4, 5). Lesbians
and their partners often face additional challenges such
as a lack of availability of health care providers offer-
ing fertility services to women who identify as lesbian.
Obstetrician–gynecologists who elect not to provide fertil-
ity services to lesbian couples or individuals should refer
them for these services. Sexual orientation should not be a
barrier to receiving fertility services to achieve pregnancy.
The American College of Obstetricians and Gynecologists
(the College) endorses equitable treatment for lesbians
and their families, not only for direct health care needs,
but also for indirect health care issues; this should include
the same legal protections afforded married couples (4).
Routine Health Visits
Comprehensive care, including prevention of cardiovas-
cular disease, obesity, cancer, and sexually transmitted
infections (STIs), is recommended for lesbian and bisex-
ual patients. Being a lesbian does not inherently affect
an individual’s health status. There are no known phys-
iologic differences between lesbians and heterosexual

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 579

 women. There may, however, be health behaviors or
health risk factors that are more common among lesbians
and bisexual women that have health consequences.
Several studies have reported higher prevalence rates
of obesity, tobacco use, and alcohol use by lesbians (6, 7).
These factors may increase the risk of type 2 diabetes,
lung cancer, and cardiovascular disease. In fact, higher
rates of heart attack have been reported in lesbians (6, 7).
Given these increased risks, routine office visits should
include counseling for weight control and smoking ces-
sation, as needed, and screening for cardiac risk factors
such as diabetes and lipid status as appropriate for the
patient’s age and medical history.
Nulligravidity, low parity, obesity, tobacco use, and
less use of oral contraceptives are more common in les-
bians than among heterosexual women (6, 7). These risk
factors are associated with breast cancer and ovarian can-
cer but more research is needed to determine actual dif-
ferences in prevalence rates of breast cancer and ovarian
cancer. General recommendations for mammography,
colorectal cancer screening, hormone therapy, and osteo-
porosis screening also should be followed for all lesbian
and bisexual patients (8).
Routine cervical cancer screening is recommended
for all women. The onset and interval for this testing
should be based on College recommendations (9). Many
health care providers incorrectly conclude that lesbian
patients do not require cervical cancer screening because
they are at low risk of cervical cancer. This is based on the
assumption that the patient has not previously had sex
with men, which is not always correct. In addition, cervi-
cal dysplasia has been reported in lesbians who have not
previously had intercourse with men (10).
Reproductive health care providers and family plan-
ning services should consider that any patient, even one
who is pregnant, may be a lesbian or bisexual woman.
Gynecologic care, including family planning and STI and
human immunodeficiency virus (HIV) screening and
prevention counseling, is recommended because most
lesbians have been sexually active with men at some point
in their lives and because some STIs can be transmitted
by exclusive lesbian sexual activity (11).
Although less research has been conducted on STIs
among lesbians and bisexual women, they may par-
ticipate in a range of sexual practices with women and
men that may put them at risk of acquiring STIs (6, 7).
Infections, including bacterial vaginosis, candidiasis, her-
pes, and human papillomavirus infections, can be con-
tracted by lesbians (6, 7). Although female-to-female
transmission of HIV appears to be possible, there have
been no confirmed cases (12). It has been noted that bisex-
ual women have the highest rates of seropositivity in com-
parison with both lesbians and heterosexual women (7).
Lack of knowledge about types of risk-taking behavior
and disease transmission also was notable among lesbi-
ans and bisexual women. Education about the risks of
STIs and dispelling the perception that transmission of
2 Committee Opinion No. 525
COMMITTEE OPINIONS
STIs between women is negligible will help patients make
informed decisions.
All patients, regardless of sexual orientation, should
be encouraged to use safe sex practices to reduce the
risk of transmitting or acquiring STIs and HIV. Safe sex
practices for lesbians and bisexual women include use of
condoms on sex toys, gloves, and dental dams, as well as
avoidance of sharing dildos and other sex toys.
Mental Health and Psychosocial
Considerations
Health care providers should be alert to the signs and
symptoms of depression, substance abuse, and intimate
partner violence in all patients and conduct appropriate
screening and intervention (8, 13). Studies have shown
that women who identify themselves as lesbians are more
likely to admit to having depression and to taking antide-
pressants (7). Lesbians report stress caused by isolation,
prejudice, stigmatization, a lack of support from peers
and family, and a lack of access to health care and mental
health care providers (6, 14).
Additionally, lesbians are more likely than heterosex-
ual women to abuse alcohol and drugs (15). Reliance on
bars as social venues, stress caused by discrimination, and
targeted advertising by tobacco and alcohol businesses in
gay and lesbian publications all contribute to increased
pressures for lesbian, gay, bisexual, and transgender indi-
viduals to engage in substance use (16).
Intimate partner violence among lesbians is a serious
public health concern. However, true prevalence esti-
mates vary widely because they often are based on studies
with varying definitions of violence, time frames, and
sampling procedures (17). Women who experience inti-
mate partner violence in their relationships are at risk of
repeated assault, increased injuries, chronic health condi-
tions, disabilities, and death (17). Health care providers
should be alert to the signs and symptoms of violence in
all relationships. For additional information, please refer
to Committee Opinion No. 518, Intimate Partner Violence
(13).
Mental health concerns also apply to youth who self-
identify as lesbian, gay, or bisexual. During adolescence,
these youth, who report lack of support from parents and
families, are at high risk of depression, suicide, and sub-
stance abuse (18). Lesbian or bisexual girls also are at high
risk of tobacco use and eating disorders. Counseling may
be very helpful for adolescents who are uncertain about
their sexual orientation or have difficulty expressing their
sexuality and can assist a lesbian or bisexual adolescent
in coping with difficulties faced at home, school, or in the
community. It should be noted that reparative therapy
aimed to change sexual orientation by provoking guilt
and anxiety to shame those who do not identify as hetero-
sexual is ineffective and harmful (19). More constructive
therapeutic goals for adolescents should be to create and
maintain self-confidence and honest relationships with
family and friends.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 580
 Changes in the Patient Care Setting
In light of the barriers to health care faced by lesbian and
bisexual patients, efforts to ensure that the health care
setting is receptive and appropriately addresses the needs
of this population are warranted. The American College
of Obstetricians and Gynecologists’ Code of Professional
Ethics states that obstetrician–gynecologists should avoid
“discrimination on the basis of race, color, religion,
national origin, sexual orientation, perceived gender, and
any basis that would constitute illegal discrimination”
(20). There are numerous ways obstetrician–gynecologists
can better meet the needs of lesbian and bisexual patients
in their practices. Specific suggestions for changes in the
office setting include the following:
1. Inform receptionists and other office staff that
patients of all sexual orientations and gender identi-
ties are welcome in the practice and should be treated
with the same respect as other patients.
2. Modify office registration forms and questionnaires
that require patients to identify their relationship
and behavioral status to obtain more accurate and
useful information (21). Examples include the fol-
lowing:
• Are you single, married, widowed, or divorced, or
do you have a domestic partner?
• Are you or have you been sexually active with United States: data from the 2006–2008 National Survey
anyone—male, female, or both male and female
partners—or are you not sexually active?
• Who are you sexually attracted to—men, women, 3. Institute of Medicine. The health of lesbian, gay, bisexual,
or both men and women?
The form can state that response to these questions
is optional. If the patient does not answer these
questions, she can be asked in person. If the patient
has concerns about confidentiality, the health care
provider does not need to write down the answer or
can code the response.
3. Have a nondiscrimination policy for your office
posted in the reception area. For example: “This
office appreciates diversity and does not discriminate
based on race, age, religion, disability, marital status,
sexual orientation, or perceived gender.”
4. Use inclusive language with all patients and neutral
terms such as “partner” or “spouse” rather than
“boyfriend” or “husband” when a patient’s partner
status is unknown.
5. Be a resource for health information about sexual
orientation and gender issues for both patients and
their families. Provide patients with educational
materials that list community resources in the recep-
tion area. Concerned families can be encouraged to
obtain counseling or contact Parents, Family, and
Friends of Lesbians and Gays (http://www.pflag.org)
for information and support.
Committee Opinion No. 525
COMMITTEE OPINIONS
Additional guidance and recommendations for im-
proving communication, cultural competence, and patient
and family centered care is available at: http://www.joint
commission.org/assets/1/18/LGBTFieldGuide.pdf.
Resources
American College of Obstetricians and Gynecologists.
Lesbian teens. In: Tool kit for teen care. 2nd ed. Washington,
DC: ACOG; 2009.
American College of Obstetricians and Gynecologists.
Health care for lesbian and bisexual women. Washington,
DC: ACOG; 2006.
American College of Obstetricians and Gynecologists
Committee on Health Care for Underserved Women.
http://www.acog.org/About_ACOG/ACOG_Depart
ments/Health_Care_for_Underserved_Women. Retrieved
January 13, 2012.
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5. O’Hanlan KA. Domestic partnership benefits at medical
universities. JAMA 1999;282:1289–92. [PubMed] [Full Text]
^
6. Mravcak SA. Primary care for lesbians and bisexual women.
Am Fam Physician 2006;74:279–86. [PubMed] [Full Text]
^
7. O’Hanlan KA, Isler CM. Health care of lesbian and bisexual
women. In: Meyer IH, Northridge ME, editors. The health
of sexual minorities: public health perspectives on lesbian,
gay, bisexual and transgender populations. New York (NY):
Springer; 2007. p. 506–22. ^
8. American College of Obstetricians and Gynecologists.
Guidelines for women’s health care: a resource manual.
3rd ed. Washington, DC: ACOG; 2007. ^
9. Cervical cytology screening. ACOG Practice Bulletin No. 109.
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& Gynecology] ^
3
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 10. O’Hanlan KA, Crum CP. Human papillomavirus-associ-
ated cervical intraepithelial neoplasia following lesbian sex.
Obstet Gynecol 1996;88:702–3. [PubMed] [Obstetrics &
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11. Office on Women’s Health, Department of Health and
Human Services. Lesbian and bisexual health. Washington,
DC: HHS; 2009. Available at: http://www.womenshealth.
gov/publications/our-publications/fact-sheet/lesbian-
bisexual-health.pdf. Retrieved January 13, 2012. ^
12. Centers for Disease Control and Prevention. HIV/AIDS
among women who have sex with women. CDC HIV/AIDS
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14. Suicide Prevention Resource Center. Suicide risk and pre-
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4 Committee Opinion No. 525
COMMITTEE OPINIONS
18. Needham BL, Austin EL. Sexual orientation, parental sup-
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Copyright May 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Health care for lesbians and bisexual women. Committee Opinion
No. 525. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;119:1077–80.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 582
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 530 • July 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Access to Postpartum Sterilization

ABSTRACT: Postpartum tubal sterilization is one of the safest and most effective methods of contraception.
Women who desire this type of sterilization typically undergo thorough counseling and informed consent during
prenatal care and reiterate their desire for postpartum sterilization at the time of their hospital admission. Not all
women who desire postpartum sterilization actually undergo the surgical procedure, and women with unfulfilled
requests for postpartum sterilization have a high rate of repeat pregnancy (approaching 50%) within the following
year. Potentially correctable barriers to obtaining postpartum sterilization include patient and health care provider
factors, as well as hospital and health care system issues. Given the consequences of a missed procedure and
the limited time frame in which it may be performed, postpartum sterilization should be considered an urgent
surgical procedure. In addition, women with government insurance face barriers to sterilization procedures based
on cumbersome consent requirements. The differences in the requirements surrounding consent for sterilization
procedures based on the type of insurance a patient has must be addressed in order to establish fair and equitable
access to sterilization procedures for all women. Policies and procedures that remove barriers to and increase
efficiency in performing postpartum sterilization could reduce cancellations of the procedure. Improving consis-
tency in accomplishing desired postpartum sterilization is an important strategy to reduce high rates of unintended
pregnancy in the United States.

Unintended pregnancy is a serious problem in the United
States that is associated with health risks and costs for
a woman, her family, and society (1, 2). Women who
continue with unintended pregnancies are more likely
to have poor health outcomes such as low birth weight
infants, infant mortality, and maternal morbidity and
mortality (1, 3). Children resulting from unintended
pregnancies have higher rates of developmental delay
(1, 3). One half of pregnancies in the United States are
unintended and often occur disproportionately in low-
income and minority populations (4). A critical factor
underlying this widespread problem is a lack of access to
effective family planning services (1, 4–6).
Postpartum sterilization is one of the most effective
and popular forms of contraception in the United States,
and it is performed after 10% of all hospital deliveries
(7, 8). Sterilization procedures are more common among
underserved women, including those with lower levels
of education and income, public health insurance or no
health insurance, high parity, and those who are black or
Hispanic. However, several barriers limit access to the
procedure for many women, especially the poor or under-
served, who desire postpartum sterilization (6, 9–12). The
immediate postpartum period following vaginal delivery
or at the time of cesarean delivery is the ideal time to
perform sterilization because of technical ease and conve-
nience for the woman and physician. The procedure itself
should not lengthen hospitalization (13). This one-time
intervention is typically covered by insurance and elimi-
nates the risk of future pregnancy (7, 14).
Only 50% of women who request postpartum steril-
ization during prenatal contraception counseling actually
undergo the procedure (15, 16). Failure to provide the
desired sterilization creates a significant increase in cost
for the woman and the health care system (17). In one
study, nearly one half of women with unfulfilled postpar-
tum sterilization requests became pregnant within 1 year,
twice the rate of women who did not request sterilization
(10). The direct annual cost of unintended pregnancy to
the health care system measures in billions of dollars (18).
Because approximately one quarter of American women
rely on female sterilization for contraception, making the
availability of postpartum sterilization a priority is critical
to reducing unintended pregnancy (6, 10, 17). Women
in the postpartum period, with the added responsibility
of caring for a newborn and varying insurance coverage,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 583

 often struggle to return to the outpatient office for alter-
native methods of contraception.
Most women are good candidates for postpartum
sterilization. Occasionally, however, maternal medical
disorders may complicate the ability to safely perform
postpartum sterilization procedures. Assessment of hem-
odynamic status and consideration of anesthetic risks are
important for women scheduled for postpartum steriliza-
tion. Although the safety of postpartum tubal sterilization
in women with preeclampsia has not been thoroughly
evaluated, in the absence of profound hemodynamic
alterations, the patient can be considered a candidate for
the procedure (19). Morbid obesity may present operative
difficulties for performing the procedure; however, the
theoretic effectiveness of the procedure should remain
unaffected by the patient’s body mass index (20). When
unforeseen morbidity occurs that prevents a sterilization
procedure or causes a woman to decide not to undergo
the procedure, alternative reversible methods of contra-
ception should be presented to the woman, including
long-acting methods that have effectiveness rates com-
parable to sterilization such as the intrauterine device or
single-rod contraceptive implant (21).
Because most women are good candidates for post-
partum sterilization and because the costs associated
with lack of provision of the procedure are high, barriers
must be overcome to improve the consistency of fulfilling
requests for postpartum sterilization. Factors that may
decrease the likelihood of a woman obtaining desired
postpartum sterilization include young age and concern
for patient regret, consent documents, lack of available
operating rooms and anesthesia, and receiving care in a
religiously affiliated hospital.
Young Age and Concern for Patient Regret
Women must be 21 years old to be eligible for a steriliza-
tion procedure covered by federal Medicaid funds, the
Indian Health Service, or U.S. military health insurance.
However, health care providers may be reluctant to
perform sterilization in women younger than 30 years
because of the increased probability of long-term regret
compared with women older than 30 years (21). The
majority of women younger than 30 years (80%) do not
regret their sterilization decision. Long-term regret is
more common among underserved women, and thor-
ough presterilization counseling may identify women
more likely to experience regret.
Consent Documents
To ensure informed consent and protect women from
coercion, federal regulations require specific sterilization
consent for women enrolled in Medicaid or covered by
other government insurance for all sterilization proce-
dures, not just postpartum sterilization. This consent
form must be signed at least 30 days before the procedure
in order for a health care provider or health care facility
to be reimbursed, and it remains valid for 180 days; if
2 Committee Opinion No. 530
COMMITTEE OPINIONS
the consent form is not signed, the patient will receive
a bill for services. Furthermore, reimbursement to the
hospital for the delivery and postpartum care may be
denied because of an improperly completed or incom-
plete federal consent form. Although the original intent
was to protect women from being sterilized against their
will, the lack of a timely signature on the federal consent
form now interferes with patient autonomy because
it has become a common reason for lack of provision
of desired postpartum sterilization (15, 16, 22, 23). In
addition, the lack of availability or failed transfer of the
completed federal consent document to the delivery
unit can result in cancellation of sterilization procedures
(14). Women with commercial or private insurance
who desire sterilization are not mandated to follow the
same consent rules—signing a consent form at least 30
days in advance—to obtain the procedure, thus creating
a two-tiered system of access. With possible Medicaid
expansions under the Patient Protection and Affordable
Care Act, this federal regulation will adversely affect an
even larger population of women. The regulation places
an undue burden on women and health care providers
and must be revised in order to create fair and equitable
access for women enrolled in Medicaid or covered by
other government insurance. Until this is accomplished,
hospital systems and obstetric health care providers
should develop appropriate policies and procedures to
ensure that the federal consent form is obtained in the
prenatal period and is available at the time of delivery. If a
woman covered by Medicaid does not receive her desired
sterilization, she may not be eligible for coverage of any
contraceptive method because Medicaid insurance often
ends shortly after the birth (17).
Lack of Available Operating Rooms or
Anesthesia
Inadequate hospital resources can hinder a woman from
obtaining her desired postpartum sterilization. Typically,
postpartum sterilization procedures are performed in
labor and delivery operating rooms with obstetric
anesthesia personnel. Performing postpartum steril-
ization may be impossible when several deliveries are
imminent or when inadequate staffing occurs in a hos-
pital’s labor and delivery ward. From the patient’s per-
spective, she has been counseled and anticipates the
procedure; she remains without oral intake for many
hours and may be separated from her newborn only to
face a canceled procedure. By its very nature, a postpar-
tum sterilization procedure cannot be scheduled in
advance, a fact that increases the difficulty of obtaining
an operating room. Consideration of other operative sites
within the hospital, such as the main operating room,
could increase the likelihood that sterilization procedures
would be accomplished. Emphasis on the urgent nature
of the procedure, rather than considering it elective,
may increase the success in scheduling these procedures
with such a short notice. Use of an existing epidural
2013 COMPENDIUM OF SELECTED PUBLICATIONS 584
 catheter is an efficient and convenient way to provide
anesthesia for sterilization after a vaginal delivery (24).
Additionally, an understanding on the part of the entire
health care team of the importance of accomplishing
the procedure and its effect on individual and public
health could increase the commitment to postpartum
sterilization.
Receiving Care in a Religiously Affiliated
Hospital
Policies at some religiously affiliated hospitals may pose a
barrier to reproductive health services (25). For example,
approximately 10% of U.S. hospitals are Catholic and
operate according to specific directives that prohibit
the performance of sterilization within the institution.
Although some religiously affiliated hospitals have devel-
oped arrangements for the provision of select reproduc-
tive health services at alternate sites, they cannot address
the needs of women who desire postpartum sterilization.
Lack of access to postpartum contraception in religiously
affiliated institutions is a barrier to the timely initiation
of contraception and could lead to increased unintended
pregnancy rates (26). Women receiving maternity care
through a religiously affiliated health care site should
be provided with information related to all types of
reproductive health services, including postpartum ster-
ilization, with appropriate referral to institutions that
perform the procedure when requested.
Conclusions and Recommendations
Access to postpartum sterilization is an important strat-
egy to reduce high rates of unintended pregnancy in the
United States. The following conclusions and recom-
mendations are presented by the American College of
Obstetricians and Gynecologists:
• Postpartum sterilization is a highly effective method
of contraception.
• Given the consequences of a missed procedure and cies and government cost savings. J Health Care Poor
the limited time frame in which it may be performed,
postpartum sterilization should be considered an
urgent surgical procedure.
• Obstetrician–gynecologists should identify and elim-
inate barriers that restrict access to postpartum ster-
ilization. Obstetrician–gynecologists need to identify
themselves as champions or patient advocates for
postpartum sterilization in their respective hospitals
and help to coordinate administration and health
care staff in streamlining access to the procedure.
• Increasing access and availability of postpartum update. OBG Manage 2008;20:S1–8. ^
sterilization may not only directly improve outcomes
for women desiring the procedure, but may decrease
overall costs to the health care system.
• There are unfair differences in consent rules sur-
rounding sterilization procedures based on insurance
type. Obstetrician–gynecologists should advocate for
fair and equitable access for women who are enrolled
Committee Opinion No. 530
COMMITTEE OPINIONS
in Medicaid or covered by other government health
insurance programs.
Resources
American College of Obstetricians and Gynecologists
American College of Obstetricians and Gynecologists.
Postpartum sterilization. Patient Education Fre-
quently Asked Questions FAQ052. Washington, DC:
American College of Obstetricians and Gynecologists;
2011. Available at: http://www.acog.org/~/media/For
%20Patients/faq052.pdf?dmc=1&ts=2012051
5T1249134768. Retrieved April 2, 2012.
American College of Obstetricians and Gynecologists.
Postpartum sterilization. Patient Education Pamphlet
AP052. Washington, DC: American College of Obste-
tricians and Gynecologists; 2011.
U.S. Department of Health and Human Services Con-
sent for Sterilization. Available at: www.hhs.gov/forms/
HHS-687.pdf.
References
1. Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J.
Disparities in family planning. Am J Obstet Gynecol 2010;
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Foster DG. Cost-benefit analysis of state- and hospital-
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10. Thurman AR, Janecek T. One-year follow-up of women with
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 11. Chan LM, Westhoff CL. Tubal sterilization trends in the
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12. Borrero S, Schwarz EB, Reeves MF, Bost JE, Creinin MD,
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13. Corson SL, Derman RJ, Tyrer LB, editors. Fertility control.
2nd ed. London (ON): Goldin Publishers; 1994. ^
14. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR,
Trussell J. The risk of ectopic pregnancy after tubal steril-
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Group. N Engl J Med 1997;336:762–7. [PubMed] [Full
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15. Zite N, Wuellner S, Gilliam M. Failure to obtain desired post-
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Factors predictive for failure to perform postpartum tubal
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4 Committee Opinion No. 530
COMMITTEE OPINIONS
22. Zite N, Wuellner S, Gilliam M. Barriers to obtaining a
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23. Gilliam M, Davis SD, Berlin A, Zite NB. A qualitative
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24. Goodman EJ, Dumas SD. The rate of successful reactiva-
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25. Gold RB. Advocates work to preserve reproductive health
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Policy 2000;3(2):3–4, 12. ^
26. Guiahi M, McNulty M, Garbe G, Edwards S, Kenton K.
Changing depot medroxyprogesterone acetate access at
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Copyright July 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Access to postpartum sterilization. Committee Opinion No. 530.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:212–15.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 586
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 535 • August 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Reproductive Health Care for Incarcerated Women

and Adolescent Females
ABSTRACT: Increasing numbers of women and adolescent females are incarcerated each year in the United
States and they represent an increasing proportion of inmates in the U.S. correctional system. Incarcerated
women and adolescent females often come from disadvantaged environments and have high rates of chronic ill-
ness, substance abuse, and undetected health problems. Most of these females are of reproductive age and are
at high risk of unintended pregnancy and sexually transmitted infections, including human immunodeficiency virus
(HIV). Understanding the needs of incarcerated women and adolescent females can help improve the provision of
health care in the correctional system.

Background parents of one or more minor children, and 19% of these

Between 1990 and 2009, the number of incarcerated
women increased 153% (1). Most women in correctional
facilities are incarcerated for nonviolent crimes. Drug
offenses are the most common felonies committed by
women in both federal (72%) and state (34%) prison
systems, and are the second most common offense com-
mitted by women in local jails (30%) (2). By the middle of
2009, 106,362 women (6.9% of all prison inmates) were
incarcerated in federal or state prisons, and by the middle
of 2011, 93,300 women (12.7% of all jail inmates) were
incarcerated in local jails (3, 4). In 2010, 306,498 females
younger than 18 years were arrested, representing 29% of
all juvenile arrests (5). Juvenile offenders may be housed
in juvenile detention homes or residential correctional
facilities or, in some cases, in adult prisons or jails.
Incarcerated women and adolescent females often
come from economically, educationally, socially, and emo-
tionally disadvantaged environments; a disproportionate
number have acute and chronic illnesses, substance abuse
problems, and undetected health issues, including repro-
ductive health needs. In one study, 27% of incarcerated
women had chlamydia and 8% had gonorrhea, compared
with rates of 0.46% and 0.13% in the general population,
respectively (6). In 2008, 2% of women in state and federal
prisons were known to be infected with human immuno-
deficiency virus (HIV) (7). Fifty-six percent of women in
federal prisons and 62% of women in state prisons were
children were in the care of someone other than a family
member during the mother’s incarceration (8).
Approximately 6–10% of incarcerated women are
pregnant, and are mostly incarcerated in local jails (9,
10). There are few studies about birth outcomes for
women who continue pregnancies during incarceration.
Although a woman retains her legal right to an abortion
during incarceration, a woman’s experience in attempt-
ing to obtain an abortion varies widely by state, region,
and individual prison (11, 12). In a survey of correctional
health officials, 68% indicated that women in their pris-
ons were allowed to have an elective abortion, but only
54% helped arrange appointments (11).
Sexually transmitted infections and pregnancies may
result from sexual victimization of women during incar-
ceration. In a survey of local jail inmates using audio
computer-assisted self-interviews to maximize confiden-
tiality and reliability, 5.1% of female inmates reported
sexual victimization (13). Of these, 3.7% of women expe-
rienced sexual victimization by another inmate and 2.0%
reported sexual victimization by a staff member (13). In
a similar survey of state and federal prison inmates, the
rate of sexual victimization among men and women was
4.5% (14). Total rates for women were not presented, but
rates were as high as 10.8% at some prisons, with sexual
victimization by a staff member reported by up to 5.3%
of women (14).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 587

 Mental health disorders and substance abuse are
common among incarcerated women. Sixty-nine per-
cent of women admitted to local jails met the crite-
ria for substance dependence or abuse (not including
tobacco use); dependence was diagnosed more com-
monly among women than among men (15). Rates of
mental health problems among women inmates ranged
from 61% in federal prisons to 75% in local jails (16).
Incarceration is an important risk factor for suicide by
adolescent inmates (17). More than 50% of women in
jail reported a history of physical or sexual abuse, and
this rate is as high as 92% among female juvenile offend-
ers in California (18, 19).
Medical Care Availability and Access
Although most state and federal prisons provide some
level of care to prisoners, availability and access to medi-
cal care in jails is variable. The short and often unpredict-
able duration of incarceration in local jails often makes
provision and continuity of care difficult. In addition,
systems of care vary in state and local prison and jail
settings. Services at state prisons and jails may be pro-
vided on site by health care providers, by arrangements
with local hospitals or clinics either on site or by inmate
transport, or by an on-site health care provider contrac-
tor. Historically, health care was delivered by way of a
“sick call,” where an inmate notified a guard or other
designated authority of the need for medical attention. A
sick call system does not allow for provision of primary
or preventive care and health education. Although many
facilities have moved to systems that provide primary
care, the increase in the number of inmates makes provi-
sion of adequate care difficult. In addition, women are
often housed in facilities with predominantly male popu-
lations, which limits the availability of health services
tailored to women’s needs. Financing of correctional
facilities, including health care, depends on legislative
appropriations that compete with other priorities. In gen-
eral, Medicaid funding cannot be used for care for adults
and adolescents in secure confinement.
No federal or state mandates require correctional
health facilities to obtain accreditation, and there is
no organization to which all facilities are accountable.
Several organizations accredit prisons, but their standards
only serve as guidelines and are followed voluntarily.
These organizations include The Joint Commission, the
National Commission on Correctional Health Care, and
the American Correctional Association. Health care stan-
dards for jails, prisons, and juvenile facilities have been
developed by the National Commission on Correctional
Health Care, the American Correctional Association, and
the American Public Health Association (20–23).
In general, care for incarcerated women and adoles-
cent females should be provided using the same guide-
lines as those for women and adolescent females who
are not incarcerated, with attention to the increased
risk of infectious diseases and mental health problems
common to incarcerated populations. Health care for
incarcerated women and adolescent females is outlined
in Table 1 (23, 24).

Table 1. Recommended Care for Incarcerated Women and Adolescent Females

Type of Care Adult Jail or Prison* Juvenile Facilities

Entering facilities Ask about any current medical problems and care and Same as in adults, but also screen for eating disorders
safety of minor children at home.
Obtain a medical history—immunization status; sexual Same as in adults
activity, contraceptive use, and menstrual cycle to assess
the need for a pregnancy test; number of pregnancies and
outcomes; history of medical problems, chronic illness,
hospitalizations, breast disease, and gynecologic problems;
and domestic violence, sexual abuse, and physical abuse
Mental health assessment Same as in adults, bearing in mind that adolescents
in correctional facilities are at higher risk of suicide
than those in the general population
Physical examination†—pelvic and breast, Pap test, and Same as in adults, except mammography and Pap
baseline mammography based on College guidelines test are unlikely to be needed. Pap test should be
In a jail setting, Pap test and mammography should performed on adolescents according to College
only be done if there is enough time to obtain results recommendations.
before release.
Laboratory work—STIs, HIV, pregnancy, hepatitis, and Same as in adults
tuberculin skin tests based on College guidelines
In a jail setting, tuberculin skin tests should only be done
if incarceration is expected to be for at least 48 hours
to see if any reaction occurs.
(continued)

2 Committee Opinion No. 535

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 588

 Table 1. Recommended Care for Incarcerated Women and Adolescent Females (continued)
Type of Care Adult Jail or Prison* Juvenile Facilities

Pregnancy care Pregnancy counseling, perinatal care, and abortion services Same as in adults
should be offered based on College guidelines
Preventive care Any additional tests, examinations, and care based on Same as in adults
College guidelines
Health education on contraception and pregnancy; tobacco, Same as in adults
alcohol, and substance abuse cessation; and parenting
Comprehensive HIV and STI treatment and prevention Same as in adults, bearing in mind that adolescents
programs are at higher risk of STIs than the adult population
Contraceptive services, including emergency contraception, Same as in adults
based on medical need or potential risk of pregnancy
Provide immunizations as necessary based on College Same as in adults, but with particular focus on HPV,
guidelines, with particular focus on influenza and meningococcal, and influenza vaccination
pneumococcal vaccination
Care for older women Hormone therapy, if indicated Not applicable
Screening, treatment, and prevention programs for Osteoporosis prevention programs may be useful
osteoporosis
Screening for depression and dementia Screening for depression
Mental health care Medication management, suicide prevention, crisis Same as in adults, noting that incarceration is a risk
intervention, substance abuse programs, and linkage to factor for suicide among adolescents
social services and community substance abuse programs
upon release
Abbreviations: College, American College of Obstetricians and Gynecologists; STIs, sexually transmitted infections; HIV, human immunodeficiency virus; HPV, human papil-
lomavirus.
*If a juvenile is housed in an adult prison or jail, the recommendations under the juvenile facilities column should be followed.
The request by either a patient or a physician to have a chaperone present during a physical examination should be accommodated regardless of the physician’s sex.
†

Data from Anno BJ. Correctional health care: guidelines for the management of an adequate delivery system. Chicago (IL): National Commission on Correctional Health Care;
2001. Available at: http://static.nicic.gov/Library/017521.pdf. Retrieved April 16, 2012; American Academy of Pediatrics, American College of Obstetricians and Gynecologists.
Guidelines for perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007; American College of Obstetricians and Gynecologists. Guidelines for adolescent
health care. 2nd ed. Washington, DC: American College of Obstetricians and Gynecologists; 2011; American College of Obstetricians and Gynecologists. Guidelines for women’s
health care: a resource manual. 3rd ed. Washington, DC: ACOG; 2007; American College of Obstetricians and Gynecologists. Well-woman care: assessments and recom-
mendations. Washington, DC: American College of Obstetricians and Gynecologists; 2012. Available at: http://www.acog.org/~/media/Departments/Annual%20Womens%20
Health%20Care/PrimaryAndPreventiveCare.pdf?dmc=1&ts=20120419T1033428879. Retrieved April 19, 2012; American Public Health Association. Standards for health services
in correctional institutions. 3rd ed. Washington, DC: APHA; 2003; Cervical cancer in adolescents: screening, evaluation, and management. Committee Opinion No. 463. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2010;116:469–72; Health care for pregnant and postpartum incarcerated women and adolescent females. Committee
Opinion No. 511. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:1198–1202; National Commission on Correctional Health Care. Standards for
health services in jails. Chicago (IL): NCCHC; 2008; National Commission on Correctional Health Care. Standards for health services in juvenile detention and confinement facili-
ties. Chicago (IL): NCCHC; 2004; National Commission on Correctional Health Care. Standards for health services in prisons. Chicago (IL): NCCHC; 2008; and Health care for youth
in the juvenile justice system. Policy Statement. American Academy of Pediatrics. Pediatrics 2011;128:1219–35.

Recommendations being addressed appropriately, such as by provid-

• Obstetrician–gynecologists should support efforts to ing training or consultation to health care provid-
improve the health care of incarcerated women and
adolescent females at the local, state, and national
levels. Activities may include the following:
— Gaining representation on the boards of correc-
tional health organizations.
— Working in correctional facilities to provide ser-
vices to incarcerated women and adolescent
females and continuing care after the woman’s
release, when feasible.
— Undertaking efforts to ensure that medical needs
of incarcerated women and adolescent females are
ers and correctional officers in prison settings.
— Advocating at the local, state, and federal levels for
increased funding to provide access to necessary
health care for incarcerated women and to restrict
shackling of women and adolescents during preg-
nancy and the postpartum period (10).
• Facilitate care provision by health care providers
to incarcerated women and adolescent females (eg,
allowing incarcerated women and adolescent females
to enter through alternate entrances to avoid stig-

Committee Opinion No. 535 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 589

 matization in the waiting room or to be seen during
off-hours).
• Ensure that adolescents only be detained or incarcer-
ated in facilities with developmentally appropriate
programs and staff trained to deal with their unique
needs. If they must be housed in adult correctional
facilities, they should be separated from the adult
population into an environment that is able to
address their specific developmental needs (24).
• Ensure that adolescents with serious mental disor-
ders are not placed in detention when they do not
face criminal charges. The placement of adolescents
with mental disorders who have been charged with
crimes and are able to be released from incarceration
into a community mental health facility should be
completed in a timely fashion.
• Facilitate collaboration between medical schools and
other health care professional schools and correc-
tional facilities to improve care to inmates.
• Obtain and support funding for research on the 09st.pdf. Retrieved April 16, 2012. ^
health needs of incarcerated women and adolescent
females, the services they receive, the qualifications
of the health care provider, the location of the ser-
vice, and the outcomes of these services.
• Support state and federal funding that increases 5. Federal Bureau of Investigation. Crime in the United States,
access to necessary health care that includes not only
disease-specific treatment, but also preventive ser-
vices and access to qualified health care providers for
incarcerated women and adolescent females.
Specific medical recommendations include the fol-
lowing:
• Correctional facilities should be adequately funded Mortal Wkly Rep 1999;48:793–6. [PubMed] [Full Text] ^
to provide a continuum of care model providing
female inmates with initial screenings, in-house
services or referrals for preventive and curative
care, including Pap tests and appropriate follow-
up, health education, and adequate planning before
release from correctional facilities.
• Health care providers and other correctional facili-
ties staff should receive appropriate training to pro-
vide care for female inmates, including the care of
pregnant women (10).
• Incarcerated women of all ages should receive repro-
ductive health care, including access to adequate con-
traception, prenatal care, and abortion services (9, 10).
• Appropriate and adequate care should be provided women and adolescent females. Committee Opinion No.
for pregnant women and adolescents, including
opioid dependence treatment, avoiding the use of
restraints, and promoting breastfeeding (10).
• If hospitalization or other off-site health care occurs, 11. Sufrin CB, Creinin MD, Chang JC. Incarcerated women
prescribed treatments, such as medications, must
continue once the patient returns to the correctional
facility.
4 Committee Opinion No. 535
COMMITTEE OPINIONS
• Incarcerated women and adolescents’ mental health
needs should be addressed.
• Incarcerated women and adolescents should be pro-
tected from sexual abuse. If sexual abuse occurs, the
guilty party should be punished to the full extent of
the law.
References
1. Glaze LE. Correctional populations in the United States,
2009. Bureau of Justice Statistics Bulletin. Washington,
DC: U.S. Department of Justice; 2010. Available at: http://
bjs.ojp.usdoj.gov/content/pub/pdf/cpus09.pdf. Retrieved
April 16, 2012. ^
2. Greenfeld LA, Snell TL. Women offenders. Bureau of Justice
Statistics Special Report. Washington, DC: U.S. Department
of Justice; 2000. Available at: http://bjs.ojp.usdoj.gov/
content/pub/pdf/wo.pdf. Retrieved April 16, 2012. ^
3. West HC. Prison inmates at midyear 2009 - statistical
tables. Washington, DC: U.S. Department of Justice; 2010.
Available at: http://bjs.ojp.usdoj.gov/content/pub/pdf/pim
4. Minton TD. Jail inmates at midyear 2011 - statistical tables.
Bureau of Justice Statistics. Washington, DC: U.S. Depart-
ment of Justice; 2012. Available at: http://bjs.ojp.usdoj.gov/
content/pub/pdf/jim11st.pdf. Retrieved May 2, 2012. ^
2010. Washington, DC: FBI; 2011. Available at: http://www.
fbi.gov/about-us/cjis/ucr/crime-in-the-u.s/2010/crime-in-
the-u.s.-2010. Retrieved April 16, 2012. ^
6. High prevalence of chlamydial and gonococcal infection
in women entering jails and juvenile detention centers—
Chicago, Birmingham, and San Francisco, 1998. Centers
for Disease Control and Prevention (CDC). MMWR Morb
7. Maruschak LM. HIV in prisons, 2007–08. Bureau of Justice
Statistics Bulletin. Washington, DC: U.S. Department of
Justice; 2010. Available at: http://bjs.ojp.usdoj.gov/content/
pub/pdf/hivp08.pdf. Retrieved April 16, 2012. ^
8. Glaze LE, Maruschak LM. Parents in prison and their
minor children. Bureau of Justice Statistics Special Report.
Washington, DC: U.S. Department of Justice; 2010. Avail-
able at: http://www.bjs.gov/content/pub/pdf/pptmc.pdf.
Retrieved April 16, 2012. ^
9. Clarke JG, Hebert MR, Rosengard C, Rose JS, DaSilva KM,
Stein MD. Reproductive health care and family planning
needs among incarcerated women. Am J Public Health
2006;96:834–9. [PubMed] [Full Text] ^
10. Health care for pregnant and postpartum incarcerated
511. American College Obstetricians and Gynecologists.
Obstet Gynecol 2011;118:1198–202. [PubMed] [Obstetrics
& Gynecology] ^
and abortion provision: a survey of correctional health
providers. Perspect Sex Reprod Health 2009;41:6–11.
[PubMed] [Full Text] ^
2013 COMPENDIUM OF SELECTED PUBLICATIONS 590
 12. Kasdan D. Abortion access for incarcerated women: are
correctional health practices in conflict with constitutional
standards. Perspect Sex Reprod Health 2009;41:59–62.
[PubMed] [Full Text] ^
13. Beck AJ, Harrison PM. Sexual victimization in local jails
reported by inmates, 2007. Bureau of Justice Statistics
Special Report. Washington, DC: U.S. Department of
Justice; 2011. Available at: http://bjs.ojp.usdoj.gov/content/
pub/pdf/svljri07.pdf. Retrieved April 16, 2012. ^
14. Beck AJ, Harrison PM. Sexual victimization in state and
federal prisons reported by inmates, 2007. Bureau of
Justice Statistics Special Report. Washington, DC: U.S.
Department of Justice; 2008. Available at: http://bjs.ojp.
usdoj.gov/content/pub/pdf/svsfpri07.pdf. Retrieved April
16, 2012. ^
15. Karberg JC, James DJ. Substance dependence, abuse, and
treatment of jail inmates, 2002. Bureau of Justice Statistics
Special Report. Washington, DC: U.S. Department of
Justice; 2005. Available at: http://bjs.ojp.usdoj.gov/content/
pub/pdf/sdatji02.pdf. Retrieved July 12, 2011. ^
16. James DJ, Glaze LE. Mental health problems of prison
and jail inmates. Bureau of Justice Statistics Special Report.
Washington, DC: U.S. Department of Justice; 2006. Avail-
able at: http://bjs.ojp.usdoj.gov/content/pub/pdf/mhppji.
pdf. Retrieved April 16, 2012. ^
17. Hayes LM. Juvenile suicide in confinement: a national
survey. Mansfield (MA): National Center on Institutions
and Alternatives; 2004. Available at: https://www.ncjrs.gov/
pdffiles1/ojjdp/grants/206354.pdf. Retrieved April 19, 2012.
^ photocopies should be directed to: Copyright Clearance Center, 222
18. Harlow CW. Prior abuse reported by inmates and pro-
bationers. Bureau of Justice Statistics Selected Findings.
Washington, DC: U.S. Department of Justice; 1999. Avail-
able at: http://bjs.ojp.usdoj.gov/content/pub/pdf/parip.
pdf. Retrieved April 18, 2012. ^
Committee Opinion No. 535
COMMITTEE OPINIONS
19. Acoca L, Dedel K. No place to hide: understanding and
meeting the needs of girls in the California juvenile justice
system. San Francisco (CA): National Council on Crime
and Delinquency; 1998. ^
20. National Commission on Correctional Health Care.
Standards for health services in jails. Chicago (IL): NCCHC;
2008. ^
21. National Commission on Correctional Health Care.
Standards for health services in juvenile detention and con-
finement facilities. Chicago (IL): NCCHC; 2004. ^
22. National Commission on Correctional Health Care.
Standards for health services in prisons. Chicago (IL):
NCCHC; 2008. ^
23. American Public Health Association. Standards for health
services in correctional institutions. Washington, DC:
APHA; 2003. ^
24. Health care for youth in the juvenile justice system. Policy
Statement. American Academy of Pediatrics. Pediatrics
2011;128:1219–35. [PubMed] [Full Text] ^
Copyright August 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Reproductive health care for incarcerated women and adolescent
females. Committee Opinion No. 535. American College of Obste-
tricians and Gynecologists. Obstet Gynecol 2012;120:425–9.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 591
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 536 • September 2012 (Replaces Committee Opinion No. 414, August 2008)
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Human Immunodeficiency Virus and Acquired

Immunodeficiency Syndrome and Women of Color
ABSTRACT: In the United States, most new cases of human immunodeficiency virus (HIV) infection and
acquired immunodeficiency syndrome (AIDS) occur among women of color (primarily African American and
Hispanic women). Most women of color acquire the disease from heterosexual contact, often from a partner
who has undisclosed risk factors for HIV infection. Safe sex practices, especially consistent condom use, must be
emphasized for all women, including women of color. A combination of testing, education, and brief behavioral
interventions can help reduce the rate of HIV infection and its complications among women of color. In addition,
biomedical interventions such as early treatment of patients infected with HIV and pre-exposure antiretroviral pro-
phylaxis of high-risk individuals offer promise for future reductions in infections.

Background 40–49 years, by 6.8% per year among women aged

Early in the human immunodeficiency virus (HIV)
and acquired immunodeficiency syndrome (AIDS) epi-
demic, HIV/AIDS was rarely diagnosed in women, but
women now account for an increasing proportion of
new HIV/AIDS diagnoses. In 1985, women represented
8% of HIV/AIDS cases, but by 2010, women accounted
for 21% of new cases (1, 2). According to a Centers for
Disease Control and Prevention (CDC) report, HIV/AIDS
is defined as HIV infection with or without AIDS. Het-
erosexual contact was the source of 86% of these new
infections (1). Many women are unaware of their male
partners’ risk factors for HIV infection (such as unpro-
tected sex with multiple partners, sex with men, or
injection drug use). Of great concern is the number of
young women with HIV infection and AIDS. In 2009,
23% of new diagnoses of HIV/AIDS were in girls in the
13–19-year-old age group, and 19% of new diagnoses
were in women in the 20–24-year-old age group (3). More
than 90% of new HIV/AIDS cases in women younger
than 25 years are from heterosexual transmission (3). Of
women with AIDS, 60% received the diagnosis before age
45 years, suggesting that many were infected as adoles-
cents (1). In older women, there also is an increase in HIV
diagnoses. Between 1999 and 2004, the number of women
with newly diagnosed HIV infections from heterosexual
activity increased by 4.8% per year among women aged
50–59 years, and by 4.1% per year among women older
than 60 years (4). There are many reasons why women
infected with HIV may have difficulty obtaining health
care, including lack of financial resources and health
insurance, lack of transportation, and the added respon-
sibility of caring for others, especially children. Lack of
access to effective therapy has been associated with an
increase in the mortality rate (5).
Women of Color
Most new cases of HIV infection among women in the
United States occur in women of color (1). The rate
of AIDS diagnosis for African American and Hispanic
women is disproportionate to this population. African
American and Hispanic women represent 25% of all U.S.
women; however, the two groups accounted for 80% of
the estimated total of new HIV diagnoses in women in
2010 (1). Among African American women, the rate of
HIV/AIDS diagnosis is 15 times the rate for white women
and more than four times the rate for Hispanic women
(6). Hispanic women are infected more than four times
the rate of white women (6). Current estimates are that
1 in 32 African American women and 1 in 106 Hispanic
women will acquire HIV infection in their lifetimes, com-
pared with 1 in 562 white women (7). Mortality rates in
women of color remain very high with African American

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 592

 women accounting for 65% of deaths among women
infected with HIV in the United States (1). The death rate
from HIV infection among African American women
was higher than for all other groups, both male and
female, except for African American men.
There are many factors associated with the increased
risk of HIV infection among women of color. Among
African American and Hispanic women living with HIV/
AIDS, the most common exposure was high-risk hetero-
sexual contact (1). The higher prevalence of HIV infection
in the African American community makes women in
that community more likely to be exposed to HIV. African
American men who have sex with men have the highest
incidence and prevalence of HIV among any ethnic or
behavioral risk group in the United States (8). Among
men who have sex with men, African American men are
more likely than European-American men to also have sex
with women and are less likely to disclose their behavior to
friends and partners, putting women at risk (9). Poverty
and economic uncertainty may make it more difficult for
women to feel empowered to negotiate condom use and
other safe sex practices (10). In addition, among African
American women, increased rates of other genital infec-
tions, including gonorrhea, chlamydia, syphilis, bacterial
vaginosis, and trichomoniasis, may increase susceptibility
to HIV infection (8, 11, 12). Racially associated differences
in allele frequencies of genes that influence susceptibil-
ity to and progression of HIV infection may increase the
risk of HIV infection in African American women (13).
High rates of incarceration in the African American com-
munity disrupt stable partnerships and promote high-risk
concurrent partnerships (14). Among Hispanic women,
traditional gender roles hinder open communication
of safe sex practices with male partners (15). Hispanic
men and women are disproportionately likely to face
serious socioeconomic barriers, including lack of educa-
tion, unemployment, inadequate health insurance, and
limited access to health care, which can increase the risk
of HIV infection (15). Language also can be a barrier for
this population, thus, culturally and linguistically focused
interventions are warranted (15).
Interventions for Women of Color
Multiple interventions at the individual, group, and com-
munity level have been assessed and found to be associ-
ated with types of behavior that prevent HIV infection
and skills such as condom use and partner communica-
tion (16). Gender-tailored and culturally appropriate
interventions are important and can reduce risk-taking
behavior and rates of sexually transmitted infections (STIs)
among adolescents of color (17–20). Behavioral inter-
ventions targeting adult women of color also are crucial
to decrease rates of morbidity and mortality from HIV
and AIDS. In a randomized controlled trial that tested the
efficacy of HIV and STI risk-reduction interventions for
African American women in primary care settings, it was
found that brief single-session, one-on-one interventions,
2 Committee Opinion No. 536
COMMITTEE OPINIONS
or group skill-building interventions may reduce behav-
ior associated with HIV and STI risk, such as unprotected
sex, and also may reduce rates of STI morbidity (21). In
multiple studies, it has been shown that brief behavioral
interventions, including personalized risk assessment,
training in negotiation skills, and identification of spe-
cific targets for behavioral change, can increase rates of
condom use and decrease rates of acquisition of STIs
compared with education alone among women of color
(21–24). These findings suggest that targeted and focused
programs can be effective among women of color. The
CDC maintains an ongoing compendium of individual,
group, and community level behavioral interventions
rated on the level of evidence of effectiveness for reduc-
ing the risk of HIV infection, increasing the rate of HIV
testing, and optimizing care for individuals with HIV
in various high-risk groups, including women of color
(16). In addition, the CDC provides support and techni-
cal assistance to health departments and community-
based organizations to provide effective interventions for
women of color and other groups.
In addition to behavioral interventions to decrease
the risk of HIV infection and transmission, several prom-
ising biomedical developments suggest a new avenue of
prevention. An international randomized trial of early
treatment of individuals with HIV showed a 96% reduc-
tion in transmission to heterosexual partners when anti-
retroviral therapy was started while the CD4+ lymphocyte
count was between 350–550 cells/microliter compared
with waiting until the CD4+ cell count decreased to less
than 250 cells/microliter (25). This study emphasizes
the importance of testing to allow early identification of
infected individuals in order to offer antiretrovirals to
preserve their own health and to minimize the risk of
partner transmission. Several studies of pre-exposure
prophylaxis with antiretrovirals for individuals without
HIV also have been reported but results have been mixed.
The Pre-exposure Prophylaxis Initiative showed a 44%
reduction in incident HIV infections among men who
had sex with men who were randomized to daily oral
tenofovir and emtricitabine compared with placebo (26).
In a study of discordant heterosexual couples in Kenya
and Uganda, among HIV-1–negative partners, there was
a relative reduction of 67% with tenofovir and 75% with
tenofovir and emtricitabine (27). In Botswana, a study
of HIV-negative, heterosexual men and women who
received daily pre-exposure prophylaxis with tenofovir
and emtricitabine or placebo, showed the efficacy of teno-
fovir and emtricitabine to be 62.2% (28). However, the
Pre-exposure Prophylaxis for Women study, which stud-
ied the use of oral tenofovir and emtricitabine, and the
oral tenofovir arm of the Vaginal and Oral Interventions
to Control the Epidemic (VOICE) study, which enrolled
high-risk women who were not infected with HIV, were
both stopped early because of futility. No benefit was
found for the use of antiretrovirals compared with pla-
cebo in preventing infection (29, 30). The oral tenofovir
2013 COMPENDIUM OF SELECTED PUBLICATIONS 593
 and emtricitabine arm of the VOICE study is continuing.
Similarly, two large studies of tenofovir vaginal gel for
HIV prevention in women have had conflicting results;
the Centre for the AIDS Programme of Research in South
Africa 004 study showed a 39% reduction in infection risk
with pericoital use compared with placebo, whereas the
VOICE study found no benefit with daily tenofovir gel
use compared with placebo (31, 32). Guidelines for use
of oral pre-exposure prophylaxis in men who have sex
with men have been developed (33), but given conflicting
results, no such guidelines are available for women. Until
groups of women likely to benefit from oral pre-exposure
prophylaxis are delineated, health care providers should
focus on behavioral interventions and counsel women to
have their partners tested for HIV.
Recommendations
All women can be affected by HIV/AIDS, but women of
color are acquiring the disease at higher rates than other
groups. Most are acquiring the disease from heterosexual
contact, often from a partner who has undisclosed risk
factors for HIV infection. Prevention and early recogni-
tion are critical, but women of color are not maximally
benefiting from these two interventions. The American
College of Obstetricians and Gynecologists recommends
routine HIV screening for women aged 19–64 years and
targeted screening for women with risk factors outside
of that age range (eg, sexually active adolescents younger
than 19 years) (34). Ideally, opt-out HIV screening should
be performed, in which the patient is notified that HIV
testing will be performed as a routine part of gyneco-
logic and obstetric care, unless the patient declines testing
(35) (see Resources). Obstetrician–gynecologists should
be aware of and comply with legal requirements regarding
HIV testing in their jurisdictions. The National HIV/AIDS
Clinicians’ Consultation Center at the University of
California–San Francisco maintains an online compen-
dium of state HIV testing laws (see Resources). Several
additional approaches can reduce the rate of HIV infec-
tion in women of color and optimize health:
• Women whose confirmatory testing yields positive dependent areas, 2010. HIV Surveillance Report. Atlanta
results and, therefore, are infected with HIV should
receive or be referred for appropriate clinical and
supportive care. Early recognition allows initiation of
optimal care and medication, when indicated, as well
as education to prevent transmission.
• Safe sex practices, especially consistent condom use, women/overview_partner.htm. Retrieved June 29, 2012. ^
must be emphasized for all women, particularly for
women of color. Patients should be asked the rea-
son they are not using condoms to assess whether
the patient feels safe negotiating condom use (see
Resources). Multiple studies have shown that behav-
ioral interventions can increase rates of condom use,
reduce risk-taking behavior, and decrease rates of
acquisition of STIs. Most interventions are designed
to be provided by nurses or peer educators and often
Committee Opinion No. 536
COMMITTEE OPINIONS
are available through local health departments or
community organizations.
• Health care providers are urged to identify resources
in their communities for training of office staff in
risk reduction interventions for women of color or
for referral of women to these programs. A combina-
tion of testing, education, and brief behavioral inter-
ventions can help reduce the rate of HIV infection
and its complications among women of color.
Resources ^
The following list is for information purposes only. Referral to these
sources and web sites does not imply the endorsement of the American
College of Obstetricians and Gynecologists. This list is not meant to be
comprehensive. The exclusion of a source or web site does not reflect the
quality of that source or web site. Please note that web sites are subject to
change without notice.
The National HIV/AIDS Clinicians’ Consultation Center.
A University of California San Francisco/San Francisco
General Hospital-based AIDS Education & Training
Centers clinical resource for health care professionals.
Available at: www.nccc.ucsf.edu/. Retrieved June 26, 2012.
Routine human immunodeficiency virus screening. Com-
mittee Opinion No. 411. American College of Obstetri-
cians and Gynecologists. Obstet Gynecol 2008;112:401–3.
[PubMed] [Obstetrics & Gynecology]
American College of Obstetricians and Gynecologists,
Futures Without Violence. Addressing intimate partner
violence, reproductive and sexual coercion: a guide for
obstetric, gynecologic and reproductive health care set-
tings. 2nd ed. Washington, DC: ACOG; San Francisco (CA):
FWV; 2012. Available at: http://www.acog.org/About
_ACOG/ACOG_Departments/Health_Care_for_Under
served_Women/~/media/Departments/Violence%20
Against%20Women/Reproguidelines.pdf. Retrieved June
29, 2012.
References
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Copyright September 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
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mission from the publisher. Requests for authorization to make
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Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Human immunodeficiency virus and acquired immunodeficiency
syndrome and women of color. Committee Opinion No. 536. Ameri-
can College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:735–9.
5
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 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 538 • October 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Nonmedical Use of Prescription Drugs

ABSTRACT: The nonmedical use of prescription drugs, particularly opioids, sedatives, and stimulants, has
been cited as epidemic in the United States, accounting for increasing numbers of emergency department visits
and deaths from reactions and overdoses. The prevalence of prescription drug abuse is similar among men and
women. Those who abuse prescription drugs most often obtain them from friends and family either through
sharing or theft. Physicians should screen all patients annually and early in prenatal care with a validated question-
naire for the nonmedical use of prescription drugs. They should provide preventive education for all patients and
referral for treatment, when psychologic or physical drug dependence is identified. Physicians should also educate
patients in the proper use, storage, and disposal of prescription drugs.

The nonmedical use of prescription drugs is a signifi-
cant problem in the United States. The purpose of this
Committee Opinion is to guide obstetrician–gynecolo-
gists in their role in prescribing drugs of potential abuse
and working with women who abuse or are dependent on
prescription drugs.
The National Survey on Drug Use and Health assesses
the nonmedical use of illicit and prescription drugs, alco-
hol, and tobacco products among civilian, noninstitution-
alized individuals aged 12 years and older in the United
States (1). Over-the-counter drugs and legitimate use of
prescribed medication are not included in the study. The
2010 National Survey on Drug Use and Health report
indicated that 2.4 million individuals used psychothera-
peutic drugs (pain relievers, tranquilizers, stimulants, or
sedatives) for nonmedical reasons for the first time within
the past year, or approximately 6,600 individuals per day,
and 7.0 million individuals used a prescription psycho-
therapeutic drug in the month before the survey without
a medical indication (1). Nonmedical use of prescription
drugs is the third most common drug category of abuse
after marijuana and tobacco (1). The percentage of indi-
viduals in the population who abuse psychotherapeutics
has remained stable since 2002; however, the rate of death
from unintentional overdose increased to approximately
27,000 deaths in 2007 (2). Among the 3 million individu-
als who used illicit drugs for the first time in 2010, 26.2%
started with psychotherapeutics, predominantly pain
relievers (1).
Prescription drug abuse is defined as the intentional use
of a medication without a prescription, in a way other than
as prescribed, or for the experience or feeling that it causes
(3). Drug addiction is characterized by an inability to con-
sistently abstain from drug use, impairment in behavior
control, a craving or increased need for drugs, a diminished
recognition of significant problems with one’s behavior
and interpersonal relationships, and a dysfunctional emo-
tional response (4). Physical dependence occurs because of
normal adaptations to chronic exposure to a drug. Those
who are physically drug dependent usually experience
withdrawal symptoms when the drug is abruptly discontin-
ued. They often develop a tolerance to the drug and require
higher doses for the same effect (3). Drug dependency is
not a synonym for drug addiction or drug abuse.
Although men are more likely to engage in substance
abuse, the rate of prescription drug abuse among women
is similar to men. Adolescent girls and women older than
35 years have significantly greater rates of abuse and
dependence on psychotherapeutic drugs than men (5, 6).
In older populations, changes in drug metabolism and the
potential for drug interactions increase the health dangers
of prescription drug misuse and abuse (3). Individuals
who report nonmedical use of prescription drugs often
report concurrent use of other drugs and alcohol.
Sources of Misused Prescription Drugs
The majority of individuals who misused prescription
pain relievers (55%) received them for free from a friend

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 597

 or relative, 17.3% obtained them as prescribed from one
physician, 4.4% bought them from a drug dealer, and
0.4% ordered them online (1). Adolescents who misuse
prescription drugs often acquire medications prescribed
to other family members, taking the medications without
the knowledge or permission of the person to whom they
were prescribed (7). Alternatively, a visitor or worker in
the home may steal the medication from an unsecured
cabinet.
Issues Specific to Women
Although there are known risk factors for drug abuse,
(eg, living in a community where drugs are easily avail-
able, tobacco use, and a family history of substance use),
patients who are not suspected also may be misusing
prescription drugs. Prescription drug abuse can lead to
adverse social consequences, such as poor judgment and
impaired decision making; increased unprotected sex;
and arguments, fights, and domestic violence, including
child abuse. The neurobehavioral effects of prescription
drug abuse, especially when mixed with alcohol, have
been cited as precipitating factors in injuries and deaths
caused by the individual engaging in drug misuse.
Prescription drug misuse does not by itself guar-
antee child neglect or prove inadequate parenting (8).
Paradoxically, a woman who pursues assistance for a
substance abuse problem may become involved with
legal and child welfare agencies, potentially leading to the
loss of custody of her children. Substance abuse treat-
ment that supports the family as a unit has been proved
to be effective for maintaining maternal sobriety and
child well-being (9). A woman must not be unnecessarily
separated from her family in order to receive appropriate
treatment.
Prescription Drugs of Abuse
Prescription drugs that are abused are most often avail-
able in tablet or capsule form. To enhance psychoactive
effects, they can be crushed or dissolved and inhaled,
injected, or used as enemas or suppositories.
Opioids
According to the 2010 National Survey on Drug Use
and Health, opioid pain relievers are the most frequently
abused prescription drugs (1). The number of indi-
viduals who received treatment for nonmedical pain
reliever abuse more than doubled between 2004 and
2009, accounting for 1,244,679 medical treatment visits
in 2009, which far exceeded medical treatment visits for
other drugs of abuse (10). White women are more likely
to abuse prescription pain relievers than women of any
other race or ethnicity (1). The 2010 National Survey
on Drug Use and Health report indicated that 23% of
women aged 18 years to 34 years reported ever having
used prescription pain relievers not prescribed to them
or taking them to experience the effect. When abused,
opioids produce varying degrees of euphoria depend-
2 Committee Opinion No. 538
COMMITTEE OPINIONS
ing on the drug’s affinity for micro-opioid receptor
binding and the ability to cross the blood-brain barrier.
Prescription opioids available in the United States include
morphine, methadone, codeine, hydrocodone, oxycodone,
propoxyphene, fentanyl, tramadol, hydromorphone, and
buprenorphine.
Overdose of opioids may lead to oversedation, aspi-
ration of stomach contents, respiratory depression, and
death. Acute opioid overdose is treated with naloxone
and respiratory support. Chronic exposure to opioids may
trigger a deregulation of the endogenous opioid receptor
system, resulting in biologic or psychologic dependence.
Withdrawal from opioid dependence is uncomfortable,
but not life-threatening for a woman who is not pregnant.
However, for pregnant women who are opioid-dependent,
abrupt withdrawal from opioids can be life-threatening to
the fetus (11). Withdrawal symptoms in opioid-depen-
dent individuals include agitation, anxiety, muscle aches,
and gastrointestinal distress. Prescription opioids are
often coformulated with acetaminophen, aspirin, or ibu-
profen. Use of acetaminophen at doses exceeding 4 g/d is
associated with liver damage and may lead to liver failure
and death (12). Aspirin and ibuprofen may precipitate
gastrointestinal bleeding and are usually contraindicated
during pregnancy. Individuals may unknowingly con-
sume dangerous amounts of the coformulated drug.
Sedatives and Tranquilizers
Sedatives (barbiturates) and tranquilizers (benzodiaz-
epines) are used as anxiolytics, sleep aids, and to treat
psychologic and neurologic conditions. Data from the
2010 National Survey on Drug Use and Health report
indicated that 7.6% of women reported ever having used
tranquilizers and 2.4% reported ever having used seda-
tives not prescribed to them or taking them to experi-
ence the effect (1). White women abused sedatives and
tranquilizers significantly more frequently than women
of any other race or ethnicity. Women older than 35
years are more likely to abuse sedatives and those aged
18 years to 50 years are more likely to abuse tranquilizers
(1). Abuse of sedatives often occurs in conjunction with
other substances or medications. The combination of
sedatives with opioids can potentiate the effect of an opi-
oid and can increase the risk of an overdose. Long-term
use and abuse of sedatives and tranquilizers can produce
dependence and addiction. Abrupt withdrawal from
these drugs, particularly from benzodiazepines and bar-
biturates, can be severe and life-threatening, and includes
seizures, acute heart conditions, and acute psychiatric
conditions (13).
Stimulants
Drugs such as amphetamines, methamphetamines, and
methylphenidate increase alertness and are used for
treatment of narcolepsy or attention-deficit/hyperactivity
disorder. They are also prescribed for short-term man-
agement of weight loss. Stimulants are misused to achieve
anorexic effects, heightened attention and wakefulness
2013 COMPENDIUM OF SELECTED PUBLICATIONS 598
 for academic enhancement, hallucinations, euphoria,
and altered perception. Nonmedical use of stimulants is
most common among students and women younger than
50 years. The 2010 National Survey on Drug Use and
Health report indicated that 6.7% of women reported
ever having used stimulants not prescribed to them (1).
White women were two to four times more likely to abuse
stimulants than women of any other race or ethnicity
(1). These drugs can be ingested or crushed for inhala-
tion or injection. Adverse effects of stimulants include
hypertension, tachycardia, arrhythmia, and psychologic
or neurologic dysfunction. Prolonged abuse of stimulants
can result in addiction. Withdrawal symptoms include
fatigue, depression, and sleep disturbances.
Anesthetics
Ketamine, a dissociative anesthetic, is the most com-
monly abused anesthetic. It is a “club drug,” a psychoac-
tive substance abused by adolescents and young adults at
bars, nightclubs, concerts, and parties. Ketamine is often
diverted from veterinary practices, and is usually snorted
or injected intramuscularly (13). Acute side effects include
central nervous system depression, psychomotor agita-
tion, rhabdomyolysis, abdominal pain, and urinary tract
symptoms. Chronic abuse can lead to psychosis, cognitive
impairment, and dependence.
Management of the Patient Misusing
Prescription Drugs
All women should be screened annually for substance
abuse, including prescription drug abuse, using a vali-
dated questionnaire such as the 4 P’s (Box 1) (14). Other
screening tools more specific to prescription drug misuse
are in development. Laboratory drug testing for prescrip-
tion drugs is not appropriate for routine well-women
care. A standard urine testing panel does not detect
synthetic opioids and does not detect some stimulants
Box 1. The 4 P’s
Parents: Did any of your parents have a problem with
alcohol or other drug use?
Partner: Does your partner have a problem with alcohol
or drug use?
Past: In the past, have you had difficulties in your life due
to alcohol or other drugs, including prescription medica-
tions?
Present: In the past month have you drunk any alcohol or
used other drugs?
Scoring: Any “yes” should trigger further questions.
Ewing H. A practical guide to intervention in health and social
services with pregnant and postpartum addicts and alcohol-
ics: theoretical framework, brief screening tool, key interview
questions, and strategies for referral to recovery resources.
Martinez (CA): The Born Free Project, Contra Costa County
Department of Health Services; 1990.
Committee Opinion No. 538
COMMITTEE OPINIONS
and benzodiazepines (15). However, when combined
with a thorough medical history, physical examination,
and screening questionnaire, biophysical drug testing
can help the clinician provide appropriate interventions
to the patient (16). If prescription drug abuse is identi-
fied, the health care provider should follow with a brief
motivational intervention as described in the American
College of Obstetricians and Gynecologists’ Committee
Opinion Number 423, Motivational Interviewing: A Tool
for Behavior Change (17). Given the potential conse-
quences of prescription drug misuse during pregnancy,
counseling on the use of effective contraception methods
should be included in the intervention. If drug depen-
dence is revealed, the patient should be referred to a
substance abuse treatment specialist (see Resources). The
problem of substance abuse is not only one of physi-
ologic dependence to a drug, but also of strong emotional
and psychologic dependence and habituation. Physical
withdrawal symptoms and psychologic cravings follow-
ing abrupt discontinuation of opioids, sedatives, and
stimulants often result in a return to drug use. Women
with a substance abuse disorder should be managed by
physicians trained in the appropriate methods to safely
withdraw medications or regulate maintenance therapy.
Underlying medical or psychologic conditions that con-
tribute to the substance abuse should be evaluated and
treated appropriately.
Unless there are specific indications, two drugs,
methadone and buprenorphine, can be legally used for
opioid withdrawal and maintenance treatment (18).
When used within a treatment program, methadone and
buprenorphine reduce criminal behavior and morbidity
related to opioid addiction and reduce disease transmis-
sion related to intravenous drug use (19). For opioid
maintenance, methadone is dispensed on a limited dose
basis within state-licensed opioid treatment programs.
Specially trained and licensed physicians can dispense
buprenorphine from their offices. The advantage of
buprenorphine over methadone is the ability to receive
multiple doses of the drug from a local primary care
physician, negating frequent visits to a drug treatment
program. However, diversion of buprenorphine is an
emerging epidemic. Diversion is defined as obtaining
medication with the intent to redistribute it to others (20).
In some areas, buprenorphine and methadone are as
readily available on the street as marijuana (21).
Overdose from methadone can lead to respiratory
depression and arrhythmias such as torsade de pointes.
The use of methadone as a prescribed pain reliever, not as
part of a drug treatment program, is discouraged because
of the high rate of drug diversion and the morbidity and
mortality associated with its use.
Prescription Drug Abuse in Pregnancy
All women should be screened early during pregnancy for
substance use, including prescription drug abuse, with a
validated questionnaire such as, but not limited to, The
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 599
 4 P’s (Box 1) (14). If biophysical testing for evidence of
substance use is indicated as a result of clinical observa-
tion or to comply with state law, the health care provider
should be aware of the potential for false-positive and
false-negative results of urine toxicology for drug use, the
typical urine drug metabolite detection times, and the
legal and social consequences of a positive test result. It
is incumbent on the health care provider, as part of the
procedure in obtaining consent before testing, to provide
information about the nature and purpose of the test
to the patient and how the results will guide manage-
ment (22). The American College of Obstetricians and
Gynecologists’ Committee Opinion Number 524, Opioid
Use, Dependence, and Addiction in Pregnancy, contains
detailed information for the prenatal health care provider
on managing a patient using opioids during pregnancy
(23). There are excellent programs that provide nonjudg-
mental integrated prenatal care, education, and substance
abuse treatment for pregnant women who misuse pre-
scription drugs. One such program is Kaiser Permanente’s
Early Start (24). Up-to-date information concerning indi-
vidual state policies on substance abuse during pregnancy
can be found in the monthly Guttmacher Institute’s State
Policies in Brief (see Resources).
Emergency Department Visits and
Overdose
In 2009, more than 1.2 million emergency department
visits occurred because of the misuse or abuse of prescrip-
tion drugs. During the same period, 974,000 emergency
department visits occurred because of the abuse of illegal
drugs (10). Unintentional opioid analgesic overdose deaths
have dramatically increased since 1999, reaching 11,500
deaths in the United States in 2007—more than the num-
ber of deaths from heroin and cocaine combined (25).
Women in the postpartum period who abused prescrip-
tion drugs during pregnancy and are not involved in sub-
stance abuse treatment are particularly at risk of overdose
because their physiologic drug requirement decreases
as their blood volume and body mass decreases (26). In
addition, women who were abstinent from drug use dur-
ing pregnancy often resume drug use postpartum, but
without the tolerance to their prepregnancy drug doses,
leaving them susceptible to overdose.
Pain Management
Patients who are prescribed opioid medications for
legitimate pain control are unlikely to abuse them (27).
However, education on the medications prescribed,
including interactions and potential for overdose, should
be stressed to help avoid emergency department visits
and overdose deaths. Physicians also should be aware
of individuals who try to exploit practitioner sensitivity
to patient pain. Use of patient pain contracts and drug
testing may help to reduce this exploitation. Referral
to a pain management expert should be considered for
patients with intractable pain.
4 Committee Opinion No. 538
COMMITTEE OPINIONS
Regulatory policies vary by state, and physicians
should be aware of the laws and regulations in their states.
With appropriate documentation of pain levels and
patient management, a physician should not fear disci-
plinary action from regulatory agencies. More informa-
tion on specific state policies and laws are available at
the Office of National Drug Control Policy web site (see
Resources).
Avoiding Diversion
Patient education is central in preventing intentional and
unintentional drug diversion. When prescribing medica-
tions that may be misused, physicians should educate
their patients on proper use, storage, and disposal of
medications:
• Patients should be instructed to take the medica-
tion only as it is prescribed to them. They should be
cautioned to not share the medication with anyone
else, including friends and relatives who may feel that
taking the patient’s medication may help them.
• Medication that may be abused should be stored in
secure places to prevent misuse by others, particu-
larly youth who may obtain them without anyone
knowing.
• Unused medications should be taken to a pharmacy
for proper disposal, or thrown away mixed in coffee
grounds or kitty litter to discourage recovery of the
medications by someone intending to misuse the drug.
Regulations to Prevent Nonmedical
Use of Prescription Drugs
Various attempts at the state and national levels have been
made to regulate the distribution and use of prescription
drugs in order to reduce misuse and overdose. In 2002,
the U.S. General Accountability Office concluded that
prescription drug monitoring programs helped reduce
drug diversion (28). Prescription drug monitoring pro-
grams usually require pharmacists to enter information
pertaining to prescriptions for controlled substances
into a state database to allow monitoring of prescribing
and filling practices. Data include the prescriber, the
patient, the drug, the dosage, and the amount dispensed.
The 2005 National All Schedules Prescription Electronic
Reporting Act was reauthorized in 2010, which funds fed-
eral grants to states for the establishment or improvement
of prescription drug monitoring programs (29, 30). As
of January 2012, 48 states had enacted prescription drug
monitoring programs (31). Access to the prescription
monitoring program’s database varies from state to state.
Methods to help reduce both prescription drug abuse
and diversion include tamper-resistant packaging, pres-
cribing only the amount of medication that would typi-
cally be used for a particular condition or procedure, not
offering prescription refills without a consultation, and
using special prescription forms for prescribing con-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 600
 trolled medications. Health care providers should be
aware of the requirements for their states.
Summary
All women should be screened annually and early in
pregnancy for nonmedical use of prescription drugs
and should be counseled when abuse is suspected or
identified. In the case of drug dependence, physicians
should offer referrals for treatment to mitigate with-
drawal symptoms and address drug-seeking behavior.
Women’s health care providers should
• follow suggestions on prescribing to reduce drug http://www.drugabuse.gov/sites/default/files/rx_drugs_
abuse and diversion.
• educate patients who have been prescribed medica-
tions to be the sole user of the drug.
• give instructions for safe medication storage and Available at: http://findtreatment.samhsa.gov. Retrieved
disposal.
• consider referral to a pain management expert for References
women with chronic pain.
• be aware of state laws addressing the prescribing of istration. Results from the 2010 National Survey on Drug
opioids and other potential drugs of addiction.
Resources ^
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The following list is for information purposes only. Referral to
these sources and web sites does not imply the endorsement of the
American College of Obstetricians and Gynecologists. This list is
not meant to be comprehensive. The exclusion of a source or web
site does not reflect the quality of that source or web site. Please
note that web sites are subject to change without notice.
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center. Available at: http://www.fsmb.org/grpol_links.
html. Retrieved June 14, 2012.
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COMMITTEE OPINIONS
Federation of State Medical Boards. Model policy for
the use of controlled substances for the treatment of
pain. Euless (TX): FSMB; 2004. Available at: http://www.
fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf.
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Guttmacher Institute. Substance abuse during pregnancy.
State Policies in Brief. New York (NY): GI; 2012. Available
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SADP.pdf. Retrieved June 14, 2012
National Institute on Drug Abuse. Commonly abused pre-
scription drugs. Bethesda (MD): NIDA; 2011. Available at:
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Substance Abuse and Mental Health Services Admin-
istration. Substance abuse treatment facility locator.
June 14, 2012.
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Use and Health: summary of national findings, NSDUH
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(MD): SAMHSA; 2011. Available at: http://www.samhsa.
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demic. Centers for Disease Control and Prevention (CDC).
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[Full Text] ^
3. National Institute on Drug Abuse. Prescription drugs: abuse
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4. American Society of Addiction Medicine. Public policy
statement: short definition of addiction. Chevy Chase
(MD): ASAM; 2011. Available at: http://www.asam.org/
docs/publicy-policy-statements/1definition_of_addiction_
short_4-11.pdf?sfvrsn=0. Retrieved June 14, 2012. ^
5. Cotto JH, Davis E, Dowling GJ, Elcano JC, Staton AB, Weiss
SR. Gender effects on drug use, abuse, and dependence: a
special analysis of results from the National Survey on Drug
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6. Merline AC, O’Malley PM, Schulenberg JE, Bachman JG,
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7. Johnston LD, O’Malley PM, Bachman JG, Schulenberg JE.
Monitoring the Future national results on adolescent drug
use: overview of key findings, 2011. Ann Arbor (MI): Institute
for Social Research, The University of Michigan; 2012.
Available at: http://monitoringthefuture.org/pubs/mono
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5
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 9. Center for Substance Abuse Treatment. Substance abuse
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10. Substance Abuse and Mental Health Services Administration.
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dence during pregnancy: effects and management. Obstet
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12. Food and Drug Administration. FDA drug safety commu-
nication: prescription acetaminophen products to be limit-
ed to 325 mg per dosage unit; boxed warning will highlight
potential for severe liver failure. Silver Spring (MD): FDA;
2011. Available at: http://www.fda.gov/Drugs/DrugSafety/
ucm239821.htm. Retrieved June 14, 2012. ^
13. Licata SC, Rowlett JK. Abuse and dependence liability of
benzodiazepine-type drugs: GABA(A) receptor modulation
and beyond. Pharmacol Biochem Behav 2008;90:74–89.
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14. Ewing H. A practical guide to intervention in health and
social services with pregnant and postpartum addicts and
alcoholics: theoretical framework, brief screening tool, key
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Copyright October 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC
20090-6920. All rights reserved.
ISSN 1074-861X
Nonmedical use of prescription drugs. Committee Opinion No. 538.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:977–82.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 602
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 542 • November 2012
Committee on Health Care for Underserved Women
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change.
The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Access to Emergency Contraception

ABSTRACT: Emergency contraception includes contraceptive methods used to prevent pregnancy in the first
few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug
Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to
access to emergency contraception remain. The purpose of this Committee Opinion is to examine the barriers to
the use of oral emergency contraception methods and to highlight the importance of increasing access.

Background Barriers to Access

Emergency contraception may be used to prevent preg-
nancy after an unprotected or inadequately protected
act of sexual intercourse. Emergency contraception is
effective in preventing pregnancy within 120 hours after
unprotected intercourse but is most effective if used with-
in 24 hours (1, 2). The most common emergency con-
traceptive method is oral progestin-only pills (levonorg-
estrel), but use of the antiprogestin ulipristal acetate
or use of a combined regimen (high doses of ethinyl
estradiol and a progestin) also are effective (3). A copper
intrauterine device (IUD) is the most effective form of
emergency contraception for medically eligible women
and may prevent pregnancy if inserted up to 5 days after
unprotected intercourse (4, 5).
Progestin-only emergency contraception is better
tolerated and more efficacious than the combined regi-
men. In the United States, the two levonorgestrel-only
regimens include a single-dose regimen (1.5 mg levonorg-
estrel) and a two-dose regimen (two tablets of 0.75 mg
of levonorgestrel taken 12 hours apart). The levonorg-
estrel-only regimens are available without a prescription
to women aged 17 years or older with government-issued
photo identification. However, the antiprogestin, a 30-mg
tablet of ulipristal acetate, requires a prescription (6).
Ulipristal acetate is at least as effective as levonorges-
trel in preventing pregnancy up to 72 hours after unpro-
tected intercourse and appears to be more effective
than levonorgestrel in preventing pregnancy when used
between 72 hours and 120 hours after unprotected inter-
course (7).
Misconceptions
Mechanism of Action
A common misconception is that emergency contracep-
tion causes an abortion. Inhibition or delay of ovulation
is the principal mechanism of action (8–13). Review of
evidence suggests that emergency contraception can-
not prevent implantation of a fertilized egg (1, 12–14).
Emergency contraception is not effective after implanta-
tion; therefore, it is not an abortifacient.
Effect on Risky Sexual Behavior
Another misconception is that making emergency con-
traception more readily available promotes risky sexual
behavior and increases the rates of unintended pregnancy
among adolescents (15). Ready access of adolescents
to emergency contraception is not associated with less
hormonal contraceptive use, less condom use, or more
unprotected sex (16). This misconception also has been
raised among adult women. However, numerous studies
have shown that this concern is unfounded (3).
Safety of Repeated Use
Data are not available on the safety of current regimens
of emergency contraception if used frequently over a long
period. However, emergency contraception may be used
more than once, even within the same menstrual cycle
(3). Information about other forms of contraception
and counseling about how to avoid future contracep-
tive failure should be made available to women who use

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 603

 emergency contraception, especially to those who use it
repeatedly.
Financial Barriers
Women’s financial resources and insurance coverage
limit access to contraceptive methods. Women who lack
health insurance or disposable income, have substantial
copayments, deductibles, or both, or do not have cov-
erage for over-the-counter medications may not have
access to any method of emergency contraception (17).
Out of pocket costs for oral emergency contraception
average $25–60 and IUD costs can be more than $500,
depending on insurance (18–20). Some insurance com-
panies reimburse women only for the cost of emergency
contraception in specific circumstances (eg, in the case of
sexual assault if a police report has been filed) and most
require a prescription (19).
Education and Practice Barriers
Although use of emergency contraception has increased,
many women and health care providers remain unfa-
miliar with the method or are unaware that a physical
examination or testing is not needed before emergency
contraception is provided. Women often are reluctant
to ask health care providers for an advance prescription
because they do not anticipate needing it and then have
difficulty locating a provider when a prescription for
emergency contraception is needed (21, 22). Health care
providers often discuss or provide emergency contracep-
tion only on request or when a woman reports an unpro-
tected sexual encounter (21). Some health care providers
believe that routine counseling about emergency contra-
ception is too time consuming or have a misperception
that the patient is unable to properly use the method (18).
Facilities
Women in underserved communities face additional
challenges in obtaining emergency contraception. Some
communities simply lack a nearby facility or a health care
provider willing to prescribe emergency contraception. In
other communities, hospitals and pharmacies affiliated
with a religious institution present a further barrier to
access (15). Emergency departments affiliated with reli-
gious institutions have been the target of legislation and
lawsuits seeking to enforce compliance with state laws
that require emergency contraception be offered to sexual
assault survivors (23). Even within the large network of
Title X funded clinics, which provide reproductive health
services to approximately 5 million low-income women
and adolescents annually, some communities do not have
a health care provider willing to prescribe emergency
contraception.
Pharmacy Barriers
Some pharmacists refuse to dispense emergency contra-
ception and some pharmacies refuse to stock emergency
contraception (17). The prescription requirement for
females younger than 17 years of age and pharmacy hours
2 Committee Opinion No. 542
COMMITTEE OPINIONS
are additional barriers. One study found that pharmacy-
related barriers occurred 30% of the time when patients
called to obtain emergency contraception, including the
need to call more than one pharmacy, wrong numbers
given by pharmacy staff, delays in speaking with a knowl-
edgeable staff member, being asked unnecessary embar-
rassing questions, and disconnection while on a phone
referral to another facility (24). Another study found that
pharmacists gave inaccurate information regarding the
correct age threshold for over-the-counter access by ado-
lescents, especially in low-income neighborhoods (25).
Pharmacists are key members of our health care system
and could be instrumental in improving access to emer-
gency contraception (22). For example, nine states allow
pharmacists to dispense emergency contraception without
a physician’s prescription under certain conditions (26).
Special Populations
Access to emergency contraception remains difficult for
adolescents, immigrants, non-English speaking women,
survivors of sexual assault, those living in areas with few
pharmacy choices, and poor women. The barriers most
frequently cited by teens are confidentiality concerns,
embarrassment, and lack of transportation to a health
care provider or a pharmacy. Because nonprescription
access to emergency contraception is restricted by age,
pharmacies must keep emergency contraception behind
the counter and request proof of age before dispensing
it, thus restricting access for females aged 17 years or
older who do not have government-issued identification.
Although more than one half of pharmacies offer Spanish
language services, expansion of Spanish and other lan-
guage services could improve timely access to emergency
contraception (18).
Up to 5% of sexual assault survivors become preg-
nant (27). A 2003 survey of Oregon hospitals found
that only 61% of hospitals routinely offered emergency
contraception to sexual assault survivors (28). Almost
one half of health care providers in emergency depart-
ments did not prescribe emergency contraception 48
hours after an assault despite proven efficacy up to 120
hours after unprotected intercourse. Thirty percent of
hospitals that provide emergency contraception to sexual
assault survivors prescribe combined oral contraceptive
pills instead of the more effective and tolerated dedicated
progestin-only product, ulipristal acetate, or insertion of
an IUD (29).
Recommendations
• Remove the age restriction (prescription only for
females younger than 17 years) to create true over-
the-counter access to emergency contraception for
all women.
• Encourage federal agencies to meet the Healthy People
2020 goal to increase to 87.7% (a 10% improvement)
the proportion of publicly funded family planning
clinics that offer methods of emergency contraception
2013 COMPENDIUM OF SELECTED PUBLICATIONS 604
 approved by the U.S. Food and Drug Administration College of Obstetricians and Gynecologists. Obstet Gynecol
on site (30). 2007;110:1203–8. [PubMed] [Obstetrics & Gynecology]
• Support media campaigns clarifying that emergency Understanding and using the U.S. Medical Eligibility
contraception will not terminate an established preg- Criteria for Contraceptive Use, 2010. Committee Opinion
nancy. No. 505. American College of Obstetricians and Gyne-
• Encourage private and public insurers to provide cologists. Obstet Gynecol 2011;118:754–60. [PubMed]
coverage for both prescription and nonprescription [Obstetrics & Gynecology]
emergency contraception and to publicize this cover- Emergency contraception. Practice Bulletin No. 112. Amer-
age to their clients (22). According to an analysis by ican College of Obstetricians and Gynecologists. Obstet
the Kaiser Foundation Health Plan in California, the Gynecol 2010;115:1100–9. [PubMed] [Obstetrics & Gyne-
distribution of both effective contraceptive methods cology]
and of emergency contraception increased once
universal contraceptive coverage was offered to its Additional Resources
members (31). The following resources are for informational purposes only.
• Amplify education campaigns that target health Referral to these sources and web sites does not imply the endorse-
care providers and their staff. Health care provid- ment of the American College of Obstetricians and Gynecologists.
ers should have refresher training sessions regard- This list is not meant to be comprehensive. The exclusion of a
ing contraceptive counseling and the effectiveness source or web site does not reflect the quality of that source or web
of each method of emergency contraception. They site. Please note that web sites are subject to change without notice.
should be reminded that emergency contraception Emergency Contraception Hotline (Available in English
can be offered up to 5 days after unprotected inter- and Spanish 24 hours a day)
course; however, the sooner it is taken, the more 1-888-NOT-2-LATE (1-888-668-2528)
effective it is (11). Most health care providers con-
sider education essential for increasing acceptance Emergency Contraception Web Site
and provision of emergency contraception (21). ec.princeton.edu
• Emphasize that a copper IUD is the most effective Reproductive Health Technologies Project: Emergency
form of emergency contraception (32). Contraception
• Write advance prescriptions for emergency contracep- www.rhtp.org/contraception/emergency
tion, particularly for females younger than 17 years, International Consortium for Emergency Contraception
to increase awareness and reduce barriers to imme- www.cecinfo.org
diate access (24).
• Integrate counseling about emergency contraception References
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21. Conard LA, Gold MA. Emergency contraceptive pills: a
review of the recent literature. Curr Opin Obstet Gynecol
2004;16:389–95. [PubMed] ^
22. Foster DG, Landau SC, Monastersky N, Chung F, Kim N,
Melton M, et al. Pharmacy access to emergency contracep-
tion in California. Perspect Sex Reprod Health 2006;38:
46–52. [PubMed] [Full Text] ^
23. Polis C, Schaffer K, Harrison T. Accessibility of emergency
contraception in California’s Catholic hospitals. Womens
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24. Nelson AL, Jaime CM. Accuracy of information given by
Los Angeles County pharmacies about emergency con-
traceptives to sham patient in need. Contraception 2009;
79:206–10. [PubMed] [Full Text] ^
25. Wilkinson TA, Fahey N, Suther E, Cabral HJ, Silverstein M.
Access to emergency contraception for adolescents. JAMA
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26. Guttmacher Institute. Emergency contraception. State
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http://www.guttmacher.org/statecenter/spibs/spib_EC.pdf.
Retrieved July 10, 2012. ^
27. Holmes MM, Resnick HS, Kilpatrick DG, Best CL. Rape-
related pregnancy: estimates and descriptive characteristics
from a national sample of women. Am J Obstet Gynecol
1996;175:320–4; discussion 324–5. [PubMed] ^
28. Bakhru A, Mallinger JB, Fox MC. Postexposure prophy-
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2010;82:168–73. [PubMed] [Full Text] ^
29. Raine TR, Harper CC, Rocca CH, Fischer R, Padian N,
Klausner JD, et al. Direct access to emergency contra-
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Copyright November 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Access to emergency contraception. Committee Opinion No. 542.
American College of Obstetricians and Gynecologists. Obstet Gyne-
col 2012;120:1250–3.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 606
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 547 • December 2012
Committee on Health Care for Underserved Women
This information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Health Care for Women in the Military and

Women Veterans
Abstract: Military service is associated with unique risks to women’s reproductive health. As increasing
numbers of women are serving in the military, and a greater proportion of United States Veterans are women,
it is essential that obstetrician–-gynecologists are aware of and well prepared to address the unique health care
needs of this demographic group. Obstetrician–-gynecologists should ask about women’s military service, know
the Veteran status of their patients, and be aware of high prevalence problems (eg, posttraumatic stress disorder,
intimate partner violence, and military sexual trauma) that can threaten the health and well-being of these women.
Additional research examining the effect of military and Veteran status on reproductive health is needed to guide
the care for this population. Moreover, partnerships between academic departments of obstetrics and gynecology
and local branches of the Veterans Health Administration are encouraged as a means of optimizing the provision
of comprehensive health care to this unique group of women.

Background TRICARE program, at the civilian sector (through Med-

Women have served in every United States military con-
flict since the American Revolution. Roles for women in
the military have diversified over time, and many cur-
rent female service members are achieving top ranks in
all branches of the military (1). Many have undergone
prolonged military deployments with war zone exposure,
and increasing numbers of women are serving in combat
support units (1). At the conclusion of their military ser-
vice, women transition back into their communities as
Veterans. Veterans are men and women who have served
on active duty in the U.S. Army, Navy, Air Force, Marine
Corps, Coast Guard, National Guard, or Reserves (2). In
2011, 8% (1.8 million) of all U.S. Veterans were women,
a proportion expected to increase to 11% (more than 2
million) by 2020 (3, 4). Women comprise approximately
14.5% of the active duty military force and almost 18%
of the National Guard and Reserves (1). In 2009, the
age distribution of women Veterans who use services
provided by the Veterans Health Administration showed
three main peaks in the mid twenties, mid forties, and
mid fifties (5). This trimodal distribution indicates the
importance of a lifespan approach to providing reproduc-
tive health care for women Veterans.
Women in the military and women Veterans may seek
primary and reproductive health care at military treat-
ment facilities, through the U.S. Department of Defense’
icaid, Medicare, or private insurance), through the U.S.
Department of Veterans Affairs (VA), or some combina-
tion thereof (6). It is critical that all health care providers
are familiar with the unique health care needs of these
women and with the health care resources (eg, Veterans
Health Administration) available to address these needs.
Connecting women Veterans to VA services may facili-
tate needed comprehensive health care; VA facilities may
be located by consulting a web-based directory (www.
va.gov/directory) or by calling 1-800-827-1000. Women
who are honorably discharged from the military may
qualify for a variety of VA benefits, including health
care benefits. This eligibility is based on multiple criteria
(details are available at http://www.va.gov/healthbenefits/
apply/veterans.asp). Many mechanisms are in place to
support the health needs of women Veterans. Each
Veterans Health Administration facility nationwide has
a designated Women Veterans Program Manager who
advocates for women and provides leadership in estab-
lishing, coordinating, and integrating quality health care
services for women. Many VA sites have specialized
women’s health clinics and services available to provide
care for women Veterans either on site or through refer-
rals to non-VA health care providers. For example, the
VA covers pregnancy-related care through arrangements
with community health care providers.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 607

 Research regarding women Veterans has increased
significantly over the past two decades (7–10). Although
limited in scope (studies are primarily observational
or descriptive, use cross-sectional designs, and study
subsets of women Veterans who used Veterans Health
Administration facilities for their health care), several
studies characterize the greater physical and psychiatric
morbidity and diminished social support of these women
compared with their civilian counterparts (7–10).
Roles of Obstetrician–Gynecologists
in the Health Care of Women in the
Military and Women Veterans
Because obstetrician–gynecologists may be the primary
medical providers for women in the military and women
Veterans, they are in a position to interact with these
women and intervene early and appropriately with their
unique reproductive health care needs. Understanding
the potential health effects of military service will help
health care providers best serve women in the military
and women Veterans across the lifespan. This com-
mittee opinion highlights unique reproductive health
needs and special considerations of this population. A
more detailed review is available at www.acog.org/goto/
underserved.
Women in the military and women Veterans are
serving or have served our country and deserve the best
health care. Efforts to undertake the following steps are
essential:
1. Assess women for history of military service and inquire
about Veteran status
Many women will not volunteer information about
military service or readily identify themselves as
Veterans. Screening women for military service (cur-
rent or past) and inquiring about Veteran status at
initial health care visits is important and may be
accomplished by asking, “Have you ever served in
the military (eg, on active duty in the U.S. Armed
Forces, Reserves, or National Guard)?” Health care
providers also should ensure that all patients who are
Veterans are aware of VA-related resources for their
physical and mental health care. This information is
available at http://www.va.gov/healthbenefits/access/
medical_benefits_package.asp. Additional infor-
mation regarding obtaining a military history can
be found at http://www.va.gov/OAA/pocketcard/
FactSheet.asp.
2. Understand reproductive health risks of military service
Military deployment to severe environments (eg, the
war zone) can result in limited access to acceptable
medical services and sanitary equipment and increase
the inconvenience and logistic difficulty of hygienic
management of menstruation. This may predispose
deployed women to greater risk of gynecologic con-
ditions, such as urinary tract infections or bacterial
vaginosis (11–13). For some women, such deploy-
2 Committee Opinion No. 547
COMMITTEE OPINIONS
ment may interrupt preventive care (eg, cervical can-
cer screening) or ongoing treatment or evaluation
for conditions, such as menorrhagia, endometriosis,
or uterine leiomyomas. Rates of abnormal Pap test
results may be elevated among women in active duty
military service who are deployed to war zones (13).
Timely access to appropriate cervical cancer screen-
ing is critical for all women.
Military service, particularly deployment to war
zones and combat exposure, can increase the risk
of mental health problems, and Veterans (including
women Veterans) have significantly elevated rates
of psychiatric illness, including depression, post-
traumatic stress disorder (PTSD), and substance
abuse compared with their civilian counterparts (14).
Deployment status is strongly associated with an
increased risk of depression during pregnancy and the
postpartum period (15). Careful screening, monitor-
ing, and treatment for depression during pregnancy
and the postpartum period are warranted for women
in active duty military service, women Veterans who
have recently returned from a war zone, or women
with a deployed partner (15). Connecting women
Veterans to VA-related mental health care during
pregnancy may be useful in helping to ensure their
timely receipt of comprehensive mental health care.
3. Be knowledgeable about family planning and contra-
ceptive considerations for deployed women and women
Veterans
Consistent with the applicable Department of Defense
regulations, family planning and contraceptive coun-
seling are available to all women in the military who
request these services (16). Depending on the loca-
tion of the deployment, contraceptive methods may
need to be altered because some combat areas are not
conducive to stocking certain contraceptives, such as
depot medroxyprogesterone acetate and the vaginal
ring. Indeed, some women report discontinuation of
contraceptive use during deployment because long
work shifts and rapid travel across multiple time
zones can affect adherence to a regular contracep-
tive schedule (12, 13). Also, harsh climate in some
deployment areas has been reported to diminish the
adhesive integrity of the patch (12, 13).
Small studies show varying rates of unintended
pregnancy among women in active duty military
service. Some estimates reveal that 50% of preg-
nancies in this population are unintended, which
is consistent with the national average. However,
other results indicate that as many as 65% of preg-
nancies in this population are unintended (17–19).
In a recent study of 3,745 women in active duty
military service aged 18–44 years, authors reported
that nearly one in five women in this population
was pregnant during 2005, and of these pregnancies,
54% were unintended (18). The American College
2013 COMPENDIUM OF SELECTED PUBLICATIONS 608
 of Obstetricians and Gynecologists (the College)
encourages the education of health care providers,
women in the military, and women Veterans regard-
ing the use of long-acting reversible contraceptives,
namely intrauterine devices and the contraceptive
implant, particularly for women facing military
deployment. The U.S. Department of Defense has
recently begun encouraging widespread provision of
the levonorgestrel intrauterine system for deployed
women.
The Veterans Health Administration offers a
wide range of prescription contraception methods,
including combination oral contraceptives, injec-
tions, implants, intrauterine devices, emergency
contraceptives, and vaginal ring products that are
available at little or no cost to eligible women
Veterans. Increased efforts to train VA primary care
providers regarding a wide range of basic reproduc-
tive health and women’s health issues, including
contraception, are ongoing in the VA health care
system. Health care providers should consistently
discuss contraceptive options with women in the
military and women Veterans just as with all other
women. Connecting women Veterans to VA services
may facilitate receipt of comprehensive health care.
For women eligible for VA benefits, this may provide
more affordable contraceptive services than through
other health systems.
Under statute, women in the military and those
women Veterans who receive insurance benefits
through the Civilian Health and Medical Program of
the Department of Veterans Affairs have more limit-
ed insurance coverage of abortion than other women
who receive health insurance through the federal
government (federal employees, and Medicaid or
Medicare beneficiaries) because they receive benefits
only in the setting of life endangerment (20, 21). The
College opposes all regulations that limit or delay
access to abortion (22). The disparity in insurance
coverage of abortion must be eliminated to provide
women in the military and women Veterans the
same coverage of abortion and related care as other
women who are insured through the federal govern-
ment.
4. Screen for interpersonal violence, including military
sexual trauma and posttraumatic stress disorder
Screening for interpersonal violence, including his-
tory of sexual assault and intimate partner violence,
is critical to the provision of optimal reproductive
health care for women. It is particularly important
for women in the military and women Veterans
who may have significantly increased rates of life-
time exposure to interpersonal violence, including
sexual assault or abuse (23, 24) and intimate partner
violence (25), compared with their civilian counter-
parts. The physical and psychosocial health sequelae
Committee Opinion No. 547
COMMITTEE OPINIONS
of interpersonal violence exposure, including delay
in seeking medical care, are well known (24–28). The
College recommends routine screening of all patients
for a history of sexual assault and paying particular
attention to those who report pelvic pain, dysmenor-
rhea, or sexual dysfunction (29). Additional informa-
tion about approaching the patient who has a history
of sexual assault can be found in Committee Opinion
No. 498, “Adult Manifestations of Childhood Sexual
Abuse” (30). The College also recommends screen-
ing and counseling for intimate partner violence dur-
ing preventive health visits and provides guidance on
screening questions (31).
Screening for sexual assault should include ques-
tions about military sexual trauma, which is the
experience of sexual harassment or attempted or
completed sexual assault during military service.
Military sexual trauma is a unique risk of military
service, and perpetrators and survivors can be of
either sex. Perpetrators may include military person-
nel, civilians, commanding officers, subordinates,
strangers, friends, or intimate partners (24). Twenty
percent of women Veterans who use Veterans Health
Administration facilities report a history of military
sexual trauma (24). This is a cause for concern
because military sexual trauma can have long-term
health implications (24, 26, 32). It is critical that
health care providers screen for military sexual trau-
ma so that they may effectively identify and address
any associated health concerns.
In the VA, such screening for military sexual
trauma, mandated by the VA for all Veterans seen
by a VA health care provider, involves two questions
that use descriptive, nonjudgmental language (24)
and can be used in any office setting:
“While you were in the military,
1. did you receive uninvited and unwanted sexual
attention, such as touching, cornering, pressure
for sexual favors, or verbal remarks?
2. did someone ever use force or threat of force
to have sexual contact with you against your
will?”
Veterans who respond positively to either question
are considered to have a positive screening result
for military sexual trauma. The College applauds
this mandate by the VA and the efforts of the U.S.
Department of Defense and encourages the continu-
ation of prioritization of efforts for primary preven-
tion of military sexual trauma. Health care providers
also are encouraged to be involved in advocacy in
professional, community, military, and educational
arenas for primary prevention of sexual trauma.
Women identified as having military sexual
trauma should be referred to a Veterans Health
Administration facility, if not already receiving care
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 609
 through such a facility. Veterans can receive care
related to military sexual trauma at any VA health
system where all treatment for mental and physical
health problems related to this diagnosis is free of
charge and unlimited in length.
The prevalence of PTSD is increased more than
twofold in women Veterans compared with their
civilian counterparts (33, 34). This is commonly
attributed to women Veterans’ greater exposure to
interpersonal violence, particularly military sexual
trauma (35). Posttraumatic stress disorder is linked
to diminished physical health (36) and decreased
willingness to pursue preventive reproductive health
care in women Veterans (37). As such, women
Veterans should be screened for PTSD and offered
referral to mental health providers or Veterans
Health Administration facilities if the screening
results warrant intensive treatment. The benefits
of universal screening in reproductive care set-
tings also should be considered. Meltzer-Brody and
colleagues have developed a PTSD screening instru-
ment specifically designed for use in obstetrics and
gynecology (38). The Veterans Health Administration
uses a four-item validated screening questionnaire to
identify patients who may have PTSD (39); instruc-
tions, questions, and scoring rules for use of this
screening tool are presented at http://www.ptsd.va.
gov/professional/pages/assessments/pc-ptsd.asp.
Additional resources for Veterans with traumatic
experiences are available at http://www.ptsd.va.gov/
public/index.asp and www.vetcenter.va.gov.
5. Promote a research agenda that studies the effect of
military status on reproductive health
Research designed to evaluate the association of
military service and women’s reproductive health
warrants immediate consideration to ensure the
development of empirically derived best practices
for their reproductive health care. The particular
research areas include the following:
• Co-occurrence of medical and mental health ID=2455. Retrieved August 16, 2012. ^
conditions in women in the military and women
Veterans and effect on reproductive health out-
comes
• The association of military deployment and unin-
tended pregnancy and the effects of military
deployment on subsequent pregnancy outcomes
• Best practices for the safe pharmacologic man-
agement of women Veterans with psychiatric ill-
ness (eg, depression or PTSD) who are pregnant
or wish to become pregnant
• The provision of perinatal care for women 9. Bean-Mayberry B, Yano EM, Washington DL, Goldzweig C,
Veterans with disabilities, including cognitive
or physical impairment that stems from trau-
matic brain injury, polytrauma, or other injury.
4 Committee Opinion No. 547
COMMITTEE OPINIONS
6. Engage with the local Veterans Health Administration
facility
It is essential that strong clinical partnerships between
public and private health care settings, academic
departments of obstetrics and gynecology, and the
VA be forged. This will allow all health care provid-
ers who treat Veterans to ensure that Veterans in
their care are aware of health care resources offered
through VA and provide referrals as needed. Such
collaboration offers unique opportunities to share
best practices, to foster the development and imple-
mentation of a robust research agenda regarding the
reproductive health care needs of women Veterans,
and to enhance delivery and coordination of care.
References
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Copyright December 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Health care for women in the military and women Veterans. Com-
mittee Opinion No. 547. American College of Obstetricians and Gyne-
cologists. Obstet Gynecol 2012;120:1538–42.
5
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COMMITTEE OPINIONS
Committee on International Affairs

2013 COMPENDIUM OF SELECTED PUBLICATIONS 612

 ACOG COMMITTEE OPINION
Number 427 • February 2009

Misoprostol for Postabortion Care

Committee on
International Affairs ABSTRACT: The World Health Organization estimates that 67,000 women, mostly
This document reflects in developing countries, die each year from untreated or inadequately treated abortion
emerging clinical and sci- complications. Postabortion care, a term commonly used by the international reproduc-
entific advances as of the
date issued and is subject tive health community, refers to a specific set of services for women experiencing prob-
to change. The information lems from all types of spontaneous or induced abortion. There is increasing evidence that
should not be construed
as dictating an exclusive misoprostol is a safe, effective, and acceptable method to achieve uterine evacuation for
course of treatment or women needing postabortion care. To reduce maternal mortality, availability of postabor-
procedure to be followed.
tion care services must be increased. Misoprostol must be readily available especially for
women who do not otherwise have access to postabortion care. Nurses and midwives
can safely provide first-line postabortion care services, including in outpatient settings,
provided they receive appropriate training and support. Access to contraception and safe
abortion services prevents complications from unsafe abortion and decreases the need
for postabortion care. It is much less expensive and far better for women’s health to
prevent the problem of unsafe abortion rather than to treat resulting complications.

Complications arising from spontaneous and
unsafely induced abortion are recognized
worldwide as a major public health concern
and are one of the leading reasons women
seek emergency care. The World Health
Organization estimates that 67,000 women,
mostly in developing countries, die each
year from untreated or inadequately treated
abortion complications (1). This represents
13% of all pregnancy-related deaths, and is
especially prevalent in low-resource settings,
wherever abortion laws are restrictive, or
when access to safe abortion services is dif-
ficult. Many women survive with chronic
pain, pelvic inflammatory disease, and infer-
tility. Most deaths and morbidities resulting
from such complications are preventable
through access to contraception and safe
abortion services.
Postabortion care, a term commonly
used by the international reproductive health
community, refers to a specific set of services
for women experiencing problems from all
types of spontaneous or induced abortions.
The American College In the United States the comparable concept
of Obstetricians involves management of incomplete abor-
and Gynecologists tion, and complications include retained
Women’s Health Care tissue, hemorrhage, and infection. Treatment
Physicians for women experiencing these problems
includes evacuation of the uterus (tradition-
ally by manual or electrical vacuum aspira-
tion, and now with the use of misoprostol as
well), pain management, and treatment for
suspected infection or other issues. Contra-
ceptive education and method provision are
considered integral parts of postabortion
care. Additionally, community and service
provider partnerships help prevent unwanted
pregnancies and unsafe abortion and mobi-
lize resources to help women receive appro-
priate and timely care for complications of
abortion.
Both expectant management and surgi-
cal evacuation of the uterus have been used
for women requiring postabortion care. In
addition, there is increasing evidence that
misoprostol is a safe, effective, and accept-
able method to achieve uterine evacuation
for women needing postabortion care. Miso-
prostol reduces the cost of postabortion
care services because it does not require the
immediate availability of sterilized equip-
ment, operating theatres, or skilled personnel
(2). It is inexpensive, does not require refrig-
eration, and may be administered by several
different routes (3). Misoprostol thus holds
the potential to extend first-line postabortion
care services beyond urban areas and hospi-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 613

 tals to settings where physicians and surgical services are
not available.
Efficacy
A review of the recent literature on misoprostol shows
that it successfully completes expulsion in approximately
66–99% of women who receive it for incomplete, inevi-
table, and missed abortion in the first trimester (4–12).
Specifically, one extensive review found median suc-
cess was 80% or higher for missed abortion and 92%
for incomplete abortion treated with misoprostol (15).
Misoprostol may be more successful at treating women
experiencing an incomplete abortion compared with a
missed abortion (12, 14). Although studies show a range
of efficacy, higher success has been achieved when clini-
cians wait for 1–2 weeks after misoprostol treatment
before judging success or failure (11, 13, 15). Efficacy
rates usually are higher in studies where outcome is deter-
mined by clinical parameters such as uterine size and
cervical exam rather than ultrasound criteria.
Indications
Misoprostol may be used to treat women with an incom-
plete and missed abortion. Incomplete abortion usually
is diagnosed when a pregnant woman has an open cer-
vix and has passed some, but not all of the products of
conception (16). Missed abortion usually is diagnosed
when a pregnant woman has a closed cervix and a uterus
that does not increase in size over time or an ultrasound
examination that shows either an anembryonic preg-
nancy or embryonic demise.
No published studies have investigated the use of
misoprostol to treat women with septic abortion.
Contraindications
Women with suspected ectopic pregnancy, hemody-
namic instability or allergies to misoprostol should not
be treated with misoprostol (13).
Protocols
The protocols listed as follows apply to women whose
uterine size is less than 12 weeks of gestation (13). The
optimal protocol has not yet been defined (15). However,
there is ample evidence in the literature to make a few key
recommendations:
• Incomplete abortion: misoprostol, 600 mcg orally
(4, 5, 9, 11, 13, 15, 17). Misoprostol, 400 mcg sublin-
gually, is a promising alternative but supporting
published research is currently limited (13).
• Missed abortion: misoprostol, 800 mcg vaginally (10,
12) or 600 mcg sublingually; may be repeated every 3
hours for two additional doses (18, 19). The impact
of repeat doses is not clear. Moistening the tablets
before vaginal application in this circumstance does
not appear to improve efficacy (20).
COMMITTEE OPINIONS
Side Effects
Women treated with misoprostol for an incomplete or
missed abortion will experience vaginal bleeding. Usually
the bleeding is not clinically significant and does not
require intervention (7, 15). Typically, women experience
bleeding heavier than a menses for approximately 3 or 4
days, and then it lightens to spotting. In one prospective,
randomized study of 652 women undergoing treatment
for early pregnancy failure, women receiving misoprostol
experienced larger decreases in hemoglobin compared
with women treated with curettage—although actual lev-
els of hemoglobin decrease were small (7). In this study,
median duration of bleeding was 12 days.
Other side effects include nausea, vomiting, fever,
and chills, most of which occur only a minority of women
(6). Diarrhea is more common following sublingual com-
pared with vaginal misoprostol (21). Misoprostol appears
to be highly acceptable for women requiring treatment
for an incomplete or missed abortion; 78–99% stated that
it was either satisfactory, very satisfactory, or would use it
again and recommend it to a friend (4–6, 11, 12).
Serious complications are rare; in one prospective
randomized trial hospitalization for endometritis or
hemorrhage occurred in less than 1% of patients (12).
In situations where safe conditions for surgery cannot
be assured, misoprostol may be the preferred method of
treatment (15).
Pain Management
Women receiving postabortion care should be offered
pain management options according to what is locally
available and clinically appropriate; ideally, both non-
steroidal antiinflammatory agents such as ibuprofen as
well as narcotic analgesics should be offered.
Infection Prevention
Universal precautions should be used when contact with
blood or body fluids is anticipated (22). Appropriate
hygiene and infection prevention behaviors are recom-
mended to prevent the spread of infection. For example,
hand washing should be done after coming into contact
with any blood or tissue, and proper infectious waste
disposal should be utilized. No evidence exists delineating
whether or not antibiotics prevent infection when used
in conjunction with postabortion care regardless of the
method of uterine evacuation used. However, antibiotics
have been shown to decrease infection in women under-
going vacuum aspiration during abortion (23). Lack of
antibiotics should not serve as an obstacle to receiving
care.
Contraception
Women should be counseled about and offered contra-
ception when receiving postabortion care. Contraceptive
acceptance and continuation rates are higher when
offered at the site of initial treatment (24–27). All women
2013 COMPENDIUM OF SELECTED PUBLICATIONS 614
 need to know that fertility returns within just a few weeks
after abortion and, thus, they need to protect themselves
from unintended pregnancy. Many women and their
partners have questions about side effects and risks of
modern contraceptive methods. These concerns should
be addressed in the counseling session. Regular supplies
of contraceptive commodities should be ensured.
Follow-up
Women should be evaluated 1–2 weeks after misoprostol
administration in order to ensure complete abortion.
This can be done through obtaining a history and clini-
cal examination (4, 11). If the process is not yet finished
and as long as the woman is clinically stable, she may
be offered a choice between expectant management or
a repeat dose of misoprostol at the follow-up visit (18).
The follow-up visit is also a good time to reiterate key
contraceptive messages and to involve the male partner.
Recommendations
• Increase availability of postabortion care services in
order to reduce maternal mortality. In many coun-
tries, postabortion care is difficult to obtain and
women often have to travel considerable distances
to reach services. The complete postabortion care
model should be expanded beyond hospital settings
to community health centers. Involvement of men
in promoting community support for access to post-
abortion care and contraceptive services should be
encouraged. Advocacy to increase awareness of the
need for timely treatment of abortion complications
also will improve access.
• Misoprostol must be readily available, especially for
women who do not otherwise have access to post-
abortion care. Barriers to a sustainable misoprostol
supply must be eliminated in order to ensure that
underserved women receive treatment.
• Postabortion care services need not be dependent
on the availability of obstetrician–gynecologists or
surgeons. Nurses and midwives can safely provide
first-line postabortion care services, including in
outpatient settings, provided they receive appropri-
ate training and support (28).
• Access to contraception and safe abortion services
prevents complications from unsafe abortion and
decreases the need for postabortion care (29, 30). It
is much less expensive and far better for women’s
health to prevent the problem of unsafe abortion
rather than to treat resulting complications.
References
1. World Health Organization. Unsafe abortion: global and
regional estimates of the incidence of unsafe abortion and
associated mortality in 2003. 5th ed. Geneva: WHO; 2007.
Available at: http://www.who.int/reproductive-health/
COMMITTEE OPINIONS
publications/unsafeabortion_2003/ua_estimates03.pdf.
Retrieved October 28, 2008.
2. You JH, Chung TK. Expectant, medical or surgical treat-
ment for spontaneous abortion in first trimester of preg-
nancy: a cost analysis. Hum Reprod 2005;20:2873–8.
3. World Health Organization. Safe abortion: technical
and policy guidance for health systems. Geneva: WHO;
2003. Available at: http://www.who.int/reproductivehealth/
publications/safe_abortion/safe_abortion.pdf. Retrieved
October 28, 2008.
4. Shwekerela B, Kalumuna R, Kipingili R, Mashaka N,
Westheimer E, Clark W, et al. Misoprostol for treatment of
incomplete abortion at the regional hospital level: results
from Tanzania. BJOG 2007;114:1363–7.
5. Dao B, Blum J, Thieba B, Raghavan S, Ouedraego M,
Lankoande J, et al. Is misoprostol a safe, effective and
acceptable alternative to manual vacuum aspiration for
postabortion care? Results from a randomised trial in
Burkina Faso, West Africa. BJOG 2007;114:1368–75.
6. Bique C, Usta M, Debora B, Chong E, Westheimer E,
Winikoff B. Comparison of misoprostol and manual vacu-
um aspiration for the treatment of incomplete abortion. Int
J Gynaecol Obstet 2007;98:222–6.
7. Davis AR, Hendlish SK, Westhoff C, Frederick MM, Zhang
J, Gilles JM, et al. Bleeding patterns after misoprostol vs
surgical treatment of early pregnancy failure: results from a
randomized trial. Am J Obstet Gynecol 2007;196:31. e1–31.
e7.
8. Graziosi GC, Mol BW, Ankum WM, Bruinse HW. Manage-
ment of early pregnancy loss. Int J Gynaecol Obstet 2004;86:
337–46.
9. Blanchard K, Taneepanichskul S, Kiriwat O, Sirimai K,
Svirirojana N, Mavimbela N, et al. Two regimens of
misoprostol for treatment of incomplete abortion. Obstet
Gynecol 2004;103:860–5.
10. Ngoc NT, Blum J, Westheimer E, Quan TT, Winikoff B.
Medical treatment of missed abortion using misoprostol.
Int J Gynaecol Obstet 2004;87:138–42.
11. Weeks A, Alia G, Blum J, Winikoff B, Ekwaru P, Durocher
J, et al. A randomized trial of misoprostol compared with
manual vacuum aspiration for incomplete abortion. Obstet
Gynecol 2005;106:540–7.
12. Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C,
Frederick MM, et al. A comparison of medical management
with misoprostol and surgical management for early preg-
nancy failure. National Institute of Child Health Human
Development (NICHD) Management of Early Pregnancy
Failure Trial. N Engl J Med 2005;353:761–9.
13. Blum J, Winikoff B, Gemzell-Danielsson K, Ho PC,
Schiavon R, Weeks A. Treatment of incomplete abortion
and miscarriage with misoprostol. Int J Gynaecol Obstet
2007;99(suppl 2):S186–9.
14. Tang OS, Ho PC. The use of misoprostol for early preg-
nancy failure. Curr Opin Obstet Gynecol 2006;18:581–6.
15. Clark W, Shannon C, Winikoff B. Misoprostol for uterine
evacuation in induced abortion and pregnancy failure.
Expert Rev Obstet Gynecol 2007;2:67–108.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 615
 16. Castleman LD, Blumenthal PD. Spontaneous and induced
abortion. In: Ryden J, Blumenthal PD, editors. Practical
gynecology: a guide for the primary care physician.
Philadelphia (PA): American College of Physicians; 2009.
p. 137–57.
17. Phupong V, Taneepanichskul S, Kriengsinyot R, Sriyirojana
N, Blanchard K, Winikoff B. Comparative study between
single dose 600 microg and repeated dose of oral misopro-
stol for treatment of incomplete abortion. Contraception
2004;70:307–11.
18. Gemzell-Danielsson K, Ho PC, Gomez Ponce de Leon R,
Weeks A, Winikoff B. Misoprostol to treat missed abortion
in the first trimester. Int J Gynaecol Obstet 2007;99(suppl
2):S182–5.
19. Tang OS, Lau WN, Ng EH, Lee SW, Ho PC. A prospective
randomized study to compare the use of repeated doses of
vaginal with sublingual misoprostol in the management of
first trimester silent miscarriages. Hum Reprod 2003;18:
176–81.
20. Gilles JM, Creinin MD, Barnhart K, Westhoff C, Frederick
MM, Zhang J, et al. A randomized trial of saline solution-
moistened misoprostol versus dry misoprostol for first-
trimester pregnancy failure. Am J Obstet Gynecol 2004;
190: 389–94.
21. Neilson JP, Hickey M, Vazquez J. Medical treatment for
early fetal death (less than 24 weeks). Cochrane Database
of Systematic Reviews 2006, Issue 3. Art. No.: CD002253.
DOI: 10.1002/14651858.CD002253.pub3.
22. Herrick J, Turner K, McInerney T, Castleman L. Infection
prevention. In: Woman-centered postabortion care: ref-
erence manual. Chapel Hill (NC): Ipas; 2004. p.31–40.
Available at:http://www.ipas.org/Publications/asset_upload
_file975_2148.pdf. Retrieved October 28, 2008.
23. Sawaya GF, Grady D, Kerlikowske K, Grimes DA.
Antibiotics at the time of induced abortion: the case for
universal prophylaxis based on a meta-analysis. Obstet
Gynecol 1996;87: 884–90.
COMMITTEE OPINIONS
24. Solo J, Billings DL, Aloo-Obunga C, Ominde A, Makumi
M. Creating linkages between incomplete abortion treat-
ment and family planning services in Kenya. Stud Fam
Plann 1999;30:17–27.
25. Johnson BR, Ndhlovu S, Farr SL, Chipato T. Reducing
unplanned pregnancy and abortion in Zimbabwe through
postabortion contraception. Stud Fam Plann 2002;33:
195–202.
26. Savelieva I, Pile JM, Sacci I, Loganathan R. Postabortion
family planning operations research study in Perm, Russia.
Washington, DC: FRONTIERS; 2003. Available at: http://
www.popcouncil.org/pdfs/frontiers/FR_FinalReports/
Russia_PAC.pdf. Retrieved October 28, 2008.
27. Rasch V, Massawe S, Yambesi F, Bergstrom S. Acceptance
of contraceptives among women who had an unsafe abor-
tion in Dar es Salaam. Trop Med Int Health 2004;9:399–
405.
28. Corbett MR, Turner KL. Essential elements of postabortion
care: origins, evolution and future directions. Int Fam Plan
Perspect 2003;29:106–11.
29. World Health Organization. Complications of abortion:
technical and managerial guidelines for prevention and
treatment. Geneva: World Health Organization; 1995.
30. Grimes DA, Benson J, Singh S, Romero M, Ganatra B,
Okonofua FE, et al. Unsafe abortion: the preventable pan-
demic. Lancet 2006;368:1908–19.
Copyright © February 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Misoprostol for postabortion care. ACOG Committee Opinion No.
427. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:465–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 616
COMMITTEE OPINIONS
Committee on Obstetric Practice

2013 COMPENDIUM OF SELECTED PUBLICATIONS 617

 ACOG
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © May 2000 by
the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
COMMITTEE OPINIONS
Committee
Opinion
Number 234, May 2000 (Replaces No. 219, August 1999)
Scheduled Cesarean Delivery and the
Prevention of Vertical Transmission
of HIV Infection
Prevention of transmission of the human immunodeficiency virus (HIV)
from mother to fetus or newborn (vertical transmission) is a major goal in
the care of pregnant women infected with HIV. An important advance in this
regard was the demonstration that treatment of the mother with zidovudine
(ZDV) during pregnancy and labor and of the neonate for the first 6 weeks
after birth could reduce the transmission rate from 25% to 8% (1).
Continuing research into vertical transmission of HIV suggests that a
substantial number of cases occur as the result of fetal exposure to the virus
during labor and delivery; the precise mechanisms are not known. Trans­
mission could occur by transplacental maternal–fetal microtransfusion of
blood contaminated with the virus during uterine contractions or by expo­­sure
to the virus in maternal cervicovaginal secretions and blood at delivery. Data
also indicate that the risk of vertical transmission is proportional to the con-
centration of virus in maternal plasma (viral load). At very low concentrations
of virus in maternal plasma (viral load less than 1,000 copies per milliliter),
the observed incidence of vertical transmission among 141 mother–infant
pairs was 0 with a 95% upper confidence bound of about 2% (2, 3).
In theory, the risk of vertical transmission in mothers with high viral loads
could be reduced by performing cesarean deliveries before the onset of labor
and before rupture of membranes (termed scheduled cesarean delivery in this
document). Early studies of the relationship between the mode of delivery
and the risk of vertical transmission yielded inconsistent results. Data from
two prospective cohort studies (4, 5), an international randomized trial (6),
and a meta-analysis of individual patient data from 15 prospective cohort
studies, including more than 7,800 mother–child pairs (7), indicate that there
is a significant relationship between the mode of delivery and vertical trans-
mission of HIV. This body of evidence, accumulated mostly before the use of
highly active antiretroviral therapy (HAART) and without any data regarding
maternal viral load, indicates that scheduled cesarean delivery reduces the
likelihood of vertical transmission of HIV compared with either unscheduled
cesarean delivery or vaginal delivery. This finding holds true whether or
not the patient is receiving ZDV therapy. Whether cesarean delivery offers
2013 COMPENDIUM OF SELECTED PUBLICATIONS 618
 any benefit to women on HAART or to women with
low or undetectable maternal viral loads is unknown.
Data are insufficient to address the question of how
long after the onset of labor or rupture of membranes
the benefit is lost. It is clear that maternal morbidity
is greater with cesarean delivery than with vaginal
delivery, as is true for women not infected with HIV
(8–10). Increases in postpartum morbidity seem to be
greatest among women infected with HIV who have
low CD4 cell counts (9).
Although many issues remain unresolved because
of insufficient data, there is consensus that the fol-
lowing should be recommended:
• Patients should be counseled that in the absence of
antiretroviral therapy, the risk of vertical transmis-
sion is approximately 25%. With ZDV therapy, the
risk is reduced to 5–8%. When care includes both
ZDV therapy and scheduled cesarean delivery, the
risk is approximately 2%. A similar risk of 2% or
less is seen among women with viral loads of less
than 1,000 copies per milliliter, even without the
systematic use of scheduled cesarean delivery. No
combination of therapies can guarantee that a new-
born will not become infected (a 0% transmission
rate).
• Women infected with HIV, whose viral loads are
greater than 1,000 copies per milliliter, should be
counseled regarding the potential benefit of sched-
uled cesarean delivery to further reduce the risk of
vertical transmission of HIV beyond that achiev-
able with antiretroviral therapy alone.
• Neonates of women at highest risk for vertical
transmission, with relatively high plasma viral
loads, are most likely to benefit from scheduled
cesarean delivery. Data are insufficient to demon-
strate a benefit for neonates of women with plasma
viral loads of less than 1,000 copies per milliliter.
The available data indicate no reduction in the
transmission rate if cesarean delivery is performed
after the onset of labor or rupture of membranes.
The decision regarding the route of delivery must
be individualized in these circumstances.
• The patient’s autonomy in making the decision
regarding route of delivery must be respected. A
patient’s informed decision to undergo vaginal
delivery must be honored, with cesarean delivery
performed only for other accepted indications and
with patient consent.
• Patients should receive antiretroviral chemothera-
py during pregnancy according to currently accept-
ed guidelines for adults (11). This should not be
interrupted around the time of cesarean delivery.
For those patients receiving ZDV, adequate lev-
COMMITTEE OPINIONS
els of the drug in the blood should be achieved if
the infusion is begun 3 hours preoperatively (1),
according to the dosing schedule recommended
by the Centers for Disease Control and Prevention
(www.cdc.gov/hiv/treatment).
• Because morbidity is increased in HIV-infected
women undergoing cesarean delivery, physicians
should consider using prophylactic antibiotics dur-
ing all such cesarean deliveries.
• The American College of Obstetricians and
Gynecologists generally recommends that sched-
uled cesarean deliveries not be performed before
39 completed weeks of gestation. In women with
HIV infection, however, delivery at 38 completed
weeks of gestation is recommended to reduce the
likelihood of onset of labor or rupture of mem-
branes before delivery.
• Best clinical estimates of gestational age should be
used for planning cesarean delivery. Amniocen­
tesis to determine fetal lung maturity in pregnant
women infected with HIV should be avoided
when­ever possible.
• Current recommendations for adults indicate that
plasma viral load should be determined at baseline
and then every 3 months or following changes in
therapy (11). Plasma viral load should be monitored,
according to these guidelines, during pregnancy as
well. The patient’s most recently determined viral
load should be used to direct counseling regarding
mode of delivery.
• Preoperative maternal health status affects the
degree of risk of maternal morbidity associated
with cesarean delivery. All women should be
clearly informed of the risks associated with cesar-
ean delivery. Ultimately, the decision to perform a
cesarean delivery must be individualized in each
case according to circumstances.
A skin-penetrating injury (eg, needlestick or
scalpel laceration) is a risk to care providers dur-
ing all deliveries, vaginal or cesarean. This risk is
not greater during cesarean delivery, although there
generally are more health care personnel present
and, thus, at risk during a cesarean delivery than
during a vaginal delivery (12). Appropriate care and
precautions against such injuries always should be
taken, but these concerns should not affect decisions
regarding route of delivery (13).
In summary, cesarean delivery performed before
the onset of labor and before rupture of membranes
effectively reduces the risk of vertical transmission
of HIV infection. Scheduled cesarean delivery should
be discussed and recommended for women with viral
loads greater than 1,000 copies per milliliter whether
2013 COMPENDIUM OF SELECTED PUBLICATIONS 619
 or not they are taking antiretroviral therapy. As with
all complex clinical decisions, the choice of delivery
must be individualized. Discussion of the option of
scheduled cesarean delivery should begin as early as
possible in pregnancy with every pregnant woman
with HIV infection to give her an adequate opportu-
nity to consider the choice and plan for the procedure.
The risks, which are greater for the mother, must be
balanced with the benefits expected for the neonate.
The patient’s autonomy must be respected when
making the decision to perform a cesarean deliv­
ery, because the potential for maternal morbidity is
significant.
References
1. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G,
O’Sullivan MJ, et al. Reduction of maternal-infant transmis-
sion of human immunodeficiency virus type 1 with zidovu-
dine treatment. Pediatric AIDS Clinical Trials Group Protocol
076 Study Group. N Engl J Med 1994;331:1173–1180
2. Mofenson LM, Lambert JS, Stiehm ER, Bethel J, Meyer
WA 3rd, Whitehouse J, et al. Risk factors for perinatal trans-
mission of human immunodeficiency virus type 1 in women
treated with zidovudine. Pediatric AIDS Clinical Trials
Group Study 185 Team. N Engl J Med 1999;341:385–393
3. Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn T,
Burchett SK, et al. Maternal levels of plasma human
immu­no­­deficiency virus type 1 RNA and the risk of peri-
natal transmission. Women and Infants Transmission Study
Group. N Engl J Med 1999;341:394–402
4. Kind C, Rudin C, Siegrist CA, Wyler CA, Biedermann K,
Lauper U, et al. Prevention of vertical HIV transmission:
additive protective effect of elective cesarean section and
zidovudine prophylaxis. AIDS 1998;12:205–210
5. Mandelbrot L, Le Chenadec J, Berrebi A, Bongain A,
Benifla JL, Delfraissy JF, et al. Perinatal HIV-1 transmis-
sion: interaction between zidovudine prophylaxis and
mode of delivery in the French Perinatal Cohort. JAMA
1998;280:55–60
COMMITTEE OPINIONS
6. The European Mode of Delivery Collaboration. Elective
caesarean-section versus vaginal delivery in prevention of
vertical HIV-1 transmission: a randomized clinical trial.
Lancet 1999;353:1035–1039
7. The International Perinatal HIV Group. The mode of deliv-
ery and the risk of vertical transmission of human immuno­
deficiency virus type 1: a meta-analysis of 15 prospective
cohort studies. N Engl J Med 1999;340:977–987
8. Nielsen TF, Hakegaard KH. Postoperative cesarean section
morbidity: a prospective study. Am J Obstet Gynecol 1983;
146:911–915
9. Semprini AE, Castagna C, Ravizza M, Fiore S, Savasi V,
Muggiasca ML, et al. The incidence of complications after
cesarean section in 156 HIV-positive women. AIDS 1996;
9:913–917
10. Bulterys M, Chao A, Dushimimana A, Saah A. Fatal com-
plications after cesarean section in HIV-infected women.
AIDS 1996;10:923–924
11. Centers for Disease Control and Prevention. Report of the
NIH Panel to define principles of therapy of HIV infec-
tion and guidelines for the use of antiretroviral agents in
HIV-infected adults and adolescents. MMWR Morb Mortal
Wkly Rep 1998;47(RR-5):1–82
12. Duff P, Robertson AW, Read JA. Single-dose cefazolin
versus cefonicid for antibiotic prophylaxis in cesarean
delivery. Obstet Gynecol 1987;70:718–721
13. Centers for Disease Control. Update: universal precautions
for prevention of transmission of human immunodeficiency
virus, hepatitis B virus, and other bloodborne pathogens
in health-care settings. MMWR Morb Mortal Wkly Rep
1988;37:377–382;387–388
Bibliography
Rodman JH, Robbins BL, Flynn PM, Fridland A. A systematic
and cellular model for zidovudine plasma concentrations and
intracellular phosphorylation in patients. J Infect Dis 1996;174:
490–499
2013 COMPENDIUM OF SELECTED PUBLICATIONS 620
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2011
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © October 2001
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Circumcision. ACOG Committee
Opinion No. 260. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2001;98:707-708
COMMITTEE OPINIONS
Committee
Opinion
Number 260, October 2001
Circumcision
ABSTRACT: The American College of Obstetricians and Gynecologists sup-
ports the current position of the American Academy of Pediatrics that finds
the existing evidence insufficient to recommend routine neonatal circumci-
sion. Given this circumstance, parents should be given accurate and impar-
tial information to help them make an informed decision. There is ample
evidence that newborns circumcised without analgesia experience pain and
stress. If circumcision is performed, analgesia should be provided.
Some studies have shown potential medical benefits to newborn male cir-
cumcision; however, these benefits are modest. The exact incidence of com-
plications after circumcision is not known, but data indicate that the rate is
low, and the most common complications are local infection and bleeding.
The current position of the American Academy of Pediatrics is that the exist-
ing evidence is insufficient to recommend routine neonatal circumcision.
The American College of Obstetricians and Gynecologists Committee on
Obstetric Practice supports this position. Given this circumstance, parents
should be given accurate and impartial information to help them make an
informed decision. It is reasonable for parents to take cultural, religious, and
ethnic traditions, as well as medical factors, into consideration when making
this decision. Circumcision of newborns should be performed only on healthy
and stable infants.
There is ample evidence that newborns circumcised without analgesia
experience pain and stress. Analgesia has been found to be safe and effective
in reducing the pain associated with circumcision. Therefore, if circumcision
is performed, analgesia should be provided. Swaddling, sucrose by mouth,
and acetaminophen administration may reduce the stress response but are
not sufficient for the operative pain and cannot be recommended as the sole
method of analgesia. EMLA cream, dorsal penile nerve block, and subcuta-
neous ring block are all reasonable options, although the subcutaneous ring
block may provide the most effective analgesia.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 621
 References Newborn. Committee on Drugs. Section on Anesthesiology.
Section on Surgery. Canadian Paediatric Society. Fetus and
1. Circumcision policy statement. Task Force on Circum­cision. Newborn Committee. Pediatrics 2000;105:454–461
American Academy of Pediatrics. Pediatrics 1999;103:686–
693
2. Prevention and management of pain and stress in the neonate.
American Academy of Pediatrics. Committee on Fetus and

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 622

 ACOG
Committee on
Obstetric Practice
Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © January 2002
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Exercise during pregnancy and
the postpartum period. ACOG
Committee Opinion No. 267.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2002;99:171–173
COMMITTEE OPINIONS
Committee
Opinion
Number 267, January 2002
Exercise During Pregnancy and the
Postpartum Period
ABSTRACT: The physiologic and morphologic changes of pregnancy may
interfere with the ability to engage safely in some forms of physical activity.
A woman’s overall health, including obstetric and medical risks, should be
evaluated before prescribing an exercise program. Generally, participation
in a wide range of recreational activities appears to be safe during pregnan-
cy; however, each sport should be reviewed individually for its potential risk,
and activities with a high risk of falling or those with a high risk of abdominal
trauma should be avoided during pregnancy. Scuba diving also should be
avoided throughout pregnancy because the fetus is at an increased risk for
decompression sickness during this activity. In the absence of either medical
or obstetric complications, 30 minutes or more of moderate exercise a day
on most, if not all, days of the week is recommended for pregnant women.
The current Centers for Disease Control and Prevention and American
College of Sports Medicine recommendation for exercise, aimed at improv-
ing the health and well-being of nonpregnant individuals, suggests that an
accumulation of 30 minutes or more of moderate exercise a day should occur
on most, if not all, days of the week (1). In the absence of either medical or
obstetric complications, pregnant women also can adopt this recommenda-
tion.
Given the potential risks, albeit rare, thorough clinical evaluation of each
pregnant woman should be conducted before recommending an exercise
program. In the absence of contraindications (see boxes), pregnant women
should be encouraged to engage in regular, moderate intensity physical
activity to continue to derive the same associated health benefits during their
pregnancies as they did prior to pregnancy.
Epidemiologic data suggest that exercise may be beneficial in the primary
prevention of gestational diabetes, particularly in morbidly obese women
(BMI >33) (2). The American Diabetes Association has endorsed exercise
as “a helpful adjunctive therapy” for gestational diabetes mellitus when
euglycemia is not achieved by diet alone (3, 4).
The cardiovascular changes associated with pregnancy are an important
consideration for pregnant women both at rest and during exercise. After
2013 COMPENDIUM OF SELECTED PUBLICATIONS 623

Absolute Contraindications to Aerobic Exercise
During Pregnancy
• Hemodynamically significant heart disease
• Restrictive lung disease
• Incompetent cervix/cerclage
• Multiple gestation at risk for premature labor
• Persistent second- or third-trimester bleeding
• Placenta previa after 26 weeks of gestation
• Premature labor during the current pregnancy
• Ruptured membranes
• Preeclampsia/pregnancy-induced hypertension
Relative Contraindications to Aerobic Exercise
During Pregnancy
• Severe anemia
• Unevaluated maternal cardiac arrhythmia
• Chronic bronchitis
• Poorly controlled type 1 diabetes
• Extreme morbid obesity
• Extreme underweight (BMI <12)
• History of extremely sedentary lifestyle
• Intrauterine growth restriction in current pregnancy
• Poorly controlled hypertension
• Orthopedic limitations
• Poorly controlled seizure disorder
• Poorly controlled hyperthyroidism
• Heavy smoker
the first trimester, the supine position results in
relative obstruction of venous return and, therefore,
decreased cardiac output and orthostatic hypoten-
sion. For this reason, pregnant women should avoid
supine positions during exercise as much as pos-
sible. Motionless standing also is associated with a
significant decrease in cardiac output so this posi-
tion should be avoided as much as possible (5).
Epidemiologic studies have long suggested that
a link exists between strenuous physical activities,
deficient diets, and the development of intrauterine
growth restriction. This is particularly true for preg-
nant women engaged in physical work. It has been
reported that pregnant women whose occupations
require standing or repetitive, strenuous, physical
work (eg, lifting) have a tendency to deliver ear-
COMMITTEE OPINIONS
lier and have small-for-gestational-age infants (6).
However, other reports have failed to confirm these
associations suggesting that several factors or con-
ditions have to be present for strenuous activities to
affect fetal growth or outcome (7, 8).
In general, participation in a wide range of
recreational activities appears to be safe. The safety
of each sport is determined largely by the specific
movements required by that sport. Participation in
recreational sports with a high potential for con-
tact, such as ice hockey, soccer, and basketball,
could result in trauma to both the woman and fetus.
Similarly, recreational activities with an increased
risk of falling, such as gymnastics, horseback riding,
downhill skiing, and vigorous racquet sports, have
an inherently high risk for trauma in pregnant and
nonpregnant women. Those activities with a high
risk of falling or for abdominal trauma should be
avoided during pregnancy (9). Scuba diving should
be avoided throughout pregnancy because during
this activity the fetus is at increased risk for decom-
pression sickness secondary to the inability of the
fetal pulmonary circulation to filter bubble formation
(10).
Exertion at altitudes of up to 6,000 feet appears
to be safe; however, engaging in physical activi-
ties at higher altitudes carries various risks (11).
All women who are recreationally active should be
made aware of signs of altitude sickness for which
they should stop the exercise, descend from the alti-
tude, and seek medical attention.
Data regarding the effects of exercise on core
temperature during pregnancy are limited (12, 13,
14). There have been no reports that hyperthermia
associated with exercise is teratogenic.
Warning Signs to Terminate Exercise
While Pregnant
• Vaginal bleeding
• Dyspnea prior to exertion
• Dizziness
• Headache
• Chest pain
• Muscle weakness
• Calf pain or swelling (need to rule out thrombo-
phlebitis)
• Preterm labor
• Decreased fetal movement
• Amniotic fluid leakage
2013 COMPENDIUM OF SELECTED PUBLICATIONS 624
 Competitive athletes are likely to encounter
the same physiologic limitations during pregnancy
faced by recreational athletes during pregnancy. The
competitors tend to maintain a more strenuous train-
ing schedule throughout pregnancy and resume high
intensity postpartum training sooner. The concerns of
the pregnant, competitive athlete fall into two general
categories: 1) the effects of pregnancy on competi-
tive ability, and 2) the effects of strenuous training
and competition on pregnancy and the fetus. Such
athletes may require close obstetric supervision.
Many of the physiologic and morphologic
changes of pregnancy persist 4–6 weeks postpar-
tum. Thus, prepregnancy exercise routines may be
resumed gradually as soon as it is physically and
medically safe. This will vary from one individual to
another with some women able to resume an exer-
cise routine within days of delivery. There are no
published studies to indicate that, in the absence of
medical complications, rapid resumption of activi-
ties will result in adverse effects. Having under-
gone detraining, resumption of activities should be
gradual. No known maternal complications are asso-
ciated with resumption of training (15). Moderate
weight reduction while nursing is safe and does not
compromise neonatal weight gain (16). Finally, a
return to physical activity after pregnancy has been
associated with decreased incidence of postpartum
depression, but only if the exercise is stress relieving
and not stress provoking (17).
Conclusions and Recommendations
• Recreational and competitive athletes with uncom-
plicated pregnancies can remain active during
pregnancy and should modify their usual exercise
routines as medically indicated. The information
on strenuous exercise is scarce; however, women
who engage in such activities require close medi-
cal supervision.
• Previously inactive women and those with medi-
cal or obstetric complications should be evaluated
before recommendations for physical activity
during pregnancy are made. Exercise during preg-
nancy may provide additional health benefits to
women with gestational diabetes.
• A physically active woman with a history of or
risk for preterm labor or fetal growth restriction
should be advised to reduce her activity in the
second and third trimesters.
COMMITTEE OPINIONS
References
1. American College of Sports Medicine. ACSM’s guide-
lines for exercise testing and prescription. 6th ed.
Philadelphia: Lippincott, Williams and Wilkins, 2000
2. Dye TD, Knox KL, Artal R, Aubry RH, Wojtowycz MA.
Physical activity, obesity, and diabetes in pregnancy. Am
J Epidemiol 1997;146:961–965
3. Jovanovic-Peterson L, Peterson CM. Exercise and the
nutritional management of diabetes during pregnancy.
Obstet Gynecol Clin North Am 1996;23:75–86
4. Bung P, Artal R. Gestational diabetes and exercise: a
survey. Semin Perinatol 1996;20:328–333
5. Clark SL, Cotton DB, Pivarnik JM, Lee W, Hankins GD,
Benedetti TJ, et al. Position change and central hemody-
namic profile during normal third-trimester pregnancy
and post partum. Am J Obstet Gynecol 1991;164:883–
887 [erratum in Am J Obstet Gynecol 1991;165:241]
6. Launer LJ, Villar J, Kestler E, deOnis M. The effect of
maternal work on fetal growth and duration of pregnancy:
a prospective study. Br J Obstet Gynaecol 1990:97;62–70
7. Saurel-Cubizolles MJ, Kaminski M. Pregnant women’s
working conditions and their changes during pregnancy:
a national study in France. Br J Ind Med 1987;44:236–243
8. Ahlborg G Jr, Bodin L, Hogstedt C. Heavy lifting during
pregnancy—a hazard to the fetus? A prospective study.
Int J Epidemiol 1990;19:90–97
9. Artal R, Sherman C. Exercise during pregnancy: safe and
beneficial for most. Phys Sports Med 1999;27:51–52, 54,
57–58
10. Camporesi EM. Diving and pregnancy. Semin Perinatol
1996;20:292–302
11. Artal R, Fortunato V, Welton A, Constantino N,
Khodiguian N, Villalobos L, et al. A comparison of
cardiopulmonary adaptations to exercise in pregnancy at
sea level and altitude. Am J Obstet Gynecol 1995;172:
1170–1180
12. Clapp JF 3rd, Capeless EL. Neonatal morphometrics
after endurance exercise during pregnancy. Am J Obstet
Gynecol 1990;163:1805–1811
13. Artal R, Wiswell RA, Drinkwater BL, eds. Exercise in
Pregnancy. 2nd ed. Baltimore: Williams and Wilkins,
1991
14. Soultanakis HN, Artal R, Wiswell RA. Prolonged exer-
cise in pregnancy: glucose homeostasis, ventilatory and
cardiovascular responses. Semin Perinatol 1996;20:315–
327
15. Hale RW, Milne L. The elite athlete and exercise in preg-
nancy. Semin Perinatol 1996;20:277–284
16. McCrory MA, Nommsen-Rivers LA, Mole PA, Lonnerdal
B, Dewey KG. Randomized trial of the short-term effects
of dieting compared with dieting plus aerobic exercise on
lactation performance. Am J Clin Nutr 1999;69:959–967
17. Koltyn KF, Schultes SS. Psychological effects of an
aerobic exercise session and a rest session following preg-
nancy. J Sports Med Phys Fitness 1997;37:287–291
2013 COMPENDIUM OF SELECTED PUBLICATIONS 625
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © February 2002
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Management of asymptomatic preg-
nant or lactating women exposed to
anthrax. ACOG Committee Opinion
No. 268. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2002;99:366–368
COMMITTEE OPINIONS
Committee
Opinion
Number 268, February 2002
Management of Asymptomatic
Pregnant or Lactating Women
Exposed to Anthrax
ABSTRACT: Anthrax infections are diagnosed by isolating Bacillus anthracis
from body fluids or by measuring specific antibodies in the blood of persons
suspected to have the disease. It is recommended that asymptomatic pregnant
and lactating women who have been exposed to a confirmed environmental
contamination or a high-risk source as determined by the local Department
of Health (not the women’s health care provider) receive prophylactic treat-
ment. A variety of antimicrobial regimens are available. Although some of
these drugs may present risks to the developing fetus, these risks are clearly
outweighed by the potential morbidity and mortality from anthrax. Guidelines
for prophylactic treatment of anthrax and treatment of suspected active cases
of anthrax are changing continually, and the Centers for Disease Control
and Prevention web site should be consulted for the latest recommendations.
Anthrax is an infection caused by Bacillus anthracis, an aerobic, gram-
positive, spore-forming, nonmotile bacillus species. There are three primary
clinical manifestations of the disease: 1) cutaneous, 2) inhalational, and 3)
gastrointestinal.
Cutaneous: This is the most common presentation, accounting for 95% of
naturally occurring infections. The organism’s portal of entry is a cut or
abrasion on the skin. The areas of greatest exposure are the hands, arms,
face or neck. Potential sources of the organism include wool, hides, and
leather and hair products of infected animals, particularly goats. Exposure
also may result from a bioterrorist act (eg, a contaminated letter). Incubation
periods may be as long as 12 days. Skin infection begins as a raised pruritic
papule, resembling an insect bite. Within 1–2 days a vesicle develops, fol-
lowed by a painless ulcer 1–3 cm in diameter with a characteristic black
necrotic eschar in the center. Localized lymphangitis and painful lymph-
adenopathy may occur. Although antibiotic therapy does not appear to
change the course of eschar formation and healing, it does decrease the risk
of systemic disease. Mortality rates are 20% if untreated, but less than 1%
with antibiotic therapy.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 626
 Inhalational: This is the most serious presentation,
resulting from deposition of spore-bearing particles
of 1–5 µm into the alveolar spaces. Macrophages
ingest the spores that are then transported to the
pulmonary lymphatics where they germinate. The
asymptomatic incubation period usually is 1–7 days
after exposure, but spores may germinate in the medi-
astinal lymphatics for up to 60 days. Once germina-
tion occurs, replicating bacteria release toxins leading
to hemorrhage, edema, and necrosis. Initial symp-
toms resemble a flulike illness with fever, cough, and
headache, but without rhinitis, followed by progres-
sive dyspnea that rapidly progresses to respiratory
failure and death within hours. Case-fatality estimates
are extremely high, even with supportive care and
appropriate antibiotics.
Gastrointestinal: The relatively rare intestinal form of
anthrax follows ingestion, deposition, and subsequent
germination of spores in the upper or lower gastroin-
testinal tract. The former leads to the oral-pharyngeal
form of the disease marked by oral-esophageal ulcers
and regional lymphadenopathy. The latter results
in acute inflammation of the intestinal tract with
symptoms that include anorexia, malaise, nausea,
vomiting, and fever. Subsequently patients infected
with gastrointestinal anthrax develop abdominal pain;
hematemesis; severe, bloody diarrhea; and sepsis.
Intestinal anthrax may be fatal in 25–60% of cases;
the effect of early antibiotic therapy is unknown.
Evaluation and Management of
Possible Anthrax Exposure Caused by
Bioterrorist Acts
The risk of anthrax exposure is remote for people
not in direct contact with the contaminated object or
site and is greatest for those present in the immediate
vicinity of contamination. The disease is not spread
by casual contact or by coughing and sneezing.
Active Infection
Anthrax infections are diagnosed by isolating B
anthracis from the blood, cerebrospinal fluid, skin
lesions, or respiratory secretions or by measuring
specific antibodies in the blood of persons suspected
to have the disease. Rapid diagnostic immunoas-
says and polymerase chain reaction are available at
national reference laboratories. Strategies of anti-
microbial treatment of active anthrax infection are
COMMITTEE OPINIONS
evolving. For the latest recommendations consult
the Centers for Disease Control and Prevention
(CDC) web site at www.cdc.gov/mmwr and www.
bt.cdc.gov.
Exposure
For asymptomatic individuals with low-risk expo-
sure, antimicrobials are not warranted until there is
an evident risk of actual exposure based on micro-
biologically documented anthrax as determined by
law enforcement and public health authorities. The
woman’s health care provider is not the party to
validate a threat.
In the current crisis, when screening for expo-
sure is deemed necessary, it is conducted by nasal
swab. The resultant secretions can be examined by
Gram stain and culture. However, given the lack of
reliability of nasal swab screening, postexposure
prophylaxis is indicated only after confirmed or
high-risk suspected exposure. In the latter cases,
treatment can be stopped if anthrax is not docu-
mented.
For adult postexposure prophylaxis against
anthrax infections, the CDC currently recommends
500 mg of ciprofloxacin orally every 12 hours for
60 days or 100 mg of doxycycline orally every 12
hours for 60 days.
Management of Exposed Asymptomatic
Pregnant or Lactating Women
At this time, the Committee on Obstetric Practice
recommends that prophylaxis of asymptomatic preg-
nant and lactating women be limited to those women
who have had exposure to a confirmed environmen-
tal contamination or who are exposed to a high-risk
source as determined by the local Department of
Health. Prophylaxis for asymptomatic pregnant or
lactating women is 500 mg of ciprofloxacin orally
every 12 hours for 60 days (6).
Ciprofloxacin and other fluoroquinolones gen-
erally are not used during pregnancy and lacta-
tion because of suggested irreversible drug-induced
arthropathy associated with such treatment in a
variety of species of adolescent animals (1–5).
However, no clear evidence of teratogenicity has
been demonstrated in humans (1–5). Despite these
concerns, the potential morbidity and mortality from
anthrax clearly outweighs these risks. Thus, if the
bacteria are shown to be sensitive to penicillin, the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 627
 treatment should be switched to 500 mg of amoxicil-
lin orally three times a day for 60 days (6).
If a woman has been prescribed ciprofloxacin
and is found to be pregnant, she should continue her
course of antibiotics for the full 60 days (6) unless
the bacteria are shown to be penicillin-sensitive.
She should then be switched to amoxicillin. A 1999
expert review of published data on experiences
with ciprofloxacin concluded that therapeutic doses
during pregnancy are unlikely to pose substantial
teratogenic risk, but the data are insufficient to state
that there is no risk (1). In the case of penicillin-
and ciprofloxacin-allergic patients, treatment should
consist of doxycycline or penicillin desensitization
should be considered if the organism is proved
sensitive (6). In this situation, the risks of anthrax
would far outweigh the risks of doxycycline to the
fetus (ie, dental staining of the primary teeth and
possible depressed bone growth and defective den-
tal enamel).
The guidelines for prophylactic treatment of
anthrax and treatment of suspected active cases of
anthrax are continually evolving. Please refer to
www.bt.cdc.gov and www.cdc.gov/mmwr for any
updates in CDC treatment guidelines.
References
1. Friedman JM, Polifka JE. Ciprofloxacin. In: Teratogenic
effects of drugs: a resource for clinicians (TERIS). 2nd
ed. Baltimore: The Johns Hopkins University Press, 2000:
149–150
COMMITTEE OPINIONS
2. Friedman JM, Polifka JE. Doxycyclicne. In: Teratogenic
effects of drugs: a resource for clinicians (TERIS). 2nd
ed. Baltimore: The Johns Hopkins University Press, 2000:
238–239
3. Center for Drug Evaluation and Research. U.S. Food
and Drug Administration. CIPRO (Ciprofloxacin) use by
pregnant and lactating women. Available at http://www.
fda.gov/cder/drug/infopage/cipro/cipropreg.htm.
Retrieved November 2, 2001
4. Center for Drug Evaluation and Research. U.S. Food and
Drug Administration. Drug preparedness and response to
bioterrorism. Available at http://www.fda.gov/cder/drug
prepare/default.htm. Retrieved November 2, 2001
5. Center for Drug Evaluation and Research. U.S. Food
and Drug Administration. Doxycycline (Vibramycin,
Monodox, Doryx, Doxy, Atridox, Periodox, Vibra-Tabs)
use by pregnant and lactating women. Available at http://
www.fda.gov/cder/drug/infopage/penG_doxy/doxypreg.
htm. Retrieved November 2, 2001
6. Updated recommendations for antimicrobial prophylaxis
among asymptomatic pregnant women after exposure to
bacillus anthracis. MMWR Morb Mortal Wkly Rep 2001;
50:960
Resources
Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen
E, Friedlander AM, et al. Anthrax as a biological weapon:
medical and public health management. Working Group on
Civilian Biodefense. JAMA 1999;281:1735–1745[erratum
JAMA 2000;283:1963]
Update: investigation of anthrax associated with intentional
exposure and interim public health guidelines, October 2001.
MMWR Morb Mortal Wkly Rep 2001;50:889–893
Use of anthrax vaccine in the United States. MMWR Morb
Mortal Wkly Rep 2000;49(RR-15):1–20
2013 COMPENDIUM OF SELECTED PUBLICATIONS 628
 ACOG Committee
Opinion
Committee on
Obstetric Practice
Reaffirmed 2005

Number 275, September 2002 (Replaces No. 121, April 1993)

This document reflects emerg­ing

clin­i­cal and scientific ad­vanc­
es as of the date issued and is
sub­ject to change. The in­for­ma­
tion should not be con­strued as
dic­tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © September 2002
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Obstetric management of patients
with spinal cord injuries. ACOG
Committee Opinion No. 275.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2002;100:625–7.
Obstetric Management of Patients
with Spinal Cord Injuries
ABSTRACT: Effective rehabilitation and modern reproductive technology
may increase the number of women considering pregnancy who have spi-
nal cord injuries (SCIs). It is important that obstetricians caring for these
patients are aware of the specific problems related to SCIs. Autonomic
dysreflexia is the most significant medical complication seen in women with
SCIs, and precautions should be taken to avoid stimuli that can lead to this
potentially fatal syndrome. Women with SCIs may give birth vaginally, but
when cesarean delivery is indicated, adequate anesthesia (spinal or epidural
if possible) is needed.
Approximately 11,000 new spinal cord injuries (SCIs) are reported per year
in the United States. More than 50% occur in persons between the ages of
16 and 30 years, with women constituting approximately 18% of these cases.
Effective rehabilitation and modern reproductive technology may increase
the number of these patients considering pregnancy.
Ideally, women with SCIs who are considering pregnancy should have
a preconceptional evaluation. Chronic medical conditions and the woman’s
adaptation to her disability must be evaluated. Baseline pulmonary function
and renal studies may be appropriate. Also, it should be recognized that fer-
tility in these patients usually is not affected, and family planning should be
discussed.
It is important that obstetricians caring for such patients acquaint
themselves with the problems related to SCIs that may occur throughout
pregnancy. Common complications affecting women with SCIs include
urinary tract infections, decubital ulcers, impaired pulmonary function, and
autonomic dysreflexia. Additional potential complications include anemia,
deep vein thrombosis, pulmonary emboli, and unattended delivery.
Common Complications
Urinary Tract Infections
Asymptomatic bacteruria occurs in a majority of patients with SCIs during
pregnancy. The incidence of lower urinary tract infections and pyelonephritis

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 629

 also is increased. Incomplete bladder emptying,
neurogenic bladder, urinary diversions, and indwell-
ing catheters contribute to this risk. Frequent urine
cultures or antibiotic suppression are indicated.
Decubital Ulcers
Decubital ulcers are a frequently preventable com-
plication in women with SCIs. During pregnancy,
women with SCIs should have routine skin exami-
nations, frequent position changes, adequate pad-
ding, and appropriately sized medical equipment
(eg, wheelchairs). Weight gain and edema also may
contribute to decubital ulceration.
Pulmonary Function
Impaired pulmonary function may be present in
women with high thoracic or cervical spine lesions.
For patients with borderline function, ventilatory
support and meticulous attention to pulmonary care
is necessary during pregnancy and delivery. Supine
positioning may further impair pulmonary function.
Serial assessments of vital capacity will help assess
the need for ventilatory assistance.
Autonomic Dysreflexia
Autonomic dysreflexia is the most significant medi-
cal complication occurring in women with SCIs
(85% of patients with lesions above T5 through
T6 level). This condition is attributed to a loss of
hypothalamic control of sympathetic spinal reflexes
and occurs in patients with viable spinal cord seg-
ments distal to the level of injury. It can occur in
patients with incomplete transections. In susceptible
patients, afferent stimuli from a hollow viscus (eg,
the bladder, bowel, or uterus) and from the skin
below the level of the lesion or of the genital areas
ascend in the spinothalamic tracts and posterior col-
umns, which causes reflex sympathetic activation
unmodified by the supraspinal centers. The resultant
catecholamine release and vasoconstriction lead to
hypertension associated with headache, bradycardia,
tachycardia, cardiac arrhythmia, sweating, flushing,
tingling, nasal congestion, piloerection, and, occa-
sionally, respiratory distress. Uteroplacental vaso-
constriction may result in fetal hypoxemia.
It is important to avoid stimuli that can lead
to autonomic dysreflexia, such as distension or
manipulation of the vagina, bladder, urethra, or
bowel. During labor, the symptoms of autonomic
dysreflexia are commonly synchronous with uterine
contractions. The severity of the syndrome during
COMMITTEE OPINIONS
labor ranges from unpleasant symptoms to hyper-
tensive encephalopathy, cerebrovascular accidents,
intraventricular and retinal hemorrhages, and death.
Therefore, continual hemodynamic monitoring dur-
ing labor is mandatory in all at-risk patients.
Although patients with SCIs may perceive no
pain during labor, anesthesia should be used to
prevent autonomic dysreflexia. Spinal or epidural
anesthesia extending to the T10 level is the most
reliable method of preventing autonomic dysreflexia
by blocking stimuli that arise from pelvic organs.
Therefore, antepartum consultation with an anesthe-
siologist and the establishment of a plan for induc-
tion of epidural or spinal anesthesia at the onset of
labor is imperative. If autonomic dysreflexia occurs
before a regional anesthetic is available or occurs
despite regional anesthesia, hypertension may be
treated with antihypertensive agents that have a
rapid onset and short duration of action (eg, sodium
nitroprusside or nitroglycerin), ganglionic block-
ing agents (eg, trimethaphan), adrenergic blocking
agents (eg, guanethidine), or a direct vasodilator (eg,
hydralazine).
If there is evidence of autonomic dysreflexia
during the second stage of labor, delivery can be
expedited by forceps or vacuum assisted delivery
with adequate anesthesia. If autonomic dysreflexia
during labor cannot be controlled by any means,
cesarean delivery may be necessary. Adequate anes-
thesia, spinal or epidural if possible, is needed for
cesarean deliveries in all patients with SCIs.
Ascertainment of Labor
Women with SCIs may give birth vaginally. Women
with spinal cord transection above the T10 segment
may have painless labor. In a patient with total
transection at a lower thoracic level, labor pain may
be so reduced that the patient is unaware of uterine
contractions, especially during sleep. However,
symptoms under the control of the sympathetic ner-
vous system (eg, abdominal or leg spasms, shortness
of breath, increased spasticity) concurrent with uter-
ine contractions may make patients aware of labor.
Patients should be instructed in uterine palpation
techniques to detect contractions at home.
General Support
Excess weight gain may increase the difficulty of
moving and transporting pregnant women with
SCIs. Muscle-strengthening exercises may be rec-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 630
 ommended for the upper extremities of nonquad-
riplegic patients. For all patients, elevation of the
legs and range-of-motion exercises may be imple-
mented as pregnancy advances. The possibility of
an increased need for social support services also
should be addressed.
Bibliography
American Society of Anesthesiologists. Standards for basic
anesthetic monitoring. In: ASA standards, guidelines and state-
ments. Park Ridge (IL): ASA; 2000. p. 5–6.
Atterbury JL, Groome LJ. Pregnancy in women with spinal
cord injuries. Nurs Clin North Am 1998;33:603–13.
COMMITTEE OPINIONS
Baker EB, Cardenas DD. Pregnancy in spinal cord injured
women. Arch Phys Med Rehabil 1996;77:501–7.
Baker EB, Cardena DD, Benedetti TJ. Risks associated with
pregnancy in spinal cord-injured women. Obstet Gynecol
1992;80:425–8.
Hambly PR, Martin B. Anaesthesia for chronic spinal cord
lesions. Anaesthesia 1998;53:273–89.
Nobunaga AI, Go BK, Karunas RB. Recent demographic and
injury trends in people served by the Model Spinal Cord Injury
Care Systems. Arch Phys Med Rehabil 1999;80:1372–82.
Paonessa K, Fernand R. Spinal cord injury and pregnancy.
Spine 1991;16:596–8.
Verduyn WH. Spinal cord injured women, pregnancy and
delivery. Paraplegia 1986;24:231–40.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 631
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2008
American Society of
Anesthesiologists
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © July 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Pain relief during labor. ACOG
Committee Opinion No. 295.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2004;104:213.
COMMITTEE OPINIONS
Committee
Opinion
Number 295, July 2004 (Replaces No. 231, February 2000)
Pain Relief During Labor
ABSTRACT: Pain management should be provided whenever medically indi-
cated. The American Society of Anesthesiologists (ASA) and the American
College of Obstetricians and Gynecologists (ACOG) believe that women
requesting epidural analgesia during labor should not be deprived of this
service based on their insurance or inadequate nursing participation in the
management of regional analgesic modalities. Furthermore, in an effort to
allow the maximum number of patients to benefit from neuraxial analgesia,
ASA and ACOG believe that labor nurses should not be restricted from par-
ticipating in the management of pain relief during labor.
Labor causes severe pain for many women. There is no other circumstance
where it is considered acceptable for an individual to experience untreated
severe pain, amenable to safe intervention, while under a physician’s care.
In the absence of a medical contraindication, maternal request is a sufficient
medical indication for pain relief during labor. Pain management should be
provided whenever medically indicated.
Of the various pharmacologic methods used for pain relief during labor
and delivery, neuraxial analgesia techniques (epidural, spinal, and combined
spinal–epidural) are the most flexible, effective, and least depressing to the
central nervous system, allowing for an alert participating woman and an
alert neonate. The American Society of Anesthesiologists (ASA) and the
American College of Obstetricians and Gynecologists (ACOG) believe that
women requesting epidural analgesia during labor should not be deprived
of this service based on their insurance or inadequate nursing participation
in the management of regional analgesic modalities. In addition, third-party
payers who provide reimbursement for obstetric services should not deny
reimbursement for labor analgesia because of an absence of “other medical
indications.” Although the availability of various methods of labor analgesia
will vary from hospital to hospital, within an institution the methods available
should not be based on a patient’s ability to pay. Furthermore, in an effort to
allow the maximum number of patients to benefit from neuraxial analgesia,
ASA and ACOG believe that labor nurses should not be restricted from par-
ticipating in the management of pain relief during labor. Under appropriate
physician supervision, labor and delivery nursing personnel who have been
properly educated and have demonstrated current competence should be able
to participate in the management of epidural infusions, including adjusting
dosage and discontinuing infusions.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 632
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2009
This document reflects emerg­ing
clin­i­cal and scientific ad­vances
as of the date issued and is sub­
ject to change. The in­for­ma­tion
should not be con­strued as dic­
tat­ing an ex­clu­sive course of
treat­ment or pro­ce­dure to be
followed.
Copyright © September 2004
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of
this publication may be repro-
duced, stored in a retrieval sys-
tem, or transmitted, in any form
or by any means, electronic,
mechanical, photocopying,
recording, or otherwise, without
prior written permission from
the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Guidelines for diagnostic imaging
during pregnancy. ACOG Committee
Opinion No. 299. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:647–51.
COMMITTEE OPINIONS
Committee
Opinion
Number 299, September 2004 (Replaces No. 158, September 1995)
Guidelines for Diagnostic Imaging
During Pregnancy
ABSTRACT: Undergoing a single diagnostic X-ray procedure does not result
in radiation exposure adequate to threaten the well-being of the developing
preembryo, embryo, or fetus and is not an indication for therapeutic abortion.
When multiple diagnostic X-rays are anticipated during pregnancy, imaging
procedures not associated with ionizing radiation, such as ultrasonography
and magnetic resonance imaging, should be considered. Additionally, it may
be helpful to consult an expert in dosimetry calculation to determine esti-
mated fetal dose. The use of radioactive isotopes of iodine is contraindicated
for therapeutic use during pregnancy. Other radiopaque and paramagnetic
contrast agents have not been studied in humans, but animal studies suggest
that these agents are unlikely to cause harm to the developing human fetus.
Although imaging techniques requiring these agents may be diagnostically
beneficial, these techniques should be used during pregnancy only if potential
benefits justify potential risks to the fetus.
Various imaging modalities are available for diagnostic use during preg-
nancy. These include X-ray, ultrasonography, magnetic resonance imaging
(MRI), and nuclear medicine studies. Of these, diagnostic X-ray is the most
frequent cause of anxiety for obstetricians and patients. Much of this anxiety
is secondary to a general belief that any radiation exposure is harmful and
will result in an anomalous fetus. This anxiety could lead to inappropriate
therapeutic abortion and litigation. Actually, most diagnostic radiologic
procedures are associated with little, if any, known significant fetal risks.
Moreover, according to the American College of Radiology, no single diag-
nostic X-ray procedure results in radiation exposure to a degree that would
threaten the well-being of the developing preembryo, embryo, or fetus (1).
Thus, exposure to a single X-ray during pregnancy is not an indication for
therapeutic abortion (2, 3).
Some women are exposed to X-rays before the diagnosis of pregnancy.
Occasionally, X-ray procedures will be indicated during pregnancy for sig-
nificant medical problems or trauma. To enable physicians to counsel patients
appropriately, the following information is provided about the potential risks
and measures that can reduce diagnostic X-ray exposure.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 633
 X-Ray Exposure
Ionizing radiation can result in the following 3 harm-
ful effects: 1) cell death and teratogenic effects, 2)
carcinogenesis, and 3) genetic effects or mutations
in germ cells (2, 3). There is little or no information
to estimate either the frequency or magnitude of
adverse genetic effects on future generations.
Units traditionally used to measure the effects
of X-ray include the rad and roentgen equivalents
man (rem). Modern units include the gray (Gy) and
sievert (Sv). The definitions of these units of mea-
sure are summarized in Table 1.
The estimated fetal exposure from some com-
mon radiologic procedures is summarized in Table
2. A plain X-ray generally exposes the fetus to
very small amounts of radiation. Commonly dur-
ing pregnancy, the uterus is shielded for nonpelvic
procedures. With the exception of barium enema
or small bowel series, most fluoroscopic examina-
tions result in fetal exposure of millirads. Radiation
exposure from computed tomography (CT) varies
depending on the number and spacing of adjacent
image sections. Although CT pelvimetry can result
in fetal exposures as high as 1.5 rad, exposure can be
reduced to approximately 250 mrad (including fetal
gonad exposure) by using a low-exposure technique
(4).
Spiral (or helical) CT allows continuous scan-
ning of the patient as the couch is moved through the
scanner, providing superior speed and image qual-
ity. Radiation exposure is affected by slice thick-
ness, the number of cuts obtained, and the “pitch,”
a ratio defined as the distance the couch travels dur-
ing one 360-degree rotation divided by the section
thickness. The patient dose is proportional to 1 per
pitch. Under typical use with a pitch of 1 or greater,
the radiation exposure to the fetus from spiral CT is
comparable to conventional CT (5).
Cell Death and Teratogenic Effects
Data from an animal study suggest that exposure to
high-dose ionizing radiation (ie, much greater than
that used in diagnostic procedures) before implanta-
tion will most likely be lethal to the embryo (2). In
other words, cell death is most likely an “all or none”
phenomenon in early embryonic development.
Myriad teratogenic effects have developed in
animals exposed to large doses of radiation (ie, 100–
200 rad). However, in humans, growth restriction,
microcephaly, and mental retardation are the most
common adverse effects from high-dose radiation
(3, 6, 7). Based on data from atomic bomb survivors,
it appears that the risk of central nervous system
effects is greatest with exposure at 8–15 weeks of
gestation, with no proven risk at less than 8 weeks
of gestation or at greater than 25 weeks of gestation
(3, 8). Thus, at 8–15 weeks of gestation, the fetus is
at greatest risk for radiation-induced mental retar-
dation, and the risk appears to be a “nonthreshold
linear function of dose” at doses of at least 20 rad
(3, 6, 8, 9). For example, the risk of severe mental
retardation in fetuses exposed to ionizing radiation
is approximately 40% at 100 rad of exposure and
as high as 60% at 150 rad of exposure (3, 8). It has
been suggested that a threshold for this adverse
effect may exist in the range of 20–40 rad (7, 8).
Even multiple diagnostic X-ray procedures rarely
result in ionizing radiation exposure to this degree.
Fetal risks of anomalies, growth restriction, or abor-
tions are not increased with radiation exposure of
less than 5 rad, a level above the range of exposure
for diagnostic procedures (2).
Carcinogenesis
The risk of carcinogenesis as a result of in utero
exposure to ionizing radiation is unclear but is
probably very small. It is estimated that a 1–2 rad

Table 1. Some Measures of Ionizing Radiation

Measure Definition Unit Unit

Exposure Number of ions produced by X-rays per kilogram of air Roentgen (R) Roentgen (R)
Dose Amount of energy deposited per kilogram of tissue Rad (rad)* Gray (Gy)
1 Gy = 100 rad
Relative Amount of energy deposited per kilogram of tissue Roentgen Sievert (Sv)
effective normalized for biological effectiveness equivalents 1 Sv = 100 rem
dose man (rem)*
*For diagnostic X-rays, 1 rad = 1 rem
Cunningham FG, Gant NF, Leveno KJ, Gilstrap LC 3rd, Hauth JC, Wenstrom KD. General considerations and maternal evaluation. In: Williams obstet-
rics. 21st ed. New York (NY): McGraw-Hill; 2001. p. 1143–58. Reproduced with permission of The McGraw-Hill Companies.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 634

 Table 2. Estimated Fetal Exposure From Some Common
Radiologic Procedures
Procedure Fetal Exposure
Chest X-ray (2 views) 0.02–0.07 mrad
Abdominal film (single view) 100 mrad
Intravenous pyelography ≥ 1 rad*
Hip film (single view) 200 mrad
Mammography 7–20 mrad
Barium enema or small bowel series 2–4 rad
CT† scan of head or chest < 1 rad
CT scan of abdomen and lumbar spine 3.5 rad
CT pelvimetry 250 mrad
*Exposure depends on the number of films
†
Abbreviation: CT, computed tomography
Data from Cunningham FG, Gant NF, Leveno KJ, Gilstrap LC 3rd, Hauth
JC, Wenstrom KD. General considerations and maternal evaluation. In:
Williams obstetrics. 21st ed. New York (NY): McGraw-Hill; 2001.
p. 1143–58.
fetal exposure may increase the risk of leukemia by
a factor of 1.5–2.0 over natural incidence and that an
estimated 1 in 2,000 children exposed to ionizing
radiation in utero will develop childhood leukemia.
This is increased from a background rate of approxi-
mately 1 in 3,000 (2, 10). If elective abortion were
chosen in every instance of fetal exposure to radia-
tion, 1,999 exposed, normal fetuses would be aborted
for each case of leukemia prevented (2, 11). It has
been estimated that the risk of radiation-induced
carcinogenesis may indeed be higher in children
compared with adults, but such risks are not likely to
exceed 1 in 1,000 children per rad (12). Thus, abor-
tion should not be recommended solely on the basis
of exposure to diagnostic radiation.
Ultrasonography
Ultrasonography involves the use of sound waves and
is not a form of ionizing radiation. There have been
no reports of documented adverse fetal effects for
diagnostic ultrasound procedures, including duplex
Doppler imaging. Energy exposure from ultrasonog-
raphy has been arbitrarily limited to 94 mW/cm2 by
the U.S. Food and Drug Administration. There are
no contraindications to ultrasound procedures during
pregnancy, and this modality has largely replaced
X-ray as the primary method of fetal imaging during
pregnancy.
COMMITTEE OPINIONS
Magnetic Resonance Imaging
With MRI, magnets that alter the energy state of
hydrogen protons are used instead of ionizing radia-
tion (13). This technique could prove especially
useful for diagnosis and evaluation of fetal central
nervous system anomalies and placental abnormali-
ties (eg, accreta, previa).
Nuclear Medicine
Nuclear studies such as pulmonary ventilation–per-
fusion, thyroid, bone, and renal scans are performed
by “tagging” a chemical agent with a radioisotope.
The fetal exposure depends on the physical and bio-
chemical properties of the radioisotope (6).
Technetium Tc 99m is one of the most com-
monly used isotopes and is used for brain, bone,
renal, and cardiovascular scans. In general, these
latter procedures result in a uterus, embryo, or fetal
exposure of less than 0.5 rad (6, 12).
One of the more common nuclear medicine
studies performed during pregnancy is the ven-
tilation–perfusion scan for suspected pulmonary
embolism. Macroaggregated albumin labeled with
Technetium Tc 99m is used for the perfusion por-
tion, and inhaled xenon gas (127Xe or 133Xe) is used
for the ventilation portion. The amount of radiation
to which the fetus is exposed is extremely small
(approximately 50 mrad) (14).
In a 2002 study, investigators calculated the
mean fetal radiation exposure resulting from heli-
cal (spiral) CT in healthy pregnant women and
compared it with reported fetal radiation doses
for ventilation–perfusion lung scanning (approxi-
mately 100–370 µGy) (15). Although the exposure
from ventilation–perfusion is relatively low, the
study found that the mean fetal doses associated
with helical CT were lower. Although exposure
varied with gestational age (3.3–20.2 µGy for
the first trimester, 7.9–76.7 µGy for the second
trimester, and 51.3–130.8 µGy for the third tri-
mester), 20 of 23 study patients exhibited a mean
fetal dose of less than 60 µGy for all 3 trimesters.
Radioactive iodine readily crosses the placenta
and can adversely affect the fetal thyroid, especially
if used after 10–12 weeks of gestation. Radioactive
isotopes of iodine used for treatment of hyperthy-
roidism are contraindicated during pregnancy, and
such therapy should be delayed until after delivery.
If a diagnostic scan of the thyroid is essential,
2013 COMPENDIUM OF SELECTED PUBLICATIONS 635
 123
I or Technetium Tc 99m should be used in place
of 131I (14).
Contrast Agents
A variety of oral and intravascular contrast agents
are used with X-ray and magnetic imaging proce-
dures. Most radiopaque agents used with CT and
conventional radiography contain derivatives of
iodine and have not been studied in humans; how-
ever iohexol, iopamidol, iothalamate, ioversol, ioxa-
glate, and metrizamide have been studied in animals
and do not appear to be teratogenic (16). Neonatal
hypothyroidism has been associated with some
iodinated agents taken during pregnancy (17). For
this reason, these compounds generally are avoided
unless essential for correct diagnosis. Studies requir-
ing views before and after the administration of con-
trast agents will necessarily have greater radiation
exposure. Although some radiopaque agents pass
into the breast milk, they have not been associated
with problems in nursing babies (16).
Paramagnetic contrast agents used during MRI
have not been studied in pregnant women. Animal
studies have demonstrated increased rates of sponta-
neous abortion, skeletal abnormalities, and visceral
abnormalities when given at 2–7 times the recom-
mended human dose (18, 19). It is not known if these
compounds are excreted into human milk. Generally,
these agents should be used during pregnancy only if
the potential benefit justifies the potential risk to the
fetus as demonstrated in animal studies.
Guidelines
The following guidelines for X-ray examination or
exposure during pregnancy are suggested:
1. Women should be counseled that X-ray expo-
sure from a single diagnostic procedure does
not result in harmful fetal effects. Specifically,
exposure to less than 5 rad has not been associ-
ated with an increase in fetal anomalies or preg-
nancy loss.
2. Concern about possible effects of high-dose
ionizing radiation exposure should not prevent
medically indicated diagnostic X-ray proce-
dures from being performed on a pregnant
woman. During pregnancy, other imaging pro-
cedures not associated with ionizing radiation
COMMITTEE OPINIONS
(eg, ultrasonography, MRI) should be consid-
ered instead of X-rays when appropriate.
3. Ultrasonography and MRI are not associated
with known adverse fetal effects.
4. Consultation with an expert in dosimetry calcu-
lation may be helpful in calculating estimated
fetal dose when multiple diagnostic X-rays are
performed on a pregnant patient.
5. The use of radioactive isotopes of iodine is
contraindicated for therapeutic use during preg-
nancy.
6. Radiopaque and paramagnetic contrast agents
are unlikely to cause harm and may be of diag-
nostic benefit, but these agents should be used
during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
References
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2. Brent RL. The effect of embryonic and fetal exposure to
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Oncol 1989;16:347–68.
3. Hall EJ. Scientific view of low-level radiation risks.
Radiographics 1991;11:509–18.
4. Moore MM, Shearer DR. Fetal dose estimates for CT
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12. Mettler FA Jr, Guiberteau MJ. Essentials of nuclear medi-
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13. Curry TS 3rd, Dowdey JE, Murry RC Jr, editors.
Christensen’s physics of diagnostic radiology. 4th ed.
Philadelphia (PA): Lea & Febiger; 1990.
14. Ginsberg JS, Hirsh J, Rainbow AJ, Coates G. Risks to
the fetus of radiologic procedures used in the diagnosis
of maternal venous thromboembolic disease. Thromb
Haemost 1989;61:189–96.
15. Winer-Muram HT, Boone JM, Brown HL, Jennings
SG, Mabie WC, Lombardo GT. Pulmonary embolism in
COMMITTEE OPINIONS
pregnant patients: fetal radiation dose with helical CT.
Radiology 2002;224:487–92.
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mation. Available at: http://www.nlm.nih.gov/medline-
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17. Mehta PS, Metha SJ, Vorherr H. Congenital iodide goi-
ter and hypothyroidism: a review. Obstet Gynecol Surv
1983;38:237–47.
18. Gadodiamide (systemic). In: USP DI: drug informa-
tion for the health care professional. 24th ed. Greenwood
Village (CO): Microdemex; 2004. Available at http://uspdi.
micromedex.com/v1/excluded/Gadodiamide(Systemic).
pdf. Retrieved June 17, 2004.
19. Gadoteridol (systemic). In: USP DI: drug information for
the health care professional. 24th ed. Greenwood Village
(CO): Microdemex; 2004. Available at: http://uspdi.
micromedex.com/v1/excluded/Gadoteridol(Systemic).pdf.
Retrieved June 17, 2004.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 637
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2008
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject
to change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © September 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, or
transmitted, in any form or by
any means, electronic, mechani-
cal, photocopying, recording, or
otherwise, without prior written
permission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Obesity in pregnancy. ACOG Com-
mittee Opinion No. 315. American
College of Obstetricians and Gyne-
cologists. Obstet Gynecol
2005;106:671–5.
COMMITTEE OPINIONS
Committee
Opinion
Number 315, September 2005
Obesity in Pregnancy
ABSTRACT: One third of adult women in the United States are obese. During
pregnancy, obese women are at increased risk for several adverse perinatal
outcomes, including anesthetic, perioperative, and other maternal and fetal
complications. Obstetricians should provide preconception counseling and
education about the possible complications and should encourage obese
patients to undertake a weight reduction program before attempting preg­
nancy. Obstetricians also should address prenatal and peripartum care con-
siderations that may be especially relevant for obese patients, including those
who have undergone bariatric surgery.
The prevalence of obesity in the United States has increased dramatically
over the past 20 years. The World Health Organization and the National
Institutes of Health define normal weight as a body mass index (BMI) of
18.5–24.9, overweight as a BMI of 25–29.9, and obesity as a BMI of 30
or greater. Obesity is further categorized by BMI into Class I (30–34.9),
Class II (35–39.9), and Class III or extreme obesity (≥40) (1, 2). (For online
BMI calculator, see www.nhlbisupport.com/bmi.) The most recent National
Health and Nutrition Examination Survey (NHANES) for 1999–2002 found
that approximately one third of adult women are obese (3). This problem is
greatest among non-Hispanic black women (49%) compared with Mexican-
American women (38%) and non-Hispanic white women (31%) (3).
Obese women are at increased risk for several pregnancy complications;
therefore, preconception assessment and counseling are strongly encouraged.
Obstetricians should provide education about the possible complications and
should encourage obese patients to undertake a weight reduction program,
including diet, exercise, and behavior modification, before attempting preg-
nancy. Specific medical clearance may be indicated for some patients.
At least three cohort studies suggest that obesity is an independent risk
factor for spontaneous abortion among women who undergo infertility treat-
ment (4–6). Given this association, obese women should be encouraged to
lose weight before beginning infertility therapy. Data also link obesity with
spontaneous abortion among women after natural conception (7).
In a prospective multicenter study of more than 16,000 patients, Class I
(BMI 30–34.9) and Class II (BMI 35–39.9) obesity was associated with an
increased risk of gestational hypertension (odds ratio [OR] = 2.5 and 3.2,
respectively), preeclampsia (OR = 1.6 and 3.3), gestational diabetes (OR =
2.6 and 4.0), and fetal macrosomia (OR = 1.7 and 1.9), when compared with
2013 COMPENDIUM OF SELECTED PUBLICATIONS 638
 a BMI of less than 30 (8). In this same study, the
cesarean delivery rate was 20.7% for women with a
BMI of 29.9 or less, 33.8% for women with a BMI
of 30–34.9, and 47.4% for women with a BMI of
35–39.9. Several other studies consistently report
higher rates of preeclampsia, gestational diabetes,
and cesarean delivery, particularly for failure to
progress, in obese women than in nonobese women
(9–12). Operative and postoperative complications
include increased rates of excessive blood loss,
operative time greater than 2 hours, wound infec-
tion, and endometritis (13–15). Surgery in obese
women poses anesthetic challenges, such as difficult
epidural and spinal placement requiring multiple
attempts and intraoperative respiratory events from
failed or difficult intubation (16). Sleep apnea occur-
ring in this group of women may further complicate
anesthetic management and postoperative care (17).
Height and weight should be recorded for all
women at the initial prenatal visit to allow calcula-
tion of the BMI. Recommendations for prenatal
weight gain should be made based on the Institute
of Medicine (IOM) guidelines, which suggest a gain
of 25–35 lb for women of normal weight, 15–25 lb
for overweight women, and 15 lb for obese women
(18). Nutrition consultation should be offered to
all obese women, and they should be encouraged
to follow an exercise program. This consultation
should continue postpartum and before attempting
another preg­nancy. Consideration should be given
to screening for gestational diabetes upon presen-
tation or during the first trimester and repeating it
later in pregnancy if the initial screening result is
negative. Because these patients are at increased risk
for emergent cesar­ean delivery and anesthetic compli-
cations, anesthesiol­­ogy consultation before delivery is
encouraged (19).
It is important to discuss potential intrapartum
complications, such as difficulty estimating fetal
weight (even with ultrasonography), inability to
obtain interpretable external fetal heart rate and uter-
ine contraction patterns, and difficulty performing
an emergent cesarean delivery. If an anesthesiology
consultation was not obtained antepartum, it should
be conducted early in labor to allow adequate time
for development of an anesthetic plan.
If obese patients require cesarean delivery, they
should receive antibiotic prophylaxis even if surgery
is elective (14). Obese women who require cesarean
delivery are more likely to have an increased inci-
dence of wound breakdowns and infections (20).
Attempts to decrease these postoperative compli-
cations have included closure of the subcutaneous
COMMITTEE OPINIONS
layers and the placement of subcutaneous drains.
Investigators have demonstrated that suture closure
of the subcutaneous layer after cesarean delivery in
obese patients may lead to a significant reduction
in the incidence of postoperative wound disruption
(21, 22). Postoperative placement of subcutaneous
draining systems, however, have not consistently
been shown to be of value in reducing postcesarean
delivery morbidity (23, 24).
It has been recommended that graduated com-
pression stockings, hydration, and early mobiliza-
tion be used during and after cesarean delivery in
obese patients. Postpartum heparin therapy has been
recommended for patients thought to be at high risk
for venous thromboembolism (25, 26); however,
data are insufficient to determine whether the ben-
efits of heparin prophylaxis in this group of patients
outweigh the risks (27, 28).
Women with a BMI of 35 or greater who have
preexisting medical conditions, such as hypertension
or diabetes, may benefit from a cardiac evaluation
(29). Because of the increased likelihood of com-
plicated and emergent cesarean delivery, extremely
obese women may require specific resources such
as additional blood products, a large operating table,
and extra personnel in the delivery room. Particular
attention to the type and placement of the surgical
incision is needed (ie, placing the incision above
the panniculus adiposus) (20, 30). The success rate
of attempted vaginal birth after cesarean delivery is
very low in extremely obese women (31). There are
additional logistical challenges to monitoring labor
and performing an emergent cesarean delivery in the
extremely obese patient. Therefore, these patients
should be counseled about these possible complica-
tions of an emergent cesarean delivery.
The number of obese women of childbear-
ing age considering bariatric surgery is increasing,
resulting in questions about pregnancy after these
types of surgeries. Early case reports and series des-
cribed various pregnancy complications after bari-
atric surgery such as gastrointestinal bleeding (32),
anemia (33), intrauterine growth restriction (34),
and neural tube defects (35, 36). However, recent
studies suggest that previous bariatric surgery is not
associated with adverse perinatal outcomes (37, 38).
Researchers have determined that pregnancies after
bariatric surgery are less likely to be complicated
by gestational diabetes, hypertension, macrosomia,
and cesarean delivery than are pregnancies of obese
women who have not had the surgery (38–40).
Bariatric surgical procedures are categorized into
two main types: malabsorptive procedures (jejuno­
2013 COMPENDIUM OF SELECTED PUBLICATIONS 639
 ileal bypass and biliopancreatic diversion) and re-
strictive procedures (gastric banding and vertical
banded gastroplasty). Both types of procedures can
result in deficiencies in iron, vitamin B12, folate,
and calcium. Women who have undergone bariatric
surgery require the following counseling before and
during pregnancy:
• Patients with adjustable gastric banding should
be advised that they are at risk of becoming
pregnant unexpectedly after weight loss follow-
ing surgery (39).
• All patients are advised to delay pregnancy for
12–18 months after surgery to avoid pregnancy
during the rapid weight loss phase (39).
• Women with a gastric band should be moni-
tored by their general surgeons during preg-
nancy because adjustment of the band may be
necessary (41).
• Patients should be evaluated for nutritional
deficiencies and vitamin supplementation where
indicated.
In counseling all obese women about potential
pregnancy complications, it is important to inform
them of the fetal risks (eg, prematurity, stillbirth,
neural tube defect, and macrosomia). Some studies
have reported a greater rate of premature delivery
for obese women than for women of normal weight
(9, 42). However, in a study of more than 2,900
obese women, prepregnancy obesity was associated
with a lower rate of spontaneous preterm birth (43).
A large Swedish cohort study reported a greater risk
of antepartum stillbirth among obese patients than
among women who had a BMI of less than 20 (42).
Data establish that the risk of neural tube defects
among obese women is double that among women
of normal weight, after correcting for diabetes as a
potential confounding factor (44–46). The benefit
of folic acid doses higher than 400 µg has not been
studied in nondiabetic obese women. Multiple stud-
ies have shown that maternal obesity and excessive
weight gain during pregnancy are associated with
macrosomic and large-for-gestational-age infants
(10, 19, 47, 48). Furthermore, these large-for-gesta-
tional-age infants are at increased risk for childhood
obesity (11, 49). The decision to perform a primary
cesarean delivery for these obese women is based
on the previously recommended maternal and fetal
indications. A cesarean delivery should be consid-
ered for those patients who have a fetus with a fetal
weight estimated to be greater than 5,000 g if the
patient does not have diabetes (50) or greater than
4,500 g if the patient has diabetes (51).
COMMITTEE OPINIONS
Recommendations for obese women who are
pregnant or planning a pregnancy include the fol-
lowing:
• Preconception counseling
• Provision of specific information concerning
the maternal and fetal risks of obesity in preg-
nancy
• Consideration of screening for gestational dia-
betes upon presentation or in the first trimester,
and repeated screening later in pregnancy if
results are initially negative
• Assessment and possible supplementation of
vitamin B12, folate, iron, and calcium for women
who have undergone bariatric surgery
• Possible use of graduated compression stock-
ings, hydration, and early mobilization during
and after cesarean delivery
• Anesthesiology consultation
• Continuation of nutrition counseling and exer-
cise program after delivery, and consultation
with weight loss specialists before attempting
another pregnancy
References
1. World Health Organization. Obesity: preventing and
managing the global epidemic. Geneva, Switzerland:
World Health Organization; 2000. WHO technical report
series 894.
2. National Heart, Lung, and Blood Institute (NHLBI) and
National Institute for Diabetes and Digestive and Kidney
Diseases (NIDDK). Clinical guidelines on the identifica-
tion, evaluation and treatment of overweight and obesity
in adults. The evidence report. Obes Res 1998;6(suppl
2):51S–210S.
3. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin
LR, Flegal KM. Prevalence of overweight and obesity
among US children, adolescents, and adults, 1999-2002.
JAMA 2004;291:2847–50.
4. Bellver J, Rossal LP, Bosch E, Zuniga A, Corona JT,
Melendez F, et al. Obesity and the risk of spontaneous
abortion after oocyte donation. Fertil Steril 2003;79:
1136–40.
5. Fedorcsak P, Storeng R, Dale PO, Tanbo T, Abyholm T.
Obesity is a risk factor for early pregnancy loss after IVF
or ICSI. Acta Obstet Gynecol Scand 2000;79:43–8.
6. Wang JX, Davies MJ, Norman RJ. Obesity increases the
risk of spontaneous abortion during infertility treatment.
Obes Res 2002;10:551–4.
7. Lashen H, Fear K, Sturdee DW. Obesity is associ-
ated with increased risk of first trimester and recurrent
miscarriage: matched case-control study. Hum Reprod
2004;19:1644–6.
8. Weiss JL, Malone FD, Emig D, Ball RH, Nyberg DA,
Comstock CH, et al. Obesity, obstetric complications
and cesarean delivery rate—a population-based screen-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 640
 ing study. FASTER Research Consortium. Am J Obstet
Gynecol 2004;190:1091–7.
9. Baeten JM, Bukusi EA, Lambe M. Pregnancy complica-
tions and outcomes among overweight and obese nullipa-
rous women. Am J Public Health 2001:91:436–40.
10. Cedergren MI. Maternal morbid obesity and the risk of
adverse pregnancy outcome. Obstet Gynecol 2004;103:
219–24.
11. Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M,
Beard RW, et al. Maternal obesity and pregnancy out-
come: a study of 287,213 pregnancies in London. Int J
Obes Relat Metab Disord 2001;25:1175–82.
12. Young TK, Woodmansee B. Factors that are associated
with cesarean delivery in a large private practice: the
importance of prepregnancy body mass index and weight
gain. Am J Obstet Gynecol 2002;187:312–8; discussion
318–20.
13. Kabiru W, Raynor BD. Obstetric outcomes associated
with increase in BMI category during pregnancy. Am J
Obstet Gynecol 2004:191:928–32.
14. Myles TD, Gooch J, Santolaya J. Obesity as an indepen-
dent risk factor for infectious morbidity in patients who
undergo cesarean delivery. Obstet Gynecol 2002;100:
959–64.
15. Perlow JH, Morgan MA. Massive maternal obesity and
perioperative cesarean morbidity. Am J Obstet Gynecol
1994;170:560–5.
16. Hood DD, Dewan DM. Anesthetic and obstetric outcome
in morbidly obese parturients. Anesthesiology 1993;79:
1210 –8.
17. Maasilta P, Bachour A, Teramo K, Polo O, Laitinen LA.
Sleep-related disordered breathing during pregnancy in
obese women. Chest 2001;120:1448–54.
18. Institute of Medicine (US). Nutritional status and weight
gain. In: Nutrition during pregnancy. Washington, DC:
National Academy Press; 1990. p. 27–233.
19. Rode L, Nilas L, Wojdemann K, Tabor A. Obesity-related
complications in Danish single cephalic term pregnancies.
Obstet Gynecol 2005;105:537–42.
20. Wall PD, Deucy EE, Glantz JC, Pressman EK. Vertical
skin incisions and wound complications in the obese par-
turient. Obstet Gynecol 2003;102(5 pt):952–6.
21. Cetin A, Cetin M. Superficial wound disruption after
cesarean section: effect of the depth and closure of subcu-
taneous tissue. Int J Gynaecol Obstet 1997;57:17–21.
22. Chelmow D, Rodriguez EJ, Sabatini MM. Suture closure
of subcutaneous fat and wound disruption after cesar-
ean section: a meta-analysis. Obstet Gynecol 2004;103:
974–80.
23. Al-Inany H, Youssef G, Abd ElMaguid A, Abdel Hamid
M, Naguib A. Value of subcutaneous drainage system
in obese females undergoing cesarean section using
Pfannenstiel incision. Gynecol Obstet Invest 2002;53:
75–8.
24. Magann EF, Chauhan SP, Rodts-Palenik S, Bufkin L,
Martin JN Jr, Morrison JC. Subcutaneous stitch closure
versus subcutaneous drain to prevent wound disruption
after cesarean delivery: a randomized clinical trial. Am J
Obstet Gynecol 2002;186:1119–23.
25. Bates SM, Greer IA, Hirsh J, Ginsberg JS. Use of
antithrombotic agents during pregnancy: the Seventh
ACCP Conference on Antithrombotic and Thrombolytic
Therapy. Chest 2004;126:627S–44S.
COMMITTEE OPINIONS
26. Royal College of Obstetricians and Gynaecologists.
Report of the RCOG working party on prophylaxis against
thromboembolism in gynaecology and obstetrics. London:
RCOG; 1995.
27. Gates S, Brocklehurst P, Davis LJ. Prophylaxis for venous
thromboembolic disease in pregnancy and the early
postnatal period. The Cochrane Database of Systematic
Reviews 2002, Issue 2. Art. No.: CD001689. DOI: 10.
1002/14651858.CD001689.
28. Hague WM, North RA, Gallus AS, Walters BN,
Orlikowski C, Burrows RF, et al. Anticoagulation in
pregnancy and the puerperium. Working Group on behalf
of the Obstetric Medicine Group of Australasia. Med J
Aust 2001;175:258–63.
29. Tomoda S, Tamura T, Sudo Y, Ogita S. Effects of obesity
on pregnant women: maternal hemodynamic change. Am
J Perinatol 1996;13:73–8.
30. Houston MC, Raynor BD. Postoperative morbidity in
the morbidly obese parturient woman: supraumbilical
and low transverse abdominal approaches. Am J Obstet
Gynecol 2000;182:1033–5.
31. Chauhan SP, Magann EF, Carroll CS, Barrilleaux PS,
Scardo JA, Martin JN Jr. Mode of delivery for the mor-
bidly obese with prior cesarean delivery: vaginal versus
repeat cesarean section. Am J Obstet Gynecol 2001;
185:349–54.
32. Ramirez MM, Turrentine MA. Gastrointestinal hemor-
rhage during pregnancy in a patient with a history of
vertical-banded gastroplasty. Am J Obstet Gynecol 1995;
173:1630–1.
33. Gurewitsch ED, Smith-Levitin M, Mack J. Pregnancy fol-
lowing gastric bypass surgery for morbid obesity. Obstet
Gynecol 1996;88:658–61.
34. Granstrom L, Granstrom L, Backman L. Fetal growth
retardation after gastric banding. Acta Obstet Gynecol
Scand 1990;69:533–6.
35. Haddow JE, Hill LE, Kloza EM, Thanhauser D. Neural
tube defects after gastric bypass. Lancet 1986;1:1330.
36. Martin L, Chavez GF, Adams MJ Jr, Mason EE, Hanson
JW, Haddow JE, et al. Gastric bypass surgery as maternal
risk factor for neural tube defects. Lancet 1988;1:640–1.
37. Marceau P, Kaufman D, Biron S, Hould FS, Lebel S,
Marceau S, et al. Outcome of pregnancies after biliopan-
creatic diversion. Obes Surg 2004;14:318–24.
38. Sheiner E, Levy A, Silverberg D, Menes TS, Levy I,
Katz M, et al. Pregnancy after bariatric surgery is not
associated with adverse perinatal outcome. Am J Obstet
Gynecol 2004;190:1335–40.
39. Martin LF, Finigan KM, Nolan TE. Pregnancy after
adjustable gastric banding. Obstet Gynecol 2000;95:
927–30.
40. Wittgrove AC, Jester L, Wittgrove P, Clark GW. Preg­
nancy following gastric bypass for morbid obesity. Obes
Surg 1998;8:461–4; discussion 465–6.
41. Weiss HG, Nehoda H, Labeck B, Hourmont K, Marth C,
Aigner F. Pregnancies after adjustable gastric banding.
Obes Surg 2001;11:303–6.
42. Cnattingius S, Bergstrom R, Lipworth L, Kramer MS.
Prepregnancy weight and the risk of adverse pregnancy
outcomes. N Engl J Med 1998;338:147–52.
43. Hendler I, Blackwell SC, Treadwell MC, Bujold E, Sokol
RJ, Sorokin Y. Does advanced ultrasound equipment
improve the adequacy of ultrasound visualization of fetal
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 cardiac structures in the obese gravid woman? Am J
Obstet Gynecol 2004;190;1616–9; discussion 1619–20.
44. Shaw GM, Velie EM, Schaffer D. Risk of neural tube
defect-affected pregnancies among obese women. JAMA
1996;275:1093–6.
45. Waller DK, Mills JL, Simpson JL, Cunningham GC,
Conley MR, Lassman MR, et al. Are obese women at
higher risk for producing malformed offspring? Am J
Obstet Gynecol 1994;170:541–8.
46. Werler MM, Louick C, Shapiro S, Mitchell AA.
Prepregnancy weight in relation to risk of neural tube
defects. JAMA 1996;275:1089–92.
47. Stephansson O, Dickman PW, Johansson A, Cnattingius
S. Maternal weight, pregnancy weight gain, and the risk
of antepartum stillbirth. Am J Obstet Gynecol 2001;
184:463–9.
COMMITTEE OPINIONS
48. Watkins ML, Rasmussen SA, Honein MA, Botto LD,
Moore CA. Maternal obesity and risk for birth defects.
Pediatrics 2003;111:1152–8.
49. Hediger ML, Overpeck MD, McGlynn A, Kuczmarski
RJ, Maurer KR, Davis WW. Growth and fatness at three
to six years of age of children born small- or large-for-
gestational age. Pediatrics 1999;104:e33.
50. Spellacy WN, Miller S, Winegar A, Peterson PQ.
Macrosomia—maternal characteristics and infant compli-
cations. Obstet Gynecol 1985;66:158–61.
51. Lipscomb KR, Gregory K, Shaw K. The outcome of
macrosomic infants weighing at least 4500 grams: Los
Angeles County + University of Southern California
experience. Obstet Gynecol 1995;85:558–64.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 642
 ACOG
Committee on
Obstetric Practice
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject to
change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © December 2005
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, post-
ed on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photo-
copying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Inappropriate use of the terms fetal
distress and birth asphyxia. ACOG
Committee Opinion No. 326. American
College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2005;106:
1469–70.
COMMITTEE OPINIONS
Committee
Opinion
Number 326, December 2005
Inappropriate Use of the Terms Fetal
Distress and Birth Asphyxia
ABSTRACT: The Committee on Obstetric Practice is concerned about the
continued use of the term “fetal distress” as an antepartum or intrapar-
tum diagnosis and the term “birth asphyxia” as a neonatal diagnosis. The
Committee reaffirms that the term fetal distress is imprecise and nonspecific.
The communication between clinicians caring for the woman and those car-
ing for her neonate is best served by replacing the term fetal distress with
“nonreassuring fetal status,” followed by a further description of findings
(eg, repetitive variable decelerations, fetal tachycardia or bradycardia, late
decelerations, or low biophysical profile). Also, the term birth asphyxia is a
nonspecific diagnosis and should not be used.
The Committee on Obstetric Practice is concerned about the continued use
of the term “fetal distress” as an antepartum or intrapartum diagnosis and the
term “birth asphyxia” as a neonatal diagnosis. The Committee reaffirms that
the term fetal distress is imprecise and nonspecific. The term has a low posi-
tive predictive value even in high-risk populations and often is associated
with an infant who is in good condition at birth as determined by the Apgar
score or umbilical cord blood gas analysis or both. The communication
between clinicians caring for the woman and those caring for her neonate
is best served by replacing the term fetal distress with “nonreassuring fetal
status,” followed by a further description of findings (eg, repetitive variable
decelerations, fetal tachycardia or bradycardia, late decelerations, or low
biophysical profile). Whereas in the past, the term fetal distress generally
referred to an ill fetus, nonreassuring fetal status describes the clinician’s
interpretation of data regarding fetal status (ie, the clinician is not reassured
by the findings). This term acknowledges the imprecision inherent in the
interpretation of the data. Therefore, the diagnosis of nonreassuring fetal
status can be consistent with the delivery of a vigorous neonate.
Because of the implications of the term fetal distress, its use may result
in inappropriate actions, such as an unnecessarily urgent delivery under
general anesthesia. Fetal heart rate patterns or auscultatory findings should
be considered when the degree of urgency, mode of delivery, and type of
anesthesia to be given are determined. Performing a cesarean delivery for a
2013 COMPENDIUM OF SELECTED PUBLICATIONS 643
 nonreassuring fetal heart rate pattern does not neces-
sarily preclude the use of regional anesthesia.
Since October 1, 1998, all inclusion terms except
“metabolic acidemia” have been removed from the
International Classification of Diseases code for
fetal distress. The Committee believes that there
should be uniformity in wording. The International
Classification of Diseases, Ninth Revision, Clinical
Modification code for fetal distress is based on fetal
metabolic acidemia and excludes abnormal fetal
acid–base balance, abnormality in fetal heart rate
or rhythm, fetal bradycardia, fetal tachycardia, and
meconium in liquor.
The term birth asphyxia is a nonspecific diagno-
sis and should not be used. The Committee strongly
supports the criteria required to define an acute
intrapartum hypoxic event sufficient to cause cere-
bral palsy, as modified by the ACOG Task Force on
Neonatal Encephalopathy and Cerebral Palsy from
the template provided by the International Cerebral
Palsy Task Force (1) (Box 1).
References
1. American College of Obstetricians and Gynecologists
COMMITTEE OPINIONS
Criteria to Define an Acute Intrapartum Hypoxic
Event as Sufficient to Cause Cerebral Palsy
1.1: Essential criteria (must meet all four)
1. Evidence of a metabolic acidosis in fetal umbilical
cord arterial blood obtained at delivery (pH <7 and
base deficit ≥12 mmol/L)
2. Early onset of severe or moderate neonatal
encephalopathy in infants born at 34 or more
weeks of gestation
3. Cerebral palsy of the spastic quadriplegic or dyski-
netic type*
4. Exclusion of other identifiable etiologies, such as
trauma, coagulation disorders, infectious condi-
tions, or genetic disorders
1.2: Criteria that collectively suggest an intrapartum
timing (within close proximity to labor and delivery, eg,
0–48 hours) but are nonspecific to asphyxial insults
1. A sentinel (signal) hypoxic event occurring imme-
diately before or during labor
2. A sudden and sustained fetal bradycardia or the
absence of fetal heart rate variability in the pres-
ence of persistent, late, or variable decelerations,
usually after a hypoxic sentinel event when the
pattern was previously normal
3. Apgar scores of 0–3 beyond 5 minutes
4. Onset of multisystem involvement within 72 hours
of birth
5. Early imaging study showing evidence of acute
nonfocal cerebral abnormality
*Spastic quadriplegia and, less commonly, dyskinetic cerebral
palsy are the only types of cerebral palsy associated with acute
hypoxic intrapartum events. Spastic quadriplegia is not specific
to intrapartum hypoxia. Hemiparetic cerebral palsy, hemiple-
gic cerebral palsy, spastic diplegia, and ataxia are unlikely to
result from acute intrapartum hypoxia (Nelson KB, Grether
JK. Potentially asphyxiating conditions and spastic cerebral
palsy in infants of normal birth weight. Am J Obstet Gynecol
1998;179:507–13.).
Modified from MacLennan A. A template for defining a causal
relation between acute intrapartum events and cerebral palsy:
international consensus statement. BMJ 1999;319:1054–9.
and American Academy of Pediatrics. Neonatal encepha-
lopathy and cerebral palsy: defining the pathogenesis and
pathophysiology. Washington, DC: American College
of Obstetricians and Gynecologists; 2003.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 644
 ACOG
Committee on
Obstetric Practice
American Academy
of Pediatrics
DEDICATED TO THE HEALTH OF ALL CHILDREN ΤΜ
Committee on
Fetus and Newborn
Reaffirmed 2010
This document reflects clincal and
scientific advances as of the date
issued and is subject to change.
The information should not be
construed as dictating an exclu-
sive course of treatment or proce-
dure to be followed.
Copyright © May 2006 by the
American Academy of Pediatrics
and the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, post-
ed on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photo-
copying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
The Apgar score. ACOG Committee
Opinion No. 333. American Academy
of Pediatrics; American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2006;107:1209–12.
COMMITTEE OPINIONS
Committee
Opinion
Number 333, May 2006 (Replaces No. 174, July 1996)
The Apgar Score
ABSTRACT. The Apgar score provides a convenient shorthand for report-
ing the status of the newborn infant and the response to resuscitation. The
Apgar score has been used inappropriately to predict specific neurologic
outcome in the term infant. There are no consistent data on the significance
of the Apgar score in preterm infants. The Apgar score has limitations, and
it is inappropriate to use it alone to establish the diagnosis of asphyxia.
An Apgar score assigned during resuscitation is not equivalent to a score
assigned to a spontaneously breathing infant. An expanded Apgar score
reporting form will account for concurrent resuscitative interventions and
provide information to improve systems of perinatal and neonatal care.
Introduction
In 1952, Dr. Virginia Apgar devised a scoring system that was a rapid
method of assessing the clinical status of the newborn infant at 1 minute of
age and the need for prompt intervention to establish breathing (1). A second
report evaluating a larger number of patients was published in 1958 (2). This
scoring system provided a standardized assessment for infants after delivery.
The Apgar score comprises 5 components: heart rate, respiratory effort,
muscle tone, reflex irritability, and color, each of which is given a score of 0,
1, or 2. The score is now reported at 1 and 5 minutes after birth. The Apgar
score continues to provide a convenient shorthand for reporting the status of
the newborn infant and the response to resuscitation. The Apgar score has
been used inappropriately in term infants to predict specific neurologic out-
come. Because there are no consistent data on the significance of the Apgar
score in preterm infants, in this population the score should not be used for
any purpose other than ongoing assessment in the delivery room. The pur-
pose of this statement is to place the Apgar score in its proper perspective.
The neonatal resuscitation program (NRP) guidelines state that “Apgar
scores should not be used to dictate appropriate resuscitative actions, nor
should interventions for depressed infants be delayed until the 1-minute
assessment” (3). However, an Apgar score that remains 0 beyond 10 min-
utes of age may be useful in determining whether additional resuscitative
efforts are indicated (4). The current NRP guidelines state that “if there is no
2013 COMPENDIUM OF SELECTED PUBLICATIONS 645
 heart rate after 10 minutes of complete and adequate
resuscitation efforts, and there is no evidence of other
causes of newborn compromise, discontinuation of
resuscitation efforts may be appropriate. Current data
indicate that, after 10 minutes of asystole, newborns
are very unlikely to survive, or the rare survivor is
likely to survive with severe disability” (3).
Previously, an Apgar score of 3 or less at 5
minutes was considered an essential requirement
for the diagnosis of perinatal asphyxia. Neonatal
Encepha­lopathy and Cerebral Palsy: Defining the
Patho­ genesis and Pathophysiology, produced in
2003 by the American College of Obstetricians and
Gynecologists in collaboration with the American
Academy of Pediatrics, lists an Apgar score of 0
to 3 beyond 5 minutes as one suggestive criterion
for an intrapartum asphyxial insult (5). However,
a per­sistently low Apgar score alone is not a spe­cific
indicator for intrapartum compromise. Further,
although the score is used widely in outcome stud-
ies, its inappropriate use has led to an erroneous
definition of asphyxia. Intrapartum asphyxia implies
fetal hypercarbia and hypoxemia, which, if pro-
longed, will result in metabolic acidemia. Because
the intrapartum disruption of uterine or fetal blood
flow is rarely, if ever, absolute, asphyxia is an
imprecise, general term. Descriptions such as hyper-
carbia, hypoxia, and metabolic, respiratory, or lactic
aci­demia are more precise for immediate assessment
of the newborn infant and retrospective assessment
of intrapartum management.
Limitations of the Apgar Score
It is important to recognize the limitations of the
Apgar score. The Apgar score is an expression of
the infant’s physiologic condition, has a limited
time frame, and includes subjective components.
In addition, the biochemical disturbance must be
significant before the score is affected. Elements of
the score such as tone, color, and reflex irritability
par­tially depend on the physiologic maturity of the
infant. The healthy preterm infant with no evidence
of asphyxia may receive a low score only because
of immaturity (6). A number of factors may influ-
ence an Apgar score, including but not limited to
drugs, trauma, congenital anomalies, infections,
hypoxia, hypovolemia, and preterm birth (7). The
incidence of low Apgar scores is inversely related to
birth weight, and a low score is limited in predicting
morbidity or mortality (8). Accordingly, it is inap-
COMMITTEE OPINIONS
propriate to use an Apgar score alone to establish the
diagnosis of asphyxia.
Apgar Score and Resuscitation
The 5-minute Apgar score, and particularly a change
in the score between 1 and 5 minutes, is a useful
index of the response to resuscitation. If the Apgar
score is less than 7 at 5 minutes, the NRP guidelines
state that the assessment should be repeated every
5 minutes up to 20 minutes (3). However, an Apgar
score assigned during a resuscitation is not equiva-
lent to a score assigned to a spontaneously breathing
infant (9). There is no accepted standard for report-
ing an Apgar score in infants undergoing resusci­
tation after birth, because many of the elements
contributing to the score are altered by resuscitation.
The concept of an “assisted” score that accounts for
resuscitative interventions has been suggested, but
the predictive reliability has not been studied. To
describe such infants correctly and provide accurate
documentation and data collection, an expanded
Apgar score report form is proposed (Fig. 1).
Prediction of Outcome
A low 1-minute Apgar score alone does not cor-
relate with the infant’s future outcome. A retrospec-
tive analysis concluded that the 5-minute Apgar
score remained a valid predictor of neonatal mortal-
ity, but using it to predict long-term outcome was
inappropriate (10). On the other hand, another study
stated that low Apgar scores at 5 minutes are associ-
ated with death or cerebral palsy, and this associa-
tion increased if both 1- and 5-minute scores were
low (11).
An Apgar score at 5 minutes in term infants cor-
relates poorly with future neurologic outcomes. For
example, a score of 0 to 3 at 5 minutes was associ-
ated with a slightly increased risk of cerebral palsy
compared with higher scores (12). Conversely, 75%
of children with cerebral palsy had normal scores
at 5 minutes (12). In addition, a low 5-minute score
in combination with other markers of asphyxia may
identify infants at risk of developing seizures (odds
ratio: 39; 95% confidence interval: 3.9­–392.5) (13).
The risk of poor neurologic outcomes increases
when the Apgar score is 3 or less at 10, 15, and 20
minutes (7).
A 5-minute Apgar score of 7 to 10 is consid-
ered normal. Scores of 4, 5, and 6 are intermediate
2013 COMPENDIUM OF SELECTED PUBLICATIONS 646
 Apgar Score Gestational age_______________weeks

Sign 0 1 2
1 minute 5 minute 10 minute 15 minute 20 minute
Color Blue or Pale Acrocyanotic Completely
Pink
Heart rate Absent <100 minute >100 minute
Reflex irritability No Response Grimace Cry or Active
Withdrawal
Muscle tone Limp Some Flexion Active Motion
Respiration Absent Weak Cry; Good, Crying
Hypoventilation
Total

Comments: Resuscitation
Minutes 1 5 10 15 20
Oxygen
PPV/NCPAP
ETT
Chest Compressions
Epinephrine

Fig. 1. Expanded Apgar score form. Record the score in the appropriate place at specific time intervals.
The additional resuscitative measures (if appropriate) are recorded at the same time that the score is reported using a
check mark in the appropriate box. Use the comment box to list other factors including maternal medications and/or
the response to resuscitation between the recorded times of scoring. PPV/NCPAP indicates positive-pressure ventila-
tion/nasal continuous positive airway pressure; ETT, endotracheal tube.

and are not markers of increased risk of neurologic
dysfunction. Such scores may be the result of
physiologic immaturity, maternal medications, the
presence of congenital malformations, and other
factors. Because of these other conditions, the Apgar
score alone cannot be considered evidence of or a
consequence of asphyxia. Other factors including
nonreassuring fetal heart rate monitoring patterns
and abnormalities in umbilical arterial blood gases,
clinical cerebral function, neuroimaging studies,
neonatal electroencephalography, placental pathol-
ogy, hematologic studies, and multisystem organ
dysfunction need to be considered when defining an
intrapartum hypoxic–ischemic event as a cause of
cerebral palsy (5).
Other Applications
Monitoring of low Apgar scores from a delivery
service can be useful. Individual case reviews can
identify needs for focused educational programs and
improvement in systems of perinatal care. Analyzing
trends allows assessment of the impact of quality
improvement interventions.
Conclusion
The Apgar score describes the condition of the
newborn infant immediately after birth (14), and
when properly applied, is a tool for standardized
assessment. It also provides a mechanism to record
fetal-to-neonatal transition. An Apgar score of 0 to
3 at 5 minutes may correlate with neonatal mortality
but alone does not predict later neurologic dysfunc-
tion. The Apgar score is affected by gestational age,
maternal medications, resuscitation, and cardio­
respiratory and neurologic conditions. Low 1- and
5-minute Apgar scores alone are not conclusive
markers of an acute intrapartum hypoxic event.
Resuscitative interventions modify the components
of the Apgar score. There is a need for perinatal
health care professionals to be consistent in assign-
ing an Apgar score during a resuscitation. The
American Academy of Pediatrics and the American

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 647

 College of Obstetricians and Gynecologists propose
use of an expanded Apgar score reporting form that
accounts for concurrent resuscitative interventions.
References
1. Apgar V. A proposal for a new method of evaluation of
the newborn infant. Curr Res Anesth Analg 1953;32:260–
7.
2. Apgar V, Holaday DA, James LS, Weisbrot IM, Berrien
C. Evaluation of the newborn infant; second report.
JAMA 1958;168:1985–8.
3. American Academy of Pediatrics, American Heart
Association. Textbook of neonatal resuscitation. 4th ed.
Elk Grove Village (IL): American Academy of Pediatrics;
Dallas (TX): American Heart Association; 2000.
4. Jain L, Ferre C, Vidyasagar D, Nath S, Sheftel D. Cardio-
pulmonary resuscitation of apparently stillborn infants:
survival and long-term outcome. J Pediatr 1991;118:778–82.
5. American Academy of Pediatrics, American College
of Obstetricians and Gynecologists. Neonatal encepha-
lopathy and cerebral palsy: defining the pathogenesis and
pathophysiology. Elk Grove Village (IL): AAP; Washing­
ton, DC: ACOG; 2003.
6. Catlin EA, Carpenter MW, Brann BS 4th, Mayfield SR,
Shaul PW, Goldstein M, et al. The Apgar score revisited:
influence of gestational age. J Pediatr 1986;109:865–8.
COMMITTEE OPINIONS
7. Freeman JM, Nelson KB. Intrapartum asphyxia and cere-
bral palsy. Pediatrics 1988;82:240–9.
8. Hegyi T, Carbone T, Anwar M, Ostfeld B, Hiatt M,
Koons A, et al. The Apgar score and its components in
the preterm infant. Pediatrics 1998;101:77–81.
9. Lopriore E, van Burk GF, Walther FJ, de Beaufort AJ.
Correct use of the Apgar score for resuscitated and intu-
bated newborn babies: questionnaire study. BMJ 2004;
329:143–4.
10. Casey BM, McIntire DD, Leveno KJ. The continuing
value of the Apgar score for the assessment of newborn
infants. N Engl J Med 2001;344:467–71.
11. Moster D, Lie RT, Irgens LM, Bjerkedal T, Markestad T.
The association of Apgar score with subsequent death and
cerebral palsy: a population-based study in term infants. J
Pediatr 2001;138:798–803.
12. Nelson KB, Ellenberg JH. Apgar scores as predictors of
chronic neurologic disability. Pediatrics 1981;68:36–44.
13. Perlman JM, Risser R. Can asphyxiated infants at risk for
neonatal seizures be rapidly identified by current high-
risk markers? Pediatrics 1996;97:456–62.
14. Papile LA. The Apgar score in the 21st century. N Engl J
Med 2001;344:519–20.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 648
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright © June 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, post-
ed on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photo-
copying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Analgesia and cesarean delivery rates.
ACOG Committee Opinion No. 339.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;107:1487–8.
COMMITTEE OPINIONS
Committee
Opinion
Number 339, June 2006 (Replaces No. 269, February 2002)
Analgesia and Cesarean
Delivery Rates
ABSTRACT: Neuraxial analgesia techniques are the most effective and least
depressant treatments for labor pain. The American College of Obstetricians
and Gynecologists previously recommended that practitioners delay initiat-
ing epidural analgesia in nulliparous women until the cervical dilatation
reached 4–5 cm. However, more recent studies have shown that epidural
analgesia does not increase the risks of cesarean delivery. The choice of
analgesic technique, agent, and dosage is based on many factors, including
patient preference, medical status, and contraindications. The fear of unnec-
essary cesarean delivery should not influence the method of pain relief that
women can choose during labor.
Neuraxial analgesia techniques (epidural, spinal, and combined spinal–epidu-
ral) are the most effective and least depressant treatments for labor pain (1,
2). Early studies generated concern that the benefits of neuraxial analgesia
may be offset by an associated increase in the risk of cesarean delivery (3, 4).
Recent studies, however, have determined that when compared with intrave-
nous systemic opioid analgesia, the initiation of early neuraxial analgesia does
not increase the risk of cesarean delivery (5–7).
In 2000, the American College of Obstetricians and Gynecologists
(ACOG) Task Force on Cesarean Delivery recommended that “when fea-
sible, obstetric practitioners should delay the administration of epidural
anesthesia in nulliparous women until the cervical dilatation reaches at least
4–5 cm” (8). This recommendation was based on earlier studies, which sug-
gested that epidural analgesia increased the risk of cesarean delivery by as
much as 12-fold (3, 4, 9, 10). Furthermore, certain studies demonstrated an
even greater association between epidural analgesia and cesarean delivery
in women who received their epidurals before reaching cervical dilatation of
5 cm (3, 9). In 2002, an evaluation of cesarean delivery sponsored by ACOG
concluded, “there is considerable evidence suggesting that there is in fact an
association between the use of epidural analgesia for pain relief during labor
and the risk of cesarean delivery (8).
Since the last Committee Opinion on analgesia and cesarean delivery,
additional studies have addressed the issue of neuraxial analgesia and its
association with cesarean delivery. Three recent meta-analyses system-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 649
 atically and independently reviewed the previous
literature, and all concluded that epidural analgesia
does not increase the rates of cesarean delivery
(odds ratio 1.00–1.04; 95% confidence interval,
0.71–1.48) (11–13). In addition, three recent ran-
domized controlled trials clearly demonstrated no
difference in rate of cesarean deliveries between
women who had received epidurals and women
who had received only intravenous analgesia (5–7).
Furthermore, a randomized trial comparing epidur-
als done early in labor versus epidurals done later
in labor demonstrated no difference in the incidence
of cesarean delivery (17.8% versus 20.7%) (5). The
use of intrathecal analgesia and the concentration of
the local anesthetic used in an epidural also have no
impact on the rate of cesarean delivery (5, 13–15).
Therefore, ACOG reaffirms the opinion it
published jointly with the American Society of
Anesthesiologists, in which the following state-
ment was articulated: “Labor causes severe pain
for many women. There is no other circumstance
where it is considered acceptable for an individual
to experience untreated severe pain, amenable to
safe intervention, while under a physician’s care. In
the absence of a medical contraindication, maternal
request is a sufficient medical indication for pain
relief during labor” (16). The fear of unnecessary
cesarean delivery should not influence the method
of pain relief that women can choose during labor.
The American College of Obstetricians and
Gynecologists recognizes that many techniques are
available for analgesia in laboring patients. None
of the techniques appears to be associated with an
increased risk of cesarean delivery. The choice of
technique, agent, and dosage is based on many fac-
tors, including patient preference, medical status,
and contraindications. Decisions regarding analge-
sia should be closely coordinated among the obste-
trician, the anesthesiologist, the patient, and skilled
support personnel.
References
1. Gibbs CP, Krischer J, Peckham BM, Sharp H,
Kirschbaum TH. Obstetric anesthesia: a national survey.
Anesthesiology 1986;65:298–306.
2. Hawkins JL, Gibbs CP, Orleans M, Martin-Salvaj G,
Beaty B. Obstetric anesthesia work force survey, 1981
versus 1992. Anesthesiology 1997;87:135– 43.
COMMITTEE OPINIONS
3. Thorp JA, Hu DH, Albin RM, McNitt J, Meyer BA,
Cohen GR, et al. The effect of intrapartum epidural
analgesia on nulliparous labor: a randomized, controlled,
prospective trial. Am J Obstet Gynecol 1993;169:851–8.
4. Ramin SM, Gambling DR, Lucas MJ, Sharma SK, Sidawi
JE, Leveno KJ. Randomized trial of epidural versus
intravenous analgesia during labor. Obstet Gynecol 1995;
86:783–9.
5. Wong CA, Scavone BM, Peaceman AM, McCarthy RJ,
Sullivan JT, Diaz NT, et al. The risk of cesarean delivery
with neuraxial analgesia given early versus late in labor.
N Engl J Med. 2005;352:655–65.
6. Sharma SK, Alexander JM, Messick G, Bloom SL,
McIntire DD, Wiley J, et al. Cesarean delivery: a ran-
domized trial of epidural analgesia versus intravenous
meperidine analgesia during labor in nulliparous women.
Anesthesiology 2002;96:546–51.
7. Halpern SH, Muir H, Breen TW, Campbell DC, Barrett J,
Liston R, et al. A multicenter randomized controlled trial
comparing patient-controlled epidural with intravenous
analgesia for pain relief in labor. Anesth Analg 2004;
99:1532–8.
8. American College of Obstetricians and Gynecologists.
Evaluation of cesarean delivery. Washington, DC:
ACOG; 2000.
9. Lieberman E, Lang JM, Cohen A, D’Agostino R Jr, Datta
S, Frigoletto FD Jr. Association of epidural analgesia with
cesarean delivery in nulliparas. Obstet Gynecol 1996;
88:993–1000.
10. Howell C, Chalmers I. A review of prospectively con-
trolled comparisons of epidural with non-epidural forms of
pain relief during labour. Int J Obstet Anesth 1992;1:93–
110.
11. Leighton BL, Halpern SH. The effects of epidural analge-
sia on labor, maternal, and neonatal outcomes: a systemic
review. Am J Obstet Gynecol 2002;186:S69–77.
12. Liu EH, Sia AT. Rates of caesarean section and instrumen-
tal vaginal delivery in nulliparous women after low con-
centration epidural infusion or opiod analgesia: systemic
review. BMJ 2004;328:1410.
13. Sharma SK, McIntire DD, Wiley J, Leveno KJ. Labor
analgesia and cesarean delivery: an individual patient
meta-analysis of nulliparous women. Anesthesiology
2004;100:142–8.
14. Effect of low-dose mobile versus traditional epidural tech-
niques on mode of delivery: a randomised controlled trial.
Comparative Obstetric Mobile Epidural Trial (COMET)
Study Group UK. Lancet 2001;358:19–23.
15. Chestnut DH, McGrath JM, Vincent RD Jr, Penning DH,
Choi WW, Bates JN, et al. Does early administration of
epidural analgesia affect obstetric outcome in nulliparous
women who are in spontaneous labor? Anesthesiology
1994;80:1201–8.
16. Pain relief during labor. ACOG Committee Opinion No.
295. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2004;104:213.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 650
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects emerging
clinical and scientific advances as
of the date issued and is subject to
change. The information should
not be construed as dictating an
exclusive course of treatment or
procedure to be followed.
Copyright © July 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or trans-
mitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or oth-
erwise, without prior written per-
mission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Mode of term singleton breech
delivery. ACOG Committee Opinion
No. 340. American College of
Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:235–7.
COMMITTEE OPINIONS
Committee
Opinion
Number 340, July 2006 (Replaces No. 265, December 2001)
Mode of Term Singleton Breech
Delivery
ABSTRACT: In light of recent studies that further clarify the long-term
risks of vaginal breech delivery, the American College of Obstetricians and
Gynecologists recommends that the decision regarding mode of delivery
should depend on the experience of the health care provider. Cesarean deliv-
ery will be the preferred mode for most physicians because of the diminish-
ing expertise in vaginal breech delivery. Planned vaginal delivery of a term
singleton breech fetus may be reasonable under hospital-specific protocol
guidelines for both eligibility and labor management. Before a vaginal
breech delivery is planned, women should be informed that the risk of peri-
natal or neonatal mortality or short-term serious neonatal morbidity may
be higher than if a cesarean delivery is planned, and the patient’s informed
consent should be documented.
During the past decade, there has been an increasing trend in the United
States to perform cesarean delivery for term singleton fetuses in a breech
presentation. In 2002, the rate of cesarean deliveries for women in labor
with breech presentation was 86.9% (1). The number of practitioners with
the skills and experience to perform vaginal breech delivery has decreased.
Even in academic medical centers where faculty support for teaching vaginal
breech delivery to residents remains high, there may be insufficient volume
of vaginal breech deliveries to adequately teach this procedure (2).
In 2000, researchers conducted a large, international multicenter ran-
domized clinical trial comparing a policy of planned cesarean delivery with
planned vaginal delivery (Term Breech Trial) (3). These investigators noted
that perinatal mortality, neonatal mortality, and serious neonatal morbid-
ity were significantly lower among the planned cesarean delivery group
compared with the planned vaginal delivery group (17/1,039 [1.6%] versus
52/1,039 [5%]), although there was no difference in maternal morbidity or
mortality observed between the groups (3). The benefits of planned cesar-
ean delivery remained for all subgroups identified by the baseline variables
(eg, older and younger women, nulliparous and multiparous women, frank
and complete type of breech presentation). They found that the reduction in
risk attributable to planned cesarean delivery was greatest among centers in
industrialized nations with low overall perinatal mortality rates (0.4% ver-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 651
 sus 5.7%). In countries with low perinatal mortality
rates, the reduction in risk was driven primarily by
the pooled rates of perinatal or neonatal mortal-
ity and serious neonatal morbidity, rather than by
the rates of mortality alone (0% versus 0.6%).
Given the results of this exceptionally large and
well-controlled clinical trial, the American College
of Obstetricians and Gynecologists’ Committee
on Obstetric Practice in 2001 recommended that
planned vaginal delivery of a term singleton breech
was no longer appropriate.
Since that time, there have been additional
publications that modify the original conclusions of
the 2000 Term Breech Trial. The same researchers
have published three follow-up studies examining
maternal outcomes at 3 months postpartum, as well
as outcomes for mothers and children 2 years after
the births (4–6). At 3 months postpartum, the risk
of urinary incontinence was lower for women in the
planned cesarean delivery group; however, there
was no difference at 2 years. At 2 years postpartum,
maternal morbidity, which was assessed via ques-
tionnaire in 917 of 1,159 (79.1%), was not different
for most maternal parameters, including breastfeed-
ing, pain, depression, menstrual problems, fatigue,
and distressing memories of the birth experience (5).
The follow-up study to address outcomes of the
children at 2 years involved 85 centers (with both
high and low perinatal mortality rates) that were cho-
sen at the start of the original trial. Most children, 923
of 1,159 (79.6%), were assessed first by a screening
questionnaire (Ages and Stages) that was completed
by their parents (4). All abnormal results were further
evaluated with a clinical neurodevelopment assess-
ment. The risk of death or neurodevelopmental delay
was no different in the planned cesarean delivery
group compared with the planned vaginal deliv-
ery group (14 children [3.1%] versus 13 children
[2.8%]; relative risk, 1.09; 95% CI, 0.52–2.30; P =
0.85). There are several explanations for this seem-
ingly contradictory finding. The follow-up study was
underpowered to show a clinically important benefit
from cesarean delivery if this were true. Only 6 of
the 16 infants who died in the neonatal period were
from centers participating in the follow-up to 2 years
(one in the planned cesarean delivery group, five in
the planned vaginal delivery group), and most of the
children with serious neonatal morbidity after birth
survived and developed normally. In this cohort, 17
out of 18 children with serious morbidity in the origi-
nal study were normal at this 24-month follow-up.
Another explanation is that the use of pooled mortal-
ity and morbidity data at the time of birth overstated
the true long-term risks of vaginal delivery (7).
COMMITTEE OPINIONS
A recent retrospective observational report
reviewed neonatal outcome in the Netherlands
before and after the publication of the Term Breech
Trial (8). Between 1998 and 2002, 35,453 term
infants were delivered. The cesarean delivery rate
for breech presentation increased from 50% to
80% within 2 months of the trial’s publication and
remained elevated. The combined neonatal mortal-
ity rate decreased from 0.35% to 0.18%, and the
incidence of reported birth trauma decreased from
0.29% to 0.08%. Of interest, a decrease in mortality
also was seen in the emergency cesarean delivery
group and the vaginal delivery group, a finding that
the authors attribute to better selection of candidates
for vaginal breech delivery.
There are many retrospective reports of vaginal
breech delivery that follow very specific protocols
and note excellent neonatal outcomes. One report
noted 298 women in a vaginal breech trial with
no perinatal morbidity and mortality (9). Another
report noted similar outcomes in 481 women with
planned vaginal delivery (10). Although they are not
randomized trials, these reports detail the outcomes
of specific management protocols and document
the potential safety of a vaginal delivery in the
properly selected patient. The initial criteria used in
these reports were similar: gestational age greater
than 37 weeks, frank or complete breech presenta-
tion, no fetal anomalies on ultrasound examina-
tion, adequate maternal pelvis, and estimated fetal
weight between 2,500 g and 4,000 g. In addition,
the protocol presented by one report required docu-
mentation of fetal head flexion and adequate amni-
otic fluid volume, defined as a 3-cm vertical pocket
(9). Oxytocin induction or augmentation was not
offered, and strict criteria were established for nor-
mal labor progress.
In light of the recent publications that further
clarify the long-term risks of vaginal breech deliv-
ery, the American College of Obstetricians and
Gynecologists’ Committee on Obstetric Practice
issues the following recommendations:
• The decision regarding the mode of delivery
should depend on the experience of the health
care provider. Cesarean delivery will be the
preferred mode of delivery for most physicians
because of the diminishing expertise in vaginal
breech delivery.
• Obstetricians should offer and perform external
cephalic version whenever possible.
• Planned vaginal delivery of a term singleton
breech fetus may be reasonable under hospital-
specific protocol guidelines for both eligibility
and labor management.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 652
 • In those instances in which breech vaginal
deliveries are pursued, great caution should be
exercised, and detailed patient informed consent
should be documented.
• Before embarking on a plan for a vaginal breech
delivery, women should be informed that the
risk of perinatal or neonatal mortality or short-
term serious neonatal morbidity may be higher
than if a cesarean delivery is planned.
• There are no recent data to support the rec-
ommendation of cesarean delivery to patients
whose second twin is in a nonvertex presenta-
tion, although a large multicenter randomized
controlled trial is in progress (www.utoronto.ca/
miru/tbs).
References
1. Martin JA, Hamilton BE, Sutton PD, Ventura SJ,
Menacker F, Munson ML. Births: final data for 2002.
Natl Vital Stat Rep 2003;52(10):1–113.
2. Lavin JP Jr, Eaton J, Hopkins M. Teaching vaginal breech
delivery and external cephalic version. A survey of fac-
ulty attitudes. J Reprod Med 2000;45:808–12.
3. Hannah ME, Hannah WJ, Hewson SA, Hodnett ED,
Saigal S, Willan AR. Planned caesarean section versus
planned vaginal birth for breech presentation at term:
a randomised multicentre trial. Term Breech Trial
Collaborative Group. Lancet 2000;356:1375–83.
4. Whyte H, Hannah ME, Saigal S, Hannah WJ, Hewson S,
Amankwah K, et al. Outcomes of children at 2 years after
planned cesarean birth versus planned vaginal birth for
breech presentation at term: the International Randomized
Term Breech Trial. Term Breech Trial Collaborative
Group. Am J Obstet Gynecol 2004;191:864–71.
COMMITTEE OPINIONS
5. Hannah ME, Whyte H, Hannah WJ, Hewson S, Amankwah
K, Cheng M, et al. Maternal outcomes at 2 years after
planned cesarean section versus planned vaginal birth for
breech presentation at term: the international random-
ized Term Breech Trial. Term Breech Trial Collaborative
Group. Am J Obstet Gynecol 2004;191:917–27.
6. Su M, Hannah WJ, Willan A, Ross S, Hannah ME.
Planned caesarean section decreases the risk of adverse
perinatal outcome due to both labour and delivery com-
plications in the Term Breech Trial. Term Breech Trial
Collaborative Group. BJOG 2004;111:1065–74.
7. Kotaska A. Inappropiate use of randomised trials to eval-
uate complex phenomena: case study of vaginal breech
delivery [published erratum appears in BMJ 2004;329:
1385]. BMJ 2004;329:1039–42.
8. Rietberg CC, Elferink-Stinkens PM, Visser GH. The
effect of the Term Breech Trial on medical intervention
behaviour and neonatal outcome in The Netherlands:
an analysis of 35,453 term breech infants. BJOG 2005;
112:205–9.
9. Alarab M, Regan C, O’Connell MP, Keane DP, O’Herlihy
C, Foley ME. Singleton vaginal breech delivery at term:
still a safe option. Obstet Gynecol 2004;103:407–12.
10. Guiliani A, Scholl WM, Basver A, Tamussino KF. Mode
of delivery and outcome of 699 term singleton breech
deliveries at a single center. Am J Obstet Gynecol 2002;
187:1694–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 653
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject
to change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © October 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system, post-
ed on the Internet, or transmitted,
in any form or by any means,
electronic, mechanical, photo-
copying, recording, or otherwise,
without prior written permission
from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Amnioinfusion does not prevent
meconium aspiration syndrome.
ACOG Committee Opinion No. 346.
American College of Obstetricians
and Gynecologists. Obstet Gynecol
2006;108:1053–5.
COMMITTEE OPINIONS
Committee
Opinion
Number 346, October 2006
Amnioinfusion Does Not Prevent
Meconium Aspiration Syndrome
ABSTRACT: Amnioinfusion has been advocated as a technique to reduce
the incidence of meconium aspiration and to improve neonatal outcome.
However, a large proportion of women with meconium-stained amniotic fluid
have infants who have taken in meconium within the trachea or bronchioles
before meconium passage has been noted and before amnioinfusion can be
performed by the obstetrician; meconium passage may predate labor. Based
on current literature, routine prophylactic amnioinfusion for the dilution of
meconium-stained amniotic fluid is not recommended. Prophylactic use of
amnioinfusion for meconium-stained amniotic fluid should be done only in
the setting of additional clinical trials. However, amnioinfusion remains a
reasonable approach in the treatment of repetitive variable decelerations,
regardless of amniotic fluid meconium status.
Meconium-stained amniotic fluid is a common obstetric situation, occurring
in 12–22% of women in labor (1, 2). Meconium aspiration syndrome is a
major complication in the neonate. This syndrome occurs in up to 10% of
infants who have been exposed to meconium-stained amniotic fluid, with
significant morbidity and mortality.
Amnioinfusion has been advocated as a technique to reduce the incidence
of meconium aspiration and to improve neonatal outcome. Although gener-
ally considered safe, reported complications associated with amnioinfusion
include uterine hypertonus, uterine rupture, placental abruption, chorioamnio-
nitis, nonreassuring fetal heart rate tracing, maternal pulmonary embolus, and
maternal death (3). The purported benefit of amnioinfusion for the dilution of
meconium-stained amniotic fluid is dilution of thick clumps of meconium.
However, a large proportion of women with meconium-stained amniotic fluid
have infants who have taken in meconium within the trachea or bronchioles
before meconium passage has been noted and before amnioinfusion can be
performed by the obstetrician. Furthermore, meconium aspiration syndrome
is hypothesized to predate labor in many cases (4). Studies were performed to
evaluate whether prophylactic amnioinfusion for meconium-stained amniotic
fluid would be beneficial and if it would decrease the incidence of meconium
aspiration syndrome (5–18).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 654
 The initial trials of amnioinfusion generally
consisted of small studies that randomized women
with moderate to thick meconium-stained amniotic
fluid to receive prophylactic amnioinfusion or no
amnioinfusion. These studies suggested that women
receiving amnioinfusion had fewer operative deliv-
eries and fetuses with significantly less distress
and less meconium below the vocal cords (5–11).
Two meta-analyses also found that amnioinfusion
significantly reduced the frequency of meconium
aspiration syndrome and the incidence of meconium
below the vocal cords in fetuses of pregnant women
with meconium-stained amniotic fluid treated with
amnioinfusion (12, 13).
A randomized trial in women with meconi-
um-stained amniotic fluid evaluated prophylactic
amnioinfusion versus therapeutic amnioinfusion for
variable decelerations occurring after enrollment
(14). The authors found no differences in operative
deliveries, fetal distress, Apgar scores, the incidence
of meconium below the fetal vocal cords, or umbili-
cal artery blood pH values between the groups. There
were four cases of meconium aspiration syndrome;
three occurred in the prophylactic amnioinfusion
group. Of the women receiving standard care, only
16% required therapeutic amnioinfusion for repeti-
tive severe variable decelerations. These findings
are consistent with studies evaluating institutional
protocols of routine prophylactic amnioinfusion for
thick meconium that found that meconium aspiration
syndrome continued to occur at the same rate, with
no improvement in neonatal outcome (15–17).
A large, international, multicenter trial random-
ized 1,998 women in labor at 36 weeks of gesta-
tion or later with thick meconium-stained amniotic
fluid to amnioinfusion or no amnioinfusion, after
stratification according to the presence or absence of
variable decelerations (18). The number of women
enrolled in this well-conducted study was greater
than in all other prior studies combined. The authors
found that amnioinfusion did not reduce perinatal
death (0.5 % in both groups) or moderate or severe
meconium aspiration (4.4 % versus 3.1 % in con-
trols), nor was there a significant reduction in cesar-
ean delivery (31.8 % versus 29.0 % in controls).
Although the absence of benefit from amnioinfusion
occurred whether or not there were variable decel-
erations, the study did not have adequate power to
definitively determine if amnioinfusion was effica-
cious in the subgroup of women with decelerations.
COMMITTEE OPINIONS
Based on current literature, routine prophylactic
amnioinfusion for meconium-stained amniotic fluid
is not recommended. Prophylactic use of amnioinfu-
sion for meconium-stained amniotic fluid should be
done only in the setting of additional clinical trials.
Data are not available on whether amnioinfusion
for fetal heart rate decelerations in the presence of
meconium-stained amniotic fluid decreases meconi-
um aspiration syndrome or other meconium-related
morbidities. However, amnioinfusion remains a
reasonable approach in the treatment of repetitive
variable decelerations, regardless of amniotic fluid
meconium status (19).
References
1. Katz VL, Bowes WA Jr. Meconium aspiration syndrome:
reflections on a murky subject. Am J Obstet Gynecol
1992;166:171–83.
2. Nathan L, Leveno KJ, Carmody TJ 3rd, Kelly AM,
Sherman ML. Meconium: a 1990s perspective on an old
obstetric hazard. Obstet Gynecol 1994;83:329–32.
3. Wenstrom K, Andrews WW, Maher JE. Amnioinfusion
survey: prevalence, protocols, and complications. Obstet
Gynecol 1995;86:572–6.
4. Ghidini A, Spong CY. Severe meconium aspiration syn-
drome is not caused by aspiration of meconium. Am J
Obstet Gynecol 2001;185:931–8.
5. Wenstrom KD, Parsons MT. The prevention of meconium
aspiration in labor using amnioinfusion. Obstet Gynecol
1989;73:647–51.
6. Sadovsky Y, Amon E, Bade ME, Petrie RH. Prophylactic
amnioinfusion during labor complicated by meconium:
a preliminary report. Am J Obstet Gynecol 1989;161:
613–7.
7. Macri CJ, Schrimmer DB, Leung A, Greenspoon JS, Paul
RH. Prophylactic amnioinfusion improves outcome of
pregnancy complicated by thick meconium and oligohy-
dramnios. Am J Obstet Gynecol 1992;167:117–21.
8. Cialone PR, Sherer DM, Ryan RM, Sinkin RA,
Abramowicz JS. Amnioinfusion during labor complicated
by particulate meconium-stained amniotic fluid decreases
neonatal morbidity. Am J Obstet Gynecol 1994;170:
842–9.
9. Eriksen NL, Hostetter M, Parisi VM. Prophylactic amnio-
infusion in pregnancies complicated by thick meconium.
Am J Obstet Gynecol 1994;171:1026–30.
10. Puertas A, Paz Carrillo MP, Molto L, Alvarez M, Sedeno
S, Miranda JA. Meconium-stained amniotic fluid in labor:
a randomized trial of prophylactic amnioinfusion. Eur J
Obstet Gynecol Reprod Biol 2001;99:33–7.
11. Rathor AM, Singh R, Ramji S, Tripathi R. Randomised
trial of amnioinfusion during labour with meconium
stained amniotic fluid. BJOG 2002;109:17–20.
12. Pierce J, Gaudier FL, Sanchez-Ramos L. Intrapartum
amnioinfusion for meconium-stained fluid: meta-analysis
of prospective clinical trials. Obstet Gynecol 2000;95:
1051–6.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 655
 13. Hofmeyr GJ. Amnioinfusion for meconium-stained liquor
in labour. The Cochrane Database of Systematic Reviews
2002, Issue 1. Art. No.: CD000014. DOI: 10.1002/
14651858.CD000014.
14. Spong CY, Ogundipe OA, Ross MG. Prophylactic amnio-
infusion for meconium-stained amniotic fluid. Am J
Obstet Gynecol 1994;171:931–5.
15. De Meeus JB, D’Halluin G, Bascou V, Ellia F, Magnin
G. Prophylactic intrapartum amnioinfusion: a controlled
retrospective study of 135 cases. Eur J Obstet Gynecol
Reprod Biol 1997;72:141–8.
16. Rogers MS, Lau TK, Wang CC, Yu KM. Amnioinfusion
for the prevention of meconium aspiration during labour.
Aust N Z J Obstet Gynaecol 1996;36:407–10.
COMMITTEE OPINIONS
17. Usta IM, Mercer BM, Aswad NK, Sibai BM. The impact
of a policy of amnioinfusion for meconium-stained amni-
otic fluid. Obstet Gynecol 1995;85:237–41.
18. Fraser WD, Hofmeyr J, Lede R, Faron G, Alexander S,
Goffinet F, et al. Amnioinfusion for the prevention of
the meconium aspiration syndrome. Amnioinfusion Trial
Group. N Engl J Med 2005;353:909–17.
19. Miyazaki FS, Nevarez F. Saline amnioinfusion for relief
of repetitive variable decelerations: a prospective random-
ized study. Am J Obstet Gynecol 1985;153:301–6.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 656
 ACOG
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects emerg­ing
clin­i­cal and scientific ad­vanc­es as
of the date issued and is sub­ject
to change. The in­for­ma­tion should
not be con­strued as dic­tat­ing an
ex­clu­sive course of treat­ment or
pro­ce­dure to be followed.
Copyright © November 2006
by the American College of
Obstetricians and Gynecologists.
All rights reserved. No part of this
publication may be reproduced,
stored in a retrieval system,
posted on the Internet, or trans-
mitted, in any form or by any
means, electronic, mechanical,
photocopying, recording, or oth-
erwise, without prior written per-
mission from the publisher.
Requests for au­tho­ri­za­tion to
make pho­to­copies should be
di­rect­ed to:
Copyright Clear­ance Center
222 Rose­wood Drive
Danvers, MA 01923
(978) 750-8400
ISSN 1074-861X
The American Col­lege of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
Umbilical cord blood gas and acid-
base analysis. ACOG Committee
Opinion No. 348. American College
of Obstetricians and Gynecologists.
Obstet Gynecol 2006;108:1319–22.
COMMITTEE OPINIONS
Committee
Opinion
Number 348, November 2006
Umbilical Cord Blood Gas and
Acid-Base Analysis
ABSTRACT: Umbilical cord blood gas and acid-base assessment are the
most objective determinations of the fetal metabolic condition at the moment
of birth. Moderate and severe newborn encephalopathy, respiratory com-
plications, and composite complication scores increase with an umbilical
arterial base deficit of 12–16 mmol/L. Moderate or severe newborn com-
plications occur in 10% of neonates who have this level of acidemia and
the rate increases to 40% in neonates who have an umbilical arterial base
deficit greater than 16 mmol/L at birth. Immediately after the delivery of the
neonate, a segment of umbilical cord should be double-clamped, divided,
and placed on the delivery table. Physicians should attempt to obtain venous
and arterial cord blood samples in circumstances of cesarean delivery for
fetal compromise, low 5-minute Apgar score, severe growth restriction,
abnormal fetal heart rate tracing, maternal thyroid disease, intrapartum
fever, or multifetal gestation.
Laboratory research demonstrates a complex relationship between fetal
(antepartum and intrapartum) asphyxia, newborn asphyxia, and possible
resulting brain damage. The degree, duration, and nature of the asphyxic
insult are modulated by the quality of the cardiovascular compensatory
response. A task force set up by the World Federation of Neurology Group
defined asphyxia as a condition of impaired blood gas exchange, leading, if
it persists, to progressive hypoxemia and hypercapnia (1). This is a precise
definition of asphyxia as it may affect the fetus and neonate. In the American
College of Obstetricians and Gynecologists’ Task Force on Neonatal
Encephalopathy and Cerebral Palsy report, asphyxia is defined as:
. . . [a] clinical situation of damaging acidemia, hypoxia, and metabolic acidosis.
This definition, although traditional, is not specific to cause. A more complete
definition of birth asphyxia includes a requirement for a recognizable sentinel
event capable of interrupting oxygen supply to the fetus or infant. This definition
fails to include conditions that are not readily recognized clinically, such as occult
abruption, but is probably correct in a majority of cases. (2)
Asphyxia may occur in a transient fashion that, although of physiologic
interest, has no pathologic sequelae. Significant fetal exposure to asphyxia
2013 COMPENDIUM OF SELECTED PUBLICATIONS 657
 leads to tissue oxygen debt, accumulation of fixed
acids, and a metabolic acidosis. Thus, for intrapar-
tum fetal asphyxia the following addition is pro-
posed for this definition:
Fetal asphyxia is a condition of impaired blood gas
exchange leading to progressive hypoxemia and
hypercapnia with a significant metabolic acidosis.
The diagnosis of intrapartum fetal asphyxia requires
a blood gas and acid-base assessment. The important
question for the clinician is what is the threshold of
metabolic acidosis beyond which fetal morbidity or
mortality may occur?
Low and associates have proposed a scoring
system for predicting the likelihood of neonatal
encephalopathy (3). They defined umbilical arterial
base deficits at birth as mild at 4–8 mmol/L, mod-
erate at 8–12 mmol/L, and severe at greater than
12 mmol/L. Newborn complications in the central
nervous system, respiratory system, cardiovascular
system, and kidney during the 5 days after delivery
were documented. Assessment of the central ner-
vous system included clinical evidence of newborn
encephalopathy defined as minor with irritability
or jitteriness, moderate with profound lethargy or
abnormal tone, and severe with coma or abnormal
tone and seizures. Cardiovascular complications
were classified as minor with bradycardia (100
beats per minute or less) or tachycardia (170 beats
per minute or more), moderate with hypotension
or hypertension (defined by the 95% confidence
limits for blood pressure in term neonates), and
severe with abnormal electrocardiographic or echo-
cardiographic findings. Respiratory complications
were classified as minor if requiring supplementary
oxygen, moderate if requiring continuous positive
airway pressure or ventilation less than 24 hours,
and severe if requiring mechanical ventilation more
than 24 hours. Abnormalities of renal function were
classified as minor if hematuria was observed, mod-
erate with an elevation of serum creatinine level
(greater than 100 mmol/L)*, and severe with anuria
or oliguria (less than 1 mL/kg/h). A scoring system
expressed the magnitude of the complications in each
neonate. The score for each complication was “1”
for minor, “2” for moderate, and “4” for severe. The
maximum complication score was “16”. Moderate
and severe newborn encephalopathy, respiratory
complications, and composite complication scores
were increased with an umbilical arterial base defi-
cit of 12–16 mmol/L. Moderate or severe newborn
*In the United States, creatinine level is expressed in mg/dL. To
convert creatinine in mmol/L to mg/dL, the value should be
divided by 88.4. In this case, 100 mmol/L is 1.14. mg/dL.
COMMITTEE OPINIONS
complications occurred in 10% of neonates with this
level of acidemia, increasing to 40% in neonates
with an umbilical arterial base deficit greater than 16
mmol/L at birth. Low and associates concluded that
the threshold of fetal metabolic acidosis at delivery
associated with moderate or severe newborn com-
plications was an umbilical arterial base deficit of
12 mmol/L and that increasing levels of metabolic
acidosis were associated with a progression of the
severity of newborn complications (3). At the mild
base deficit range, there is no association with
abnormal newborn outcome. A similar threshold for
neonatal neurologic complications has been reported
by other investigators (4, 5). Importantly, and in con-
trast to moderate or severe levels of acidemia, term
neonates exposed to mild antepartum fetal asphyxia
were not at an increased risk of minor motor or cog-
nitive defects at the age of 4–8 years compared with
controls with no evidence of asphyxia (6).
Term Infants
The prevalence of fetal asphyxia, ranging from mild
to severe at delivery, in the term infant is reported
at 25 per 1,000 live births; of these, 15% are either
moderate or severe (3.75 per 1,000) (7). Even at
these levels of acidemia, it must be appreciated
that most fetuses will not be injured, yielding a
final overall incidence of neonatal encephalopathy
attributable to intrapartum hypoxia, in the absence
of any other preconception or antepartum abnor-
malities, of approximately 1.6 per 10,000 (8, 9).
Similar observations have been reported from Japan,
where among a series of 10,030 infants there were
nine cases of cerebral palsy at age 1 year or older
diagnosed by pediatric neurologists. Analysis of
these cases reveals that preexisting asphyxia existed
before the initiation of fetal monitoring in six cases;
two of the cases involved cytomegalovirus infec-
tions and one case involved a maternal amniotic
fluid embolism (10). These investigators concluded
that in low-risk pregnancies, cerebral palsy caused
by intrapartum asphyxia was restricted to unavoid-
able intrapartum accidents.
Preterm Infants
Low and colleagues reported that the prevalence of
asphyxia in preterm infants was 73 per 1,000 live
births (7). Of these, 50% were at the moderate to
severe level of asphyxia. The authors caution that
it remains to be determined how often the asphyxia
recognized at delivery may have been present before
2013 COMPENDIUM OF SELECTED PUBLICATIONS 658
 the onset of labor. This point is particularly germane
in the preterm infant, inasmuch as medical or obstet-
ric complications or both often are the preceding
event necessitating the preterm delivery. Examples
include significant degrees of intrauterine growth
restriction, placental abruption, chorioamnionitis
with funisitis, and severe preeclampsia, each of
which has been shown to be a significant indepen-
dent risk factor for moderate or severe neonatal
encephalopathy (8, 9).
Acidemia and Cerebral Palsy
Both the International Cerebral Palsy Task Force
and the American College of Obstetricians and
Gynecologists’ Task Force on Neonatal Encepha-
lopathy and Cerebral Palsy have published criteria
to define an acute intrapartum event as sufficient
to cause cerebral palsy (2, 11). Among the essen-
tial criteria cited by both task forces is evidence of
metabolic acidosis in fetal umbilical cord arterial
blood obtained at delivery (pH less than 7 and base
deficit greater than or equal to 12 mmol/L) (see box).
Additionally, the National Collaborating Center for
Women’s and Children’s Health, commissioned by
the National Institute for Clinical Excellence, has
recommended that umbilical artery pH be performed
after all cesarean deliveries for suspected fetal com-
promise, to allow review of fetal well-being and to
guide ongoing care of the infant (12).
Technique for Obtaining Cord Blood
Samples
Immediately after the delivery of the neonate, a seg-
ment of umbilical cord should be double-clamped,
divided, and placed on the delivery table pending
assignment of the 5-minute Apgar score. Values from
the umbilical cord artery provide the most accurate
information regarding fetal and newborn acid-base
status. A clamped segment of cord is stable for pH
and blood gas assessment for at least 60 minutes, and
a cord blood sample in a syringe flushed with heparin
is stable for up to 60 minutes (13, 14). If the 5-minute
Apgar score is satisfactory and the infant appears sta-
ble and vigorous, the segment of umbilical cord can
be discarded. If a serious abnormality that arose in
the delivery process or a problem with the neonate’s
condition or both persist at or beyond the first 5 min-
utes, blood can be drawn from the cord segment and
sent to the laboratory for blood gas analysis. Analysis
COMMITTEE OPINIONS
of paired arterial and venous specimens should pre-
vent debate over whether a true arterial specimen
was obtained. Therefore, the Committee on Obstetric
Practice recommends obtaining an arterial umbilical
cord blood sample, but, where possible, obtaining
both venous and arterial samples (paired specimen).
It is important to label the sample as either venous or
arterial. Similarly, in known high-risk circumstances,
such as severe growth restriction, an abnormal fetal
heart rate tracing, maternal thyroid disease, intrapar-
tum fever, or multifetal gestations, it is prudent to
obtain blood gas and acid-base assessments (2). It
should be noted that it occasionally may be difficult
to obtain an adequate cord arterial blood sample. If
the practitioner encounters difficulty in obtaining
arterial blood from the umbilical cord (ie, in a very
preterm infant), a sample obtained from an artery
on the chorionic surface of the placenta will provide
accurate results (15). These arteries are relatively
easy to identify because they cross over the veins.
Criteria to Define an Acute Intrapartum Hypoxic
Event as Sufficient to Cause Cerebral Palsy
Essential criteria (must meet all four):
1. Evidence of a metabolic acidosis in fetal umbilical
cord arterial blood obtained at delivery (pH <7 and
base deficit ≥12 mmol/L)
2. Early onset of severe or moderate neonatal
encephalopathy in infants born at 34 or more
weeks of gestation
3. Cerebral palsy of the spastic quadriplegic or dyski-
netic type*
4. Exclusion of other identifiable etiologies, such as
trauma, coagulation disorders, infectious condi-
tions, or genetic disorders
*Spastic quadriplegia and, less commonly, dyskinetic cerebral
palsy are the only types of cerebral palsy associated with acute
hypoxic intrapartum events. Spastic quadriplegia is not specific
to intrapartum hypoxia. Hemiparetic cerebral palsy, hemiplegic
cerebral palsy, spastic diplegia, and ataxia are unlikely to result
from acute intrapartum hypoxia (Nelson KB, Grether JK. Poten-
tially asphyxiating conditions and spastic cerebral palsy in
infants of normal birth weight. Am J Obstet Gynecol 1998;179:
507–13.).
Excerpted from American Academy of Pediatrics, American
College of Obstetricians and Gynecologists. Neonatal encepha-
lopathy and cerebral palsy: defining the pathogenesis and
pathophysiology. Elk Grove Village (IL): AAP; Washington,
DC: ACOG; 2003. Modified from MacLennan A. A template for
defining a causal relation between acute intrapartum events
and cerebral palsy: international consensus statement. BMJ
1999;319:1054–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 659
 Conclusion
Umbilical cord arterial blood acid-base and gas
assessment remains the most objective determina-
tion of the fetal metabolic condition at the moment
of birth. Thresholds have been established below
which it is unlikely that an intrapartum asphyxial
insult will have resulted in neurologic injury to the
infant. Additionally, most infants born with umbili-
cal arterial metabolic acidemia at a level consis-
tent with causing a neurologic injury will, in fact,
develop normally.
Physicians should attempt to obtain venous and
arterial cord blood samples in the following situa-
tions:
• Cesarean delivery for fetal compromise
• Low 5-minute Apgar score
• Severe growth restriction
• Abnormal fetal heart rate tracing
• Maternal thyroid disease
• Intrapartum fever
• Multifetal gestations
References
1. Bax M, Nelson KB. Birth asphyxia: a statement. World
Federation of Neurology Group. Dev Med Child Neurol
1993;35:1022–4.
2. American Academy of Pediatrics, American College
of Obstetricians and Gynecologists. Neonatal encepha-
lopathy and cerebral palsy: defining the pathogenesis
and pathophysiology. Elk Grove Village (IL): AAP;
Washington, DC: ACOG; 2003.
3. Low JA, Lindsay BG, Derrick EJ. Threshold of metabolic
acidosis associated with newborn complications. Am J
Obstet Gynecol 1997;177:1391–4.
4. Winkler CL, Hauth JC, Tucker JM, Owen J, Brumfield
CG. Neonatal complications at term as related to the
degree of umbilical artery acidemia. Am J Obstet Gynecol
1991;164:637–41.
COMMITTEE OPINIONS
5. Goldaber KG, Gilstrap LC, 3rd, Leveno KJ, Dax JS,
McIntire DD. Pathologic fetal acidemia. Obstet Gynecol
1991;78:1103–7.
6. Handley-Derry M, Low JA, Burke SO, Waurick M,
Killen H, Derrick EJ. Intrapartum fetal asphyxia and the
occurrence of minor deficits in 4- to 8-year-old children.
Dev Med Child Neurol 1997;39:508–14.
7. Low JA. Determining the contribution of asphyxia to
brain damage in the neonate. J Obstet Gynaecol Res
2004;30:276–86.
8. Badawi N, Kurinczuk JJ, Keogh JM, Alessandri LM,
O’Sullivan F, Burton PR, et al. Antepartum risk factors
for newborn encephalopathy: the Western Australian
case-control study. BMJ 1998;317:1549–53.
9. Badawi N, Kurinczuk JJ, Keogh JM, Alessandri LM,
O’Sullivan F, Burton PR, et al. Intrapartum risk factors
for newborn encephalopathy: the Western Australian
case-control study. BMJ 1998;317:1554–8.
10. Sameshima H, Ikenoue T, Ikeda T, Kamitomo M, Ibara
S. Unselected low-risk pregnancies and the effect of con-
tinuous intrapartum fetal heart rate monitoring on umbili-
cal blood gases and cerebral palsy. Am J Obstet Gynecol
2004;190:118–23.
11. MacLennan A. A template for defining a causal relation
between acute intrapartum events and cerebral palsy:
international consensus statement. BMJ 1999;319: 1054–
9.
12. National Collaborating Centre for Women’s and Children’s
Health. Caesarean section. London (UK): RCOG Press;
2004.
13. Duerbeck NB, Chaffin DG, Seeds JW. A practical
approach to umbilical artery pH and blood gas determina-
tions. Obstet Gynecol 1992;79:959–62.
14. Strickland DM, Gilstrap LC 3rd, Hauth JC, Widmer K.
Umbilical cord pH and PCO2: effect of interval from
delivery to determination. Am J Obstet Gynecol 1984;
148:191–4.
15. Riley RJ, Johnson JW. Collecting and analyzing cord
blood gases. Clin Obstet Gynecol 1993;36:13–23.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 660
 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 376 • August 2007
Nalbuphine Hydrochloride Use for
Intrapartum Analgesia
ABSTRACT: Safety concerns have been raised regarding the use of nalbuphine
hydrochloride during labor. The American College of Obstetricians and Gynecologists
finds data are insufficient to recommend any changes in nalbuphine hydrochloride admin-
istration at this time.
Nalbuphine hydrochloride (formerly marketed as Nubain) is a synthetic opioid agonist–
antagonist analgesic commonly used for intrapartum analgesia. Concerns for fetal safety
have been raised by one pharmaceutical company that no longer manufactures this agent
(www.fda.gov/medwatch/safety/2005/aug_PI/Nubain_PI.pdf). To date there are insufficient
data to support these concerns or to recommend any change in the administration of this
medication for analgesia in labor.
Copyright © August 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW,
PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be repro-
duced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the pub-
lisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Nalbuphine hydrochloride use for intrapartum analgesia. ACOG Committee Opinion No. 376. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2007;110:449.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 661
 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 379 • September 2007
Management of Delivery of a Newborn
With Meconium-Stained Amniotic Fluid
ABSTRACT: In accordance with the new guidelines from the American Academy
of Pediatrics and the American Heart Association, all infants with meconium-stained
amniotic fluid should no longer routinely receive intrapartum suctioning. If meconium is
present and the newborn is depressed, the clinician should intubate the trachea and suc-
tion meconium and other aspirated material from beneath the glottis.
In 2006, the American Academy of Pediatrics tone, and a heart rate greater than 100 beats
and the American Heart Association pub- per minute, there is no evidence that tracheal
lished new guidelines on neonatal resuscita- suctioning is necessary. Injury to the vocal
tion (1). The most significant impact these cords is more likely to occur when attempt-
new guidelines have on obstetricians relates ing to intubate a vigorous newborn.
to the management of delivery of a new-
born with meconium-stained amniotic fluid. Reference
Previously, management of a newborn with 1. 2005 American Heart Association (AHA)
meconium-stained amniotic fluid included guidelines for cardiopulmonary resuscitation
suctioning of the oropharynx and nasophar- (CPR) and emergency cardiovascular care
ynx on the perineum after the delivery of the (ECC) of pediatric and neonatal patients:
head but before the delivery of the shoulders pediatric basic life support. American Heart
Association. Pediatrics 2006;117:e989–1004.
(intrapartum suctioning). Current evidence
does not support this practice because rou-
tine intrapartum suctioning does not prevent
or alter the course of meconium aspiration Copyright © September 2007 by the American College
of Obstetricians and Gynecologists, 409 12th Street,
syndrome (1). SW, PO Box 96920, Washington, DC 20090-6920.
The Committee on Obstetric Practice All rights reserved. No part of this publication may be
agrees with the recommendation of the reproduced, stored in a retrieval system, posted on the
Internet, or transmitted, in any form or by any means,
American Academy of Pediatrics and the electronic, mechanical, photocopying, recording, or
American Heart Association that all infants otherwise, without prior written permission from the
with meconium-stained amniotic fluid should publisher. Requests for authorization to make pho-
tocopies should be directed to: Copyright Clearance
no longer routinely receive intrapartum suc- Center, 222 Rosewood Drive, Danvers, MA 01923,
tioning. If meconium is present and the (978) 750-8400.
newborn is depressed, the clinician should Management of delivery of a newborn with mecon-
intubate the trachea and suction meconium ium-stained amniotic fluid. ACOG Committee Opinion
No. 379. American College of Obstetricians and Gyne-
or other aspirated material from beneath the cologists. Obstet Gynecol 2007;110:739.
glottis. If the newborn is vigorous, defined as
having strong respiratory efforts, good muscle ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 662
 ACOG COMMITTEE OPINION
Number 381 • October 2007

Subclinical Hypothyroidism in Pregnancy

Committee on ABSTRACT: Subclinical hypothyroidism is diagnosed in asymptomatic women
Obstetric Practice when the thyroid-stimulating hormone level is elevated and the free thyroxine level is
within the reference range. Thyroid hormones, specifically thyroxine, are essential for
Reaffirmed 2010
normal fetal brain development. However, data indicating fetal benefit from thyroxine
This document reflects supplementation in pregnant women with subclinical hypothyroidism currently are not
emerging clinical and
scientific advances as of available. Based on current literature, thyroid testing in pregnancy should be performed
the date issued and is on symptomatic women and those with a personal history of thyroid disease or other
subject to change. The
information should not be medical conditions associated with thyroid disease (eg, diabetes mellitus). Without evi-
construed as dictating an dence that identification and treatment of pregnant women with subclinical hypothyroid-
exclusive course of treat-
ment or procedure to be ism improves maternal or infant outcomes, routine screening for subclinical hypothyroid-
followed. ism currently is not recommended.

Subclinical hypothyroidism is diagnosed in overt hypothyroidism (elevated TSH and

asymptomatic women when the thyroid-
stimulating hormone (TSH) level is elevated
and the free thyroxine (T4) level is within the
reference range. During pregnancy, the diag-
nosis of thyroid abnormalities is confused by
significant but reversible changes in maternal
thyroid physiology that lead to alterations
in thyroid function tests during gestation.
These changes are related to estrogen-medi-
ated increases in maternal thyroid-binding
protein, structural homology between TSH
and human chorionic gonadotropin, and
a relative decrease in availability of iodide
during pregnancy (1). There are gestational
age-specific normograms and thresholds for
evaluating thyroid status during pregnancy
(2–4).
Thyroid hormones, specifically T4, are
essential for normal fetal brain development
(5). Before 12 weeks of gestation, a time
when the fetal thyroid begins to concentrate
iodine and synthesize T4, the fetus is entirely
dependent on maternal transfer of thyroid
hormones. Brain development begins during
this period of fetal dependency in the first tri-
mester and continues throughout pregnancy
and on into infancy. In the case of pregnant
The American College women who are iodine-deficient, in which
of Obstetricians thyroxine production in both mother and
and Gynecologists fetus is insufficient throughout pregnancy,
Women’s Health Care the impact on neurodevelopment of off-
Physicians spring can be dramatic (6). In women with
low free T4 levels), T4 supplementation dur-
ing pregnancy also has been associated with
improved pregnancy outcomes. However,
data indicating fetal benefit from T4 supple-
mentation in pregnant women with sub-
clinical hypothyroidism are not currently
available.
Interest in thyroid disease in preg-
nancy, especially subclinical hypothyroid-
ism, has escalated in part because of reports
suggesting that variously defined thyroid
deficiency (including both overt and sub-
clinical disease) during pregnancy results
in impaired neurodevelopment in offspring
(7, 8). Further, other reports have associ-
ated subclinical hypothyroidism with pre-
term delivery (3, 9). These findings have
led some national societies as well as public
interest groups to recommend routine thy-
roid screening during pregnancy (10). The
rationale for routine screening of pregnant
women is tied both to the prevalence of
subclinical hypothyroidism and the poten-
tial benefits of treatment during pregnancy.
The prevalence of subclinical hypothyroid-
ism could be anticipated to be between 2%
and 5% of women screened, depending on
the TSH and free T4 level thresholds applied,
and this represents most women who
would be identified with thyroid deficiency
through routine screening (3). According to
criteria established by The U.S. Preventive

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 663

 Services Task Force, before recommending screening of
asymptomatic individuals, there must be demonstrated
improvement in important health outcomes of those
individuals identified through screening (11, 12). As
stated previously, benefit of treatment to either mother or
fetus has not yet been demonstrated in pregnant women
with subclinical hypothyroidism.
Based on current literature, thyroid testing in preg-
nancy should be performed on symptomatic women and
those with a personal history of thyroid disease or other
medical conditions associated with thyroid disease (eg,
diabetes mellitus). In these women, it is most appropri-
ate to assess TSH levels first and then evaluate other
thyroid functions if the TSH level is abnormal. Women
with established overt thyroid disease (hyperthyroidism
or hypothyroidism) should be appropriately treated to
maintain a euthyroid state throughout pregnancy and
during the postpartum period. Without evidence that
identification and treatment of pregnant women with
subclinical hypothyroidism improves maternal or infant
outcomes, routine screening for subclinical hypothyroid-
ism is not currently recommended.
References
1. Glinoer D, de Nayer P, Bourdoux P, Lemone M, Robyn
C, van Steirteghem A, et al. Regulation of maternal thy-
roid during pregnancy. J Clin Endocrinol Metab 1990;71:
276–87.
2. Dashe JS, Casey BM, Wells CE, McIntire DD, Byrd EW,
Leveno KJ, et al. Thyroid-stimulating hormone in singleton
and twin pregnancy: importance of gestational age-specific
reference ranges. Obstet Gynecol 2005;106:753–7.
3. Casey BM, Dashe JS, Wells CE, McIntire DD, Byrd W,
Leveno KJ, et al. Subclinical hypothyroidism and pregnancy
outcomes. Obstet Gynecol 2005;105:239–45.
4. Casey BM, Dashe JS, Spong CY, McIntire DD, Leveno
KJ, Cunningham GF. Perinatal significance of isolated
maternal hypothyroxinemia identified in the first half of
pregnancy. Obstet Gynecol 2007;109:1129–35.
5. Morreale de Escobar G, Obregon MJ, Escobar del Rey F.
Is neuropsychological development related to maternal
hypothyroidism or to maternal hypothyroxinemia? J Clin
Endocrinol Metab 2000;85:3975–87.
COMMITTEE OPINIONS
6. Glinoer D. Pregnancy and iodine. Thyroid 2001;11:471–81.
7. Haddow JE, Palomaki GE, Allan WC, Williams JR, Knight
GJ, Gagnon J, et al. Maternal thyroid deficiency during
pregnancy and subsequent neuropsychological develop-
ment of the child. N Engl J Med 1999;341:549–55.
8. Pop VJ, Kuijpens JL, van Baar AL, Verkerk G, van Son MM,
de Vijlder JJ, et al. Low maternal free thyroxine concentra-
tions during early pregnancy are associated with impaired
psychomotor development in infancy. Clin Endocrinol
1999;50:149–55.
9. Stagnaro-Green A, Chen X, Bogden JD, Davies TF, Scholl
TO. The thyroid and pregnancy: a novel risk factor for very
preterm delivery. Thyroid 2005;15:351–7.
10. Gharib H, Tuttle RM, Baskin HJ, Fish LH, Singer PA,
McDermott MT. Subclinical thyroid dysfunction: a joint
statement on management from the American Association
of Clinical Endocrinologists, the American Thyroid Asso-
ciation, and The Endocrine Society. Consensus Statement
#1. American Association of Clinical Endocrinologists;
American Thyroid Association; The Endocrine Society.
Thyroid 2005;15:24–8; response 32–3.
11. Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD,
Teutsch SM, et al. Current methods of the US Preventive
Services Task Force: a review of the process. Methods Work
Group, Third US Preventive Services Task Force. Am J Prev
Med 2001;20(suppl):21–35.
12. Surks MI, Ortiz E, Daniels GH, Sawin CT, Col NF, Cobin
RH, et al. Subclinical thyroid disease: scientific review and
guidelines for diagnosis and management. JAMA 2004;
291:228–38.
Copyright © October 2007 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Subclinical hypothyroidism in pregnancy. ACOG Committee Opinion
No. 381. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2007;110:959–60.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 664
 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
Reaffirmed 2010
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 382 • October 2007
Fetal Monitoring Prior to Scheduled
Cesarean Delivery
ABSTRACT: There are insufficient data to determine the value of fetal monitoring
prior to scheduled cesarean delivery in patients without risk factors.
With the increasing rate of scheduled cesarean deliveries in the United States, clinicians and
hospitals must decide whether there is need to determine fetal status prior to scheduled
cesarean delivery. At the present time there are insufficient data to determine the value of
fetal monitoring, either by electronic fetal heart rate monitoring or by ultrasound, prior to
scheduled cesarean delivery in patients without risk factors. The decision to monitor the fetus
prior to scheduled cesarean delivery should be individualized. Presence of fetal heart tones
prior to surgery should be documented.
Copyright © October 2007 by the American College of Obstetricians and Gynecologists, 409 12th Street,
SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the pub-
lisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Fetal monitoring prior to scheduled cesarean delivery. ACOG Committee Opinion No. 382. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2007;110:961.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 665
 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
Reaffirmed 2011
This Committee Opinion
was developed with the
assistance of William
A. Engle, MD, Kay M.
Tomashek, MD, Carol
Wallman, MSN, and the
American Academy of
Pediatrics Committee on
Fetus and Newborn.
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 404 • April 2008
Late-Preterm Infants
ABSTRACT: Late-preterm infants (defined as infants born between 340⁄7 weeks and
366⁄7 weeks of gestation) often are mistakenly believed to be as physiologically and meta-
bolically mature as term infants. However, compared with term infants, late-preterm
infants are at higher risk than term infants of developing medical complications, resulting
in higher rates of infant mortality, higher rates of morbidity before initial hospital dis-
charge, and higher rates of hospital readmission in the first months of life. Preterm deliv-
ery should occur only when an accepted maternal or fetal indication for delivery exists.
Collaborative counseling by both obstetric and neonatal clinicians about the outcomes of
late-preterm births is warranted unless precluded by emergent conditions.
During the past decade, the proportion of Summary
all U.S. births that were late-preterm births During the initial birth hospitalization, late-
(defined as birth between 340⁄7 weeks and 366⁄7
preterm infants are 4 times more likely than
weeks of gestation) increased 16% (1). The term infants to have at least 1 medical condi-
rate of all preterm births (defined as birth tion diagnosed and 3.5 times more likely to
at less than 37 weeks of gestation) in the
have 2 or more conditions diagnosed (6).
United States increased from 10.9% in 1990 Late-preterm infants are more likely than
to 12.7% in 2005 (2), an increase of 16.5%.
term infants to be diagnosed during the birth
This increase largely was caused by the in- hospitalization with temperature instability
crease in late-preterm births. Late-preterm (6), hypoglycemia (6), respiratory distress (6,
infants often are mistakenly believed to be as 8–11), apnea (12, 13), jaundice (6), and feed-
physiologically and metabolically mature as ing difficulties (6). During the first month
term infants. However, compared with term after birth, late-preterm infants are also more
infants, late-preterm infants are at higher likely than term infants to develop hyper-
risk of developing medical complications bilirubinemia (14–17) and to be readmitted
resulting in higher rates of infant mortal- for hyperbilirubinemia (18–20) and non–
ity, higher rates of morbidity before initial
jaundice-related diagnoses such as feeding
hospital discharge (3–5), and higher rates of
difficulties and “rule-out sepsis” (18).
hospital readmission in the first months of
In 2002, the neonatal mortality rate
life (4–6).
(deaths among infants 0–27 days’ chronolog-
Infant Implications ic age) for late-preterm infants was 4.6 times
higher than the rate for term infants (4.1 vs
Late-preterm births make up 71% of all
preterm births (1). It is important to limit 0.9 per 1000 live births, respectively). This
late-preterm deliveries to those with a clear difference in neonatal mortality has widened
maternal or fetal indication for delivery. As slightly since 1995, when there was a fourfold
the number of late-preterm births increases, difference in rates between late-preterm and
it is important to understand the unique term infants (4.8 vs 1.2 per 1000 live births,
problems that this growing population of respectively). The infant mortality rate was
infants may experience. also higher among late-preterm infants than
The American Academy of Pediatrics term infants in 2002 (7.7 vs 2.5 per 1000 live
has published guidelines for the care of late- births, respectively). This threefold differ-
preterm infants (7). The following sections ence has remained relatively constant since
contain extracts taken from these guidelines. 1995, at which time the infant mortality rate
2013 COMPENDIUM OF SELECTED PUBLICATIONS 666
 was 9.3 per 1000 live births among late-preterm infants
and 3.1 per 1000 live births among term infants.
Pulmonary Function
After birth, infants with fetal lung structure and
immature functional capacity are at greatest risk of respi-
ratory distress, need for oxygen and positive-pressure
ventilation, and admission for intensive care (6, 9, 21,
22). From 340⁄7 through 366⁄7 weeks’ gestation, terminal
respiratory units of the lung evolve from alveolar saccules
lined with both cuboidal type II and flat type I epithelial
cells (terminal sac period) to mature alveoli lined primar-
ily with extremely thin type I epithelial cells (alveolar
period) (23, 24). During the alveolar period, pulmonary
capillaries also begin to bulge into the space of each ter-
minal sac, and adult pool sizes of surfactant are attained
(25). Functionally, this immature lung structure may be
associated with delayed intrapulmonary fluid absorption,
surfactant insufficiency, and inefficient gas exchange (8,
26).
Apnea occurs more frequently among late-preterm
infants than term infants. The incidence of apnea in late-
preterm infants is reported to be between 4% and 7% (12,
21, 27, 28) compared with less than 1% to 2% at term (12,
29). The predisposition to apnea in late-preterm infants
is associated with several underlying factors including
increased susceptibility to hypoxic respiratory depression,
decreased central chemosensitivity to carbon dioxide,
immature pulmonary irritant receptors, increased respi-
ratory inhibition sensitivity to laryngeal stimulation, and
decreased upper airway dilator muscle tone (12, 13, 21,
30, 31).
Cardiac Function
It is generally believed that structural and functional
immaturity restricts the amount of cardiovascu-
lar reserve that is available during times of stress (32, 33).
Immature cardiovascular function also may complicate
recovery of the late-preterm infant with respiratory dis-
tress because of delayed ductus arteriosus closure and
persistent pulmonary hypertension (34).
Cold Response
Late-preterm infants have less white adipose tissue for
insulation, and they cannot generate heat from brown
adipose tissue as effectively as infants born at term. In
addition, late-preterm infants are likely to lose heat more
readily than term infants, because they have a larger ratio
of surface area to weight and are smaller in size.
Hypoglycemia
The incidence of hypoglycemia is inversely proportional
to gestational age. Preterm infants are at increased risk
of developing hypoglycemia after birth, because they
have immature hepatic glyco-genolysis and adipose tissue
lipolysis, hormonal dysregulation, and deficient hepatic
gluconeogenesis and ketogenesis. Blood glucose concen-
trations among preterm infants typically decrease to a
nadir 1 to 2 hours after birth and remain low until meta-
COMMITTEE OPINIONS
bolic pathways can compensate or exogenous sources
of glucose are provided (35, 36). Immature glucose
regulation likely occurs in late-preterm infants, because
hypoglycemia that requires glucose infusion during the
initial birth hospitalization occurs more frequently than
in term infants (6).
Jaundice
Jaundice and hyperbilirubinemia occur more com-
monly and are more prolonged among late-preterm
infants than term infants, because late-preterm infants
have delayed maturation and a lower concentration of
uridine diphosphoglucuronate glucuronosyltransferase
(14, 37). Late-preterm infants are 2 times more likely
than term infants to have significantly elevated bilirubin
concentrations and higher concentrations 5 and 7 days
after birth (14). Late-preterm infants also have immature
gastrointestinal function (38, 39) and feeding difficul-
ties that predispose them to an increase in enterohepatic
circulation, decreased stool frequency, dehydration, and
hyperbilirubinemia (15, 19, 20, 40–46). Feeding during
the birth hospitalization may be transiently successful
but not sustained after discharge. Feeding difficulties in
late-preterm infants that are associated with relatively
low oromotor tone, function, and neural maturation also
predispose these infants to dehydration and hyperbiliru-
binemia (45–48).
Obstetric Implications
Because of the aforementioned increase in rates of mor-
bidity and mortality of late-preterm infants, preterm
delivery should only occur when an accepted maternal or
fetal indication for delivery exists. Examples may include
nonreassuring fetal status or a maternal condition that is
likely to be improved by delivery. Collaborative counsel-
ing by both obstetric and neonatal clinicians about the
outcomes of late-preterm births is warranted unless pre-
cluded by emergent conditions.
References
1. Davidoff MJ, Dias T, Damus K, Russell R, Bettegowda R,
Dolans, et al. Changes in the gestational age distribution
among U.S. singleton births: impact on rates of late preterm
birth, 1992 to 2002. Semin Perinatol 2006;30:8–15.
2. Hamilton BE, Martin JA, Ventura SJ. Births: preliminary
data for 2005. Natl Vital Stat Rep 2006;55(11):1–18.
3. Kramer MS, Demissie K, Yang H, Platt RW, Sauve R, Liston
R. The contribution of mild and moderate preterm birth
to infant mortality. Fetal and Infant Health Study Group
of the Canadian Perinatal surveillance System. JAMA
2000;284: 843–9.
4. Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M,
Barfield W, Weiss J, Evans S. Risk factors for neonatal
morbidity and mortality among “healthy,” late preterm
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the gastrointestinal tract. In: Taeusch HW, Ballard RA, permission from the publisher. Requests for authorization to make
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ed. Philadelphia (PA): Elsevier Saunders; 2005. p. 1071–85. Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
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COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 669

 ACOG COMMITTEE OPINION
Number 418 • September 2008 (Replaces No. 304, November 2004)

Prenatal and Perinatal Human

Immunodeficiency Virus Testing:
Expanded Recommendations
Committee on ABSTRACT: Early identification and treatment of all pregnant women with human
Obstetric Practice immunodeficiency virus (HIV) is the best way to prevent neonatal disease and improve
Reaffirmed 2011
the woman’s health. Human immunodeficiency virus screening is recommended for
all pregnant women after they are notified that they will be tested for HIV infection as
This document reflects part of the routine panel of prenatal blood tests unless they decline the test (ie, opt-out
emerging clinical and
scientific advances as screening). Repeat testing in the third trimester, or rapid HIV testing at labor and delivery
of the date issued and as indicated or both also are recommended as additional strategies to further reduce
is subject to change. The
information should not be the rate of perinatal HIV transmission. The American College of Obstetricians and
construed as dictating an Gynecologists makes the following recommendations: obstetrician–gynecologists should
exclusive course of treat-
ment or procedure to be follow opt-out prenatal HIV screening where legally possible; repeat conventional or rapid
followed. HIV testing in the third trimester is recommended for women in areas with high HIV
prevalence, women known to be at high risk for acquiring HIV infection, and women
who declined testing earlier in pregnancy; rapid HIV testing should be used in labor for
women with undocumented HIV status following opt-out screening; and if a rapid HIV
test result in labor is positive, immediate initiation of antiretroviral prophylaxis should be
recommended without waiting for the results of the confirmatory test.

The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
The Centers for Disease Control and Preven-
tion (CDC) estimates that 40,000 new cases
of human immunodeficiency virus (HIV)
infection still occur in the United States each
year (1). This figure includes approximately
138 infants infected via mother-to-child (ver-
tical) transmission (2). Antiretroviral medi-
cations given to women with HIV perinatally
and to their newborns in the first weeks of
life reduce the vertical transmission rate from
25% to 2% or less (3–6). Even instituting
maternal prophylaxis during labor and deliv-
ery, or neonatal prophylaxis within 24–48
hours of delivery, or both can substantially
decrease rates of infection in infants (4). A
retrospective review of HIV-exposed infants
in New York State showed a transmission
rate of approximately 10% when zidovudine
prophylaxis was begun intrapartum or if
given to newborns within 48 hours of life.
There is no significant reduction of neonatal
transmission if therapy is started after 3 days
of life (4). Early identification and treatment
of pregnant women and prophylactic treat-
ment of newborns in the first hours of life are
essential to prevent neonatal disease.
Prenatal Human
Immunodeficiency Virus
Testing
All pregnant women should be screened for
HIV infection as early as possible during each
pregnancy after they are notified that HIV
screening is recommended for all pregnant
patients and that they will receive an HIV
test as part of the routine panel of prenatal
tests unless they decline (opt-out screening).
No woman should be tested without her
knowledge; however, no additional process
or written documentation of informed con-
sent beyond what is required for other rou-
tine prenatal tests is required for HIV testing.
Pregnant women should be provided with
oral or written information about HIV (1, 7)

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 670

 that includes an explanation of HIV infection, a descrip-
tion of interventions that can reduce HIV transmission
from mother to infant, the meanings of positive and
negative test results, and the opportunity to ask questions
and decline testing (1). If a patient declines HIV testing,
this should be documented in the medical record and
should not affect access to care. Women who decline an
HIV test because they have had a previous negative test
result should be informed of the importance of retest-
ing during each pregnancy (1). The American College of
Obstetricians and Gynecologists, the American Academy
of Pediatrics (7), and the CDC (1, 8) recommend opt-out
HIV screening for pregnant women. Since the release of
CDC recommendations in September 2006 (1), some
states have changed their state laws and regulations to
opt-out screening. Obstetrician–gynecologists should be
aware of and comply with their states’ legal requirements
for perinatal HIV screening. Legal requirements for
perinatal HIV testing may be verified by contacting state
or local public health departments. The National HIV/
AIDS Clinicians’ Consultation Center at the University of
California–San Francisco maintains an online compendi-
um of state HIV testing laws that can be a useful resource
(see Resources). The Centers for Disease Control and
Prevention recommend that jurisdictions with barriers
to routine prenatal screening using opt-out screening
consider addressing them (9).
Perinatal Human Immunodeficiency
Virus Testing
The conventional HIV testing algorithm, which may take
up to 2 weeks to complete if a result is positive, begins
with a screening test, the enzyme-linked immunosorbent
assay (ELISA) that detects antibodies to HIV; if the results
are positive, it is followed by a confirmatory test, either a
Western blot or an immunofluorescence assay (IFA). A
positive ELISA test result is not diagnostic of HIV infec-
tion unless confirmed by the Western blot or IFA. The
sensitivity and specificity of ELISA with a confirmatory
Western blot test are greater than 99%. The false-positive
rate for ELISA with a confirmatory Western blot test is 1
in 59,000 tests. If the ELISA test result is positive and the
Western blot or IFA test result is negative, the patient is
not infected and repeat testing is not indicated.
If the ELISA test result is repeatedly positive and
the Western blot result contains some but not all of the
viral bands required to make a definitive diagnosis, the
test result is labeled indeterminate. Most patients with
indeterminate test results are not infected with HIV.
However, consultation with a health care provider well
versed in HIV infection is recommended. This specialist
may suggest viral load testing or repeat testing later in
pregnancy to rule out the possibility of recent infection.
If the screening (eg, ELISA) and confirmatory test
(eg, Western blot or IFA) results are both positive, the
patient should be given her results in person. The impli-
cations of HIV infection and vertical transmission should
COMMITTEE OPINIONS
be discussed with the patient. Additional laboratory eval-
uation, including CD4 count, HIV viral load, resistance
testing, hepatitis C virus antibody, hepatitis B surface
antigen, complete blood count with platelet count, and
baseline chemistries with liver function tests, will be use-
ful before prescribing antiretroviral prophylaxis.
A rapid HIV test is an HIV screening test with results
available within hours. Obstetrician–gynecologists may
use rapid testing as their standard outpatient test and
should also use rapid testing in labor and delivery (see
details as follows regarding labor and delivery). A negative
rapid test result is definitive. A positive rapid test result is
not definitive and must be confirmed with a supplemental
test, such as a Western blot or IFA test. Rapid test results
usually will be available during the same clinical visit that
the specimen (eg blood, or oral swab) is collected. Health
care providers who use these tests must be prepared to
provide counseling to pregnant women who receive
positive rapid test results the same day that the specimen is
collected. Pregnant women with positive rapid test results
should be counseled regarding the meaning of these pre-
liminary positive test results and the need for confirmato-
ry testing. As with conventional HIV testing, consultation
with a health care provider well versed in HIV infection
is recommended. To code for rapid testing, the modifier
92 is added to the basic HIV testing Current Procedural
Terminology (CPT ®)* code 86701-86703) (10). If the
results of the rapid test and the confirmatory test are dis-
crepant, both tests should be repeated and consultation
with an infectious disease specialist is recommended.
Any woman who arrives at a labor and delivery facil-
ity with undocumented HIV status should be screened
with a rapid HIV test unless she declines (opt-out screen-
ing) in order to provide an opportunity to begin prophy-
laxis of previously undiagnosed infection before delivery
(1). Data from several studies indicate that 40–85% of
infants infected with HIV are born to women whose HIV
infection is unknown to their obstetric provider before
delivery (11–14). If a rapid test is used in labor and HIV
antibodies are detected, immediate initiation of antiret-
roviral prophylaxis should be recommended without
waiting for the results of the confirmatory test to further
reduce possible transmission to the infant. All antiretro-
viral prophylaxis should be discontinued if the confirma-
tory test result is negative (11). Recommendations for
the use of antiretroviral medications in pregnant women
infected with HIV are available at www.aidsinfo.nih.gov
and are updated frequently.
The rapid HIV antibody screening tests, which are
approved by the U.S. Food and Drug Administration, all
have sensitivity and specificity equal to or greater than
99% (15). As with all screening tests, the likelihood of a
*Current Procedural Terminology (CPT)® is copyright 2008 by
American Medical Association. All rights reserved. No fee schedules,
basic units, relative values, or related listings are included in CPT. The
AMA assumes no liability for the data contained herein. CPT® is a
trademark of the American Medical Association.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 671
 false-positive result is higher in populations with low HIV
prevalence when compared with populations with high
HIV prevalence. Additionally, at present it is not known
how the false-positive rate for rapid testing will compare
with the false-positive rate for conventional testing.
If the rapid HIV test result at labor and delivery is pos-
itive, the obstetric provider should take the following steps:
1. Tell the woman she may have HIV infection and that
her neonate also may be exposed
2. Explain that the rapid test result is preliminary and
that false-positive results are possible
3. Assure the woman that a second test is being done
right away to confirm the positive rapid test result
4. Immediate initiation of antiretroviral prophylaxis
should be recommended without waiting for the
results of the confirmatory test to reduce the risk of
transmission to the infant
5. Once the woman gives birth, discontinue maternal
antiretroviral therapy pending receipt of confirma-
tory test results
6. Tell the woman that she should postpone breast-
feeding until the confirmatory result is available
because she should not breast-feed if she is infected
with HIV
7. Inform pediatric care providers (depending on state
requirements) of positive maternal test results so
that they may institute the appropriate neonatal
prophylaxis
Repeat Human Immunodeficiency
Virus Testing in the Third Trimester
Repeat testing in the third trimester should be considered
in jurisdictions with elevated HIV or AIDS incidence and
in health care facilities in which prenatal screening identi-
fies at least one HIV-infected pregnant woman per 1,000
women screened (1). Additionally, although physicians
need to be aware of and follow their states’ perinatal HIV
screening requirements, repeat testing in the third tri-
mester, preferably before 36 weeks of gestation, is recom-
mended for pregnant women at high risk for acquiring
HIV. Criteria for repeat testing can include (1):
• Have been diagnosed with another sexually trans-
mitted disease in the last year
• Injection drug use or the exchange of sex for money
or drugs
• A new or more than one sex partner during this
pregnancy or a sex partner(s) known to be HIV-
positive or at high risk
Women who are candidates for third-trimester test-
ing, including those who declined testing earlier in preg-
nancy, should be given a conventional or rapid HIV test
rather than waiting to receive a rapid test at labor and
delivery (as allowed by state laws and regulations).
COMMITTEE OPINIONS
Recommendations
Given the enormous advances in the prevention of peri-
natal transmission of HIV, it is clear that early identifica-
tion and treatment of all pregnant women with HIV is
the best way to prevent neonatal disease and also may
improve the women’s health. Therefore, the American
College of Obstetricians and Gynecologists makes the fol-
lowing recommendations:
• Screen all pregnant women for HIV as early as pos-
sible during each pregnancy following opt-out pre-
natal HIV screening where legally possible
• Repeat HIV testing in the third trimester is recom-
mended for women in areas with high HIV preva-
lence, women known to be at high risk for acquiring
HIV infection, and women who declined testing
earlier in pregnancy
• Use conventional or rapid HIV testing for women
who are candidates for third-trimester testing
• Use rapid HIV testing in labor for women with un-
documented HIV status following opt-out screening
• If a rapid HIV test result in labor is positive, immedi-
ate initiation of antiretroviral prophylaxis should be
recommended without waiting for the results of the
confirmatory test
Resources
AIDSinfo
PO Box 6303
Rockville, MD 20849-6303
1-800-448-0440
www.aidsinfo.nih.gov
The American College of Obstetricians and Gynecologists
409 12th Street SW, PO Box 96920
Washington, DC 20090-6920
800-673-8444 or (202) 638-5577
www.acog.org
Perinatal HIV page: www.acog.org/goto/HIV
ACOG Bookstore: www.acog.org/bookstore
Centers for Disease Control and Prevention
1600 Clifton Road NE
Atlanta, GA 30333
(404) 639-3311 or 800-232-4636
www.cdc.gov
HIV/AIDS page: www.cdc.gov/hiv
National AIDS Hotline: 800-342-AIDS (2437) (English);
800-344-7432 (Spanish); 800-243-7889 (TTY, deaf access)
www.cdc.gov/hiv
National HIV/AIDS Clinicians’ Consultation Center
UCSF Department of Family and Community Medicine at
San Francisco General Hospital
1001 Potrero Ave., Bldg. 20, Ward 22
San Francisco, CA 94110
(415) 206-8700
Perinatal HIV Hotline: 1-888-448-8765
www.nccc.ucsf.edu
2013 COMPENDIUM OF SELECTED PUBLICATIONS 672
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COMMITTEE OPINIONS
hiv/topics/perinatal/resources/other/dear_colleague-2003.
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Copyright © September 2008 by the American College of Obstet-
ricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this pub-
lication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to
make photocopies should be directed to: Copyright Clearance Center,
222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Prenatal and perinatal human immunodeficiency virus testing:
expanded recommendations. ACOG Committee Opinion No. 418.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2008;112:739–42.
ISSN 1074-861X
2013 COMPENDIUM OF SELECTED PUBLICATIONS 673
 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
COMMITTEE OPINIONS
Number 433 • May 2009 (Replaces No. 256, May 2001)
Optimal Goals for Anesthesia Care in
Obstetrics
ABSTRACT: A joint statement from the American Society of Anesthesiologists and
the American College of Obstetricians and Gynecologists was developed to address
issues of concern to both specialties. Good obstetric care requires the availability of
qualified personnel and equipment to administer general or regional anesthesia both
electively and emergently. The extent and degree to which anesthesia services are
available varies widely among hospitals. However, for hospitals providing obstetric care,
certain optimal anesthesia goals should be sought.
This joint statement from the American cluding an emergency cesarean delivery
Society of Anesthesiologists and the American in cases of vaginal birth after cesarean
College of Obstetricians and Gynecologists delivery (1). The definition of immedi-
has been designed to address issues of con- ately available personnel and facilities
cern to both specialties. Good obstetric care remains a local decision based on each
requires the availability of qualified per- institution’s available resources and geo-
sonnel and equipment to administer gen- graphic location.
eral or regional anesthesia both electively and V. Appointment of a qualified anesthesiol-
emergently. The extent and degree to which ogist to be responsible for all anesthetics
anesthesia services are available varies widely administered. There are many obstetric
among hospitals. However, for any hospi- units where obstetricians or obstetrician-
tal providing obstetric care, certain optimal supervised nurse anesthetists administer
anesthesia goals should be sought as follows: labor anesthetics. The administration of
I. Availability of a licensed practitioner who general or regional anesthesia requires
is credentialed to administer an appro- both medical judgment and technical
priate anesthetic whenever necessary. skills. Thus, a physician with privileges
For many women, regional anesthesia in anesthesiology should be readily
(epidural, spinal, or combined spinal available.
epidural) will be the most appropri-
ate anesthetic. Persons administering or supervising
obstetric anesthesia should be qualified to
II. Availability of a licensed practitioner manage the infrequent but occasional life-
who is credentialed to maintain sup- threatening complications of major regional
port of vital functions in any obstetric anesthesia such as respiratory and cardiovas-
emergency. cular failure, toxic local anesthetic convul-
III. Availability of anesthesia and surgical
sions, or vomiting and aspiration. Mastering
personnel to permit the start of a cesa- and retaining the skills and knowledge
rean delivery within 30 minutes of the necessary to manage these complications
decision to perform the procedure.
require adequate training and frequent appli-
IV. Immediate availability of appropriate
cation.
facilities and personnel, including obstet- To ensure the safest and most effective
ric anesthesia, nursing personnel, and a anesthesia for obstetric patients, the director
physician capable of monitoring labor of anesthesia services, with the approval of
and performing cesarean delivery, in- the medical staff, should develop and enforce
2013 COMPENDIUM OF SELECTED PUBLICATIONS 674
 written policies regarding provision of obstetric anesthe-
sia as follows:
I. A qualified physician with obstetric privileges to per-
form operative vaginal or cesarean delivery should
be readily available during administration of anes-
thesia. Readily available should be defined by each
institution within the context of its resources and
geographic location. Regional or general anesthe-
sia or both should not be administered until the
patient has been examined and the fetal status and
progress of labor evaluated by a qualified individual.
A physician with obstetric privileges who concurs
with the patient’s management and has knowledge
of the maternal and fetal status and the progress
of labor should be readily available to handle any
obstetric complications that may arise. A physician
with obstetric privileges should be responsible for
midwifery back up in hospital settings that utilize
certified nurse–midwives and certified midwives as
obstetric providers.
II. Availability of equipment, facilities, and support
personnel equal to that provided in the surgical
suite. This should include the availability of a prop-
erly equipped and staffed recovery room capable of
receiving and caring for all patients recovering from
major regional or general anesthesia. Birthing facili-
ties, when used for analgesia or anesthesia, must be
appropriately equipped to provide safe anesthetic
care during labor and delivery or postanesthesia
recovery care.
III. Personnel other than the surgical team should be
immediately available to assume responsibility for
resuscitation of the depressed newborn. The surgeon
and anesthesiologist are responsible for the mother
and may not be able to leave her to care for the new-
born even when a regional anesthetic is functioning
adequately. Individuals qualified to perform neona-
tal resuscitation should demonstrate:
A. Proficiency in rapid and accurate evaluation of the
newborn condition, including Apgar scoring
B. Knowledge of the pathogenesis of a depressed
newborn (acidosis, drugs, hypovolemia, trauma,
anomalies, and infection), as well as specific indi-
cations for resuscitation
C. Proficiency in newborn airway management,
laryngoscopy, endotracheal intubations, suction-
ing of airways, artificial ventilation, cardiac mas-
sage, and maintenance of thermal stability
In larger maternity units and those functioning as
high-risk centers, 24-hour in-house anesthesia, obstetric,
and neonatal specialists usually are necessary. Preferably,
the obstetric anesthesia services should be directed by
an anesthesiologist with special training or experience
in obstetric anesthesia. These units also will frequently
COMMITTEE OPINIONS
require the availability of more sophisticated monitoring
equipment and specially trained nursing personnel.
A survey jointly sponsored by the American Society
of Anesthesiologists and The American College of
Obstetricians and Gynecologists found that many hospi-
tals in the United States have not yet achieved the goals
mentioned previously. Deficiencies were most evident in
smaller delivery units. Some small delivery units are nec-
essary because of geographic considerations. Currently,
approximately 34% of hospitals providing obstetric care
have fewer than 500 deliveries per year (2). Providing
comprehensive care for obstetric patients in these small
units is extremely inefficient, not cost-effective, and
frequently impossible. Thus, the following recommenda-
tions are made:
1. Whenever possible, small units should consolidate.
2. When geographic factors require the existence of
smaller units, these units should be part of a well-
established regional perinatal system.
The availability of the appropriate personnel to assist
in the management of a variety of obstetric problems is
a necessary feature of good obstetric care. The presence
of a pediatrician or other trained physician at a high-risk
cesarean delivery to care for the newborn, or the avail-
ability of an anesthesiologist during active labor and
delivery when vaginal birth after cesarean delivery is
attempted and at a breech or multifetal delivery are
examples. Frequently, these physicians spend a consid-
erable amount of time standing by for the possibility
that their services may be needed emergently but may
ultimately not be required to perform the tasks for which
they are present. Reasonable compensation for these
standby services is justifiable and necessary.
A variety of other mechanisms have been suggested
to increase the availability and quality of anesthesia ser-
vices in obstetrics. Improved hospital design, which places
labor and delivery suites closer to the operating rooms,
would allow for more efficient supervision of nurse–anes-
thetists. Anesthesia equipment in the labor and delivery
area must be comparable to that in the operating room.
Finally, good interpersonal relations between obste-
tricians and anesthesiologists are important. Joint meet-
ings between the two departments should be encouraged.
Anesthesiologists should recognize the special needs and
concerns of obstetricians and obstetricians should recog-
nize anesthesiologists as consultants in the management
of pain and life-support measures. Both should recognize
the need to provide high-quality care for all patients.
References
1. Vaginal birth after previous cesarean delivery. ACOG
Practice Bulletin No. 54. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2004;104:203–12.
2. Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric
anesthesia workforce survey: twenty-year update. Anesthe-
siology 2005;103:645–53.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 675
 Copyright © May 2009 by the American College of Obstetricians
and Gynecologists and the American Society of Anesthesiologists.
All rights reserved. No part of this publication may be reproduced,
stored in a retrieval system, posted on the Internet, or transmitted,
in any form or by any means, electronic, mechanical, photocopying,
recording, or otherwise, without prior written permission from the
publisher. Requests for authorization to make photocopies should
be directed to: Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Optimal goals for anesthesia care in obstetrics. ACOG Committee
Opinion No. 433. American College of Obstetricians and Gynecolo-
gists and American Society of Anesthesiologists. Obstet Gynecol
2009;113:1197–9.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 676

 ACOG COMMITTEE OPINION
Committee on
Obstetric Practice
This document reflects
emerging clinical and sci-
entific advances as of the
date issued and is subject
to change. The information
should not be construed
as dictating an exclusive
course of treatment or pro-
cedure to be followed.
The American College
of Obstetricians
and Gynecologists
Women’s Health Care
Physicians
COMMITTEE OPINIONS
Number 435 • June 2009
Postpartum Screening for Abnormal
Glucose Tolerance in Women Who Had
Gestational Diabetes Mellitus
ABSTRACT: Establishing the diagnosis of gestational diabetes mellitus offers an
opportunity not only to improve pregnancy outcome, but also to decrease risk factors
associated with the subsequent development of type 2 diabetes. The American College
of Obstetricians and Gynecologists’ Committee on Obstetric Practice recommends that
all women with gestational diabetes mellitus be screened at 6–12 weeks postpartum and
managed appropriately.
Gestational diabetes mellitus (GDM), defined interventions to decrease incident diabetes.
as carbohydrate intolerance leading to hyper- However, there is marked variability in the
glycemia with onset or first recognition proportion of women with GDM who are
during pregnancy, affects 2–10% of pregnan- screened postpartum as well as in the type of
cies in the United States depending on the screening used (6–7, 9, 15–20).
characteristics of the population studied (1). Either a fasting plasma glucose test or
Gestational diabetes mellitus is characterized the 75-g, 2-hour oral glucose tolerance test
by insulin resistance that is specific to preg- are appropriate for diagnosing diabetes.
nancy. This Committee Opinion augments Although the fasting plasma glucose test is
ACOG Practice Bulletin No. 30: Gestational easier to perform, it lacks sensitivity for detect-
Diabetes (2) by highlighting recent thinking ing other forms of abnormal glucose metabo-
about the risk for diabetes mellitus among lism; results of the oral glucose tolerance test
women whose pregnancies were affected by can confirm an impaired fasting glucose level
GDM, and presents recommendations for and impaired glucose tolerance (see Table 1).
screening and management for these women. In light of this, the Fifth International Work-
Although the carbohydrate intolerance shop on GDM recommended that women
of GDM frequently resolves after delivery (3, with GDM undergo a 75-g oral glucose toler-
4), up to one third of affected women will ance test 6–12 weeks postpartum (21).
have diabetes or impaired glucose metabo- Establishing the diagnosis of GDM offers
lism at postpartum screening, and it has been an opportunity not only to improve preg-
estimated that 15–50% will develop diabetes nancy outcome, but also to affect risk factors
in the decades following the affected preg- associated with the subsequent development
nancy (5–12). The original cutoff points for of type 2 diabetes. The American College of
performing an abnormal glucose tolerance Obstetricians and Gynecologists’ Committee
test in pregnancy were chosen for their abil- on Obstetric Practice recommends that all
ity to predict the subsequent onset of type 2 women with GDM be screened at 6–12 weeks
diabetes mellitus (13). Postpartum screening postpartum and managed appropriately (see
at 6–12 weeks has been recommended for Fig. 1). The American Diabetes Association
women who had GDM to identify women recommends repeat testing at least every
with diabetes mellitus, or impaired fasting 3 years for women who had a pregnancy
glucose level, or impaired glucose tolerance affected by GDM and normal results of post-
(14, 19). The latter two may respond to partum screening (14). For women who may
life-style modification and pharmacologic have subsequent pregnancies, screening more
2013 COMPENDIUM OF SELECTED PUBLICATIONS 677
 Table 1. Diagnostic criteria for diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance.
Impaired Fasting Impaired Glucose
Test Diabetes Glucose Tolerance

Fasting plasma Fasting plasma glucose is Fasting plasma glucose NA

glucose greater than or equal to 126 is 100–125
75-g 2 hr oral glucose Fasting plasma glucose is Fasting plasma glucose 2-hr plasma glucose is
tolerance test greater than or equal to 126 is 100–125 140–199
or
2-hr plasma glucose is
greater than or equal to 200

Gestational diabetes

FPG or 75-g 2 hr OGTT at 6–12 weeks postpartum

Diabetes mellitus Impaired fasting glucose or IGT or both Normal

Refer for diabetes management Assess glycemic status every

Consider referral for management
3 years
Weight loss and physical activity
counseling as needed Weight loss and physical activity
counseling as needed
Consider metformin if combined
impaired fasting glucose and IGT
Medical nutrition therapy
Yearly assessment of glycemic status

Fig. 1. Management of postpartum screening results. Abbreviations: FPG, fasting plasma glucose; OGTT, oral glucose
tolerance test; IGT, impaired glucose tolerance.

frequently has the advantage of detecting abnormal
glucose metabolism before pregnancy and provides an
opportunity to ensure preconception glucose control
(21). Women should be encouraged to discuss their
GDM history and need for screening with all of their
health care providers.
References
1. Hunt KJ, Schuller KL. The increasing prevalence of dia-
betes in pregnancy. Obstet Gynecol Clin North Am 2007;
34:173–99, vii.
2. Gestational diabetes. ACOG Practice Bulletin No. 30.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2001;98:525–38.
3. Kaaja RJ, Greer IA. Manifestations of chronic disease dur-
ing pregnancy. JAMA 2005;294:2751–7.
4. Buchanan TA, Xiang AH. Gestational diabetes mellitus.
J Clin Invest 2005;115:485–91.
5. Russell MA, Phipps MG, Olson CL, Welch HG, Carpenter
MW. Rates of postpartum glucose testing after gestational
diabetes mellitus. Obstet Gynecol 2006;108:1456–62.
6. Kim C, Tabaei BP, Burke R, McEwen LN, Lash RW,
Johnson SL, et al. Missed opportunities for type 2 diabetes
mellitus screening among women with a history of gesta-
tional diabetes mellitus. Am J Public Health 2006;96:1643–
8.
7. Smirnakis KV, Chasan-Taber L, Wolf M, Markenson G,
Ecker JL, Thadhani R. Postpartum diabetes screening
in women with a history of gestational diabetes. Obstet
Gynecol 2005;106:1297–303.
8. Schaefer-Graf UM, Buchanan TA, Xiang AH, Peters RK,
Kjos SL. Clinical predictors for a high risk for the devel-
opment of diabetes mellitus in the early puerperium in

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 678

 women with recent gestational diabetes mellitus. Am J
Obstet Gynecol 2002;186:751–6.
9. Conway DL, Langer O. Effects of new criteria for type 2
diabetes on the rate of postpartum glucose intolerance in
women with gestational diabetes. Am J Obstet Gynecol
1999;181:610–4.
10. Albareda M, Caballero A, Badell G, Piquer S, Ortiz A, de
Leiva A, et al. Diabetes and abnormal glucose tolerance in
women with previous gestational diabetes. Diabetes Care
2003;26:1199–205.
11. Lee AJ, Hiscock RJ, Wein P, Walker SP, Permezel M.
Gestational diabetes mellitus: clinical predictors and long-
term risk of developing type 2 diabetes: a retrospective
cohort study using survival analysis. Diabetes Care 2007;30:
878–83.
12. Kim C, Newton KM, Knopp RH. Gestational diabetes
and the incidence of type 2 diabetes: a systematic review.
Diabetes Care 2002;25:1862–8.
13. O’Sullivan JB, Mahan CM. Criteria for the oral glucose
tolerance test in pregnancy. Diabetes 1964;13:278–85.
14. American Diabetes Association. Standards of medical care
in diabetes—2008. Diabetes Care 2008;31(suppl 1):S12–54.
15. Gabbe SG, Gregory RP, Power ML, Williams SB, Schulkin
J. Management of diabetes mellitus by obstetrician-gyne-
cologists. Obstet Gynecol 2004;103:1229–34.
16. Dacus JV, Meyer NL, Muram D, Stilson R, Phipps P, Sibai
BM. Gestational diabetes: postpartum glucose tolerance
testing. Am J Obstet Gynecol 1994;171:927–31.
17. Almario CV, Ecker T, Moroz LA, Bucovetsky L, Berghella
V, Baxter JK. Obstetricians seldom provide postpartum
diabetes screening for women with gestational diabetes. Am
J Obstet Gynecol 2008;198:528.e1–528.e5.
COMMITTEE OPINIONS
18. Hunt KJ, Conway DL. Who returns for postpartum glucose
screening following gestational diabetes mellitus? Am J
Obstet Gynecol 2008;198:404.e1–404.e6.
19. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF,
Lachin JM, Walker EA, et al. Reduction in the incidence
of type 2 diabetes with lifestyle intervention or metformin.
Diabetes Prevention Program Research Group. N Engl J
Med 2002;346:393–403.
20. Dietz PM, Vesco KK, Callaghan WM, Bachman DJ, Bruce
FC, Berg CJ, et al. Postpartum screening for diabetes after
a gestational diabetes mellitus-affected pregnancy. Obstet
Gynecol 2008;112:868–74.
21. Metzger BE, Buchanan TA, Coustan DR, de Leiva A,
Dunger DB, Hadden DR, et al. Summary and recommen-
dations of the Fifth International Workshop-Conference on
Gesta-tional Diabetes Mellitus [published erratum appears
in Diabetes Care 2007;30:3154]. Diabetes Care 2007;30
(suppl 2):S251–60.
Copyright © June 2009 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Postpartum screening for abnormal glucose tolerance in women who
had gestational diabetes mellitus. ACOG Committee Opinion No.
435. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;113:1419–21.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 679
 ACOG COMMITTEE OPINION
ACOG Number
COMMITTEE
441 • September 2009
OPINION
Number 441 • September 2009
Oral Intake During Labor
Committee on
Oral Intake During Labor
ABSTRACT: There is insufficient evidence to address the safety of any particular
Obstetric Practice fasting period for solids in obstetric patients. Expert opinion supports that patients under-
Committee on
This document reflects
ABSTRACT:
going There
either elective is insufficient
cesarean evidence
delivery or elective to address the
postpartum safety
tubal of should
ligation any particular
under-
Obstetricclinical
Reaffirmed
emerging Practice
2011and sci- fasting period for solids in obstetric patients. Expert opinion supports that patients
go a fasting period of 6–8 hours. Adherence to a predetermined fasting period before under-
entific advances as of the
This issued
date document
and is reflects
subject
going either elective cesarean delivery or elective postpartum tubal ligation should
nonelective surgical procedures (ie, cesarean delivery) is not possible. Therefore, solid under-
emerging
change. clinical and sci- go a fasting
to
entific
The information
advances as
should not be construed of the foods should period of 6–8
be avoided hours. Adherence
in laboring patients. to a predetermined fasting period before
datedictating
as issued andan is subject
exclusive
nonelective surgical procedures (ie, cesarean delivery) is not possible. Therefore, solid
to change.
course The information
of treatment or pro- foods should be avoided in laboring patients.
should to
cedure notbe be construed
followed.
as dictating an exclusive Over the past 60 years, the incidence of There is insufficient evidence to address
course of treatment or pro- maternal death because of aspiration has the safety of any particular fasting period for
cedure to be followed.
Over the dramatically.
decreased past 60 years, the incidence
Contributing to this of solidsThere is insufficient
in obstetric evidence
patients. Expertto opinion
address
maternal have
decrease deathbeen because of aspiration
hospital policies and has the safety of
supports thatanypatients
particular fasting period
undergoing for
either
decreased to
strategies dramatically.
reduce maternal Contributing to this
gastric volume solids incesarean
elective obstetric patients.
delivery Expert postpar-
or elective opinion
decrease
and increase have been
gastric pHhospital policies and
and improvements in supports
tum tubal that patients
ligation shouldundergoing either
undergo a fasting
strategiesanesthesia
obstetric to reduce practice.
maternal This gastric hasvolume
led to electiveofcesarean
period delivery
6–8 hours. or elective
Adherence to apostpar-
prede-
and increase
questions aboutgastric
the pH andofimprovements
utility very restrictive in tum tubalfasting
termined ligationperiod
shouldbefore
undergo a fasting
nonelective
obstetric
oral intakeanesthesia
policies in practice.
laboring This has ledand
patients to period ofprocedures
surgical 6–8 hours.(ie,Adherence to a prede-
cesarean delivery) is
questions
calls about the
to liberalize utility
these of veryinrestrictive
policies low-risk termined
not possible.fasting period
Therefore, before
solid foodsnonelective
should be
oral intake policies in laboring patients and
patients. surgical in
avoided procedures (ie, cesarean delivery) is
laboring patients.
callsThere
to liberalize these policies
is insufficient evidence in to
low-risk
draw not possible. Therefore, solid foods should be
patients.
conclusions about the relationship between Resource
avoided in laboring patients.
There
fasting timesis forinsufficient
clear liquids evidence
and thetorisk draw
of Practice guidelines for obstetric anesthesia: an
conclusions
emesis or refluxabout the relationship
or both or pulmonary between
aspi- Resource
updated report by the American Society of
fastingduring
ration times for clearAlthough
labor. liquids and theretheisrisk
some of Practice guidelines Task
Anesthesiologists for obstetric
Force onanesthesia:
Obstetrican
emesis or reflux
disagreement, or both
most or pulmonary
experts agree that aspi- oral updated report
Anesthesia. by theSociety
American American Society of
of Anesthesiol-
ration of
intake during
clear labor.
liquidsAlthough
during labor theredoesis some
not Anesthesiologists
ogists Task Force Task Force onAnesthesia.
on Obstetric Obstetric
disagreement,
increase maternal most experts agree that oral
complications. Anesthesia. American
Anesthesiology Society of Anesthesiol-
2007;106:843–63. Available at:
intakeThe of oral
clearintake
liquidsofduringmodest labor does not
amounts of ogists Task Force on Obstetric Anesthesia.
http://www.asahq.org/publicationsAndSer
increase
clear maternal
liquids may becomplications.
allowed for patients with Anesthesiology 2007;106:843–63.
vices/OBguide.pdf. Retrieved JuneAvailable
11, 2009.at:
The oral intake
uncomplicated labor.ofThe modest
patient amounts
without of http://www.asahq.org/publicationsAndSer
clear liquids may
complications be allowedelective
undergoing for patients
cesareanwith vices/OBguide.pdf. Retrieved June 11, 2009.
uncomplicated
delivery may have labor.
modest Theamounts
patient of without
clear Copyright © September 2009 by the American College
of Obstetricians and Gynecologists, 409 12th Street,
complications
liquids up to 2undergoing
hours before elective cesarean
induction of SW, PO Box 96920, Washington, DC 20090-6920. All
delivery may have modest Copyright © September
No part2009 by the AmericanmayCollege
anesthesia. Examples of clearamounts of clear
liquids include, rights reserved.
of Obstetricians and
of this publication be
liquids
but up limited
are not to 2 hours before
to, water, fruitinduction
juices with- of reproduced, stored in aGynecologists, 409posted
retrieval system, 12th Street,
on the
SW, PO Box 96920, Washington, DC 20090-6920.
Internet, or transmitted, in any form or by any means, All
anesthesia.
out Examples ofbeverages,
pulp, carbonated clear liquidsclearinclude,
tea, rights reserved.
electronic, No part
mechanical, of this publication
photocopying, recording,may be
or oth-
but arecoffee,
not limited to, water, fruit juices with- reproduced,
erwise, stored
without priorinwritten
a retrieval system, from
permission postedtheonpub-
the
black and sports drinks. Particulate Internet, or transmitted, in any form or byphotocopies
any means,
out pulp, fluidscarbonated lisher. Requests for authorization to make
containing shouldbeverages,
be avoided.clear Patientstea, electronic,
should mechanical,
be directed photocopying,
to: Copyright recording,
Clearance Center,or 222
oth-
blackrisk
with coffee, andfor
factors sports drinks.(eg,
aspiration Particulate
morbid erwise, without
Rosewood Drive,prior written
Danvers, MApermission from
01923, (978) the pub-
750-8400.
lisher. Requests for authorization to make photocopies
containing
obesity, fluids should
diabetes, be avoided.
and difficult Patients
airway), or should be directed to: Copyright Clearance Center, 222
ISSN 1074-861X
with riskatfactors
patients increased for risk
aspiration (eg, morbid
for operative deliv- Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
The American College obesity,
ery may diabetes,
require further and difficult
restrictionsairway),
of oralor Oral intake during labor. ACOG Committee Opinion No.
ISSNAmerican
441. 1074-861X College of Obstetricians and Gynecolo-
of Obstetricians patientsdetermined
at increased
The Gynecologists
American College
intake, onrisk for operative
a case-by-case deliv-
basis. gists. Obstet Gynecol 2009;114:714.
and ery may require further restrictions of oral Oral intake during labor. ACOG Committee Opinion No.
of Obstetricians 441. American College of Obstetricians and Gynecolo-
Women’s Health Care intake, determined on a case-by-case basis. gists. Obstet Gynecol 2009;114:714.
and Gynecologists
Physicians
Women’s Health Care
Physicians

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 680

 ACOG COMMITTEE OPINION
Number 443 • October 2009 (Replaces No. 264, December 2001)

Air Travel During Pregnancy

Committee on ABSTRACT: In the absence of obstetric or medical complications, pregnant women
Obstetric Practice can observe the same precautions for air travel as the general population and can fly safely.
This document reflects Pregnant women should be instructed to continuously use their seat belts while seated,
emerging clinical and sci- as should all air travelers. Pregnant air travelers may take precautions to ease in-flight
entific advances as of the
date issued and is subject discomfort and, although no hard evidence exists, preventive measures can be used to
to change. The information minimize risks of venous thrombosis. For most air travelers, the risks to the fetus from
should not be construed
as dictating an exclusive exposure to cosmic radiation are negligible. For pregnant aircrew members and other
course of treatment or frequent flyers, this exposure may be higher. Information is available from the FAA to
procedure to be followed.
estimate this exposure.

Occasional air travel during pregnancy is
generally safe. Recent cohort studies suggest
no increase in adverse pregnancy outcomes
for occasional air travelers (1, 2). Most com-
mercial airlines allow pregnant women to fly
up to 36 weeks of gestation. Some restrict
pregnant women from international flights
earlier in gestation and some require docu-
mentation of gestational age. For specific
airline requirements, women should check
with the individual carrier. Civilian and mili-
tary aircrew members who become pregnant
should check with their specific agencies
for regulations or restrictions to their flying
duties.
Air travel is not recommended at any
time during pregnancy for women who have
medical or obstetric conditions that may be
exacerbated by flight or that could require
emergency care. The duration of the flight
also should be considered when planning
travel. Pregnant women should be informed
that the most common obstetric emergencies
occur in the first and third trimesters.
In-craft environmental conditions, such
as changes in cabin pressure and low humid-
ity, coupled with the physiologic changes of
pregnancy, do result in adaptations, includ-
ing increased heart rate and blood pres-
The American College sure, and a significant decrease in aerobic
of Obstetricians capacity (3, 4). The risks associated with
and Gynecologists long hours of air travel immobilization and
Women’s Health Care low cabin humidity, such as lower extrem-
Physicians ity edema and venous thrombotic events,
recently have been the focus of attention for
all air travelers. Despite the lack of evidence
of such events during pregnancy, certain
preventive measures can be used to minimize
these risks, eg, use of support stockings and
periodic movement of the lower extremities,
avoidance of restrictive clothing, occasional
ambulation, and maintenance of adequate
hydration.
Because severe air turbulence cannot be
predicted and the subsequent risk for trauma
is significant should this occur, pregnant
women should be instructed to use their
seatbelts continuously while seated. The seat-
belt should be belted low on the hipbones,
between the protuberant abdomen and pelvis.
Several precautions may ease discomfort for
pregnant air travelers. For example, gas-
producing foods or drinks should be avoided
before scheduled flights because entrapped
gases expand at altitude (5). Preventive anti-
emetic medication should be considered for
women with increased nausea.
Available information suggests that noise,
vibration, and cosmic radiation present a neg-
ligible risk for the occasional pregnant air
traveler (6, 7). Both the National Council on
Radiation Protection and Measurements and
the International Commission on Radiological
Protection recommend a maximum annual
radiation exposure limit of 1 millisievert
(mSv) (100 rem) for members of the gen-
eral public and 1 mSv over the course of a
40-week pregnancy (7). Even the longest

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 681

 available intercontinental flights will expose passen-
gers to no more than 15% of this limit (7); therefore,
it is unlikely that the occasional traveler will exceed
current exposure limits during pregnancy. However,
aircrew or frequent flyers may exceed these limits. The
Federal Aviation Administration and the International
Commission on Radiological Protection consider aircrew
to be occupationally exposed to ionizing radiation and
recommend that they be informed about radiation expo-
sure and health risks (8, 9). A tool to estimate an indi-
vidual exposure to cosmic radiation from a specific flight
is available from the Federal Aviation Administration on
its web site (http://jag.cami.jccbi.gov/cariprofile.asp).
In the absence of a reasonable expectation for obstet-
ric or medical complications, occasional air travel is safe
for pregnant women. Women should check with specific
carriers for airline requirements.
References
1. Chibber R, Al-Sibai MH, Qahtani N. Adverse outcome of
pregnancy following air travel: a myth or a concern? Aust N
Z J Obstet Gynaecol 2006;46:24–8.
2. Freeman M, Ghidini A, Spong CY, Tchabo N, Bannon PZ,
Pezzullo JC. Does air travel affect pregnancy outcome? Arch
Gynecol Obstet 2004;269:274–7.
3. Huch R, Baumann H, Fallenstein F, Schneider KT, Holdener
F, Huch A. Physiologic changes in pregnant women and
their fetuses during jet air travel. Am J Obstet Gynecol 1986;
154:996–1000.
COMMITTEE OPINIONS
4. Artal R, Fortunato V, Welton A, Constantino N, Khodiguian
N, Villalobos L, et al. A comparison of cardiopulmonary
adaptations to exercise in pregnancy at sea level and altitude.
Am J Obstet Gynecol 1995;172:1170–8; discussion 1178– 80.
5. Bia FJ. Medical considerations for the pregnant traveler.
Infect Dis Clin North Am 1992;6:371–88.
6. Morrell S, Taylor R, Lyle D. A review of health effects of
aircraft noise. Aust N Z J Public Health 1997;21:221–36.
7. Barish RJ. In-flight radiation exposure during pregnancy.
Obstet Gynecol 2004;103:1326–30.
8. Federal Aviation Administration. In-flight radiation expo-
sure. Advisory Circular No. 120-61A Washington, DC:
FAA; 2006.
9. The 2007 recommendations of the International Commis-
sion on Radiological Protection. International Commission
on Radiological Protection. IRCP Publication 103. Ann
IRCP 2007;37:(2–4);1–332.
Copyright © October 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Air travel during pregnancy. ACOG Committee Opinion No. 443.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;114:954–5.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 682
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 453 • February 2010

Committee on Obstetric Practice

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Screening for Depression During and After Pregnancy

ABSTRACT: Depression is very common during pregnancy and the postpartum period. At this time, there is
insufficient evidence to support a firm recommendation for universal antepartum or postpartum screening. There are
also insufficient data to recommend how often screening should be done. There are multiple depression screening
tools available for use.

Clinical depression is common in reproductive-aged Conclusion

women (1). A recent retrospective cohort analysis in a
large U.S. managed care organization found that one in
seven women was treated for depression between the
year prior to pregnancy and the year after pregnancy (2).
According to the World Health Organization, depres-
sion is the leading cause of disability in women, which
accounts for $30 billion to $50 billion in lost productivity
and direct medical costs in the United States each year (3).
Screening for, diagnosing, and treating depression
have the potential to benefit a woman and her family.
Infants of depressed mothers display delayed psycho-
logic, cognitive, neurologic, and motor development (3).
Furthermore, children’s mental and behavioral disorders
improve when maternal depression is in remission (4).
Women with current depression or a history of major
depression warrant particularly close monitoring and
evaluation. Pregnancy and the postpartum period repre-
sent an ideal time during which consistent contact with
the health care delivery system will allow women at risk
to be identified and treated.
There are multiple depression screening tools avail-
able for use. These tools usually can be completed in
less than 10 minutes. Most have a specificity ranging
from 77% to 100%. Thus, it can be argued that sensitiv-
ity should be the determining factor to maximize the
number of depressed patients identified. Many of these
screening tools have been validated with specific eth-
nic populations. Examples of highly sensitive screening
tools include the Edinburgh Postnatal Depression Scale,
Postpartum Depression Screening Scale, and Patient
Health Questionnaire-9 (see Additional Resources) (5).
Other appropriate screening tools are listed in Table 1.
Depression is very common during pregnancy and the
postpartum period. At this time there is insufficient evi-
dence to support a firm recommendation for universal
antepartum or postpartum screening. There are also
insufficient data to recommend how often screening
should be done. However, screening for depression has
the potential to benefit a woman and her family and
should be strongly considered. Women with a positive
assessment require follow-up evaluation and treatment
if indicated. Medical practices should have a referral pro-
cess for identified cases. Women with current depression
or a history of major depression warrant particularly close
monitoring and evaluation.
Coding
Many payers require that evaluation and management
services linked to mental health diagnoses be performed
only by a psychiatrist or psychologist. Such payers typi-
cally cross-check the diagnosis submitted against the
health care provider’s specialty. The appropriate diag-
nosis code will depend on the nature of the patient’s
depression. Postpartum depression is assigned to code
648.4X (X is an indication that a fifth digit is required).
However, if a code from the mental health chapter of
the International Classification of Diseases, Ninth Revis-
ion, Clinical Modification (codes 290–319) is submit-
ted by a health care provider whose specialty does not
match their criteria, the claim is often denied. Medical
practices should check with all payers concerning cov-
erage for mental health services before billing for these
services.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 683

 Table 1. Depression Screening Tools
Number Time to Sensitivity/ Spanish
Screening Tool of Items Complete specificity Available

Edinburgh Postnatal 10 Less than 5 min Sensitivity: 59–100% Yes

Depression Scale (EPDS) Specificity: 49–100%
Postpartum Depression 35 5–10 min Sensitivity: 91–94% Yes
Screening Scale (PDSS) Specificity: 72–98%
Patient Health Questionnaire-9 9 Less than 5 min Sensitivity: 75% Yes
(PHQ-9) Specificity: 90%
Beck Depression Inventory 21 5–10 min Sensitivity: 47.6–82% Yes
(BDI) Specificity: 85.9–89%
Beck Depression Inventory-II 21 5–10 min Sensitivity: 56–57% Yes
(BDI-II) Specificity: 97–100%
Center for Epidemiologic 20 5–10 min Sensitivity: 60% Yes
Studies Depression Scale Specificity: 92%
(CES-D)
Zung Self-Rating 20 5–10 min Sensitivity: 45–89% No
Depression Scale (Zung SDS) Specificity: 77–88%

Data from Boyd RC, Le HN, Somberg R. Review of screening instruments for postpartum depression. Arch Womens Ment Health
2005;8:141–53; Sharp LK, Lipsky MS. Screening for depression across the lifespan: a review of measures for use in primary care settings.
Am Fam Physician 2002;66:1001–8; and Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD:
the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999;282:1737–44.

References Albany (NY): ACOG; 2008. Available at: http://mail.ny.acog.org/

1. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G,
Swinson T. Perinatal depression: a systematic review of preva-
lence and incidence. Obstet Gynecol 2005; 106:1071–83.
2. Dietz PM, Williams SB, Callaghan WM, Bachman DJ,
Whitlock EP, Hornbrook MC. Clinically identified maternal
depression before, during, and after pregnancies ending in live
births. Am J Psychiatry 2007;164:1515–20.
3. Gjerdingen DK, Yawn BP. Postpartum depression screening:
importance, methods, barriers, and recommendations for
practice. J Am Board Fam Med 2007;20:280–8.
4. Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A,
Wisniewski SR, Fava M, et al. Remissions in maternal depres-
sion and child psychopathology: a STAR*D-child report.
STAR*D-Child Team [published erratum appears in JAMA
2006;296:1234]. JAMA 2006;295:1389–98.
5. Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T,
Gartlehner G, et al. Perinatal depression: prevalence, screening
accuracy, and screening outcomes. Evid Rep Technol Assess
2005;119:1–8.
website/ Depression ToolKit.pdf. Retrieved October 14, 2009.
Dell DL. Depression in women. Clin Update Womens Health Care
2002;I:1– 82.
University of California. San Francisco, Fresno, School of Medicine.
Edinburgh Postnatal Depression Scale (EPDS). Available at: http://
www.fresno.ucsf.edu/pediatrics/downloads/edinburghscale.pdf.
Retrieved October 14, 2009.
Beck CT, Gable RK. Postpartum depression screening scale (PDSS).
Los Angeles (CA): Western Psychological Services; 2002.
MacArthur Initiative on Depression and Primary Care. Patient health
questionnaire (PHQ-9). Available at: http://depression-primarycare.
org/clinicians/toolkits/materials/forms/phq9. Retrieved October 14,
2009.
Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL,
Stotland N, et al. The management of depression during pregnancy:
a report from the American Psychiatric Association and the
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009; 114:703–13.

Additional Resources Copyright February 2010 by the American College of Obstetricians

Perinatal Depression Information Network (PDIN)
www.pdinfonetwork.org
Perinatal Depression Information Network (PDIN) is a
nationally recognized web-based platform of state-specif-
ic perinatal depression initiatives with resources for pro-
fessionals as well as women and their families and friends.
Publications
American College of Obstetricians and Gynecologists, District II/NY.
Perinatal depression screening: tools for obstetrician–gynecologists.
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Screening for depression during and after pregnancy. Committee
Opinion No. 453. American College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2010;115:394–5.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 684

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 455 • March 2010

Committee on Obstetric Practice

This document reflects emerging clinical and scientific advances as of the date issued and is
The Society for subject to change. The information should not be construed as dictating an exclusive course of
Maternal Fetal Medicine treatment or procedure to be followed.

Magnesium Sulfate Before Anticipated Preterm Birth

for Neuroprotection
Abstract: Numerous large clinical studies have evaluated the evidence regarding magnesium sulfate, neuro-
protection, and preterm births. The Committee on Obstetric Practice and the Society for Maternal-Fetal Medicine
recognize that none of the individual studies found a benefit with regard to their primary outcome. However, the
available evidence suggests that magnesium sulfate given before anticipated early preterm birth reduces the risk
of cerebral palsy in surviving infants. Physicians electing to use magnesium sulfate for fetal neuroprotection should
develop specific guidelines regarding inclusion criteria, treatment regimens, concurrent tocolysis, and monitoring
in accordance with one of the larger trials.

In the 1990s, observational studies suggested an associa-
tion between prenatal exposure to magnesium sulfate and
less frequent subsequent neurologic morbidities (1–3).
Subsequently, several large randomized prospective clini-
cal trials have been performed to evaluate the utility of
magnesium sulfate for fetal and neonatal neuroprotection
(4–9).
In 1997, researchers reported on an interim analysis
of 134 women participating in a four-arm single center
trial of magnesium sulfate for prevention of cerebral palsy
(4, 5). The incidence of infant death was not greater in the
neuroprotection arm, in which 57 women (59 infants)
in preterm labor before 34 weeks of gestation and with
cervical dilatation greater than 4 cm were randomized
to magnesium sulfate treatment or placebo treatment.
However, total infant death was more common when this
group was combined with the unblinded cohort in which
magnesium sulfate tocolysis was compared with other
tocolytic agents. Recruitment to the study was discontin-
ued because of these results.
In 2003, researchers reported the results of a multi-
center placebo-controlled study of 1,062 women (1,255
infants) in whom delivery was planned or expected within
24 hours at less than 30 weeks of gestation (see Table 1)
(6). Primary outcomes included infant death or cerebral
palsy or both by 2 years corrected age. No significant
reductions in the occurrences of infant death or cerebral
palsy or both were seen with magnesium sulfate treat-
ment. In a secondary analysis, the researchers demon-
strated significantly less frequent “substantial gross motor
dysfunction” or death or both in the infants exposed to
magnesium sulfate. Substantial gross motor dysfunction is
defined as inability to walk without assistance.
One study reported the results of a randomized
clinical trial that enrolled 564 gravid women (688 infants)
before 33 weeks of gestation with planned or expected
delivery within 24 hours (see Table 1) (7). Women were
randomized to magnesium sulfate treatment or placebo
treatment. The primary outcome for this study was infant
death or severe white matter injury. The study evaluated
infant outcomes before hospital discharge and found
no significant differences in total infant death or severe
white matter injury or both between magnesium sulfate
treatment and placebo treatment groups (7). In a 2-year
follow-up evaluation, these investigators did not find sta-
tistically significant reductions in cerebral palsy or death
or both, but did demonstrate significant reductions in
death or “gross motor dysfunction” or both and death or
“motor or cognitive dysfunction” or both with magne-
sium sulfate treatment (9).
Researchers published results from a multicenter
trial of 2,241 women at imminent risk for delivery before
32 weeks of gestation in which women were randomized
to magnesium sulfate treatment or placebo treatment
groups (see Table 1) (8). The primary outcome was a total
of stillbirth or infant death by 1 year or moderate to severe

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 685

 cerebral palsy at or beyond 2 years. There was no signifi-
cant reduction in the primary outcome with magnesium
sulfate treatment. There was a reduction in moderate to
severe cerebral palsy in the magnesium sulfate treatment
group, and in a secondary analysis, less frequent overall
cerebral palsy in the magnesium sulfate treatment group
(4.2% compared with 7.3%, P =0.004).
A recent meta-analysis synthesized the results of the
clinical trials of magnesium sulfate for neuroprotection
(10). Pooling the results of the available clinical trials of
magnesium sulfate for neuroprotection suggests that pre-
natal administration of magnesium sulfate reduces the
occurrence of cerebral palsy when given with neuroprotec-
tive intent (relative risk [RR], 0.71; 95% confidence interval
[CI], 0.55–0.91). Likewise, the meta-analysis suggested
that magnesium sulfate given with neuroprotective intent
reduced the total occurrences of death and cerebral palsy
(summary RR, 0.85; 95% CI, 0.74–0.98). The results of this
meta-analysis did not suggest any effect on fetal or infant
death with magnesium sulfate therapy (summary RR, 0.95;
95% CI, 0.80–1.12). Two subsequent meta-analyses of
similar design have confirmed these results (11, 12).
None of the aforementioned trials demonstrated sig-
nificant pregnancy prolongation when magnesium sulfate
was given for neuroprotection. Although minor maternal
complications were more common with magnesium sul-
fate in the three major trials, serious maternal complica-
tions (eg, death, cardiac arrest, and respiratory failure)
were not more frequent in these studies or on meta-
analysis (6–8, 10).
Although the goal of each of the three major ran-
domized clinical trials was to evaluate the effect of
magnesium sulfate treatment on neurodevelopmental
outcomes and death, comparison is made difficult by dif-
ferences in inclusion and exclusion criteria, populations
studied, magnesium sulfate regimens, gestational age
with treatment, and outcomes studied between the trials.
The Committee on Obstetric Practice and the Society
for Maternal-Fetal Medicine recognize that none of the
individual studies found a benefit with regard to their pri-
mary outcome. However, the available evidence suggests
that magnesium sulfate given before anticipated early
preterm birth reduces the risk of cerebral palsy in surviv-
ing infants. Physicians electing to use magnesium sulfate
for fetal neuroprotection should develop specific guide-
lines regarding inclusion criteria, treatment regimens,
concurrent tocolysis, and monitoring in accordance with
one of the larger trials (see Table 1) (6–8).

Table 1. Inclusion Criteria, Treatment Regimens, and Concurrent Tocolysis of Large Trials
Total Death and
Number of Cerebral Cerebral
Study Participants Inclusions Dose Duration Palsy Death Palsy

Crowther 1,255 Less than 30 weeks 4 g load Up to 24 hours RR, 0.83; RR,0.83; RR, 0.83;
of gestation; 1 g/hr 95% CI, 95 % CI, 95% CI,
likely delivery 0.66–1.03 0.64–1.09 0.54–1.27
within 24 hours
Marret 688 Less than 33 weeks 4 g load only Loading dose OR, 0.80; OR, 0.85; OR, 0.70;
of gestation only 95% CI, 95% CI, 95% CI,
0.58–1.10 0.55–1.32 0.41–1.19
Rouse 2,241 24–31 weeks 6 g load Up to 12 hours; RR, 0.97; RR, 1.12; RR, 0.55;
of gestation; 2 g/hr treatment 95% CI, 95% CI, 95% CI,
at high risk of resumed when 0.77–1.23 0.85–1.47 0.32–0.95
spontaneous birth delivery imminent

CI, confidence interval; RR, relative risk; OR, odds ratio.

Data from Crowther CA, Hiller JE, Doyle LW, Haslam RR. Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial.
Australasian Collaborative Trial of Magnesium Sulphate (ACTOMg SO4) Collaborative Group. JAMA 2003;290:2669–76; Marret S, Marpeau L, Zupan-Simunek V, Eurin D,
Leveque C, Hellot MF, et al. Magnesium sulphate given before very-preterm birth to protect infant brain: the randomised controlled PREMAG trial. PREMAG trial group.
BJOG 2007;114:310–8; and Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, et al. A randomized, controlled trial of magnesium sulfate for the prevention of
cerebral palsy. Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. N Engl J Med 2008;359:895–905.

References low-birth-weight children aged 3 to 5 years. JAMA 1996;

1. Nelson KB, Grether JK. Can magnesium sulfate reduce
the risk of cerebral palsy in very low birthweight infants?
Pediatrics 1995;95:263–9.
2. Schendel DE, Berg CJ, Yeargin-Allsopp M, Boyle CA,
Decoufle P. Prenatal magnesium sulfate exposure and the
risk for cerebral palsy or mental retardation among very
276:1805–10.
3. Paneth N, Jetton J, Pinto-Martin J, Susser M. Magnesium
sulfate in labor and risk of neonatal brain lesions and
cerebral palsy in low birth weight infants. The Neonatal
Brain Hemorrhage Study Analysis Group. Pediatrics 1997;
99:E1.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 686

 4. Mittendorf R, Covert R, Boman J, Khoshnood B, Lee KS,
Siegler M. Is tocolytic magnesium sulphate associated with
increased total paediatric mortality? Lancet 1997;350:1517–8.
5. Mittendorf R, Dambrosia J, Pryde PG, Lee KS, Gianopoulos JG,
Besinger RE, et al. Association between the use of antenatal
magnesium sulfate in preterm labor and adverse health
outcomes in infants. Am J Obstet Gynecol 2002;186:1111–8.
6. Crowther CA, Hiller JE, Doyle LW, Haslam RR. Effect
of magnesium sulfate given for neuroprotection before
preterm birth: a randomized controlled trial. Australasian
Collaborative Trial of Magnesium Sulphate (ACTOMg
SO4) Collaborative Group. JAMA 2003;290:2669–76.
7. Marret S, Marpeau L, Zupan-Simunek V, Eurin D, Leveque C,
Hellot MF, et al. Magnesium sulphate given before very-
preterm birth to protect infant brain: the randomised
controlled PREMAG trial. PREMAG trial group. BJOG
2007;114:310–8.
8. Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY,
Mercer BM, et al. A randomized, controlled trial of mag-
nesium sulfate for the prevention of cerebral palsy. Eunice
Kennedy Shriver NICHD Maternal-Fetal Medicine Units
Network. N Engl J Med 2008;359:895–905. photocopying, recording, or otherwise, without prior written permis-
9. Marret S, Marpeau L, Follet-Bouhamed C, Cambonie G,
Astruc D, Delaporte B, et al. Effect of magnesium sul-
phate on mortality and neurologic morbidity of the very-
preterm newborn (of less than 33 weeks) with two-year
neurological outcome: results of the prospective PREMAG
trial. le groupe PREMAG [French]. Gynecol Obstet Fertil
2008;36:278–88.
COMMITTEE OPINIONS
10. Doyle LW, Crowther CA, Middleton P, Marret S, Rouse D.
Magnesium sulphate for women at risk of preterm birth
for neuroprotection of the fetus. Cochrane Database of
Systematic Reviews 2009, Issue 1. Art. No.: CD004661.
DOI: 10.1002/14651858.CD004661.pub3.
11. Conde-Agudelo A, Romero R. Antenatal magnesium sul-
fate for the prevention of cerebral palsy in preterm infants
less than 34 weeks’ gestation: a systematic review and meta-
analysis. Am J Obstet Gynecol 2009;200:595–609.
12. Costantine MM, Weiner SJ. Effects of antenatal exposure
to magnesium sulfate on neuroprotection and mortal-
ity in preterm infants: a meta-analysis. Eunice Kennedy
Shriver National Institute of Child Health and Human
Development Maternal-Fetal Medicine Units Network.
Obstet Gynecol 2009;114:354–64.
Copyright March 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechanical,
sion from the publisher. Requests for authorization to make photocop-
ies should be directed to: Copyright Clearance Center, 222 Rosewood
Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Magnesium sulfate before anticipated preterm birth for neuroprotec-
tion. Committee Opinion No. 455. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2010;115:669–71.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 687
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 462 • August 2010

Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Moderate Caffeine Consumption During Pregnancy

ABSTRACT: Moderate caffeine consumption (less than 200 mg per day) does not appear to be a major con-
tributing factor in miscarriage or preterm birth. The relationship of caffeine to growth restriction remains undeter-
mined. A final conclusion cannot be made at this time as to whether there is a correlation between high caffeine
intake and miscarriage.

Because caffeine crosses the placenta (1) and increases
maternal catecholamine levels, concerns have been raised
about a potential relationship between caffeine exposure
and the incidence of spontaneous miscarriage. However,
studies investigating the association between caffeine
intake and miscarriage have been limited by small sample
size and the retrospective collection of data influenced
by recall bias, particularly in patients interviewed after
pregnancy loss (2, 3).
Two recent studies have attempted to overcome this
limitation by prospectively monitoring a large popula-
tion of women receiving prenatal care before 16 weeks of
gestation, collecting data on caffeine consumption during
early gestation, and adjusting for relevant confounders. A
study conducted by Savitz et al examined 2,407 pregnan-
cies that resulted in 258 pregnancy losses before 20 weeks
of gestation (4). Caffeine exposure was analyzed with
respect to intake: none; less than or equal to the median
consumption, which was approximately 200 mg per day;
or greater than 200 mg per day (Table 1). Three time points
were analyzed: 1) before pregnancy; 2) 4 weeks after the
most recent menstrual period; and 3) at the time of the
interview, which occurred before 16 weeks of gestation.
Applying an adjusted survival model, levels of caffeine
consumption at all three time points and at all levels of
consumption were unrelated to the risk of miscarriage.
Reported caffeine exposure at the time of the interview
was associated with an increased miscarriage risk among
those women with pregnancy losses before the interview.
This was thought to reflect recall bias. Ultimately, the study
did not show an association between caffeine consumption
and miscarriage, regardless of the amount consumed.
Weng et al performed a population-based prospective
cohort study in which women were interviewed regard-
ing caffeine exposure at a median gestational age of 71
days (10 weeks) (5). Caffeine exposure was divided into
none, less than 200 mg per day, and greater than 200 mg
per day. Of the 1,063 pregnant women interviewed, 172
experienced a miscarriage during their pregnancies. The
investigators found an increased risk of miscarriage with
higher levels of caffeine consumption, with an adjusted
hazard ratio of 2.23 (95% confidence interval [CI] 1.34–
3.69) for intake of 200 mg per day or more. In contrast
to the findings of the Savitz et al study, the timing of the
interview in relation to a miscarriage did not affect the
positive association identified between caffeine consump-
tion and miscarriage.
Table 1. Caffeine Content of Foods and Beverages
Milligrams of
Food and Beverages Caffeine (Average)
Coffee (8 oz)
Brewed, drip 137
Instant 76
Tea (8 oz)
Brewed 48
Instant 26–36
Caffeinated soft drinks (12 oz) 37
Hot cocoa (12 oz) 8–12
Chocolate milk (8 oz) 5–8
Candy
Dark chocolate (1.45 oz) 30
Milk chocolate (1.55 oz) 11
Semi-sweet chocolate (1/4 cup) 26–28
Chocolate syrup (1 tbsp) 3
Coffee ice cream or frozen yogurt 2
(1/2 cup)
U.S. Department of Agriculture, Agricultural Research Service, 2000.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 688

 Although both studies involved appropriate statisti-
cal analyses and large study populations, they reached
contradictory conclusions. Factors that may account
for the discrepancy include 1) differences in popula-
tions studied, 2) different analytic approaches, and 3)
issues related to the baseline risk of miscarriage and
corresponding statistical power. Because of the conflict-
ing results of these two large studies, a recommendation
regarding higher levels of caffeine consumption and the
risk of miscarriage cannot be made at this time. Neither
report demonstrated a significant increase in the risk of
miscarriage with levels of caffeine intake less than 200
mg per day.
Two large studies have been performed to assess the
relationship between caffeine intake and preterm birth.
A randomized double-blind controlled trial of caffeine
reduction in 1,207 women evaluated birth data for 1,153
singleton live births (6). An average intake of 182 mg
per day of caffeine did not affect length of gestation.
Additionally, a prospective, population-based cohort
study conducted by Clausson et al evaluated the effect
of caffeine consumption on gestational age at delivery in
873 singleton births (7). Again, no association was found
between caffeine and preterm birth. Consequently, it
does not appear that moderate caffeine intake is a con-
tributor to preterm birth.
Studies also have investigated whether caffeine con-
tributes to intrauterine growth restriction (IUGR).
Although caffeine does cross the placenta, it has been
shown that caffeine does not cause a decrease in uterine
blood flow or fetal oxygenation (8). Two studies have
assessed the relationship between caffeine consumption
and mean birth weight differences (6, 7), and two others
have recently reported on IUGR. A study of 2,635 low-
risk pregnant women recruited between 8 weeks and 12
weeks of gestation was performed to determine if a rela-
tionship exists between caffeine consumption and IUGR
(9). Intrauterine growth restriction was the primary out-
come measure and was defined by birth weight less than
the 10th percentile on a personalized growth chart. Of
the 2,635 women, IUGR was identified in 343 (13%) of
the newborns. The association of caffeine intake with the
incidence of IUGR was equivocal at all levels of caffeine
consumption. Compared with an average daily consump-
tion of less than 100 mg, odds ratios (OR) for IUGR at
increasing levels of caffeine intake are as follows: con-
sumption of 100–199 mg per day (OR, 1.2; 95% CI, 0.9–
1.6), 200–299 mg per day (OR, 1.5; 95% CI, 1.1–2.1), and
more than 300 mg per day (OR, 1.4; 95% CI, 1.0–2.0).
A prospective cohort study found no association between
caffeine consumption and IUGR (3). Thus, at this time,
there is no clear evidence that caffeine exposure increases
the risk of IUGR.
COMMITTEE OPINIONS
Moderate caffeine consumption (less than 200 mg
per day) does not appear to be a major contributing fac-
tor in miscarriage or preterm birth. The relationship of
caffeine to IUGR remains undetermined. A final conclu-
sion cannot be made at this time as to whether there is a
correlation between high caffeine intake and miscarriage.
References
1. Goldstein A, Warren R. Passage of caffeine into human
gonadal and fetal tissue. Biochem Pharmacol 1962;11:
166–8.
2. Maconochie N, Doyle P, Prior S, Simmons R. Risk factors for
first trimester miscarriage––results from a UK-population-
based case-control study. BJOG 2007;114:170–86.
3. Mills JL, Holmes LB, Aarons JH, Simpson JL, Brown ZA,
Jovanovic-Peterson LG, et al. Moderate caffeine use and
the risk of spontaneous abortion and intrauterine growth
retardation. JAMA 1993;269:593–7.
4. Savitz DA, Chan RL, Herring AH, Howards PP, Hartmann KE.
Caffeine and miscarriage risk. Epidemiology 2008;19:55–62.
5. Weng X, Odouli R, Li DK. Maternal caffeine consumption
during pregnancy and the risk of miscarriage: a prospective
cohort study. Am J Obstet Gynecol 2008;198:279.el–279.e8.
6. Bech BH, Obel C, Henriksen TB, Olsen J. Effect of reduc-
ing caffeine intake on birth weight and length of gestation:
randomised controlled trial. BMJ 2007;334:409.
7. Clausson B, Granath F, Ekbom A, Lundgren S, Nordmark A,
Signorello LB, et al. Effect of caffeine exposure during preg-
nancy on birth weight and gestational age. Am J Epidemiol
2002;155:429–36.
8. Conover WB, Key TC, Resnik R. Maternal cardiovascular
response to caffeine infusion in the pregnant ewe. Am J
Obstet Gynecol 1983;145:534–8.
9. Maternal caffeine intake during pregnancy and risk of fetal
growth restriction: a large prospective observational study.
CARE Study Group. BMJ 2008;337:a2332.
Copyright August 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Moderate caffeine consumption during pregnancy. Committee Opin-
ion No. 462. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:467–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 689
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 465 • September 2010

Committee on Obstetric Practice

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Antimicrobial Prophylaxis for Cesarean Delivery: Timing

of Administration
ABSTRACT: Antimicrobial prophylaxis for cesarean delivery has been a general practice for cesarean deliv-
eries because it significantly reduces postoperative maternal infectious morbidity. Recently, several random-
ized clinical trials investigated the timing of antimicrobial prophylaxis for cesarean delivery. The Committee on
Obstetric Practice recommends antimicrobial prophylaxis for all cesarean deliveries unless the patient is already
receiving appropriate antibiotics (eg, for chorioamnionitis) and that prophylaxis should be administered within
60 minutes of the start of the cesarean delivery.

Antimicrobial prophylaxis for cesarean delivery has been
a general practice for cesarean deliveries because it sig-
nificantly reduces postoperative maternal infectious mor-
bidity (1). These antibiotics have been administered
intraoperatively after umbilical cord clamping for two
theoretic concerns related to the fetus: 1) antibiotics in
neonatal serum may mask newborn positive bacterial
culture results; and 2) fetal antibiotic exposure could lead
to an increase in newborn colonization or infection with
antibiotic-resistant organisms. Recently, several random-
ized clinical trials investigated the timing of antimicrobial
prophylaxis for cesarean delivery (2–4).
Surgical research data support antimicrobial pro-
phylaxis administration, ideally within 30 minutes and
certainly within 2 hours of the time of skin incision, to
prevent surgical site infection (5). In one study, 1.4% of
patients who received perioperative antimicrobial pro-
phylaxis within 3 hours after skin incision had wound
infections, versus 0.6% of patients who were given pre-
operative prophylaxis in the 2 hours before skin incision
(5). The infusion should be timed so that a bactericidal
serum level is established by the time of skin incision, and
to maintain therapeutic levels throughout the operation
(6). For longer surgical procedures, readministration of
the drug is indicated at intervals of one or two times the
half-life of the drug (using the same dose) (7). Narrow-
spectrum antibiotics that are effective against gram-posi-
tive bacteria, gram-negative bacteria, and some anaerobic
bacteria, such as a first-generation cephalosporin, are
mainly used for prophylaxis for cesarean delivery. After a
single 1 gram intravenous dose of cefazolin, a therapeutic
level is maintained for approximately 3–4 hours. A larger
dose may be indicated if a woman is obese. For women
with a significant allergy to β-lactam antibiotics, such as
cephalosporins and penicillins, clindamycin with genta-
micin is a reasonable alternative.
In a 2007 randomized, controlled trial designed to
examine maternal infectious morbidity rates after cesar-
ean delivery, 175 and 182 women received antibiot-
ics preoperatively and after umbilical cord clamping,
respectively (2). This study included both laboring and
nonlaboring women. The administration of cefazolin (1 g,
intravenously) 15–60 minutes before cesarean delivery
(preoperative group) was associated with a significant
reduction of endometritis of 1% compared with a rate
of 5% in women who received the same medication after
umbilical cord clamping (cord-clamp group) (2). There
was no significant difference in the rates of postoperative
wound infections in the two treatment groups. Overall,
the total postoperative infection rates were decreased sig-
nificantly from 11.5% to 4.5% in the preoperative group
compared with the cord-clamp group. There were no dif-
ferences in the rates of neonatal sepsis, neonatal intensive
care unit admission, or neonatal sepsis due to resistant
organisms, although the study was not designed with suf-
ficient power to address these secondary outcomes.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 690

 In 2005, another randomized controlled trial evalu-
ated the administration of cefazolin (2 g, intravenously)
at the time of skin incision (at-incision group) compared
with administration after umbilical cord clamping in
women in labor undergoing cesarean delivery (cord-
clamping group) (3). The investigators observed a sig-
nificant decrease in endometritis (7.8% versus 14.8%
in the at-incision group and the cord-clamping group,
respectively), but not wound infection (3.9% versus
5.4% in at-incision group and cord-clamping group,
respectively) (3). The initial power analysis for this study
suggested that 270 women per group were needed, but
the interim analysis determined a need for only 150 per
group; therefore, the study was stopped with 153 and 149
women per group for the at-incision and cord-clamping
groups, respectively. In addition, the infection rates for
both groups in this study were three times higher than in
the 2007 study. There were no differences in rates of neo-
natal intensive care unit admission, neonatal sepsis, or
suspected sepsis between the groups although this study
also was underpowered for evaluation of these secondary
outcomes. The only other randomized trial examining
cefazolin was smaller (90 patients), and found no sig-
nificant difference in maternal infectious outcome (4).
These investigators observed similar rates of endometritis
(2% versus 2.4% in the preoperative antibiotic group and
the after-cord-clamping group, respectively) and wound
infection (2% versus 4.9% in preoperative antibiotic
group and after-cord-clamping group, respectively) (4, 8).
From these data, it would appear that preoperatively
administered antimicrobial prophylaxis does not appear
to have any deleterious effects on mother or neonate.
Preoperative administration significantly reduces endo-
metritis and total maternal infectious morbidity com-
pared with administration of antibiotics after umbilical
cord clamping (8). These data further suggest that pre-
operative antimicrobial prophylaxis for cesarean delivery
is not associated with an increase in neonatal infectious
morbidity or the selection of antimicrobial resistant
bacteria causing neonatal sepsis. However, because the
studies were not powered to analyze those outcomes,
additional prospective evaluation is warranted.
The Committee on Obstetric Practice recommends
antimicrobial prophylaxis for all cesarean deliveries
unless the patient is already receiving appropriate anti-
biotics (eg, for chorioamnionitis) and that prophylaxis
should be administered within 60 minutes of the start of
the cesarean delivery. When this is not possible (eg, need
for emergent delivery), prophylaxis should be adminis-
tered as soon as possible.
COMMITTEE OPINIONS
References
1. Smaill FM, Gyte GM. Antibiotic prophylaxis versus no
prophylaxis for preventing infection after cesarean section.
Cochrane Database of Systematic Reviews 2010, Issue 1.
Art. No.: CD007482. DOI: 10.1002/14651858.CD007482.
pub2.
2. Sullivan SA, Smith T, Chang E, Hulsey T, Vandorsten JP,
Soper D. Administration of cefazolin prior to skin incision
is superior to cefazolin at cord clamping in preventing post-
cesarean infectious morbidity: a randomized, controlled
trial [published erratum appears in Am J Obstet Gynecol
2007;197:333]. Am J Obstet Gynecol 2007;196:455.e1–455.
e5.
3. Thigpen BD, Hood WA, Chauhan S, Bufkin L, Bofill J,
Magann E, et al. Timing of prophylactic antibiotic admin-
istration in the uninfected laboring gravida: a randomized
clinical trial. Am J Obstet Gynecol 2005;192:1864-8; discus-
sion 1868–71.
4. Wax JR, Hersey K, Philput C, Wright MS, Nichols KV,
Eggleston MK, et al. Single dose cefazolin prophylaxis for
postcesarean infections: before vs. after cord clamping.
J Matern Fetal Med 1997;6:61–5.
5. Classen DC, Evans RS, Pestotnik SL, Horn SD, Menlove RL,
Burke JP. The timing of prophylactic administration of
antibiotics and the risk of surgical-wound infection. N Engl
J Med 1992;326:281–6.
6. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR.
Guideline for prevention of surgical site infection, 1999.
Hospital Infection Control Practices Advisory Committee.
Infect Control Hosp Epidemiol 1999;20:250-78; quiz 279–
80.
7. Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS,
Wittmann DH. Antimicrobial prophylaxis for surgical
wounds. Guidelines for clinical care [published erratum
appears in Arch Surg 1993;128:410]. Arch Surg 1993;128:7
9–88.
8. Costantine MM, Rahman M, Ghulmiyah L, Byers BD,
Longo M, Wen T, et al. Timing of perioperative antibiotics
for cesarean delivery: a metaanalysis. Am J Obstet Gynecol
2008;199:301.e1–301.e6.
Copyright September 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Antimicrobial prophylaxis for cesarean delivery: timing of administra-
tion. Committee Opinion No. 465. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2010;116:791–2.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 691
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 468 • October 2010 (Replaces No. 305, November 2004)

Committee on Obstetric Practice

This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Influenza Vaccination During Pregnancy

Abstract: Preventing influenza during pregnancy is an essential element of prenatal care, and the most effec-
tive strategy for preventing influenza is annual immunization. The Centers for Disease Control and Prevention’s
Advisory Committee on Immunization Practice recommends influenza vaccination for all women who will be
pregnant through the influenza season (October through May in the United States). The American College of
Obstetricians and Gynecologists’ Committee on Obstetric Practice supports this recommendation. No study to
date has shown an adverse consequence of inactivated influenza vaccine in pregnant women or their offspring.
Vaccination early in the season and regardless of gestational age is optimal, but unvaccinated pregnant women
should be immunized at any time during influenza season as long as the vaccine supply lasts.

Influenza vaccination is an essential element of prena-
tal care because pregnant women are at an increased
risk of serious illness due to influenza. Most reports of
excess seasonal influenza-related morbidity have focused
on excess hospital admissions for respiratory illness dur-
ing influenza season. For example, a retrospective cohort
study in Nova Scotia compared hospitalizations and
respiratory illness among pregnant women during influ-
enza season with hospital admissions during influenza
season for the same women in the year before their
pregnancies. Women were more likely to have increased
medical visits or increased lengths of stay if hospitalized
for respiratory illnesses during pregnancy than when not
pregnant, especially during the third trimester; the asso-
ciation between pregnancy status and hospital admission
was particularly striking for women with comorbidities
(1). In addition to the risks from seasonal influenza,
pregnant women experienced excess mortality during the
influenza pandemics of 1918–1919, 1957–1958, and most
recently, the 2009 pandemic (2–10).
The Centers for Disease Control and Prevention’s
Advisory Committee on Immunization Practices (ACIP)
recommends that all women who will be pregnant during
influenza season (October through May in the United
States) receive inactivated influenza vaccine at any point
in gestation; live attenuated influenza vaccine is contra-
indicated for pregnant women (11). No study to date has
shown an adverse consequence of inactivated influenza
vaccine in pregnant women or their offspring (12). The
vaccine is made the same way each year, with the only
difference being the use of a new strain of influenza based
on predictions of prevalent strains in the community.
There have been no reports of any adverse outcomes in
pregnant women or their infants. Thimerosal, a mercury-
containing preservative used in multidose vials, has not
been shown to cause any adverse effects except for occa-
sional local skin reactions. There is no scientific evidence
that thimerosal-containing vaccines cause adverse effects
in children born to women who received vaccines with
thimerosal. Hence, ACIP does not indicate a preference
for thimerosal-containing or thimerosal-free vaccines for
any group, including pregnant women (11). In addition
to the benefits of immunization for pregnant women, a
prospective, controlled, blinded randomized trial dem-
onstrated fewer cases of laboratory-confirmed influenza
among infants whose mothers had been immunized com-
pared with women in the control group, as well as fewer
cases of respiratory illness with fever. Maternal immunity
is the only effective strategy in newborns because the vac-
cine is not approved for use in infants younger than 6
months (13).
The American College of Obstetricians and Gynecol-
ogists’ Committee on Obstetric Practice supports ACIP’s
recommendation that all women who are pregnant
during influenza season receive inactivated influenza
vaccine. Despite the safety of the vaccine, many obste-
trician–gynecologists have not participated in influenza
vaccination programs. Survey data suggest vaccination

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 692

 rates in pregnancy for seasonal influenza in recent years
of 15–25% (11) and for 2009, an H1N1 vaccination
rate of 38% (14). However, small numbers of pregnant
women were surveyed, and confidence intervals around
the estimates are wide. Provider education with simple
chart prompts has been shown to increase the frequency
of discussion between physicians and pregnant women
regarding influenza and vaccination (15). This is par-
ticularly important because it has been shown that lack
of knowledge about the benefits of the vaccine is a barrier
to vaccine acceptance (16, 17).
Pregnant women represent a vulnerable population
with regard to influenza, and influenza vaccination is an
integral element of prenatal care. It is imperative that
health care providers, health care organizations, and pub-
lic health officials continue efforts to improve the rate of
influenza vaccination among pregnant women.
References
1. Dodds L, McNeil SA, Fell DB, Allen VM, Coombs A, Scott J,
et al. Impact of influenza exposure on rates of hospital
admissions and physician visits because of respiratory ill-
ness among pregnant women. CMAJ 2007;176:463–8.
2. Harris JW. Influenza occurring in pregnant women: a sta-
tistical study of thirteen hundred and fifty cases. J Am Med
Assoc 1919;72:978–80.
3. Freeman DW, Barno A. Deaths from Asian influenza associ-
ated with pregnancy. Am J Obstet Gynecol 1959;78:1172–5.
4. Greenberg M, Jacobziner H, Pakter J, Weisl BA. Maternal
mortality in the epidemic of Asian influenza, New York
City, 1957. Am J Obstet Gynecol 1958;76:897–902.
5. Jamieson DJ, Honein MA, Rasmussen SA, Williams JL,
Swerdlow DL, Biggerstaff MS, et al. H1N1 2009 influ-
enza virus infection during pregnancy in the USA. Novel
Influenza A (H1N1) Pregnancy Working Group. Lancet
2009;374:451–8.
6. Louie JK, Acosta M, Jamieson DJ, Honein MA. Severe 2009
H1N1 influenza in pregnant and postpartum women in
California. California Pandemic (H1N1) Working Group.
New Engl J Med 2010;362:27–35.
7. Saleeby E, Chapman J, Morse J, Bryant A. H1N1 influ-
enza in pregnancy: cause for concern. Obstet Gynecol 2009;
114:885–91.
8. Greer LG, Abbassi-Ghanavati M, Sheffield JS, Casey BM.
Diagnostic dilemmas in a pregnant woman with influenza
A (H1N1) infection. Obstet Gynecol 2010;115:409–12.
9. Brown CM. Severe influenza A virus (H1N1) infection in
pregnancy. Obstet Gynecol 2010;115:412–4.
10. Siston AM, Rasmussen SA, Honein MA, Fry AM, Seib K,
Callaghan WM, et al. Pandemic 2009 influenza A (H1N1)
virus illness among pregnant women in the United States.
COMMITTEE OPINIONS
Pandemic H1N1 Influenza in Pregnancy Working Group.
JAMA 2010;303:1517–25.
11. Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM,
Mootrey G, et al. Prevention and control of seasonal influ-
enza with vaccines: recommendations of the Advisory
Committee on Immunization Practices (ACIP), 2009. Centers
for Disease Control and Prevention [published erratum
appears in MMWR Morb Mortal Wkly Rep 2009;58:896–7].
MMWR Recomm Rep 2009;58(RR-8):1–52.
12. Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA,
Omar SB. Safety of influenza vaccination during pregnancy.
Am J Obstet Gynecol 2009;201:547–52.
13. Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E,
et al. Effectiveness of maternal influenza immunization in
mothers and infants [published erratum appears in N Engl
J Med 2009;360:648]. N Engl J Med 2008;359:1555–64.
14. Interim results: influenza A (H1N1) 2009 monovalent
vaccination coverage––United States, October-December
2009. Centers for Disease Control and Prevention (CDC).
MMWR Morb Mortal Wkly Rep 2010;59:44–8.
15. Wallis DH, Chin JL, Sur DK, Lee MY. Increasing rates of
influenza vaccination during pregnancy: a multisite inter-
ventional study. J Am Board Fam Med 2006;19:345–9.
16. Beigi RH, Switzer GE, Meyn LA. Acceptance of a pan-
demic avian influenza vaccine in pregnancy. J Reprod Med
2009;54:341–6.
17. Yudin MH, Salaripour M, Sgro MD. Pregnant women’s
knowledge of influenza and the use and safety of the influ-
enza vaccine during pregnancy. J Obstet Gynaecol Can
2009;31:120–5.
Resources
Centers for Disease Control and Prevention
www.cdc.gov/flu
www.cdc.gov/flr/professional/index.htm
FLU.GOV
www.flu.gov
Copyright October 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Influenza vaccination during pregnancy. Committee Opinion No. 468.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2010;116:1006–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 693
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 474 • February 2011 (Replaces No. 284, August 2003)
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Nonobstetric Surgery During Pregnancy

ABSTRACT: The American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice
acknowledges that the issue of nonobstetric surgery during pregnancy is an important concern for physicians who
care for women. It is important for a physician to obtain an obstetric consultation before performing nonobstetric
surgery and some invasive procedures (eg, cardiac catheterization or colonoscopy) because obstetricians are
uniquely qualified to discuss aspects of maternal physiology and anatomy that may affect intraoperative mater-
nal–fetal well-being. Ultimately, each case warrants a team approach (anesthesia and obstetric care providers,
surgeons, pediatricians, and nurses) for optimal safety of the woman and the fetus.

The American College of Obstetricians and Gynecologists’
Committee on Obstetric Practice acknowledges that the
issue of nonobstetric surgery during pregnancy is an
important concern for physicians who care for women.
Because of the difficulty of conducting large-scale ran-
domized clinical trials in this population, there are
no data to allow for specific recommendations. It is
important for a physician to obtain an obstetric consulta-
tion before performing nonobstetric surgery and some
invasive procedures (eg, cardiac catheterization or colo-
noscopy) because obstetricians are uniquely qualified to
discuss aspects of maternal physiology and anatomy that
may affect intraoperative maternal–fetal well-being. The
following generalizations may be helpful to guide deci-
sion making:
• No currently used anesthetic agents have been shown • A qualified individual should be readily available to
to have any teratogenic effects in humans when using
standard concentrations at any gestational age.
• Fetal heart rate monitoring may assist in maternal
positioning and cardiorespiratory management, and
may influence a decision to deliver the fetus.
The following recommendations represent the consensus
of the committee:
• A pregnant woman should never be denied indicated simultaneous electronic fetal heart rate and contrac-
surgery, regardless of trimester.
• Elective surgery should be postponed until after after the procedure to assess fetal well-being and the
delivery.
• If possible, nonurgent surgery should be performed
in the second trimester when preterm contractions
and spontaneous abortion are least likely.
When nonobstetric surgery is planned, the primary
obstetric care provider should be notified. If that health
care provider is not at the institution where surgery is
to be performed, another obstetric care provider with
privileges at that institution should be involved. If fetal
monitoring is to be used, consider the following recom-
mendations:
• Surgery should be done at an institution with neona-
tal and pediatric services.
• An obstetric care provider with cesarean delivery
privileges should be readily available.
interpret the fetal heart rate patterns.
General guidelines for fetal monitoring include the fol-
lowing:
• If the fetus is considered previable, it is generally
sufficient to ascertain the fetal heart rate by Doppler
before and after the procedure.
• At a minimum, if the fetus is considered to be viable,
tion monitoring should be performed before and
absence of contractions.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 694

 • Intraoperative electronic fetal monitoring may be The decision to use fetal monitoring should be indi-
appropriate when all of the following apply:
— The fetus is viable.
— It is physically possible to perform intraoperative
electronic fetal monitoring.
— A health care provider with obstetric surgery privi-
leges is available and willing to intervene during
the surgical procedure for fetal indications.
— When possible, the woman has given informed
consent to emergency cesarean delivery.
— The nature of the planned surgery will allow the
safe interruption or alteration of the procedure
to provide access to perform emergency delivery.
In select circumstances, intraoperative fetal monitoring
may be considered for previable fetuses to facilitate posi-
tioning or oxygenation interventions.
2 Committee Opinion No. 474
COMMITTEE OPINIONS
vidualized and, if used, should be based on gestational age,
type of surgery, and facilities available. Ultimately, each
case warrants a team approach (anesthesia and obstetric
care providers, surgeons, pediatricians, and nurses) for
optimal safety of the woman and the fetus.
Copyright February 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Nonobstetric surgery during pregnancy. Committee Opinion No. 474.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2011;117:420–1.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 695
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 475 • February 2011 (Replaces No. 402, March 2008)
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Antenatal Corticosteroid Therapy for Fetal Maturation

ABSTRACT: A single course of corticosteroids is recommended for pregnant women between 24 weeks
and 34 weeks of gestation who are at risk of preterm delivery within 7 days. A single course of antenatal corti-
costeroids should be administered to women with premature rupture of membranes before 32 weeks of gesta-
tion to reduce the risks of respiratory distress syndrome, perinatal mortality, and other morbidities. The efficacy
of corticosteroid use at 32–33 completed weeks of gestation for preterm premature rupture of membranes is
unclear, but treatment may be beneficial, particularly if pulmonary immaturity is documented. Sparse data exist on
the efficacy of corticosteroid use before fetal age of viability, and such use is not recommended. A single rescue
course of antenatal corticosteroids may be considered if the antecedent treatment was given more than 2 weeks
prior, the gestational age is less than 32 6/7 weeks, and the women are judged by the clinician to be likely to give
birth within the next week. However, regularly scheduled repeat courses or multiple courses (more than two) are
not recommended. Further research regarding the risks and benefits, optimal dose, and timing of a single rescue
course of steroid treatment is needed.

In 2000, the National Institute of Child Health and Human
Development and the Office of Medical Applications of
Research of the National Institutes of Health convened
a consensus conference on antenatal steroids, entitled
“Consensus Development Conference on Antenatal Cor-
ticosteroids Revisited: Repeat Courses,” to address the
issue of repeated courses of corticosteroids for fetal matur-
ation. The consensus panel from this conference reaf-
firmed the 1994 consensus panel’s recommendation of
giving a single course of corticosteroids to all pregnant
women between 24 weeks and 34 weeks of gestation who
are at risk of preterm delivery within 7 days (1). Because
of insufficient scientific evidence, the panel also recom-
mended that repeat corticosteroid courses, including so-
called “rescue therapy,” should not be routinely used but
should be reserved for women enrolled in clinical trials.
Multiple Weekly or Every Other Week
Courses
There is no convincing scientific evidence that antena-
tal corticosteroid therapy increases the risk of neonatal
infection, although multiple courses have been associated
with fetal adrenal suppression (2). Follow-up studies of
adolescents aged 14 years who were exposed to at least
one course of corticosteroid treatment indicate there
is no apparent risk of an adverse neurodevelopmental
outcome associated with antenatal corticosteroid use (3).
In a randomized trial of single versus multiple courses of
antenatal corticosteroids, a reduction in birth weight and
an increase in the number of infants who were small for
gestational age was found, especially after four courses of
corticosteroids (4). Although not consistent, six studies
found decreased birth weight and head circumference
with repeat courses (4–10) and three studies did not
(11–13). The 2000 consensus panel concluded that stud-
ies regarding the possible benefits and risks of repeat
courses of antenatal corticosteroids are limited because
of their study design and “methodologic inconsistencies.”
The 2000 consensus panel noted that, although there is
a suggestion of possible benefit from repeated courses
(especially in the reduction and severity of respiratory
distress), there also are animal and human data that
suggest deleterious effects on the fetus regarding cerebral
myelination, lung growth, and function of the hypo-
thalamic–pituitary–adrenal axis. Follow-up of children
at 2 years of age exposed to repeat courses of antenatal
corticosteroids showed no significant difference in physi-
cal or neurocognitive measures in two studies (14–15),

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 696

 and the same outcome was found in younger children in
a third study (16). Although not statistically significant,
the relative risk of cerebral palsy in infants exposed to
multiple courses of antenatal corticosteroids (relative
risk, 5.7; 95% confidence interval, 0.7–46.7; P=0.12) in
one study is of concern and warrants further study (14).
Maternal effects include increased risk of infection and
suppression of the hypothalamic–pituitary–adrenal axis
(6, 17).
Rescue Courses
The utility of a rescue course of steroids remains ques-
tionable for those patients who received treatment early
in pregnancy and present again after more than 1–2
weeks with a recurrent or new risk of preterm birth.
Although the initial data (18) suggested the benefit of
steroids may decrease after 7 days, the duration of ste-
roid benefit remains controversial (19). A multicenter
randomized trial of a single rescue course was performed
in 437 patients without preterm premature rupture of
membranes (PROM) who had completed a single course
of antenatal steroids before 30 weeks of gestation and at
least 14 days before inclusion, and were judged to have
a recurring threat of preterm birth in the coming week
before 33 weeks of gestation (20). The investigators
found a significant reduction in respiratory distress syn-
drome, the need for surfactant, and composite morbidity
for those giving birth before 34 weeks of gestation and
for the overall cohort. No increase in newborn complica-
tions or intrauterine growth restriction was identified,
although the power to evaluate these individual outcomes
was low. Long-term outcome data are not available for
these patients.
Betamethasone Versus
Dexamethasone
Betamethasone and dexamethasone are the most widely
studied corticosteroids and they generally have been
preferred for antenatal treatment to accelerate fetal organ
maturation. Both cross the placenta in their active form
and have nearly identical biologic activity. Both lack
mineralocorticoid activity and have relatively weak immu-
nosuppressive activity with short-term use. Although
betamethasone and dexamethasone differ only by a sin-
gle methyl group, betamethasone has a longer half-life
because of its decreased clearance and larger volume of
distribution (21). The 2000 consensus panel reviewed
all available reports on the safety and efficacy of beta-
methasone and dexamethasone. It did not find significant
scientific evidence to support a recommendation that
betamethasone should be used preferentially instead of
dexamethasone. Of the 10 trials included in a Cochrane
review on this issue, there were no differences in perinatal
death or alterations in biophysical activity, but there was a
decreased incidence of intraventricular hemorrhage with
dexamethasone treatment (22). Alternatively, an obser-
vational study reported less frequent adverse neurological
2 Committee Opinion No. 475
COMMITTEE OPINIONS
outcome at 18–22 months after betamethasone exposure
(23). These inconsistent and limited data are not consid-
ered sufficient to recommend one steroid regimen over
the other.
Recommendations
The Committee on Obstetric Practice recommends either
of the following corticosteroid courses:
• Betamethasone (12 mg) given intramuscularly 24
hours apart for two doses
• Dexamethasone (6 mg) given intramuscularly every
12 hours for four doses
A single course of corticosteroids is recommended for
pregnant women between 24 weeks and 34 weeks of ges-
tation who are at risk of preterm delivery within 7 days
(24). A single course of antenatal corticosteroids should
be administered to women with PROM before 32 weeks
of gestation to reduce the risks of respiratory distress
syndrome, perinatal mortality, and other morbidities.
The efficacy of corticosteroid use at 32–33 completed
weeks of gestation for preterm PROM is unclear based
on available evidence, but treatment may be beneficial,
particularly if pulmonary immaturity is documented.
There are no data regarding the efficacy of corticosteroid
use before viability, and it is not recommended. A single
rescue course of antenatal corticosteroids may be consid-
ered if the antecedent treatment was given more than 2
weeks prior, the gestational age is less than 32 6/7 weeks,
and the women are judged by the clinician to be likely to
give birth within the next week (20). However, regularly
scheduled repeat courses or multiple courses (more than
two) are not recommended. Further research regarding
the risks and benefits, optimal dose, and timing of a single
rescue course of steroid treatment is needed.
References
1. Antenatal corticosteroids revisited: repeat courses. NIH
Consens Statement 2000;17(2):1–18.
2. Kairalla AB. Hypothalamic-pituitary-adrenal axis func-
tion in premature neonates after extensive prenatal treat-
ment with betamethasone: a case history. Am J Perinatol
1992;9:428–30.
3. Doyle LW, Ford GW, Rickards AL, Kelly EA, Davis NM,
Callanan C, et al. Antenatal corticosteroids and outcome at
14 years of age in children with birth weight less than 1501
grams. Pediatrics 2000;106:E2.
4. Wapner RJ, Sorokin Y, Thom EA, Johnson F, Dudley DJ,
Spong CY, et al. Single versus weekly courses of antenatal
corticosteroids: evaluation of safety and efficacy. National
Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network. Am J Obstet
Gynecol 2006;195:633–42.
5. French NP, Hagan R, Evans SF, Godfrey M, Newnham JP.
Repeated antenatal corticosteroids: size at birth and sub-
sequent development. Am J Obstet Gynecol 1999;180:
114–21.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 697
 6. Abbasi S, Hirsch D, Davis J, Tolosa J, Stouffer N, Debbs R,
et al. Effect of single versus multiple courses of antenatal
corticosteroids on maternal and neonatal outcome. Am J
Obstet Gynecol 2000;182:1243–9.
7. Banks BA, Cnaan A, Morgan MA, Parer JT, Merrill JD,
Ballard PL, et al. Multiple courses of antenatal corticoste-
roids and outcome of premature neonates. North Ameri-
can Thyrotropin-Releasing Hormone Study Group. Am J
Obstet Gynecol 1999;181:709–17.
8. Bloom SL, Sheffield JS, McIntire DD, Leveno KJ. Antenatal
dexamethasone and decreased birth weight. Obstet Gynecol
2001;97:485–90.
9. Thorp JA, Jones PG, Knox E, Clark RH. Does antenatal
corticosteroid therapy affect birth weight and head circum-
ference? Obstet Gynecol 2002;99:101–8.
10. Murphy KE, Hannah ME, William AR, Hewson SA, et
al. Multiple courses of antenatal corticosteroids for pre-
term birth (MACS): a randomised controlled trial. Lancet
2008;372:2143–9.
11. Guinn DA, Atkinson MW, Sullivan L, Lee M, MacGregor
S, Parilla BV, et al. Single vs weekly courses of antenatal
corticosteroids for women at risk of preterm delivery: A
randomized controlled trial. JAMA 2001;286:1581–7.
12. Pratt L, Waschbusch L, Ladd W, Gangnon R, Hendricks
SK. Multiple vs. single betamethasone therapy. Neonatal
and maternal effects. J Reprod Med 1999;44:257–64.
13. Shelton SD, Boggess KA, Murtha AP, Groff AO, Herbert
WN. Repeated fetal betamethasone treatment and birth
weight and head circumference. Obstet Gynecol 2001;
97:301–4.
14. Wapner RJ, Sorokin Y, Mele L, Johnson F, Dudley DJ,
Spong CY, et al. Long-term outcomes after repeat doses of
antenatal corticosteroids. National Institute of Child Health
and Human Development Maternal-Fetal Medicine Units
Network. N Engl J Med 2007;357:1190–8.
15. Crowther CA, Doyle LW, Haslam RR, Hiller JE, Harding JE,
Robinson JS. Outcomes at 2 years of age after repeat doses
of antenatal corticosteroids. ACTORDS Study Group. N
Engl J Med 2007;357:1179–89.
16. Asztalos EV, Murphy KE, Hannah ME, Willan AR,
Matthews SG, Ohlsson A, et al. Multiple courses of ante-
natal corticosteroids for preterm birth study: 2-year out-
comes. Multiple Courses of Antenatal Corticosteroids
for Preterm Birth Study Collaborative Group. Pediatrics
2010;126:e1045–55.
17. McKenna DS, Wittber GM, Nagaraja HN, Samuels P.
The effects of repeat doses of antenatal corticosteroids on
Committee Opinion No. 475
COMMITTEE OPINIONS
maternal adrenal function. Am J Obstet Gynecol 2000;183:
669–73.
18. Liggins GC, Howie RN. A controlled trial of antepartum
glucocorticoid treatment for prevention of the respiratory
distress syndrome in premature infants. Pediatrics 1972;
50:515–25.
19. Peaceman AM, Bajaj K, Kumar P, Grobman WA. The
interval between a single course of antenatal steroids and
delivery and its association with neonatal outcomes. Am J
Obstet Gynecol 2005;193:1165–9.
20. Garite TJ, Kurtzman J, Maurel K, Clark R. Impact of a ‘res-
cue course’ of antenatal corticosteroids: a multicenter ran-
domized placebo-controlled trial. Obstetrix Collaborative
Research Network [published erratum appears in Am J
Obstet Gynecol 2009;201:428]. Am J Obstet Gynecol 2009;
200:248.e1–248.e9.
21. Fanaroff AA, Hack M. Periventricular leukomalacia––pros-
pects for prevention. N Engl J Med 1999;341:1229–31.
22. Brownfoot FC, Crowther CA, Middleton P. Different
corticosteroids and regimens for accelerating fetal lung
maturation for women at risk of preterm birth. Cochrane
Database of Systematic Reviews 2008, Issue 4. Art. No.:
CD006764. DOI: 10.1002/14651858.CD006764.pub2; 10.
1002/14651858.CD006764.pub2.
23. Lee BH, Stoll BJ, McDonald SA, Higgins RD. Neuro-
developmental outcomes of extremely low birth weight
infants exposed prenatally to dexamethasone versus beta-
methasone. National Institute of Child Health and Human
Development Neonatal Research Network. Pediatrics
2008;121:289–96.
24. Roberts D, Dalziel SR. Antenatal corticosteroids for accel-
erating fetal lung maturation for women at risk of preterm
birth. Cochrane Database of Systematic Reviews 2006, Issue 3.
Art. No.: CD004454. DOI: 10.1002/14651858.CD004454.
pub2; 10.1002/14651858.CD004454.pub2.
Copyright February 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
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Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Antenatal corticosteroid therapy for fetal maturation. Committee
Opinion No. 475. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;117:422–4.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 698
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 476 • February 2011
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Planned Home Birth

ABSTRACT: Although the Committee on Obstetric Practice believes that hospitals and birthing centers are
the safest setting for birth, it respects the right of a woman to make a medically informed decision about delivery.
Women inquiring about planned home birth should be informed of its risks and benefits based on recent evidence.
Specifically, they should be informed that although the absolute risk may be low, planned home birth is associ-
ated with a twofold to threefold increased risk of neonatal death when compared with planned hospital birth.
Importantly, women should be informed that the appropriate selection of candidates for home birth; the availability
of a certified nurse–midwife, certified midwife, or physician practicing within an integrated and regulated health
system; ready access to consultation; and assurance of safe and timely transport to nearby hospitals are critical to
reducing perinatal mortality rates and achieving favorable home birth outcomes.

In the United States, approximately 25,000 births (0.6%)
per year occur in the home (1). Approximately one fourth
of these births are unplanned or unattended (2). Among
women who originally intend to give birth in a hospital
or those who make no provisions for professional care
during childbirth, subsequent unplanned home births
are associated with high rates of perinatal and neonatal
mortality (3). The relative risk versus benefit of a planned
home birth, however, remains the subject of current
debate.
High-quality evidence to inform this debate is lim-
ited. To date there have been no adequate randomized
clinical trials of planned home birth (4). In developed
countries where home birth is more common than in
the United States, attempts to conduct such studies have
been unsuccessful largely because pregnant women have
been reluctant to participate in clinical trials involving
randomization to home or hospital birth (5, 6). Con-
sequently, most information on planned home births
comes from observational studies. Observational studies
of planned home birth often are limited by methodologi-
cal problems, including small sample sizes (7–10); lack of
an appropriate control group (11–14); reliance on birth
certificate data with inherent ascertainment problems (2,
15); ascertainment relying on voluntary submission of
data or self-reporting (7, 12, 14, 16); a limited ability to
accurately distinguish between planned and unplanned
home births (15, 17); variation in the skill, training, and
certification of the birth attendant (14, 15, 18); and an
inability to account for and accurately attribute adverse
outcomes associated with antepartum or intrapartum
transfers (8, 15, 19). Although some modern observation-
al studies overcome many of these limitations, the reports
describe planned home births within tightly regulated and
integrated provincial health care systems, which may not
be generalizable to current practice in the United States
(7, 8, 10, 11, 15, 16, 20–23). Furthermore, no studies are
of sufficient size to compare maternal mortality between
planned home and hospital birth and few, when consid-
ered alone, are large enough to compare perinatal and
neonatal mortality rates. Despite these limitations, when
viewed collectively, recent reports have clarified a number
of important issues regarding the maternal and newborn
outcomes of planned home birth when compared with
planned hospital births.
Wax and colleagues recently conducted a meta-
analysis of observational studies comparing the newborn
and maternal outcomes for planned home birth with
those of planned hospital birth (24) (Table 1). Although
perinatal mortality rates were similar among planned
home births and planned hospital births, planned home
births were associated with a twofold-increased risk of
neonatal death. When limited to only nonanomalous
newborns, the increased risk of neonatal death was even

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 699

 Table 1. Maternal and Neonatal Outcomes in Planned Home Birth Versus Planned Hospital Births
Planned
Home Birth
Neonatal death–– 2.0/1,000
all newborns
Neonatal death–– 1.5/1,000
nonanomalous
Episiotomy 7.0%
Operative vaginal 3.5%
delivery
Cesarean delivery 5.0%
Third- or fourth- 1.2%
degree laceration
Maternal infection 0.7%
Data from Wax JR, Lucas FL, Lamont M, Pinette MG, Cartin A, Blackstone DO. Maternal and newborn outcomes in planned home
birth versus planned hospital births—a meta-analysis. Am J Obstet Gynecol 2010;203:243.e1–8.
higher––almost threefold higher in planned home births.
These results did not change when the investigators
performed sensitivity analyses excluding older studies or
poorer quality studies. No maternal deaths were reported
among 10,977 planned home births (95% confidence
interval, 0–27.3/100,000 live births). When compared
with planned hospital births, planned home births are
associated with fewer maternal interventions, including
epidural analgesia, electronic fetal heart rate monitor-
ing, episiotomy, operative vaginal delivery, and cesarean
delivery. Planned home births are associated with fewer
third-degree lacerations or fourth-degree lacerations,
less maternal infection and similar rates of postpartum
hemorrhage, perineal laceration, vaginal laceration, and
umbilical cord prolapse. Rates of preterm birth before
37 weeks of gestation and low birth weight were lower
for planned home birth, likely because of selection bias.
The reported risk of needing an intrapartum transport to
a hospital is 25–37% for nulliparous women and 4–9%
for multiparous women (25). Most of these intrapartum
transports are for lack of progress in labor, nonreassuring
fetal status, need for pain relief, hypertension, bleeding,
and fetal malposition.
It is important to note that reports suggesting that
planned home births are safe involved only healthy preg-
nant women. Recent cohort studies reporting lower peri-
natal mortality rates with planned home birth describe
the use of strict selection criteria for appropriate candi-
dates (21, 22). These criteria include the absence of any
preexisting maternal disease, the absence of significant
disease arising during the pregnancy, a singleton fetus,
a cephalic presentation, gestational age greater than 36
weeks and less than 41 completed weeks of pregnancy,
labor that is spontaneous or induced as an outpatient,
and that the patient has not been transferred from
2 Committee Opinion No. 476
COMMITTEE OPINIONS
95%
Planned Confidence
Hospital Birth Odds Ratio Interval
0.9/1,000 2.0 1.2–3.3
0.4/1,000 2.9 1.3–6.2
10.4% 0.26 0.24–0.28
10.2% 0.26 0.24–0.28
9.3% 0.42 0.39–0.45
2.5% 0.38 0.33–0.45
2.6% 0.27 0.19–0.39
another referring hospital. Failure to adhere to such cri-
teria (because of postterm pregnancy, twins, or breech
presentation) is clearly associated with a higher risk of
perinatal death (23, 26). Although patients with one prior
cesarean delivery were considered candidates for home
birth in both Canadian studies, neither report provided
details of the outcomes specific to patients attempting
vaginal birth after cesarean delivery at home. Because
of the risks associated with a trial of labor after cesarean
delivery and that uterine rupture and other complica-
tions may be unpredictable, the American College of
Obstetricians and Gynecologists recommends that a trial
of labor after cesarean delivery be undertaken in facilities
with staff immediately available to provide emergency
care (27). The American College of Obstetricians and
Gynecologists’ Committee on Obstetric Practice consid-
ers a prior cesarean delivery to be an absolute contraindi-
cation to planned home birth.
Another factor influencing the safety of planned
home birth is the availability of safe and timely intra-
partum transfer of the laboring patient. The relatively
low perinatal and newborn mortality rates reported for
planned home births from Ontario, British Columbia,
and the Netherlands were from highly integrated health
care systems with established criteria and provisions for
emergency intrapartum transport (12–14). Cohort stud-
ies conducted in areas without such integrated systems
and those where the receiving hospital may be remote
with the potential for delayed or prolonged intrapartum
transport generally report higher rates of intrapartum
and neonatal death (6, 9, 11, 19). The Committee on
Obstetric Practice believes that the availability of timely
transfer and an existing arrangement with a hospital for
such transfers is a requirement for consideration of a
home birth.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 700
 A characteristic common to those cohort studies
reporting lower rates of perinatal mortality in North
America is the provision of care by well-educated, highly
trained, certified midwives who are well integrated into
the health care system (21, 22). In the United States, certi-
fied nurse–midwives and certified midwives are certified
by the American Midwifery Certification Board. This
certification depends on the completion of an accredited
educational program and meeting standards set by the
American Midwifery Certification Board. According to
the National Center for Health Statistics, more than 90%
of attended home births in the United States are attended
by midwives (28). However, only approximately 25% of
these are attended by certified nurse–midwives or certified
midwives. The remaining 75% are attended by other mid-
wives; the category used by the National Center for Health
Statistics that includes certified professional midwives, lay
midwives, and others. The recognition and regulation of
certified professional midwives and lay midwives varies
tremendously from state to state. At this time, for quality
and safety reasons, the American College of Obstetricians
and Gynecologists does not support the provision of care
by lay midwives or other midwives who are not certified
by the American Midwifery Certification Board.
Summary
Although the Committee on Obstetric Practice believes
that hospitals and birthing centers are the safest setting
for birth, it respects the right of a woman to make a medi-
cally informed decision about delivery. Women inquiring
about planned home birth should be informed of its risks
and benefits based on recent evidence. Specifically, they
should be informed that although the absolute risk may
be low, planned home birth is associated with a twofold
to threefold increased risk of neonatal death when com-
pared with planned hospital birth. Importantly, women
should be informed that the appropriate selection of
candidates for home birth; the availability of a certified
nurse–midwife, certified midwife, or physician practicing
within an integrated and regulated health system; ready
access to consultation; and assurance of safe and timely
transport to nearby hospitals are critical to reducing
perinatal mortality rates and achieving favorable home
birth outcomes.
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characteristics of home and other out-of-hospital births
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58:1,14–16.
2. Wax JR, Pinette MG, Cartin A, Blackstone J. Maternal
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3. Collaborative survey of perinatal loss in planned and
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COMMITTEE OPINIONS
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7. Wiegers TA, Keirse MJ, van der Zee J, Berghs GA. Outcome
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Peacock D, et al. Outcomes of planned home births versus
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13. Murphy PA, Fullerton J. Outcomes of intended home
births in nurse-midwifery practice: a prospective descrip-
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14. Johnson KC, Daviss BA. Outcomes of planned home births
with certified professional midwives: large prospective
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Outcomes of planned home births in Washington State:
1989-1996. Obstet Gynecol 2002;100:253–9.
16. Lindgren HE, Radestad IJ, Christensson K, Hildingsson
IM. Outcome of planned home births compared to hos-
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2008;87:751–9.
17. Mori R, Dougherty M, Whittle M. An estimation of intra-
partum-related perinatal mortality rates for booked home
births in England and Wales between 1994 and 2003 [pub-
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2008;115:554–9.
18. Schramm WF, Barnes DE, Bakewell JM. Neonatal mortal-
ity in Missouri home births, 1978-84. Am J Public Health
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3
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 19. Parratt J, Johnston J. Planned homebirths in Victoria,
1995–1998. Aust J Midwifery 2002;15:16–25.
20. de Jonge A, van der Goes BY, Ravelli AC, Amelink-Verburg
MP, Mol BW, Nijhuis JG, et al. Perinatal mortality and
morbidity in a nationwide cohort of 529,688 low-risk
planned home and hospital births. BJOG 2009;116:1177–84.
21. Janssen PA, Saxell L, Page LA, Klein MC, Liston RM,
Lee SK. Outcomes of planned home birth with registered
midwife versus planned hospital birth with midwife or phy-
sician [published erratum appears in CMAJ 2009;181:617].
CMAJ 2009;181:377–83.
22. Hutton EK, Reitsma AH, Kaufman K. Outcomes associated
with planned home and planned hospital births in low-risk
women attended by midwives in Ontario, Canada, 2003-
2006: a retrospective cohort study. Birth 2009;36:180–9.
23. Kennare RM, Keirse MJ, Tucker GR, Chan AC. Planned
home and hospital births in South Australia, 1991–2006:
differences in outcomes. Med J Aust 2010;192:76–80.
24. Wax JR, Lucas FL, Lamont M, Pinette MG, Cartin A,
Blackstone J. Maternal and newborn outcomes in planned
home birth vs planned hospital births: a metaanalysis. Am J
Obstet Gynecol 2010;203:243.e1,243.e8.
25. Wax JR, Pinette MG, Cartin A. Home versus hospital
birth—process and outcome. Obstet Gynecol Surv 2010;65:
132–40.
4 Committee Opinion No. 476
COMMITTEE OPINIONS
26. Bastian H, Keirse MJ, Lancaster PA. Perinatal death asso-
ciated with planned home birth in Australia: population
based study. BMJ 1998;317:384–8.
27. Vaginal birth after previous cesarean delivery. Practice
Bulletin No. 115. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2010;116:450–63.
28. Centers for Disease Control and Prevention. Data access:
VitalStats. Available at: http//www.cdc.gov/nchs/vitalstats.
htm. Retrieved October 15, 2010.
Copyright February 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Planned home birth. Committee Opinion No. 476. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2011;117:425–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 702
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 485 • April 2011 (Replaces No. 279, December 2002)
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Prevention of Early-Onset Group B Streptococcal

Disease in Newborns
ABSTRACT: In 2010, the Centers for Disease Control and Prevention revised its guidelines for the preven-
tion of perinatal group B streptococcal disease. Although universal screening at 35–37 weeks of gestation and
intrapartum antibiotic prophylaxis continue to be the basis of the prevention strategy, these new guidelines con-
tain important changes for clinical practice. The Committee on Obstetric Practice endorses the new Centers for
Disease Control and Prevention recommendations, and recognizes that even complete implementation of this
complex strategy will not eliminate all cases of early-onset group B streptococcal disease.

Implementation of national guidelines for intrapartum • A revised algorithm for management of newborns
antibiotic prophylaxis since the 1990s has resulted in an with respect to risk of early-onset group B strepto-
approximate 80% reduction in the incidence of early- coccal disease
onset neonatal sepsis due to group B streptococci (GBS).
The Committee on Obstetric Practice endorses the new
Yet, GBS remains the leading cause of infectious mor-
CDC recommendations and recognizes that even com-
tality and morbidity among newborns (1). In 2010, the
plete implementation of this complex strategy will not
Centers for Disease Control and Prevention (CDC), in
eliminate all cases of early-onset group B streptococcal
collaboration with several professional groups, including
disease.
the American College of Obstetricians and Gynecologists,
issued its third set of GBS prevention guidelines (1). Background
Although universal screening at 35–37 weeks of gestation
Group B streptococci, also known as Streptococcus aga-
and intrapartum antibiotic prophylaxis continue to be
lactiae, emerged as an important cause of perinatal mor-
the basis of the prevention strategy, these new guidelines
bidity and mortality in the 1970s (2, 3). Between 10%
contain important changes for clinical practice (Table 1),
and 30% of pregnant women are colonized with GBS
including the following:
in the vagina or rectum (4–7). The organism may cause
• Expanded recommendations on laboratory methods maternal urinary tract infection, amnionitis, endometri-
for identification of GBS tis, sepsis, or, rarely, meningitis (8–13). Invasive group
• Clarification of the inoculum required for reporting B streptococcal disease in the newborn is characterized
GBS detected in the urine of pregnant women primarily by sepsis and pneumonia, or, less frequently,
meningitis (1).
• Updated algorithms for GBS screening and intrapar-
Vertical transmission of GBS during labor or delivery
tum antibiotic prophylaxis for women with preterm
may result in invasive infection in the newborn during the
labor or preterm premature rupture of membranes
first week of life, known as early-onset group B strepto-
(PROM)
coccal infection. Since the early 1990s, national guidelines
• A change in the recommended dosage of penicillin-G have resulted in an 80% decrease in the incidence of
for intrapartum antibiotic prophylaxis early-onset group B streptococcal sepsis, from 1.7 cases to
• Updated intrapartum antibiotic prophylaxis regi- less than 0.4 cases per 1,000 live births (1). As expected,
mens for women with penicillin allergy the guidelines have had no effect on late-onset disease

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 703

 Table 1. Comparison of Key Points in the 2002 and 2010 Centers for Disease Control and Prevention Guidelines for the Prevention
of Perinatal Group B Streptococcal Disease
Topic in the Guidelines Key Points Unchanged From 2002 Key Points Changed From 2002

Universal screening for GBS
Preterm delivery
GBS specimen collection and
processing
Intrapartum antibiotic prophylaxis
Other obstetric management
issues
Newborn management
Abbreviations: CDC, Centers for Disease Control and Prevention; CFU, colony-forming units; GBS, group B streptococci; IAP, intrapartum antibiotic prophylaxis; PROM, prema-
ture rupture of membranes.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of Bacterial Diseases,
National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep 2010;59(RR–10):1–36.
Universal screening at 35–37 weeks of gestation
remains the sole strategy for IAP.
Rectovaginal swab specimens collected at
35–37 weeks of gestation remains the
recommendation.
Penicillin remains drug of choice, with ampicillin
as an alternative. Cefazolin remains the drug of
choice for penicillin allergy without anaphylaxis,
angioedema, respiratory distress, or urticaria.
GBS isolates from women at high risk of
anaphylaxis should be tested for susceptibility to
clindamycin and erythromycin. Vancomycin use is
recommended if isolate is resistant to either
clindamycin or erythromycin.
Permissive statement for limited role of nucleic
acid amplification tests for intrapartum testing
for GBS
New and separate algorithms for preterm labor
and for preterm PROM (see Fig. 1 and Fig. 2)
Transport options clarified
Identification options expanded to include use of
chromogenic media and nucleic acid amplification
tests.
Laboratories to report GBS in concentrations
of greater than or equal to 104 CFU in urine
culture specimens (previously, it was GBS “in
any concentration”)
Definition of high risk for anaphylaxis is clarified.
Minor change in penicillin dose permitted
Erythromycin is no longer recommended under
any circumstances.
D-test recommended to detect inducible
resistance in isolates tested for susceptibility
to clindamycin and erythromycin
Data are not sufficient to make recommendations
regarding the timing of procedures intended to
facilitate progression of labor, such as amniotomy,
in GBS-colonized women.
Intrapartum antibiotic prophylaxis is optimal if
administered at least 4 hours before delivery;
therefore, such procedures should be timed
accordingly, if possible.
No medically necessary obstetric procedure
should be delayed in order to achieve 4 hours of
GBS prophylaxis before delivery.
Algorithm now applies to all newborns, whether
or not from GBS-positive mothers.
Clarification of “adequate” IAP. See full CDC
guidelines for details.

(defined as occurring in infants older than 6 days). The
2010 CDC guidelines focus on the prevention of early-
onset group B streptococcal disease.
Factors Associated With Early-Onset
Disease
The primary risk factor for early-onset group B strepto-
coccal infection is maternal intrapartum rectovaginal col-
onization with GBS (1). Other clinical risk factors include
gestational age of less than 37 weeks, prolonged rupture
of membranes, intra-amniotic infection, young maternal
age, and black race (1). Neonates born to women who
have previously given birth to a GBS-infected newborn
(14–16) or who have heavy GBS colonization, such as
that seen with group B streptococcal bacteriuria, are at
increased risk of neonatal infection (1, 17–21).

2 Committee Opinion No. 485

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 704

 Identifying Candidates for Intrapartum group B streptococcal bacteriuria is detected, antibiotics
Antibiotic Prophylaxis should be administered (1). Because women who had
GBS colonization during a previous pregnancy are likely
The 2010 CDC guidelines recommend a universal cul-
not to be colonized during subsequent pregnancies, they
ture-based strategy for identifying candidates for GBS
require culture evaluation for GBS with each pregnancy
intrapartum antibiotic prophylaxis. Screening of all
but not intrapartum antibiotic prophylaxis unless there
women at 35–37 weeks of gestation is conducted by
is an indication for GBS prophylaxis during the current
obtaining a single swab specimen from the lower vagina
pregnancy.
(introitus) and rectum (through the anal sphincter), plac-
The new guidelines provide updated algorithms for
ing the swab in transport media, and using selective broth
screening for GBS and intrapartum antibiotic prophy-
media (see Box 1). All women in whom cultures are posi-
laxis for women with preterm labor or preterm prema-
tive for GBS are to be given intrapartum antibiotic pro-
ture rupture of membranes (PROM) (Fig. 1 and Fig. 2).
phylaxis in labor unless a cesarean delivery is performed
Intrapartum antibiotic prophylaxis is to be administered
before onset of labor in a woman with intact amniotic
to women with unknown culture status who are in pre-
membranes. Cultures for GBS are not required in women
term labor with significant risk of imminent delivery or
who have group B streptococcal bacteriuria during the
who have preterm PROM, rupture of membranes for 18
current pregnancy or who have previously given birth
or more hours, or intrapartum fever (temperature greater
to a neonate with early-onset group B streptococcal dis-
than or equal to 100.4°F or greater than or equal to 38°C)
ease because these women should receive intrapartum
(Table 2).
antibiotic prophylaxis. If at any time during pregnancy
Intrapartum Antibiotic Prophylactic
Agents
Box 1. Procedures for Collecting Clinical
Specimens for Culture of Group B Penicillin remains the agent of choice for intrapartum
Streptococci at 35–37 Weeks of Gestation prophylaxis, with ampicillin as an acceptable alternative
(Fig. 3). In view of increasing rates of resistance of GBS
• Swab the lower vagina (vaginal introitus), followed by to erythromycin (up to 32% or more for invasive iso-
the rectum (ie, insert swab through the anal sphincter) lates), erythromycin is no longer recommended. Group
using the same swab or two different swabs. Cultures B streptococci may show either inducible or intrinsic
should be collected in the outpatient setting by the resistance to clindamycin. Inducible resistance is detected
health care provider or, with appropriate instruction, by the D-test, which tests the isolate for resistance to both
the patient herself. Cervical, perianal, perirectal, or clindamycin and erythromycin. Clindamycin continues
perineal specimens are not acceptable, and a specu- to be recommended only if the isolate is susceptible to
lum should not be used for culture collection.
both clindamycin and erythromycin, or if the isolate is
• Place the swab(s) into a nonnutritive transport medium. sensitive to clindamycin and the D-zone test result for
Appropriate transport systems (eg, Stuart or Amies inducible resistance is negative (1). Intravenous admin-
media with or without charcoal) are commercially
available. Group B streptococci isolates can remain
istration is the route recommended for intrapartum GBS
viable in transport media for several days at room tem- prophylaxis. No oral or intramuscular regimen has been
perature; however, the recovery of isolates declines shown to be effective (1).
over 1–4 days, especially at elevated temperatures,
which can lead to false-negative test results. Intrapartum Antibiotic Prophylaxis
• Specimen requisitions should clearly indicate that The benefit of prevention of group B streptococcal early-
specimens are for group B streptococci culture. onset infection in the newborn greatly outweighs the
• Patients who state they are allergic to penicillin should risk to the woman and her fetus of maternal allergic
be evaluated for risk of anaphylaxis. If a woman is reactions to antibiotics during labor. Allergic reactions
determined to be at high-risk of anaphylaxis*, suscep- occur in an estimated 0.7–4% of all treatment courses
tibility testing for clindamycin and erythromycin should with penicillin, with the risk of anaphylaxis estimated at
be ordered. 4/10,000–4/100,000 recipients (1). The Committee agrees
*Patients with a history of any of the following after receiving with the CDC that local health agencies should establish
penicillin or a cephalosporin are considered to be at high risk surveillance systems to monitor the incidence of early-
of anaphylaxis: anaphylaxis, angioedema, respiratory distress, onset neonatal group B streptococcal disease, the emer-
and urticaria. gence of infection in women and their newborns that is
Data from Verani JR, McGee L, Schrag SJ. Prevention of caused by resistant organisms, and other complications
perinatal group B streptococcal disease––revised guide-
lines from CDC, 2010. Division of Bacterial Diseases, National
of widespread maternal antibiotic administration, such as
Center for Immunization and Respiratory Diseases, Centers for severe allergic reactions.
Disease Control and Prevention (CDC). MMWR Recomm Rep The Committee believes that when culture results are
2010;59(RR–10):1–36. not available, intrapartum antibiotic prophylaxis should
be offered only on the basis of the presence of intrapartum

Committee Opinion No. 485 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 705

 Patient admitted with diagnosis of preterm labor

Obtain vaginal–rectal swab specimen for GBS culture* and start GBS prophylaxis†

Patient progressing in true labor?‡

Yes No

Continue GBS prophylaxis until delivery§ Discontinue GBS prophylaxis

Obtain GBS culture results

Not available before labor onset

Positive Negative
and patient still preterm

GBS prophylaxis No GBS prophylaxis;|| Repeat vaginal–rectal

at onset of true labor culture if patient reaches 35–37 weeks of
gestation and has not yet given birth¶

*If patient has undergone vaginal–rectal GBS culture within the preceding 5 weeks, the results of that culture should guide management. GBS-
colonized women should receive intrapartum antibiotic prophylaxis. No antibiotics are indicated for GBS prophylaxis if the result of a vaginal–rectal
screen within 5 weeks was negative.
†
See Figure 3 for recommended antibiotic regimens.
‡
Patient should be regularly assessed for progression to true labor; if the patient is considered not to be in true labor, discontinue GBS prophylaxis.
§
If GBS culture results become available before delivery and are negative, then discontinue GBS prophylaxis.
||
Unless subsequent GBS culture result before delivery is positive
¶
A negative GBS screen result is considered valid for 5 weeks. If a patient with a history of preterm labor is readmitted with signs and symptoms of
preterm labor and had a negative GBS screen result more than 5 weeks prior, she should be rescreened and managed according to this algorithm at
that time.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of
Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR–10):1–36.

Figure 1. Algorithm for group B streptococci intrapartum prophylaxis for women with preterm labor. Abbreviation:
GBS, group B streptococci.

4 Committee Opinion No. 485

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 706

 Obtain vaginal–rectal swab for GBS culture* and start
antibiotics for latency† or GBS prophylaxis‡

Patient entering labor?

Yes No

Continue antibiotics until delivery Continue antibiotics per standard of care

if receiving for latency; or continue§
antibiotics for 48 hours if receiving
GBS prophylaxis

Obtain GBS culture results

Positive Not available before labor onset Negative

GBS prophylaxis No GBS prophylaxis;|| repeat vaginal–rectal

at onset of labor culture if patient reaches 35–37 weeks of
gestation and has not yet given birth¶

*If patient has undergone vaginal–rectal GBS culture within the preceding 5 weeks, the results of that culture should guide management. GBS-
colonized women should receive intrapartum antibiotic prophylaxis. No antibiotics are indicated for GBS prophylaxis if the result of a vaginal–rectal
screen within 5 weeks was negative.
†
Antibiotics given for latency in the setting of preterm premature rupture of membranes that include ampicillin, 2 g intravenously once, followed by
1 g intravenously every 6 hours for at least 48 hours are adequate for GBS prophylaxis. If other regimens are used, GBS prophylaxis should be initi-
ated in addition.
‡
See Figure 3 for recommended antibiotic regimens.
§
GBS prophylaxis should be discontinued at 48 hours for women with preterm premature rupture of membranes who are not in labor. If results from
a GBS screen performed on admission become available during the 48-hour period and are negative, GBS prophylaxis should be discontinued at
that time.
||
Unless subsequent GBS culture result before delivery is positive
¶
A negative GBS screen result is considered valid for 5 weeks. If a patient with preterm premature rupture of membranes is entering labor and had a
negative GBS screen result more than 5 weeks prior, she should be rescreened and managed according to this algorithm at that time.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of
Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR–10):1–36.

Figure 2. Algorithm for group B streptococci intrapartum prophylaxis for women with preterm premature rupture of
membranes. Abbreviation: GBS, group B streptococci.

Committee Opinion No. 485 5

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 707

 Patient allergic to penicillin?

No Yes

Penicillin G, 5 million units IV as initial Patient with a history of any of the following
dose, then 2.5–3 million units* after receiving penicillin or a cephalosporin?†
every 4 hours until delivery • Anaphylaxis
or • Angioedema
Ampicillin, 2 g IV as initial dose, then • Respiratory distress
1 g IV every 4 hours until delivery • Urticaria

No Yes

Cefazolin, 2 g IV as initial dose, then Isolate sensitive to clindamycin‡

1 g IV every 8 hours until delivery and erythromycin§

No Yes

Vancomycin, 1 g IV every Clindamycin, 900 mg IV

12 hours until delivery every 8 hours until delivery

*Doses ranging from 2.5 to 3.0 million units are acceptable for the doses administered every 4 hours following the initial dose. The choice of dose
within that range should be guided by which formulations of penicillin G are readily available in order to reduce the need for pharmacies to specially
prepare doses.
†
Penicillin-allergic patients with a history of anaphylaxis, angioedema, respiratory distress, or urticaria following administration of penicillin or a
cephalosporin are considered to be at high risk of anaphylaxis and should not receive penicillin, ampicillin, or cefazolin for group B streptococci
(GBS) intrapartum prophylaxis. For penicillin-allergic patients who do not have a history of those reactions, cefazolin is the preferred agent because
pharmacologic data suggest it achieves effective intra-amniotic concentrations. Vancomycin and clindamycin should be reserved for penicillin-
allergic women at high risk of anaphylaxis.
‡
If laboratory facilities are adequate, clindamycin and erythromycin susceptibility testing should be performed on prenatal GBS isolates from penicil-
lin-allergic women at high risk of anaphylaxis. If no susceptibility testing is performed, or the results are not available at the time of labor, vancomy-
cin is the preferred agent for GBS intrapartum prophylaxis for penicillin-allergic women at high risk of anaphylaxis.
§
Resistance to erythromycin is often but not always associated with clindamycin resistance. If an isolate is resistant to erythromycin, it may have
inducible resistance to clindamycin, even if it appears susceptible to clindamycin. If a GBS isolate is susceptible to clindamycin, resistant to erythro-
mycin, and D-zone testing for inducible resistance has been performed and the result is negative (no inducible resistance), then clindamycin can be
used for GBS intrapartum prophylaxis instead of vancomycin.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of
Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR–10):1–36.

Figure 3. Recommended regimens for intrapartum antibiotic prophylaxis for prevention of early-onset group B strepto-
coccal disease (broader spectrum agents, including an agent active against group B streptococci, may be necessary for
treatment of chorioamnionitis). Abbreviation: IV, intravenously.

6 Committee Opinion No. 485

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 708

 Table 2. Indications and Nonindications for Intrapartum Antibiotic Prophylaxis to Prevent Early-Onset
Group B Streptococcal Disease
Intrapartum GBS Prophylaxis Indicated Intrapartum GBS Prophylaxis not Indicated

Previous infant with invasive GBS disease
GBS bacteriuria during any trimester of the current
pregnancy
Positive GBS screening culture during current
pregnancy* (unless a cesarean delivery, is performed
before onset of labor on a woman with intact amniotic
membranes)
Unknown GBS status at the onset of labor (culture not
done, incomplete, or results unknown) and any of
the following:
• Delivery at less than 37 weeks of gestation
• Amniotic membrane rupture greater than or equal
to 18 hours
• Intrapartum temperature greater than or equal to
100.4°F (greater than or equal to 38.0°C)‡
• Intrapartum NAAT§ positive for GBS
Colonization with GBS during a previous pregnancy
(unless an indication for GBS prophylaxis is present
for current pregnancy)
GBS bacteriuria during previous pregnancy (unless
another indication for GBS prophylaxis is present for
current pregnancy)
Cesarean delivery performed before onset of labor on a
woman with intact amniotic membranes, regardless of
GBS colonization status or gestational age
Negative vaginal and rectal GBS screening culture
† result in late gestation* during the current pregnancy,
regardless of intrapartum risk factors

Abbreviations: GBS, group B streptococci; NAAT, nucleic acid amplification test.

*Optimal timing for prenatal GBS screening is at 35–37 weeks of gestation.
†
Recommendations for the use of intrapartum antibiotics for prevention of early-onset GBS disease in the setting of preterm delivery are presented
in Figure 3.
‡
If amnionitis is suspected, broad-spectrum antibiotic therapy that includes an agent known to be active against GBS should replace GBS prophylaxis.
§
NAAT testing for GBS is optional and may not be available in all settings. If intrapartum NAAT result is negative for GBS but any other intrapar-
tum risk factor (delivery at less than 37 weeks of gestation, amniotic membrane rupture at 18 hours or more, or temperature greater than or equal
to 100.4°F [greater than or equal to 38.0°C]) is present, then intrapartum antibiotic prophylaxis is indicated.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of
Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR–10):1–36.

risk factors for early-onset group B streptococcal disease
(Table 2). The Committee strongly recommends against
administering intrapartum antibiotic prophylaxis to a
woman with rupture of membranes for 18 hours or more
with a culture negative for GBS at 35–37 weeks of gesta-
tion; antibiotics should be administered after 18 hours of
ruptured membranes only when GBS culture results are
not known. In these clinical scenarios, antibiotics should
be administered only if there is chorioamnionitis or other
indications, such as pyelonephritis.
Preterm Labor and Preterm Premature Rupture
of Membranes
The Committee supports the revised algorithms for
management of women with preterm labor and for pre-
term PROM (Fig. 1 and Fig. 2). The Committee concurs
with the CDC that intrapartum prophylaxis for GBS is
not recommended for women undergoing a planned
cesarean delivery in the absence of labor and rupture of
membranes, regardless of the gestational age, even among
GBS-positive women. All patients undergoing cesarean
delivery should have prophylactic antibiotics adminis-
tered before the incision to reduce the risk of postopera-
tive infections (23). Patients expected to have planned
cesarean deliveries should nonetheless undergo culture
screening at 35–37 weeks of gestation because onset of
labor or rupture of membranes may occur before the
planned cesarean delivery.
Obstetric Management
The Committee has insufficient data to support or dis-
courage the use of scalp electrodes or fetal scalp and
blood pH determinations in women known to be GBS
colonized. Furthermore, the risks of membrane stripping
in GBS-colonized women have not been investigated;
therefore, data are insufficient to encourage or discourage
this practice in these women.
Specimen Collection and Processing
Laboratories must process GBS cultures correctly using
the recommended selective broth media for results to
be accurate. Culture specimens should be collected by
swabbing the lower vagina (not by speculum examination)
and rectum (ie, through the anal sphincter), to maximize
the likelihood of GBS recovery (see Box 1). The new
guidelines provide expanded recommendations for lab-

Committee Opinion No. 485 7

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 709

 oratory methods for the identification of GBS, with the
options of using pigmented broth or DNA probe, latex
agglutination, or nucleic acid amplification test (NAAT)
after incubation for 18–24 hours. However, use of NAAT
to detect GBS directly from rectovaginal specimens (ie,
without incubation of the specimen for 18–24 hours) has
a very limited role. In settings where NAAT is available for
GBS detection, obstetric providers can choose to perform
intrapartum testing on rectovaginal specimens when the
GBS culture status is unknown and when there are no
intrapartum risk factors (temperature greater than or equal
to 100.4°F [greater than or equal to 38.0°C] or duration of
rupture of membranes for 18 hours or more) at the time of
testing and when the patient is at term. Women with
a positive intrapartum NAAT result for GBS should
receive intrapartum antibiotic prophylaxis. If an intra-
partum risk factor develops subsequent to the test, intra-
partum antibiotic prophylaxis should be given regardless
of the NAAT results (ie, even if the NAAT result was
negative) (1).

Yes Full diagnostic evaluation*

Signs of neonatal sepsis?
Antibiotic therapy†
No
Yes Limited evaluation§
Maternal chorioamnionitis?‡
Antibiotic therapy†
No
No
GBS prophylaxis indicated for mother?|| Routine clinical care¶

Yes

Mother received 4 hours or more of Yes

Observation for 48 hours or more¶ #
intravenous penicillin, ampicillin, or
cefazolin before delivery?
No

Greater than or equal to 37 weeks of Yes

Observation for 48 hours or more**
gestation and duration of membrane
rupture less than 18 hours?
No
Either less than 37 weeks of gestation or Yes Limited evaluation§
duration of membrane rupture greater Observation for 48 hours or more¶
than or equal to 18 hours?

*Full diagnostic evaluation includes a blood culture, a complete blood count, including white blood cell differential, platelet counts, chest radiograph
(if respiratory abnormalities are present), and lumbar puncture (if patient is stable enough to tolerate procedure and sepsis is suspected).
†
Antibiotic therapy should be directed toward the most common causes of neonatal sepsis, including intravenous ampicillin for GBS and coverage for
other organisms (including Escherichia coli and other gram-negative pathogens) and should take into account local antibiotic resistance patterns.
‡
Consultation with obstetric providers is important to determine the level of clinical suspicion for chorioamnionitis. Chorioamnionitis is diagnosed
clinically and some of the signs are nonspecific.
§
Limited evaluation includes blood culture (at birth), and complete blood count with differential and platelets (at birth or at 6–12 hours of life or
both).
||
GBS prophylaxis is indicated if one or more of the following is present: 1) mother is GBS positive within preceding 5 weeks; 2) GBS status
unknown, with one or more intrapartum risk factors, including less than 37 weeks of gestation, duration of rupture of membranes for 18 hours or
more, or temperature greater than or equal to 100.4°F (greater than or equal to 38.0°C); 3) group B streptococcal bacteriuria during current preg-
nancy; 4) history of a previous infant with group B streptococcal disease.
¶
If signs of sepsis develop, a full diagnostic evaluation should be conducted and antibiotic therapy initiated.
#
If greater than or equal to 37 weeks of gestation, observation may occur at home after 24 hours if other discharge criteria have been met, access
to medical care is readily available, and a person who is able to comply fully with instructions for home observation will be present. If any of these
conditions is not met, the infant should be observed in the hospital for at least 48 hours and until discharge criteria are achieved.
**Some experts recommend a complete blood count with differential and platelets at 6–12 hours of age.
Data from Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease––revised guidelines from CDC, 2010. Division of
Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). MMWR Recomm
Rep 2010;59(RR–10):1–36.

Figure 4. Algorithm for secondary prevention of early-onset group B streptococcal disease among newborns. Abbrevia-
tion: GBS, group B streptococci.

8 Committee Opinion No. 485

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 710

 Management of Neonates
The new guidelines provide a revised algorithm for the
prevention of early-onset group B streptococcal disease
among neonates (Fig. 4). These may be accessed in the
full CDC guidelines, which are available at http://www.
cdc.gov/groupbstrep/guidelines/provisional-recs.htm.
References
1. Verani JR, McGee L, Schrag SJ. Prevention of perinatal
group B streptococcal disease––revised guidelines from
CDC, 2010. Division of Bacterial Diseases, National
Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention (CDC).
MMWR Recomm Rep 2010;59(RR–10):1–36.
2. Schrag SJ, Zywicki S, Farley MM, Reingold AL, Harrison LH,
Lefkowitz LB, et al. Group B streptococcal disease in the
era of intrapartum antibiotic prophylaxis. N Engl J Med B streptococcal bacteriuria in pregnancy. Am J Obstet
2000;342:15–20.
3. Early-onset group B streptococcal disease—United States, 19. Moller M, Thomsen AC, Borch K, Dinesen K, Zdravkovic M.
1998–1999. MMWR Morb Mortal Wkly Rep 2000;49:
793–6.
4. Anthony BF, Okada DM, Hobel CJ. Epidemiology of group Lancet 1984;2:69–70.
B Streptococcus: longitudinal observations during preg-
nancy. J Infect Dis 1978;137:524–30.
5. Regan JA, Klebanoff MA, Nugent RP. The epidemiology of
group B streptococcal colonization in pregnancy. Vaginal
Infections and Prematurity Study Group. Obstet Gynecol
1991;77:604–10.
6. Dillon HC Jr, Gray E, Pass MA, Gray BM. Anorectal and Scand J Infect Dis 1985;17:195–9.
vaginal carriage of group B streptococci during pregnancy.
J Infect Dis 1982;145:794–9.
7. Boyer KM, Gadzala CA, Kelly PD, Burd LI, Gotoff SP.
Selective intrapartum chemoprophylaxis of neonatal group
B streptococcal early-onset disease. II. Predictive value of
prenatal cultures. J Infect Dis 1983;148:802–9.
8. Pass MA, Gray BM, Dillon HC Jr. Puerperal and perinatal
infections with group B streptococci. Am J Obstet Gynecol
1982;143:147–52.
9. Bobitt JR, Ledger WJ. Amniotic fluid analysis. Its role in
maternal neonatal infection. Obstet Gynecol 1978;51:56–62.
10. Braun TI, Pinover W, Sih P. Group B streptococcal men-
ingitis in a pregnant woman before the onset of labor. Clin
Infect Dis 1995;21:1042–3.
11. Yancey MK, Duff P, Clark P, Kurtzer T, Frentzen BH,
Kubilis P. Peripartum infection associated with vaginal
group B streptococcal colonization. Obstet Gynecol 1994;
84:816–9.
12. Fox BC. Delayed-onset postpartum meningitis due to group
B streptococcus. Clin Infect Dis 1994;19:350.
13. Aharoni A, Potasman I, Levitan Z, Golan D, Sharf M.
Postpartum maternal group B streptococcal meningitis.
Rev Infect Dis 1990;12:273–6.
Committee Opinion No. 485
COMMITTEE OPINIONS
14. Carstensen H, Christensen KK, Grennert L, Persson K,
Polberger S. Early-onset neonatal group B streptococcal
septicaemia in siblings. J Infect 1988;17:201–4.
15. Faxelius G, Bremme K, Kvist-Christensen K, Christensen P,
Ringertz S. Neonatal septicemia due to group B strepto-
cocci--perinatal risk factors and outcome of subsequent
pregnancies. J Perinat Med 1988;16:423–30.
16. Christensen KK, Dahlander K, Linden V, Svenningsen N,
Christensen P. Obstetrical care in future pregnancies after
fetal loss in group B streptococcal septicemia. A prevention
program based on bacteriological and immunological fol-
low-up. Eur J Obstet Gynecol Reprod Biol 1981;12:143–50.
17. Pass MA, Gray BM, Khare S, Dillon HC Jr. Prospective
studies of group B streptococcal infections in infants. J
Pediatr 1979;95:437–43.
18. Wood EG, Dillon HC Jr. A prospective study of group
Gynecol 1981;140:515–20.
Rupture of fetal membranes and premature delivery associ-
ated with group B streptococci in urine of pregnant women.
20. Liston TE, Harris RE, Foshee S, Null DM Jr. Relationship of
neonatal pneumonia to maternal urinary and neonatal iso-
lates of group B streptococci. South Med J 1979;72:1410–2.
21. Persson K, Christensen KK, Christensen P, Forsgren A,
Jorgensen C, Persson PH. Asymptomatic bacteriuria during
pregnancy with special reference to group B streptococci.
22. Prevention of perinatal group B streptococcal disease: a
public health perspective. Centers for Disease Control and
Prevention [published erratum appears in MMWR Morb
Mortal Wkly Rep 1996;45:679]. MMWR Recomm Rep
1996;45(RR-7):1–24.
23. Antimicrobial prophylaxis for cesarean delivery: timing of
administration. Committee Opinion No. 465. American
College of Obstetricians and Gynecologists. Obstet Gynecol
2010;116:791–2.
Copyright April 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Prevention of early-onset group B streptococcal disease in newborns.
Committee Opinion No. 485. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1019–27.
9
2013 COMPENDIUM OF SELECTED PUBLICATIONS 711
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 494 • June 2011
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Sulfonamides, Nitrofurantoin, and Risk of Birth Defects

ABSTRACT: The evidence regarding an association between the nitrofuran and sulfonamide classes of
antibiotics and birth defects is mixed. As with all patients, antibiotics should be prescribed for pregnant women
only for appropriate indications and for the shortest effective duration. During the second and third trimesters,
sulfonamides and nitrofurantoins may continue to be used as first-line agents for the treatment and prevention
of urinary tract infections and other infections caused by susceptible organisms. Prescribing sulfonamides or
nitrofurantoin in the first trimester is still considered appropriate when no other suitable alternative antibiotics are
available. Pregnant women should not be denied appropriate treatment for infections because untreated infections
can commonly lead to serious maternal and fetal complications.

Because antibiotics are commonly prescribed in preg-
nancy, there is a considerable body of pharmacoepide-
miologic data addressing the relationship of antibiotic
exposure and birth defects. The debate surrounding this
relationship was heightened in November 2009, with a
new publication by Crider and colleagues (1). The goal of
this Committee Opinion is to assess the current evidence
regarding the use of certain specific antibiotics in preg-
nancy and their association with birth defects (1).
In 2009, Crider and colleagues published a pop-
ulation-based case–control study of the relationship
between antibiotics and birth defects that used data from
the National Birth Defects Prevention Study. In this
study, two classes of antibiotics commonly used to treat
urinary tract infections—1) nitrofuran derivatives and
2) sulfonamides—were found to be significantly associ-
ated with multiple birth defect categories. Although this
was a large study, it has several significant limitations.
First, it is subject to recall bias because women were
asked about antibiotic use after pregnancy. Second, the
prescription of antibiotics was not confirmed by the
medical record; approximately 35% of patients could not
recall the specific product name. Third, because this was
an observational study, it is not possible to determine
whether the birth defect was due to the antibiotic itself,
the infection for which the antibiotic was prescribed, or
some other confounding factor. Other studies examin-
ing the relationship between prenatal exposure to these
antibiotics and birth defects have reported potential fetal
risks, whereas other studies have not found such risks
among other populations or when using different epide-
miologic methods (2–8).
It is reassuring that commonly used antibiotics,
namely, penicillins, erythromycin, cephalosporins, and a
less commonly used group, the quinolones, were not
associated with an increased risk of birth defects in the
2009 study (1). These findings are in agreement with
many other studies also reporting no increased risk of
birth defects associated with prenatal exposure to penicil-
lin (9), ampicillin (10), augmentin (6), pivampicillin (11),
cephalosporins (12–13), gentamicin (14), oxacillin (15),
erythromycin (16), metronidazole (17), and quinolones
(18–19).
Conclusion and Recommendations
Commonly used antibiotics, such as penicillins, eryth-
romycin, and cephalosporins, have not been found to
be associated with an increased risk of birth defects.
However, the evidence regarding an association between
the nitrofuran and sulfonamide classes of antibiotics
and birth defects is mixed. As with all patients, antibiot-
ics should be prescribed for pregnant women only for
appropriate indications and for the shortest effective
duration. In pregnancy, many urine cultures show bacte-
rial contaminants that do not represent true infection.
Thus, cultures showing mixed gram-positive bacteria,
lactobacilli, and Staphylococcus species (other than S sap-
rophyticus), may be presumed to be contaminants and not

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 712

 treated. When selecting an antibiotic for a true infection
during the first trimester of pregnancy (that is, during
organogenesis), health care providers should consider
and discuss with patients the benefits as well as the poten-
tial unknown risks of teratogenesis and maternal adverse
reactions. Prescribing sulfonamides or nitrofurantoin in
the first trimester is still considered appropriate when no
other suitable alternative antibiotics are available. During
the second and third trimesters, sulfonamides and nitro-
furantoins may continue to be used as first-line agents for
the treatment and prevention of urinary tract infections
and other infections caused by susceptible organisms
(8). Pregnant women should not be denied appropriate
treatment for infections because untreated infections can
commonly lead to serious maternal and fetal complica-
tions.
References
1. Crider KS, Cleves MA, Reefhuis J, Berry RJ, Hobbs CA,
Hu DJ. Antibacterial medication use during pregnancy
and risk of birth defects: National Birth Defects Prevention
Study. Arch Pediatr Adolesc Med 2009;163:978–85.
2. Hernandez-Diaz S, Werler MM, Walker AM, Mitchell AA.
Folic acid antagonists during pregnancy and the risk of
birth defects. N Engl J Med 2000;343:1608–14.
3. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J. The ter-
atogenic risk of trimethoprim-sulfonamides: a population
based case-control study. Reprod Toxicol 2001;15:637–46.
4. Czeizel AE, Puho E, Sorensen HT, Olsen J. Possible associa-
tion between different congenital abnormalities and use of
different sulfonamides during pregnancy. Congenit Anom
(Kyoto) 2004;44:79–86.
5. Norgard B, Czeizel AE, Rockenbauer M, Olsen J, Sorensen HT.
Population-based case control study of the safety of sul-
fasalazine use during pregnancy. Aliment Pharmacol Ther
2001;15:483–6.
6. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J.
Augmentin treatment during pregnancy and the preva-
lence of congenital abnormalities: a population-based case-
control teratologic study. Eur J Obstet Gynecol Reprod Biol
2001;97:188–92.
7. Czeizel A. A case-control analysis of the teratogenic effects
of co-trimoxazole. Reprod Toxicol 1990;4:305–13.
8. Forna F, McConnell M, Kitabire FN, Homsy J, Brooks JT,
Mermin J, et al. Systematic review of the safety of trime-
thoprim-sulfamethoxazole for prophylaxis in HIV-infected
pregnant women: implications for resource-limited set-
tings. AIDS Rev 2006;8:24–36.
9. Dencker BB, Larsen H, Jensen ES, Schonheyder HC,
Nielsen GL, Sorensen HT. Birth outcome of 1886 pregnan-
cies after exposure to phenoxymethylpenicillin in utero.
Clin Microbiol Infect 2002;8:196–201.
2 Committee Opinion No. 494
COMMITTEE OPINIONS
10. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J. A
population-based case-control teratologic study of ampi-
cillin treatment during pregnancy. Am J Obstet Gynecol
2001;185:140–7.
11. Larsen H, Nielsen GL, Sorensen HT, Moller M, Olsen J,
Schonheyder HC. A follow-up study of birth outcome
in users of pivampicillin during pregnancy. Acta Obstet
Gynecol Scand 2000;79:379–83.
12. Berkovitch M, Merlob P. Use of cephalosporins during
pregnancy and in the presence of congenital abnormalities
[letter]. Am J Obstet Gynecol 2002;187:817;author reply
817.
13. Czeizel AE, Sorensen HT, Rockenbauer M, Olsen J. A
population-based case-control teratologic study of nalidixic
acid. Int J Gynaecol Obstet 2001;73:221–8.
14. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J. A
teratological study of lincosamides. Scand J Infect Dis 2000;
32:579–80.
15. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J.
Teratogenic evaluation of oxacillin. Scand J Infect Dis 1999;
31:311–2.
16. Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J. A
population-based case-control teratologic study of oral
erythromycin treatment during pregnancy. Reprod Toxicol
1999;13:531–6.
17. Sorensen HT, Larsen H, Jensen ES, Thulstrup AM,
Schonheyder HC, Nielsen GL, et al. Safety of metronida-
zole during pregnancy: a cohort study of risk of congenital
abnormalities, preterm delivery and low birth weight in 124
women. J Antimicrob Chemother 1999;44:854–6.
18. Schaefer C, Amoura-Elefant E, Vial T, Ornoy A, Garbis H,
Robert E, et al. Pregnancy outcome after prenatal quino-
lone exposure. Evaluation of a case registry of the European
Network of Teratology Information Services (ENTIS). Eur J
Obstet Gynecol Reprod Biol 1996;69:83–9.
19. Larsen H, Nielsen GL, Schonheyder HC, Olesen C, Sorensen
HT. Birth outcome following maternal use of fluoroquino-
lones. Int J Antimicrob Agents 2001;18:259–62.
Copyright June 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Sulfonamides, nitrofurantoin, and risk of birth defects. Committee
Opinion No. 494. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;117:1484–5.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 713
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 495 • July 2011
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Vitamin D: Screening and Supplementation During

Pregnancy
ABSTRACT: During pregnancy, severe maternal vitamin D deficiency has been associated with biochemical
evidence of disordered skeletal homeostasis, congenital rickets, and fractures in the newborn. At this time, there
is insufficient evidence to support a recommendation for screening all pregnant women for vitamin D deficiency.
For pregnant women thought to be at increased risk of vitamin D deficiency, maternal serum 25-hydroxyvitamin D
levels can be considered and should be interpreted in the context of the individual clinical circumstance. When
vitamin D deficiency is identified during pregnancy, most experts agree that 1,000–2,000 international units per
day of vitamin D is safe. Higher dose regimens used for treatment of vitamin D deficiency have not been studied
during pregnancy. Recommendations concerning routine vitamin D supplementation during pregnancy beyond
that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials.

Vitamin D is a fat-soluble vitamin obtained largely from
consuming fortified milk or juice, fish oils, and dietary
supplements. It also is produced endogenously in the skin
with exposure to sunlight. Vitamin D that is ingested or
produced in the skin must undergo hydroxylation in the
liver to 25-hydroxyvitamin D (25-OH-D), then further
hydroxylation primarily in the kidney to the physiologi-
cally active 1,25-dihydroxyvitamin D. This active form
is essential to promote absorption of calcium from the
gut and enables normal bone mineralization and growth.
During pregnancy, severe maternal vitamin D deficiency
has been associated with biochemical evidence of disor-
dered skeletal homeostasis, congenital rickets, and frac-
tures in the newborn (1, 2).
Recent evidence suggests that vitamin D deficiency
is common during pregnancy especially among high-risk
groups, including vegetarians, women with limited sun
exposure (eg, those who live in cold climates, reside in
northern latitudes, or wear sun and winter protective
clothing) and ethnic minorities, especially those with
darker skin (3–5). Newborn vitamin D levels are largely
dependent on maternal vitamin D status. Consequently,
infants of mothers with or at high risk of vitamin D defi-
ciency are also at risk of vitamin D deficiency (5–6).
For the individual pregnant woman thought to
be at increased risk of vitamin D deficiency, the serum
concentration of 25-OH-D can be used as an indica-
tor of nutritional vitamin D status. Although there is
no consensus on an optimal level to maintain overall
health, most agree that a serum level of at least 20 ng/mL
(50 nmol/L) is needed to avoid bone problems (7–10).
Based on observations of biomarkers of vitamin D activ-
ity, such as parathyroid hormone, calcium absorption,
and bone mineral density, some experts have suggested
that vitamin D deficiency should be defined as circulating
25-OH-D levels less than 32 ng/mL (80 nmol/L) (11). An
optimal serum level during pregnancy has not been deter-
mined and remains an area of active research.
In 2010, the Food and Nutrition Board at the
Institute of Medicine of the National Academies estab-
lished that an adequate intake of vitamin D during
pregnancy and lactation was 600 international units
per day (12). Most prenatal vitamins typically contain
400 international units of vitamin D per tablet. Sum-
marizing recent observational and interventional stud-
ies, the authors of a recent clinical report from the
Committee on Nutrition of the American Academy of
Pediatrics suggested that a daily intake higher than that
recommended by the Food and Nutrition Board may be
needed to maintain maternal vitamin D sufficiency (13).
Although data on the safety of higher doses are lacking,
most experts agree that supplemental vitamin D is safe

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 714

 in dosages up to 4,000 international units per day during
pregnancy or lactation (12).
At this time there is insufficient evidence to support
a recommendation for screening all pregnant women for
vitamin D deficiency. For pregnant women thought to be
at increased risk of vitamin D deficiency, maternal serum
25-OH-D levels can be considered and should be inter-
preted in the context of the individual clinical circum-
stance. When vitamin D deficiency is identified during
pregnancy, most experts agree that 1,000–2,000 interna-
tional units per day of vitamin D is safe. Higher dose regi-
mens used for the treatment of vitamin D deficiency have
not been studied during pregnancy. Recommendations
concerning routine vitamin D supplementation during
pregnancy beyond that contained in a prenatal vitamin
should await the completion of ongoing randomized
clinical trials. At this time, there is insufficient evidence to
recommend vitamin D supplementation for the preven-
tion of preterm birth or preeclampsia.
References
1. Pawley N, Bishop NJ. Prenatal and infant predictors of
bone health: the influence of vitamin D. Am J Clin Nutr
2004;80:1748S–51S.
2. Gale CR, Robinson SM, Harvey NC, Javaid MK, Jiang B,
Martyn CN, et al. Maternal vitamin D status during preg-
nancy and child outcomes. Princess Anne Hospital Study
Group. Eur J Clin Nutr 2008;62:68–77.
3. Hollis BW, Wagner CL. Assessment of dietary vitamin D
requirements during pregnancy and lactation. Am J Clin
Nutr 2004;79:717–26.
4. Lee JM, Smith JR, Philipp BL, Chen TC, Mathieu J, Holick
MF. Vitamin D deficiency in a healthy group of mothers
and newborn infants. Clin Pediatr (Phila) 2007;46:42–4.
5. Bodnar LM, Simhan HN, Powers RW, Frank MP,
Cooperstein E, Roberts JM. High prevalence of vitamin D
insufficiency in black and white pregnant women residing
in the northern United States and their neonates. J Nutr
2007;137:447–52.
2 Committee Opinion No. 495
COMMITTEE OPINIONS
6. Dijkstra SH, van Beek A, Janssen JW, de Vleeschouwer LH,
Huysman WA, van den Akker EL. High prevalence of
vitamin D deficiency in newborn infants of high-risk
mothers [published erratum appears in Arch Dis Child
2007;92:1049]. Arch Dis Child 2007;92:750–3.
7. Holick MF. Vitamin D deficiency. N Engl J Med 2007;
357:266–81.
8. Bouillon R, Norman AW, Lips P. Vitamin D deficiency.
N Engl J Med 2007;357:1980–1; author reply 1981–2.
9. Vitamin D supplementation: Recommendations for Cana-
dian mothers and infants. Paediatr Child Health 2007;
12:583–98.
10. National Institutes of Health, Office of Dietary Supplements.
Vitamin D. Available at: http://ods.od.nih.gov/factsheets/
list-all/VitaminD. Retrieved December 16, 2010.
11. Hollis BW, Wagner CL. Normal serum vitamin D levels.
N Engl J Med 2005;352:515–6; author reply 515–6.
12. Institute of Medicine of the National Academies (US).
Dietary reference intakes for calcium and vitamin D.
Washington, DC: National Academy Press; 2010.
13. Wagner CL, Greer FR. Prevention of rickets and vitamin D
deficiency in infants, children, and adolescents. American
Academy of Pediatrics Section on Breastfeeding; American
Academy of Pediatrics Committee on Nutrition [published
erratum appears in Pediatrics 2009;123:197]. Pediatrics 2008;
122:1142–52.
Copyright July 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Vitamin D: screening and supplementation during pregnancy. Com-
mittee Opinion No. 495. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;118:197–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 715
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 504 • September 2011
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Screening and Diagnosis of Gestational Diabetes

Mellitus
ABSTRACT: Gestational diabetes mellitus (GDM), defined as carbohydrate intolerance that begins or is first
recognized during pregnancy, is associated with increased maternal, fetal, and neonatal risks. The prevalence of
GDM in the United States is increasing, probably because of increasing rates of overweight and obesity. A univer-
sal recommendation for the ideal approach for screening and diagnosis of GDM remains elusive. At this time, the
Committee on Obstetric Practice continues to recommend a two-step approach to screening and diagnosis. All
pregnant women should be screened for GDM, whether by patient history, clinical risk factors, or a 50-g, 1-hour
glucose challenge test at 24–28 weeks of gestation. The diagnosis of GDM can be made based on the result of
the 100-g, 3-hour oral glucose tolerance test, for which there is evidence that treatment improves outcome.

Gestational diabetes mellitus (GDM) is defined as car-
bohydrate intolerance that begins or is first recognized
during pregnancy (1). This condition is associated with
increased risks for the fetus and newborn, including mac-
rosomia, shoulder dystocia, birth injuries, hyperbilirubi-
nemia, hypoglycemia, respiratory distress syndrome, and
childhood obesity. Maternal risks include preeclampsia,
cesarean delivery, and an increased risk of developing
type-2 diabetes later in life. Although the prevalence
varies significantly among different populations and eth-
nicities, as well as with the diagnostic criteria used, GDM
complicates approximately 7% of all pregnancies in the
United States (2). Importantly, the prevalence of GDM
in the United States is increasing, probably because of
increasing rates of overweight and obesity (3–5). Specific
risk factors and the degree of their influence on GDM
prevalence are difficult to quantify across populations.
However, a number of clinical risk factors have been
demonstrated to be associated with an increased likeli-
hood of GDM, including age, ethnicity, obesity, family
history of diabetes, and past obstetric history (1).
Numerous national and international medical orga-
nizations, along with expert panels and working groups,
have issued specific guidelines with recommendations for
screening and diagnosing GDM. In 2001, the American
College of Obstetricians and Gynecologists recommended
that all pregnant women should be screened for GDM—
whether by patient history, clinical risk factors, or with a
50-g, 1-hour loading test at 24–28 weeks of gestation to
determine blood glucose levels––and suggested relying on
the result of the 100-g, 3-hour oral glucose tolerance test
for diagnosis (often referred to as a “two-step” method)
(1). The U.S. Preventive Services Task Force concluded in
2008 that current evidence was insufficient to establish the
balance of benefits and harms for screening for GDM (6).
In 2008, the Hyperglycemia and Adverse Pregnancy
Outcomes Study Cooperative Research Group published
the results of a large, multicenter, multinational obser-
vational study designed to examine the relationship
between maternal hyperglycemia less severe than overt
diabetes mellitus and adverse pregnancy outcomes (7).
The study demonstrated a clear and continuous rela-
tionship between maternal hyperglycemia and increas-
ing rates of large for gestational age infants, cord blood
C-peptide (evidence of fetal hyperinsulinemia), neonatal
hypoglycemia, and cesarean delivery. Following this, the
International Association of Diabetes in Pregnancy Study
Group published recommendations for the diagnosis and
classification of hyperglycemia during pregnancy (8). In
addition to recommendations concerning the identifica-
tion of overt diabetes during pregnancy, the International
Association of Diabetes in Pregnancy Study Group rec-
ommended a simplified “one-step” approach to the
screening and diagnosis of GDM with a 75-g, 2-hour glu-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 716

 cose tolerance test. Notably, adoption of these guidelines Table 1. Diagnostic Criteria for the 100-g, 3-Hour Tolerance
would result in GDM being diagnosed in approximately Test for Gestational Diabetes Mellitus*
18% of all pregnant women (8). Furthermore, despite Plasma or Serum
recent randomized clinical trials demonstrating that the Glucose Level Plasma Level
treatment of mild GDM reduces neonatal morbidity
(9, 10), there is no evidence that the identification and Carpenter and Coustan National Diabetes Data
treatment of women based on the new International Status Conversion Group Conversion
Association of Diabetes in Pregnancy Study Group rec-
(mg/dL) (mmol/L) (mg/dL) (mmol/L)
ommendations will lead to clinically significant improve-
ments in maternal and neonatal outcomes and it would Fasting 95 5.3 105 5.8
lead to a significant increase in health care costs. 1 hour 180 10.0 190 10.6
A universal recommendation for the ideal approach 2 hours 155 8.6 165 9.2
for screening and diagnosis of GDM remains elusive.
Significant questions remain regarding the implications 3 hours 140 7.8 145 8.0
on health care costs, the effect of GDM diagnosis on the *A positive diagnosis requires that two or more thresholds be met or exceeded.
pregnant woman and her family, the effect of diagnosis Adapted with permission from the Expert Committee on the Diagnosis and
on obstetric interventions in pregnancy, and whether Classification of Diabetes Mellitus. Report of the Expert Committee on the
the identification and treatment of GDM will improve Diagnosis and Classification of Diabetes Mellitus. Diab Care 2000;23(suppl 1):
meaningful perinatal, neonatal, and maternal outcomes. S4–S19.

Conclusion
The recent studies on GDM and its increasing incidence
in the United States underscore the need for the devel-
opment of uniform screening and diagnostic criteria.
The National Institutes of Health is planning a Consen-
sus Development Conference to determine the optimal
approach to screening and diagnosis in the United States.
Consensus regarding optimal diagnostic criteria among
the many groups and professional organizations will
further much needed research regarding the benefits and
harms of screening and diagnosis of GDM.
Recommendations
At this time, the Committee on Obstetric Practice contin-
ues to recommend the following:
1. All pregnant women should be screened for GDM,
whether by patient history, clinical risk factors, or a
50-g, 1-hour loading test to determine blood glucose
levels.
2. The diagnosis of GDM can be made based on the
result of the 100-g, 3-hour oral glucose tolerance test,
for which there is evidence that treatment improves
outcome. Either the plasma or serum glucose level
established by Carpenter and Coustan or the plasma
level designated by the National Diabetes Data
Group are appropriate to use (see Table 1). A posi-
tive diagnosis requires that two or more thresholds
be met or exceeded.
3. Diagnosis of GDM based on the one-step screen-
ing and diagnosis test outlined in the International
Association of Diabetes in Pregnancy Study Group
guidelines is not recommended at this time because
there is no evidence that diagnosis using these cri-
teria leads to clinically significant improvements in
maternal or newborn outcomes and it would lead to
a significant increase in health care costs.
References
1. Gestational diabetes. ACOG Practice Bulletin No. 30.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2001;98:525–38.
2. Nicholson W, Bolen S, Witkop CT, Neale D, Wilson L, Bass
E. Benefits and risks of oral diabetes agents compared with
insulin in women with gestational diabetes: a systematic
review. Obstet Gynecol 2009;113:193–205.
3. Getahun D, Nath C, Ananth CV, Chavez MR, Smulian JC.
Gestational diabetes in the United States: temporal trends
1989 through 2004. Am J Obstet Gynecol 2008;198:
525.e1–525.e5.
4. Lawrence JM, Contreras R, Chen W, Sacks DA. Trends
in the prevalence of preexisting diabetes and gestational
diabetes mellitus among a racially/ethnically diverse popu-
lation of pregnant women, 1999–2005. Diabetes Care
2008;31:899–904.
5. Kim SY, England L, Wilson HG, Bish C, Satten GA,
Dietz P. Percentage of gestational diabetes mellitus attrib-
utable to overweight and obesity. Am J Public Health 2010;
100:1047–52.
6. Screening for gestational diabetes mellitus: U.S. Preventive
Services Task Force recommendation statement. U.S.
Preventive Services Task Force. Ann Intern Med 2008;
148:759–65.
7. Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U,
Coustan DR, et al. Hyperglycemia and adverse pregnancy
outcomes. HAPO Study Cooperative Research Group.
N Engl J Med 2008;358:1991–2002.
8. Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano
PA, Damm P, et al. International association of diabetes
and pregnancy study groups recommendations on the
diagnosis and classification of hyperglycemia in pregnancy.
International Association of Diabetes and Pregnancy Study
Groups Consensus Panel. Diabetes Care 2010;33:676 –82.
9. Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS,
Robinson JS. Effect of treatment of gestational diabetes

2 Committee Opinion No. 504

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 717

 mellitus on pregnancy outcomes. Australian Carbohydrate
Intolerance Study in Pregnant Women (ACHOIS) Trial
Group. N Engl J Med 2005;352:2477–86.
10. Landon MB, Spong CY, Thom E, Carpenter MW, Ramin
SM, Casey B, et al. A multicenter, randomized trial of
treatment for mild gestational diabetes. Eunice Kennedy
Shriver National Institute of Child Health and Human
Development Maternal-Fetal Medicine Units Network.
N Engl J Med 2009;361:1339–48.
Committee Opinion No. 504
COMMITTEE OPINIONS
Copyright September 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Screening and diagnosis of gestational diabetes mellitus. Committee
Opinion No. 504. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;118:751–3.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 718
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 514 • December 2011
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Emergent Therapy for Acute-Onset, Severe

Hypertension With Preeclampsia or Eclampsia
ABSTRACT: Acute-onset, persistent (lasting 15 minutes or more), severe systolic (greater than or equal to
160 mm Hg) or severe diastolic hypertension (greater than or equal to 110 mm Hg) or both in pregnant or postpar-
tum women with preeclampsia or eclampsia constitutes a hypertensive emergency. Severe systolic hypertension
may be the most important predictor of cerebral hemorrhage and infarction in these patients and if not treated
expeditiously can result in maternal death. Intravenous labetalol and hydralazine are both considered first-line drugs
for the management of acute, severe hypertension in this clinical setting. Close maternal and fetal monitoring by
the physician and nursing staff are advised. Order sets for the use of labetalol and hydralazine for the initial man-
agement of acute, severe hypertension in pregnant or postpartum women with preeclampsia or eclampsia have
been developed.

Risk reduction and successful, safe clinical outcomes for
women with preeclampsia or eclampsia require avoidance
and management of severe systolic and severe diastolic
hypertension. How to integrate standardized order sets
into everyday safe practice in the United States is a chal-
lenge. Increasing evidence indicates that standardization
of care improves patient outcomes (1). Introducing into
obstetric practice standardized, evidence-based clini-
cal guidelines for the management of patients with
preeclampsia and eclampsia has been demonstrated to
reduce the incidence of adverse maternal outcomes (2, 3).
With the advent of pregnancy hypertension guidelines
in the United Kingdom, care of maternity patients with
preeclampsia or eclampsia improved significantly, and
maternal mortality rates decreased because of a reduction
in cerebral and respiratory complications (4, 5).
Acute-onset, severe systolic (greater than or equal to
160 mm Hg) or severe diastolic (greater than or equal to
110 mm Hg) hypertension or both can occur in pregnant
or postpartum women with any hypertensive disorders
during pregnancy. Acute-onset, severe hypertension that
is accurately measured using standard techniques and
is persistent for 15 minutes or more is considered a
hypertensive emergency. This occurs in the second half
of gestation in patients not known to have chronic hyper-
tension who develop sudden, severe hypertension (ie,
with preeclampsia, gestational hypertension, or HELLP
[hemolysis, elevated liver enzymes, low platelets] syn-
drome) or, less frequently, in patients with chronic hyper-
tension who are developing superimposed preeclampsia
with acutely worsening, difficult to control, severe hyper-
tension. It is well known that severe hypertension can cause
central nervous system injury. Two thirds of the maternal
deaths in the most recent Confidential Inquiries report
from the United Kingdom for 2003 –2005 resulted from
either cerebral hemorrhage or infarction (4). The degree
of systolic hypertension (as opposed to the level of dia-
stolic hypertension or relative increase or rate of increase
of mean arterial pressure from baseline levels) may be the
most important predictor of cerebral injury and infarction.
In a recent case series of 28 women with severe preeclamp-
sia and stroke, all but 1 woman had severe systolic hyper-
tension (greater than or equal to 160 mm Hg) just before
a hemorrhagic stroke, and 54% died, whereas only 13%
had severe diastolic hypertension (greater than or equal
to 110 mm Hg) in the hours preceding stroke (6). A simi-
lar relationship between severe systolic hypertension and
risk of hemorrhagic stroke has been observed in nonpreg-
nant adults (7). Thus, systolic BP of 160 mm Hg or greater
is widely adopted as the definition of severe hypertension
in pregnant or postpartum women (8, 9).
Pregnant or postpartum women with acute-onset,
severe systolic or severe diastolic hypertension or both
require antihypertensive therapy. The goal is not to nor-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 719

 malize BP, but to achieve a range of 140–160/90–100
mmHg in order to prevent repeated, prolonged expo-
sure of the patient to severe systolic hypertension, with
subsequent loss of cerebral vasculature autoregulation.
When this happens, maternal stabilization should occur
before delivery, even in urgent circumstances (10). When
acute-onset, severe hypertension is diagnosed in the office
setting, the patient should be sent to the hospital expedi-
tiously for treatment. Also, if transfer to a tertiary center is
likely (eg, for preterm severe preeclampsia), BP should be
stabilized and other measures instituted as appropriate,
such as magnesium sulfate before transfer. Another risk for
severe hypertension is endotracheal intubation, an inter-
vention that is well known to increase BP sometimes to
severe levels that require emergent therapeutic interven-
tion (10). Induction of general anesthesia and intubation
should never be undertaken without first taking steps to
eliminate or minimize the hypertensive response to intu-
bation. Close maternal and fetal monitoring by the physi-
cian and nursing staff are advised during the treatment
of acute-onset, severe hypertension, and judicious fluid
administration is recommended even in the case of oligu-
ria. After initial stabilization, the team should monitor BP
closely and institute maintenance therapy as needed.
Recommendations
First-Line Therapy
Intravenous labetalol and hydralazine are both consid-
ered first-line medications for the management of acute-
onset, severe hypertension in pregnant and postpartum
women; less information currently exists for the use of
calcium channel blockers for this clinical indication.
Patients may respond to one drug and not the other.
Magnesium sulfate is not recommended as an antihyper-
tensive agent, but magnesium sulfate remains the drug of
choice for seizure prophylaxis in severe preeclampsia and
for controlling seizures in eclampsia. Box 1 and Box 2
outline order sets for the use of labetalol and hydralazine
for the initial management of acute-onset, severe hyper-
tension in pregnant or postpartum women with pre-
eclampsia or eclampsia (11). Although both medications
are appropriately used for the treatment of hypertensive
emergencies in pregnancy, each agent can be associated
with adverse effects. Parenteral hydralazine may increase
the risk of maternal hypotension (systolic BP 90 mm Hg
or less) (11). Parenteral labetalol may cause neonatal
bradycardia and should be avoided in women with
asthma or heart failure (12, 13). No significant changes
in umbilical blood flow have been observed with the use
of either labetalol or hydralazine (14), and maternal and
perinatal outcomes are similar for both drugs (15). If
intravenous access is not yet obtained and treatment for
acute-onset, severe hypertension is urgently needed, a
200 mg-dose of labetalol can be administered orally and
repeated in 30 minutes if an appropriate improvement is
not observed (5).
2 Committee Opinion No. 514
COMMITTEE OPINIONS
Second-Line Therapy
In the rare circumstance that intravenous bolus labetalol
or hydralazine or both fail to relieve acute-onset, severe
hypertension and are given in successive appropriate
doses such as those outlined in the order sets (see Box 1
and Box 2), emergent consultation with an anesthesiolo-
gist, maternal–fetal medicine subspecialist, or critical care
specialist to discuss second-line intervention is recom-
mended. Second line alternatives to consider include
labetalol or nicardipine by infusion pump (16–18).
Box 1. Order Set for Severe Intrapartum
or Postpartum Hypertension Initial
First-Line Management With Labetalol*
1. Notify physician if systolic BP measurement is greater
than or equal to 160 mm Hg or if diastolic BP mea-
surement is greater than or equal to 110 mm Hg.
2. Institute fetal surveillance if undelivered and fetus is
viable.
3. Administer labetalol (20 mg IV over 2 minutes).
4. Repeat BP measurement in 10 minutes and record
results.
5. If either BP threshold is still exceeded, administer
labetalol (40 mg IV over 2 minutes). If BP is below
threshold, continue to monitor BP closely.
6. Repeat BP measurement in 10 minutes and record
results.
7. If either BP threshold is still exceeded, administer
labetalol (80 mg IV over 2 minutes). If BP is below
threshold, continue to monitor BP closely.
8. Repeat BP measurement in 10 minutes and record
results.
9. If either BP threshold is still exceeded, administer
hydralazine (10 mg IV over 2 minutes). If BP is below
threshold, continue to monitor BP closely.
10. Repeat BP measurement in 20 minutes and record
results.
11. If either BP threshold is still exceeded, obtain emer-
gency consultation from maternal–fetal medicine,
internal medicine, anesthesia, or critical care spe-
cialists.
12. Give additional antihypertensive medication per spe-
cific order.
13. Once the aforementioned BP thresholds are achieved,
repeat BP measurement every 10 minutes for 1 hour,
then every 15 minutes for 1 hour, then every 30 min-
utes for 1 hour, and then every hour for 4 hours.
14. Institute additional BP timing per specific order.
Abbreviations: BP, blood pressure; IV, intravenously.
*See text for important adverse effects and contraindications.
Data from Report of the National High Blood Pressure Education
Program Working Group on High Blood Pressure in Pregnancy.
Am J Obstet Gynecol 2000;183:S1–S22.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 720

Box 2. Order Set for Severe Intrapartum
or Postpartum Hypertension Initial
First-Line Management With Hydralazine*
1. Notify physician if systolic BP is greater than or
equal to 160 mm Hg or if diastolic BP is greater than
or equal to 110 mm Hg.
2. Institute fetal surveillance if undelivered and fetus is
viable.
3. Administer hydralazine (5 mg or 10 mg IV over 2
minutes).
4. Repeat BP measurement in 20 minutes and record
results.
5. If either BP threshold is still exceeded, administer
hydralazine (10 mg IV over 2 minutes). If BP is below
threshold, continue to monitor BP closely.
6. Repeat BP measurement in 20 minutes and record
results.
7. If either BP threshold is still exceeded, administer
labetalol (20 mg IV over 2 minutes). If BP is below
threshold, continue to monitor BP closely.
8. Repeat BP measurement in 10 minutes and record
results.
9. If either BP threshold is still exceeded, administer
labetalol (40 mg IV over 2 minutes) and obtain emer-
gency consultation from maternal–fetal medicine,
internal medicine, anesthesia, or critical care spe-
cialists.
10. Give additional antihypertensive medication per
specific order.
11. Once the aforementioned BP thresholds are achieved,
repeat BP measurement every 10 minutes for 1 hour,
then every 15 minutes for 1 hour, then every 30 min-
utes for 1 hour, and then every hour for 4 hours.
12. Institute additional BP timing per specific order.
Abbreviations: BP, blood pressure; IV, intravenously.
*See text for important adverse effects and contraindications.
Data from Report of the National High Blood Pressure Education
Program Working Group on High Blood Pressure in Pregnancy.
Am J Obstet Gynecol 2000;183:S1–S22.
Transplacental passage is minimal, as are changes in
umbilical artery Doppler velocimetry (19).
Sodium nitroprusside should be reserved for extreme
emergencies and used for the shortest amount of time
possible because of concerns about cyanide and thio-
cyanate toxicity in the mother and fetus or newborn and
increased intracranial pressure with potential worsening
of cerebral edema in the mother (11). Once the hyperten-
sive emergency is treated, a complete and detailed evalu-
ation of maternal and fetal well-being is needed with,
among many issues, consideration of need for subsequent
pharmacotherapy and appropriate timing of delivery.
Committee Opinion No. 514
COMMITTEE OPINIONS
References
1. Kirkpatrick DH, Burkman RT. Does standardization of
care through clinical guidelines improve outcomes and
reduce medical liability? Obstet Gynecol 2010;116:1022– 6.
2. Menzies J, Magee LA, Li J, MacNab YC, Yin R, Stuart H,
et al. Instituting surveillance guidelines and adverse out-
comes in preeclampsia. Preeclampsia Integrated Estimate of
RiSk (PIERS) Study Group. Obstet Gynecol 2007;110:121–7.
3. von Dadelszen P, Sawchuck D, McMaster R, Douglas MJ,
Lee SK, Saunders S, et al. The active implementation of
pregnancy hypertension guidelines in British Columbia.
Translating Evidence-Based Surveillance and Treatment
Strategies (TESS) Group. Obstet Gynecol 2010;116:659–66.
4. Saving Mothers’ Lives: reviewing maternal deaths to make
motherhood safer: 2006–08. The Eighth Report on Con-
fidential Enquiries into Maternal Deaths in the United King-
dom. Centre for Maternal and Child Enquiries (CMACE).
BJOG 2011;118(suppl 1):1–203.
5. Tuffnell DJ, Jankowicz D, Lindow SW, Lyons G, Mason GC,
Russell IF, et al. Outcomes of severe pre-eclampsia/eclamp-
sia in Yorkshire 1999/2003. Yorkshire Obstetric Critical
Care Group. BJOG 2005;112:875 – 80.
6. Martin JN Jr, Thigpen BD, Moore RC, Rose CH, Cushman J,
May W. Stroke and severe preeclampsia and eclampsia: a
paradigm shift focusing on systolic blood pressure. Obstet
Gynecol 2005;105:246 – 54.
7. Lindenstrom E, Boysen G, Nyboe J. Influence of systolic
and diastolic blood pressure on stroke risk: a prospective
observational study. Am J Epidemiol 1995;142:1279 – 90.
8. Diagnosis, evaluation, and management of the hypertensive
disorders of pregnancy. SOGC Clinical Practice Guideline
No. 206. Society of Obstetricians and Gynaecologists of
Canada. J Obstet Gynaecol Can 2008;30(suppl 1):S1–S48.
9. Confidential Enquiries into Maternal Deaths. Why moth-
ers die 1997–1999. The fifth report of the Confidential
Enquiries into Maternal Deaths in the United Kingdom.
London (UK): RCOG Press; 2001.
10. Lyons G. Saving mothers’ lives: confidential enquiry into
maternal and child health 2003–5. Int J Obstet Anesth
2008;17:103–5.
11. Report of the National High Blood Pressure Education
Program Working Group on High Blood Pressure in Preg-
nancy. Am J Obstet Gynecol 2000;183:S1–S22.
12. Magee LA, Cham C, Waterman EJ, Ohlsson A, von
Dadelszen P. Hydralazine for treatment of severe hyper-
tension in pregnancy: meta-analysis. BMJ 2003;327:955–60.
13. Magee LA, von Dadelszen P. The management of severe
hypertension. Semin Perinatol 2009;33:138–42.
14. Baggio MR, Martins WP, Calderon AC, Berezowski AT,
Marcolin AC, Duarte G, et al. Changes in fetal and maternal
Doppler parameters observed during acute severe hyper-
tension treatment with hydralazine or labetalol: a random-
ized controlled trial. Ultrasound Med Biol 2011;37:53–8.
15. Duley L, Henderson-Smart DJ, Meher S. Drugs for treat-
ment of very high blood pressure during pregnancy.
Cochrane Database of Systematic Reviews 2006, Issue 3.
Art. No.: CD001449. DOI: 10.1002/14651858.CD001449.
pub2.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 721
 16. Prometheus Laboratories Inc. Trandate® (labetalol hydro-
chloride) tablets. San Diego (CA): Prometheus Labora-
tories; 2010. Available at: http://www.prometheuslabs.com/
Resources/PI/TrandateTab.pdf. Retrieved August 25, 2011.
17. Vadhera RB, Pacheco LD, Hankins GD. Acute antihyper-
tensive therapy in pregnancy-induced hypertension: is
nicardipine the answer? Am J Perinatol 2009;26:495 – 9.
18. Nij Bijvank SW, Duvekot JJ. Nicardipine for the treatment
of severe hypertension in pregnancy: a review of the litera-
ture. Obstet Gynecol Surv 2010;65:341–7.
19. Carbonne B, Jannet D, Touboul C, Khelifati Y, Milliez J.
Nicardipine treatment of hypertension during pregnancy.
Obstet Gynecol 1993;81:908 –14.
4 Committee Opinion No. 514
COMMITTEE OPINIONS
Copyright December 2011 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Emergent therapy for acute-onset, severe hypertension with pre-
eclampsia or eclampsia. Committee Opinion No. 514. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:
1465–8.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 722
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 521 • March 2012 (Replaces No. 438, August 2009)
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information
should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Update on Immunization and Pregnancy: Tetanus,

Diphtheria, and Pertussis Vaccination
ABSTRACT: In light of the recent increased incidence of pertussis in the United States, in 2011, the Centers
for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved recommendations
for the use of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) for pregnant
women. Furthermore, the committee updated Tdap recommendations for special situations during pregnancy and
for persons in contact with infants. The revised guidelines, which are based on a review of data on Tdap safety,
immunogenicity, and barriers to receipt of Tdap, are designed to facilitate the use of Tdap to reduce the burden
of disease and risk of transmission to infants. There is no evidence of adverse fetal effects from the vaccination
of pregnant women with an inactivated virus, bacterial vaccine, or toxoid, and these should be administered if
indicated. The American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice supports
the revised recommendations on the administration of Tdap during pregnancy.

Immunization During Pregnancy Updated Immunization Guidelines:

Ideally, vaccines should be administered before concep-
tion. Prenatal care offers the opportunity to review immu-
nization status. The American College of Obstetricians
and Gynecologists (the College) recommends routine
assessment of each pregnant woman’s immunization
status and appropriate immunization if indicated. There
is no evidence of adverse fetal effects from the vaccination
of pregnant women with an inactivated virus, bacterial
vaccine, or toxoid, and these should be administered if
indicated. However, live vaccines do pose a theoretical
risk to the fetus and generally should be avoided dur-
ing pregnancy. The benefits of vaccinations outweigh
any unproven potential concerns. There is no evidence
that any vaccine is associated with an increased risk of
autism or of adverse effects due to exposure to traces of
the mercury-containing preservative thimerosal (1–6).
When deciding whether to immunize a pregnant woman
with a vaccine not routinely recommended in pregnancy,
the risk of exposure to the disease, as well as the benefits
of vaccination for reducing the deleterious effects on the
woman and the fetus, must be balanced against unknown
risks of the vaccine. All vaccines administered should be
fully documented in the patient’s permanent medical
record (7).
Tetanus, Diphtheria, and Pertussis
In light of the recent increased incidence of pertussis in
the United States, in 2011, the Centers for Disease Control
and Prevention’s Advisory Committee on Immunization
Practices (ACIP) approved recommendations for the
use of the tetanus toxoid, reduced diphtheria toxoid and
acellular pertussis vaccine (Tdap) for pregnant women.
Furthermore, the committee updated Tdap recommen-
dations for special situations during pregnancy and for
persons in contact with infants (8). The revised guide-
lines, which are based on a review of data on Tdap safety,
immunogenicity, and barriers to receipt of Tdap, are
designed to facilitate the use of Tdap to reduce the burden
of disease and risk of transmission to infants. The College’s
Committee on Obstetric Practice supports these revised
recommendations, which are summarized as follows.
Use of the Tetanus Toxoid, Reduced Diphtheria
Toxoid and Acellular Pertussis Vaccine in
Pregnant Women
Women’s health care providers should implement a Tdap
vaccination program for pregnant women who previously
have not received Tdap. Health care providers should
administer Tdap during pregnancy, preferably during the

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 723

 third trimester or late second trimester (ie, after 20 weeks
of gestation). Alternatively, if not administered during
pregnancy, Tdap should be administered immediately
postpartum to ensure pertussis immunity and reduce the
risk of transmission to the newborn (8). Regardless of the
trimester, health care providers are encouraged to report
Tdap administration to the appropriate manufacturer’s
pregnancy registry.
Special Situations During Pregnancy
Tetanus Booster
Health care providers should administer Tdap during
pregnancy, preferably during the third trimester or late
second trimester (ie, after 20 weeks of gestation), if a teta-
nus and diphtheria (TD) booster vaccination is indicated
(ie, more than 10 years since the previous TD vaccina-
tion) for a pregnant woman who has not received Tdap
previously (8).
Wound Management
As part of standard wound management care to prevent
tetanus, a tetanus toxoid-containing vaccine might be
recommended for a pregnant woman if 5 years or more
have elapsed since the previous TD booster vaccination.
If a TD booster vaccination is indicated for a pregnant
woman who has not received Tdap previously, health
care providers should administer Tdap (8).
Unknown or Incomplete Tetanus Vaccination
To ensure protection against maternal and neonatal teta-
nus, pregnant women who never have been vaccinated
against tetanus should receive three vaccinations contain-
ing tetanus and reduced diphtheria toxoids during preg-
nancy. The recommended schedule is 0, 4 weeks, and 6–12
months. One dose of the TD booster vaccine should be
replaced by Tdap, preferably during the third trimester or
late second trimester (ie, after 20 weeks of gestation) (8).
Vaccination of Adolescents and Adults in
Contact With Infants
The ACIP recommends that adolescents and adults, (eg,
siblings, parents, grandparents, child care providers, and
health care providers, including individuals aged 65 years
and older) who have or who anticipate having contact
with an infant younger than 12 months of age and who
have not received Tdap previously, should receive a single
dose of Tdap to protect against pertussis and reduce the
likelihood of transmission (8). Ideally, these adolescents
and adults should receive Tdap at least 2 weeks before
they have contact with the infant.
Current Immunization Guidelines and
Information
Immunization guidelines are subject to change. Extensive
information for health care providers and consumers about
vaccines can be obtained at www.cdc.gov/vaccines and on
the College’s immunization web site at www.immunization
forwomen.org/. The ACIP issues recommendations on
immunization that are updated regularly and are available
at www.cdc.gov/vaccines/pubs/ACIP-list.htm.
2 Committee Opinion No. 521
COMMITTEE OPINIONS
Resources
Advisory Committee for Immunization Practices Recom-
mendations, available at http://www.cdc.gov/vaccines/
pubs/ACIP-list.htm
American College of Obstetricians and Gynecologists’
immunization web site, available at www.immunization
forwomen.org
Centers for Disease Control and Prevention’s Vaccines
and Immunizations Information Page, available at http://
www.cdc.gov/vaccines
References
1. Thompson WW, Price C, Goodson B, Shay DK, Benson P,
Hinrichsen VL, et al. Early thimerosal exposure and neuropsy-
chological outcomes at 7 to 10 years. Vaccine Safety Datalink
Team. N Engl J Med 2007;357:1281–92. [PubMed] [Full Text]
^
2. Centers for Disease Control and Prevention. Vaccine safety:
thimerosal. Available at: http://www.cdc.gov/vaccinesafety/Con
cerns/thimerosal/index.html. Retrieved October 28, 2011. ^
3. Food and Drug Administration. Thimerosal in vaccines.
Rockville (MD): FDA; 2010. Available at: http://www.fda.gov/
BiologicsBloodVaccines/SafetyAvailability/Vaccine
Safety/UCM096228. Retrieved October 28, 2011. ^
4. Joint statement of the American Academy of Pediatrics (AAP)
and the United States Public Health Service (USPHS).
Pediatrics 1999;104:568–9. [PubMed] [Full Text] ^
5. Thimerosal in vaccines—An interim report to clinicians.
American Academy of Pediatrics. Committee on Infectious
Diseases and Committee on Environmental Health. Pediatrics
1999;104:570–4. [PubMed] [Full Text] ^
6. Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E,
et al. Effectiveness of maternal influenza immunization in
mothers and infants [published erratum appears in N Engl
J Med 2009;360:648]. N Engl J Med 2008;359:1555–64.
[PubMed] [Full Text] ^
7. Centers for Disease Control and Prevention. Epidemiology
and prevention of vaccine-preventable diseases. 12th ed.
Washington, DC: Public Health Foundation; 2011. Avail-
able at: http://www.cdc.gov/vaccines/pubs/pinkbook/index.
html. Retrieved October 28, 2011. ^
8. Updated recommendations for use of tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis (Tdap) vaccine from
the Advisory Committee on Immunization Practices, 2010.
Centers for Disease Control and Prevention (CDC). MMWR
Morb Mortal Wkly Rep 2011;60:13–5. [PubMed] [Full Text]
^
Copyright March 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
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ISSN 1074-861X
Update on immunization and pregnancy: tetanus, diphtheria, and
pertussis vaccination. Committee Opinion No. 521. American College
of Obstetricians and Gynecologists. Obstet Gynecol 2012;119:690–1.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 724
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 529 • July 2012
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Placenta Accreta
ABSTRACT: Placenta accreta is a potentially life-threatening obstetric condition that requires a multidis-
ciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the
increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial
damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the
uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to mini-
mize potential maternal or neonatal morbidity and mortality. Grayscale ultrasonography is sensitive enough and
specific enough for the diagnosis of placenta accreta; magnetic resonance imaging may be helpful in ambiguous
cases. Although recognized obstetric risk factors allow the identification of most cases during the antepartum
period, the diagnosis is occasionally discovered at the time of delivery. In general, the recommended management
of suspected placenta accreta is planned preterm cesarean hysterectomy with the placenta left in situ because
attempts at removal of the placenta are associated with significant hemorrhagic morbidity. However, surgical man-
agement of placenta accreta may be individualized. Although a planned delivery is the goal, a contingency plan for
an emergency delivery should be developed for each patient, which may include following an institutional protocol
for maternal hemorrhage management.

Placenta accreta is a general term used to describe the clini-
cal condition when part of the placenta, or the entire pla-
centa, invades and is inseparable from the uterine wall (1).
When the chorionic villi invade only the myometrium,
the term placenta increta is appropriate; whereas placenta
percreta describes invasion through the myometrium and
serosa, and occasionally into adjacent organs, such as the
bladder. Clinically, placenta accreta becomes problematic
during delivery when the placenta does not completely
separate from the uterus and is followed by massive
obstetric hemorrhage, leading to disseminated intravas-
cular coagulopathy; the need for hysterectomy; surgical
injury to the ureters, bladder, bowel, or neurovascular
structures; adult respiratory distress syndrome; acute
transfusion reaction; electrolyte imbalance; and renal
failure. The average blood loss at delivery in women with
placenta accreta is 3,000–5,000 mL (2). As many as 90%
of patients with placenta accreta require blood transfu-
sion, and 40% require more than 10 units of packed red
blood cells. Maternal mortality with placenta accreta has
been reported to be as high as 7% (3). Maternal death
may occur despite optimal planning, transfusion manage-
ment, and surgical care. From a cohort of 39,244 women
who underwent cesarean delivery, researchers identified
186 that had a cesarean hysterectomy performed (4). The
most common indication was placenta accreta (38%).
Incidence
The incidence of placenta accreta has increased and seems
to parallel the increasing cesarean delivery rate. Research-
ers have reported the incidence of placenta accreta as 1 in
533 pregnancies for the period of 1982–2002 (5). This con-
trasts sharply with previous reports, which ranged from
1 in 4,027 pregnancies in the 1970s, increasing to 1 in
2,510 pregnancies in the 1980s (6, 7).
Repeat Cesarean Delivery and Other
Risk Factors
Women at greatest risk of placenta accreta are those who
have myometrial damage caused by a previous cesarean
delivery with either anterior or posterior placenta pre-
via overlying the uterine scar. The authors of one study
found that in the presence of a placenta previa, the risk
of placenta accreta was 3%, 11%, 40%, 61%, and 67% for
the first, second, third, fourth, and fifth or greater repeat
cesarean deliveries, respectively (8). Placenta previa with-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 725

 out previous uterine surgery is associated with a 1–5%
risk of placenta accreta. Besides advanced maternal age
and multiparity, reported risk factors include any condi-
tion resulting in myometrial tissue damage followed by a
secondary collagen repair, such as previous myomectomy,
endometrial defects due to vigorous curettage resulting in
Asherman syndrome (9), submucous leiomyomas, ther-
mal ablation (10), and uterine artery embolization (11).
Diagnosis
The value of making the diagnosis of placenta accreta
before delivery is that it allows for multidisciplinary
planning in an attempt to minimize potential maternal
or neonatal morbidity and mortality. The diagnosis is
usually established by ultrasonography and occasionally
supplemented by magnetic resonance imaging (MRI).
Ultrasonography
Transvaginal and transabdominal ultrasonography are
complementary diagnostic techniques and should be
used as needed. Transvaginal ultrasound is safe for
patients with placenta previa and allows a more complete
examination of the lower uterine segment. A normal pla-
cental attachment site is characterized by a hypoechoic
boundary between the placenta and the bladder. The
ultrasonographic features suggestive of placenta accreta
include irregularly shaped placental lacunae (vascular
spaces) within the placenta, thinning of the myome-
trium overlying the placenta, loss of the retroplacental
“clear space,” protrusion of the placenta into the blad-
der, increased vascularity of the uterine serosa–bladder
interface, and turbulent blood flow through the lacunae
on Doppler ultrasonography (12, 13). The presence and
increasing number of lacunae within the placenta at
15–20 weeks of gestation have been shown to be the most
predictive ultrasonographic signs of placenta accreta,
with a sensitivity of 79% and a positive predictive value of
92% (14). These lacunae may result in the placenta hav-
ing a “moth-eaten” or “Swiss cheese” appearance.
Overall, grayscale ultrasonography is sufficient to
diagnose placenta accreta, with a sensitivity of 77–87%,
specificity of 96–98%, a positive predictive value of
65–93%, and a negative predictive value of 98 (13, 14).
The use of power Doppler, color Doppler, or three-
dimensional imaging does not significantly improve the
diagnostic sensitivity compared with that achieved by
grayscale ultrasonography alone (15).
Magnetic Resonance Imaging
Magnetic resonance imaging is more costly than ultraso-
nography and requires both experience and expertise in
the evaluation of abnormal placental invasion. Although
most studies have suggested comparable diagnostic accu-
racy of MRI and ultrasonography for placenta accreta,
MRI is considered an adjunctive modality and adds little
to the diagnostic accuracy of ultrasonography. However,
when there are ambiguous ultrasound findings or a sus-
picion of a posterior placenta accreta, with or without
2 Committee Opinion No. 529
COMMITTEE OPINIONS
placenta previa, ultrasonography may be insufficient. A
prospective series of 300 cases published in 2005 showed
that MRI was able to outline the anatomy of the invasion
and relate it to the regional anastomotic vascular system
(16). In addition, this study showed that using axial MRI
slices enabled confirmation of parametrial invasion and
possible ureteral involvement.
Controversy surrounds the use of gadolinium-based
contrast enhancement even though it adds to specific-
ity of the placenta accreta diagnosis by MRI. The use
of gadolinium contrast enables MRI to more clearly
delineate the outer placental surface relative to the myo-
metrium and differentiate between the heterogeneous
vascular signals within the placenta from those caused by
maternal blood vessels. The uncertainty surrounds the
risk of possible fetal effects because it is able to cross the
placenta and readily enters the fetal circulatory system.
The Contrast Media Safety Committee of the European
Society of Urogenital Radiology reviewed the literature
and determined that no effect on the fetus has been re-
ported following the use of gadolinium contrast media
(17). However, the American College of Radiology guid-
ance document for safe MRI practices recommends that
intravenous gadolinium should be avoided during preg-
nancy and should be used only if absolutely essential (18).
Management
General Considerations
It is critically important that obstetricians and radiologists
are familiar with the risk factors and diagnostic modali-
ties for placenta accreta because of its potential emergent
nature and the associated risk of life-threatening hemor-
rhage. If there is a strong suggestion for the presence of
abnormal placental invasion, health care providers prac-
ticing at small hospitals or institutions with insufficient
blood bank supply or inadequate availability of subspe-
cialty and support personnel should consider patient
transfer to a tertiary perinatal care center. Improved out-
comes have been demonstrated when these patients give
birth in specialized tertiary centers (19).
Delivery planning may involve an anesthesiologist,
obstetrician, pelvic surgeon such as a gynecologic oncolo-
gist, intensivist, maternal–fetal medicine specialist, neo-
natologist, urologist, hematologist, and interventional
radiologist to optimize the patient’s outcome (19). To
enhance patient safety, it is important that the delivery
be performed by an experienced obstetric team that
includes an obstetric surgeon, with other surgical special-
ists, such as urologists, general surgeons, and gynecologic
oncologists, available if necessary. Because of the risk of
massive blood loss, attention should be paid to maternal
hemoglobin levels in advance of surgery, if possible (20).
Many patients with placenta accreta require emergency
preterm delivery because of the sudden onset of mas-
sive hemorrhage. Autologous blood salvage devices have
proved safe, and the use of these devices may be a valu-
able adjunct during the surgery (21).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 726
 Delivery Planning
The timing of delivery in cases of suspected placenta
accreta must be individualized. This decision should be
made jointly with the patient, obstetrician, and neona-
tologist. Patient counseling should include discussion of
the potential need for hysterectomy, the risks of profuse
hemorrhage, and possible maternal death. A guiding
principle in management is to achieve a planned deliv-
ery because data suggest greater blood loss and complica-
tions in emergent cesarean hysterectomy versus planned
cesarean hysterectomy (22). Although a planned deliv-
ery is the goal, a contingency plan for emergency delivery
should be developed for each patient, which may include
following an institutional protocol for maternal hemor-
rhage management.
The timing of delivery should be individualized,
depending on patient circumstances and preferences.
One option is to perform delivery after fetal pulmonary
maturity has been demonstrated by amniocentesis. How-
ever, the results of a recent decision analysis suggested
that combined maternal and neonatal outcomes are
optimized in stable patients with delivery at 34 weeks of
gestation without amniocentesis (23). The decision to
administer antenatal corticosteroids and the timing of
administration should be individualized.
The delivery should be performed in an operating
room with the personnel and support services needed
to manage potential complications. Assessment by the
anesthesiologist should occur as early as possible before
surgery. Both general and regional anesthetic techniques
have been shown to be safe in these clinical situations; the
judgment of which type of technique to be used should
be made on an individual basis. Pneumatic compression
stockings should be placed preoperatively and main-
tained until the patient is fully ambulatory. Prophylactic
antibiotics are indicated, with repeat doses after 2–3
hours of surgery or 1,500 mL of estimated blood loss.
Preoperative cystoscopy with placement of ureteral stents
may help prevent inadvertent urinary tract injury. Some
advise that a three-way Foley catheter be placed in the
bladder through the urethra to allow irrigation, drainage,
and distension of the bladder, as necessary, during dissec-
tion. Preoperatively, the blood bank should be placed on
alert for a potential massive hemorrhage. Current recom-
mendations for blood replacement in trauma situations
suggest a 1:1 ratio of packed cells to fresh frozen plasma.
Institutionally established massive transfusion protocols
should be followed. Packed red blood cells and thawed
fresh frozen plasma should be available in the operating
room. Additional units of blood and coagulation fac-
tors should be infused quickly and as necessitated by the
patient’s vital signs and hemodynamic stability.
Surgical Approach
Generally, the recommended management of suspected
placenta accreta is planned preterm cesarean hysterec-
tomy with the placenta left in situ because removal of the
Committee Opinion No. 529
COMMITTEE OPINIONS
placenta is associated with significant hemorrhagic mor-
bidity. However, this approach might not be considered
first-line treatment for women who have a strong desire
for future fertility. Therefore, surgical management of
placenta accreta may be individualized.
Consideration should be given to placing the patient
on the operating table in specialized stirrups in a modi-
fied dorsal lithotomy position with left lateral tilt to allow
for direct assessment of vaginal bleeding, provide access
for placement of a vaginal pack, and allow additional
space for a surgical assistant. Because the procedure is
anticipated to be prolonged, padding and positioning to
prevent nerve compression and the prevention and treat-
ment of hypothermia are important (24). Minimizing
blood loss is critical. The choice of incision should be
made based on the patient’s body habitus and history
of surgery. The use of a midline vertical incision may be
considered because it provides sufficient exposure if hys-
terectomy becomes necessary. A classic uterine incision,
often transfundal, may be necessary to avoid the placenta
and allow delivery of the infant. Ultrasound mapping of
the placental attachment site, either preoperatively or
intraoperatively, may be helpful. Because the positive
predictive value of ultrasonography for placenta accreta
ranges from 65% to 93% (12, 13), it is reasonable to await
spontaneous placental separation to confirm placenta
accreta clinically.
Generally, planned attempts at manual placental
removal should be avoided. If hysterectomy becomes
necessary, the standard approach is to leave the placenta
in situ, quickly use a “whip stitch” to close the hyster-
otomy incision, and proceed with hysterectomy. Whereas
hysterectomy is performed in the usual fashion, dissec-
tion of the bladder flap may be performed relatively late,
after vascular control of the uterine arteries is achieved,
in cases of anterior accreta, depending on intraoperative
findings. Occasionally, a subtotal hysterectomy can be
safely performed, but persistent bleeding from the cervix
may preclude this approach and make total hysterectomy
necessary.
There are reports of an alternative approach to the
management of placenta accreta that includes ligating
the cord close to the fetal surface, removing the cord,
and leaving the placenta in situ, potentially with partial
placental resection to minimize its size. However, this
approach should be considered only when the patient
has a strong desire for future fertility as well as hemo-
dynamic stability, normal coagulation status, and is
willing to accept the risks involved in this conservative
approach. The patient should be counseled that the out-
come of this approach is unpredictable and that there
is an increased risk of significant complications as well
as the need for later hysterectomy. Reported cases of
subsequent successful pregnancy in patients treated with
this approach are rare. This approach should be aban-
doned and hysterectomy performed if excessive bleeding
is noted. Of the 26 patients treated with this approach,
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 727
 21 (80.7%) successfully avoided hysterectomy, whereas
5 (19.3%) eventually required it. However, the majority
of the 21 patients who avoided hysterectomy did require
additional treatment, including hypogastric artery liga-
tion, arterial embolization, methotrexate, blood product
transfusion, antibiotics, or curettage (25). Except in
specific cases, hysterectomy remains the treatment of
choice for patients with placenta accreta.
Interventional Radiologic Procedures
Current evidence is insufficient to make a firm recom-
mendation on the use of balloon catheter occlusion or
embolization to reduce blood loss and improve surgical
outcome, but individual situations may warrant their
use. Despite initial enthusiasm about the utility of balloon
catheter occlusion, available data are unclear regarding
its efficacy. Although some investigators have reported
reduced blood loss (26), there have been other reports of
no benefits (27) and even of significant complications (28).
Methotrexate
The folate antagonist methotrexate has been proposed
as an adjunctive treatment for placenta accreta. Some
have opined that after delivery, the trophoblasts are no
longer dividing, thereby rendering methotrexate ineffec-
tive. Small studies have reported mixed results (29, 30).
Although uterine conservation was achieved in one study,
most of the patients subsequently developed postpartum
hemorrhage that required hysterectomy. Other reports
documented failure of treatment with methotrexate (30).
Thus, there are no convincing data for the use of metho-
trexate for postpartum management of placenta accreta.
Retained Placenta After Vaginal Delivery
Occasionally, a retained placenta or persistent post-
partum bleeding develops after vaginal delivery. After
reassessment of the risk factors for placenta accreta,
the possibility of abnormal placental invasion must be
considered before proceeding with additional attempts
at manual or surgical removal because these may only
worsen the hemorrhage and increase the risk of maternal
morbidity and mortality. When the diagnosis of placenta
accreta is suspected, management options might include
intrauterine balloon tamponade, selective pelvic emboli-
zation in stable cases, and emergency surgery.
Recommendations and Conclusions
• Women at greatest risk of placenta accreta are those Am J Obstet Gynecol 1996;175:1632–8. [PubMed] ^
who have myometrial damage caused by an earlier
cesarean delivery with either an anterior or posterior
placenta previa overlying the uterine scar.
• Grayscale ultrasonography is sensitive (77–87%) Development Maternal-Fetal Medicine Units Network.
and specific (96–98%) for the diagnosis of placenta
accreta.
• If there is a strong suggestion of the presence of 5. Wu S, Kocherginsky M, Hibbard JU. Abnormal placenta-
abnormal placental invasion, health care providers
practicing at small hospitals or at institutions with
4 Committee Opinion No. 529
COMMITTEE OPINIONS
insufficient blood bank supply or inadequate avail-
ability of subspecialty and support personnel should
consider patient transfer to a tertiary perinatal care
center.
• To enhance patient safety, it is important that the
delivery be performed in an operating room by an
experienced obstetric team that includes an obstet-
ric surgeon, with other surgical specialists, such as
urologists, general surgeons, and gynecologic oncol-
ogists, available if necessary. Improved outcomes
have been demonstrated when women with placenta
accreta give birth in specialized tertiary centers.
• Preoperative patient counseling should include dis-
cussion of the potential need for hysterectomy, the
risks of profuse hemorrhage, and possible maternal
death.
• Although a planned delivery is the goal, a contin-
gency plan for emergency delivery should be devel-
oped for each patient, which may include following
an institutional protocol for maternal hemorrhage
management.
• The timing of delivery should be individualized,
depending on patient circumstances. Combined
maternal and neonatal outcome is optimized in
stable patients with a planned delivery at 34 weeks of
gestation without amniocentesis.
• The decision to administer antenatal corticosteroids
and the timing of administration should be individu-
alized.
• Generally, the recommended management of sus-
pected placenta accreta is planned preterm cesarean
hysterectomy with the placenta left in situ because
removal of the placenta is associated with significant
hemorrhagic morbidity. However, surgical manage-
ment of placenta accreta may be individualized.
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13. Warshak CR, Eskander R, Hull AD, Scioscia AL, Mattrey RF,
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16. Palacios Jaraquemada JM, Bruno CH. Magnetic reso-
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17. Webb JA, Thomsen HS, Morcos SK. The use of iodinated
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Copyright July 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
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ISSN 1074-861X
Placenta accreta. Committee Opinion No. 529. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2012;120:207–11.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 729
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 533 • August 2012
Committee on Obstetric Practice
This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Lead Screening During Pregnancy and Lactation

Abstract: Prenatal lead exposure has known adverse effects on maternal health and infant outcomes across
a wide range of maternal blood lead levels. Adverse effects of lead exposure are being identified at lower levels
of exposure than previously recognized in both children and adults. In 2010, the Centers for Disease Control and
Prevention issued the first guidelines regarding the screening and management of pregnant and lactating women
who have been exposed to lead.

Prenatal lead exposure has known adverse effects on
maternal health and infant outcomes across a wide range
of maternal blood lead levels (1). Adverse effects of lead
exposure are being identified at lower levels of expo-
sure than previously recognized in both children and
adults (2–7). In 2010, the Centers for Disease Control
and Prevention issued the first guidelines regarding the
screening and management of pregnant and lactating
women who have been exposed to lead (8).
Background
Environmental policies and public health education pro-
grams have led to significant reductions in cases of lead
exposure in the United States (9). Despite these improve-
ments, approximately 1% of women of childbearing age
(15–49 years) have blood lead levels greater than or equal
to 5 micrograms/dL (8).
Although no threshold has been found to trigger the
adverse health effects of lead (8), in nonpregnant adults
blood lead levels less than 5 micrograms/dL are consid-
ered normal, blood lead levels between 5 micrograms/dL
and 10 micrograms/dL require follow-up, and blood
lead levels greater than 10 micrograms/dL are managed
with environmental assessment and abatement of expo-
sures. Chelation therapy is considered at blood lead
levels greater than 40 micrograms/dL for symptomatic
individuals, and levels greater than 70 micrograms/dL are
considered a medical emergency. In children, treatment is
recommended at blood lead levels of 45 micrograms/dL
or greater.
The main target for lead toxicity is the nervous
system, both in adults and children (10). High levels of
exposure can result in delirium, seizures, stupor, coma,
or even death. Other overt signs and symptoms of lead
toxicity may include hypertension, peripheral neuropa-
thy, ataxia, tremor, headache, loss of appetite, weight
loss, fatigue, muscle and joint aches, changes in behavior
and concentration, gout, nephropathy, lead colic, and
anemia. Health effects of chronic low-level exposure in
adults include cognitive decline, hypertension and other
cardiovascular effects, decrements in renal function, and
adverse reproductive outcome. The developing nervous
systems in children make them more susceptible to the
neurologic effects of lead toxicity.
Adverse Health Effects of Prenatal
Exposure
Lead readily crosses the placenta by passive diffusion
and has been detected in the fetal brain as early as the
end of the first trimester (8). Elevated lead levels in preg-
nancy have been associated with several adverse outcomes,
including gestational hypertension, spontaneous abor-
tion, low birth weight, and impaired neurodevelopment
(11–14).
Lead exposure has been associated with an increased
risk of gestational hypertension, but the magnitude of the
effect, the exposure level at which risk begins to increase,
and whether risk is most associated with acute or cumu-
lative exposure remain uncertain. Also, it is unclear
whether lead-induced increases in blood pressure during
pregnancy lead to severe hypertension or preeclampsia
(11, 15–18).
Evidence shows that maternal exposure to high levels
of lead increases the risk of spontaneous abortion (19).

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 730

 However, data for an association between low or moder-
ate lead levels and spontaneous abortion are inconsistent.
The strongest available evidence comes from a prospec-
tive study of 668 pregnant women in Mexico City that
demonstrated a statistically significant dose–response
relationship between low-to-moderate maternal blood
lead levels and the risk of spontaneous abortion (12).
Yet, another longitudinal study of 351 women in Japan
showed no difference in blood lead levels between spon-
taneous abortion cases (n=15) and ongoing pregnancies
(20). Larger prospective studies are needed to further
clarify the effects of low and moderate levels of lead on
spontaneous abortion risk.
More recent and well-designed studies suggest that
maternal lead exposure during pregnancy is inversely
related to fetal growth, as reflected by duration of preg-
nancy and infant size. One study that used a registry-based
approach found that offspring of mothers occupation-
ally exposed to lead had an increased risk of low birth
weight (relative risk [RR], 1.34; confidence interval [CI],
1.12–1.6) compared with infants of women not exposed
to lead (13). A case–control study in Mexico City found
umbilical cord blood lead levels to be higher in preterm
infants (mean value, 9.8 micrograms/dL) compared with
term infants (mean value, 8.4 micrograms/dL) (21). A
birth cohort study, also conducted in Mexico City, found
maternal bone lead burden to be inversely related to
offspring weight (22), length, and head circumference at
birth (23).
A large number of studies provide evidence that
prenatal lead exposure impairs children’s neurodevelop-
ment. Some prospective studies have included children
with low levels of prenatal lead exposure and continue
to detect inverse associations with neurodevelopment,
although these data are less consistent than those related
to the high levels of lead exposure. In one study, each
1 microgram/dL increase in umbilical cord blood lead
was found to be associated with a reduction of 0.6 points
in the mental development index scores of the Bayley
Scales of Infant Development at age 3 months, with simi-
lar results at age 6 months (14, 24). However, another
prospective cohort study found that the relationship
between prenatal blood lead levels and early childhood
IQ is not linear, with the strongest postnatal effects noted
at low levels of prenatal exposure (25). The available data
are inadequate to establish the presence or absence of an
association between maternal lead exposure and major
congenital anomalies in the fetus.
Lead Exposure During Breastfeeding
Although the benefits of breastfeeding generally outweigh
the risks of environmental exposure, the effects of breast-
feeding on infant lead levels have been studied. Lead has
been detected in the breast milk of women in population-
based studies; however, the availability of high-quality
data to assess the risk for toxicity to the breastfeeding
infant is limited (8). Although infant blood lead levels
2 Committee Opinion No. 533
COMMITTEE OPINIONS
have been correlated with the duration of breastfeeding
(26), the ratio of breast milk lead levels to blood lead
levels has been found to be less than 3% (27). According
to the American Academy of Pediatrics, because of the
contribution of lead levels found in infant formula and
other infant foods, breastfed infants of mothers with nor-
mal blood lead levels are actually exposed to slightly less
lead than if they were not breastfed (28).
Screening and Management
Pregnancy
The Centers for Disease Control and Prevention (CDC)
and the American College of Obstetricians and Gyne-
cologists do not recommend blood lead testing of all preg-
nant women in the United States. Obstetric health care
providers should consider the possibility of lead exposure
in individual pregnant women by evaluating risk factors
for exposure as part of a comprehensive health risk assess-
ment and perform blood lead testing if a single risk factor
is identified. Assessment of lead exposure should take
place at the earliest contact with the pregnant patient.
Important risk factors for lead exposure in preg-
nant women are listed in Box 1. Lead-based paint is less
likely to be an important exposure source for pregnant
women than it is for children, except during renovation
or remodeling in older homes. Women should take pre-
cautions when repainting surfaces with deteriorated paint
or performing any remodeling or renovation work that
disturbs painted surfaces, such as scraping off paint or
tearing out walls (8).
For pregnant women with blood lead levels of
5 micrograms/dL or higher, sources of lead exposure
should be identified and women should receive counseling
regarding avoidance of further exposure. Confirmatory
and follow-up blood lead testing should be performed
in accordance with the CDC’s recommended schedules
(Table 1) and maternal or umbilical cord blood lead
levels should be measured at delivery (8). Women with
confirmed blood lead levels of 45 micrograms/dL or
more should be treated in consultation with clinicians
experienced in the management of lead toxicity and
high-risk pregnancy. Once the source of lead exposure
is identified and eliminated, the initial decrease in blood
lead level occurs relatively rapidly because of lead’s short
(35-day) initial half-life in blood (29). This initial rapid
decrease is followed by a slow, continuous decrease over
several months to several years because of mobilization of
lead from stores in the bone (8). Recommendations for
the frequency of blood lead follow-up tests are included
in Table 1.
Adequate dietary intake of calcium, iron, zinc, vita-
min C, vitamin D, and vitamin E is known to decrease
lead absorption (30, 31). Iron-deficiency anemia is associ-
ated with elevated blood lead levels and may increase lead
absorption. During pregnancy and lactation, lead from
prior exposures can be mobilized from bones because
2013 COMPENDIUM OF SELECTED PUBLICATIONS 731
 Table 1. Frequency of Maternal Blood Lead Follow-up
Box 1. Risk Factors for Lead Exposure in Testing During Pregnancy ^
Pregnant and Lactating Women ^ Venous Blood
• Recent emigration from or residency in areas where Lead Level*
ambient lead contamination is high—women from (micrograms/dL) Perform Follow-up Test(s)†
countries where leaded gasoline is still being used (or
was recently phased out) or where industrial emissions Less than 5 • None (no follow-up testing is indicated)
are not well controlled. 5–14 • Within 1 month
• Living near a point source of lead—examples include • Obtain a maternal blood lead level‡ or cord
lead mines, smelters, or battery recycling plants (even
if the establishment is closed). blood lead level at delivery
• Working with lead or living with someone who does— 15–24 • Within 1 month and then every 2–3 months
women who work in or who have family members who • Obtain a maternal blood lead level‡ or cord
work in an industry that uses lead (eg, lead production, blood lead level at delivery
battery manufacturing, paint manufacturing, ship build-
ing, ammunition production, or plastic manufacturing). • More frequent testing may be indicated
• Using lead-glazed ceramic pottery—women who cook, based on risk factors
store, or serve food in lead-glazed ceramic pottery made 25–44 • Within 1–4 weeks and then every month
in a traditional process and usually imported by individu-
• Obtain a maternal blood lead level ‡ or cord
als outside the normal commercial channels.
blood lead level at delivery
• Eating nonfood substances (pica)—women who eat or
mouth nonfood items that may be contaminated with 45 or more • Within 24 hours and then at frequent
lead, such as soil or lead-glazed ceramic pottery. intervals depending on clinical interventions
• Using alternative or complementary substances, herbs, and trend in blood lead levels
or therapies—women who use imported home rem- • Consultation with a clinician experienced in
edies or certain therapeutic herbs traditionally used by the management of pregnant women with
East Indian, Indian, Middle Eastern, West Asian, and blood lead levels in this range is strongly
Hispanic cultures that may be contaminated with lead.
advised
• Using imported cosmetics or certain food products—
women who use imported cosmetics, such as kohl or • Obtain a maternal blood lead level or cord
surma or certain imported foods or spices that may be blood lead level at delivery
contaminated with lead.
*Venous blood sample is recommended for maternal blood lead testing.
• Engaging in certain high-risk hobbies or recreational †
The higher the blood lead level on the screening test, the more urgent the need for
activities—women who engage in high-risk activities confirmatory testing.
(eg, stained glass production or pottery making with
certain leaded glazes and paints) or have family mem-
‡
If possible, obtain a maternal blood lead level before delivery because blood lead
levels tend to increase over the course of pregnancy.
bers who do.
Modified from Centers for Disease Control and Prevention. Guidelines for the
• Renovating or remodeling older homes without lead identification and management of lead exposure in pregnant and lactating women.
hazard controls in place—women who have been dis- Atlanta (GA): CDC; 2010. Available at: http://www.cdc.gov/nceh/lead/publications/
turbing lead paint, creating lead dust, or both or have leadandpregnancy2010.pdf. Retrieved March 7, 2012.
been spending time in such a home environment.
• Consumption of lead-contaminated drinking water—
women whose homes have leaded pipes or source lines of the increased bone turnover. Pregnant and lactating
with lead. women with a current or past blood lead level of 5 micro-
• Having a history of previous lead exposure or evidence grams/dL or higher should receive specific nutritional
of elevated body burden of lead—women who may recommendations regarding calcium and iron supplemen-
have high body burdens of lead from past exposure, tation. A balanced diet that contains 2,000 mg of calcium
particularly those who have deficiencies in certain key and 60–120 mg of iron daily is recommended (8). This can
nutrients (calcium or iron).
be achieved through either food intake or supplementa-
• Living with someone identified with an elevated lead tion. Supplements should be divided into doses of 500 mg
level—women who may have exposure in common with
a child, close friend, or other relative living in the same
of calcium and 60 mg of iron to improve absorption.
environment. Lactation
Modified from Centers for Disease Control and Prevention. Women with risk factors for elevated lead levels (Box 1)
Guidelines for the identification and management of lead expo-
sure in pregnant and lactating women. Atlanta (GA): CDC; who have not been screened during pregnancy should be
2010. Available at: http://www.cdc.gov/nceh/lead/publications/ screened postpartum if they plan to breastfeed. Initiation
leadandpregnancy2010.pdf. Retrieved March 7, 2012. of breastfeeding should be encouraged postpartum in a
woman with a blood lead level less than 40 micrograms/dL.

Committee Opinion No. 533 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 732

 A woman with a confirmed blood lead level of 40 micro-
grams/dL or higher should not initiate breastfeeding and
should be advised to pump and discard her breast milk
until her blood lead level has decreased to less than
40 micrograms/dL. Blood lead measurements should be
repeated every 1–2 weeks after the source of exposure
has been identified and removed. At maternal blood lead
levels of 5–39 micrograms/dL, breastfeeding should be
initiated and accompanied by sequential testing of infant
blood lead levels to monitor trends. If the infant’s blood
lead level is greater than 5 micrograms/dL, breastfeeding
should be discontinued until the maternal blood lead
level decreases. If no external source is identified, and the
maternal blood lead level is greater than 20 micrograms/
dL and the infant blood lead level is 5 micrograms/dL or
more, breast milk should be suspected as the source and
temporary interruption of breastfeeding until the mater-
nal blood lead level decreases should be considered.
In addition to removing the source of lead exposure
for the mother and infant, several nutritional interven-
tions have been studied. Calcium supplementation (1,200
mg daily) has been associated with a 5–10% decrease in
breast milk lead levels among women over the course of
lactation (31–34), suggesting that calcium supplementa-
tion also may be an intervention strategy to reduce lead
in breast milk from both current and previously accumu-
lated sources. Among women in the postpartum period,
increased intakes of vitamin C also have been associated
with decreased levels of lead in breast milk.
Conclusions and Recommendations
• Routine blood lead testing of all pregnant women is microg/dL and child intelligence at 6 years of age. Environ
not recommended.
• Risk assessment of lead exposure should take place 4. Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst
at the earliest contact with pregnant or lactating
women, and blood lead testing should be performed
if a single risk factor is identified (Box 1).
• Elevated lead levels in pregnancy have been associ-
ated with gestational hypertension, spontaneous
abortion, low birth weight, and impaired neurode-
velopment.
• Prenatal lead exposure has known adverse effects on 6. Navas-Acien A, Guallar E, Silbergeld EK, Rothenberg
maternal health and infant outcomes across a wide
range of maternal blood lead levels.
• Pregnant women with blood lead levels of 5 micro-
grams/dL or higher should be treated as follows:
— Sources of lead exposure should be identified.
— Women should receive counseling regarding
avoidance of further exposure and receive specific
nutritional recommendations regarding calcium
and iron supplementation because these strategies
can decrease their lead levels.
— Confirmatory and follow-up blood lead test-
ing should be performed in accordance with the
CDC’s recommended schedules (Table 1).
4 Committee Opinion No. 533
COMMITTEE OPINIONS
• Women with confirmed blood lead levels of
45 micrograms/dL or more should be treated in con-
sultation with clinicians experienced in the manage-
ment of lead toxicity and high-risk pregnancy.
• Initiation of breastfeeding should be encouraged
postpartum in a woman with a blood lead level less
than 40 micrograms/dL.
• A breastfeeding woman with a confirmed blood lead
level of 40 micrograms/dL or higher should be
advised to pump and discard her breast milk until her
blood lead level has decreased to less than 40 micro-
grams/dL.
• If no external source is identified, and the maternal
blood lead level is greater than 20 micrograms/dL
and the infant blood lead level is 5 micrograms/dL or
more, breast milk should be suspected as the source
and temporary interruption of breastfeeding until
the maternal blood lead level decreases should be
considered.
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Sanin LH, Aro A, Schnaas L, et al. Effect of maternal bone
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COMMITTEE OPINIONS
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Copyright August 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Lead screening during pregnancy and lactation. Committee Opinion
No. 533. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2012;120:416–20.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 734
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 543 • December 2012
Committee on Obstetric Practice
This Committee Opinion was developed by the Committee on Obstetric Practice with the assistance of the American
Academy of Pediatrics. The American Academy of Pediatrics endorses this document. This information should not
be construed as dictating an exclusive course of treatment or procedure to be followed.

Timing of Umbilical Cord Clamping After Birth

ABSTRACT: The optimal timing for clamping the umbilical cord after birth has been a subject of controversy
and debate. Although many randomized controlled trials in term and preterm infants have evaluated the benefits
of delayed umbilical cord clamping versus immediate umbilical cord clamping, the ideal timing for cord clamping
has yet to be established. Several systematic reviews have suggested that clamping the umbilical cord in all births
should be delayed for at least 30–60 seconds, with the infant maintained at or below the level of the placenta
because of the associated neonatal benefits, including increased blood volume, reduced need for blood transfu-
sion, decreased incidence of intracranial hemorrhage in preterm infants, and lower frequency of iron deficiency
anemia in term infants. Evidence exists to support delayed umbilical cord clamping in preterm infants, when
feasible. The single most important clinical benefit for preterm infants is the possibility for a nearly 50% reduction
in intraventricular hemorrhage. However, currently, evidence is insufficient to confirm or refute the potential for
benefits from delayed umbilical cord clamping in term infants, especially in settings with rich resources.

Before the mid 1950s, the term “early clamping” was
defined as umbilical cord clamping within 1 minute of
birth, and “late clamping,” as umbilical cord clamping
more than 5 minutes after birth. In a series of studies of
blood volume changes after birth carried out by investi-
gators in Sweden, the United States, and Canada, it was
reported that in healthy term infants, more than 90% of
blood volume was achieved within the first few breaths
the infant took after birth (1). Because of these findings
and the lack of specific recommendations regarding the
optimal timing, the interval between birth and umbili-
cal cord clamping began to be shortened. In most cases,
umbilical cord clamping is performed within 15–20 sec-
onds after birth, with the infant maintained at or below
the level of the placenta. Although many randomized
controlled trials of term and preterm infants have evaluat-
ed the benefits of immediate umbilical cord clamping ver-
sus delayed umbilical cord clamping (generally defined as
umbilical cord clamping performed 30–60 seconds after
birth) (2–26), the ideal timing for umbilical cord clamp-
ing has yet to be established and continues to be a subject
of controversy and debate (21, 27–29).
Concerns exist regarding universally adopting delayed
umbilical cord clamping. Delay in umbilical cord clamp-
ing may jeopardize timely resuscitation efforts, if needed,
especially in preterm infants. However, because the pla-
centa continues to perform gas exchange after delivery,
sick and preterm infants are likely to benefit most from
additional blood volume derived from a delay in umbili-
cal cord clamping. Another concern has been raised that
delay in umbilical cord clamping increases the potential
for excessive placental transfusion, which can lead to
neonatal polycythemia, especially in the presence of risk
factors for fetal polycythemia, such as maternal diabetes,
severe intrauterine growth restriction, and high altitude.
Additionally, delayed umbilical cord clamping (with the
infant placed at or below the level of the placenta) may be
technically difficult in some circumstances. Another issue
is that delayed umbilical cord clamping might interfere
with attempts to collect cord blood for banking. However,
the routine practice of umbilical cord clamping should
not be altered for the collection of umbilical cord blood
for banking (30).
Neonatal Outcomes
Physiologic studies in term infants have shown that a
transfer from the placenta of approximately 80 mL of
blood occurs by 1 minute after birth, reaching approxi-
mately 100 mL at 3 minutes after birth (16, 31, 32). This
additional blood can supply extra iron, amounting to

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 735

 40–50 mg/kg of body weight. This extra iron, combined
with body iron (approximately 75 mg/kg of body weight)
present at birth in a full-term newborn, may help prevent
iron deficiency during the first year of life (33).
Several systematic reviews have suggested that
clamping the umbilical cord in all births should be
delayed for at least 30–60 seconds, with the infant main-
tained at or below the level of the placenta because of the
associated neonatal benefits (1, 21, 29, 33–35), includ-
ing increased blood volume (2, 3, 13, 31, 36–40), reduced
need for blood transfusion (17, 22, 41), decreased inci-
dence of intracranial hemorrhage in preterm infants (10,
18, 29), and decreased frequency of iron deficiency anemia
in term infants (7–9, 13, 24–26, 35–37, 40, 42).
In addition, a longer duration of placental transfu-
sion after birth may be beneficial because this blood is
enriched with immunoglobulins and stem cells, which
provide the potential for improved organ repair and
rebuilding after injury from disorders caused by preterm
birth (39, 43). Although the magnitude of the benefits
from enhanced placental stem cell transfusion has not
been well studied, the other neonatal benefits have led
investigators to consider revising umbilical cord clamp-
ing practice guidelines (4, 28, 40, 44–48).
Maternal Outcomes
The effect of delayed umbilical cord clamping on mater-
nal outcomes has not been adequately studied. Some
studies have shown no increase in the incidence of post-
partum hemorrhage from delayed umbilical cord clamp-
ing. However, this remains a theoretic concern because
blood flow through the spiral arteries and veins in a term
uterus is approximately 600 mL/min. Concerns regard-
ing maternal risks become particularly relevant in special
circumstances in which the benefits of delayed umbilical
cord clamping need to be balanced with the timely resus-
citation of the woman (eg, in cases of hemorrhage from
placenta previa or placental abruption after delivery of a
preterm infant).
Clinical Trials in Term Infants
A 2008 Cochrane review assessed the effect of umbili-
cal cord clamping in term infants on maternal and fetal
outcomes in 11 clinical trials that involved 2,989 women
and their infants (42). Reviewers found no significant dif-
ferences in postpartum hemorrhage between the women
whose infants underwent early umbilical cord clamping
(within 1 minute after birth) and late umbilical cord
clamping group (at least 1 minute after birth or after ces-
sation of cord pulsation) in any of the five trials (2,236
women) that measured this outcome (relative risk [RR]
for postpartum hemorrhage of 500 mL or more, 1.22;
95% confidence interval [CI], 0.96–1.55). The review-
ers found that late umbilical cord clamping had positive
and negative effects on neonatal outcomes. In five tri-
als, which involved a total of 1,762 infants, a significant
increase was noted in the need for phototherapy for jaun-
2 Committee Opinion No. 543
COMMITTEE OPINIONS
dice after birth among infants in the late umbilical cord
clamping group (RR, 1.69; 95% CI, 1.08–2.63). How-
ever, infants who underwent late umbilical cord clamp-
ing had significantly higher levels of hemoglobin (Hb)
compared with infants in the early umbilical cord clamp-
ing group (weighted mean difference, 2.17 g/dL; 95% CI,
0.28–4.06). Infant ferritin levels remained higher in
infants in the late umbilical cord clamping group com-
pared with those in the early umbilical cord clamping
group until 6 months (weighted mean difference, 11.8
micrograms per liter; 95% CI, 4.07–19.53).
Clinical Trials in Preterm Infants
In a systematic review of 10 trials of early umbilical cord
clamping versus delayed umbilical cord clamping in 454
preterm infants (at less than 37 weeks of gestation), no
statistically significant differences were found between
the groups for cord blood pH (mean difference, 0.01;
95% CI, –0.03–0.05), Apgar scores (RR for 5-minute
Apgar score of less than 8, 1.17; 95% CI, 0.62–2.2), and
body temperature at admission (mean difference, 0.14 °C;
95% CI, –0.31–0.03) (2, 29). Benefits of delayed umbili-
cal cord clamping included a reduced need for blood
transfusions for low blood pressure (RR, 0.39; 95% CI,
0.18 to 0.85) and anemia (RR, 0.49; 95% CI, 0.31–0.81).
No significant differences were noted for infant deaths
(RR, 0.71; 95% CI, 0.3–1.69), but a significant reduction
in the incidence of intraventricular hemorrhage with
delayed umbilical cord clamping was reported by 7 of the
10 published studies (RR, 0.53; 95% CI, 0.35–0.79).
Another systematic review on this topic analyzed the
results from 15 eligible studies (738 premature infants)
(21). Infants were born between 24 weeks of gestation
and 36 weeks of gestation. The maximum delay in umbil-
ical cord clamping was 180 seconds. Delaying umbilical
cord clamping was associated with fewer infants who
required transfusion for anemia (seven trials, 392 infants;
RR, 0.61; 95% CI, 0.46–0.81) and for low blood pressure
(four trials with estimable data for 90 infants; RR, 0.52;
95% CI, 0.28–0.94); and less intraventricular hemorrhage
(ultrasound diagnosis all grades) (10 trials, 539 infants;
RR; 0.59; 95% CI, 0.41–0.85) compared with immedi-
ate umbilical cord clamping. For other outcomes (infant
death, severe [grade 3–4] intraventricular hemorrhage, and
periventricular leukomalacia), no clear differences were
identified between groups; however, many trials were
affected by incomplete reporting and wide confidence
intervals. Outcome after discharge from the hospital was
reported for one small study, and no significant differ-
ences were reported between the groups in mean Bayley
II scores at age 7 months (corrected for gestation at birth
and involved 58 children) (21).
Umbilical Cord Milking
One clinical trial and a secondary analysis from the same
trial have compared “milking” of a 20-cm segment of the
umbilical cord versus immediate umbilical cord clamp-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 736
 ing in preterm singleton infants born between 24 weeks
of gestation and 28 weeks of gestation (49, 50). Significant
findings in the clinical study included higher initial Hb
concentration, higher mean systemic blood pressure,
reduced need for blood transfusion, and higher urine
output during the first 72 hours in the group that under-
went umbilical cord milking compared with the group
that underwent immediate umbilical cord clamping.
The group that underwent umbilical cord milking also
required a shorter duration of supplemental oxygen and
mechanical ventilation. A 2011 randomized controlled
trial of 58 preterm neonates (born at 24–32 6/7 weeks of
gestation) randomized to receive either repeated milking
of the umbilical cord (4 times) or delayed umbilical cord
clamping of 30 seconds found that the two strategies had
similar effects on Hb levels after birth (51). More studies
are needed to evaluate the potential benefits and risks of
umbilical cord milking, and at this time there is insuf-
ficient evidence to support umbilical cord milking in
preterm infants.
Conclusion
Currently, insufficient evidence exists to support or to
refute the benefits from delayed umbilical cord clamp-
ing for term infants that are born in settings with rich
resources. Although a delay in umbilical cord clamping
for up to 60 seconds may increase total body iron stores
and blood volume, which may be particularly beneficial
in populations in which iron deficiency is prevalent,
these potential benefits must be weighed against the
increased risk for neonatal phototherapy. In addition,
no difference is apparent between infants who undergo
early umbilical cord clamping versus those who undergo
delayed umbilical cord clamping with respect to imme-
diate birth outcomes, such as Apgar scores, umbilical
cord pH, or respiratory distress caused by polycythemia
(51). Although maternal outcomes have not been rigor-
ously studied, the incidence of postpartum hemorrhage
is reported to be similar between immediate umbilical
cord clamping groups and late umbilical cord clamping
groups.
However, evidence supports delayed umbilical cord
clamping in preterm infants. As with term infants, delay-
ing umbilical cord clamping to 30–60 seconds after birth
with the infant at a level below the placenta is associated
with neonatal benefits, including improved transitional
circulation, better establishment of red blood cell volume,
and decreased need for blood transfusion. The single
most important clinical benefit for preterm infants is the
possibility for a nearly 50% reduction in intraventricular
hemorrhage. It is important to note that the timing of
umbilical cord clamping should not be altered for the pur-
pose of collecting umbilical cord blood for banking (30).
Future Research
Although many randomized controlled trials that
involved term infants and preterm infants have evaluated
Committee Opinion No. 543
COMMITTEE OPINIONS
the benefits of delayed umbilical cord clamping versus
immediate umbilical cord clamping, the ideal timing for
umbilical cord clamping has yet to be established. Further
studies also are needed to evaluate the optimal timing of
umbilical cord clamping, the management of the third
stage of labor in relation to umbilical cord clamping,
and the timing of umbilical cord clamping in relation
to the initiation of voluntary or assisted ventilation in
the neonate. The ideal time for clamping the umbilical
cord after cesarean delivery versus vaginal birth is an
especially important area for future research. Premature
infants, who may benefit most from delayed umbilical
cord clamping, are more likely to be delivered by cesarean
delivery because their mothers may have other medical
and obstetric complications.
Large clinical trials are needed to investigate the effect
of delayed umbilical cord clamping on infants delivered
at less than 28 weeks of gestation. Further investigation
is required to evaluate management of umbilical cord
clamping in women with high-risk pregnancies whose
infants are prone to develop polycythemia. The risks of
umbilical cord milking remain unknown, and more
studies are needed to compare milking of the umbilical
cord with delayed umbilical cord clamping. The value
of enhanced stem cell and plasma transfusion associated
with delayed cord clamping with respect to immediate
and long-term immunity, host defense, and repair is
another important area for future research.
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COMMITTEE OPINIONS
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Copyright December 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Timing of umbilical cord clamping after birth. Committee Opinion
No. 543. American College of Obstetricians and Gynecologists. Obstet
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 739
COMMITTEE OPINIONS
Committee on Patient Safety and
Quality Improvement

2013 COMPENDIUM OF SELECTED PUBLICATIONS 740

 ACOG COMMITTEE OPINION
ACOG Number
COMMITTEE
447 • December 2009
OPINION
(Replaces No. 286, October 2003)
Number 447 • December 2009 (Replaces No. 286, October 2003)
Patient Safety in Obstetrics and
Patient Safety in Obstetrics and
Gynecology
Committee on Patient
Gynecology
ABSTRACT: Since publication of the Institute of Medicine’s landmark report To Err is
Safety and Quality Human: Building a Safer Health System, emphasis on patient safety has steadily increased.
Committee on Patient
Improvement ABSTRACT: Since publication
Obstetrician–gynecologists of the Institute
should continuously of Medicine’s
incorporate elements landmark report
of patient To Err
safety is
into
Safety
This and Quality
document reflects Human:
their Building
practices anda Safer Health System
also encourage others, emphasis on patient
to use these safety has steadily increased.
practices.
Reaffirmedconcepts
Improvement
emerging 2012 on Obstetrician–gynecologists should continuously incorporate elements of patient safety into
patient safety and is sub-
This todocument
ject change. The reflects
infor- their practices and also encourage others to use these practices.
emergingshould
mation concepts
not be on
patient safety and is sub- The American College of Obstetricians and medical errors. According to the Agency
construed as dictating an
ject to change.
exclusive courseThe infor-
of treat- Gynecologists (ACOG) is committed to for Healthcare Research and Quality
mationor should
ment procedurenotto be
be The American
improving qualityCollege
andofsafety
Obstetricians
in women’s and medical errors.
(AHRQ), a safety According
culturetorefers
the Agency
to “a
construed as dictating an
followed.
exclusive course of treat- Gynecologists
health care. The (ACOG)
Institute ofis Medicine
committed report, to for Healthcare
commitment Research
to safety and Quality
that permeates all
ment or procedure to be improving
To quality Building
Err Is Human: and safety in women’s
a Safer Health (AHRQ),
levels of ana organization,
safety culturefrom refers to “a
frontline
followed.
health care.
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are a commitment
personnel to toexecutive
safety thatmanagement”
permeates all
To Err Is Human:
significant cause ofBuildingdeath and a Safer
injuryHealth
(1). levels
(2). of an organization,
Associated with a safetyfrom frontline
culture is the
System, notes
Despite that errors
disagreements overin health
the actualcarenum-
are a personnel
concept of ato“justexecutive
culture,”management”
which recog-
significant
bers cause
cited, all health of care
death and injuryagree
professionals (1). (2). Associated
nizes that competent with a professionals
safety culturemake is the
Despite
that disagreements
patient over the actual
safety is extremely num-
important concept ofand
mistakes a “just culture,” which
acknowledges thatrecog-
even
bersshould
and cited, all
be health
addressed carebyprofessionals agree
the overall health nizes that competent
competent professionals professionals
may developmake
that patient
care system.safetyThe isAmerican
extremelyCollegeimportant of mistakes and
unhealthy norms, acknowledges that even
such as shortcuts or
and should beand
Obstetricians addressed by the overall
Gynecologists continueshealthto competent
routine ruleprofessionals
violations, but may has develop
zero
care system.
emphasize its The Americancommitment
long-standing College of unhealthy norms,
tolerance for reckless such as shortcuts(2).
behavior or
Obstetricians
to quality and and Gynecologists
patient continues
safety by codifying to
a set routine rule
“Frontline violations,
personnel feelbut has zero
comfortable
emphasize
of objectives its that
long-standing
should be commitment
adopted by tolerance errors—including
disclosing for reckless behavior their own— (2).
to quality and patient safetyinbytheir
obstetrician–gynecologists codifying a set
practices. “Frontline
while personnel
maintaining feel comfortable
professional account-
of objectives that should are
Obstetrician–gynecologists be adopted
encouraged by disclosing
ability” (2).errors—including
A just culture recognizestheir own— that
obstetrician–gynecologists
to promulgate these principles in their practices.
in the hospi- while maintaining
some rate of human professional account-
error is inevitable,
Obstetrician–gynecologists
tals and other settings where are theyencouraged
practice. ability” (2).inAcomplex
especially just culture recognizes
endeavors suchthat
as
to promulgate these principles in the hospi- some
the rate ofofhuman
delivery errorTherefore,
health care. is inevitable,the
Patient
tals and other Safety
settingsObjectives
where they practice. especially
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of safesuchhealthas
I. Develop a commitment to encourage a the delivery
care should of be health care. and
to identify Therefore,
study the
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of patientObjectives
safety first stepand in the delivery of occurrence
safe health
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culture of patient
component safety commitment to
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gynecologists shouldofadopt errorand
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that reduce the likeli-
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hood of system should adopt
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cause
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outcomes. that culture
reduce the alsolikeli-
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ognize Promoting safetyfor
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ognizes system failures that
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those in the health
systemically. Women’s carehealth
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providers Just culture
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ognize
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that encourages Women’s health
disclosure andcare should
exchange care providers
behaviors to follow
that would these safe prac-
be characterized as
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event ofenvironment
errors, near tices once
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behavior” and behavior.”
or “reckless to avoid
and
The Gynecologists
American College that encourages
misses, and adverse disclosure
outcomes. and exchange behaviors
At-risk that would
behavior is thebe characterized
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of Obstetricians
Women’s Health Care of information
A culture of in the eventshould
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where therule bend-
rate of
Women’s Health Care A culture of safety should be the ing that tends to naturally occur over
Physicians framework for any effort to reduce time in systems where the rate of

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 741

 adverse outcomes is very low. Reckless behavior is
the type of behavior that clearly puts patients at sig-
nificant risk of harm and shows a conscious disre-
gard of unreasonable risk. In a just culture, instances
of adverse outcomes or failure to follow safety pro-
tocols are investigated fairly and openly. The general
principle when dealing with these situations is sum-
marized as “console the human error; coach the at-
risk behavior; and punish the reckless behavior” (3).
Institution of these principles establishes an
atmosphere where all caregivers feel safe in report-
ing errors, near misses, and at-risk behaviors by
themselves and others. This will promote and
increase error reporting and identify potentially hid-
den problems, as well as motivate health care
providers to find system problems and collaborate
to resolve system failures.
The role of leadership, whether in the inpatient
or outpatient setting, is essential in facilitating an
effective patient safety program. Strong leadership
within obstetrics and gynecology is necessary to
advocate for the provision of both financial and
human resources to achieve patient safety goals.
Efforts devoted to optimizing communication and
collaboration among the various members of the
health care team are equally important in promot-
ing these principles of patient safety.
II. Implement recommended safe medication practices
Most medical errors are caused by problems associ-
ated with the use of medications; therefore, efforts
to reduce the occurrence of these errors should be
ongoing. Although computerized physician order
IV. Improve communication with health care providers
entry systems can be effective in reducing prescrib-
ing errors, they are costly and may not collect data
that support quality improvement activities (4, 5).
In the absence of computerized physician order
entry systems, the following steps should be adopted
to reduce errors in prescribing and administering
medications (6):
• Improve legibility of handwriting
• Avoid use of nonstandard abbreviations
• Check for drug allergies and sensitivities
• Always use a leading 0 for doses of less than 1
unit (eg, 0.1 mg, not .1 mg), and never use a trail-
ing 0 after a decimal (eg, 1 mg, not 1.0 mg):
“always lead, never follow”
• All verbal orders should be written down by the
individual receiving the order and read back to
the prescriber verbatim to ensure accuracy
III. Reduce the likelihood of surgical errors
Surgical errors may involve the performance of the
incorrect operation or a procedure on the wrong site
or wrong patient. Although these errors occur much
2 ACOG Committee Opinion No. 447
COMMITTEE OPINIONS
less frequently than medication errors, the conse-
quences of these errors are always significant. The
attending obstetrician–gynecologist who is ulti-
mately responsible for the patient’s care should work
with other operating room personnel, such as nurses
and anesthesiologists, to be certain that systems are
in place to ensure proper patient and procedure
identification. The obstetrician–gynecologist also
should use a preoperative verification process to
confirm, with the patient, the intended procedure to
be performed.
There are several resources available to promote
this verification process. The Joint Commission
developed the Universal Protocol and associated
“Speak Up” program to address this. It is designed to
ensure correct person, correct site, and correct pro-
cedure through the elements of a preprocedure veri-
fication process, marking the procedure site, and
performing a “time-out” before starting the proce-
dure. The World Health Organization’s Safe Surgery
Saves Lives program, endorsed by the International
Federation of Gynecology and Obstetrics (FIGO), has
recently been shown to significantly reduce surgical
morbidity and mortality in multiple settings (7). It is
a 19-item safe surgery checklist that includes a sign-in
procedure before induction of anesthesia, a time-out
procedure before skin incision, and a sign-out proce-
dure before the patient leaves the operating room.
Universal application of these techniques should be
strongly advocated for and practiced by all obstetri-
cian–gynecologists as proven methods to improve
the safety of our patients in the operating room.
Communication between all members of the health
care team is a crucial element in patient safety. In its
analysis of sentinel events, the Joint Commission
found that almost two thirds of the events involved
communication failure as a root cause (8). Training
in teamwork and communication techniques is
increasingly being recognized as a cornerstone of a
robust patient safety program; AHRQ developed the
TeamSTEPPS™ program to address this issue (9).
One key communication tool that it advocates is
SBAR–Situation, Background, Assessment, and
Recommendation or Request. It is a structured sys-
tem to communicate critical information clearly
and efficiently. It allows caregivers to provide infor-
mation on what is happening to the patient, what
the clinical background is, what they think the prob-
lem is, and what they would recommend or what
action is being requested. This information can then
be appropriately understood and acted upon.
A time of great potential for miscommunication
is during patient handoffs. This occurs during shift
changes for nurses, laborists, or practice partners.
The Joint Commission states: “The primary objec-
2013 COMPENDIUM OF SELECTED PUBLICATIONS 742
 tive of a handoff is to provide accurate information
about a patient’s care, treatment and services, cur-
rent condition, and any recent or anticipated
changes. The information communicated during a
handoff must be accurate to meet patient safety
goals” (10). TeamSTEPPS™ includes a structured
technique for handoffs, which may facilitate the
transmission of clinical and patient safety informa-
tion in a way that prevents the omission of critical
aspects of the treatment plan.
An increased awareness of the importance of
clear communication between all members of the
health care team will measurably enhance the safety
of the care delivered by obstetrician–gynecologists.
Training around these issues for all health care
providers is highly recommended.
V. Improve communication with patients
Communication is a core element of the physi-
cian–patient relationship and is essential for the
delivery of high quality, safe patient care. According
to the Code of Professional Ethics of the American
College of Obstetricians and Gynecologists, “the
patient–physician relationship has an ethical basis
and is built on confidentiality, trust, and honesty”
(11). It also states “the obstetrician–gynecologist
should deal honestly with patients and colleagues.
Communication should be complete, clear, concise,
and timely” (12). To be prepared for occurrences of
adverse events, ACOG encourages the development
and use of written policies that address the timing,
content, communication, and documentation of
disclosure. The American College of Obstetricians
and Gynecologists believes that it is the moral obli-
gation of every physician to communicate honestly
with patients, particularly those who experience an
adverse outcome. Open communication and trans-
parency in health care will increase trust, improve
patient satisfaction, and may decrease liability expo-
sure (13).
VI. Establish a partnership with patients to improve
safety
Patients who are involved in making their health
care decisions have better outcomes than those who
are not (14). According to the ACOG Committee
Opinion, Informed Consent, the “involvement of
patients in [decisions about their own medical care]
is good for their health—not only because it is a
protection against treatment that patients might
consider harmful, but because it contributes posi-
tively to their well-being” (15). Patients should be
encouraged to ask questions about medical proce-
dures, the medications they are taking, and any
other aspect of their care. Patient education materi-
als developed by ACOG and other organizations are
available.
ACOG Committee Opinion No. 447
COMMITTEE OPINIONS
VII. Make safety a priority in every aspect of practice
The discipline of obstetrics and gynecology has a
long tradition of leadership in quality assessment
activities, which have been associated with an in-
crease in patient safety. The quest for patient safety
is an ongoing, continuously refined process incor-
porating information sharing and collaboration into
daily practice. Emphasizing compassion, communi-
cation, and patient-focused care will aid in creating
a culture of excellence. Opportunities to improve
patient safety should be used whenever identified.
References
1. Institute of Medicine (US). To err is human: building a safer
health system. Washington, DC: National Academy Press;
2000.
2. Agency for Healthcare Research and Quality. Patient safety
network: glossary. Available at: http://www.psnet.ahrq.gov/
glossary.aspx. Retrieved July 31, 2009.
3. Marx D. Patient safety and the “just culture”: a primer for
health care executives. New York (NY): Trustees of
Columbia University in the City of New York. 2001.
Available at http://www.mers-tm.org/support/Marx_Primer.
pdf. Retrieved June 29, 2009.
4. Kelly WN, Rucker TD. Compelling features of a safe
medication-use system. Am J Health Syst Pharm. 2006;
63:1461–8.
5. Agency for Healthcare Research and Quality. Women’s
health care in the United States: selected findings from the
2004 National Healthcare Quality and Disparities Reports.
AHRQ Pub No. 05-P021. Rockville (MD): AHRQ; 2005.
Available at http://www.ahrq.gov/qual/nhqrwomen/nhqr-
women.htm. Retrieved July 30, 2009.
6. Safe use of medication. ACOG Committee Opinion No. 331.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2006;107:969–72.
7. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH,
Dellinger EP, et al. A surgical safety checklist to reduce
morbidity and mortality in a global population. Safe Surgery
Saves Lives Study Group. N Engl J Med 2009;360:491–9.
8. Joint Commission. Preventing infant death and injury dur-
ing delivery. Sentinel Event Alert Issue No. 30. Oakbrook
Terrace (IL): Joint Commission; 2004. Available at:
http://www.jointcommission.org/SentinelEvents/Sentinel
EventAlert/sea_30.htm. Retrieved June 12, 2009.
9. Agency for Healthcare Research and Quality. TeamSTEPPS™:
national implementation. Available at: http://teamstepps.
ahrq.gov/index.htm. Retrieved July 30, 2009.
10. Joint Commission on Accreditation of Healthcare
Organizations. Patient safety: essentials for healthcare. 4th ed.
Oakbrook Terrace (IL): Joint Commission Resources; 2006.
11. American College of Obstetricians and Gynecologists. Code
of professional ethics of the American College of Obstet-
ricians and Gynecologists. Washington, DC: ACOG; 2008.
Available at: http://www.acog.org/from_home/acogcode.pdf.
Retrieved July 30, 2009.
12. Communication strategies for patient handoffs. ACOG
Committee Opinion No. 367. American College of
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 743
 Obstetricians and Gynecologists. Obstet Gynecol 2007;109:
1503–5.
13. Kraman SS, Hamm G. Risk management: extreme honesty
may be the best policy. Ann Intern Med 1999;131:963–7.
14. Kaplan SH, Gandek B, Greenfield S, Rogers W, Ware JE.
Patient and visit characteristics related to physicians’ partic-
ipatory decision-making style. Results from the Medical
Outcomes Study. Med Care 1995;33:1176–87.
15. Informed consent. ACOG Committee Opinion No. 439.
American College of Obstetricians and Gynecologists. Obstet
Gynecol 2009;114:401–8.
Additional Resources
Agency for Healthcare Research and Quality. Medical
errors and patient safety. Available at http://www.ahrq.
gov/qual/errorsix.htm. Retrieved July 30, 2009.
Joint Commission. Universal protocol for preventing
wrong site, wrong person surgery. Oakbrook Terrace (IL):
Joint Commission; 2009. Available at http://www. joint-
commission.org/PatientSafety/UniversalProtocol.
Retrieved June 10, 2009.
National Patient Safety Foundation. 268 Summer Street,
6th Floor, Boston, MA 02210, (617) 391-9900, http://
www. npsf.org.
4 ACOG Committee Opinion No. 447
COMMITTEE OPINIONS
The Just Culture Community, 2200 W. Spring Creek
Parkway, Suite A, Plano, TX 75023, (214) 778-2010, http://
www.justculture.org.
U.S. Department of Veterans Affairs. National Center for
Patient Safety. Available at http://www.patientsafety.gov.
Retrieved July 30, 2009.
World Health Organization: Safe surgery saves lives: the
second global patient safety challenge. Geneva: WHO;
2009. Available at http://www.who.int/patientsafety/
safesurgery/en. Retrieved July 30, 2009.
Copyright © December 2009 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, posted on the Internet, or
transmitted, in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permis-
sion from the publisher. Requests for authorization to make photo-
copies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Patient safety in obstetrics and gynecology. ACOG Committee
Opinion No. 447. American College of Obstetricians and Gynecolo-
gists. Obstet Gynecol 2009;114:1424–7.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 744
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 459 • July 2010

Committee on Patient Safety and Quality Improvement

This document reflects emerging concepts on patient safety and is subject to change. The infor-
Reaffirmed 2012 mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

The Obstetric–Gynecologic Hospitalist

ABSTRACT: The work models for the obstetric–gynecologic hospitalist and the obstetric laborist are gaining
popularity and momentum in hospitals across the nation. These models could be timely solutions to the chal-
lenging demands of the general practice of obstetrics and gynecology. The American College of Obstetricians
and Gynecologists supports the continued development of the obstetric–gynecologic hospitalist model as one
potential solution to achieving increased professional and patient satisfaction while maintaining safe and effective
care across delivery settings.

The obstetric–gynecologic hospitalist concept emerged
from the hospitalist movement of the 1990s. The term
hospitalist, coined in 1996 by Wachter and Goldman (1),
refers to physicians whose primary professional focus is
the general medical care of hospitalized patients. Their
activities may include patient care, teaching, research, and
leadership related to hospital care. Hospitalists help man-
age the continuum of patient care in the hospital, often
seeing patients in the emergency department, following
them into the critical care unit, and organizing postacute
care (2). Hospitalists are increasingly present as members
of departments of medicine across the United States.
According to the American Hospital Association’s survey,
in 2007 there were 28,000 practicing hospitalists.
Laborist Concept
The term laborist most commonly refers to an obstetri-
cian–gynecologist who is employed by a hospital or
physician group and whose primary role is to care for
laboring patients and to manage obstetric emergencies
(2). Responsibilities may be broad or narrow in focus,
and can range from admitting and providing care for low-
risk patients in early labor to delivering babies of all
patients for a group specializing in maternal–fetal medi-
cine. Depending on the hospital system, whether acad-
emic or nonacademic, laborists may provide direct
resident and student supervision with teaching respon-
sibilities, provide backup support to certified nurse–
midwives (CNMs) and family physicians, or provide
care for unassigned patients. Other responsibilities could
include assisting in surgery, providing backup support
for precipitous deliveries, and providing a respite for a
fatigued practitioner. An obstetric–gynecologic hospital-
ist may provide in-house gynecologic services as well,
performing inpatient consultation and seeing patients in
the emergency department as necessary. The hospital also
may use multidisciplinary laborist staffing, with CNMs
serving as CNM laborists within the scope of their prac-
tice in individual states. The CNM laborists may be hired
either by physician practices or hospitals to attend to a
variety of coverage options.
Benefits and Limitations
For the obstetric–gynecologic hospitalist, practicing solely
in the hospital setting relieves the pressures of a private
practice, such as overhead and collections, and may help
with liability premiums. Among the possible benefits may
be more predictable schedules, competitive compensa-
tion, paid benefits, and guaranteed time off.
The benefits to the hospital include enhancement of
patient safety and an increased level of nursing satisfaction
because a health care provider is always present and avail-
able. In addition, improved outcomes may result from
laborists being well rested when coming onto their shifts
in the labor and delivery unit.
Laborists are challenged by the ongoing desire of
patients to continue their patient–physician relation-
ship and share this very personal and special time of
pregnancy with a clinician they know and have come to
trust. Because patients may value this relationship with
their primary clinicians during pregnancy, the obstetri-

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 745

 cian should inform patients that laborists are part of the
health care team that may provide their care.
A key element for instituting an obstetric–gyneco-
logic hospitalist program within a facility is the estab-
lishment of clear communication methods between
obstetric–gynecologic hospitalists and primary health
care providers. Handoff of patients, updates on progress,
and follow-up, are all important areas to address because
communication gaps are a potential source of patient
injury.
One area central to the laborist–private practice
partnership that may not be clear focuses on cost and
reimbursement. Private clinicians are concerned about
whether labor management or delivery of their patients’
babies by a laborist will affect their income. Delivery fees
are often a major portion of compensation for pregnancy
care, and as such, concern arises as to whether private
attending physicians working with laborists can continue
to bill for a global fee. The hospital may bill for the labor-
ists’ services, which helps partially offset the expense
of having this service available. The economics of this
equation—including delivery, consultation, and assistant
fees—will require further evaluation in each setting con-
sidering use of a laborist.
For obstetrician–gynecologists in general practice
in the community, having an obstetric–gynecologic hos-
pitalist in practice at their admitting hospital affords
several advantages. For example, obstetric–gynecologic
hospitalists can assume the responsibilities of on-call
obligations, which for the busy, general obstetric–gyne-
cologic practice commonly extend beyond 24 hours. This
often is followed by postcall ambulatory office hours (3).
Obstetric–gynecologic hospitalists can provide cover-
age for patients who come to the hospital uninsured or
unassigned for prenatal care. An obstetric–gynecologic
hospitalist program affords office-based physicians
greater autonomy over their personal and family lives.
Physicians in private practice benefit by having coverage
for their unscheduled laboring patients if they cannot
get to the hospital, are in the middle of busy office
hours, or have scheduled operative cases. Depending on
the circumstances, they may choose to use the services
of the laborist or come in themselves. In addition, the
laborist is readily available to respond to any obstetric
emergencies or urgent needs and is at the patient’s bed-
side expeditiously, offering a timely assessment at the
time of admission.
In some ways, a laborist can function in a manner
similar to a partner in absentia. While a health care pro-
vider finishes office hours, completes an operating room
case, or gets a few more hours of sleep, the laborist can
attend to the health care provider’s hospital patients, thus
saving the primary health care provider multiple trips to
the hospital. A successful laborist program may be one of
the first steps toward assisting communities faced with a
shortage of obstetricians. This model also may provide
an alternative for obstetricians who are considering giv-
2 Committee Opinion No. 459
COMMITTEE OPINIONS
ing up obstetric practice that requires both prenatal and
delivery services.
Many university-based teaching institutions have an
implicit version of the obstetric–gynecologic hospitalist
model that relates to their faculty who are required by
the Accreditation Council for Graduate Medical Educa-
tion/Residency Review Committee mandate to supervise
residents in-house. The difference between this and a
true laborist program is that the laborist position can be
expanded to include nonacademic private practice health
care providers. Depending on the type of laborist pro-
gram an institution uses, one might staff the labor and
delivery unit full time with these acute-care physicians,
while prenatal care is provided as a separate entity in the
office. Further, the model can be altered to allow private
practitioners to receive updates on their patients from the
laborist while in the office, the operating room, or at home,
and be given a choice of if or when they would like to come
in. Finally, the laborist may assist in such early labor care
events as monitoring fetal heart tracings, performing cervi-
cal examinations and amniotomy, starting labor induction,
initiating oxytocin augmentation, or ordering epidurals,
and documenting these events in the medical record.
One primary limitation of the laborist model focuses
on the nonlaborist maintaining obstetric privileges in
the hospital setting. Hospitals may require physicians
to perform a minimum number of procedures to retain
their privileges. It may be more difficult for office-based
physicians to demonstrate current clinical competence
if most of their in-hospital patient care is handled by
laborists. This is a critical consideration in establishing an
obstetric–gynecologic hospitalist program.
Obstetrician–gynecologists in different phases of
their careers will have different responses to the obstetric–
gynecologic hospitalist role. The obstetric–gynecologic hos-
pitalist model may be met with some resistance from
some physicians and patients. It will require a paradigm
shift for certain obstetrician–gynecologists to accept the
use of obstetric–gynecologic hospitalists in their respective
facilities. However, this model may be appealing, particu-
larly for younger obstetrician–gynecologists who are con-
cerned about liability coverage, establishing an independent
practice, and maintaining a comfortable life style.
Other Considerations
Successful implementation of an obstetric–gynecologic
hospitalist program will require consideration of a num-
ber of factors. The most important of these factors is
establishing mechanisms for communication between
the obstetric–gynecologic hospitalist and the patient’s
primary physician, including ready access to the patient’s
complete ambulatory records. Another important con-
sideration is the establishment of protocols and policies
that all health care providers agree to accept. Consensus
has to be reached on various clinical approaches, includ-
ing indications for induction, management of preeclamp-
sia, and prepartum and postpartum order sets (4).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 746
 An ideal obstetric–gynecologic hospitalist program
might have a group of health care providers led by a med-
ical director who assists in coordinating schedules, proto-
cols, policies, and committee meetings at which both the
obstetric–gynecologic hospitalists and private practitio-
ners are represented. Obstetric–gynecologic hospitalists
should not be expected to provide patient care according
to private practitioners’ instructions with which they dis-
agree or which are not supported by clinical evidence or
hospital policy. Standardized order sets and antepartum
records among all affiliated private practitioners would
decrease the frequency and number of adjudication con-
versations.
Various Models
The probability and success of a laborist program will
vary by hospital type (teaching versus nonteaching), size
of service (number of deliveries), number of obstetricians
who support such a program, community circumstances,
financial circumstances, and reimbursement methods.
No one approach will fit all situations. The costs of
employing obstetric–gynecologic hospitalists may be off-
set by an increase in patient safety, improved documenta-
tion, lower liability payouts, and the ability to bill for the
obstetric–gynecologic hospitalists’ services.
Summary
The obstetric–gynecologic hospitalist model has the
potential to achieve benefits for the obstetrician–
gynecologist given the varied demands of the specialty.
These demands may include heavy call schedules; high
volume; the potential for emergent situations, particu-
larly in obstetrics; and the increasing number of in-office
and outpatient procedures. These factors also must be
balanced within the medical–legal climate of medicine
because the option of prenatal care may be limited by the
liability carrier. There may be added potential benefits to
patients and their families.
The separation of the prenatal care process from
labor and delivery is one solution for physicians who,
for a variety of reasons, may be considering giving up
the practice of obstetrics. A balance between a combined
obstetric–gynecologic practice versus a gynecology-only
practice may be achieved through an obstetric–gyneco-
logic hospitalist program.
For the various reasons outlined in this Committee
Opinion, the American College of Obstetricians and
Gynecologists supports the continued development of
the obstetric–gynecologic hospitalist model as one poten-
tial approach to achieving increased professional and
patient satisfaction while maintaining safe and effective
care across delivery settings.
Resources
Barbieri RL. Enhancing our practice environment in
order to support a long, fulfilling, and productive career.
Obstet Gynecol 2008;112:7–9.
Committee Opinion No. 459
COMMITTEE OPINIONS
Hobson K. Division of labor. There’s a new doc in town.
But mom probably won’t meet this obstetrician until her
labor pains start. US News World Rep 2005;139(21):67–9.
Koch, EG. Springtime for obstetrics and gynecology:
will the specialty continue to blossom? [letter]. Obstet
Gynecol 2004;103:198–9.
Lowes R. Hospitalist movement moves into OB. Med
Econ 2006;83:22.
Pellegrini, VA. Physician burnout: a time for healing.
Obstet Gynecol Surv 2007;62:285–6.
Petrikovsky BM. The laborist: Do not repeat the mistakes
of other medical systems [letter]. Am J Obstet Gynecol
2003;189:899.
Wachter RM. (2006). Reflections: The hospitalist move-
ment a decade later. J Hosp Med 2006;1:248–52.
Wachter RM, Goldman L. The hospitalist movement 5
years later. JAMA 2002;287:487–94.
Weinstein L, Wolfe HM. The downward spiral of physi-
cian satisfaction: an attempt to avert a crisis within the
medical profession. Obstet Gynecol 2007;109:1181–3.
Society of Hospital Medicine
1500 Spring Garden, Suite 501
Philadelphia, PA 19130
1-800-843-3360
http://www.hospitalmedicine.org/
References
1. Wachter RM, Goldman L. The emerging role of “hospi-
talists” in the American healthcare system. N Engl J Med
1996;335:514–7.
2. Weinstein L. The laborist: a new focus of practice for the
obstetrician. Am J Obstet Gynecol 2003;188:310–2.
3. Schauberger CW, Gribble RK, Rooney BL. On call: a sur-
vey of Wisconsin obstetric groups. Am J Obstet Gynecol
2007;196:39.e1–39.e4.
4. Gussman D, Mann W. The laborists: a flexible concept.
Washington (DC): American College of Obstetricians and
Gynecologists; 2007. Available at: http://www.acog.org/
departments/dept_notice.cfm?recno=19&bulletin=4093.
Retrieved March 9, 2010.
Copyright July 2010 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
The obstetric–gynecologic hospitalist. Committee Opinion No. 459.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2010;116:237–9.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 747
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

COMMITTEE OPINION
Number 464 • September 2010 (Replaces No. 328, February 2006)

Committee on Patient Safety and Quality Improvement

This document reflects emerging concepts on patient safety and is subject to change. The infor-
Reaffirmed 2012 mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Patient Safety in the Surgical Environment

ABSTRACT: Ensuring patient safety in the operating room begins before the patient enters the operative
suite and includes attention to all applicable types of preventable medical errors (including, for example, medica-
tion errors), but surgical errors are unique to this environment. Steps to prevent wrong-site, wrong-person, wrong-
procedure errors, or retained foreign objects have been recommended, starting with structured communication
between the patient, the surgeon(s), and other members of the health care team. Prevention of surgical errors
requires the attention of all personnel involved in the patient’s care.

Potentially preventable surgical errors have received Systems Approach

increasing attention in recent years, although they appear
to occur relatively infrequently compared with other
types of medical errors. The Joint Commission has col-
lected data on reported sentinel events since 1995 with
wrong-site surgery consistently ranked as the most fre-
quently cited reason (1). In 2008, the year for which most
recent data are available, there were 116 wrong-site sur-
gery sentinel events reviewed. Although specialty specific
statistics are not included on the Joint Commission’s web
site, no surgical specialty is immune from surgical errors
(1). Classic examples in the specialty of obstetrics and
gynecology include wrong procedures, such as tubal liga-
tion without consent.
Terminology
The term wrong-site surgery is used to refer to any surgical
procedure performed on the wrong patient, wrong body
part, wrong side of the body, or at the wrong level of the
correctly identified anatomic site (2). The following terms
can be used to describe the various specific errors:
• Wrong-patient surgery describes a surgical proce-
dure performed on a different patient than the one
intended to receive the operation.
• Wrong-side surgery indicates a surgical procedure per-
formed on the wrong extremity or side of the patient’s
body (eg, the left ovary rather than the right ovary).
• Wrong-level surgery and wrong-part surgery are used step, all relevant information sources, verified by a prede-
to indicate surgical procedures that are performed at
the correct operative site, but at the wrong level or
part of the operative field or patient’s anatomy.
Particularly because of the potential for serious harm
from surgical errors, vigorous efforts are required to
eliminate or reduce their frequency. Preventing a surgi-
cal error appears to be amenable to a systems approach
involving a team effort by all individuals participating in
the surgical process. Although all members of the surgi-
cal team share this responsibility, the primary surgeon
should oversee these efforts. The Joint Commission has
identified the following factors that may contribute to an
increased risk of wrong-site surgery:
• Multiple surgeons involved in the case
• Multiple procedures during a single surgical visit
• Unusual time pressures to start or complete the pro-
cedure
• Unusual physical characteristics, including morbid
obesity or physical deformity
A common theme in cases of wrong-site surgery
involves failed communication between the surgeon(s),
the other members of the health care team, and the
patient. Communication is crucial throughout the surgi-
cal process, particularly during the preoperative assess-
ment of the patient and the procedures used to verify the
operative site. Effective preoperative patient assessment
includes a review of the medical record or imaging stud-
ies immediately before starting surgery. To facilitate this
termined checklist, should be available in the operating
room and rechecked by the entire surgical team before
the operation begins. A briefing is important for assigning

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 748

 essential roles and establishing expectations. Introduction nizing that this is problematic in emergency situations,
of each person in the operating room by name and role, such as an emergency cesarean delivery.
even if team members are familiar, is recommended for
improved communication. Whenever possible, the patient World Health Organization Surgical Safety
(or the patient’s designee) should be involved in the pro- Checklist
cess of identifying the correct surgical site, both during Another useful tool to promote patient safety in the sur-
the informed consent process and in the physical act of gical setting is the surgical safety checklist published by
marking the intended surgical site in the preoperative area. the World Health Organization. The checklist is based
A formal procedure for final confirmation of the correct on the successful international program “Safe Surgery
patient and surgical site (a “time out”) that requires the Saves Lives,” which incorporates validated checklists to
participation of all members of the surgical team may be be reviewed by the surgical team before induction of
helpful. Time outs may include not only verification of the anesthesia, before skin incision, and before the patient
patient and the surgical site, but also relevant medical his- leaves the operating room (4). It is inappropriate to place
tory, allergies, administration of appropriate preoperative total reliance on the surgeon to identify the correct sur-
antibiotics, and deep vein thrombosis prophylaxis. gical site or to assume that the surgeon should never be
questioned. The risk of error may be reduced by involv-
Improving Patient Safety in the ing the entire surgical team in the site verification process
Surgical Environment and encouraging any member of that team to point out a
The Universal Protocol possible error without fear of ridicule or reprimand.
In 2003, the Joint Commission published “Universal Patient Involvement
Protocol for Preventing Wrong Site, Wrong Procedure, A relatively new but essential element of the overall pro-
and Wrong Person Surgery” (2). The universal protocol, cess is the formal enlistment of the patient in the effort to
now included in the chapter on national patient safety avert errors in the operative arena. Involving the patient
goals in the Joint Commission’s accreditation manual, in this manner requires personal effort by the surgeon to
involves the completion of three principal components educate the patient during the preoperative evaluation
before initiation of any surgical procedure (3): process. The patient, who has the greatest stake in avoid-
1. Preprocedure verification process ing errors, thus becomes integrally involved in helping
The health care team ensures that all relevant documents ensure that errors are avoided.
and related information or equipment are Granting Privileges for New
• available before the start of the procedure; Procedures
• correctly identified, labeled, and matched to the New techniques and new equipment are important
patient’s identifiers; and components for developing and delivering the best qual-
• reviewed and are consistent with the patient’s expec- ity care in the operating room, but they also represent
tations and with the team’s understanding of the sources of potential surgical error. Whenever possible,
intended patient, procedure, and site. a surgeon who is incorporating a new surgical tech-
nique should be proctored or supervised by a colleague
The team must address missing information or discrep- more experienced in the technique until competency
ancies before starting the procedure. has been satisfactorily demonstrated. In some circum-
2. Marking the operative site stances, however, a technique may be so innovative that
Procedures that require marking of the incision or inser- no other surgeon at that facility has more experience. In
tion site include those where there is more than one such situations, it may be necessary to require reciprocal
possible location for the procedure or when performing proctoring at another hospital or grant temporary privi-
the procedure would negatively affect quality or safety. leges to someone from another hospital to supervise the
According to the Joint Commission, the site does not applicant. The surgeon performing the procedure should
need to be marked in cases where bilateral structures have already documented skills and experience in the
(such as ovaries) are removed (3). Although the Joint related surgical arena.
Commission does not require a specific site marking When new equipment is introduced, all members of
method, each facility should be consistent in the method the surgical team must be trained on and practice with
it uses ensuring that the mark is unambiguous. Only the the new equipment as appropriate for the extent of their
correct site should be marked; an “X” or “No” should involvement, and all personnel involved must be aware
never be used on the wrong site. of all safety features, warnings, and alarms of the device.
Whenever possible, the institution’s medical engineering
3. Performing a “time out” before the procedure department should inspect the equipment and verify that
The operative team conducts a final assessment that the it is functioning properly before the equipment is put into
correct patient, site, and procedure are identified, recog- clinical use. Any informational material (eg, user manu-

2 Committee Opinion No. 464

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 749

 als, operating instructions) provided by the manufacturer complications by attending physicians after performing
of the equipment should be carefully reviewed by the nighttime procedures found an increased rate of surgical
principal users and should be familiar to anyone using complications when physicians had slept less than 6 hours
the equipment. Labels attached to the device or plastic (9). Adequate backup personnel should be available to
cards summarizing instructions for proper use may be relieve individuals who detect diminished performance
helpful until everyone involved is comfortable with the in themselves or others due to fatigue, so that the risk of
new equipment. All necessary adaptors, attachments, error is not increased.
and supplies should be in the room or readily available
before beginning surgery with the new equipment. Any Medication Errors
recommended protective devices, such as eye shields or The surgical environment deserves heightened vigilance
special draping material, should be used for the safety of to prevent medication errors because medication orders
all concerned. The lead surgeon using the new equipment often are given verbally rather than in writing, making
should have demonstrated competency in the use of the such orders particularly vulnerable to misinterpretation
device, resulting in the granting of privileges. Leaders or misapplication. Increased stress or confusion during
of each surgically oriented department will determine urgent situations in the operating room may increase the
the specific requirements for granting privileges to their possibility of error in prescribing, administering, or moni-
members for the use of new techniques or equipment. toring medications. For these reasons, medication error
It is never appropriate for nonmedical, noncredentialed in the surgical arena may not be addressed by the safety
individuals, such as industry representatives, to perform measures (eg, electronic order entry) proved effective in
the actual surgery. Such individuals should be excluded other environments. It may be wise for the surgical team
from the operating room if their presence would present to agree on protocols for administering commonly used
a distraction or discomfort for any member of the essen- medications or treatments and to practice their imple-
tial operating room team. Additional information on mentation. Timely and effective communication between
requests for new privileges can be found in Quality and the surgical and anesthesia teams, including read backs
Safety in Women’s Health Care, 2nd edition. as necessary, during the entire procedure may help avoid
errors that could result from misunderstanding.
Stress and Fatigue
A well-recognized source of human error is excessive Retained Foreign Objects
stress and fatigue. According to the Health and Safety The Joint Commission includes unintended retention of a
Laboratory, Britain’s leading industrial health and safety foreign object in a patient after surgery or other procedure
facility and an agency of the British Health and Safety as a reviewable sentinel event (10). In its statement on the
Executive, disrupted sleep patterns and inadequate sleep prevention of retained foreign objects after surgery, the
can result in fatigue and reduced levels of cognitive per- American College of Surgeons recommends consistent
formance thus increasing the risk of an accident. Human application and adherence to standardized counting pro-
error arising from fatigue may have catastrophic results cedures and documentation of the surgical counts, instru-
in safety critical environments (5). Sleep deprivation ments or items intentionally left as packing, and actions
can cause errors in performing even the most familiar taken if count discrepancies occur (11). Other protocols
tasks; for example, the National Highway Traffic Safety to prevent unintentional retention of foreign objects dur-
Administration reports that sleepy drivers cause at least ing surgery and vaginal delivery have been developed. For
100,000 automobile accidents annually in the United example, the Institute for Clinical Systems Improvement’s
States, resulting in approximately 40,000 injuries and protocol suggests that sponges, needles, and sharp instru-
1,500 deaths (6). For this reason, many industries have ments are counted before and after surgery and vaginal
already imposed strict limitations on working hours delivery. Only radiopaque sponges and soft goods should
for individuals in vulnerable occupations, such as truck be placed on surgical trays or delivery fields. If the counts
drivers, airline pilots and crew members, air traffic con- at the end of the case are either incorrect or compro-
trollers, and power plant personnel. The Accreditation mised, then an abdominal or vaginal examination must
Council on Graduate Medical Education has enacted be performed. If the counts are still not reconciled, radio-
restrictions on resident work hours to prevent sleep graphic imaging for retained foreign objects will need to
deprivation, stress, and fatigue that might increase the be obtained (12).
risk of error (7, 8). Although no legal restrictions have yet
been imposed on the work hours of physicians in clinical Teaching
practice, common sense dictates that the surgeon and Trainees, such as obstetric–gynecologic residents, surgi-
the surgical team should be alert and well rested when cal residents, anesthesiology residents, medical students,
initiating major surgical procedures. Emergency situa- nursing students, and operating room technician stu-
tions may be particularly hazardous as an environment dents, may be part of the surgical environment in the
for error, especially if the surgical team is stressed and operating room or labor and delivery suite. The education
fatigued already. A recent study that examined the risk of process in these environments presents special challenges

Committee Opinion No. 464 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 750

 in protecting patient safety. It is a fundamental principle
that all trainees must be meticulously supervised and
assisted when participating in surgery. Both the trainee on Patient Safety in the Office Setting, patients have the
and the supervisor should be alert, well rested, and well
prepared in advance for the surgical procedure being
performed. Because patient safety depends on effective accreditation is something more practices may seek in the
communication among all members of the health care
team, trainees should be conversant in the pertinent
terminology before starting the procedure. The presence
of noninvolved individuals as observers in the operating
room or delivery suite may be a distraction to the surgical
team and, therefore, should receive careful consideration
before they are admitted. The current development of
virtual surgery training techniques may become useful
for students to learn and practice surgical skills before
attempting procedures in the operating room.
Obstetric Surgery
Operating on pregnant patients creates unique respon-
sibilities in ensuring patient safety because two or more
patients are involved simultaneously—the woman and
the fetus(es)—each with different needs. Adequate per-
sonnel who will ensure proper attention to the condition
of each patient must be present. Particular attention
is needed to address administration of the different
medications appropriate for the pregnant patient and
her fetus(es) or the newborn patient(s), such as dosage
and timing of antibiotics or analgesics for mother or
newborn(s) or both. The obstetric surgeon also needs
to communicate with a pediatrics team in a timely and
effective manner to reduce the possibility of error in care
of the neonate. The occasional use of blood transfusion
opens another potential avenue for introduction of error
because calling for the administration of blood products
may take place under especially stressful and hectic con-
ditions. Checklists and protocols for massive transfusion
in the event of significant obstetric hemorrhage are rec-
ommended for labor and delivery units. Much obstetric of the surgical team is crucial throughout the surgical
surgery is by nature unplanned as the course of the
delivery unfolds, and obstetric emergencies can progress
rapidly, increasing the possibility of error if protocols and
standardized procedures are skipped or abbreviated.
Freestanding Surgical Units
In recent years, many surgical procedures traditionally
performed only in hospitals or similar institutions have
increasingly been performed in physicians’ offices or
freestanding surgical facilities. This trend has produced
cost savings and convenience for patients as well as
health care providers and will likely continue. However, mise patient safety. Patient safety in surgery demands the
because these facilities may not be subject to the same
level of scrutiny or administrative oversight as hospitals,
surgeons who use these facilities must be particularly
vigilant against inadequate training of personnel, inap-
propriate or poorly maintained equipment and instru-
ments, and ineffective protocols or practices, all of which
may increase the likelihood of medical error and jeopardy
4 Committee Opinion No. 464
COMMITTEE OPINIONS
to patient safety. According to the American College of
Obstetricians and Gynecologists’ Presidential Task Force
right to expect the same level of safety regardless of where
they seek treatment (13). This task force also notes that
future. Many states already require it if certain levels of
anesthesia are used in the office or surgical center—typi-
cally moderate sedation or deeper anesthesia will trigger
this requirement (13). Such requirements will likely
improve the quality and safety of care provided in these
settings.
Distractions
Beepers, radios, telephone calls, and other potential
nonessential activities and distractions in the surgical
environment should be kept to a minimum, if allowed
at all, especially during critical stages of the operation.
Just as pilots maintain “sterile cockpits,” a Federal Aviation
Administration regulation requiring pilots to refrain from
nonessential activities during critical parts of a flight,
all members of the operating room team also should
postpone nonessential conversation until surgery is fin-
ished (14). Similarly, it may be preferable to ask nones-
sential personnel to remain outside the operating room
while surgery is being performed. Everyone on the team is
mutually accountable for minimizing distractions.
Conclusion
Although medical errors can occur in any aspect of
medicine, the surgical environment presents additional,
special challenges to safeguarding patient safety. Because
these injuries can be serious, particular care is appro-
priate in creating checklists, systems, and routines that
reduce the likelihood of wrong-patient, wrong-side,
wrong-part surgical errors, and retained foreign objects.
Along with these tools, communication among members
process, particularly during the preoperative phase. The
wide variety of techniques, instruments, and technology
used for surgical procedures makes granting privileges of
surgeons critically important. Freestanding surgical units
may need to be particularly vigilant in ensuring that per-
sonnel and equipment are in good condition for surgery.
Protocols and procedures to identify and manage stress
and fatigue in surgical personnel may help to avoid surgi-
cal errors and patient injuries. The operating room is an
appropriate educational environment, but the presence
of observers at any level must not be allowed to compro-
full attention of skilled individuals using well-functioning
equipment under adequate supervision.
References
1. The Joint Commission. Sentinel events statistics. Oakbrook
Terrace (IL): Joint Commission; 2009. Available at: http://www.
jointcommission.org/SentinelEvents/Statistics. April 30, 2010.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 751
 2. The Joint Commission. Universal protocol for preventing 10. The Joint Commission. Sentinel Events (SE). In:
wrong site, wrong procedure, and wrong person surgery. Comprehensive accreditation manual. CAMH for hospi-
Oakbrook Terrace (IL): Joint Commission; 2009. Available at: tals: the official handbook. Oakbrook Terrace (IL): Joint
http://www.jointcommission.org/PatientSafety/Universal Commission, 2010. P. SE-1–18.
Protocol. Retrieved April 30, 2010. 11. Statement on the prevention of retained foreign bodies after
3. The Joint Commission. National patient safety goals surgery. Bull Am Coll Surg 2005;90:15–16.
(NPSG). In: Comprehensive accreditation manual. CAMH 12. Institute for Clinical Systems Improvement. Health care
for hospitals: the official handbook. Oakbrook Terrace (IL): protocol: prevention of unintentionally retained foreign
Joint Commission; 2010. P. NPSG-1–25. objects during vaginal deliveries. 3rd ed. Bloomington (MN):
4. World Health Organization. Surgical safety checklist. ICSI; 2009. Available at: http://www.icsi.org/retained_
Geneva: WHO; 2009. Available at: http://whqlibdoc.who. foreign_objects_during_vaginal_deliveries/retained_for-
int/publications/2009/9789241598590_eng_Checklist.pdf. eign_objects_during_vaginal_deliveries__prevention_of_
Retrieved April 30, 2010. untentionally__protocol_.html. Retrieved April 30, 2010.
5. Health and Safety Executive (UK). Human factors: fatigue. 13. American College of Obstetricians and Gynecologists.
Available at: http://www.hse.gov.uk/humanfactors/topics/ Report of the Presidential Task Force on Patient Safety in
fatigue.htm. Retrieved April 30, 2010. the Office Setting. Washington, DC: American College of
Obstetricians and Gynecologists; 2010.
6. National Highway Traffic Safety Administration. The dan-
gers of drowsy driving—some startling statistics. Available 14. Federal Aviation Administration. Approach and landing
at: http://www.nhtsa.dot.gov/PEOPLE/injury/drowsy_ accident reduction: sterile cockpit, fatigue. Safety Alert for
driving1/human/drows_driving/index.html. Retrieved Operators 06004. Washington, DC: FAA; 2006. Available
April 30, 2010. at: http://www.faa.gov/other_visit/aviation_industry/
airline_operators/airline_safety/safo/all_safos/media/
7. Accreditation Council for Graduate Medical Education. 2006/safo06004.pdf. Retrieved April 30, 2010.
Common program requirements: VI. Resident duty hours
in the learning and working environment. Chicago (IL):
ACGME; 2007. Available at: http://www.acgme.org/ Copyright September 2010 by the American College of Obstetricians
acWebsite/dutyHours/dh_ComProgrRequirements and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
DutyHours0707.pdf. Retrieved April 30, 2010. be reproduced, stored in a retrieval system, posted on the Internet,
8. Buysse D, Barzansky B, Dinges D, Hogan E, Hunt CE, or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
Owens J, et al. Sleep, fatigue, and medical training: setting permission from the publisher. Requests for authorization to make
an agenda for optimal learning and patient care. Sleep photocopies should be directed to: Copyright Clearance Center, 222
2003;26:218–25. Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
9. Rothschild JM, Keohane CA, Rogers S, Gardner R, Lipsitz SR, ISSN 1074-861X
Salzberg CA, et al. Risks of complications by attending Patient safety in the surgical environment. Committee Opinion No.
physicians after performing nighttime procedures. JAMA 464. American College of Obstetricians and Gynecologists. Obstet
2009;302:1565–1572. Gynecol 2010;116:786–90.

Committee Opinion No. 464 5

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 752

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee Opinion
Number 472 • November 2010
Committee on Patient Safety and Quality Improvement
This document reflects emerging clinical and scientific advances as of the date issued and is
subject to change. The information should not be construed as dictating an exclusive course of
treatment or procedure to be followed.

Patient Safety and the Electronic Health Record

ABSTRACT: The electronic health record (EHR) has the potential to improve the quality, safety, and efficiency
of patient care when fully implemented, yet adoption of this tool has been slow. The advantages of the EHR
include facilitating improved communication between health care providers; assisting with medication safety,
tracking, and reporting; and promoting quality of care through optimized compliance with guidelines. Despite
obstacles to widespread adoption and implementation, use of the EHR as a real-time, evidence-based support
tool can help busy obstetrician–gynecologists improve the quality of the care they provide through improved care
coordination, communication, and documentation.

The electronic health record (EHR) has the potential
to improve the quality, safety, and efficiency of patient
care when fully implemented (1). Use of the EHR can
improve communication among health care providers
and increase team effort among providers. Its use can
assist with medication safety, tracking, and reporting and
eliminate concerns about the legibility of paper medi-
cal records. Most importantly, its use has been shown
to have an effect on quality of care through optimized
compliance with guidelines (2). The use of preassembled
ordering and documenting tools within an EHR may
simplify the documentation process, although care must
be taken when using templates to avoid importing previ-
ous notes without updating data, assessment, and plans.
When using templates, the record must be reviewed and
edited to ensure that it accurately documents the patient
encounter. Record uniformity may reduce practice varia-
tions and can standardize health care, procedures, and
follow-up (3). In addition, a more complete record can
be created by offering staff additional questions, informa-
tion, or alerts (4). However, like paper medical records,
EHRs are only as accurate as the information entered
into them. Electronic health records provide the benefit
of improving the legibility of prescriptions, potentially
reducing the risk of some medication errors. Health care
providers have the benefit of accessing information from
an online formulary, assuming that it is updated on an
ongoing basis, as well as providing real-time medication
alerts. It also can aid with medication reconciliation for
each patient.
Electronic health records can also open communi-
cation with patients through online secure portals and
reception area kiosks. These encourage patient partnering
by allowing patients to enter personal or medical history
information, make appointments, request refills on pre-
scriptions, or obtain laboratory results. These kiosks and
web portals can also be made interactive so patients may
receive targeted education materials and other informa-
tion (5).
Tracking and Reporting
The ability of an EHR to store and retrieve data makes it
a logical tool to improve the quality of patient care. Using
an EHR can consolidate patient information, such as
diagnoses, medications, and test results, which may ena-
ble providers to deliver safer, more effective health care.
Decision-making support, such as prompts and remind-
ers when tests are due or when specific care does not
meet guidelines, provides the clinician with a tool to
provide quality care. The enhanced ability of a health care
provider to clearly document all aspects of the encounter
using an EHR may also ensure proper billing and coding
to optimize reimbursement. Outside the patient encoun-
ter, EHRs may improve tracking for patient follow-up
care, especially with missed appointments. They can also
flag abnormal test results and store information about a
patient’s symptoms. In addition, a well-designed EHR will
enable providers to search for specific patient populations
to ensure that quality measures (such as mammograms,
Pap tests, or hemoglobin A1C assessments) are up-to-date.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 753

 Improve Health Care Delivery and Office Efficiency
Office efficiency and the ability to streamline work-flow
processes may improve with the use of EHRs because of
timely access to medical records, especially to records at
multiple or remote locations. This cross-over frequently
occurs between inpatient and ambulatory care settings.
Improved efficiency can translate into increases in direct
patient care time, and in the accuracy, legibility, and
completeness of the data entered into an EHR (6).
The improvement of office efficiency and the avail-
ability of legible documentation may also improve billing
efficiency, generate referrals, and increase office revenue.
This is possible because the system provides clear, timely,
and legible documentation to support expanded clinical
team initiatives (7).
Changes in Work Flow
Changes in work flow and redistribution of existing
work have impeded the adoption of EHRs. Whether it is
order entry or retrieval and viewing of information, these
processes are more intricately related to the documenta-
tion process of physicians. The design of many vendor-
provided EHRs adds structure to this process, which may
not always be intuitive to the user. The system may be dif-
ficult to learn and the practice may be less productive as
the new technology is assimilated, especially at the outset
(8). Additional staffing resources may be necessary until
the system is fully implemented.
The change of the clinician’s focus from the patient to
a machine is also a concern. This may even detract from the
patient encounter and may, at least temporarily, result in a
decrease in the number of patients seen. It may also have an
effect on residents and students. This may reduce the learn-
ing potential of a patient encounter as residents become
more focused on placing orders or typing notes rather than
obtaining a detailed medical history and performing an
adequate physical examination. It is important for all health
care providers to understand that even the best EHRs are
not a substitute for listening to patients. Appropriate place-
ment of the computer screen during the patient encounter
may also improve the communication process.
The Joint Commission’s Sentinel Event Alert 42,
Safely Implementing Health Information and Converging
Technologies, outlines the effect technology can have on
health care processes, work flow, and safety (9). Various
technology-related adverse events already have been
reported to the U.S. Food and Drug Administration,
including medication errors, confusion between patient
records, loss of information or corruption of data, and
software incompatibility.
Keys to Implementation
A key to implementation is to identify champions or
leaders among health care providers who can bridge the
training programs from the vendors to the health care
providers. These champions need to continuously engage
in improving systems and related work-flow processes
to make them more effective and efficient. There are few
COMMITTEE OPINIONS
things that can undermine the use of EHRs faster than a
system that is unreliable, slow, or unable to take advan-
tage of new, powerful advances in health care informa-
tion systems (10).
Acceptance of EHR implementation within an insti-
tution is facilitated when a single, specific program is
installed across a network of computers, along with the
establishment of an information technology support
department provided by the organization. This allows
uniformity of communication and a complete interface
between group practices and the institution. More impor-
tantly, it allows the institution to provide an information
technology support department, through partnership
with a particular vendor. The members of the informa-
tion technology department can meet with clinicians
regularly to review usage, navigation, and updates to the
system. Also, the information technology support depart-
ment should be available, at any time, for immediate
consultation to troubleshoot any system problems, such
as retrieval of lost data due to power outages, or to assist
the clinician in efficiently using the system. The efficiency
of the department is dependent on how well it can train
and assist clinicians, along with upgrading the system as
problems or inefficiencies are discovered. Efficiency is
maximized when the information technology support
department includes vendor-supported personnel who
are able to adapt the software for the institution.
Balancing Patient Privacy and Security and a
Physician’s Need for Patient Information
The American College of Obstetricians and Gynecologists
holds patient privacy and the confidentiality of a patient’s
medical records in the highest regard and respects the
fundamental right of an individual patient to make
her own choices about her health care. Protecting
patients’ health information is of paramount impor-
tance. Electronic record keeping within a physician’s
office can make a patient’s medical record more secure.
Health information technology systems can block unau-
thorized viewers and keep track of when and by whom a
record was viewed.
Health information technology systems should
be compatible with the requirements of the Health
Insurance Portability and Accountability Act and flexible
enough to accommodate state privacy laws, a particular
concern for adolescent care, assisted reproductive tech-
nology, and genetic testing. Health information technol-
ogy systems must integrate these various rules.
There are compelling reasons why physicians should
have access to shareable, complete medical records. But
there are also compelling reasons, based on respect for
patients’ privacy and right to make their own health
decisions, for limiting physician access to some patient
medical information. In many cases, the clinical benefit
derived from a physician’s knowledge of sensitive per-
sonal health information may not be significant enough
to outweigh the patient’s need for confidentiality and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 754
 privacy. At one end of the continuum, patients would
have no control over the content of or access to their
records, and all of the patient’s physicians would have full
access to all of the patient’s medical information. At the
other end, a patient may wish to block access to or delete
important information from his or her medical record,
leaving physicians with only some information.
The American College of Obstetricians and
Gynecologists has strong concerns about allowing patients
to delete information from their records entirely or to
block provider access to any information in their records.
The Health Insurance Portability and Accountability Act
allows patients to request that inaccurate information be
corrected, but not to demand changes for other reasons.
Blocking access to selected information gives the patient
significant control over her record, but could also hinder
a physician’s ability to provide the best patient care. The
American College of Obstetricians and Gynecologists
supports patients being active health care consumers but
recognizes the importance of physician access to medical
information for accurate diagnosis and treatment.
Because of the unique nature of the practice of
obstetrics and gynecology, it is difficult to develop an
EHR capable of following the flow of a prenatal record
with its frequent encounters and timely laboratory testing,
imaging, and counseling. All of these encounters need
to be continually accessed most easily on a single screen
within a problem-oriented chart that is automatically
populated from multiple areas of care, including labora-
tory and radiology results, office visits, and labor and
delivery. In addition, EHRs need to provide a safety net
with clinical decision support to aid busy providers with
alerts and guideline compliance assistance (11).
Conclusions
The use of health information technology may improve
health care quality; however, more studies need to be
conducted to examine the benefits of the EHR and its
effect on improving patient safety and health care out-
comes (4). Many of the analyses conducted to date are
through single-site studies and national estimates are
based on extrapolations from these single-site studies (12).
As data demonstrating the benefits of EHR use become
available, including improved communication across the
continuum of care, improvements in patient outcomes,
and reduction in medication errors or lower readmission
rates, the need for health care information technology
will become obvious (13). Using an EHR as a real-time,
evidence-based support tool can help busy obstetrician–
gynecologists improve the quality of the care they provide
through improved health care coordination, communi-
cation, and documentation.
References
1. Bates DW, Ebell M, Gotlieb E, Zapp J, Mullins HC. A pro-
posal for electronic medical records in U.S. primary care.
J Am Med Inform Assoc 2003;10:1–10.
COMMITTEE OPINIONS
2. Classen D, Bates DW, Denham CR. Meaningful use of
computerized prescriber order entry. J Patient Saf 2010;
6:15–23.
3. Brokel JM, Harrison MI. Redesigning care processes using
an electronic health record: a system’s experience. Jt Comm
J Qual and Patient Saf 2009;35:82–92.
4. Bernstein PS, Merkatz IR. Reducing errors and risk in a pre-
natal network with an electronic medical record. J Reprod
Med 2007;52:987–93.
5. Gill JM. EMRs for improving quality care: promise and
pitfalls. Fam Med 2009;41(7):513–5.
6. Poissant L, Pereira J, Tamblyn R, Kawasumi Y. The impact
of electronic health records on time efficiency of physicians
and nurses: a systematic review. J Am Med Inform Assoc
2005;12:505–16.
7. Lorenzi NM, Kouroubali A, Detmer DE, Bloomrosen M.
How to successfully select and implement electronic health
records (EHR) in small ambulatory practice settings. BMC
Med Inform Decis Mak 2009;9:15.
8. Mehta NB, Partin MH. Electronic health records: a primer
for practicing physicians. Clev Clinc J Med 2007;74:826–30.
9. The Joint Commission. Safely implementing health infor-
mation and converging technologies. Sentinel Event Alert
Issue No. 42. Oakbrook Terrace (IL): Joint Commission;
2008. Available at: http://www.jointcommission.org/Sentinel
Events/SentinelEventAlert/sea_42.htm. Retrieved June 8,
2010.
10. Glaser J. Implementing electronic health records: 10 factors
for success. Healthc Financ Manage 2009;63(1):50–2, 54.
11. McCoy MJ, Diamond AM, Strunk AL. Special require-
ments of electronic medical record systems in obstetrics
and gynecology. Obstet Gynecol 2010;116:140–3.
12. Gluck ME. Is health information technology associated with
patient safety in the United States? Find Brief 2009;12:1–3.
13. Walker JM, Carayon P. From tasks to processes: the case for
changing health information technology to improve health
care. Health Aff 2009;28:467–77.
Resource
Certification Commission for Health Information Technology
200 South Wacker Drive, Suite 3100
Chicago, IL 60606
(312) 674-4930
http://www.cchit.org
Copyright November 2010 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written
permission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Patient safety and the electronic health record. Committee Opinion
No. 472. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:XX–XX.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 755
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 487 • April 2011 (Replaces No. 353, December 2006)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The infor-
mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Preparing for Clinical Emergencies in Obstetrics

and Gynecology
ABSTRACT: Patient care emergencies may periodically occur at any time in any setting, particularly the
inpatient setting. To respond to these emergencies, it is important that obstetrician–gynecologists prepare them-
selves by assessing potential emergencies that might occur, creating plans that include establishing early warning
systems, designating specialized first responders, conducting emergency drills, and debriefing staff after actual
events to identify strengths and opportunities for improvement. Having such systems in place may reduce or
prevent the severity of medical emergencies.

A practicing obstetrician–gynecologist may be faced with
a sudden patient emergency at any time. Whether it is
severe shoulder dystocia, catastrophic surgical or obstetric
hemorrhage, or an anaphylactic reaction to an injection
in the office, it will require prompt response. Preparation
for potential emergencies requires planning. Issues to
consider include advance provisioning of resources,
establishing an early warning system, designating special-
ized first responders, and holding drills to ensure that
everyone knows what to do in an emergency. Beyond
these basics, certain principles of communication and
teamwork will increase the efficiency and effectiveness of
the emergency response.
Planning
Planning for potential emergency events is challenging.
At a minimum, it should involve an assessment of the
potential or actual risks related to the practice setting or
the patient population. For example, in the outpatient
setting, are medications given or procedures performed
that may result in anaphylaxis, airway compromise, or
hemorrhage? In the inpatient setting, unit data or risk
management data may reflect common and uncommon
emergency situations that have occurred.
Advance Provision of Resources in the
Outpatient Setting
A common practice for health care–related emergencies
is the availability of the crash cart. All physicians should
be familiar with the crash cart. Placing all necessary items
in a known, central location ensures that time is not lost
gathering supplies in an emergency. Appropriate changes
should be made to the crash cart as evidence-based
changes are made to the Advanced Cardiac Life Support
protocol. Advance provision of resources also may be
extended, for example, to the management of eclampsia
and malignant hyperthermia. Physicians in outpatient
settings may wish to create a small kit for handling allergic
reactions if they are not able to maintain a full crash cart.
As with a crash cart, the kit must be checked regularly to
ensure that perishable supplies have not been retained
beyond expiration dates. All health care providers need to
know how to use the allergic reaction kit.
Early Warning Systems in the
Inpatient Setting
Some emergencies are truly sudden and catastrophic, such
as a ruptured aneurysm, massive pulmonary embolus, or
complete abruptio placentae in the setting of trauma.
However, many emergencies are preceded by a period
of instability during which timely intervention may help
avoid disaster. The rapid response team is set up to handle
such emergencies. However, even without the use of a
rapid response team, nurses and other bedside caregivers
need to recognize that certain changes in a patient’s con-
dition can indicate an emergency that requires immedi-
ate intervention. These changes include some events not
usually considered to be emergencies, such as agitation or

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 756

 new onset difficulty with movement. Ideally, each service
will examine its own historical call data to determine
which events require activation of the early warning
system. It is imperative that bedside personnel be able
to request immediate help, without recrimination, when
such changes occur. For example, the nurse who calls
the rapid response team regarding the anxious postop-
erative patient with new onset shortness of breath must
not be dismissed as failing to recognize a panic attack
but instead praised for following protocol. The protocol
should provide for a full evaluation of the problem. Some
organizations have formalized the emergency communi-
cation process using a standardized communication tool,
such as “SBAR” (Situation, Background, Assessment, and
Recommendation); all health care providers are encour-
aged to follow it to clearly communicate the patient care
issue. Standardized responses will increase the efficiency
of care and allow a continuous quality improvement pro-
cess to assess the effectiveness of the interventions.
Rapid Response Team
Medical emergency teams, otherwise known as rapid
response teams, are designated emergency response
teams. These teams of clinicians bring critical care exper-
tise to the patient’s bedside or wherever it is needed.
Activation of rapid response team intervention occurs
when predefined criteria are met, although the team
intervention also may be activated for other reasons.
Rapid response team intervention should be a no-fault
process. The team is available at all times with author-
ity to summon further help as needed. By designating
criteria that define an emergency, it becomes clear when
to call for help. For example, if a maternal or postopera-
tive heart rate of more than 140 beats per minute is the
criterion, the nurse who notes such a heart rate would
immediately call the medical emergency team. This
contrasts with the common practice of calling an attend-
ing physician and awaiting a call back for orders before
intervention. Activation of rapid response team interven-
tion before a full arrest may lead to improved survival
of hospitalized patients and decreased admissions to an
intensive care unit (1). It is important to emphasize that
if there is a teaching service, calling the house officer
does not substitute for triggering rapid response team
intervention. Similarly, calling the in-house physician
in a nonteaching setting does not substitute activating
rapid response team intervention. Rapid response teams
usually have advanced practice nurses and respiratory
therapists as first responders and are expected to respond
to the problem in a standardized fashion.
The goal of standardized response and rapid effec-
tive recognition and correction of problems is better
met with a small stable group. Development of a rapid
response system is one of the patient safety initiatives
currently being promoted by the Institute for Healthcare
Improvement (2) and the Agency for Healthcare Research
and Quality. Blueprints for setting up such a system, as
2 Committee Opinion No. 487
COMMITTEE OPINIONS
well as other resources, may be found on the web sites of
these organizations.
Establishing a rapid response system involves a mul-
tistep process (3–5). First, key staff must be identified for
the response team. Second, the criteria for activation of
intervention by the response team should be determined.
Third, the staff involved with the rapid response system
must be educated on their respective roles. Fourth, a
means of evaluating feedback and process improvement
must be established. Finally, the effectiveness of the rapid
response system must be monitored. The rapid response
system can be divided into four components: 1) activators,
2) responders, 3) quality improvement, and 4) admin-
istration (6).
The activators are those individuals who may acti-
vate the rapid response system. Activators may be floor
staff, a patient, a family member, specialists, or anyone
concerned about the condition of a particular patient.
Team members from the nursing staff or floor staff are
trained to monitor for disturbances in any indicators of
acute distress. These indicators are determined by the
individual medical treatment facilities.
Once the rapid response system is activated, the
responders arrive at the bedside, along with the attending
physician, to treat the patient and stabilize her condition.
Responders will then determine the disposition of the
patient. Options for this can include transfer to a higher
level of care, a handoff to the primary team (nurse or
physician or both), or revision of the current treatment
plan. Activators may become responders to help aid in
stabilizing the patient’s condition.
When the responders arrive, the activators must be
prepared to exchange information. A communication pro-
tocol such as SBAR may be used. Using such a protocol
allows the activators to exchange information with the
responders in a clear and concise manner. This will help
ensure that expeditious care is provided to the patient.
During the response phase, other tools may be
implemented to help facilitate care for the patient. Before
initiation of the response phase, a discussion, or brief,
should be conducted to assign essential roles, establish
expectations and climate, and anticipate outcomes and
likely contingencies. The primary purpose of the commu-
nication protocol is to develop a common understanding
of the patient’s issues so that a consensus for the patient’s
treatment plan can be reached. A team huddle, designed
to reinforce plans already in place and to assess the need
to adjust the plan, also may be used to review situational
awareness and to troubleshoot and revise the current plan
of action, if needed. A check back, time out, or call out
may be used to ensure closed-loop communication.
The quality improvement team supports activators
and responders by reviewing the events surrounding the
activation of the rapid response system and evaluating the
process. An informal information exchange, or debrief, is
designed to improve team performance and effectiveness
as part of the action review. Once the review is complete,
2013 COMPENDIUM OF SELECTED PUBLICATIONS 757
 the administration team then provides organizational
resources to implement improvements in the process.
Emergency Drills and Simulation
The principle that standardized care can result in safe care
applies to emergencies as well as to routine care. Thus,
each service should consider a protocol for manage-
ment of common emergencies, such as emergency cesar-
ean deliveries or postpartum hemorrhage. This training
may use a sophisticated simulated environment, but it
also may use the everyday workspace in a mock event.
Protocols also can be reinforced by being prominently
displayed as posters, pocket cards, or other aids.
Using drills to train physicians to respond to emer-
gencies has several theoretical advantages. Adult learning
theory supports the importance of experiential learning.
Emergencies occur in a specific physical setting and may
involve a group of nurses, physicians, and other health
care providers attempting to respond. By conducting
a drill in a realistic simulator or in the actual patient
care setting, issues related to the physical environment
become obvious.
Emergency drills also allow physicians and others to
practice principles of effective communication in a crisis.
Many aspects of the medical environment work against
effective communication, including the often hierarchical
hospital structure, and the nature of the training, work
setting, and the different educational backgrounds and
levels of understanding of the health care team. Many
physicians are accustomed to talking to nurses. Effective
teamwork requires talking with each other. It requires
that there be a team leader coordinating the response,
but it also should empower all members of the team to
share information. By practicing together, barriers hin-
dering communication and teamwork can be overcome.
Effective drills may lead to improved standardization of
response, health care provider satisfaction, and patient
outcomes.
Simulator training also may be beneficial with respect
to identifying common clinical errors made during emer-
gencies and correcting those deficiencies (7). Although
this is promising, there are limited data to suggest that
improved proficiency with simulation models correlates
with increased proficiency during actual emergencies (8).
Conclusion
The obstetrician–gynecologist practices in an environ-
ment where true emergencies will periodically occur.
Preparation for these in-hospital situations requires that
emergency supplies be placed in locations well known
to members of the rapid response team. In addition,
Committee Opinion No. 487
COMMITTEE OPINIONS
the members of the rapid response team must clearly be
defined. The criteria used to activate rapid response team
intervention also must be clearly defined and dissemi-
nated among potential activators well in advance of any
emergency. It is also important for members of the rapid
response team to receive ongoing education and training
regarding important changes in the management of any
potential emergency to ensure maximal preparedness.
The exact nature of the preparation will depend on the
work environment and the resources available.
References
1. Dacey MJ, Mirza ER, Wilcox V, Doherty M, Mello J, Boyer A,
et al. The effect of a rapid response team on major clinical
outcome measures in a community hospital. Crit Care Med
2007;35:2076–82.
2. Institute for Healthcare Improvement. Establish a rapid
response team. Available at: http://www.ihi.org/IHI/Topics/
CriticalCare/IntensiveCare/Changes/EstablishaRapid
ResponseTeam.htm. Retrieved December 13, 2010.
3. Mahlmeister LR. Best practices in prenatal care: the role of
rapid response teams in perinatal units. Legal issues and risk
management. J Perinat Neonatal Nurs 2006;20:287–9.
4. Gosman GG, Baldisseri MR, Stein KL, Nelson TA,
Pedaline SH, Waters JH, et al. Introduction of an obstetric-
specific medical emergency team for obstetric crises: imple-
mentation and experience. Am J Obstet Gynecol 2008;
198:367.e1–367.e7.
5. Clements CJ, Flohr-Rincon S, Bombard AT, Catanzarite
V. OB team stat: rapid response to obstetrical emergencies.
Nurs Womens Health 2007;11:194–9.
6. Agency for Healthcare Research and Quality. TeamSTEPPS®
Rapid Response Systems module: instructor’s materials.
Available at: http://www.ahrq.gov/teamsteppstools/rrs/
rrsinstructmod.htm. Retrieved December 13, 2010.
7. Gardner R, Raemer DB. Simulation in obstetrics and gyne-
cology. Obstet Gynecol Clin N Am 2008;35:97–127, ix.
8. Maslovitz S, Barkai G, Lessing JB, Ziv A, Many A. Recurrent
obstetric management mistakes identified by simulation.
Obstet Gynecol 2007;109:1295–300.
Copyright April 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Preparing for clinical emergencies in obstetrics and gynecology.
Committee Opinion No. 487. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1032–4.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 758
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

Committee opinion
Number 490 • May 2011 (Replaces No. 320, November 2005)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The infor-
mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Partnering With Patients to Improve Safety

Abstract: Actively involving patients in the planning of health services is recommended as a means of improv-
ing the quality of care. This can increase patient engagement and reduce risk resulting in improved outcomes,
satisfaction, and treatment adherence.

The foundation for a positive physician–patient interac-
tion is formed by establishing a partnership and creating a
meaningful dialogue. Accomplishing this in a brief office
visit may be challenging, but with adequate planning these
encounters can be structured in a positive way. Improving
communication with patients, listening to their concerns,
and facilitating active partnerships should be central to
any patient safety strategy (1). Involving patients in the
planning of health services also is recommended as a
means of improving the quality of care (2). Additionally,
several studies indicate that physician–patient communi-
cation problems may account for an increase in medical
professional liability actions (3, 4).
Information Sharing
Patients are responsible for providing their physicians
with the information that is necessary to reach an accu-
rate diagnosis or treatment plan. To facilitate this process,
patients should be encouraged to discuss the reasons for
their visits and use the “Ask Me 3” questions developed by
the Partnership for Clear Health Communication at the
National Patient Safety Foundation and adopted by the
World Health Organization as follows (5):
1. What is my primary problem?
2. What do I need to do?
3. Why is it important for me to do this?
In response, physicians should actively listen to engage
their patients. Physicians also can solicit the patient’s
concerns and opinions by asking open-ended questions
and asking patients to share key information such as
their medical histories (including illnesses, immuniza-
tions, and hospitalization), medication history (includ-
ing over-the-counter [OTC] medications and dietary
supplements), and any allergies, reactions, or sensitivities
experienced after taking medications. In addition to the
physician, other staff, such as nurses and physician assis-
tants, may play an important role in ensuring appropriate
communication.
Health Literacy
According to an Institute of Medicine report, “nearly
half of all American adults—90 million people—have
difficulty understanding and acting upon health informa-
tion” (6). The Institute of Medicine defines health literacy
as “the degree to which individuals have the capacity to
obtain, process, and understand basic health information
and services needed to make appropriate health deci-
sions” (6). Cultural barriers also can impede physician–
patient communication. Consequently, it is important
for clinicians to use proven strategies to facilitate com-
munication with patients. Listed as follows are examples
of useful methods (7):
• Speaking slowly and using plain, nonmedical lan-
guage
• Limiting the amount of information provided and
repeating the information
• Using teach-back or show-me techniques (asking the
patient to repeat any instructions given) to confirm
that the patient understands what has been explained
• Encouraging patients to ask questions
• Providing written materials to reinforce oral explana-
tions
The tool kit entitled Health Literacy and Patient Safety:
Help Patients Understand, 2nd edition, developed by the

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 759

 American Medical Association, includes an instructional
video and a detailed manual for clinicians that may be
helpful (7).
Informed Consent
Informed consent is a process, not a form (8). At the end
of this process, the patient should understand her diag-
nosis, recommended treatment, potential complications,
and treatment options. This discussion should be docu-
mented in the medical record. It often is helpful to invite
the patient to bring a relative or a close friend to this
discussion because this may help the patient retain the
information given to her. There are many commercially
available videotapes and printed materials, including
those produced by the American College of Obstetricians
and Gynecologists that can reinforce—but not replace—
this process.
In addition to informed consent is the model of
shared medical decision making. First described in the
1970s, shared medical decision making can be considered
in certain cases requiring informed consent (9). Simple
informed consent is appropriate in situations of sig-
nificant risk, particularly when only one treatment option
exists. Shared medical decision making, however, applies
when there are two or more reasonable medical options
(10). Shared medical decision making is a process in which
the physician shares with the patient all relevant risk and
benefit information on all treatment alternatives and the
patient shares with the physician all relevant personal
information that might make one treatment or side effect
more or less tolerable than others (11). It can increase
patient engagement and reduce risk resulting in improved
outcomes, satisfaction, and treatment adherence (12). In
a study of breast cancer patients, a majority (97%) pre-
ferred a shared decision-making model with a collab-
orative approach to proceed with a treatment choice (13),
rather than simple informed consent.
In reality, decision making is a continuum with
the physician leading the discussion on one end, and
with patients making the decision on the other end.
Although medical knowledge is tipped toward the pro-
vider end of the continuum, in shared medical decision
making, a middle ground is sought that incorporates
sound medical care and a patient’s personal preferences.
Patient-centered goals also may have a part in the decis-
ion-making process. However, physicians should provide
their clinical judgment on best choices when they believe
a clear benefit exists.
Medications
Medication errors are the largest source of preventable
adverse events. It is important for patients to provide
their physicians with a list of the prescription and non-
prescription medications they take, including vitamins
and herbal supplements. Whenever new prescriptions
are given, patients should be told why the medication
2 Committee Opinion No. 490
COMMITTEE OPINIONS
is being prescribed and given instructions for taking the
medication. For example, if a medication is to be taken
three times per day, the patient should be told what time
of day the medication should be taken, whether it should
be taken with food or without food, how much should
be taken at one time, how long the medication should
be continued, possible interactions with other medica-
tions the patient is taking, and whether any medications
(including OTC medications), foods, or alcohol are
contraindicated while taking this medication. Physicians
should encourage their patients to maintain a list of all
the medications, vitamins, herbal supplements, and OTC
medications they are taking and share the list with any
other physicians they may be seeing. Medication forms
or pill cards may be useful to facilitate this process (see
Resources).
Follow-up
Physicians should discuss how test results will be com-
municated. Tracking strategies should be developed
for the office and may include logbooks or computer
prompts. The goal should be communication of every test
result to the patient on a timely basis. Tracking of high-
priority tests (eg, Pap tests, mammograms, and biopsy
results) should be established. Clinicians should inform
their patients that not receiving results does not neces-
sarily mean that there is not an issue. Patients should be
given a reasonable time frame within which they should
expect to be informed about their test results, and they
should be encouraged to call if they have not heard from
the office at the end of that period.
Conclusion
Partnering with patients to improve communication
results in increased patient satisfaction, increased diag-
nostic accuracy, enhanced adherence to therapeutic rec-
ommendations, and improved quality of care.
Resources
Cultural sensitivity and awareness in the delivery of health
care. Committee Opinion No. 493. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2011;
117:1258–61.
Effective patient–physician communication. Committee
Opinion No. 492. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;117:1254–7.
Health literacy. Committee Opinion No. 491. American
College of Obstetricians and Gynecologists. Obstet Gyne-
col 2011;117:1250–3.
Jacobson KL, Kripalani S, Gazmararian JA, McMorris KJ.
How to create a pill card (Prepared under contract No.
290-00-0011 T07). AHRQ Publication No. 08-M016.
Rockville (MD): Agency for Healthcare Research and
Quality; 2008. Available at: http://www.ahrq.gov/qual/
pillcard/pillcard.pdf. Retrieved July 6, 2010.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 760
 Surgery and patient choice. ACOG Committee Opinion
No. 395. American College of Obstetricians and Gynecol-
ogists. Obstet Gynecol 2008;111:243–7.
References
1. Vincent CA, Coulter A. Patient safety: what about the
patient? Qual Saf Health Care 2002;11:76–80.
2. Crawford MJ, Rutter D, Manley C, Weaver T, Bhui K,
Fulop N, et al. Systematic review of involving patients in
the planning and development of health care. BMJ 2002;
325:1263.
3. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors
that prompted families to file medical malpractice claims
following perinatal injuries. JAMA 1992;267:1359–63.
4. Hickson GB, Clayton EW, Entman SS, Miller CS, Githens PB,
Whetten-Goldstein K, et al. Obstetricians’ prior malprac-
tice experience and patients’ satisfaction with care. JAMA
1994;272:1583–7.
5. National Patient Safety Foundation, Partnership for Clear
Health Communication. Ask me 3. Available at: http://
www.npsf.org/askme3. Retrieved July 6, 2010.
6. Institute of Medicine (US). Health literacy. A prescription or transmitted, in any form or by any means, electronic, mechani-
to end confusion. Washington, DC: National Academies
Press; 2004.
7. Weiss BD. Health literacy and patient safety: help patients
understand. 2nd ed. Chicago (IL): American Medical
Association Foundation; 2007. Available at: http://www.
ama-assn.org/ama1/pub/upload/mm/367/healthlitclini-
cians.pdf. Retrieved July 6, 2010.
Committee Opinion No. 490
COMMITTEE OPINIONS
8. Informed consent. ACOG Committee Opinion No. 439.
American College of Obstetricians and Gynecologists.
Obstet Gynecol 2009;114:401–8.
9. Charles C, Gafni A, Whelan T. Shared decision-making in
the medical encounter: what does it mean? (or it takes at
least two to tango). Soc Sci Med 1997;44:681–92.
10. Whitney SN, McGuire AL, McCullough LB. A typology
of shared decision making, informed consent, and simple
consent. Ann Intern Med 2004;140(1):54–59.
11. Kaplan RM. Shared medical decisionmaking. A new tool
for preventive medicine. Am J Prev Med 2004;26(1):81–83.
12. de Haes H. Dilemmas in patient centeredness and shared
decision making: a case for vulnerability. Patient Educ Couns
2006;62:291–8.
13. King JS, Moulton BW. Rethinking informed consent: the
case for shared medical decision-making. Am J Law Med
2006;32:429–501.
Copyright May 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Partnering with patients to improve safety. Committee Opinion No.
490. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;117:1247–9.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 761
 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 508 • October 2011 (Replaces No. 366, May 2007)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The infor-
mation should not be construed as dictating an exclusive course of treatment or procedure to
be followed.

Disruptive Behavior
ABSTRACT: Disruptive physician behavior may have a negative effect on patient care. Consequently, it is
important that a systematic process be in place to discourage, identify, and remedy episodes of disruptive behavior.

A growing number of organizations recognize that disrup-
tive behavior may compromise patient care. Numerous
reports of disruptive physician behavior in the media and
literature demonstrate its negative effect on patient care
and other staff. The problem is so significant that, in July
2008, The Joint Commission issued the Sentinel Event
Alert 40, “Behaviors that undermine a culture of safety”
(1). The American Medical Association’s Report of the
Council on Ethical and Judicial Affairs defines disruptive
behavior as “a style of interaction...that interferes with
patient care...[and] that tends to cause distress among
other staff and affect overall morale within the work
environment, undermining productivity and possibly
leading to high staff turnover or even resulting in ineffec-
tive or substandard care” (2). Several types of behavior
can create distress or negatively affect morale in the work
environment. The following are examples of disruptive
physician behavior:
•
Profane or disrespectful language
•
Yelling, berating, or insulting others
•
Throwing instruments, charts, or other objects
•
Bullying, demeaning, or intimidating conversations
•
Criticizing other health care providers or organiza-
tions in front of patients or other staff
• Sexual comments or innuendo (3)
• Insidious intimidation, such as sarcasm, nonverbal correcting disruptive behavior. An effective approach,
gestures, or passive–aggressive behavior (4)
Yelling, insulting others, or a refusal to carry out duties as follows.
are among the most common types of behaviors reported.
The targets of such behavior are often coworkers with
less status than the offending individual as exemplified
by the relationships between staff physicians and nurses,
residents, or medical students (5). A consequence of these
behaviors is corruption of teamwork.
Best estimates suggest that a small number of physi-
cians (3–5%) are responsible for most of the reported
disruptive behavior (5). Although relatively few physi-
cians exhibit these behaviors, 95% of physician executives
reported knowing of “disturbing, disruptive and poten-
tially dangerous behaviors on a regular basis” (6). One
study concluded that many disruptive physicians began
to show evidence of such behavior as medical students
(7), highlighting the potential importance of recognizing
behavioral patterns early in career development.
Ultimately, disruptive behavior may have a negative
effect on patient safety and quality of care by causing oth-
ers to avoid the disruptive physician. Staff may refrain
from asking the disruptive physician for help or clarifica-
tion and hesitate to make health care-related suggestions
about patient care. Additionally, patients who witness the
behavior may lose confidence in the physician as well as
the institution.
Several factors contribute to a reluctance to sys-
tematically confront disruptive behavior. These include
financial concerns, such as losing physician referrals,
threats to take one’s practice to another hospital, and fear
of retribution (eg, lawsuit for antitrust or defamation of
character) (8). Nevertheless, institutions and practices
should develop a multifaceted approach for dealing with
disruptive behavior. It is essential that the administration
fully support and show commitment to addressing and
for example, would include the components described
Establishing a Code of Conduct
The Joint Commission requires that a code of conduct
be established that “defines acceptable, disruptive, and
inappropriate behaviors” (9). When establishing a code
of conduct, institutions should stipulate behavioral

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 762

 standards and the consequences for failure to comply.
Specific examples of unacceptable behavior should be
included to provide guidance for leadership, employ-
ees, and staff in determining what constitutes disrup-
tive behavior. As required by The Joint Commission,
a process for managing disruptive and inappropriate
behaviors should be created and implemented (9). At
initial appointment and each reappointment, each medi-
cal staff member should acknowledge acceptance of both
the behavioral standards and the consequences of failure
to comply, as detailed in the code of conduct, consistent
with provisions contained in the medical staff bylaws. A
training program about the code and attendant behav-
ioral expectations may be included as part of this approach.
Instituting a Monitoring and Reporting
System
A monitoring system may be considered. Systematic
review could include regular surveys of staff, focus
groups, peer and team member evaluations, and direct
observation to detect incidents of disruptive behavior (3). Special attention should be given to the possibility of
Implementing a confidential system for reporting also
could include routine confidential evaluations and for-
mal analysis of complaints from patients, coworkers, or
others. These evaluations should be provided in a con-
fidential manner to the appropriate administrative indi-
vidual, such as the chair of the department of obstetrics
and gynecology or the chief of staff for resolution. The
individual in question should be notified and given an
opportunity to respond to the complaint.
Educating, Reporting, and Training
A concerted effort should be made within each organiza-
tion to educate the entire staff (ie, medical, nursing, and
ancillary staff) about patient safety exposures that are
associated with disruptive and inappropriate behaviors.
The importance of reporting these behaviors should be
emphasized as a mechanism to eliminate these behaviors
and increase patient safety. Confidentiality of report-
ing should be emphasized to ensure privacy and reduce
potential fears about retribution (10). Additionally, lead-
ers of both the medical and nursing staff should undergo
specific training in intervention techniques to help coun-
sel individuals in their respective disciplines who exhibit
disruptive or intimidating behavior.
Establishing a Resolution
Any complaints should be handled in a confidential man-
ner with interventions designed to assist in behavioral
change whenever possible. Complaint resolution should
be consistent with medical staff, departmental, or other
institutional policies and procedures. Appropriate steps
should be taken to resolve the problem. Disciplinary
actions should be appropriate to the type of infraction
and frequency of behavior, including any mitigating
factors. Each institution should establish thresholds for
taking action that depend on the severity of the behavior.
2 Committee Opinion No. 508
COMMITTEE OPINIONS
Some actions may merit zero tolerance. All attempts to
address disruptive behavior should be clearly and thor-
oughly documented. The department chair or appro-
priate leader should be informed of individuals with
persistent problem behaviors and should be responsible
for establishing an appropriate response. The response
may include some or all of the following steps:
• Face-to-face meeting with the physician exhibiting
disruptive behavior
• A follow-up meeting (if the problem is still unre-
solved), resulting in a behavioral contract setting forth
any disciplinary actions that may be taken if the dis-
ruptive behavior persists
• Formal counseling
• Administrative hearing
• Summary suspension for egregious behavior
Assessment and treatment programs that are tailored
to the individual should be made available as necessary.
substance abuse or psychiatric diagnosis, which can
contribute to disruptive behavior. At least initially, these
programs should attempt to enable the individual to con-
tinue or resume practice.
Conclusion
Disruptive physician behavior creates a difficult work-
ing environment for all staff and threatens the quality of
patient care and, ultimately, patient safety. Colleagues
often find confronting these individuals difficult. There-
fore, it is important that clear standards of behavior are
established and all staff are informed of such standards, as
well as the consequences of persistent disruptive behavior.
Confidential reporting systems, as well as assistance pro-
grams for the offending physician, should be established.
A clear hospital-wide policy and procedure relating to
disruptive behavior should be available to all physicians
and uniformly enforced by hospital administration.
References
1. The Joint Commission. Behaviors that undermine a cul-
ture of safety. Sentinel Event Alert Issue No. 40. Oakbrook
Terrace (IL): Joint Commission; 2008. Available at http://
www.jointcommission.org/assets/1/18/SEA_40.PDF.
Retrieved May 31, 2011.
2. American Medical Association. Physicians with disruptive
behavior. In: Code of medical ethics: current opinions
and annotations. 2010-11 ed. Chicago (IL): AMA: 2010.
p. 326–8.
3. Porto G, Lauve R. Disruptive clinician: a persistent threat
to patient safety. Patient Saf Qual Healthc July/August
2006:16–24. Available at http://www.psqh.com/julaug06/
disruptive.html. Retrieved July 19, 2011.
4. Zimmerman T, Amori G. The silent organizational pathol-
ogy of insidious intimidation. J Healthc Risk Manag 2011;
30(3):5–6, 8–15.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 763
 5. Leape LL, Fromson JA. Problem doctors: is there a system- 10. Rosenstein AH, O’Daniel M. A survey of the impact of
level solution? Ann Intern Med 2006;144:107–15. disruptive behaviors and communication defects on patient
6. Weber DO. For safety’s sake disruptive behavior must be safety. Jt Comm J Qual Patient Saf 2008;34:464–71.
tamed. Physician Exec 2004;30:16–7.
7. Papadakis MA, Teherani A, Banach MA, Knettler TR,
Rattner SL, Stern DT, et al. Disciplinary action by medical
Copyright October 2011 by the American College of Obstetricians and
boards and prior behavior in medical school. N Engl J Med Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
2005;353:2673–82. DC 20090-6920. All rights reserved. No part of this publication may
8. ECRI Institute. Disruptive practitioner behavior. Healthcare be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
Risk Control Medical Staff Supplement A. Plymouth cal, photocopying, recording, or otherwise, without prior written per-
Meeting (PA): ECRI Institute; 2009. mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
9. The Joint Commission. Leaders create and maintain a cul- Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ture of safety and quality throughout the hospital. Standard
LD.03.01.01. In: Comprehensive accreditation manual. ISSN 1074-861X
CAMH for hospitals: the official handbook. Oakbrook Disruptive behavior. Committee Opinion No. 508. American College
Terrace (IL): Joint Commission; 2010. P. LD-15–LD-16. of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:970–2.

Committee Opinion No. 508 3

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 764

 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 517 • February 2012 (Replaces No. 367, June 2007)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.

Communication Strategies for Patient Handoffs

ABSTRACT: Handoff communication, which includes up-to-date information regarding patient care, treat-
ment and service, condition, and any recent or anticipated changes, should be interactive to allow for discussion
between those who give and receive patient information. It requires a process for verification of the received
information, including read-back or other methods, as appropriate.

Patient handoffs are a necessary component of current
medical care. Accurate communication of information
about a patient from one member of the health care team
to another is a critical element of patient care and safety; it
is also one of the least studied and taught elements of daily
patient care. One of the leading causes of medical errors
is a breakdown in communication. This breakdown may
occur between clinicians at any level of the health care
system. Communication failures also have been found to
be a leading cause of preventable error in studies of closed
malpractice claims (1, 2). In the era of collaborative care,
effective clinician-to-clinician communication is impor-
tant to facilitate continuity of care, eliminate preventable
errors, and provide a safe patient environment.
Communication is the process by which information
is exchanged between individuals, groups, and organiza-
tions. In order to be effective, communication should be
complete, clear, concise, and timely. Barriers to effective
communication include factors such as lack of time,
hierarchies, defensiveness, varying communication styles,
distraction, fatigue, conflict, and workload.
One predictable and critical communication event
is the patient handoff. A handoff may be described as
the transfer of patient information and knowledge, along
with authority and responsibility, from one clinician or
team of clinicians to another clinician or team of clini-
cians during transitions of care across the continuum. It
should include an opportunity to ask questions, clarify,
and confirm the information being transmitted. As part
of its standard of provision of care, treatment, and ser-
vices, The Joint Commission requires that the “process
for hand-off communication provides for the opportu-
nity for discussion between the giver and the receiver of
patient information” (3). Consideration should be given
to the implementation of a standardized approach for
handoff communication. A process for guiding the hand-
off process should include the following:
• Interactive communications
• Limited interruptions
• A process for verification
• An opportunity to review any relevant historical data (4)
Properly executed handoffs are interactive and
include the opportunity for questions and answers. A
handoff may occur during the transfer of care in any of
several circumstances, including from one on-call physi-
cian to another, from the office physician to the hospital
laborist or vice versa, or from the generalist obstetrician–
gynecologist to the specialist. It also may occur between
the attending physician and a resident or between the
attending physician and nursing staff. Every important
aspect of the patient’s condition and circumstance must
be accurately communicated and acknowledged from one
party to the other for a safe and effective handoff to occur.
Communication at the time of the handoff should result
in a clear understanding by each clinician about who is
responsible for which aspects of the patient’s care. E-mail
may constitute an appropriate form of handoff if receipt
is acknowledged. Voice mail or other unacknowledged
messages, however, do not constitute an acceptable form
of handoff.
Both patient handoffs and ongoing clinical com-
munication can be improved to promote high-quality
medical care. Factors that may affect communication
processes—physical environment, confidentiality, lan-
guage, organizational culture, communication method,
and documentation—should be addressed.

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 765

 Physical Environment
The physical environment in which the interaction takes
place may hinder effective communication. For example,
a noisy nursing station is a less desirable setting for com-
municating handoff information than a quiet confer-
ence room located away from other distractions. Having
discussions in an environment without distractions
will enhance communication during handoffs. Clinical
acuity of the patient’s condition must be considered in
deciding the circumstances, the setting, and the content
of the handoff communication. Consideration should
be given to conducting handoffs in the patient room as
appropriate.
Confidentiality
Care must be taken to maintain patient confidentiality
by allowing only those involved with her care to hear or
view protected health care information. Consideration
of privacy when transmitting patient information is also
important. Physicians must be aware of and comply
with Health Insurance Portability and Accountability Act
regulations.
Language
Language differences may interfere with the accurate details. It also allows the receiving party to have a paper-
transfer of information. Using standardized medical
terminology avoids errors in communication that may
occur when colloquialisms are used. The use of abbrevia-
tions, other than those that are well known and widely
accepted, should be discouraged. Common terminol-
ogy for interpretation of the fetal heart rate tracing has
been standardized by the National Institute of Child
Health and Human Development, the American College
of Obstetricians and Gynecologists, and the Society for
Maternal–Fetal Medicine (5). This terminology also has
been adopted by the Association of Women’s Health,
Obstetric, and Neonatal Nurses and the American Col-
lege of Nurse–Midwives. Awareness of cultural, profes-
sional, and gender differences in communication style is
also an important factor in how clinical information is
presented and received.
Organizational Culture
A primary person or team should be identified as respon-
sible for each patient. The method of access to the pri-
mary contact should be clearly established, and a backup
system should be identified in case the primary contact is
unavailable (6).
The hierarchy of personnel, particularly in teach-
ing settings, also may inhibit the transfer of important
information about the patient (7). For example, when
information about the patient’s care is being conveyed,
a first-year resident or nurse should be made to feel as
comfortable talking with the senior attending physician
as with another resident. Every member of the health care
team that is present should be encouraged to participate
2 Committee Opinion No. 517
COMMITTEE OPINIONS
in and contribute to the transfer of information without
reluctance. Senior physicians should also serve as role
models for attentive listening and the elicitation of con-
cerns from other team members.
Communication Method
Ineffective organization of the information by the sender
and lack of attention by the receiver are two signifi-
cant barriers to the effective transfer of vital informa-
tion. Structured forms of communication, such as the
Situation-Background-Assessment-Recommendation
(also referred to as SBAR) technique, should be consid-
ered. Communication may be verbal, written, or both
(8). The Joint Commission requires that staff use a record
and read-back process before taking action on a verbal
order or verbal report of a critical test result (3). Verbal
communication includes a face-to-face conversation or
a telephone call. Face-to-face exchange of information
is generally the preferred form of verbal communication
because it allows direct interaction among those present.
Not only may questions be asked and answered, but also
further nonverbal information may be expressed by body
language and facial expression. Written communication
may assist the person conveying clinical information in
organizing his or her thoughts and presenting important
generated or computer-generated hard copy of informa-
tion for reference. However, written communication
lacks the subjective interpersonal aspect of verbal com-
munication. The most effective handoff of patient infor-
mation includes both verbal and written components (9).
Performing the handoff in a routine time and man-
ner also can improve the sharing of information. Patient
handoffs should take priority over all other duties except
for emergencies (6). The TeamSTEPPS™ system devel-
oped by the Agency for Healthcare Research and Quality
and the United States Department of Defense, which is
available to the public online, is an evidence-based team-
work system to improve communication and teamwork
skills among health care providers (10). It includes strate-
gies to enhance information exchange during transitions
of care. The TeamSTEPPS™ program includes the “I
PASS THE BATON” mnemonic, as shown in Table 1,
which may facilitate the process for handoffs and health
care transitions (10).
Documentation
The written component of the handoff may be produced
by hand or electronically. One of the main advantages of
an electronic medical record is that it eliminates illegibil-
ity. Illegible handwriting has been shown to be a major
contributor to errors in patient care. Although there is no
universally accepted protocol for all of the information
that a written handoff should contain, there are several
key elements that should be present in any transfer of
patient care, whether oral or written. These include
pertinent demographic information, a brief history and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 766
 Table 1. “I PASS THE BATON” Mnemonic for Handoffs and Health Care Transitions ^
I Introduction
P Patient
A Assessment
S Situation
S SAFETY Concerns
The
B Background
A Actions
T Timing
O Ownership
N Next
Modified from Agency for Healthcare Research and Quality. TeamSTEPPS™: national implementation. Available at http://teamstepps.ahrq.gov.
the results of a physical examination, an active prob-
lem list, medications and allergies, pending test results,
ongoing or anticipated therapy, key patient values and
preferences, and any other critical information, which
should be documented in the patient’s medical record
if not already present. Using the Situation-Background-
Assessment-Recommendation technique as a guide may
facilitate the documentation process, as necessary. Such
information as code status, psychosocial status, family
issues, and long-term care issues also may be included as
circumstances warrant.
Conclusion
Providing a safe health care environment for patients must
become the hallmark of future health care. By improving
both the processes for communication between clinicians
and the transfer of information among members of the
health care team, the care that patients receive will be
optimized; ideally, the process will be seamless. Studies
are currently underway to determine the most effective
methods to perform and teach the transfer of patient
information. Physicians must strive to improve their
communication skills, not only with each other, but also
when interacting with other members of the health care
team. Awareness of the importance and challenges of
effective communication and implementation of effec-
tive communication processes, especially as it relates to
handoffs, will help decrease errors that result in adverse
events and provide a safe patient environment.
Committee Opinion No. 517
COMMITTEE OPINIONS
Introduce yourself and your role or job (include patient)
Name, identifiers, age, sex, location
Present chief complaint, vital signs, symptoms, and diagnosis
Current status or circumstances, including code status, level of
(un)certainty, recent changes, and response to treatment
Critical lab values or reports, socioeconomic factors, allergies, and alerts
(eg, falls or isolation)
Comorbidities, previous episodes, current medications, and family history
What actions were taken or are required? Provide brief rationale
Level of urgency and explicit timing and prioritization of actions
Who is responsible (person or team) including patient or family?
What will happen next? Are there anticipated changes? What is the plan?
Are there contingency plans?
References
1. Kachalia A, Gandhi TK, Puopolo AL, Yoon C, Thomas EJ,
Griffery R, et al. Missed and delayed diagnoses in the emer-
gency department: a study of closed malpractice claims
from 4 liability insurers. Ann Emerg Med 2007;49:196–205.
[PubMed] ^
2. Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical
errors involving trainees: a study of closed malpractice
claims from 5 insurers. Arch Intern Med 2007;167:2030–6.
[PubMed] [Full Text] ^
3. The Joint Commission. Comprehensive accreditation man-
ual. CAMH for hospitals: the official handbook. Oakbrook
Terrace (IL): Joint Commission; 2010. ^
4. Agency for Healthcare Research and Quality. Patient safety
primers: handoffs and signouts. Available at: http://psnet.
ahrq.gov/primer.aspx?primerID=9. Retrieved July 28, 2011.
^
5. Macones GA, Hankins GD, Spong CY, Hauth J, Moore T.
The 2008 National Institute of Child Health and Human
Development workshop report on electronic fetal moni-
toring: update on definitions, interpretation, and research
guidelines. Obstet Gynecol 2008;112:661–6. [PubMed]
[Obstetrics & Gynecology] ^
6. Williams RG, Silverman R, Schwind C, Fortune JB, Sutyak J,
Horvath KD, et al. Surgeon information transfer and
communication: factors affecting quality and efficiency of
inpatient care. Ann Surg 2007;245:159–69. [PubMed] [Full
Text] ^
7. Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR,
Rogers SO, Zinner MJ, et al. Patterns of communication
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 767
 breakdowns resulting in injury to surgical patients. J Am
Coll Surg 2007;204:533–40. [PubMed] [Full Text] ^
8. Institute for Healthcare Improvement. SBAR technique
or communication: a situational briefing model. Available
at: http://www.ihi.org/knowledge/Pages/Tools/SBARTech
niqueforCommunicationASituationalBriefingModel.aspx.
Retrieved July 28, 2011. ^
9. Arora VM, Manjarrez E, Dressler DD, Basaviah P,
Halasyamani L, Kripalani S. Hospitalist handoffs: a system-
atic review and task force recommendations. J Hosp Med
2009;4:433–40. [PubMed] ^
10. Agency for Healthcare Research and Quality. Team
STEPPS™: national implementation. Available at: http://
teamstepps.ahrq.gov. Retrieved July 28, 2011. ^
4 Committee Opinion No. 517
COMMITTEE OPINIONS
Copyright February 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Communication strategies for patient handoffs. Committee Opinion
No. 517. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2012;119:408–11.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 768
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 519 • March 2012 (Replaces No. 398, February 2008)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be construed as
dictating an exclusive course of treatment or procedure to be followed.

Fatigue and Patient Safety

ABSTRACT: It has long been recognized that fatigue can affect human cognitive and physical function.
Although there are limited published data on the effects of fatigue on health care providers, including full-time
practicing physicians, there is increasing awareness within the patient safety movement that fatigue, even partial
sleep deprivation, impairs performance.

A safe and effective health care system must be struc-
tured to minimize error and confusion. Individuals who
are tired are more likely to make mistakes. Reducing
fatigue may improve patient care and safety as well as
improve health care provider’s performance satisfaction
and increase communication. One of the most signifi-
cant limitations in evaluating fatigue is the absence of an
available metric for accurately measuring fatigue and its
subsequent effect on patient care.
Physicians are expected to offer safe and effective care
to their patients. For clinicians, maturity requires recog-
nition that medicine is a human endeavor. While indi-
viduals develop their clinical skills, they become aware of
their own unique strengths and weaknesses. Professionals
regularly seek consultations when a problem exceeds their
experience or expertise. Seeking assistance when one is
fatigued is beginning to be seen in a similar light. Fatigue
may affect a health care provider’s skills and abilities,
communication, and possibly outcomes. Because of a
lack of research on the subject, there are no current guide-
lines placing any limits on the volume of deliveries and
procedures performed by a single individual or the length
of time one may be on call and still perform procedures.
Physicians at all stages in their careers need to be cogni-
zant of the demands placed on them professionally and
personally and should strive to achieve a balance that will
not lead to excessive fatigue or overcommitment.
In July 2003, the Accreditation Council for Graduate
Medical Education enacted resident duty-hour limits to
promote high-quality learning and safe care in teaching
institutions. In December 2008, the Institute of Medicine
Committee on Optimizing Graduate Medical Trainee
(Resident) Hours and Work Schedules to Improve
Patient Safety published a report entitled Resident Duty
Hours: Enhancing Sleep, Supervision, and Safety. Among
the various recommendations, a 5-hour protected sleep
interval following 16 continuous hours on call was sug-
gested (1). Revised Accreditation Council for Graduate
Medical Education duty-hour recommendations that
began in July 2011 established new limits on resident
duty hours and also emphasized the importance of faculty
supervision, hand-over processes, and management of
alertness. Duty periods for first-year residents must not
exceed 16 hours. Although intermediate-level and senior
residents may be scheduled for a maximum of 24 hours of
continuous duty, programs must encourage residents, as
professionals, to use alertness-management strategies to
maintain alertness in the context of patient care respon-
sibilities (2).
The National Sleep Foundation recommends 8 hours
of sleep per night for an adult (3). The average U.S. adult
sleeps only approximately 7 hours per night. Sleep depri-
vation can be caused by insufficient sleep or fragmented
sleep or both. Although there is wide variation in sleep
needs, individuals do not get accustomed to less sleep
than what is biologically required. One cannot store up
sleep. Recovery from a period of insufficient sleep requires
at least two or three full nights of adequate uninterrupted
sleep (3).
A number of uncontrolled studies have analyzed the
effect of sleep restriction on cognitive function (4–6). The
authors of one small study compared reaction times and
performance on a driving simulator between residents
who had ingested alcohol but were rested and residents
who were on a call rotation every fourth night and found
that performance was comparable (4). Emergency depart-
ment physicians who were rested have been compared
with others on sequential night call (7, 8). The disruption

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 769

 of sleep produced by shift work had a significant effect on
both visual memory and cognitive performance. Another
study that examined the risk of complications by attend-
ing physicians after performing nighttime procedures
found an increased rate of surgical complications when
physicians had sleep opportunities of less than 6 hours
(9). For the obstetrician cohort, the authors concluded
that a larger study with increased statistical power would
be necessary to further explore the effects of sleep depri-
vation on the population of physicians managing labor
and delivery patients after being on call.
Several reviews of the medical literature show that
even a single night of missed sleep measurably affects cog-
nitive performance (10–13). When adults do not sleep
at least 5 hours per night, language and numeric skills,
retention of information, short-term memory, and con-
centration all decrease on standardized testing. Speed of
performance may be affected more than accuracy. For
example, surgeons operated more slowly in simulated
procedures when sleep deprived and emergency depart-
ment physicians took longer to intubate a mannequin.
In other industries, fatigue often is invoked as a
cause of error and accident. The National Transportation
Safety Board rates excessive sleepiness as the second lead-
ing cause of driving accidents in the United States (14).
A study by the Federal Railroad Administration showed
that human factor errors are responsible for almost 40%
of all train accidents over the past 5 years and that fatigue
played a role in approximately 25% of the accidents (15).
However, there is no clear evidence in health care that
restricting work hours improves patient outcome. Several
potential explanations for this exist. In the residency set-
ting, work-hour restriction has often resulted in utiliz-
ing a night-float system, which has not been shown to
decrease fatigue. Repeated episodes of working at night
may result in sleep deprivation because physicians find
themselves unable to rest during the day. Even a single
night of complete sleep loss can require up to 3 days for
recovery (8, 16).
Memory consolidation and insight formation require
sleep. Sleep-deprived adults tend to exhibit impaired com-
plex problem solving skills and continue with solutions
that do not work (17). The need for sleep, like the need for
food, can affect decision making. Fatigue may drive indi-
viduals to avoid work responsibilities to address sleep
deprivation. Safe and effective care requires mindful com-
munication between the patient and the physician and
between the physician and other caregivers. Mood may be
even more affected by sleep deprivation than cognitive or
motor performance and may have a significant effect on
a physician’s ability to communicate effectively (12).
Office medical directors and chairs of hospital depart-
ments of obstetrics and gynecology should consider
developing call schedules and associated policies that
balance the need for continuity of care and a health care
provider’s need for rest. If patient care responsibilities
preclude scheduled rest, alertness-management strategies
2 Committee Opinion No. 519
COMMITTEE OPINIONS
may be helpful. Consideration can be given to the follow-
ing guidelines suggested by the National Highway Traffic
Safety Administration (14):
• Structure work to take advantage of circadian influ-
ences.
• Recognize that the urge to sleep is very strong
between 2 am and 9 am, and especially between 3 am
and 5 am. Avoid unnecessary work at that time.
• Sleep when sleepy.
• Provide for backup during times impairment is likely.
• Go to sleep immediately after working a night shift to
maximize sleep length.
• Apply good sleep habits. The sleep environment
should be quiet and dark. It should have adequate
ventilation and a comfortable temperature to allow
daytime sleep.
• Recognize behavioral changes such as irritability that
may indicate dangerous levels of fatigue.
• Use naps strategically. A 2-hour nap before a night
shift will help prevent sleepiness. If a 2-hour nap can-
not be scheduled, then sleep no more than 45 min-
utes to avoid deep sleep and subsequent difficulty
with arousal.
From an individual perspective, health care providers
should ask themselves the following questions when con-
sidering their schedules:
• Should I work a half day or a full day in the clinic
after a night on call? Should I be at work for any
length of time after a night on call?
• Should I perform surgery if I have been awake most
of the previous night or should the procedure be
rescheduled?
• What backup system is available if I recognize a wor-
risome level of fatigue?
• What adjustments should be made to my call sched-
ule to avoid a worrisome level of fatigue?
Because physicians may not easily be able to assess
the degree of their own fatigue, it also may be prudent
for groups or departments to consider processes that
provide backup care when physician fatigue may dimin-
ish the quality of care. Physicians may consider postpon-
ing tasks that can be performed more safely at a later
time. Departments and groups also should recognize
that fatigue might arise from obligations outside the
workplace. Some departments have systems that encour-
age collaboration between practices when a health care
provider has not had a sufficient period of uninterrupted
sleep. Physicians should not fear economic or other pen-
alties for requesting assistance.
Although the implication of the studies mentioned
is that quality of care may be enhanced by increased
physician rest, there is no current evidence that proves
this premise. Additional research on the effects of fatigue
2013 COMPENDIUM OF SELECTED PUBLICATIONS 770
 on experienced practicing obstetrician–gynecologists is
necessary before specific national guidelines that are
evidence-based can be promulgated to improve over-
all patient safety and care. Although there are limited
published data on the effects of fatigue on health care
providers, including full-time practicing physicians, there
is increasing awareness within the patient safety move-
ment that fatigue, even partial sleep deprivation, impairs
performance. Because of the issues of patient safety, prac-
ticing physicians can consider evaluating the effects that
fatigue has on their professional and personal lives (eg,
adjust workloads, work hours, and time commitments to
avoid fatigue when caring for patients.)
Resource
National Sleep Foundation
1010 North Glebe Road
Suite 310
Arlington, VA 22201
(703) 243-1697
www.sleepfoundation.org
References
1. Institute of Medicine. Resident duty hours: enhancing
sleep, supervision, and safety. Washington, DC: National
Academies Press; 2009. ^
2. Nasca TJ, Day SH, Amis ES Jr. The new recommendations
on duty hours from the ACGME Task Force. N Engl J Med
2010;363:e3. [PubMed] [Full Text] ^
3. Malik SW, Kaplan J. Sleep deprivation. Prim Care 2005;32:
475–90. [PubMed] ^
4. Arnedt JT, Owens J, Crouch M, Stahl J, Carskadon MA.
Neurobehavioral performance of residents after heavy night
call vs after alcohol ingestion. JAMA 2005;294:1025–33.
[PubMed] [Full Text] ^
5. Dawson D, Reid K. Fatigue, alcohol and performance
impairment. Nature 1997;388:235. [PubMed] ^
6. Australian Transport Safety Bureau. Development of mea-
sures of fatigue: using an alcohol comparison to validate
the effects of fatigue on performance. Road Safety Research
Report CR 189. Canberra: ATSB; 2000. Available at: http://
www.infrastructure.gov.au/roads/safety/publications/2000/
pdf/Fatig_Alc.pdf. Retrieved September 7, 2011. ^
7. Rollinson DC, Rathlev NK, Moss M, Killiany R, Sassower KC,
Auerbach S, et al. The effects of consecutive night shifts on
neuropsychological performance of interns in the emer-
gency department: a pilot study. Ann Emerg Med 2003;
41:400–6. [PubMed] ^
Committee Opinion No. 519
COMMITTEE OPINIONS
8. Dula DJ, Dula NL, Hamrick C, Wood GC. The effect of
working serial night shifts on the cognitive functioning of
emergency physicians. Ann Emerg Med 2001;38:152–5.
[PubMed] ^
9. Rothschild JM, Keohane CA, Rogers S, Gardner R, Lipsitz SR,
Salzberg CA, et al. Risk of complications by attending physi-
cians after performing nighttime procedures. JAMA 2009;
302:1565–72. [PubMed] [Full Text] ^
10. Pilcher JJ, Huffcutt AI. Effects of sleep deprivation on per-
formance: a meta-analysis. Sleep 1996;19:318–26.
[PubMed] ^
11. Agency for Healthcare Research and Quality. The effect of
health care working conditions on patient safety. Evidence
Report/Technology Assessment No. 74. Rockville (MD):
AHRQ; 2003. Available at: http://www.ncbi.nlm.nih.gov/
books/NBK36875/. Retrieved August 30, 2011. ^
12. Friedman WA. Resident duty hours in American neuro-
surgery. Neurosurgery 2004;54:925–31; discussion 931–3.
[PubMed] ^
13. Smith-Coggins R, Rosekind MR, Hurd S, Buccino KR.
Relationship of day versus night sleep to physician per-
formance and mood. Ann Emerg Med 1994;24:928–34.
[PubMed] ^
14. National Transportation Safety Board. Factors that affect
fatigue in heavy truck accidents. NTSB Safety Study NTSB/
SS-95/01. Washington, DC: NTSB; 1995. ^
15. Federal Railroad Administration. The railroad fatigue risk
management program at the Federal Railroad Admini-
stration: past, present and future. Washington, DC: FRA;
2006. Available at: http://www.fra.dot.gov/downloads/safety/
fatiguewhitepaper112706.pdf. Retrieved September 7, 2011.
^
16. Kuhn G. Circadian rhythm, shift work, and emergency
medicine. Ann Emerg Med 2001;37:88–98. [PubMed] ^
17. Ellenbogen JM. Cognitive benefits of sleep and their loss due
to sleep deprivation. Neurology 2005;64:E25–7. [PubMed]
^
Copyright March 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Fatigue and patient safety. Committee Opinion No. 519. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2012;
119:683–5.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 771
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 520 • March 2012 (Replaces No. 380, October 2007)
Committee on Patient Safety and Quality Improvement
Committee on Professional Liability
This document reflects emerging concepts on patient safety and is subject to change. The information should not be construed as
dictating an exclusive course of treatment or procedure to be followed.

Disclosure and Discussion of Adverse Events

ABSTRACT: Disclosure and discussion of adverse events in health care with the patient are morally and
ethically necessary to achieve the optimal goal of respecting patient autonomy. Improving the disclosure process
through education, policies, programmatic training, and accessible resources will enhance patient satisfaction,
strengthen the physician–patient relationship, reduce physician stress, and, most importantly, promote safe and
high-quality health care.

Adverse outcomes, preventable or otherwise, are an
uncomfortable reality of medical care. Thus, health care
providers and institutions should understand how to best
disclose and discuss adverse events with patients and their
families.
Disclosing information about adverse events likely
has benefits for both parties through a strengthened
physician–patient relationship and a promotion of trust.
Studies show that in the event of an adverse outcome,
patients expect and want timely and full disclosure of the
event, an acknowledgement of responsibility, an under-
standing of what happened, expressions of sympathy, and
a discussion of what is being done to prevent recurrence
(1, 2). Surveys have shown that patients are more likely to
sue if they perceive that an honest disclosure of the event
was absent (3, 4). In studies of patients who sued their
health care providers for adverse perinatal events, 43%
were driven by a suspicion of a cover-up or by the desire
for revenge (5). Research demonstrates that disclosure of
adverse events is associated with higher ratings of quality
by patients, an improved rate of recovery, a decrease in
the number of malpractice suits, and a decrease in the
average settlement amount (6, 7). Additionally, disclosure
of adverse events can be important for both the patient’s
and the health care team’s healing process (8).
The call for health care organizations to develop pro-
cesses for full disclosure is broad-based. Patient advocacy
groups, patient safety experts, ethicists, policy makers,
accrediting organizations, and physician groups all advo-
cate the adoption of policies related to the disclosure and
discussion of adverse events. The Institute of Medicine
proposes a multifaceted approach toward reducing and
managing adverse events, including the establishment of a
national focus on patient safety, the creation of a manda-
tory reporting system, raising standards and expectations
for safety improvements at the national level, and creating
safety systems in health care organizations (9).
The Joint Commission requires that accredited hos-
pitals inform patients of adverse events. According to The
Joint Commission Standard RI.01.02.01, “the licensed
independent practitioner responsible for managing the
patient’s care, treatment, and services, or his or her des-
ignee, informs the patient about unanticipated outcomes
of care, treatment, and services” (10). A similar state-
ment is found in the ethics code of the American Medical
Association, which states that in cases in which “a patient
suffers significant medical complications that may have
resulted from a physician’s mistake . . . the physician is ethi-
cally required to inform the patient of all the facts neces-
sary to ensure understanding of what has occurred” (11).
In 2011, the Institute for Healthcare Improvement
published a second edition of its white paper that provides
an overall approach and tools designed to support pro-
cesses for managing serious clinical adverse events (12).
The American College of Obstetricians and Gynecologists
supports these efforts and seeks to assist members in
understanding the value of disclosure and discussion in
the face of preventable and nonpreventable adverse events
and to provide guidance for such conversations.
Barriers to full disclosure are many and include
fear of retribution for reporting an adverse event, lack
of training, a culture of blame, and fear of lawsuits
(13–15). To reduce these concerns, it is recommended
that health care facilities establish a nonpunitive, blame-
free culture that encourages staff to report adverse events
and near misses (close calls) without fear of retaliation.
Removing blame, however, does not eliminate individual
responsibility. Promoting a just culture enables frontline

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 772

 personnel to feel comfortable disclosing errors while
maintaining professional accountability. A just culture
recognizes that competent professionals make mistakes
and acknowledges that even competent professionals
may develop unhealthy norms, but has zero tolerance for
reckless behavior (16).
A number of health care organizations, insurance
carriers, and states have developed programs to educate
physicians about disclosure. One example is the consen-
sus statement of the Harvard Hospitals, When Things
Go Wrong: Responding to Adverse Events (17). These pro-
grams can provide valuable guidance and education
about the specifics of disclosure and apology. COPIC, a
professional liability insurance carrier for academic and
community physicians in Colorado, provides its physi-
cians with a training program and ongoing support in
error disclosure under the “3Rs Program,” which stands
for recognize, respond, and resolve unanticipated medi-
cal events (18).
In addition to addressing points from this brief
overview, physicians may wish to refer to other resources
before meeting with a patient and her family (18, 19)
(Box 1). To frame the process of a timely and accurate
disclosure, understanding and remembering who, what,
when, where, and how is helpful (6):
Who—The attending physician should lead the
discussion. If the physician cannot be present, it is
preferable to have a senior member of the health
care team lead the discussion. The circumstances
of the adverse event will often dictate what other
members of the health care team must also be pres-
ent. Whenever possible, at least two members of the
health care team should be involved in any discus-
sion of an adverse event with the patient and her
family.
What—Only factual information must be commu-
nicated to the patient. Patients must be reassured
that as additional, reliable information is obtained,
they will be notified promptly.
When—Even if all details of the incident are not
known, disclosure must be timely. Disclosure should
occur as soon as reasonably possible, while empha-
sizing to patients that it is an ongoing process of
communication.
Where—Disclosure should occur in a quiet and con-
fidential setting that will be most comfortable to the
patient.
How—Patient dignity must always be respected. A
disclosure conversation should include empathy for
an acknowledgment of what patients and their fami-
lies have experienced.
It is important to understand the difference between
expressions of sympathy (acknowledgement of suffering)
and apology (accountability for suffering). Expressions of
2 Committee Opinion No. 520
COMMITTEE OPINIONS
sympathy are always appropriate. The appropriateness of
an apology, however, will vary from case to case. When
considering whether an apology is appropriate, the physi-
cian should seek advice from the hospital’s risk manager
and the physician’s liability carrier. Among other matters,
the issue of appropriateness of recording the conversation
by the patient or her family can be discussed with these
entities. It is also important to be knowledgeable about
the state’s laws on apology and disclosure because these
laws vary and may have an effect on the way in which the
disclosure is conducted.
Box 1. Discussions With Patients
on Adverse Events
These general guidelines regarding disclosure conversa-
tions with a patient and/or her family may be helpful:
• If possible, before the disclosure, the facts of the error
should be gathered and investigated so that only the
most accurate information can be shared with the
patient.
• Disclosure, especially if the event is serious, should
be done as soon as possible. If all the facts are not yet
known, promise to return when the facts are known.
• Confidentiality must be preserved. The meeting with
the patient should take place in a private setting.
Determine whether a support person or guardian
should be present with the patient during the disclo-
sure.
• The disclosure itself should be done by the treating
physician or someone with whom the patient has
developed a relationship and trust who can begin the
conversation. Depending on the facility’s policy, the
risk manager or facility’s attorney, the nurse manager,
and others may be present during the disclosure.
• The focus should be on the patient’s condition, con-
cerns, and treatment plan and the patient should be
told that her treatment and care are the utmost con-
cern.
• Try to convey the information in terms that are under-
standable to the patient and that minimize patient
stress. Explain the known facts regarding what hap-
pened; it may not be possible to explain why it
happened. Let the family and patient know what will
be done to investigate the cause of the adverse event
and to prevent the error from occurring again, and
work with the patient to develop a treatment plan to
remedy or mitigate the effects of any injury resulting
from the error.
• Make sure to express appropriate regret for the error
and concern for the patient and her family.
Reproduced with the permission of Wolters Kluwer Health.
Pelt JL, Faldmo LP. Physician error and disclosure. Clin Obstet
Gynecol 2008;51:700–8. [PubMed]
2013 COMPENDIUM OF SELECTED PUBLICATIONS 773
 Health care institutions should have written poli-
cies that address the management of adverse events. The
Institute for Healthcare Improvement’s white paper is
an excellent resource for developing or improving these
policies. It contains the information necessary to form a
crisis management plan, establish a crisis management
team, and organize the internal and external communica-
tion needed for success (12). Once policies are developed,
health care organizations should work with health care
providers to assess the need for additional resources and
training such as disclosure coaching, mediation, and
emotional support for health care workers involved in
harmful medical errors (14, 20). Individual physicians
and physician practice groups may contact their local
hospitals, liability carriers, specialty organizations, or
medical societies for disclosure assistance training and
resources available to them. Anyone involved in disclo-
sure should be instructed not to make promises they can-
not guarantee. For example, a patient should not be told
that she will not incur expenses, only to later receive a bill.
Rather, she should be advised that the hospital finance
department or the physician office will work with her to
address these charges.
Several organizations have reported on the success
of their disclosure programs. One of the oldest pro-
grams advocating full disclosure of medical errors is the
Veterans Affairs Medical Center in Lexington, Kentucky.
In 1999, after their full disclosure policy had been in place
for 10 years, they reported that their facility’s median
liability payments were one fifth of the median liability
settlements for the private sector (21). The University
of Michigan Health System reported a 50% reduction in
legal fees and actions since implementing a policy in 2001
that encouraged disclosure and apology (22–24), and the
Illinois Medical Center at Chicago noted an average 50%
decrease in legal costs per case (25).
Disclosure and discussion of adverse events is criti-
cal to creating and maintaining high-quality health care
and the integrity of the physician–patient relationship.
A commitment on the part of all health care providers
to establish programs and develop the tools needed to
educate patients, health care providers, and families is
necessary. The American College of Obstetricians and
Gynecologists strongly supports these endeavors.
References
1. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ,
Levinson W. Patients’ and physicians’ attitudes regarding
the disclosure of medical errors. JAMA 2003;289:1001–7.
[PubMed] [Full Text] ^
2. Mazor KM, Simon SR, Yood RA, Martinson BC, Gunter MJ,
Reed GW, et al. Health plan members’ views about disclo-
sure of medical errors. Ann Intern Med 2004;140:409–18.
[PubMed] [Full Text] ^
3. Vincent C, Young M, Phillips A. Why do people sue doc-
tors? A study of patients and relatives taking legal action.
Lancet 1994;343:1609–13. [PubMed] ^
Committee Opinion No. 520
COMMITTEE OPINIONS
4. Beckman HB, Markakis KM, Suchman AL, Frankel RM.
The doctor–patient relationship and malpractice. Lessons
from plaintiff depositions. Arch Intern Med 1994;154:
1365–70. [PubMed] ^
5. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors
that prompted families to file medical malpractice claims
following perinatal injuries. JAMA 1992;267:1359–63.
[PubMed] ^
6. Weiss PM, Miranda F. Transparency, apology and disclo-
sure of adverse outcomes. Obstet Gynecol Clin North Am
2008;35:53–62, viii. [PubMed] ^
7. Helmchen LA, Richards MR, McDonald TB. How does
routine disclosure of medical error affect patients’ propen-
sity to sue and their assessment of provider quality?
Evidence from survey data. Med Care 2010;48(11):955–61.
[PubMed] ^
8. Allan A, McKillop D. The health implications of apologiz-
ing after an adverse event. Int J Qual Health Care 2010;
22:126–31. [PubMed] [Full Text] ^
9. Institute of Medicine. To err is human: building a safer
health system. Washington, DC: National Academy Press;
2000. ^
10. The Joint Commission. Comprehensive accreditation man-
ual. CAMH for hospitals: the official handbook. Oakbrook
Terrace (IL): Joint Commission; 2010. ^
11. American Medical Association. Patient information. In:
Code of medical ethics of the American Medical Asso-
ciation: current opinions with annotations. 2010–2011 ed.
Chicago (IL): AMA; 2010. p. 280–3. ^
12. Conway J, Federico F, Stewart K, Campbell MJ. Respectful
management of serious clinical adverse events (second edi-
tion). IHI Innovation Series white paper. Cambridge (MA):
Institute for Healthcare Improvement; 2011. Available at:
http://www.ihi.org/knowledge/Pages/IHIWhitePapers/
RespectfulManagementSeriousClinicalAEsWhitePaper.
aspx. Retrieved December 7, 2011. ^
13. Finkelstein D, Wu AW, Holtzman NA, Smith MK. When
a physician harms a patient by a medical error: ethical,
legal, and risk-management considerations. J Clin Ethics
1997;8:330–5. [PubMed] ^
14. Goldberg RM, Kuhn G, Andrew LB, Thomas HA Jr. Coping
with medical mistakes and errors in judgment. Ann Emerg
Med 2002;39:287–92. [PubMed] ^
15. Mello MM, Studdert DM, DesRoches CM, Peugh J, Zapert
K, Brennan TA, et al. Caring for patients in a malpractice
crisis: physician satisfaction and quality of care. Health Aff
2004;23:42–53. [PubMed] [Full Text] ^
16. Marx D. Patient safety and the “just culture”: a primer
for health care executives. New York (NY): Trustees of
Columbia University in the City of New York; 2001. Avail-
able at: http://www.mers-tm.org/support/Marx_Primer.
pdf. Retrieved August 16, 2011. ^
17. Massachusetts Coalition for the Prevention of Medical
Errors. When things go wrong: responding to adverse
events. A consensus statement of the Harvard Hospitals.
Burlington (MA): MCPME; 2006. Available at: http://www.
macoalition.org/documents/respondingToAdverseEvents.
pdf. Retrieved August 15, 2011. ^
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 774
 18. COPIC Companies. 3Rs program. Denver (CO): COPIC
Companies; 2009. Available at: http://www.callcopic.com/
home/what-we-offer/coverages/medical-professional-
liability-insurance-ne/nebraska-pli/special-programs/
3rs-program. Retrieved August 16, 2011. ^
19. Woods JR, Rozovsky FA. What do I say? Communicating
intended or unanticipated outcomes in obstetrics. San Fran-
cisco (CA): Jossey-Bass; 2003. ^
20. Liebman CB, Hyman CS. A mediation skills model to
manage disclosure of errors and adverse events to patients.
Health Aff 2004;23:22–32. [PubMed] [Full Text] ^
21. Kraman SS, Hamm G. Risk management: extreme honesty
may be the best policy. Ann Intern Med 1999;131:963–7.
[PubMed] [Full Text] ^
22. Gallagher TH, Levinson W. Disclosing harmful medical
errors to patients: a time for professional action. Arch
Intern Med 2005;165:1819–24. [PubMed] ^
23. National Medical Error Disclosure and Compensation Act,
S 1784, 109th Cong, 1st Sess (2005). Available at: http://
www.gpo.gov/fdsys/pkg/BILLS-109s1784is/pdf/BILLS-
109s1784is.pdf. Retrieved August 15, 2011. ^
4 Committee Opinion No. 520
COMMITTEE OPINIONS
24. Boothman RC, Blackwell AC, Campbell DA Jr, Commiskey
E, Anderson S. A better approach to medical malpractice
claims? The University of Michigan experience. J Health Life
Sci Law 2009;2:125–59. [PubMed] ^
25. McDonald TB, Helmchen LA, Smith KM, Centomani N,
Gunderson A, Mayer D, et al. Responding to patient safety
incidents: the “seven pillars.” Qual Saf Health Care 2010;
19:e11. [PubMed] [Full Text] ^
Copyright March 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Disclosure and discussion of adverse events. Committee Opinion
No. 520. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;119:686–9.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 775
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 523 • May 2012
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.

Re-entering the Practice of Obstetrics and Gynecology

ABSTRACT: Re-entering the practice of obstetrics and gynecology after a period of inactivity can pose a
number of obstacles for a physician. Preparing for the leave of absence may help reduce the difficulties physi-
cians may face upon re-entering practice.

Physicians decide to modify or leave practice for a wide
variety of reasons. Factors may include unexpected injury
or illness, military service, the need to care for family
members, or continuing education. Some physicians may
decide to modify their practices, for example, by not
practicing obstetrics, by practicing as a hospital-based
obstetrician (laborist), or by eliminating surgery from
their practices. Leaving medical practice may be emo-
tionally charged and may potentially affect relationships
with patients, practice partners, colleagues, and family
members. There also may be financial implications con-
nected to a modification of practice. Consequently, creat-
ing a plan in advance is recommended, particularly if the
physician plans to re-enter practice at a future date. This
document includes information for physicians who vol-
untarily modify or leave clinical practice and are in good
standing in their practice setting at the time of modifica-
tion or departure (Box 1).
Advance Considerations
Physicians planning to leave or significantly modify their
practices should understand the complexities involved
with re-entering practice. Because a physician who leaves
a medical practice is in a significantly different position
from a physician who continues to practice at a reduced
schedule (1), the following should be considered:
• Practice Partners—Communicate future plans with of physical illness or injury or to take care of a family
colleagues with as much advance notice as possible,
particularly those with whom call responsibilities are
shared.
• Patients—Patients should be notified of plans to • Financial—Contact the appropriate professional
modify practice. State licensing boards may require
patient notification of leaves of absence and transfers
of patient care, including medical records.
• Licensing and Certification—Become familiar with
requirements for change of practice activity because
these vary among states. It is important to consider
state requirements for maintenance of licensure
and whether it is possible to place one’s license in
an inactive status. Additionally, be aware that Main-
tenance of Certification (MOC) requirements by the
American Board of Obstetrics and Gynecology are
based on an annual cycle.
• Clinical Competence—Maintaining clinical compe-
tence is critical to the re-entry process. Staying
knowledgeable about current practice guidelines and
recommendations may be accomplished by network-
ing with colleagues or identifying a mentor with whom
to meet during the period of clinical inactivity (1).
Attending continuing medical education (CME) pro-
grams, either in person or online, also should be
considered. Whenever possible, physicians in active
practice should cooperate with retraining efforts of
returning peers and colleagues.
• Employment—If employed, discussions regarding
leaves of absence should be held with the appropri-
ate member of the human resources department to
discuss issues such as defined benefits and potential
requirements during a short or extended leave of
practice. When a physician leaves practice because
member, provisions of the Family and Medical Leave
Act may be applicable and may require advance noti-
fication.
liability carrier if leaving practice. Consider whether
extended reporting period endorsement (tail cover-
age) will be necessary and, if so, who will pay for this

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 776

 coverage. Fees for licensure and professional asso-
ciation membership may still need to be paid dur-
ing any absence. Physicians with academic careers
should understand that an absence may affect future
promotions or tenure.
Alternative Practice Considerations
During any period of clinical inactivity, physicians are
likely to fall behind in incorporating new knowledge
into clinical practice. New drugs, devices, and evidence-
based changes in clinical decision making are continuously
incorporated into clinical care. In addition, changes in
electronic interfaces, information technology, and equip-
ment will occur, potentially resulting in a knowledge
gap upon return to practice. Consequently, physicians
should consider participating in activities that keep them
informed of changes in clinical care by volunteering,
teaching, or shadowing a physician (1). Job sharing or
locum tenens work is another option for maintaining at
least some clinical practice during a period of inactivity.
Thorough records should be maintained to document
practice activities that will be needed for future practice
or employment opportunities. These records also will be
important for maintaining CME requirements for licen-
sure and specialty board certification. Keeping up with
current literature is also valuable even when CME credit
is not available.
It also may be useful to network with colleagues
during a period of reduced practice or inactivity. For
example, attending local medical society meetings may
provide opportunities to keep up with changes in local
medical referral relationships and other local health sys-
tem matters (1).

Preparing for Re-entry

Box 1. Considerations at Various Stages Unless adequate advance preparations are made before
of the Re-entry Process ^ leaving clinical practice, physicians may face a number of
barriers upon re-entry. The following elements should be
Before Leaving considered when returning to practice:
• Communicate with practice partners regarding
coverage • Current Licensure and Drug Enforcement Agency
Registration and State-Specific Controlled Prescrib-
• Inform patients about intended plans
ing Licensure—Difficulties may exist in meeting
• Contact medical liability carrier state licensing board requirements for re-entry. Most
• Find out requirements for maintenance of licensure states recommend, and several require, that physi-
and certification cians who take a leave of absence for more than
• Review medical staff bylaws provisions about return 24 months participate in a physician re-entry pro-
to practice after period of inactivity gram (2). The amount of time needed or required
for educational experiences to be able to re-enter
During Absence
practice may be quite extensive. Unless adequately
• Participate in continuing medical education activities prepared, a physician returning to practice may not
and catalog hours
have obtained sufficient CME credit to fulfill the
• Consider volunteering, teaching, or shadowing a respective state’s requirements for maintainance of
physician licensure. Sufficient time should be allotted to ensure
• Maintain current licensure, which will be difficult to that the pertinent state licensing provisions have
get back once it has expired* been met before re-entry.
During Re-entry • Board Certification and Maintenance of Certifica-
• Ensure the following are in place*: tion—The American Board of Obstetrics and Gyne-
cology has the option to designate a Diplomate as
—Board certification
“not currently in practice.” These physicians would
—Licenses only need to complete Parts 1 through 3 of the MOC.
—Medical liability insurance When returning to practice, the Diplomate would
—Drug Enforcement Administration registration, if simply notify the American Board of Obstetrics and
applicable Gynecology and the designation “not currently in
—Credentialing: hospital (including proctor) and practice” would be removed. However, Diplomates
insurance carriers who have not kept up with MOC will need to pass a
• Investigate re-entry programs re-entry test.
*American Academy of Pediatrics. A physician reentry into
• Medical Liability Insurance—Many organizations,
the workforce inventory. Elk Grove Village (IL): AAP; 2010. insurers, or managed care organizations may be
Available at: http://www.physicianreentry.org/yahoo_site_ unwilling to provide coverage to physicians who
admin/assets/docs/Inventory_Checklist_Web_Version. have not recently been in practice. Consequently, it is
10125922.pdf. Retrieved October 20, 2011. important to contact the professional liability carrier
well in advance of plans to return to practice.

2 Committee Opinion No. 523

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 777

 • Credentialing and Privileging—There may be sig-
nificant variations of requirements between hospitals
for a physician seeking reinstatement of hospital
privileges. The hospital may be unwilling to grant
privileges to a physician who has been out of prac-
tice. Even when an application is accepted, it may be
difficult to find a physician on staff at the hospital
willing to serve as a proctor during the provisionary
period. Physicians who left practice for a medical
reason should obtain documentation from their
physicians as to their fitness for the return to practice
or any limitations to their ability to practice (1).
• Current Clinical Competence—The most difficult standards for re-entry programs or suggested standards
part of resuming practice after a period of inactivity
is the ability to demonstrate current clinical com-
petence. When a physician has not practiced at all
during the period of inactivity, it may be necessary
to consider participating in a re-entry program. Fac-
tors that influence the duration and intensity of
re-entry requirements are highly individualized and compensation of preceptors.
include not only the length of the absence, but
also the experience level of the physician involved.
Re-entry programs differ in experience offered, time
in retraining, and supervision. Programs vary with
regard to cost, distance from home, and flexibility.
At this time, no standardization or oversight across with the standardized assessment tools through the Post
programs is offered. The programs also may struggle
to provide documentation sufficient to adequately
establish physician competency. Re-entering prac-
tice requires regaining the numerous skills inherent
in the practice of medicine, a process that may take
months to accomplish. Simulation training may play
an important part in various components of retrain-
ing. The Joint Commission now requires a period of
Focused Professional Practice Evaluation for every
physician initially requesting privileges (3). However,
it is the responsibility of the chair or chief of staff,
and ultimately the governing board, to confirm that
the physician has demonstrated current competence
in order to grant privileges to admit and care for
patients.
Physicians who are returning to practice after a
period of inactivity will need to consider a variety of fac-
tors before applying for hospital privileges. Factors such
as liability insurance, proctoring, and, most importantly,
demonstrating current clinical competence, will be criti-
cal. If retraining is necessary, the cost must be determined
and the responsible party(ies)—the physician, hospital,
or medical staff—must have a mechanism for contribut-
ing specifically to those costs.
Re-entry Programs
Few organizations have developed re-entry programs for
physicians who have taken time off from clinical practice.
At the present time, none are endorsed or sponsored by
the American College of Obstetricians and Gynecologists.
Committee Opinion No. 523
COMMITTEE OPINIONS
In general, there are two types of re-entry programs: 1)
evaluation and assessment and 2) retraining.
Evaluation and assessment programs, which consti-
tute the majority of programs currently available, do not
involve retraining. They are short in duration and last sev-
eral days at most. They focus on the cognitive component
of practice. In contrast, retraining programs may last for
weeks to months. They typically cover cognitive skills and
fund of knowledge but often not the manual skills applied
in surgery. Currently, there are no accrediting bodies that
oversee and approve the content of these programs.
At the present time, no specialty society has endorsed
for hospitals to use when credentialing and privileging
re-entering physicians. Procedural and technical certifi-
cations are the most challenging component and, at this
time, are individualized. Considerations for the develop-
ment of a re-entry program include competition with
residents for cases, use of simulators for manual skills, and
The National Board of Medical Examiners and the
Federation of State Medical Boards have developed a
collaborative relationship with a number of national
assessment programs that have the capability to provide
localized, performance-based assessments in conjunction
Licensure Assessment System (4). Information from these
organizations’ web sites may serve as a resource. In addi-
tion, a collaborative endeavor called the Physician Re-entry
into the Workforce Project, which consists of organizations
such as the American Medical Association, the American
Academy of Family Physicians, and the American Academy
of Pediatrics, examines practice re-entry and creates guide-
lines, recommendations, and strategies that will serve to
assist and protect physicians (1) (see Resources).
Conclusion
There are times in a professional career where leaving
practice is a necessity; in these situations, strong con-
sideration should be given to the logistics involved in
practice re-entry. These factors may be costly and time
consuming. Consequently, when possible, it is important
to carefully plan both practice departure and re-entry and
allow sufficient time and resources for these processes.
Using a departure checklist, which includes the following
elements, could be useful:
• Suspend medical license, hospital privileges, insurer
credentials, professional liability insurance, and
board certification in such a way that they can be
reactivated with minimal difficulty.
• Continue contact with the profession and colleagues
through MOC, attending grand rounds, CME oppor-
tunities, and social networking.
When possible, physicians should strongly consider
the option of limited clinical activity rather than none
at all. Because there is no national standard for practice
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 778
 departure and re-entry and because all credentialing Physician Reentry Program
and privileging is local, each physician and hospital will Cedars-Sinai Medical Center
ultimately have to determine the process by which the 8700 Beverly Boulevard
hospital and professional liability carriers will credential Los Angeles, CA 90048
and privilege physicians re-entering practice. Tel: (310) 423-5262
Web: www.cedars-sinai.edu/Medical-Professionals/
Resources ^ Resources-for-Physicians/Reentry-Program.aspx
Center for Transforming Medical Education, American Physician Re-Entry Program
Medical Association. Physician re-entry to the workforce: Oregon Health and Science University
Continuing Medical Education, L-602
recommendations for a coordinated approach. Chicago 3181 SW Sam Jackson Park Road
(IL): AMA; 2010. Available at: http://www.ama-assn.org/ Portland, OR 97239
ama1/pub/upload/mm/40/physician-reentry-recommen- Tel: (503) 494-4904
dations.pdf. Retrieved October 20, 2011. Web: www.ohsu.edu/xd/education/schools/school-of-
American Medical Association. Physician re-entry. medicine/gme-cme/cme/physician-reentry.cfm.
Available at: http://www.ama-assn.org/ama/pub/educa- Upstate New York Clinical Competency Center at Albany
tion-careers/finding-position/physician-reentry.page. Medical College
Retrieved October 20, 2011. MC #34 47 New Scotland Avenue
Albany, NY 12208
Physician Re-entry Programs (as of August 2011)* Tel: (518) 262-5919
The Center for Personalized Education for Physicians
(CPEP)
7351 Lowry Boulevard, Suite 100 References
Denver, CO 80230 1. American Academy of Pediatrics. A physician reentry
Tel: (303) 577-3232 into the workforce inventory. Elk Grove Village (IL):
Web: www.cpepdoc.org AAP; 2010. Available at: http://www.physicianreentry.org/
Drexel Medicine® Physician Refresher/Re-Entry Course yahoo_site_admin/assets/docs/Inventory_Checklist_Web_
Drexel University College of Medicine Version.10125922.pdf. Retrieved October 20, 2011. ^
Office of Continuing Medical Education 2. Bower EA, English C, Choi D, Cedefeldt AS, Girard ED.
1427 Vine Street, Room 405 Education to return nonpracticing physicians to clinical
Philadelphia, PA 19102 activities: a case study in physician reentry. J Contin Educ
Tel: (215) 762-2580 Health Prof 2010;30:89–94. [PubMed] ^
(215) 991-8535 3. The Joint Commission. Comprehensive accreditation man-
Web: http://webcampus.drexelmed.edu/refresher/ ual. CAMH for hospitals: the official handbook. Oakbrook
default.asp Terrace (IL): Joint Commission; 2011. ^
Florida Competency Advancement Program
4. National Board of Medical Examiners. Post-licensure assess-
PO Box 100277
ment system (PLAS). Available at: http://www.nbme.org/
Gainesville, FL 32610
clinicians/collaborators.html. Retrieved October 20, 2011.
Tel: (352) 273-9063
^
KSTAR Program
Texas A & M Health Science Center
Health Professions Education Building
8447 State Highway 47
Bryan, Texas 77807
Tel: (979) 436-0390
Web: www.rchitexas.org/KStar/index.html
PACE Program
University of California, San Diego
1899 McKee Street, Suite 126
San Diego, CA 92110 Copyright May 2012 by the American College of Obstetricians and
Tel: (619) 543-6770 Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
Web: www.paceprogram.ucsd.edu be reproduced, stored in a retrieval system, posted on the Internet,
Pennsylvania Medical Society or transmitted, in any form or by any means, electronic, mechani-
PMSCO Healthcare Consulting cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
777 East Park Drive photocopies should be directed to: Copyright Clearance Center, 222
Harrisburg, PA 17111 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Tel: (888) 294-4336
ISSN 1074-861X
Web: www.consultpmsco.com
Re-entering the practice of obstetrics and gynecology. Committee
*Inclusion in this listing should not be construed as support or endorse- Opinion No. 523. American College of Obstetricians and Gynecologists.
ment by the American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;119:1066–9.

4 Committee Opinion No. 523

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 779

 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS
COMMITTEE OPINION
Number 526 • May 2012
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.
Standardization of Practice to Improve Outcomes
ABSTRACT: Protocols and checklists have been shown to improve patient safety through standardization
and communication. Standardization of practice to improve quality outcomes is an important tool in achieving the
shared vision of patients and their health care providers.
Protocols and checklists have been shown to reduce
patient harm through improved standardization and
communication (1–7). In the absence of evidenced-based
medicine for a given clinical decision (8), development of
these protocols sometimes may be contentious. However,
the use of checklists and protocols has clearly been dem-
onstrated to improve outcomes and their use is strongly
encouraged (1). Refinement and sophistication of check-
lists has shown decreased morbidity and mortality by
meeting standards of care (9). Factors other than patient
safety and quality, such as cost containment and utiliza-
tion, should not be the prime consideration for using
these tools.
It is clear that wide variation exists in many areas
of practice within obstetrics and gynecology. Two types
of variation are recognized by scholars in the field of
medical process improvement. Necessary clinical variation
is that which is dictated by, among others, differences
such as a patient’s age, ethnicity, weight, medical history,
and desired outcomes of therapy. Unexplained clinical
variation is that which is not accounted for by any of
these things. Variation in processes of care is problematic
because it leads to increased rates of error. Performing
critical tasks the same way every time can reduce the kind
of slips and lapses that all human beings are subject to,
especially when fatigue is a factor and in stressful environ-
ments such as the labor and delivery suite or operating
room. Elimination of variation in processes has been a
cornerstone of improved performance and reliability
over the past several decades in commercial aviation. In
health care, a similar level of success has been achieved
in the field of anesthesia, where adverse events have been
significantly reduced over the past 25 years through stan-
dardization of patient monitoring, dispensing of inhaled
gases, and medication administration. In obstetrics, stan-
COMMITTEE OPINIONS
dardization of antenatal testing for group B streptococci,
combined with standardized antibiotic prophylaxis, has
resulted in a marked reduction in the incidence of neona-
tal group B streptococcal infection. Similarly, standard-
ization of any process of care through the use of protocols
and checklists can be expected to achieve a similar reduc-
tion in harmful events. These should be recognized as a
guide to the management of a clinical situation or process
of care that will apply to most patients. For the occasional
patient whose care proves to be an exception for valid
reasons, the physician should document in the medical
record why the protocol is not being followed.
It is imperative that obstetrician–gynecologists take
the lead in designing and collaboratively implementing
standardized protocols and checklists for their practices
in the hospital and the office setting. If physicians are
not actively engaged in defining the process, it may be
imposed on them from external sources. If externally
crafted, the process and requirements may or may not
be evidence-based or appropriate. The motivation and
intent for any protocol or checklist should be to ensure
high-quality, safe, and, when possible, evidence-based
practice. Although not driven by economics, standard-
ization often will result in significant economic savings.
When standardized care is used, quality increases, varia-
tion decreases, and cost decreases (8, 10–13).
The process to develop these protocols must be col-
laborative, inclusive, and multidisciplinary, and should
include hospital administration working with and sup-
porting health care providers, patient advocates, nurses,
and support staff in their initiatives. Although the com-
ponents of a particular checklist or protocol may be
established at a national level and some requirements
may be mandated by regulatory agencies such as federal
or state governments or The Joint Commission, they may
2013 COMPENDIUM OF SELECTED PUBLICATIONS 780
 be adapted to the local practice setting; thus, standard-
ization of checklists or protocols within an institution is
strongly encouraged. It is important that physicians are
informed whenever checklists or protocols are to be used.
Encouraging input from physicians in the review and dis-
tribution of checklists and protocols will help foster buy-
in from physicians for their use. Procedures should be in
place for notifying and training all practitioners whenever
the use of these tools is to be implemented.
Adverse outcomes often occur because of system
deficiencies or inadequate safety measures that fail to pre-
vent error from causing harm. Standardization is a pro-
cess to be used to overcome system deficiencies, which,
with data analysis, will decrease or prevent errors or
reduce the likelihood of their recurrence.
Obstetrician–gynecologists are committed to con-
tinuously improving safety in the care of their patients.
Standardization of practice to improve quality outcomes
is an important tool in achieving the inspired shared
vision of patients and their health care providers. The
responsibility clearly focuses on innovative, empowered,
and committed physician leadership. Continuous quality
improvement depends on a disciplined and well-defined
data-driven process that is constantly monitored and
improved. The process is ideally led by obstetrician–
gynecologists in collaboration with nurses and other
health care professionals to achieve the highest level of
quality and safety in women’s health care.
References
1. Gawande A. The checklist manifesto: how to get things
right. New York (NY): Metropolitan Books; 2009. ^
2. Kirkpatrick DH, Burkman RT. Does standardization of
care through clinical guidelines improve outcomes and
reduce medical liability? Obstet Gynecol 2010;116:1022–6.
[PubMed] [Obstetrics & Gynecology] ^
3. Patient safety in obstetrics and gynecology. ACOG Com-
mittee Opinion No. 447. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2009;114:1424–7.
[PubMed] [Obstetrics & Gynecology] ^
4. Pizzi L, Goldbarb N, Nash D. Crew resource management
and its applications in medicine. In: Agency for Healthcare
Research and Quality. Making health care safer: a criti-
cal analysis of patient safety practices. Evidence Report/
Technology Assessment No. 43. Rockville (MD): AHRQ;
2001. p. 505–13. ^
2 Committee Opinion No. 526
COMMITTEE OPINIONS
5. Ransom SB, Pinsky WW, Tropman JE, editors. Enhancing
physician performance: advanced principles of medical
management. Tampa (FL): American College of Physician
Executives; 2001. ^
6. Berwick DM. A user’s manual for the IOM’s ‘Quality
Chasm’ report. Health Aff 2002;21(3):80–90. [PubMed]
[Full Text] ^
7. Grol R. Between evidence-based practice and total quality
management: the implementation of cost-effective care.
Intl J Qual Health Care 2000;12:297–304. [PubMed] [Full
Text] ^
8. Landon BE, Norwood SL, Blumenthal D, Daley J. Physician
clinical performance assessment: prospects and barriers.
JAMA 2003;290:1183–9. [PubMed] [Full Text] ^
9. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH,
Dellinger EP, et al. A surgical safety checklist to reduce mor-
bidity and mortality in a global population. Safe Surgery
Saves Lives Study Group. N Engl J Med 2009;360:491–9.
[PubMed] [Full Text] ^
10. Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker
N, de Bernis L. Evidence-based, cost-effective interven-
tions: how many newborn babies can we save? Lancet
Neonatal Survival Steering Team. Lancet 2005;365:977–88.
[PubMed] [Full Text] ^
11. Timmermans S, Mauck A. The promises and pitfalls
of evidence-based medicine. Health Aff 2005;24:18–28.
[PubMed] [Full Text] ^
12. Priori SG, Klein W, Bassant JP. Medical Practice Guidelines.
Separating science from economics. European Society of
Cardiology. Eur Heart J 2003;24:1962–4. [PubMed] [Full
Text] ^
13. Brown GC, Brown MM, Sharma S. Health care in the
21st century: evidence-based medicine, patient preference-
based quality, and cost effectiveness. Qual Manag Health
Care 2000;9:23–31. [PubMed] ^
Copyright May 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Standardization of practice to improve outcomes. Committee Opinion
No. 526. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;119:1081–2.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 781
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 531 • August 2012 (Replaces No. 331, April 2006 and No. 400, March 2008)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.

Improving Medication Safety

ABSTRACT: Despite significant national attention, medical errors continue to pervade the U.S. health care
system. Medication-related errors consistently rank at the top of all medical errors, which account for thousands
of preventable deaths annually in the United States. There are a variety of methods—ranging from broad-based
error reduction strategies to the adoption of sophisticated health information technologies—that can assist obste-
trician–gynecologists in minimizing the risk of medication errors. Practicing obstetrician–gynecologists should be
familiar with these various approaches that, along with efforts directed at assisting the patient in understanding
the medical condition for which a medication is prescribed, can improve the safety and efficacy of medication use.

Background designed equipment, noisy working conditions, interrup-

In its report, Preventing Medication Errors, the Institute of
Medicine (IOM) defines a medication error as “any error
occurring in the medication-use process” (1). Examples
include wrong dosage prescribed, wrong dosage admin-
istered for a prescribed medication, or failure to give a
medication (by the health care provider) or take a medi-
cation (by the patient). Research has shown that there is
at least one medication error per hospital patient per day
(1). Studies indicate that 400,000 preventable drug-related
injuries occur each year in hospitals, which result in
additional costs estimated at 3.5 billion dollars (1). Many
of the early studies identified rates of errors and adverse
drug events in large, academic hospitals; however, one
study reported an adverse drug event rate of 15.0 per 100
admissions in the community setting, where most patients
receive care (2). These results are twice the adverse drug
event rate identified in earlier studies performed in the
academic setting (6.5 adverse drug events per 100 admis-
sions) (3). Seventy five percent of the adverse drug events
identified in this study were classified as preventable.
Despite improved technology in the health care set-
ting, errors related to medication use continue. In a study
that involved 10 hospitals in North Carolina, investigators
reported that harm occurred in 18.1% of patient admis-
sions. Among the causes of harm, medications are ranked
second after procedures (4).
Human factors inherently limit the safety of health
care processes and contribute to medication errors.
Factors such as fatigue, inattention, memory lapse, lack
of knowledge, failure to communicate, use of poorly
tions, and numerous other personal and environmental
factors all play a role. Researchers have found that com-
munication errors are the most common contributing
factor in medication errors and adverse drug events (5).
Communication issues noted in this study included both
written and verbal issues. Examples of written communi-
cation problems included wrong dosages or wrong drugs
on written prescriptions or wrong medications noted on
patient medication lists. Verbal communication issues
noted included “misunderstood verbal physician orders,
miscommunication between patients and pharmacists,
and miscommunication between nurses and pharmacists
regarding correct medication or dosage” (5). According
to The Joint Commission, accurate and complete medica-
tion reconciliation, the process of comparing a patient’s
medication orders to all of the medications that the
patient has been taking, can prevent numerous prescrib-
ing and administration errors (6). Leading patient safety
organizations are focusing on improving practices that
involve medication prescribing and administration and
have endorsed systems improvements, including auto-
mated and nonautomated technologies to reduce harmful
medication-related errors.
Research has shown that approximately 75% of all
medication errors occur at the ordering or administra-
tion phase (3). There are several types and causes of
medication order errors, such as allergy-related contrain-
dications that go undetected, inappropriate dosage forms,
and excessive dose administration (7, 8). Medication order
errors also occur from fundamental causes, such as

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 782

 poorly written or misinterpreted handwritten medica-
tion orders. Recent findings suggest that incomplete
computer-generated prescriptions also can be fraught
with errors, which indicates that “implementing a com-
puterized prescribing system without comprehensive
functionality and processes in place to ensure meaningful
system use does not decrease medication errors” (9).
The complexity of prescribing drugs is attributed,
in part, to the number of agents, which has increased at
a staggering rate. Prescription problems, such as illegible
words, missing components, and the inappropriate use of
abbreviations, have been anecdotally reported for many
years. The problem has been compounded in recent years
because of the influx of new drugs with names that look-
alike and soundalike, which make prescription interpre-
tation more difficult (10). Similarity, soundalike trade
names also can be problematic. The Institute for Safe
Medication Practices issues alerts about similarities in
medication names or packaging.
Broad-Based Strategies for Improving
Medication Safety
A fundamental step in improving medication safety is for
physicians and other health care providers to be famil-
iar with the medications that are available to treat their
patients. There are several ways to accomplish this:
• Maintain up-to-date references of current medica-
tions and have those references available at the time
the drug is prescribed.
• Understand the patient’s condition and diagno-
sis and indications for the medication considered,
including all alternative therapies.
• Consider conditions that may affect the efficacy of acceptable abbreviations. The Joint Commission has
the medication, such as dosages, route of administra-
tion, patient weight, renal and hepatic functioning,
and other important patient characteristics, such as
pregnancy.
• Understand the potential interactions between a viations and other medication safety recommenda-
newly prescribed medication and other medications
already being used by the patient, including non-
prescribed medications and supplements, as well as
therapies being considered (including surgical treat-
ments).
• Recognize the potential risk of high-alert medica-
tions, those drugs that bear a heightened risk of caus-
ing significant patient harm if there is an error in the
medication-use process. Intravenous oxytocin has
been identified by the Institute for Safe Medication
Practices as one such drug (11).
Other strategies to improve medication safety include the
following:
• Ensure that a patient’s current medication is contin-
ued, if appropriate, when admitting that patient to
the hospital and that additional medication used dur-
2 Committee Opinion No. 531
COMMITTEE OPINIONS
ing the hospital stay is compatible with the patient’s
current therapeutic regimen.
• Emphasize medication reconciliation during periods
of care transition, including admission and discharge
and subsequent follow-up in the ambulatory setting.
• Provide relevant patient education about the reason
the medication is needed. Pay attention to cultural
or educational needs to ensure understanding, and
communicate the reasons for changes to a patient’s
medication regimen.
The essentials of safely writing medication orders include
focusing on certain elements of the order as follows:
• Medication orders should be legible and should
include the following components: name of the
drug, dose, route of administration, frequency (or
rate), reason or conditions under which the drug
should be administered if prescribing pro re nata
(p.r.n.); and patient’s weight and age (if relevant to
dosage). Writing an incomplete medication order
substantially increases the risk of a medication error.
The prescriber’s signature and identification number
should be included in the prescription.
• Zeros and decimal points. The misusage of leading
decimals and trailing zeros can be dangerous. The
adage “always lead, never follow” can help mitigate
errors, which can lead to 10-fold or 100-fold dosage
errors (eg, always write 0.1, never write 1.0).
• Standardized abbreviations. The use of nonstandard-
ized abbreviations creates confusion and can con-
tribute to medication errors if the abbreviations are
not interpreted as intended by the prescriber. Most
health care institutions have standardized lists of
also developed a list of “Do Not Use” abbreviations
that has been supported by the American College of
Obstetricians and Gynecologists. In addition, some
organizations provide alerts about dangerous abbre-
tions on their web sites (11, 12).
• Pro re nata medication orders. When prescribing a
medication, it is important to provide the reasons for
giving the medication or the parameters for giving a
p.r.n. dose. This is particularly helpful in preventing
errors with medications that soundalike and look-
alike or for medications that are to be given on an as-
needed basis (eg, p.r.n. moderate to severe cramping,
rather than just p.r.n.).
• Verbal medication orders should be limited to urgent
situations in which written (or electronic) medication
orders are not feasible. To ensure accuracy, verbal
medication orders (whether in person or by tele-
phone) should always be followed by a read-back by
the person receiving the order. The prescriber should
ask the receiver to repeat the order to the prescriber
if it has not been read back already. Because many
2013 COMPENDIUM OF SELECTED PUBLICATIONS 783
 drugs have names that soundalike, it is also helpful to
include the indication for the drug in verbal medica-
tion orders.
Interruptions may potentially result in medical
errors. It is important for all members of the team to
eliminate or minimize interruptions of the nurse who
is preparing medications or in the process of dispensing
medications. Strategies, such as no distraction zones, do
not disturb signs over medication preparation areas, and
use of colored vests worn by health care providers during
the medication administration process are examples of
methods for alerting colleagues not to interrupt health
care providers while they are focused on tasks related to
the preparation or administration of medications.
Using Health Information Technology
to Improve Medication Safety
In 2009, the Health Information Technology for Economic
and Clinical Health Act created an opportunity for
professionals and hospitals to qualify for Medicare and
Medicaid incentive payments if they implemented a certi-
fied electronic health record (EHR) technology that met
specific objectives. As of 2011, health care providers and
hospitals must demonstrate “meaningful use of a certified
EHR” in order to receive these bonus payments. Among
the Meaningful Use Core Measures, several objectives are
specific to medication management and include the fol-
lowing (13):
• Maintain an active medication allergy list chances that illegible prescriptions or improper dosages
• Maintain an active medication list
• Use computerized physician order entry for medica-
tion orders
• Generate and transmit electronic prescriptions for
noncontrolled substances
There are many information technology applications
for medication safety. These include computerized physi-
cian order entry, electronic prescribing, automated dis-
pensing cabinets, bar coding coupled with an electronic
medication administration record, and intravenous infu-
sion technology (smart pumps). Evidence now exists to
support the patient safety benefit of each of these technol-
ogy systems. Two technology-based strategies specific to
obstetrician–gynecologists who have direct involvement
in the ordering and prescribing of medications include
computerized physician order entry and electronic pre-
scribing.
Computerized Physician Order Entry
Computerized physician order entry refers to a computer-
based system of ordering medications, laboratory tests,
and diagnostic tests. Health care providers directly enter
orders into a computer system that ensures standardized,
legible, and complete orders. To maximize its benefits,
computerized physician order entry should include some
levels of clinical decision support. A clinical decision sup-
Committee Opinion No. 531
COMMITTEE OPINIONS
port system is an “active knowledge system that uses two
or more items of patient data to generate case-specific
advice” (14). The system typically is designed to integrate
a medical knowledge base, patient data, and an inference
engine to generate case-specific advice. Computerized
physician order entry has been evaluated and endorsed by
the IOM, Agency for Health Care Research and Quality,
The Leapfrog Group, National Quality Forum, Institute
for Safe Medication Practices, and the American Hospital
Association (14–16).
To meet Stage 1 Meaningful Use criteria, eligible
health care providers must demonstrate that more than
30% of their patients who have at least one medication
listed on their medication list have at least one medication
order entered using computerized physician order entry.
Electronic Prescribing
Electronic prescribing (also known as e-prescribing) refers
to a prescriber’s ability to electronically send an accu-
rate, error-free, and understandable prescription directly
to a pharmacy from the point-of-care (17). Although
electronic prescribing is a function usually found within
computerized physician order entry systems and embed-
ded in many, if not all, electronic medical records, free-
standing electronic prescribing systems also are available.
These programs are Internet accessible and can be used
with existing office computers or wireless systems. Similar
to computerized provider order entry, electronic pre-
scribing can contribute to patient safety by reducing the
are accidentally written. In addition, the direct transmis-
sion of a prescription to the pharmacy, as well as the
formulary checks many systems can perform, have the
potential to reduce phone calls from pharmacists who
request clarification (1). Research has shown that elec-
tronic prescribing with direct transmission can reduce
dispensing errors and, therefore, improve safety. In
one study, the electronic prescribing dispensing error
rate for electronically transmitted prescriptions from a
clinic directly to the pharmacy was one half that of the
clinic’s baseline dispensing error rate (P=0.03), which had
involved generating the prescription with an outpatient
computerized physician order entry system, printing it,
and giving it to the patient (18). Stage 1 Meaningful Use
Criteria also includes the requirement that “more than
40 percent of all permissible prescriptions written by the
eligible provider are transmitted electronically using cer-
tified EHR technology” (13).
Computerized physician order entry systems are
primarily beneficial during the ordering and transcrip-
tion processes. Errors can still occur if physicians override
important and relevant system alerts. Both computerized
physician order entry and many electronic prescribing
systems are written with clinical decision support sys-
tems, a critical safety feature that alerts prescribers about
potential drug, allergy, or disease contraindications to
a medication before it is prescribed. Some clinical deci-
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 784
 sion support features are comprehensive, but not clini-
cally relevant and, thereby, generate a large number of
alerts (also known as pop-ups) to which prescribers may
become desensitized (also known as pop-up fatigue).
Studies show that health care providers override between
49–96% of these alerts because of clinical irrelevance
(19). Customizing drug alert systems to make them more
clinically relevant, including tiering of alerts and incor-
porating patient-specific data into the development of
clinical decision support software, can help maximize the
use of clinical decision support systems (20, 21).
Major challenges exist in implementing automated
system technology. Such challenges can significantly
affect their adoption, effectiveness, or both. These chal-
lenges include cost to implement, intuitive user inter-
faces, engagement of health care providers in system
design and integration into health care processes, health
care provider resistance to change, increased time and
workload, fears regarding loss of control over clinical care
and how data will be used, and health care provider work-
arounds that intentionally bypass safety features.
Studies have shown that acceptance of a clinical deci-
sion support system is significantly improved if health
care providers trust the system to help them take better
care of their patients, the system reminds them of some-
thing they may have forgotten, or it provides them with
information that was previously unavailable (22).
Patient Education and Shared Decision
Making to Enhance Medication Safety
Regardless of whether nonautomated or automated sys-
tems are used as part of the medication order process,
patients need to be involved in the process as appropri-
ate. Clinicians should confirm with the patient that she
understands the medical condition for which a medica-
tion has been prescribed. For example, the teach-back
method is useful for determining the retention and
understanding of medication usage by asking the patient
to repeat her understanding of the information back to
the health care provider. Engaging the patient in her
own care may improve adherence, outcome, and patient
satisfaction, and also reduce opportunities for error. This
requires the concerted effort of all members of the medi-
cal team, both in and out of the hospital. Such education
may take the form of oral communication or handouts
that explain the use, dosage, expected benefits, and possi-
ble adverse effects of the medication prescribed. Patients
should be given ample opportunity to ask questions and
reiterate, to the clinician’s satisfaction, their understand-
ing of proper use of their medications. Allergies should
be well documented and reviewed with the patient. A
list of other medications currently used by the patient
should be documented, and the patient should retain
a copy of this list for personal benefit and to show to
health care providers at each encounter. Extending this
education to family members who will assist the patient
4 Committee Opinion No. 531
COMMITTEE OPINIONS
in medication use may promote the accurate use of the
prescribed medication.
Conclusion
Health care providers feel a sense of urgency to reduce
medical errors that occur as a result of their care.
Obstetrician–gynecologists need heightened vigilance
with regard to the medication use process when caring
for both the pregnant woman and her fetus, as well as the
postreproductive woman with the potential for increased
comorbidities. Following these suggestions related to
medication safety will not only assist in reducing errors
but, more importantly, will create the awareness neces-
sary to provide safe care.
Automated health care technologies hold perhaps
the greatest potential for dramatically reducing the inci-
dence of harm caused by medication-related errors.
Equally clear is the fact that the effect of these technolo-
gies depends on the speed with which national standards
emerge and the success with which they are integrated
into well-designed care processes. In the meantime, non-
automated methods can still be used to improve medica-
tion safety. The American College of Obstetricians and
Gynecologists encourages health care providers to con-
tinue to examine all aspects of medication safety, both in
the hospital setting as well as within their offices.
Resources
The following list is for information purposes only. Referral to these
sources and web sites does not imply the endorsement of the American
College of Obstetricians and Gynecologists. This list is not meant to be
comprehensive. The exclusion of a source or web site does not reflect the
quality of that source or web site. Please note that web sites are subject to
change without notice.
Centers for Medicare and Medicaid Services. Medicare’s
practical guide to the Electronic Prescribing (eRX) Incen-
tive Program. Baltimore (MD):CMS;2011. Available at
https://www.cms.gov/partnerships/downloads/11399-P.
pdf. Retrieved April 2, 2012.
Fischer, MA. The National e-Prescribing Patient Safety
Initiative: removing one hurdle, confronting others, Drug
Saf 2007;30:461–64. [Pub Med]
Institute for Safe Medication Practices
200 Lakeside Drive, Suite 200
Horsham, PA 19044
(215) 947-7797
http://www.ismp.org
National Coordinating Council for Medication Error
Reporting and Prevention
http://www.nccmerp.org
Tamblyn R, Huang A, Taylor L, Kawasumi Y, Bartlett G,
Grad R, et al. A randomized trial of the effectiveness of
on-demand versus computer-triggered drug decision sup-
port in primary care. J Am Med Inform Assoc 2008;15:
430–38. [PubMed] [Full Text]
2013 COMPENDIUM OF SELECTED PUBLICATIONS 785
 References
1. Institute of Medicine. Preventing medication errors.
Washington, DC: National Academies Press; 2007. ^
2. Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL,
Yoon C, et al. Adverse drug event rates in six commu-
nity hospitals and the potential impact of computerized
physician order entry for prevention. J Gen Intern Med
2010;25:31–8. [PubMed] [Full Text]^
3. Bates, DW, Cullen DJ, Laird N, Petersen LA, Small SD,
Servi D, et al. Incidence of adverse drug events and
potential adverse drug events. Implications for prevention.
ADE Prevention Study Group. JAMA 1995;274:29–34.
[PubMed]^
4. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD,
Goldmann DA, Sharek PJ. Temporal trends in rates of
patient harm resulting from medical care [published erra-
tum appears in N Engl J Med 2010;363:2573]. N Engl J Med
2010;363:2124–34. [PubMed] [Full Text]^
5. Hickner J, Zafar A, Kuo GM, Fagnan LJ, Forjuob SN,
Knox LM, et al. Field test results of ambulatory medication
error and adverse drug event reporting system–MEADERS.
Ann Fam Med 2010;8:517–525. [PubMed] [Full Text]^
6. The Joint Commission. Using medication reconciliation
to prevent errors. Sentinel Event Alert Issue 35. Oakbrook
Terrace (IL): Joint Commission; 2006. Available at: http://
www.jointcommission.org/assets/1/18/SEA_35.PDF.
Retrieved April 20, 2012.^
7. Lesar TS, Briceland L, Stein DS. Factors related to errors in
medication prescribing. JAMA 1997;277:312–7. [PubMed]
^ 21. Phansalkar S, Edworthy J, Hellier E, Seger DL, Schedlbauer A,
8. Davis NM, Cohen MR, Teplitsky B. Look-alike and sound-
alike drug names: the problem and the solution. Hosp
Pharm 1992;27:95–8, 102–5, 108–10. [PubMed]^
9. Nanji KC, Rothschild JM, Salzberg C, Keohane CA,
Zigmont K, Devita J, Gandhi TK, et al. Errors associated
with outpatient computerized prescribing systems. J Am
Med Inform Assoc 2011;18:767–73. [PubMed]^
10. Cohen MR, Smetzer JL. ISMP medication error report
analysis. Hosp Pharm 2010;45:352–5.^
11. Institute for Safe Medication Practices. ISMP’s list of high-
alert medications. Horsham (PA): ISMP; 2011. Available
at http://www.ismp.org/tools/highalertmedications.pdf.
Retrieved April 2, 2012.^
12. Institute for Safe Medication Practices. ISMP’s list of con-
fused drug names. Horsham (PA): ISMP; 2011. Available
at http://www.ismp.org/tools/confuseddrugnames.pdf.
Retrieved April 2, 2012.^
13. American Medical Association. Meaningful use glossary
and requirements table 2011–2012. Available at: http://
www.ama-assn.org/resources/doc/hit/meaningful-use-
table.pdf. Retrieved April 2, 2012.^
Committee Opinion No. 531
COMMITTEE OPINIONS
14. National Quality Forum. Safe practices for better health-
care: 2010 update. Washington, DC: NQF; 2010.^
15. Institute of Medicine. To err is human: building a safer
health system. Washington, DC: National Academies Press;
2000.^
16. Kaushal R, Bates DW. Computerized physician order entry
(CPOE) with clinical decision support systems (CDSSs). In:
Agency for Healthcare Research and Quality. Making health
care safer: a critical analysis of patient safety practices.
Evidence Report/Technology Assessment No. 43. Rockville
(MD): AHRQ; 2001. p. 59–69. Available at: http://www.
ahrq.gov/clinic/ptsafety/pdf/chap6.pdf. Retrieved April 2,
2012.^
17. Centers for Medicare and Medicaid Services. E-prescribing.
Available at: http://www.cms.gov/Eprescribing. Retrieved
April 2, 2012.^
18. Moniz TT, Seger AC, Keohane CA, Seger DL, Bates DW,
Rothschild JM. Addition of electronic prescription trans-
mission to computerized prescriber order entry: Effect on
dispensing errors in community pharmacies. Am J Health
Syst Pharm 2011;68:158–63. [PubMed]^
19. van der Sijs H, Aarts J, Vulto A, Berg M. Overriding of
drug safety alerts in computerized physician order entry.
J Am Med Inform Assoc 2006;13:138–47. [PubMed] [Full
Text]^
20. Paterno MD, Maviglia SM, Gorman, PN, Seger DL,
Yoshida,E, Seger AC, et al. Tiering drug-drug interaction
alerts by severity increases compliance rates. J Am Med
Inform Assoc 2009;16:40–6. [PubMed] [Full Text]^
Avery AJ, et al. A review of human factors principles for
the design and implementation of medication safety alerts
in clinical information systems. J Am Med Inform Assoc
2010;17:493–501. [PubMed] [Full Text]^
22. Sittig DF, Krall MA, Dykstra RH, Russell A, Chin HL. A
survey of factors affecting clinician acceptance of clinical
decision support. BMC Med Inform Decis Mak 2006;6:6.
[PubMed] [Full Text]^
Copyright August 2012 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Improving medication safety. Committee Opinion No. 531. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2012;
120:406–10.
5
2013 COMPENDIUM OF SELECTED PUBLICATIONS 786
 The American College of
Obstetricians and Gynecologists
WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 546 • December 2012 (Replaces No. 461, August 2010)
Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be
construed as dictating an exclusive course of treatment or procedure to be followed.

Tracking and Reminder Systems

ABSTRACT: An accurate and effective tracking or reminder system is useful for the modern practice of
obstetrics and gynecology. Practices should not rely solely on the patient to complete all ordered studies and
to follow up on health care provider recommendations. Health care providers should encourage their patients to
complete studies believed essential for patient care within an acceptable time frame. Each office should establish
a simple, reliable tracking and reminder system to facilitate communication, improve patient safety and quality of
care, and minimize missed or delayed diagnoses.

The accurate and timely flow of information between
patients and health care providers is important for safe
and effective care. Patient visits often require some form
of follow-up that involves further screening, referrals,
communication of test results, or consultations. Health
care providers’ offices should have procedures in place
to track these events effectively and to enhance the qual-
ity of care and patient safety. An effective and reliable
reminder system need not be complex or expensive but
is a necessity for obstetric and gynecologic care in all
practice settings. Failure to follow up may cause delayed
or missed diagnoses or treatment, which may result in
an adverse patient outcome and potential liability for
the health care provider. Failure to follow up on labo-
ratory results has been identified as one of the leading
causes of lawsuits in the outpatient setting (1, 2). Courts
have held that the health care professional is responsible
for contacting patients about laboratory, imaging, and
consultation results; however, patients have the respon-
sibility to follow through on their health care providers’
recommendations. An adequate tracking system can help
reduce risks and provide safe, high-quality patient care.
Tracking and reminder systems can help practices and
patients increase their rates of preventive screening tests.
Health care providers should recognize the potential to
improve patient safety by adopting tracking and reminder
systems. Additionally, practices increasingly are being
measured on rates of preventive services delivered to their
patients, such as cervical cancer, breast cancer, and colon
cancer screening. As more health care providers adopt an
electronic health record (EHR) system, choosing a system
that can enhance the tracking and reminder process is an
important consideration.
The process of tracking patients begins at the initial
visit with the health care provider explaining to the
patient the need for any test, referral, or follow-up. This
discussion is then documented in the chart. Clear infor-
mation and instructions can help the patient participate
in her care and understand why a test or appointment
is important. Additional information, including printed
information supplied by the office or produced from the
EHR, may provide written confirmation of instruction
and recommended testing. When an EHR is available, the
patient also may access this information through a patient
portal. Patient adherence to physician recommendations
may improve when a patient is provided with follow-up
information. The next step is to promptly log these open
items into a tracking or reminder system and review them
frequently and regularly according to the office’s estab-
lished procedures.
An appropriate tracking system can be manual or
electronic. A successful system may be in the form of a
logbook, card files, file folders, or computer system, or
any system accessible for ongoing updating and monitor-
ing. Computerized systems can be helpful, but they also
may be expensive and time-consuming. As more practices
incorporate EHRs, the use of computer-driven tracking
and reminder systems will become more common. In
many EHR systems, health care providers can receive
notifications when preventive screening tests are due or
overdue, and many systems also will search for the results
of previously ordered tests. In practices without an EHR

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 787

 system, a simple paper-based “tickler system” can be devel-
oped. No matter which system is used, data entry should
be prompt and correct.
Once information is entered into the EHR system, it
should be retrieved and reviewed regularly with accom-
panying documentation of any actions taken or discus-
sions held with the patient. Information on each patient
should be reviewed throughout the entire process from
data input through resolution. To decrease the risk of
system failure, the number of steps in the process should
be minimized.
Trackable Information
Each office should establish priorities for tracking impor-
tant information, test results, and follow-up ordered by
the health care provider. As the tracking system is tested
and improved, additional elements can be added. Listed
as follows are examples of information, test results, and
follow-up that should be tracked in obstetric and gyneco-
logic practices:
• Pap test results and follow-up, or need for colpos-
copy
• Mammography results and recommended follow-up
• Pertinent laboratory tests and radiologic studies
• Pathology reports from procedures performed
• Results of genetic testing, with emphasis on time- and efficient. It should be updated and monitored
sensitive results, such as multiple marker tests
• Details of on-call emergencies
• Consultations and referrals to other health care pro-
viders, noting whether the patient has visited with
the health care provider and whether the health care
provider’s report has been filed in the chart
• Referrals of patients from other health care provid-
ers, with notification to the referring health care
provider after the patient has been seen
Follow-up appointments should be scheduled if
necessary. Patients should be reminded about the impor-
tance of keeping any postoperative visits and other
follow-up appointments. If a patient does not appear for
a scheduled appointment, that fact should be recorded in
her medical record. Although patients cannot be forced
to keep their appointments, an attempt should be made
to contact them when an appointment is missed and to
assist them in rescheduling.
Suggested Characteristics of the
Reminder System
The following characteristics are important for any
reminder system, whether electronic or paper based:
• Policies and procedures––An office policy and pro-
cedure on tracking should be developed with input
from the staff. All office members should agree to
follow the same protocols. The policy should address
how to contact the patient and how to document
2 Committee Opinion No. 546
COMMITTEE OPINIONS
the follow-up in the patient’s chart. Time frames for
when to expect test results should be defined, and a
protocol should be established for handling delayed
or missing reports.
• Health Insurance Portability and Accountability Act
(HIPAA) compliance––When contacting patients,
whether by mail or electronically, health care provid-
ers and their staff must follow the Health Insurance
Portability and Accountability Act regulations (3).
Care also must be taken to limit the amount of infor-
mation disclosed by way of voice mail or to other
individuals who may answer the call without prior
consent. Instead, it may be preferable to leave a name
and telephone number, asking the patient to call the
office.
• Specificity––The reminder system should contain
specific data and dates, including the dates for
receipt of information and timelines for notifying the
patient.
• Central location––The reminder system should be
centrally located in the office and should not be kept
in individual patient charts. Reminders should be
accessible to the entire staff.
• Reliability––The tracking system should not be
the responsibility of a single individual. Office staff
should be cross-trained so that the system is reliable
regularly.
Sample Tracking Form
A tracking form can pinpoint key follow-up areas. Listed
as follows are the important elements to be tracked:
• Date ordered
• Patient name
• Identifying number
• Test, procedure, consultation, or referral
• Date of test results
• Follow-up required
• Evaluation completed and patient notified
Results of all Pap tests, mammograms, consultations, and
pathology reports provided on paper should be reviewed,
initialed, and dated by a health care provider who has
been designated to perform this function. Electronic
results should be signed off electronically and time
stamped. Test results should then be filed permanently in
the patient’s chart, whether paper or electronic, includ-
ing a notation of what follow-up tests or procedures are
recommended.
Patients should be made aware of the office practice
for notification of test results and should be instructed
to call back for test results if they are not received in
a timely fashion. However, the office should not rely
solely on the patient to call back for test results but should
have a more effective system. Computerized tracking and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 788
 reminder systems, although not required, are available
with custom alerts, telephone reminders, and telephone
numbers to call for automated test results using indi-
vidual identifying numbers. Some practices are now using to discuss system failures will render safe patient care and
secure patient portals where patients can receive their test
results electronically, and can receive electronic remind-
ers about when their next test should be scheduled.
Allowing patients to view their test results electronically
can improve patient satisfaction with the results noti-
fication process as well as the communication of their
treatment plan (4). In many cases, educational material
describing the purpose of the recommended tests also
can be accessed by the patient. In considering the use of
a computerized tracking and reminder system, factors
such as staff time, cost, ease of use, and effect on end-user
workflow should be evaluated. Allowing all personnel
who participate in health care record tracking to provide
input into the system design and implementation should
encourage its use. As practices increasingly incorporate
EHRs to meet Meaningful Use requirements, the use of
the EHR to facilitate the tracking and reminder process is
a logical progression. The use of EHRs also can facilitate
tracking appointments, test results, and patient remind-
ers. Use of tracking systems may enhance the quality of
care, patient outcomes, and patient satisfaction while
helping to improve patient safety (5).
Designing and implementing a tracking and reminder pub2. [PubMed] [Full Text] ^
system also provides an opportunity to develop further
a culture of safety in the office. A system that is stan-
dardized, simple, and accessible to all potential users
will reduce the likelihood of error. When problems or
mistakes occur, staff should be encouraged to report
them. Errors are a valuable way to learn why and how
systems fail, and exploring the causes of errors provides
Committee Opinion No. 546
COMMITTEE OPINIONS
an opportunity to improve those systems. Ultimately, an
informed and involved patient, a well-designed tracking
system, and health care providers and staff who feel safe
improve outcomes.
References
1. Institute of Medicine. Health IT and patient safety: build-
ing safer systems for better care. Washington, DC: National
Academies Press; 2012. ^
2. Gandhi, TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon
C, Brennan TA, et al. Missed and delayed diagnoses in the
ambulatory setting: a study of closed malpractice claims.
Ann Intern Med 2006;145:488–96. [PubMed] [Full Text]^
3. Department of Health and Human Services. HIPAA––fre-
quently asked questions. Available at: http://www.hhs.gov/
ocr/privacy/hipaa/faq. Retrieved August 24, 2012. ^
4. Matheny ME, Gandhi TK, Orav EJ, Ladak-Merchant Z,
Bates DW, Kuperman GJ, et al. Impact of an automated
test results management system on patients’ satisfaction
about test result communication. Arch Inter Med 2007;167:
2233–9. [PubMed] [Full Text] ^
5. Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP,
Grimshaw J. The effects of on-screen, point-of-care
computer reminders on process and outcomes of care.
Cochrane Database of Systematic Reviews 2009, Issue 3.
Art. No.: CD001096. DOI: 10.1002/14651858.CD001096.
Copyright December 2012 by the American College of Obstetricians
and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved.
ISSN 1074-861X
Tracking and reminder systems. Committee Opinion No. 546.
American College of Obstetricians and Gynecologists. Obstet Gyne-
col 2012;120:1535–7.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 789
COMMITTEE OPINIONS
Committee on Professional Liability

2013 COMPENDIUM OF SELECTED PUBLICATIONS 790

 The American College of Obstetricians and Gynecologists
Women’s Health Care Physicians

CommiTTee opinion
Number 497 • August 2011 (Replaces No. 406, May 2008)
Committee on Professional Liability
This document provides risk management information that is current as of the date issued
and is subject to change. This document does not define a standard of care nor should it be
interpreted as legal advice.
The Committee on Professional Liability gratefully acknowledges Irving G. Leon, PhD,
Adjunct Associate Professor of Obstetrics and Gynecology, University of Michigan Health
System, Ann Arbor, for his contributions to this document.

Coping With the Stress of Medical Professional

Liability Litigation
ABSTRACT: Obstetrician–gynecologists should recognize that being a defendant in a medical professional
liability lawsuit can be one of life’s most stressful experiences. Negative emotions in response to a lawsuit are
normal, and physicians may need help from family members, peers, or professionals to cope with this stress.
Open communication will assist in reducing emotional isolation and self-blame. However, pertinent legal and clinical
aspects of a case must be kept confidential, except for disclosure within the confines of a protected counselor–
patient relationship as determined by state law.

The American Congress of Obstetricians and Gynecol-
ogists (ACOG) is concerned about the psychologic and
emotional effects of medical professional liability litiga-
tion on physicians, especially because of the high rate
of claims that obstetrician–gynecologists experience.
According to a recent ACOG survey, 90.5% of ACOG
Fellows have been sued, and 42.8% of this group have
experienced at least one claim resulting from care pro-
vided during residency. Defendant physicians may experi-
ence a wide range of distressing emotions and increased
stress, which can disrupt their personal lives and the lives
of their families, their relationships with patients, and their
medical practices. Because a medical professional liabil-
ity case in obstetrics and gynecology usually takes several
years to resolve, this stressful period can seem interminable.
Embedded in most liability litigation is a “bad out-
come,” which, with or without actual medical error,
profoundly affects physicians. A 2008 national survey
indicated that 75% of obstetricians felt that caring for a
patient with a stillbirth took a large toll on them, with
almost 10% seriously considering giving up obstetric
practice (1). When medical error is involved, many phys-
icians experience increased somatic and psychologic
distress (2, 3).
Guilt and shame typically are the primary feelings
that should be recognized and addressed during, and
following, liability litigation. Deep shame and a reduced
sense of self-worth may be felt in response to litigation
because of a fear of public exposure. Anxiety is the usual
reaction to these threats to one’s integrity, self-confidence,
and well-being. Whether consciously experienced or not,
depressive reactions and a sense of diminished self-worth
commonly follow guilt. When a lawsuit is completely
unexpected, its effect may be traumatic, resulting in
shock and numbness, alternating with a hyperarousal
state, including sleeplessness and tension. An institution’s
rapid intervention to emotionally support clinicians may
offer sufficient help to health care providers involved in
adverse events; however, the grinding, drawn-out reper-
cussions of a prolonged lawsuit frequently require more
extensive support, including professional mental health
resources (4).
Claims managers and defense attorneys often advise
physicians not to speak to anyone regarding any aspect of
a medical liability case. Nevertheless, physicians need to
express their emotional responses to being sued. Literal
adherence to the advice to speak to no one can result in
isolation, increased stress, and dysfunctional behavior.
Such behavior may jeopardize family and work relation-
ships. The ability to function professionally and to repre-
sent oneself appropriately and effectively during pretrial
discovery and trial also may be adversely affected. Thus,

COMMITTEE OPINIONS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 791

 physicians are encouraged to inform family members of
the lawsuit, the allegations, the potential for publicity,
and any expected testimony, while maintaining confi-
dentiality about the specifics of the case. Children should
be told about the lawsuit and their questions honestly
answered, commensurate with their age and ability to
understand the information. Open communication with
family members will assist in reducing emotional isola-
tion and self-blame (5).
Certainly, material legal and clinical aspects of a case
must be kept confidential, except for disclosure within
the confines of a protected counselor–patient relation-
ship. For the most part, state laws determine whether
communications with clergy, psychiatrists, or other men-
tal health professionals will be afforded legal protection
against disclosure.* Moreover, that privilege may be
deemed waived if third parties are present when such
communications occur.
Despite the anxiety and stress caused by the demands
of the litigation process, the opportunity for critical
learning and professional development to facilitate deal-
ing with future adverse outcomes should not be over-
looked. By maintaining honest, collaborative, caring
communication with patients, physicians may prevent
a breakdown in the doctor–patient relationship, which
frequently contributes to litigation (6, 7). Moreover,
within the context of a patient-centered risk management
program, disclosure, apology, and, when appropriate,
offers of restitution may result in diminished litigation
and associated litigation-related stress (8–10).
In coping with medical error, it may be necessary for
some physicians to develop a more realistic, less idealized,
and more forgiving sense of personal identity, compe-
tence, and self-confidence. Errors in decision making
cannot be avoided throughout one’s career. One of the
healthiest responses is recognition of the error and the
development of a plan to decrease the likelihood of future
similar occurrences. This activity often provides comfort
and healing to the physician.
Obstetrician–gynecologists should recognize that
being a defendant in a medical professional liability
lawsuit can be one of life’s most stressful experiences.
Negative emotions in response to a lawsuit are normal
and physicians may need help from professionals or
peers to cope with this stress. Residents, as young physi-
cians in training, may be particularly vulnerable to the
psychologic and emotional upheaval that often occurs
when named in a medical liability claim. State or local
medical societies and medical liability insurance carriers
often sponsor support groups for defendant physicians
and their families. Support mechanisms for residents also
*In courts, the doctrine of privilege affords protection against compul-
sory disclosure of confidential communications between persons such
as physician and patient, psychotherapist and client, lawyer and client,
confessor and penitent, and husband and wife. Whether or not such a
privilege exists in a particular judicial venue is determined by federal law
and the statutory and common law of the jurisdiction.
2 Committee Opinion No. 497
COMMITTEE OPINIONS
may be available through residency program directors,
department chairs, departments of risk management,
or mentors. In the absence of such services, individual
professional counseling can be of great benefit. Rapid
intervention facilitates healthier coping strategies and can
restore a sense of equilibrium and self-esteem during an
unpredictable time.
Resources
American College of Obstetricians and Gynecologists.
From exam room to courtroom: navigating litigation and
coping with stress [CD-ROM]. Washington, DC: ACOG;
2006.
Brazeau CM. Coping with the stress of being sued. Fam
Pract Manag 2001;8:41–4.
Bub B. The nightmare of litigation: a survivor’s true story.
OBG Manage 2005;17(1):21–2, 25–7.
Charles S. Medical liability litigation as a disruptive life
event. Bull Am Coll Surg 2005;90:17–23.
Charles SC. How to handle the stress of litigation. Clin
Plast Surg 1999;26:69–77, vii.
Hutchison JR, Hutchison S. The toughest part of being
sued. Med Econ 1995;72(23):36–7, 41–4, 48, passim.
James JM, Davis WE. Physicians survival guide to litiga-
tion stress: understanding, managing, and transcending
a malpractice crisis. Lafayette (CA): Physician Health
Publications; 2006.
Physician Litigation Stress Resource Center. Available
at: http://www.physicianlitigationstress.org. Retrieved
March 22, 2011.
Settel KM. The impact of malpractice litigation on physi-
cians. Forum 1998;19(4):13–5.
Sorrel AL. Litigation stress: being sued is personal as well as
professional. Some programs are helping physicians cope.
American Medical News. November 2, 2009. Available
at: http://www.ama-assn.org/amednews/2009/11/02/
prsa1102.htm. Retrieved March 22, 2011.
References
1. Gold KJ, Kuznia AL, Hayward RA. How physicians cope
with stillbirth or neonatal death: a national survey of obste-
tricians. Obstet Gynecol 2008;112:29–34.
2. Waterman AD, Garbutt J, Hazel E, Dunagan WC, Levinson W,
Fraser VJ, et al. The emotional impact of medical errors on
practicing physicians in the United States and Canada. Jt
Comm J Qual Patient Saf 2007;33:467–76.
3. West CP, Huschka MM, Novotny PJ, Sloan JA, Kolars JC,
Habermann TM, et al. Association of perceived medical
errors with resident distress and empathy: a prospective
longitudinal study. JAMA 2006;296:1071–8.
4. Scott SD, Hirschinger LE, Cox KR, McCoig M, Hahn-
Cover K, Epperly KM, et al. Caring for our own: deploying
a systemwide second victim rapid response team. Jt Comm
J Qual Patient Saf 2010;36:233–40.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 792
 5. Charles SC, Frisch PR. Adverse events, stress, and litigation:
a physician’s guide. New York (NY): Oxford University
Press; 2005.
6. Beckman HB, Markakis KM, Suchman AL, Frankel RM. The
doctor-patient relationship and malpractice. Lessons from
plaintiff depositions. Arch Intern Med 1994;154:1365–70.
7. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors
that prompted families to file medical malpractice claims
following perinatal injuries. JAMA 1992;267:1359–63.
8. Kachalia A, Kaufman SR, Boothman R, Anderson S, Welch K,
Saint S, et al. Liability claims and costs before and after
implementation of a medical error disclosure program.
Ann Intern Med 2010;153:213–21.
9. Quinn RE, Eichler MC. The 3Rs program: the Colorado
experience. Clin Obstet Gynecol 2008;51:709–18.
10. Helmchen LA, Richards MR, McDonald TB. How does
routine disclosure of medical error affect patients’ pro-
pensity to sue and their assessment of provider quality?
Evidence from survey data. Med Care 2010;48:955–61.
Committee Opinion No. 497
COMMITTEE OPINIONS
Copyright August 2011 by the American College of Obstetricians and
Gynecologists, 409 12th Street, SW, PO Box 96920, Washington,
DC 20090-6920. All rights reserved. No part of this publication may
be reproduced, stored in a retrieval system, posted on the Internet,
or transmitted, in any form or by any means, electronic, mechani-
cal, photocopying, recording, or otherwise, without prior written per-
mission from the publisher. Requests for authorization to make
photocopies should be directed to: Copyright Clearance Center, 222
Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
ISSN 1074-861X
Coping with the stress of medical professional liability litigation.
Committee Opinion No. 497. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2011;118:389–91.
3
2013 COMPENDIUM OF SELECTED PUBLICATIONS 793
PATIENT SAFETY CHECKLISTS

2013 COMPENDIUM OF SELECTED PUBLICATIONS 794

 the american college of
obstetricians and Gynecologists
Women’s Health Care Physicians

Patient Safety Checklist ✓ Number 2 • November 2011

InpatIent InductIon of Labor

Date ____________ Patient ______________________________ Date of birth ___________ MR # ___________
Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery_______________ Best estimated gestational age at delivery _________________
Indication for induction ________________

Fetal Presentation (1)

❏ Vertex
❏ Other __________
❏ If other, physician or certified nurse–midwife notified
Estimated fetal weight __________
❏ Patient has a completed medical history and physical examination
❏ Known allergies identified ___________________
❏ Medical factors that could effect anesthetic choices identified ___________________
❏ Pertinent prenatal laboratory test results (eg, group B streptococci or hematocrit) available (2, 3)
❏ Other special concerns identified (eg, medical problems and special needs):________________
❏ Patient counseled about risks and benefits of induction of labor (1)
❏ Consent form signed as required by institution
Bishop Score (see below) (1): __________
bishop Scoring System
factor
dilation position of effacement cervical
Score (cm) cervix (%) Station* consistency
0 Closed Posterior 0–30 -3 Firm
1 1–2 Midposition 40– 50 -2 Medium
2 3–4 Anterior 60–70 -1, 0 Soft
3 5–6 — 80 +1, +2 —

*Station reflects a −3 to +3 scale.

Modified from Bishop EH. Pelvic scoring for elective induction. Obstet Gynecol 1964;24:266–8.

❏ Orders received (1)

❏ Oxytocin
❏ Cervical ripening

VOL. 118, NO. 5, NOVEMBER 2011 OBSTETRICS & GYNECOLOGY 1205

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 795
 references
1. Induction of labor. ACOG Practice Bulletin No. 107. American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;114:386–97.
2. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Antepartum care. In: Guidelines for
perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 83–137.
3. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Perinatal infections. In: Guidelines
for perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 303–48.

Standardization of health care processes and reduced variation has been shown to improve outcomes
and quality of care. The American College of Obstetricians and Gynecologists has developed a series
of patient safety checklists to help facilitate the standardization process. This checklist reflects emerg-
ing clinical, scientific, and patient safety advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to
be followed. Although the components of a particular checklist may be adapted to local resources,
standardization of checklists within an institution is strongly encouraged.

How to use this checklist

The Patient Safety Checklist on Inpatient Induction of Labor should be completed by the health care provider at the time
of the patient’s admission.

Copyright November 2011 by the American College of Obstetricians and Gynecologists. 409 12th Street, SW, PO Box 96920, Wash-
ington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the
Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance
Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.
Inpatient induction of labor. Patient Safety Checklist No. 2. American College of Obstetricians and Gynecologists. Obstet Gynecol
2011;118:1205–6.

1206 Patient Safety Checklist Inpatient Induction of Labor OBSTETRICS & GYNECOLOGY

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 796

 The American College of
Obstetricians and Gynecologists
Women’s Health Care Physicians

Patient Safety Checklist ✓ Number 3 • December 2011

SChedulinG PlAnned CeSAreAn delivery

Date _____________ Patient _____________________________ Date of birth__________ MR # ____________
Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery_______________ Best estimated gestational age (at admission) ______________
Proposed cesarean delivery date __________

Indication (choose one):

❏ Medically indicated: Diagnosis: ______________________________________________
❏ Repeat cesarean delivery (choose one) (1, 2):
❏ Trial of labor not appropriate: Reason:______________________________________
❏ Trial of labor offered
❏ Yes
❏ No: Reason:____________________________________
❏ Patient counseled about risks and benefits of cesarean delivery versus trial of labor and
vaginal delivery (1, 3)
❏ Consent form signed as required by the institution
❏ Repeat cesarean delivery for logistical reasons: Circumstances:_________________________________
❏ Elective primary cesarean delivery at maternal request (4):
❏ Patient counseled about risks and benefits of cesarean delivery versus vaginal delivery (1, 3)
❏ Consent form signed as requested by institution
❏ Gestational age of 39 0/7 weeks or greater confirmed by either of the following criteria (5):
❏ Ultrasound measurement at less than 20 weeks of gestation supports gestational age of 39 weeks or greater
❏ Fetal heart tones have been documented as present for 30 weeks of gestation by Doppler ultrasonography
If this is an elective cesarean delivery and gestational age is 39 0/7 weeks or less, reason for variance:

Results of amniocentesis (if performed): __________________________________________________________

❏ Preoperative and pertinent prenatal laboratory test results (eg, group B streptococci or hematocrit) available (2)
❏ Special concerns (eg, allergies, medical problems, and special needs) _________________________________
❏ Pertinent comorbid risk factors (maternal and fetal) _______________________________________________
To be completed by reviewer:
❏ Approved cesarean delivery for gestational age equal to or greater than 39 0/7 weeks by the afore-
mentioned dating criteria
❏ Approved cesarean delivery before 39 0/7 weeks of gestation (medical indication)
❏ HARD STOP – gestational age, indication, consent, or other issues prevent initiating planned cesarean delivery
without further information or consultation with department chair

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 797

 references
1. Vaginal birth after cesarean delivery. Practice Bulletin No. 115. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:786–90.
2. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Intrapartum and postpartum care.
In: Guidelines for perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 139–74.
3. Surgery and patient choice. ACOG Committee Opinion No. 395. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2008;111:243–7.
4. Cesarean delivery on maternal request. ACOG Committee Opinion No. 394. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2007;110:1501.
5. Fetal lung maturity. ACOG Practice Bulletin No. 97. American College of Obstetricians and Gynecologists. Obstet Gynecol
2008;112:717–26.

Standardization of health care processes and reduced variation has been shown to improve outcomes
and quality of care. The American College of Obstetricians and Gynecologists has developed a series
of patient safety checklists to help facilitate the standardization process. This checklist reflects emerg-
ing clinical, scientific, and patient safety advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to
be followed. Although the components of a particular checklist may be adapted to local resources,
standardization of checklists within an institution is strongly encouraged.

how to use This Checklist

The Patient Safety Checklist on Scheduling Planned Cesarean Delivery should be completed by the health care pro-
vider and submitted to the respective hospital to schedule a planned cesarean delivery. The hospital should establish
procedures to review the appropriateness of the scheduling based on the information contained in the checklist. A hard
stop should be called if there are questions that arise that require further information or consultation with the depart-
ment chair.

Copyright December 2011 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted
on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, with-
out prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright
Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Scheduling planned cesarean delivery. Patient Safety Checklist No. 3. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2011;118:1469–70.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 798

 The American College of
Obstetricians and Gynecologists
Women’s Health Care Physicians

Patient Safety Checklist ✓ Number 4 • December 2011

PReOPeRATive PlAnned CesAReAn deliveRy

Date _____________ Patient ______________________________ Date of birth __________ MR # ___________
Physician ______________________________________ Gravidity/Parity _________________________________
Best estimated gestational age ___________ Indication ________________

❏ Patient has a complete medical history and physical examination

❏ Known allergies identified
❏ Medical factors that could affect anesthetic choices identified
❏ Patient counseled about risks and benefits of cesarean delivery versus trial of labor and vaginal delivery (1, 2)
❏ Consent form signed as required by institution
❏ Appropriate preoperative and pertinent prenatal laboratory test results (eg, group B streptococci or hematocrit)
available (3)
❏ Antibiotic prophylaxis administered within 60 minutes before incision (4)
❏ Appropriate deep vein thrombosis prophylaxis administered (3, 5)
❏ Yes
❏ No: Reason:____________________________________
❏ Presence of fetal heart tones documented before incision (6)
❏ Yes
❏ No: Reason:___________________________________
❏ Risk factors identified:
❏ If at risk of bleeding more than 1,000 mL, adequate intravenous access and fluids planned and packed cells
and blood products available
❏ Airway
❏ Allergies
❏ Notification of neonatal or pediatric departments if necessary
❏ A “time out” is conducted before the start of surgery to confirm the patient's name, allergies, and consent; to
confirm the surgery to be performed; and to identify team member names and roles (7)
❏ Surgical counts performed before incision (surgical counts are reconfirmed postoperatively)
References
1. Vaginal birth after cesarean delivery. Practice Bulletin No. 115. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:786–90.
2. Surgery and patient choice. ACOG Committee Opinion No. 395. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2008;111:243–7.
3. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Intrapartum and postpartum care. In:
Guidelines for perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 139–74.
4. Antimicrobial prophylaxis for cesarean delivery: timing of administration. Committee Opinion No. 465. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2010;116:791–2.
(continued)

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 799

 References (continued)
5. Obesity in pregnancy. ACOG Committee Opinion No. 315. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2005;106:671–5.
6. Fetal monitoring prior to scheduled cesarean delivery. ACOG Committee Opinion No. 382. American College of Obstetricians
and Gynecologists. Obstet Gynecol 2007;110:961–2.
7. Patient safety in the surgical environment. Committee Opinion No. 464. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2010;116:786–90.

Standardization of health care processes and reduced variation has been shown to improve outcomes
and quality of care. The American College of Obstetricians and Gynecologists has developed a series
of patient safety checklists to help facilitate the standardization process. This checklist reflects emerg-
ing clinical, scientific, and patient safety advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be
followed. Although the components of a particular checklist may be adapted to local resources, stan-
dardization of checklists within an institution is strongly encouraged.

How to Use This Checklist

The Patient Safety Checklist on Preoperative Planned Cesarean Delivery should be completed by the health care pro-
vider during the patient’s admission.

Copyright December 2011 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted
on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, with-
out prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright
Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Preoperative planned cesarean delivery. Patient Safety Checklist No. 4. American College of Obstetricians and Gynecologists.
Obstet Gynecol 2011;118:1471–2.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 800

 The American College of
Obstetricians and Gynecologists
Women’s Health Care Physicians

Patient Safety Checklist ✓

Number 5 • December 2011
(Replaces Patient Safety Checklist No. 1, November 2011)

SChedulinG induCTiOn Of lAbOr

Date _____________ Patient ______________________________ Date of birth___________ MR # __________
Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery_______________ Best estimated gestational age at delivery _________________
Proposed induction date ________________ Proposed admission time _____________
❏ Gestational age of 39 0/7 weeks or older confirmed by either of the following criteria (1):
❏ Ultrasound measurement at less than 20 weeks of gestation supports gestational age of
39 weeks or greater
❏ Fetal heart tones have been documented as present for 30 weeks of gestation by
Doppler ultrasonography

Indication for induction: (choose one)

❏ Medical complication or condition (1): Diagnosis: ________________________________
❏ Nonmedically indicated (1–3): Circumstances: __________________________________
Patient counseled about risks, benefits, and alternatives to induction of labor (1)
❏ Consent form signed as required by institution
Bishop Score (see below) (1): ________

bishop Scoring System

factor
dilation Position of effacement Station* Cervical
Score (cm) Cervix (%) Consistency
0 Closed Posterior 0–30 -3 Firm
1 1–2 Midposition 40– 50 -2 Medium
2 3–4 Anterior 60–70 -1, 0 Soft
3 5–6 — 80 +1, +2 —

*Station reflects a −3 to +3 scale.

Modified from Bishop EH. Pelvic scoring for elective induction. Obstet Gynecol 1964;24:266–8.

❏ Pertinent prenatal laboratory test results (eg, group B streptococci or hematocrit) available (4, 5)
❏ Special concerns (eg, allergies, medical problems, and special needs): _____________________
To be completed by reviewer:
❏ Approved induction after 39 0/7 weeks of gestation by aforementioned dating criteria
❏ Approved induction before 39 0/7 weeks of gestation (medical indication)
❏ HARD STOP – gestational age, indication, consent, or other issues prevent initiating induction without further
information or consultation with department chair

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 801

 references
1. Induction of Labor. ACOG Practice Bulletin No. 107. American College of Obstetricians and Gynecologists. Obstet Gynecol
2009;114:386–97.
2. Caughey AB, Sundaram V, Kaimal AJ, Cheng YW, Gienger A, Little SE, et al. Maternal and neonatal outcomes of elective
induction of labor. Evidence Report/Technology Assessment No. 176. (Prepared by the Stanford University-UCSF Evidence-
based Practice Center under contract No. 290-02-0017.) AHRQ Publication No. 09-E—5. Rockville (MD): Agency for
Healthcare Research and Quality; 2009.
3. Clark SL, Frye DR, Meyers JA, Belfort MA, Dildy GA, Kofford S, et al. Reduction in elective delivery <39 weeks of gesta-
tion: comparative effectiveness of 3 approaches to change and the impact on neonatal intensive care admission and stillbirth.
Am J Obstet Gynecol 2010;203:449.e1–449.e6.
4. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Antepartum care. In: Guidelines for
perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 83–137.
5. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Perinatal infections. In: Guidelines
for perinatal care. 6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. p. 303–48.

Standardization of health care processes and reduced variation has been shown to improve outcomes
and quality of care. The American College of Obstetricians and Gynecologists has developed a series
of patient safety checklists to help facilitate the standardization process. This checklist reflects emerg-
ing clinical, scientific, and patient safety advances as of the date issued and is subject to change. The
information should not be construed as dictating an exclusive course of treatment or procedure to be
followed. Although the components of a particular checklist may be adapted to local resources, stan-
dardization of checklists within an institution is strongly encouraged.

how to use This Checklist

The Patient Safety Checklist on Scheduling Induction of Labor should be completed by the health care provider and
submitted to the respective hospital to schedule an induction of labor. The hospital should establish procedures to review
the appropriateness of the scheduling based on the information contained in the checklist. A hard stop should be called
if there are questions that arise that require further information or consultation with the department chair.

Copyright December 2011 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on
the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior
written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance
Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Scheduling induction of labor. Patient Safety Checklist No. 5. American College of Obstetricians and Gynecologists. Obstet Gynecol
2011;118:1473–4.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 802

 Patient Safety Checklist ✓ Number 6 • August 2012

DOCUMENTING SHOULDER DYSTOCIA

Date _____________ Patient _____________________________ Date of birth _________ MR # ____________
Physician or certified nurse–midwife _____________________________ Gravidity/Parity______________________
Timing:
Onset of active labor __________ Start of second stage ______
Delivery of head __________ Time shoulder dystocia recognized and help called _________
Delivery of posterior shoulder __________ Delivery of infant ________

Antepartum documentation:
❏ Assessment of pelvis
❏ History of prior cesarean delivery: Indication for cesarean delivery: ________________________________
❏ History of prior shoulder dystocia ❏ History of gestational diabetes
❏ Largest prior newborn birth weight _________ ❏ Estimated fetal weight ________
❏ Cesarean delivery offered if estimated fetal weight greater than 4,500 g (if the patient has diabetes mellitus)
or greater than 5,000 g (if patient does not have diabetes mellitus)
Intrapartum documentation:
❏ Mode of delivery of vertex:
❏ Spontaneous ❏ Operative delivery: Indication:_________________________________________
❏ Vacuum ❏ Forceps
❏ Anterior shoulder:
❏ Right ❏ Left
❏ Traction on vertex:
❏ None ❏ Standard
❏ No fundal pressure applied
❏ Maneuvers utilized (1):
❏ Hip flexion (McRoberts maneuver) ❏ Suprapubic pressure (stand on the side of the occiput)
❏ Delivery of posterior arm ❏ All fours (Gaskin maneuver)
❏ Posterior scapula (Woods maneuver) ❏ Anterior scapula (Rubin maneuver)
❏ Abdominal delivery ❏ Zavanelli maneuver
❏ Episiotomy:
❏ None ❏ Median ❏ Mediolateral ❏ Proctoepisiotomy
❏ Extension of episiotomy:
❏ None ❏ Third degree ❏ Fourth degree
❏ Laceration:
❏ Third degree ❏ Fourth degree
❏ Cord blood gases sent to the laboratory:
❏ Yes: Results: _____________________________
❏ No (continued)

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 803

 (continued)
❏ Status of neonate prior to leaving delivery room or operating room:
Apgar scores ___________________
Evidence of injury_______________
Birth weight (if available)_________
❏ Staff present ____________________________________________________________________
❏ Family members present ___________________________________________________________
❏ Patient and family counseled ❏ Debriefing with appropriate personnel
Postpartum/neonatal documentation:
❏ Delivery discussed with family ❏ Perineal assessment if third or fourth degree laceration
❏ Monitored for postpartum hemorrhage:
❏ Yes: Results: ____________________________
❏ No
❏ Communication with pediatrics department if there is evidence of injury or asphyxia
❏ Coordination of follow-up care for mother and baby
❏ Monitored for postpartum depression:
❏ Yes: Results: ____________________________
❏ No
Procedural Elements for Shoulder Dystocia
The following steps should be taken when managing shoulder dystocia:
1. Call for help from pediatrics, anesthesia, and neonatal intensive care unit staff, and assign a timekeeper
2. Initiate maneuver (eg, McRoberts maneuver)
3. Re-evaluate course of actions, including using other maneuvers or repeating maneuvers if unsuccessful
4. Consider abdominal delivery
5. Document event—move to documentation checklist

Reference
1. Shoulder dystocia. ACOG Practice Bulletin No. 40. American College of Obstetricians and Gynecologists. Obstet Gynecol
2002;100:1045–50. [PubMed] [Obstetrics & Gynecology] ^

Standardization of health care processes and reduced variation has been shown to improve out-
comes and quality of care. The American College of Obstetricians and Gynecologists has developed
a series of Patient Safety Checklists to help facilitate the standardization process. This checklist
reflects emerging clinical, scientific and patient safety advances as of the date issued and is subject
to change. The information should not be construed as dictating an exclusive course of treatment or
procedure to be followed. Although the components of a particular checklist may be adapted to local
resources, standardization of checklists within an institution is strongly encouraged.

How to Use This Checklist

The Patient Safety Checklist on Documenting Shoulder Dystocia should be used to guide the documentation process
if a patient has experienced shoulder dystocia.

Copyright August 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted
on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, with-
out prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright
Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Documenting shoulder dystocia. Patient Safety Checklist No. 6. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2012;120:430–1.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 804

 Patient Safety Checklist ✓ Number 7 • August 2012

MAGNESIUM SULFATE BEFORE ANTICIPATED PRETERM BIRTH FOR NEUROPROTECTION

Date _____________ Patient ______________________________ Date of birth___________ MR # __________
Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery______________ Best estimated gestational age ____________

Criteria (1):
❏ Gestational age less than or equal to 31 6/7 weeks
and
❏ Singleton or multiple pregnancy at risk for delivery within the next 30 minutes to 24 hours
and either
❏ Active preterm labor with cervix 4–8 cm dilated or preterm premature rupture of membranes if rupture
occurred later than 22 weeks
or
❏ Indicated preterm birth within the next 24 hours. (If the planned delivery is for severe preeclampsia or
hemolysis, elevated liver enzymes, and low platelet count [HELLP], the full antiseizure magnesium sulfate
regimen should be administered as minimal therapy.)
Exclusions:
❏ Unwillingness to intervene for the benefit of the fetus
❏ Maternal contraindications to receiving magnesium sulfate
Counseling:
❏ Temporary side effects of magnesium sulfate administration
❏ No documented benefit in neonatal survival
❏ Risk of moderate to severe cerebral palsy decreased by approximately 50%
❏ In all other ways, routine care will be provided (steroids, tocolysis, antibiotics, or induction for preterm
premature rupture of membranes if indicated)
Specific considerations with therapy:
❏ Consider the effect of administering magnesium sulfate if any other tocolytic agent, such as a calcium
channel blocker, is being given
❏ Adjust the dose of magnesium sulfate appropriately if administered to women with altered renal function
Suggested treatment regimens from large trials (1):
Crowther Regimen (2):
❏ Bolus 4 g magnesium sulfate intravenously (IV) over 20 minutes
❏ Follow bolus with magnesium sulfate 1 g/hr IV until birth or up to 24 hours
Rouse Regimen (3):
❏ Bolus 6 g magnesium sulfate IV over 20–30 minutes
❏ Follow bolus with magnesium sulfate 2 g/hr IV for 12 hours
(continued)

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 805

 Rouse Regimen (3) (continued):
❏ Discontinue maintenance dose if delivery has not occurred within 12 hours and is no longer considered
imminent. Resume the maintenance dose if the risk of imminent delivery recurs within 6 hours.
❏ Repeat loading dose and subsequent maintenance therapy as listed previously if risk of imminent delivery
recurs after 6 hours
Marret Regimen (4):
❏ Bolus 4 g magnesium sulfate over 30 minutes
❏ No maintenance dose administered
Modification of any of the aforementioned regimens:
❏ Detailed description of the modified regimen entered in patient’s chart

Resource
Costantine MM, Weiner SJ. Effects of antenatal exposure to magnesium sulfate on neuroprotection and mortality in preterm
infants: a meta-analysis. Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal
Medicine Units Network. Obstet Gynecol 2009;114:354 – 64. [PubMed] [Obstetrics & Gynecology]

References
1. Magnesium sulfate before anticipated preterm birth for neuroprotection. Committee Opinion No. 455. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2010;115:669–71. [PubMed] [Obstetrics & Gynecology] ^
2. Crowther CA, Hiller JE, Doyle LW, Haslam RR. Effect of magnesium sulfate given for neuroprotection before preterm birth:
a randomized controlled trial. JAMA 2003;290:2669–76. [PubMed] [Full Text] ^
3. Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, et al. A randomized, controlled trial of magnesium sul-
fate for the prevention of cerebral palsy. Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. N Engl J
Med 2008;359:895–905. [PubMed] [Full Text] ^
4. Marret S, Marpeau L, Zupan-Simunek V, Eurin D, Leveque C, Hellot MF, et al. Magnesium sulfate given before
very-preterm birth to protect infant brain: the randomised controlled PREMAG trial. PREMAG trial group.
BJOG 2007;114:310–8. [PubMed] [Full Text] ^

Standardization of health care processes and reduced variation has been shown to improve out-
comes and quality of care. The American College of Obstetricians and Gynecologists has developed
a series of Patient Safety Checklists to help facilitate the standardization process. This checklist
reflects emerging clinical, scientific and patient safety advances as of the date issued and is subject
to change. The information should not be construed as dictating an exclusive course of treatment or
procedure to be followed. Although the components of a particular checklist may be adapted to local
resources, standardization of checklists within an institution is strongly encouraged.

How to Use This Checklist

The Patient Safety Checklist on Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection should be
completed by the health care provider during the patient’s admission.

Copyright August 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted
on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, with-
out prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright
Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

Magnesium sulfate before anticipated preterm birth for neuroprotection. Patient Safety Checklist No. 7. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2012;120:432–3.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 806

 Patient Safety Checklist ✓ Number 8 • November 2012

APPROPRIATENESS OF TRIAL OF LABOR AFTER PREVIOUS CESAREAN DELIVERY

(ANTEPARTUM PERIOD)
Date _____________ Patient ______________________________ Date of birth ___________ MR # __________
Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery______________ Best estimated gestational age ____________

❏ Patient counseled on the risks, benefits, chances of success, and alternatives of trial of labor after previous
cesarean delivery (TOLAC) (1)
❏ Patient is provided with information about TOLAC
❏ Patient is informed of her hospital’s ability to perform an emergency cesarean delivery and the availability
and timeliness of services provided by the obstetric, newborn, and anesthetic caregivers (1)
❏ Documentation of previous cesarean delivery available
❏ Yes: Indication:____________________________________________________________________
❏ Previous cesarean incision is neither a classical incision nor a T-incision and there is no history of
uterine rupture or extensive transfundal uterine surgery
❏ No
❏ Vaginal delivery is otherwise not contraindicated for TOLAC
❏ After balancing the risks and chances of success, the patient and her health care provider feel that the patient
is an appropriate candidate (2)
❏ Yes
❏ No

References
1. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for perinatal care.
6th ed. Elk Grove Village (IL): AAP; Washington, DC: ACOG; 2007. ^
2. Vaginal birth after previous cesarean delivery. Practice Bulletin No. 115. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2010;116:450–63. [PubMed] [Obstetrics & Gynecology] ^

Standardization of health care processes and reduced variation has been shown to improve out-
comes and quality of care. The American College of Obstetricians and Gynecologists has developed
a series of Patient Safety Checklists to help facilitate the standardization process. This checklist
reflects emerging clinical, scientific, and patient safety advances as of the date issued and is subject
to change. The information should not be construed as dictating an exclusive course of treatment or
procedure to be followed. Although the components of a particular checklist may be adapted to local
resources, standardization of checklists within an institution is strongly encouraged.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 807

 How to Use This Checklist
The Patient Safety Checklist on Appropriateness of Trial of Labor After Previous Cesarean Delivery should be
completed by the health care provider early in the course of prenatal care for patients for whom a trial of labor after
a previous cesarean delivery may be appropriate.

Copyright November 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved.

Appropriateness of trial of labor after previous cesarean delivery (antepartum period). Patient Safety Checklist No. 8. American
College of Obstetricians and Gynecologists. Obstet Gynecol 2012;120:1254–5.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 808

 Patient Safety Checklist ✓ Number 9 • November 2012

TRIAL OF LABOR AFTER PREVIOUS CESAREAN DELIVERY (INTRAPARTUM ADMISSION)

Date _____________ Patient ______________________________ Date of birth ___________ MR # __________

Physician or certified nurse–midwife _____________________________ Last menstrual period _________________
Gravidity/Parity ___________________________
Estimated date of delivery______________ Best estimated gestational age ____________

❏ Patient has been counseled on the risks, benefits, chances of success, and alternatives of planned trial of labor
after cesarean delivery (TOLAC) (1)
❏ Patient is informed of the facility’s ability to perform an emergency cesarean delivery and the availability and
timeliness of services provided by the obstetric, newborn, and anesthetic caregivers
❏ After balancing the risks and chances of success, the patient and her health care provider have concluded that
the patient continues to be an appropriate candidate for TOLAC
❏ Yes
❏ No
❏ Patient has signed a consent form for TOLAC and emergency cesarean delivery as required by the institution
❏ Health care provider providing prenatal care has informed the Labor and Delivery team that the patient is
attempting TOLAC:
❏ Physician or certified nurse midwife
❏ Anesthesiologist
❏ Pediatrician or other appropriate health care provider
❏ Appropriate nursing staff
❏ Misoprostol (prostaglandin E1) is NOT used to ripen the cervix or induce labor when the fetus is
potentially viable

References
1. Vaginal birth after previous cesarean delivery. Committee Opinion No. 115. American College of Obstetricians and
Gynecologists. Obstet Gynecol 2010;116:450–63. [PubMed] [Obstetrics & Gynecology] ^

Standardization of health care processes and reduced variation has been shown to improve out-
comes and quality of care. The American College of Obstetricians and Gynecologists has developed
a series of Patient Safety Checklists to help facilitate the standardization process. This checklist
reflects emerging clinical, scientific, and patient safety advances as of the date issued and is subject
to change. The information should not be construed as dictating an exclusive course of treatment or
procedure to be followed. Although the components of a particular checklist may be adapted to local
resources, standardization of checklists within an institution is strongly encouraged.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 809

 How to Use This Checklist
The Patient Safety Checklist on Trial of Labor After Previous Cesarean Delivery should be completed by the health
care provider when a patient who is undergoing a trial of labor after a previous cesarean delivery is admitted to
Labor and Delivery.

Copyright November 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920,
Washington, DC 20090-6920. All rights reserved.

Trial of labor after previous cesarean delivery (intrapartum admission). Patient Safety Checklist No. 9. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2012;120:1256–7.

PATIENT SAFETY CHECKLISTS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 810

 READING THE
MEDICAL LITERATURE

2013 COMPENDIUM OF SELECTED PUBLICATIONS 811


Developed under the direction
of the ACOG Committee on
Practice Patterns:
James R. Scott, MD, Chair
Daniel W. Cramer, MD, ScD
Herbert B. Peterson, MD
Benjamin P. Sachs, MD
Mary L. Segars Dolan, MD, MPH
Stanley Zinberg, MD
Director of Practice Activities
Nancy E. O’Reilly, MHS
Manager, Practice Activities
Peter J. Sebeny
Research Associate
READING THE MEDICAL LITERATURE
Reading
the Medical
Literature
Applying Evidence to Practice
Reading the Medical Literature is designed as a resource for Fellows of the
American College of Obstetricians and Gynecologists (ACOG) and others
to offer a better understanding of evidence-based medicine, particularly
as it relates to the development of ACOG’s clinical practice guidelines. As
evidence-based medicine continues to develop and to be integrated into clini-
cal practice, an understanding of its basic elements is critical in translating
the medical literature into appropriate clinical practice. The emphasis on
evidence-based medicine has taken on new and greater importance as the
environment of clinical practice grows more diverse, with increased access to
more information by both physicians and patients and the changing allocation
of resources. Practice guidelines are a formal synthesis of evidence, developed
according to a rigorous research and review process. This document provides
an overview of ACOG’s guideline development process, including elements
of study design that are linked to the strength of the evidence. Reading the
Medical Literature is not intended to serve as a comprehensive overview of the
scientific methods of epidemiology and study design. Rather, it is provided to
serve as a readily available introduction to and overview of the topic.
In 1995, ACOG began developing scientifically based practice guidelines,
formerly known as Practice Patterns and subsequently as Practice Bulletins.
The guidelines are derived from the best available evidence of clinical effi-
cacy and consideration of costs, with recommendations explicitly linked to
the evidence. These evidence-based practice guidelines are intended to be a
means of improving the quality of health care, decreasing its cost, and dimin-
ishing professional liability. They are proscriptive in nature and, therefore,
directive in their approach.
This document describes how ACOG Practice Committees identify, eval-
uate, and synthesize evidence from the medical literature to produce practice
guidelines. In particular, this document briefly describes various study
designs evaluated in the production of evidence-based guidelines and the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 812
 decision-making steps used to construct evidence-based
recommendations on clinical issues. Also highlighted are
potential major flaws in study design that affect the validity
and applicability of study results, as well as the strength of
the evidence. This document includes a glossary of com-
monly encountered epidemiologic and biostatistic terms
found in reports of scientific evidence, as well as sugges-
tions for further reading.
Selection of Topics
Topics developed into evidence-based practice guide-
lines are selected based on clinical issues in obstetrics
and gynecology with unexplained variations in practice
or because there are differences between what is known
scientifically and what is practiced. Once a topic has been
identified, objectives of the guideline are developed and
research questions are formulated to guide the literature
search. The research questions highlight the most impor-
tant aspects of a particular clinical issue, focusing on areas
relevant to practice and useful in patient management.
Searching the Literature
In the ACOG Resource Center, medical librarians with
extensive subject expertise perform a literature search
based on the clinical questions and objectives. The
search includes a review of the MEDLINE database, the
Cochrane Library, ACOG’s internal resources and docu-
ments, and other databases as appropriate. In addition,
ACOG librarians review more than 200 journals. This
process locates relevant articles from journals not indexed
in MEDLINE and those not yet indexed.
The search is limited to documents published in
English, and a specific strategy may be used to refine
the search further. This filter strategy restricts the search
by study design or publication type and is similar to the
process used by the Cochrane Library. No further screen-
ing or elimination of records is done by the librarians.
Updated searches are conducted as the topic is developed
or further revised.
Literature Analysis
After results of the literature search are compiled, the study
abstracts are reviewed to assess the relevance of each study
or report. Those articles appropriate for further critical
appraisal are obtained and subdivided according to the
research question they address. The bibliographies of these
articles are also reviewed to identify additional studies that
may not have been identified in the initial literature search.
READING THE MEDICAL LITERATURE
The data in the literature are evaluated to provide
answers to the clinical questions. The articles obtained for
review are organized by study design to ascertain the pos-
sible strengths and weaknesses inherent in each study, as
well as the quality of evidence they may provide. Certain
aspects of a clinical issue may not be addressed in research
studies, and expert opinion may be used and identified as
such.
The levels of evidence used are based on the method
used by the U.S. Preventive Services Task Force. The U.S.
Preventive Services Task Force was a 20-member panel
of scientific and medical experts charged with developing
recommendations on appropriate use of clinical interven-
tions. Their recommendations were based on a systematic
review of the evidence of clinical effectiveness.
Types of Study Designs
Intervention Studies
Level I Evidence
Commonly referred to as clinical trials, intervention
studies are characterized by the investigators’ roles in
assigning subjects to exposed and nonexposed groups and
following the subjects to assess outcome. Intervention
studies may involve the use of a comparison group, which
may include subjects under another treatment, drug, test,
or placebo.
Randomized controlled trials are characterized by the
prospective assignment of subjects, through a random
method, into an experimental group and a control (pla-
cebo) group. The experimental group receives the drug
or treatment to be evaluated, while the control group
receives a placebo, no treatment, or the standard of care.
Both groups are followed for the outcome(s) of interest.
Randomization is the most reliable method to ensure that
the participants in both groups are as similar as possible
with respect to all known or unknown factors that might
affect the outcome.
s
Example
Postmenopausal women are identified from a
population and randomly assigned either to a
study group that will be prescribed hormone
replacement therapy or to a control group that
will be prescribed a placebo. Both groups of
women are observed prospectively to deter-
mine who in each group subsequently develops
endometrial cancer. The rate at which women
prescribed hormone replacement therapy devel-
op endometrial cancer is compared to that of
women in the control group.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 813

s
Major Study Flaws
• Randomization was not valid and resulted
in a differential assignment of treatment that
affected the outcomes.
• The sample size was too small to detect a
clinically important difference.
• Poor compliance or loss to follow-up was
significant enough to affect the outcomes.
Level II-1 Evidence
Controlled trials without randomization are intervention
studies in which allocation to either the experimental
or control group is not based on randomization, making
assignment subject to biases that may influence study
results. Conclusions drawn from these types of studies are
considered to be less reliable than those from randomized
controlled trials.
s
Example
Postmenopausal women are identified from a
population and assigned in a nonrandomized
manner either to a study group that will be
prescribed hormone replacement therapy or to a
control group that will be prescribed a placebo.
Both groups of women are observed prospec-
tively to determine who subsequently develops
endometrial cancer. The rate at which women
prescribed hormone replacement therapy devel-
op endometrial cancer is compared to that of
women in the control group.
s
Major Study Flaws
• Nonrandom group assignment resulted in
unequal distribution of known and unknown
factors that may influence the outcome.
• Other potential flaws are the same as those
for randomized controlled trial (Level I).
Observational Studies
Level II-2 Evidence
There are two types of observational studies in this cat-
egory: cohort and case-control. In these studies, the inves-
tigator has no role in assignment of study exposures but,
rather, observes the natural course of events of exposure
and outcome.
The starting point for a cohort study is exposure sta-
tus. Subjects are classified on the basis of the presence
or absence of exposure to a risk factor, a treatment, or an
intervention and then followed for a specified period to
determine the presence or absence of disease. Cohort stud-
ies can be of two different types determined by the timing
READING THE MEDICAL LITERATURE
of initiation of the study: retrospective (nonconcurrent) or
prospective (concurrent) studies. In a prospective cohort
study, the groups of exposed and unexposed subjects have
been identified and the investigator must conduct follow-
up for an adequate period to ascertain the outcome of
interest. In a retrospective cohort study, both the exposure
and outcomes of interest already have occurred by the
initiation of the study. The rate of disease in the exposed
group is divided by the rate of disease in the unexposed
group, yielding a rate ratio or relative risk.
s
Example
A group of postmenopausal women who have
been prescribed hormone replacement therapy
is identified (study group), as is an otherwise
similar group of postmenopausal women who
have not been prescribed hormone replacement
therapy (control group). The study and control
groups are observed to determine who subse-
quently develops endometrial cancer. The rate
at which women using hormone replacement
therapy develop endometrial cancer is com-
pared with that of women not using hormone
replacement therapy who also develop endome-
trial cancer.
s
Major Study Flaws
• Criteria for determining exposure status were
inadequately defined.
• The assessments of the outcome for the
exposed and nonexposed groups differed in a
biased manner.
• The nonexposed comparison group was inap-
propriate.
A case-control study is a retrospective study in which
a group of subjects with a specified outcome (cases) and a
group without that same outcome (controls) are identified.
Thus, the starting point for a case-control study is disease
status. Investigators then compare the extent to which each
subject was previously exposed to the variable of interest
such as a risk factor, a treatment, or an intervention. A
disadvantage of this study type is that assessment of expo-
sure may have been influenced by disease status, including
the possibility that cases recalled their exposure differ-
ently than controls. The odds of exposure in the case group
compared with the odds of exposure in the control group
provide the measure of association between the disease and
exposure (odds ratio).
s
Example
Researchers conduct a case-control study
to assess the relationship between hormone
replacement therapy and endometrial cancer.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 814
 A group of women who have recently devel-
oped endometrial cancer (cases) and a group of
women with similar characteristics who did not
develop endometrial cancer (controls) are iden-
tified. The use of hormone replacement therapy
for each woman in the case group and the
control group is determined to assess exposure
history. The odds that women who developed
endometrial cancer had used hormone replace-
ment therapy are compared with the odds that
women who did not develop endometrial cancer
had used hormone replacement therapy. These
odds are calculated to determine any association
of hormone replacement therapy to endometrial
cancer.
s
Major Study Flaws
• The case or control group preferentially
included or excluded subjects with a particu-
lar exposure history.
• Cases or controls were selectively more like-
ly to recall or admit to a particular exposure.
• The possibility of known or unknown factors
that may have been related to both exposure
status and outcome were not adequately con-
sidered and assessed.
Level II-3 Evidence
Cross-sectional studies are observational studies that
assess the status of individuals with respect to the presence
or absence of both exposure and outcome at a particular
time. In this type of study, one is unlikely to be able to
discern the temporal relationship between an exposure and
outcome. Results from cross-sectional studies can yield
correlations and disease prevalence. Prevalence is defined
as the proportion of individuals with a disease at a specific
time; in contrast, incidence is the number of new cases
occurring over a specified period.
Uncontrolled investigational studies report the results
of treatment or interventions in a particular group, but lack
a control group for comparison. They may demonstrate
impressive results, but in the absence of a control group
the results may be attributable to factors other than the
intervention or treatment.
Of all observational studies, cross-sectional and uncon-
trolled investigational studies provide the least evidence
of causation.
s
Example
Postmenopausal women are identified from a
population and surveyed at a particular time
about their current intake of calcium. Bone
densitometry is evaluated in these women at the
READING THE MEDICAL LITERATURE
same time to identify signs of osteoporosis. In
this cross-sectional study, a measure of calcium
intake in women with and without signs of
osteoporosis is compared.
s
Major Study Flaws
• It is usually not possible to determine the
temporal relationship between disease and
exposure.
• Other factors that may contribute to the
disease, particularly past exposure to factors
other than the factor under study, are not
taken into consideration.
Level III Evidence
These studies provide limited information about the rela-
tionship between exposure and the outcome of interest.
This category includes descriptive studies, such as case
reports and case series, and expert opinion, which is often
based on clinical experience.
A case study describes clinical characteristics or other
interesting features of a single patient or a series of pa-
tients. The latter is referred to as a case series.
Expert opinion often is used to make recommenda-
tions. This type of evidence includes findings from expert
panels and committees and the opinions of respected
experts in a particular field.
Other Study Designs
A meta-analysis is a systematic structured process, not
merely a literature review. It combines results from more
than one investigation to obtain a weighted average of the
effect of a variable or intervention on a defined outcome.
This approach can increase precision of the exposure to
the outcome measured, although it is important to add
that the validity of the conclusions of the meta-analysis
depends largely on the quality of its component studies.
Results are usually presented in a graph that illustrates the
measure of association by each study type and the overall
summary association (Fig. 1).
A decision analysis is a type of study that uses math-
ematical models of the sequences of multiple strategies to
determine which are optimal. The basic framework is the
decision tree in which branches of the tree represent key
probabilities or decisions. Decision analysis is driven by key
assumptions. Ideally the assumptions are based on data that
may include findings from meta-analyses. Often a decision
analysis is undertaken when there are inadequate data to
perform a meta-analysis (Fig. 2).
Cost-benefit analysis and cost-effectiveness analysis are
related analytic methods that compare health care practices
or techniques in terms of their relative economic efficiencies
2013 COMPENDIUM OF SELECTED PUBLICATIONS 815
 MacDonald

Depalo

Meta-analysis
M1 Breslow-Day P=0.69

Malkasean

Vergote

Meta-analysis M2 P=0.58
0 0.1 1 10 100
No Adjuvant Therapy Deaths Progestagen Deaths

Fig. 1. Effects on endometrial cancer deaths: progestagen versus no adjuvant treatment.

(Reprinted from the European Journal of Obstetrics, Gynecology, and Reproductive Biology, Vol. 65. Martin-Hirsch PL, Lilford RJ, Jarvis GJ. Adjuvant
progestagen therapy for the treatment of endometrial cancer: review and meta-analyses of published randomized controlled trials, p. 205, © 1996, with
permission from Elsevier Science Ireland Ltd, Bay 15K, Shannon Industrial Estate, Co. Clare, Ireland.)

Surgical Death ▲
Operative Death from Vaginal Cancer Death
▲

Complication
Total
● Recovers Long-Term Disability
● Dysfunction
▲

●
Cured
▲

Uneventful Healthy
▲

Hysterectomy
■ Uneventful
▲

Healthy
Cured
▲

Subtotal Operative Recovers Long-Term Disability

● Complication ● Dysfunction
▲

● Death from Cervical Cancer

▲

Surgical Death Death

▲

Fig. 2. Decision model. Square at far left, choice between two treatment options: total or subtotal hysterectomy. Round nodes, chance
outcomes; end branches, final outcome states.
(Scott JR, Sharp HT, Dodson MK, Norton PA, Warner HR. Subtotal hysterectomy in modern gynecology: a decision analysis. Am J Obstet Gynecol 1997;176:1187.
Reprinted with permission.)

READING THE MEDICAL LITERATURE 2013 COMPENDIUM OF SELECTED PUBLICATIONS 816

 in providing health benefits. In a cost-effectiveness analysis,
the net monetary costs of a health care intervention are
compared with some measure of clinical outcome or effec-
tiveness. In a cost-benefit analysis, the net monetary costs
of a health care intervention typically are compared with the
net monetary costs of the clinical outcome or effectiveness.
Therefore, a cost-benefit analysis compares costs associated
with an intervention with monetary benefits from the use of
that intervention. The advantage of a cost-benefit analysis is
the ability to use dollars for comparison across interventions.
The disadvantage is the difficulty in assigning a monetary
value to health status or quality of life.
Developing Evidence-Based
Recommendations
Having stated the clinical question and assembled and grad-
ed the literature using the levels just outlined, recommenda-
tions are formulated according to the quality and quantity of
evidence. Based on the highest available level of evidence,
recommendations are provided and graded according to the
following categories:
A There is good evidence to support the recommendation.
B There is fair evidence to support the recommendation.
C There is insufficient evidence to support the recommen-
dation; however, the recommendation may be made on
other grounds.
D There is fair evidence against the recommendation.
E There is good evidence against the recommendation.
This method explicitly links recommendations to the
evidence. Determination of the quality of the evidence and
the strength of recommendations are based on good, fair, or
insufficient evidence. These descriptors address the levels
of evidence and also provide a qualitative review of the evi-
dence in terms of its methodologic strengths and weakness-
es. A prerequisite for inclusion of each study in the analysis
is that it provides overall evidence of “good quality.”
It is important to note that an exact correlation does
not exist between the strength of the recommendation and
the level of evidence (ie, an “A” grade does not necessar-
ily require Level I evidence, nor does Level I evidence
necessarily lead to an “A” grade). For example, for some
clinical issues a randomized trial is not possible for medical
or ethical reasons, and recommendations must be based on
evidence from other types of studies (Level II-2, II-3). In
other cases, high-quality studies have produced conflicting
results, or evidence of significant benefit is offset by evi-
dence of important harm from the intervention. Although
these studies may be randomized controlled trials (Level I),
insufficient or conflicting evidence would result in a “C”
recommendation.
READING THE MEDICAL LITERATURE
Implications for Practice
Medicine will continue to face the rapid introduction
of new technologies, rationing of health resources, and
increasing attention to the quality and outcomes of medi-
cal care. Physicians will have to acquire the skills neces-
sary to review the medical literature critically to identify
the best evidence in managing patients. This process for
developing practice guidelines identifies available evi-
dence and constructs recommendations based on the best
evidence so that obstetrician–gynecologists can continue
to provide the highest quality of care.
s
Glossary*
Accuracy: The degree to which a measurement or an esti-
mate based on measurements represents the true value of
the attribute that is being measured.
Bias: Deviation of results or inferences from the truth, or
processes leading to such deviation; it is any trend in the
collection, analysis, interpretation, publication, or review
of data that can lead to conclusions that are systemati-
cally different from the truth. Three frequently occurring
types of bias include selection bias, information bias, and
confounding. Selection bias is error due to systematic dif-
ferences in characteristics between those who are selected
for study and those who are not. Information bias, also
called observational bias, is a flaw in measuring exposure
or outcome data that results in different quality (accuracy)
of information between comparative groups. Recall bias is
an example of information bias. The third example of bias,
confounding, describes a situation in which the effects of
two processes are not separated; it is the distortion of the
apparent effect of an exposure on risk brought about by
the association with other factors that can influence the
outcome.
Confidence interval: An indication of the variability of
a point estimate, such as an odds ratio or relative risk. In
general, the wider the confidence interval, the less precise
the point estimate. The 95% confidence interval is often
used. As an example, if the 95% confidence interval does
not overlap 1.0, then one would reject the null hypothesis.
Confounding variable (syn: confounder): A variable
that can cause or prevent the outcome of interest, is not
an intermediate variable, and is associated with the factor
under investigation. Unless it is possible to adjust for con-
founding variables, their effects cannot be distinguished
from those factor(s) being studied. Bias can occur when
adjustment is made for any factor that is caused in part
by the exposure and is also correlated with the outcome.
*Adapted from A Dictionary of Epidemiology, third edition. Last JM, ed. Used
by permission of Oxford University Press.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 817
 Incidence: The number of instances of illness commenc-
ing, or persons falling ill, during a given period in a speci-
fied population. More generally, the number of new events
(eg, new cases of a disease in a defined population) within
a specified period.
Null hypothesis (test hypothesis): The statistical hypoth-
esis that one variable has no association with another
variable or set of variables, or that two or more population
distributions do not differ from one another. In simplest
terms, the null hypothesis states that the results observed
in a study, experiment, or test are no different from what
might have occurred as a result of the operation of chance
alone.
Odds ratio (syn: cross product ratio, relative odds):
The ratio of two odds. The exposure odds ratio for a set
of case control data is the ratio of the odds in favor
of exposure among the cases (a/b) to the odds in favor of
exposure among noncases (c/d). A 2 × 2 table (Table 1) can
be used to illustrate this calculation of odds ratios.
Table 1. Odds Ratio Calculations*
Exposed Unexposed
Disease a b
No disease c d
*The odds ratio is ad/bc.
P-value: The probability that a test statistic would be as
extreme or more extreme than observed if the null hypoth-
esis were true. The letter P, followed by the abbreviation
n.s. (not significant) or by the symbol < (less than) and a
decimal notation such as 0.01 or 0.05, is a statement of
the probability that the difference observed could have
occurred by chance if the groups were really alike (ie,
under the null hypothesis). Investigators may arbitrarily
set their own significance levels, but in most biomedical
and epidemiologic work, a study result whose probability
value is less than 5% (P <0.05) or 1% (P <0.01) is consid-
ered sufficiently unlikely to have occurred by chance and
would justify the designation “statistically significant.” By
convention, most investigators choose P <0.05 as statisti-
cally significant.
Power (statistical power): The ability of a study to dem-
onstrate an association if one exists. The power of the
study is determined by several factors, including the fre-
quency of the condition under study, the magnitude of the
effect, the study design, and sample size.
Prevalence: The number of events (eg, instances of a
given disease or other condition) in a given population at a
designated time; sometimes used to mean prevalence rate.
When used without qualification, the term usually refers to
the situation at a specified time (point prevalence).
READING THE MEDICAL LITERATURE
Relative risk: The ratio of risk of disease or death among
the exposed to that of the risk among the unexposed; this
usage is synonymous with risk ratio. If the relative risk is
above 1.0, then there is a positive association between the
exposure and the disease; if it is less than 1.0, then there is
a negative association.
Sensitivity and specificity: Sensitivity is the proportion
of truly diseased persons in the screened population who
are identified as diseased by the screening test. Specificity
is the proportion of truly nondiseased persons who are so
identified by the screening test. Table 2 illustrates these
quantities.
In screening and diagnostic tests, the probability that
a person with a positive test is a true positive (ie, does
have the condition) is referred to as the predictive value
of a positive test. The predictive value of a negative test is
the probability that a person with a negative test does not
have the condition. The predictive value of a screening test
is determined by the sensitivity and specificity of the test
and by the prevalence of the condition for which the test is
being used.
Positive predictive value = a/a+b
Negative predictive value = d/c+d
Table 2. Sensitivity and Specificity Calculations
True Status
Screening Test
Results Diseased Not Diseased Total
Positive a b a+b
Negative c d c+d
Total a + c b + d a+b+c+d
a = Diseased individuals detected by the test (true positives)
b = Nondiseased individuals positive by the test (false positives)
c = Diseased individuals not detected by the test (false negatives)
d = Nondiseased individuals negative by the test (true negatives)
Sensitivity = a/a+c; specificity = d/b+d.
Type I error: The error of rejecting a true null hypothesis
(ie, declaring that a difference exists when it does not).
Type II error: The error of failing to reject a false null
hypothesis (ie, declaring that a difference does not exist
when in fact it does).
Suggested Reading
s
Asilomar Working Group on Recommendations for Reporting
of Clinical Trials in the Biomedical Literature. Checklist of
information for inclusion in reports of clinical trials. Ann Intern
Med 1996;124:741–743
2013 COMPENDIUM OF SELECTED PUBLICATIONS 818
 Chalmers TC, Smith H Jr, Blackburn B, Silverman B, Schroeder
B, Reitman D, et al. A method for assessing the quality of a ran-
domized control trial. Control Clin Trials 1981; 2:31–49
DuRant RH. Checklist for the evaluation of research articles.
J Adolesc Health 1994;15:4–8
Grisso JA. Making comparisons. Lancet 1993;342:157–160
Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical
literature. II. How to use an article about therapy or prevention.
A. Are the results of the study valid? Evidence-Based Medicine
Working Group. JAMA 1993;270:2598–2601
Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical
literature. II. How to use an article about therapy or prevention.
B. What were the results and will they help me in caring for my
patients? Evidence-Based Medicine Working Group. JAMA
1994;271:59–63
Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ,
Cook RJ. Users’ guides to the medical literature. IX. A method
for grading health care recommendations. Evidence-Based
Medicine Working Group. JAMA 1995;274:1800–1804
Hadorn DC, Baker D, Hodges JS, Hicks N. Rating the quality
of evidence for clinical practice guidelines. J Clin Epidemiol
1996;49:749–754
Hayward RS, Wilson MC, Tunis SR, Bass EB, Guyatt G.
Users’ guides to the medical literature. VIII. How to use
clinical practice guidelines. A. Are the recommendations valid?
The Evidence-Based Medicine Working Group. JAMA 1995;
274:570–574
Jaeschke R, Guyatt GH, Sackett DL. Users’ guides to the
medical literature. III. How to use an article about a diagnostic
test. B. What are the results and will they help me in caring for
my patients? The Evidence-Based Medicine Working Group.
JAMA 1994;271:703–707
READING THE MEDICAL LITERATURE
Laupacis A, Wells G, Richardson WS, Tugwell P. Users’
guides to the medical literature. V. How to use an article about
prognosis. Evidence-Based Medicine Working Group. JAMA
1994;272:234–237
Naylor CD, Guyatt GH. Users’ guides to the medical literature.
X. How to use an article reporting variations in the outcomes of
health services. The Evidence-Based Medicine Working Group.
JAMA 1996;275:554–558
Naylor CD, Guyatt GH. Users’ guides to the medical literature.
XI. How to use an article about a clinical utilization review.
Evidence-Based Medicine Working Group. JAMA 1996;275:
1435–1439
Oxman AD. Checklists for review articles. BMJ 1994;309:
648–651
Oxman AD, Cook DJ, Guyatt GH. Users’ guides to the medi-
cal literature. VI. How to use an overview. Evidence-Based
Medicine Working Group. JAMA 1994;272:1367–1371
Oxman AD, Sackett DL, Guyatt GH. Users’ guides to the
medical literature. I. How to get started. The Evidence-Based
Medicine Working Group. JAMA 1993;270:2093–2095
Peipert JF, Gifford DS, Boardman LA. Research design and
methods of quantitative synthesis of medical evidence. Obstet
Gynecol 1997;90:473–478
Richardson WS, Detsky AS. Users’ guides to the medical lit-
erature. VII. How to use a clinical decision analysis. A. Are the
results of the study valid? Evidence-Based Medicine Working
Group. JAMA 1995;273:1292–1295
Wilson MC, Hayward RS, Tunis SR, Bass EB, Guyatt G.
Users’ guides to the medical literature. VIII. How to use clinical
practice guidelines. B. What are the recommendations and will
they help you in caring for your patients? The Evidence-Based
Medicine Working Group. JAMA 1995;274:1630–1632
Copyright © 1998
The American College of Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
2013 COMPENDIUM OF SELECTED PUBLICATIONS 819
PRACTICE BULLETINS
The Committee on Practice Bulletins—
Obstetrics

2013 COMPENDIUM OF SELECTED PUBLICATIONS 820


This Practice Bulletin was
developed by the ACOG Com­­­
mittee on Prac­tice Bulletins—
Obstetrics with the assistance
of Michael L. Socol, MD, and
T. Flint Porter, MD, MPH.
The in­for­ma­tion is de­signed
to aid practitioners in mak-
ing decisions about appropri-
ate obstetric and gynecologic
care. These guidelines should
not be construed as dic­tat­ing
an ex­ clu­sive course of treat-
ment or proce­dure. Variations
in prac­tice may be warranted
based on the needs of the in­di­
vid­u­al pa­tient, resources, and
lim­it­a­tions unique to the insti-
tution or type of prac­tice.
Reaffirmed 2010
PRACTICE BULLETINS
ACOG
PRACTICE
BULLETIN
Clinical Management Guidelines for
Obstetrician–Gynecologists
Number 4, May 1999
(Replaces Educational Bulletin Number 147, October 1990)
Prevention of Rh D
Alloimmunization
Before the introduction of anti-D immune globulin (formerly referred to as
Rho[D] immune globulin), hemolytic disease of the fetus and newborn affected
9–10% of pregnancies and was a major cause of perinatal morbidity and mor-
tality (1, 2). Among Rh D-alloimmunized pregnancies, mild-to-moderate hemo-
lytic anemia and hyperbilirubinemia occur in 25–30% of fetuses/neonates, and
hydrops fetalis occurs in another 25% of such cases (3). The administration of
anti-D immune globulin is successful in reducing the rate of developing antibod-
ies to the D antigen. Protocols for the antenatal and postpartum administration
of anti-D immune globulin have been responsible for the dramatic decrease in
alloimmunization and subsequent hemolytic disease in the past two decades.
However, Rh D alloimmunization remains a clinical concern, with many cases
due to failure to follow established protocols. Finally, there is concern that
overuse of anti-D immune globulin may lead to a worldwide shortage. The pur-
pose of this document is to provide direction for the appropriate and efficient
management of patients at risk in order to further decrease the frequency of Rh
D alloimmunization.
Background
Nomenclature
Nomenclature of blood group systems, including the Rh system, may appear con-
fusing to the clinician. According to the American Medical Association Manual
of Style, erythrocyte antigen and phenotype terminology should use single letters
or dual letters depending on the antigen in question (eg, O, AB, Le, Rh) (4). A
second designation should be used for specific subtypes (eg, Rh D, Rh C). This
publication uses the designation Rh D to signify the erythrocyte antigen. Women
2013 COMPENDIUM OF SELECTED PUBLICATIONS 821
 who carry the Rh D antigen are identified as Rh D positive,
and those who do not carry the Rh D antigen are identified
as Rh D negative. The use of immune globulin to counter
the Rh D antigen is referred to as anti-D immune globulin.
Causes of Rh D Alloimmunization
One study indicates that 17% of Rh D-negative women
who do not receive anti-D immune globulin prophylaxis
during pregnancy will become alloimmunized (5). Nearly
90% of these cases result from fetomaternal hemorrhage
at delivery. Approximately 10% of cases result from
spontaneous antenatal fetomaternal hemorrhage, and most
of these cases occur in the third trimester. The amount of
Rh D-positive blood required to cause alloimmunization is
small. Most women who become alloimmunized do so as a
result of fetomaternal hemorrhage of less than 0.1 mL (6).
Several first- and second-trimester clinical events may
cause Rh D alloimmunization. Therapeutic and spontane-
ous abortions are associated respectively with a 4–5% and
a 1.5–2% risk of alloimmunization in susceptible (nonal-
loimmunized) women (6–8). Ectopic pregnancy also is
associated with alloimmunization in susceptible women.
Threatened abortion infrequently causes alloimmuniza-
tion, although approximately 10% of women with threat-
ened abortion have evidence of fetomaternal hemorrhage
(9).
Clinical procedures, which may breach the integrity
of the choriodecidual space, also may cause Rh D alloim-
munization. Chorionic villus sampling is associated with
a 14% risk of fetomaternal hemorrhage (10) of more than
0.6 mL (11), and amniocentesis is associated with a 7–15%
risk of fetomaternal hemorrhage, even if the placenta is
not traversed (5, 12). Likewise, cordocentesis and other
percutaneous fetal procedures pose a risk for fetomaternal
hemorrhage, although the actual risk of alloimmunization
has not been quantified (13, 14). External cephalic version,
whether or not it is successful, results in fetomaternal hem-
orrhage in 2–6% of cases (15, 16).
Anti-D Immune Globulin to Prevent
Alloimmunization
The correct administration of anti-D immune globulin
dramatically reduces the rate of alloimmunization. Initial
studies proved that the postpartum administration of a
single dose of anti-D immune globulin to susceptible Rh
D-negative women within 72 hours of delivery reduced the
alloimmunization rate by 90% (17). It was subsequently
recognized that third-trimester antenatal alloimmunization
posed a lingering and significant problem; later it was
shown that the routine antenatal administration of anti-D
immune globulin to Rh D-negative women at 28–29 weeks
of gestation reduced the rate of third-trimester alloimmuni-
zation from nearly 2% to 0.1% (6). With the effectiveness
PRACTICE BULLETINS
of anti-D immune globulin clearly demonstrated, authori-
ties recommended its administration to Rh D-negative
women who were undergoing clinical events or
procedures associated with potential fetomaternal hemor-
rhage.
In the United States, recommendations for the
administration of anti-D immune globulin were intro-
duced in the 1970s. The current antenatal immunopro-
phylaxis regimen of a single dose of 300 µg at 28 weeks
of gestation was based on recommendations from the
1977 McMaster Conference, and is associated with a
low failure rate (18). The efficacy of the single antenatal
dose of 300 µg at 28 weeks of gestation is comparable to
the same dose given at both 28 weeks and 34 weeks of
gestation (6). In one study of antenatal prophylaxis, three
women who delivered more than 12 weeks after their
antenatal dose was administered became alloimmunized.
Based on these limited data, some authorities recommend
that if delivery has not occurred within 12 weeks of the
injection, at 28 weeks of gestation, a second 300 µg dose
of anti-D immune globulin should be given (5).
In the United Kingdom, recommendations (19, 20)
differ somewhat from those in the United States in that
antenatal prophylaxis is given at both 28 weeks and 34
weeks of gestation, and the dose for each antenatal ad-
ministration, as well as the dose given after delivery, is
100 µg. These recommendations are based on two stud-
ies (21, 22) that demonstrated the superiority of a regi-
men of 100 µg of anti-D immune globulin at 28 weeks
and 34 weeks of gestation and postpartum compared
with a regimen of only postpartum administration. The
British regimen uses less anti-D immune globulin (300
µg versus 600 µg) to achieve similarly low rates of allo-
immunization (7, 20), but requires a third injection at 34
weeks of gestation.
Anti-D immune globulin is extracted by cold alco-
hol fractionation from plasma donated by individuals
with high-titer D immune globulin G antibodies. It has
been shown experimentally that one prophylactic dose
of 300 µg of anti-D immune globulin can prevent Rh
D alloimmunization after an exposure to up to 30 mL
of Rh D-positive blood or 15 mL of fetal cells (23). For
exposure to larger volumes of Rh D-positive blood, more
anti-D immune globulin is required. Accordingly, the
American Association of Blood Banks and the National
Blood Transfusion Service of the United Kingdom
recommend that Rh D-negative mothers delivering Rh
D-positive infants undergo a test to screen for fetoma-
ternal hemorrhage in excess of the amount covered by
the standard dose of anti-D immune globulin. This test
will determine if additional anti-D immune globulin is
necessary (24, 25). In the past, the American College of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 822
 Obstetricians and Gynecologists recommended that only
women with certain high-risk conditions, such as those
experiencing abruptio placenta or manual removal of the
placenta, be screened for excess fetomaternal hemorrhage.
However, this policy has been shown to miss 50% of cases
requiring more than the standard postpartum dose of anti-
D immune globulin (26).
The risk of transmission of viral infections (human
immunodeficiency virus [HIV] and hepatitis B and hepati-
tis C viruses) through anti-D immune globulin is minimal
to absent (27). All plasma lots used for the production of
anti-D immune globulin have been tested for viral infec-
tion since 1985. Moreover, the fractionation process used
to prepare anti-D immune globulin effectively removes
any viral particles that may be present.
Failure to Prevent Rh D
Alloimmunization
In spite of recommendations for immunoprophylaxis, 0.1–
0.2% of susceptible Rh D-negative women still become
alloimmunized (21). There are two primary reasons for the
continuing problem.
One reason women become alloimmunized is failure
to implement recommended immunoprophylaxis pro-
tocols, resulting in preventable Rh D alloimmunizations.
Two recent studies from the United Kingdom emphasize
the scope of the problem. One study of more than 900 Rh
D-negative women reported that only 59% received rec-
ommended treatment with anti-D immune globulin after
potentially alloimmunizing clinical events (8). Another
study showed that 16% of 63 cases of Rh D alloimmu-
nization occurred because of failure to follow recommen-
dations for administration of anti-D immune globulin (28).
Preventable Rh D alloimmunization occurs in susceptible
Rh D-negative women for the following three reasons:
1. Failure to administer an antenatal dose of anti-D
immune globulin at 28–29 weeks of gestation
2. Failure to recognize clinical events that place patients
at risk for alloimmunization and failure to administer
anti-D immune globulin appropriately
3. Failure to administer or failure to administer timely
anti-D immune globulin postnatally to women who
have given birth to an Rh D-positive or untyped fetus
The second reason for the continuing problem of Rh
D alloimmunization is the small rate (0.1–0.2%) of spon-
taneous immunization despite the recommended prophy-
laxis protocol. These cases most often occur in pregnancies
during which there have been no prior overt sensitizing
events. This problem may become the largest single cause
of new Rh D alloimmunization, because alloimmunization
from other causes has decreased proportionally (28).
PRACTICE BULLETINS
Potential Shortage of Anti-D Immune
Globulin
Anti-D immune globulin is collected by apheresis from
volunteer donors who have high titers of circulating
anti-Rh D antibodies. The donated plasma is pooled and
fractionated by commercial manufacturers, and anti-D
immune globulin is prepared in varying doses. The num-
ber of potential donors may be dwindling worldwide,
raising concern about future supplies of anti-D immune
globulin (29, 30). Experts in the United Kingdom estimate
that supplies of anti-D immune globulin are inadequate
for immunoprophylaxis of all susceptible Rh D-negative
women, both primigravidas and multiparas, if standard
recommendations are followed (19). In Australia, a short-
age prompted importation of anti-D immune globulin.
Subsequently, some physicians proposed strictly limit-
ing the dose given for first-trimester indications and
discontinuing administration of anti-D immune globulin
after external cephalic version (unless fetomaternal hem-
orrhage is documented), ectopic pregnancy, or threatened
miscarriage (31). Others disagreed, considering it unethi-
cal to withhold anti-D immune globulin in any situation.
Estimates regarding future needs compared with poten-
tial supply in the United States have not been published;
however, limiting doses for first-trimester indications
and using lower doses of Rh D immune globulin for
antenatal prophylaxis may be necessary.
Cost-Effectiveness of Rh D Prophylaxis
Programs
The cost-effectiveness of preventing perinatal mortality
and morbidity secondary to Rh D hemolytic disease of
the newborn is an important consideration. Economic
analysis of anti-D immune globulin prophylaxis is based
on the cost of anti-D immune globulin and the number of
alloimmunizations that would be prevented. In 1977, the
McMaster Conference concluded that routine postnatal
prophylaxis was cost-effective but that routine antena-
tal treatment should be undertaken only if supplies of
anti-D immune globulin were adequate and if cases of
hemolytic disease of the newborns occurred that might
have been prevented by antenatal treatment (7). Some
experts concluded that antenatal prophylaxis is effective
only in primigravidas (32), and the debate regarding the
cost-effectiveness of antenatal prophylaxis of all preg-
nant women remains unsettled (20, 32–37). The Scottish
National Blood Transfusion Service has concluded that
the administration of 100 µg of anti-D immune globulin
at 28 weeks and 34 weeks of gestation is cost-effective
only in primigravidas (38). Others estimate that the most
cost-effective antenatal regimen is a single dose of 250 µg
of anti-D immune globulin at 28 weeks of gestation (39).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 823
 The use of anti-D prophylaxis in the case of certain
clinical events is even more controversial. For example,
the risk of Rh D alloimmunization from threatened abor-
tion in the first trimester is uncertain, though probably very
small. The cost-effectiveness of anti-D immune globulin
for threatened abortion, which has never been studied, is
questionable (19).
In summary, the cost-effectiveness of antenatal Rh D
immune globulin to all Rh D-negative pregnant women
and in all circumstances wherein fetomaternal hemorrhage
might occur has not been proved. Available data support
that third-trimester antenatal prophylaxis is cost-effective
in primigravidas. As long as the supply of anti-D immune
globulin is adequate and data do not exist to support other
recommendations, most experts believe that it is unethical
to withhold anti-D immune globulin from any patient at
risk of Rh D alloimmunization (19). Recommendations for
the use of anti-D immune globulin in this document will
be made accordingly.
Clinical Considerations and
Recommendations
Should anti-D immune globulin ever be with-
s
held from a woman undergoing sterilization?
The use of anti-D immune globulin following postpar-
tum and postabortal sterilization should be guided by
the patient’s desire for protection against any chance of
alloimmunization. Proponents of its use maintain that
anti-D immune globulin administration will preserve the
future option of transfusing Rh D-positive blood in times of
emergency (40). Opponents of this view cite the low prob-
ability of sensitization with the previous pregnancy and the
improbability of receiving Rh D-incompatible blood (41).
How should one deal with the issue of paternity?
s
If the father is known to be Rh D negative, antenatal pro-
phylaxis is unnecessary. If there is doubt about the father’s
identity or his blood type, anti-D immune globulin prophy-
laxis should be given.
Is it necessary to repeat antibody screening in
s
patients at 28 weeks of gestation prior to the
administration of anti-D immune globulin?
The American Association of Blood Banks recommends
that the physician should consider a repeat antibody screen
prior to the administration of antenatal anti-D immune
globulin if the patient was screened for antibodies prior
to 28 weeks of gestation (24). The primary rationale for
repeating the antibody screen is to identify women who
have become alloimmunized before 28 weeks of gestation
PRACTICE BULLETINS
in order to manage their pregnancies properly. However,
the incidence of Rh D alloimmunization occurring prior
to 28 weeks of gestation is reported to be as low as 0.18%
(18), and the cost-effectiveness of routinely repeating the
antibody test has not been studied. The consequences of
antenatal Rh D alloimmunization can be severe, but the
decision to obtain a repeat antibody screen should be
dictated by individual circumstances and left to the judg-
ment of the physician.
Is anti-D immune globulin indicated in a sen-
s
sitized pregnancy?
If Rh D antibodies are present, anti-D immune globu-
lin is not beneficial, and management should proceed
in accordance with protocols for Rh D-alloimmunized
pregnancies.
How should a Du blood type be interpreted,
s
and what management should be under-
taken?
In the past, a woman whose blood was typed as Du was
thought to have blood cells positive for a variant of the
Rh D antigen. Nomenclature and practice have changed
in recent years, and currently the Du designation has been
changed to “weak D positive” (24). Patients with this
designation are considered Rh D positive and should not
receive anti-D immune globulin. In some centers, the Du
antigen is not assessed, and women may unnecessarily
receive anti-D immune globulin. In the rare circumstance
of delivery by a woman whose antenatal Rh status is neg-
ative or unknown and whose postpartum screen reveals
a Du-positive or weak D-positive result, anti-D immune
globulin should be given, and the possibility of fetoma-
ternal hemorrhage should be investigated (24).
Is threatened abortion an indication for anti-D
s
immune globulin prophylaxis?
Whether to administer anti-D immune globulin to a
patient with threatened abortion and a live embryo or fetus
at or before 12 weeks of gestation is controversial, and no
evidence-based recommendation can be made. The Rh D
antigen has been reported on fetal erythrocytes as early
as 38 days of gestation (42), and fetomaternal hemorrhage
has been documented in women with threatened abor-
tion from 7 to 13 weeks of gestation (9). However, Rh D
allo-immunization apparently attributable to threatened
abortion is exceedingly rare. Experts have compared the
overall benefit with the cost of the widespread use of anti-
D immune globulin for a condition as common as threat-
ened abortion (19, 43), and, thus, many physicians do not
routinely administer anti-D immune globulin to women
with threatened abortion and a live embryo or fetus up to
12 weeks of gestation.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 824
 How much anti-D immune globulin should be
s
given for first-trimester events and procedures?
Because the red cell mass of the first-trimester fetus is
small, the dose of anti-D immune globulin necessary for
first-trimester events is 50 µg to protect against sensitiza-
tion by 2.5 mL of red blood cells (5, 44). If therapeutic or
spontaneous abortion occurs after the first trimester, the
standard 300 µg dose is recommended (5).
Should anti-D immune globulin be given in
s
cases of molar pregnancy?
Although reported (45), the risk of Rh D alloimmunization
in cases of hydatidiform mole is unknown. In theory, Rh
D alloimmunization would not occur in cases of classic
complete molar pregnancy because organogenesis does
not occur, and Rh D antigens are probably not present on
trophoblast cells, although this theory has been disputed
(46–48). In partial and transitional molar pregnancies,
however, the embryo may not die until after erythrocyte
production has begun, making maternal exposure to the Rh
D antigen possible (49). Given that the diagnosis of partial
versus complete molar pregnancy depends on pathologic
and cytogenetic evaluations, it seems reasonable to admin-
ister anti-D immune globulin to Rh D-negative women
who are suspected of molar pregnancy and who undergo
uterine evacuation.
Should anti-D immune globulin be given in
s
cases of intrauterine fetal death occurring in the
second or third trimester?
Fetal death is due to fetomaternal hemorrhage in 11–13%
of cases in which no obvious other cause (eg, maternal
hypertensive disease, fetal anomalies) is found (50, 51).
Rh D alloimmunization has been reported in cases of fetal
death from massive fetomaternal hemorrhage (52), although
the influence of this cause on the overall problem of Rh
D alloimmunization is unknown. The efficacy of anti-D
immune globulin in this clinical situation has not been
tested in properly designed trials. However, authorities
agree that anti-D immune globulin should be administered
to Rh D-negative women who experience fetal death in the
second or third trimester. All such cases should be screened
for excessive fetomaternal hemorrhage to determine if
additional anti-D immune globulin is required (25, 53).
Is second- or third-trimester antenatal hemor-
s
rhage an indication for anti-D immune globulin
prophylaxis?
In patients with second- or third-trimester antenatal hem-
orrhage, the risk of Rh D alloimmunization is uncertain.
Although the efficacy of anti-D immune globulin in this
clinical situation has not been tested in properly designed
trials, authorities agree that anti-D immune globulin should
be administered to Rh D-negative women with second- or
PRACTICE BULLETINS
third-trimester hemorrhage (25, 53). Management of the
patient with persistent or intermittent antenatal bleed-
ing is complex. Though unproven, one commonly used
strategy is to monitor the Rh D-negative patient with
continuing antenatal hemorrhage with serial indirect
Coombs testing approximately every 3 weeks. If the
result is positive, indicating the persistence of anti-D
immune globulin, no additional treatment is necessary. If
the Coombs test is negative, excessive fetomaternal hem-
orrhage may have occurred, and a Kleihauer-Betke test
should be performed in order to determine the amount of
additional anti-D immune globulin necessary.
Is anti-D immune globulin prophylaxis indi-
s
cated after abdominal trauma in susceptible
pregnant women?
Although the exact risk of Rh D alloimmunization is
unknown, abdominal trauma may be associated with
fetomaternal hemorrhage, which may lead to alloimmu-
nization (54–57). The efficacy of anti-D immune globulin
in this clinical situation has not been tested in prop-
erly designed trials. However, authorities agree that
anti-D immune globulin should be administered to Rh
D-negative women who have experienced abdominal
trauma (25, 53). Also, all of these patients should be
screened for excessive fetomaternal hemorrhage.
What should be done if an Rh D-negative
s
patient is discharged without receiving anti-D
immune globulin after a potentially sensitizing
event?
Volunteers have been shown to receive partial protection
if anti-D immune globulin was given as late as 13 days
after exposure (58). The longer prophylaxis is delayed
the less likely it is that the patient will be protected, but
it has been recommended that a patient may still receive
some benefit from anti-D immune globulin as late as 28
days postpartum (5).
How long does the effect of anti-D immune
s
globulin last?
The half-life of anti-D immune globulin is 24 days,
although titers decrease over time. If delivery occurs
within 3 weeks of the standard antenatal anti-D immune
globulin administration, the postnatal dose may be with-
held in the absence of excessive fetomaternal hemorrhage
(53). The same is true when anti-D immune globulin is
given for antenatal procedures, such as external cephalic
version or amniocentesis, or for third-trimester bleeding.
An excessive amount of fetal erythrocytes not covered by
anti-D immune globulin administration can be assumed
to have entered maternal blood if either the results of
the Kleihauer-Betke test are positive or the results of the
indirect Coombs test are negative.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 825
 Should administration of anti-D immune glob-
s
s
ulin be repeated in patients with a postdate
pregnancy?
s s
One study found that three patients became alloim-
munized to the Rh D antigen when delivery occurred
more than 12 weeks after the standard prophylaxis at
28 weeks of gestation (5). Based on these limited data,
some experts have recommended that if delivery has not
occurred within 12 weeks after injection at 28 weeks of
gestation, a second antenatal dose should be given (5).
Because this recommendation is based on so few cases,
the final decision whether to administer a second dose
should be left to the physician’s judgment.
s s s s
Should all Rh D-negative women be screened
s
for excessive fetomaternal hemorrhage after
delivery of an Rh D-positive infant?
The risk of excessive fetomaternal hemorrhage exceeding
30 mL (the amount covered by the standard 300 µg dose
of anti-D immune globulin) at the time of delivery is ap-
proximately 1 in 1,250 (5). Previous American College
of Obstetricians and Gynecologists documents have
recommended that only pregnancies designated as high
risk be screened for excessive fetomaternal hemorrhage,
including cases of abdominal trauma, abruptio placentae,
placenta previa, intrauterine manipulation, multiple ges-
tation, or manual removal of the placenta. However, such
a screening program has been reported to detect only 50%
of patients who required additional anti-D immune globu-
lin (26). Based on this finding, the American Association
of Blood Banks has recommended that all Rh D-negative
women who deliver Rh D-positive infants be screened
using the Kleihauer-Betke or rosette test (24).
Summary
The reduction in the incidence of Rh D alloimmuniza-
tion is a prototype for the effectiveness of preventive
medicine. Some controversies remain, however, such as
the use of anti-D immune globulin in patients with either
threatened abortion or antenatal hemorrhage. Similarly,
it may not be cost-effective either to screen all Rh
D-negative patients with an indirect Coombs test at 24–28
weeks of gestation or to screen all postpartum patients for
excessive fetomaternal hemorrhage.
The following recommendations are based on good
and consistent scientific evidence (Level A):
The Rh D-negative woman who is not Rh D-alloimmunized
should receive anti-D immune globulin:
At approximately 28 weeks of gestation, unless the
s
father of the baby is also known to be Rh D negative
PRACTICE BULLETINS
Within 72 hours after the delivery of an Rh D-positive
infant
After a first-trimester pregnancy loss
After invasive procedures, such as chorionic villus
sampling, amniocentesis, or fetal blood sampling
The following recommendations are based pri-
marily on consensus and expert opinion (Level C):
Anti-D immune globulin prophylaxis should be consid-
ered if the patient has experienced:
Threatened abortion
Second- or third-trimester antenatal bleeding
External cephalic version
Abdominal trauma
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2. Huchcroft S, Gunton P, Bowen T. Compliance with post­
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 11. Blakemore KJ, Baumgarten A, Schoenfeld-Dimaio M, 26. Ness PM, Baldwin ML, Niebyl JR. Clinical high-risk
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after external cephalic version at term. Aust N Z J Obstet 31. de Crespigny L, Davison G. Anti-D administration in early
Gynaecol 1995;35:173–174 (Level II-3) pregnancy—time for a new protocol. Aust N Z J Obstet
16. Marcus RG, Crewe-Brown H, Krawitz S, Katz J. Feto- Gynaecol 1995;35:385–387 (Level III)
maternal haemorrhage following successful and un­ suc­ 32. Tovey LA, Taverner JM. A case for the antenatal ad­min­is­
cess­ful attempts at external cephalic version. Br J Obstet tra­tion of anti-D immunoglobulin to primigravidae. Lancet
Gynaecol 1975;82:578–580 (Level III) 1981;1:878–881 (Level III)
17. Freda VJ, Gorman JG, Pollack W, Bowe E. Prevention of 33. Clarke C, Whitfield AG. Rhesus immunization during
Rh hemolytic disease—ten years’ clinical experience with pregnancy: the cause for antenatal anti-D. BMJ 1980;280:
Rh immune globulin. N Engl J Med 1975;292:1014–1016 903–904 (Level III)
(Level III)
34. Tovey GH. Should anti-D immunoglobulin be given ante-
18. Bowman JM, Chown B, Lewis M, Pollock JM. Rh isoim­ natally? Lancet 1980;2:466–468 (Level II-3)
mu­ni­za­tion during pregnancy: antenatal prophylaxis. Can
Med Assoc J 1978;118:623–627 (Level III) 35. Bowman JM, Friesen AD, Pollack JM, Taylor WE.
WinRho: Rh immune globulin prepared by ion exchange
19. Robson SC, Lee D, Urbaniak S. Anti-D immunoglobulin for in­tra­ve­nous use. Can Med Assoc J 1980;123:1121–
in RhD prophylaxis. Br J Obstet Gynaecol 1998;105: 1127 (Level II-3)
129–134 (Level III)
36. Bowman JM, Pollock JM. Failures of intravenous Rh
20. Statement from the consensus conference on anti-D pro­ im­mune globulin prophylaxis: an analysis of the reasons
phy­lax­is. 7 and 8 April 1997. The Royal College of Phy­ for such failures. Transfus Med Rev 1987;1:101–112
si­cians of Edinburgh. The Royal College of Obstetricians (Level III)
and Gynaecologists, UK. Vox Sang 1998;74:127–128
(Level III) 37. Torrance GW, Zipursky A. Cost-effectiveness of an­tepar­
tum prevention of Rh immunization. Clin Perinatol 1984;
21. Tovey LA, Townley A, Stevenson BJ, Taverner J. The 11:267–281 (Level III)
Yorkshire antenatal anti-D immunoglobulin trial in primi­
gravidae. Lancet 1983;2:244–246 (Level II-2) 38. Cairns JA. Economics of antenatal prophylaxis. Br J
Obstet Gynaecol 1998;105(suppl 18):19–22 (Level III)
22. Huchet J, Dallemagne S, Huchet C, Brossard Y, Larsen M,
Parnet-Mathieu F. Antepartum administration of pre­ven­ 39. Vick S, Cairns J, Urbaniak S, Whitfield C, Raafat A. Cost-
tive treatment of Rh-D immunization in rhesus-negative effectiveness of antenatal anti-D prophylaxis. Health Econ
women. Parallel evaluation of transplacental passage of 1996;5:319–328 (Cost-effectiveness analysis)
fetal blood cells. Results of a multicenter study carried out 40. Gorman JG, Freda VJ. Rh immune globulin is indicated
in the Paris region. J Gynecol Obstet Biol Reprod (Paris) for Rh-negative mothers undergoing sterilization. Am J
1987;16:101–111 (Level II-2) Obstet Gynecol 1972;112:868–869 (Level III)
23. Pollack W, Ascari WQ, Kochesky RJ, O’Connor RR, Ho 41. Scott JR, Guy LR. Is Rh immunoglobulin indicated in
TY, Tripodi D. Studies on Rh prophylaxis. 1. Relationship patients having puerperal sterilization? Obstet Gynecol
between doses of anti-Rh and size of antigenic stimulus. 1975;46:178–180 (Level II-3)
Transfusion 1971;11:333–339 (Level II-1) 42. Bergstrom H, Nillson L, Ryttinger L. Demonstration of Rh
24. Snyder EL. Prevention of hemolytic disease of the new- antigens in a 38-day old fetus. Am J Obstet Gynecol 1967;
born due to anti-D. Prenatal/perinatal testing and Rh 1:130–133 (Level III)
immune globulin administration. American Association 43. Haines P. An overview from a panel member. Br J Obstet
of Blood Banks Association Bulletin 1998;98(2):1­ –6 Gynaecol 1998;105(suppl 18):5–6 (Level III)
(Level III)
44. Stewart FH, Burnhill MS, Bozorgi N. Reduced dose of Rh
25. National Blood Transfusion Service Immunoglobulin immunoglobulin following first trimester pregnancy ter­
Work­ing Party. Recommendations for the use of anti-D mi­na­tion. Obstet Gynecol 1978;51:318–322 (Level II-1)
im­mu­no­glo­b­u­lin. 1991;137–145 (Level III)

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 45. Price JR. RH sensitization by hydatiform mole. N Engl J
Med 1968;278:1021 (Level III)
46. Fischer HE, Lichtiger B, Cox I. Expression of Rh0(D)
antigen in choriocarcinoma of the uterus in an Rh0(D)-
negative patient: report of a case. Hum Pathol 1985;16:
1165–1167 (Level III)
47. van’t Veer MB, Overbeeke MA, Geertzen HG, van der
Lans SM. The expression of Rh-D factor in human tropho-
blast. Am J Obstet Gynecol 1984;150:1008–1010 (Level
III)
48. Goto S, Nishi H, Tomoda Y. Blood group Rh-D factor
in human trophoblast determined by immunofluores-
cent meth­od. Am J Obstet Gynecol 1980;137:707–712
(Level III)
49. Morrow CP, Curtin JP. Tumors of the placental tropho-
blast. In: Synopsis of gy­ne­co­log­ic on­col­o­gy. 5th ed. New
York: Churchill Livingstone, 1998:315–351 (Level III)
50. Laube DW, Schauberger CW. Fetomaternal bleeding as
a cause for “unexplained” fetal death. Obstet Gynecol
1982;60:649–651 (Level III)
51. Owen J, Stedman CM, Tucker TL. Comparison of prede-
livery versus postdelivery Kleihauer-Betke stains in cases
of fetal death. Am J Obstet Gynecol 1989;161:663–666
(Level III)
52. Stedman CM, Quinlan RW, Huddleston JF, Cruz AC,
Kellner KR. Rh sensitization after third-trimester fetal
death. Obstet Gynecol 1988;71:461–463 (Level III)
53. American Association of Blood Banks. Technical Manual.
12th ed. Bethesda, Maryland: American Association of
Blood Banks, 1996 (Level III)
54. Rose PG, Strohm PL, Zuspan FP. Fetomaternal hem-
orrhage following trauma. Am J Obstet Gynecol
1985;153:844–847 (Level II-2)
55. Chhibber G, Zacher M, Cohen AW, Kline AJ. Rh isoim­
mu­ni­za­tion following abdominal trauma: a case report.
Am J Obstet Gynecol 1984;149:692 (Level III)
56. Kettel LM, Branch DW, Scott JR. Occult placental abrup-
tion after maternal trauma. Obstet Gynecol 1988;71:
449–453 (Level III)
57. Dahmus MA, Sibai BM. Blunt abdominal trauma: are
there any predictive factors for abruptio placentae or
maternal-fetal distress? Am J Obstet Gynecol 1993;
169:1054–1059 (Level III)
58. Samson D, Mollison PL. Effect on primary Rh im­mu­ni­
za­tion of delayed administration of anti-Rh. Immunology
1975;28:349–357 (Level II-1)
PRACTICE BULLETINS
The MEDLINE database, the Cochrane Library, and
ACOG’s own internal resources and documents were used
to con­duct a lit­er­a­ture search to lo­cate rel­e­vant ar­ti­cles
pub­lished be­tween Jan­u­ary 1980 and De­cem­ber 1998. The
search was re­strict­ed to ar­ti­cles pub­lished in the English
lan­guage. Pri­or­i­ty was giv­en to ar­ti­cles re­port­ing results of
orig­i­nal re­search, al­though re­view ar­ti­cles and com­men­tar­
ies also were con­sult­ed. Ab­stracts of re­search pre­sent­ed at
sym­po­sia and sci­en­tif­ic con­fer­enc­es were not con­sid­ered
adequate for in­clu­sion in this doc­u­ment. Guide­lines pub­
lished by or­ga­ni­za­tions or in­sti­tu­tions such as the Na­tion­al
In­sti­tutes of Health and the Amer­i­can Col­lege of Ob­ste­
tri­cians and Gy­ne­col­o­gists were re­viewed, and ad­di­tion­al
studies were lo­cat­ed by re­view­ing bib­liographies of iden-
tified ar­ti­cles. When re­li­able re­search was not avail­able,
ex­pert opin­ions from ob­ste­tri­cian–gy­ne­col­o­gists were used.
Studies were reviewed and evaluated for qual­it­y ac­cord­ing
to the method outlined by the U.S. Pre­ven­tive Services
Task Force:
I Evidence obtained from at least one prop­
er­
ly
de­signed randomized controlled trial.
II-1 Evidence obtained from well-designed con­
trolled
tri­als without randomization.
II-2 Evidence obtained from well-designed co­ hort or
case–control analytic studies, pref­er­a­bly from more
than one center or research group.
II-3 Evidence obtained from multiple time series with or
with­out the intervention. Dra­mat­ic re­sults in un­con­
trolled ex­per­i­ments could also be regarded as this
type of ev­i­dence.
III Opinions of respected authorities, based on clin­i­cal
ex­pe­ri­ence, descriptive stud­ies, or re­ports of ex­pert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and grad­ed ac­cord­ing to the
following categories:
Level A—Recommendations are based on good and con­
sis­tent sci­en­tif­ic evidence.
Level B—Recommendations are based on limited or in­con­
sis­tent scientific evidence.
Level C—Recommendations are based primarily on con­
sen­sus and expert opinion.
Copyright © May 1999 by the American College of Ob­ste­tri­
cians and Gynecologists. All rights reserved. No part of this
pub­li­ca­tion may be reproduced, stored in a re­triev­al sys­tem, or
trans­mit­ted, in any form or by any means, elec­tron­ic, me­chan­i­
cal, pho­to­copy­ing, recording, or oth­er­wise, without pri­or written
per­mis­sion from the publisher.
ISSN 1099-3630
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920
2013 COMPENDIUM OF SELECTED PUBLICATIONS 828

This Practice Bulletin was
developed by the ACOG Com-
mittee on Practice Bulletins—
Obstetrics with the assistance of
Robert M. Silver, MD, Richard
L. Berkowitz, MD, and James
Bussel, MD. The information is
designed to aid practitioners in
making decisions about appro-
priate obstetric and gynecologic
care. These guidelines should
not be construed as dictating an
exclusive course of treatment or
procedure. Variations in prac-
tice may be warranted based
on the needs of the individual
patient, resources, and limita-
tions unique to the institution or
type of practice.
Reaffirmed 2012
PRACTICE BULLETINS
ACOG
PRACTICE
BULLETIN
Clinical Management Guidelines for
Obstetrician–Gynecologists
Number 6, September 1999
Thrombocytopenia
in Pregnancy
Thrombocytopenia in pregnant women is diagnosed frequently by obstetricians
because platelet counts are now included with automated complete blood cell
counts (CBCs) obtained during routine prenatal screening (1). The condition is
common, occurring in 7–8% of pregnancies (2). Thrombocytopenia can result
from a variety of physiologic or pathologic conditions, several of which are
unique to pregnancy. Some causes of thrombocytopenia are serious medical
disorders that have the potential for profound maternal and fetal morbidity. In
contrast, other conditions, such as gestational thrombocytopenia, are benign
and pose no maternal or fetal risks. Because of the increased recognition of
maternal and fetal thrombocytopenia, there are numerous controversies regard-
ing obstetric management. Clinicians must weigh the risks of maternal and fetal
bleeding complications against the costs and morbidity of diagnostic tests and
invasive interventions.
Background
Platelet Function
Unlike other bleeding disorders in which bruising often is the initial clinical
manifestation, platelet disorders, such as thrombocytopenia, usually result in
bleeding into mucous membranes. Although bruising can occur, the most com-
mon manifestations of thrombocytopenia are petechiae, ecchymoses, epistaxis,
gingival bleeding, and menometrorrhagia. In contrast to hemophilia, bleeding
into joints usually does not occur; life-threatening bleeding is less common but
can occur, resulting in hematuria, gastrointestinal bleeding, and, although rare,
intracranial hemorrhage.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 829
 Definition of Thrombocytopenia
The normal range of the platelet count in nonpregnant
individuals is 150,000–400,000/µL. In this population,
thrombocytopenia is defined as any platelet value less
than 150,000/µL, with counts of 100,000–150,000/µL
indicative of mild thrombocytopenia, 50,000–100,000/µL
indicative of moderate thrombocytopenia, and less than
50,000/µL indicative of severe thrombocytopenia. The
definition of thrombocytopenia is somewhat arbitrary and
not necessarily clinically relevant. Clinically significant
bleeding usually is limited to patients with platelet counts
less than 10,000/µL. Serious bleeding complications are
rare, even in those with severe thrombocytopenia (3).
Excessive bleeding associated with trauma or surgery is
uncommon unless the patient’s platelet count is less than
50,000/µL. The mean platelet count in pregnant women is
lower than in nonpregnant individuals (4, 5).
Differential Diagnosis of
Thrombocytopenia
Thrombocytopenia is due to either increased platelet
destruction or decreased platelet production. In pregnan-
cy, the former is responsible for most cases (2). Increased
platelet destruction can be caused by an immunologic
destruction, abnormal platelet activation, or platelet con-
sumption resulting from excessive bleeding or exposure
to abnormal vessels. Decreased platelet production is less
common, and usually is associated with either leukemia,
aplastic anemia, or folate deficiency (6, 7).
The most common cause of thrombocytopenia dur-
ing pregnancy is gestational thrombocytopenia, which
accounts for about two thirds of cases (2) (see the box).
Gestational Thrombocytopenia
Gestational thrombocytopenia, also termed essential
thrombocytopenia or benign or incidental thrombocyto-
penia of pregnancy, is by far the most common cause
of mild thrombocytopenia during pregnancy, affecting
up to 8% of gestations (2). There are several character-
istics of this condition (2). First, the thrombocytopenia
is relatively mild with platelet counts usually remaining
greater than 70,000/µL. However, a lower threshold for
gestational thrombocytopenia has never been established.
Second, women are asymptomatic with no history of
bleeding. The thrombocytopenia usually is detected as
part of routine prenatal screening. Third, women have no
history of thrombocytopenia prior to pregnancy (except
in previous pregnancies). Although gestational throm-
bocytopenia may recur in subsequent pregnancies (8),
the recurrence risk is unknown. Fourth, platelet counts
usually return to normal within 2–12 weeks following
PRACTICE BULLETINS
Causes of Thrombocytopenia in Pregnancy
Gestational thrombocytopenia
Pregnancy-induced hypertension
HELLP syndrome
Pseudothrombocytopenia (laboratory artifact)
Human immunodeficiency virus (HIV) infection
Immune thrombocytopenic purpura
Systemic lupus erythematosus
Antiphospholipid syndrome
Hypersplenism
Disseminated intravascular coagulation
Thrombotic thrombocytopenic purpura
Hemolytic uremic syndrome
Congenital thrombocytopenias
Medications (heparin, quinine, quinidine,
zidovudine, sulfonamides)
delivery. Finally, there is an extremely low risk of fetal
or neonatal thrombocytopenia. In a large, prospectively
evaluated cohort study of 756 women with gestational
thrombocytopenia, only one woman’s infant had a plate-
let count of less than 50,000/µL (9). However, this infant
had thrombocytopenia due to congenital bone marrow
dysfunction. Another study confirmed the extremely low
risk of fetal thrombocytopenia in women with gestational
thrombocytopenia (10). Thus, women with gestational
thrombocytopenia are not at risk for maternal or fetal
hemorrhage or bleeding complications.
Although its cause is uncertain, gestational thrombo-
cytopenia may be due to accelerated platelet consumption
(4). Antiplatelet antibodies often are detectable in women
with gestational thrombocytopenia, but neither their pres-
ence nor their absence can be used to diagnose the disorder
or differentiate it from immune thrombocytopenic purpura
(ITP) (11). Indeed, there are no specific diagnostic tests
to definitively distinguish gestational thrombocytopenia
from mild ITP (1). The primary means of differentiation
is to monitor platelet counts closely, to look for levels that
decrease below the 50,000–70,000/µL range, and to docu-
ment a normal neonatal platelet count and a restoration of
normal maternal platelet values after delivery.
Thrombocytopenia with an
Immunologic Basis
Thrombocytopenia with an immunologic basis during
pregnancy can be broadly classified as two disorders:
neonatal alloimmune thrombocytopenia and ITP, an
2013 COMPENDIUM OF SELECTED PUBLICATIONS 830
 autoimmune condition. Neonatal alloimmune thrombocyto-
penia has no effect on the mother but probably is responsible
for more intracranial hemorrhage due to thrombocytopenia
than all the other primary thrombocytopenic conditions
combined. In contrast, ITP may affect both mothers and
fetuses, but with appropriate management the outcome for
both is excellent.
Neonatal Alloimmune Thrombocytopenia
Neonatal alloimmune thrombocytopenia is the platelet
equivalent of hemolytic (Rh) disease of the newborn,
developing as a result of maternal alloimmunization to
fetal platelet antigens. It affects one in 1,000–2,000 live
births and can be a serious and potentially life-threatening
condition (12, 13). Unlike Rh disease, neonatal alloim-
mune thrombocytopenia can occur during a first pregnan-
cy. Almost half of the clinically evident cases of neonatal
alloimmune thrombocytopenia are discovered in the first
live-born infant (14).
In typical cases of unanticipated neonatal alloim-
mune thrombocytopenia, the mother is healthy and has
a normal platelet count, and her pregnancy, labor, and
delivery are indistinguishable from those of other low-risk
obstetric patients. The neonates, however, are either born
with evidence of profound thrombocytopenia or develop
symptomatic thrombocytopenia within hours after birth.
Affected infants often manifest generalized petechiae or
ecchymoses over the presenting fetal part. Hemorrhage
into viscera and bleeding following circumcision or veni-
puncture also may ensue. The most serious complication
of neonatal alloimmune thrombocytopenia is intracranial
hemorrhage, which occurs in 10–20% of infants (14, 15).
Fetal intracranial hemorrhage due to neonatal alloimmune
thrombocytopenia can occur in utero, and 25–50% of
fetal intracranial hemorrhage in untreated mothers may
be detected by ultrasonography before the onset of labor
(16). Ultrasonographic findings may include intracranial
hemorrhage, porencephalic cysts, and obstructive hydro-
cephalus. These observations are in contrast to neonatal
intracranial hemorrhage due to ITP, which is exceedingly
rare and usually occurs during the neonatal period.
Several polymorphic, diallelic antigen systems resid-
ing on platelet membrane glycoproteins are responsible
for neonatal alloimmune thrombocytopenia. Many of
these antigen systems have several names because they
were identified in different parts of the world concurrent-
ly. Recently, a uniform nomenclature has been adopted
that describes these antigens as human platelet antigens
(HPA-1 and HPA-2), with alleles designated as “a” or “b”
(17). Although there are at least 10 officially recognized
platelet-specific antigens at this time, more than 50% of
the reported cases in Caucasians and most of the severe
PRACTICE BULLETINS
cases have occurred as a result of sensitization against
HPA-1a, also known as PlA1 and Zwa.
Fetal thrombocytopenia due to HPA-1a sensitization
tends to be severe and can occur early in gestation. In a
cohort study of 107 fetuses with neonatal alloimmune
thrombocytopenia (97 with HPA-1a incompatibility)
studied in utero before receiving any therapy, 50% had
initial platelet counts of less than 20,000/µL (13). This
percentage included 21 of 46 fetuses tested before 24
weeks of gestation. Furthermore, this series documented
that the fetal platelet count decreases at a rate of more
than 15,000/µL per week in the absence of therapy.
The recurrence risk of neonatal alloimmune throm-
bocytopenia is extremely high and approaches 100% in
cases involving HPA-1a if the subsequent sibling carries
the pertinent antigen (13). Thus, the recurrence risk is
related to the zygosity of the father. As with red cell
alloimmunization, the disease tends to be equally severe
or progressively worse in subsequent pregnancies.
Immune Thrombocytopenic Purpura
Acute ITP is a self-limited disorder that usually occurs in
childhood. It may follow a viral infection and rarely per-
sists. Chronic ITP typically occurs in the second or third
decade of life and has a female to male ratio of 3:1 (18).
Estimates of the frequency of ITP during pregnancy vary
widely, affecting one in 1,000–10,000 pregnancies (19).
Immune thrombocytopenic purpura is characterized
by immunologically mediated platelet destruction. The
patient produces IgG antiplatelet antibodies that recog-
nize platelet membrane glycoproteins. This process leads
to increased platelet destruction by cells of the reticulo-
endothelial system (18). The rate of destruction exceeds
the compensatory ability of the bone marrow to produce
new platelets, which leads to thrombocytopenia. Most
of the platelet destruction occurs in the spleen, although
other sites also are involved.
There are no pathognomonic signs, symptoms, or
diagnostic tests for ITP; it is a diagnosis of exclusion.
However, four findings have been traditionally associ-
ated with the condition: 1) persistent thrombocytopenia
(platelet count <100,000/µL with or without accompa-
nying megathrombocytes on the peripheral smear), 2)
normal or increased numbers of megakaryocytes deter-
mined from bone marrow, 3) exclusion of other systemic
disorders or drugs that are known to be associated with
thrombocytopenia, and 4) absence of splenomegaly.
Most women with ITP have a history of bruising
easily and petechiae, or of possible epistaxis and gingi-
val bleeding, which precedes their pregnancy, but some
women are completely asymptomatic. Important hemor-
rhagic symptoms rarely occur unless the platelet count
2013 COMPENDIUM OF SELECTED PUBLICATIONS 831
 is less than 20,000/µL. It is believed that the course
of ITP usually is not affected by pregnancy, although
there have been anecdotal reports of patients’ conditions
worsening during pregnancy and improving postpartum
(20, 21). Pregnancy may be adversely affected by severe
thrombocytopenia, and the primary risk to the mother is
hemorrhage during the peripartum period.
Maternal IgG antiplatelet antibodies can cross the
placenta, placing the fetus and neonate at risk for the
development of thrombocytopenia. Retrospective case
series of ITP in pregnancy indicate that 12–15% of
infants born to mothers with ITP will develop plate-
let counts less than 50,000/µL (22, 23). Sometimes,
this results in minor clinical bleeding such as purpura,
ecchymoses, or melena. On rare occasions, fetal throm-
bocytopenia associated with ITP leads to intracranial
hemorrhage unrelated to the mode of delivery. When
it occurs, intracranial hemorrhage can result in severe
neurologic impairment and even death. Serious bleeding
complications are estimated to occur in 3% of infants
born to women with ITP, and the rate of intracranial
hemorrhage is less than 1% (22, 23). These data may
overestimate the risk, as a result of publication bias. In
a prospective, population-based study of almost 16,000
pregnancies delivered at a single center, no infant born
to a mother with ITP suffered intracranial hemorrhage
(9). The only three infants with intracranial hemorrhage
had neonatal alloimmune thrombocytopenia, not ITP.
The platelet count of the affected newborn usually will
decrease after delivery, and the nadir may not be reached
for several days (20).
Pregnancy-Induced Hypertension
Pregnancy-induced hypertension (PIH) is reported to be
the cause of 21% of cases of maternal thrombocytope-
nia (9). The thrombocytopenia usually is moderate, and
platelet counts rarely decrease below 20,000/µL. Clinical
hemorrhage is uncommon unless the patient develops
disseminated intravascular coagulopathy, but a decreas-
ing maternal platelet count generally is considered a sign
of worsening disease and is an indication for delivery.
In some cases, microangiopathic hemolytic anemia
and elevated liver function tests are associated with
thrombocytopenia in individuals with PIH. Such indi-
viduals are considered to have HELLP syndrome.
The cause of thrombocytopenia in women with
severe PIH is unknown. The disease is associated
with a state of accelerated platelet destruction, platelet
activation, increased platelet volume, and increased
megakaryocyte activity (21). Increased levels of platelet-
associated IgG have been detected in patients with PIH
(24). However, this finding is nonspecific and does not
necessarily imply an immunologic basis for the throm-
PRACTICE BULLETINS
bocytopenia. Platelet function also may be impaired in
women with PIH, even if their platelet count is normal. It
is noteworthy that the platelet count may decrease before
the other clinical manifestations of PIH are apparent (25).
The neonates of mothers with PIH are at increased
risk of neonatal thrombocytopenia (2). However, this is
true only for infants born prematurely, and especially
those with growth restriction. Term infants of mothers
with PIH are no more likely to have thrombocytopenia
than are controls. In a study of 1,414 mothers with hyper-
tension, neonatal thrombocytopenia associated with PIH
rarely decreased below 20,000/µL and caused no fetal
bleeding complications (9).
Clinical Considerations and
Recommendations
What is the appropriate workup for maternal
s
thrombocytopenia?
When thrombocytopenia is diagnosed in a pregnant
woman, it is important that the diagnosis be as precise as
possible. The differential diagnosis of thrombocytopenia
in pregnancy includes gestational thrombocytopenia,
pseudothrombocytopenia, HIV infection, drug-induced
thrombocytopenia, PIH, HELLP syndrome, thrombotic
thrombocytopenic purpura, hemolytic uremic syndrome,
disseminated intravascular coagulation, systemic lupus
erythematosus, antiphospholipid syndrome, and congeni-
tal thrombocytopenias. These disorders usually can be
determined on the basis of a detailed medical and fam-
ily history and a physical examination, with attention to
blood pressure, splenomegaly, HIV serology, and adjunc-
tive laboratory studies as appropriate.
A CBC and examination of the peripheral blood
smear generally are indicated in the evaluation of maternal
thrombocytopenia. A CBC is helpful to exclude pancyto-
penia. Evaluation of the peripheral smear serves to rule
out platelet clumping that may be associated with pseudo-
thrombocytopenia. Bone marrow biopsy rarely is needed
to distinguish between inadequate platelet production and
increased platelet turnover. Numerous assays have been
developed for both platelet-associated (direct) antibodies
and circulating (indirect) antiplatelet antibodies. Although
many individuals with ITP will have elevated levels of
platelet-associated antibodies and sometimes circulating
antiplatelet antibodies, these assays are not recommended
for the routine evaluation of maternal thrombocytopenia
(26). Tests for antiplatelet antibodies are nonspecific,
poorly standardized, and subject to a large degree of inter-
laboratory variation (1). Also, gestational thrombocyto-
penia and ITP cannot be differentiated on the basis of
antiplatelet antibody testing (11).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 832
 If drugs and other medical disorders are excluded,
the primary differential diagnosis in the first and second
trimesters will be either gestational thrombocytopenia
or ITP. It should be noted that although gestational
thrombocytopenia can occur in the first trimester, it typi-
cally becomes manifest later in pregnancy. In general, in
a woman with no history of thrombocytopenia or the
milder the thrombocytopenia, the more likely she is to
have gestational thrombocytopenia. If the platelet count is
less than 70,000/µL, ITP is more likely to be present, and
if the platelet count is less than 50,000/µL, ITP is almost
certainly present. During the third trimester or postpartum
period, the sudden onset of significant maternal thrombo-
cytopenia should lead to consideration of PIH, thrombotic
thrombocytopenic purpura, hemolytic uremic syndrome,
acute fatty liver, or disseminated intravascular coagula-
tion, although ITP can present this way as well.
When should women with ITP receive medical
s
therapy?
The goal of medical therapy during pregnancy in women
with ITP is to minimize the risk of bleeding complica-
tions associated with severe thrombocytopenia. Because
the platelet function of these patients usually is normal,
it is not necessary to maintain their counts in the normal
range. There is general agreement that asymptomatic
pregnant women with platelet counts greater than 50,000/
µL do not require treatment. Also, most authorities rec-
ommend treatment in the presence of a platelet count
significantly less than 50,000/µL or in the presence of
bleeding. However, the degree of thrombocytopenia in
asymptomatic pregnant women that requires treatment is
somewhat controversial, and consultation from a physi-
cian experienced in these matters should be considered.
Higher counts (eg, >50,000/µL) are desirable for inva-
sive procedures and delivery, which may be associated
with hemorrhage, the need for surgery, or the desire to
use regional anesthesia. Bleeding times are not useful in
assessing platelet function in patients with ITP.
What therapy should be used to treat ITP dur-
s
ing pregnancy?
The first line of treatment for ITP is prednisone, usu-
ally initiated in a dosage of 1–2 mg/kg/d. A response to
antenatal corticosteroids usually occurs within 3–7 days
and reaches a maximum within 2–3 weeks. Once platelet
counts reach acceptable levels, the dosage can be tapered
by 10–20% per week until the lowest dosage required
to maintain a platelet count greater than 50,000/µL is
reached. An increase in the platelet count occurs in about
70% of patients, and up to 25% will achieve complete
remission (27).
Intravenous immune globulin (IVIG) is appropriate
therapy for cases refractory to steroids as well as in cir-
PRACTICE BULLETINS
cumstances such as platelet counts less than 10,000/µL
in the third trimester, or platelet counts less than 30,000/
µL associated with bleeding or with preoperative or pre-
delivery status. A response to therapy can be expected in
as few as 6 hours or in as many as 72 hours. In 70% of
cases, the platelet count will return to pretreatment lev-
els within 30 days after treatment (26, 28). Intravenous
immune globulin is costly and of limited availability.
When considering use of IVIG, it is prudent to seek
consultation from a physician experienced in such cases.
Splenectomy is associated with complete remis-
sion in approximately 66% of patients with ITP (18);
however, it often is not successful in patients who do not
respond to intravenous immunoglobulin (29). The proce-
dure usually is avoided during pregnancy because of fetal
risks and technical difficulties late in gestation. However,
splenectomy can be accomplished safely during preg-
nancy, ideally in the second trimester. It is appropriate
for severe cases (platelet counts of less than 10,000/µL)
that have failed treatment with antenatal corticosteroids
and IVIG (26).
Platelet transfusions should be used only as a tem-
porary measure to control life-threatening hemorrhage
or to prepare a patient for surgery. The usual increase in
platelets of approximately 10,000/µL per unit of platelets
transfused is not achieved in patients with ITP because of
the decreased survival of donor platelets. Thus, 6–10 U
of platelet concentrate should be transfused. Other drugs
used to treat ITP such as colchicine, azathioprine, vinca
alkaloids, cyclophosphamide, and danazol have potential
adverse fetal effects.
What additional specialized care should
s
women with ITP receive?
Other than serial assessment of the maternal platelet
count (every trimester in asymptomatic women in remis-
sion and more frequently in thrombocytopenic individu-
als), little specialized care is required. Pregnant women
with ITP should be instructed to avoid nonsteroidal anti-
inflammatory agents, salicylates, and trauma. Individuals
with splenectomies should be immunized against pneu-
mococcus, Hemophilus influenzae, and meningococcus.
If the diagnosis of ITP is made, consultation and ongoing
evaluation with a physician experienced in such matters
is appropriate.
Can fetal or neonatal intracranial hemorrhage
s
be prevented in pregnancies complicated by
ITP?
It is logical to assume that therapies known to increase
the maternal platelet count in patients with ITP also
would improve the fetal platelet count. However, medi-
cal therapies such as IVIG (30) and steroids (22,
30–32) do not reliably prevent fetal thrombocytopenia or
2013 COMPENDIUM OF SELECTED PUBLICATIONS 833
 improve fetal outcome. Because some of these therapies
(eg, IVIG) have not been adequately tested in appropriate
trials, there are insufficient data to recommend maternal
medical therapy for fetal indications.
Some investigators have recommended cesarean
delivery to decrease the risk of intracranial hemorrhage
by avoiding the potential trauma associated with vaginal
birth (33). This strategy was based on anecdotal reports
of intracranial hemorrhage associated with vaginal deliv-
ery (34) as well as the biologic plausibility of the hypoth-
esis. Others have proposed that cesarean delivery be
reserved for fetuses with platelet counts less than 50,000/
µL (35, 36). This tactic was prompted by the observation
that the risk of fetal bleeding is inversely proportional to
the platelet count, and bleeding problems are extremely
rare in fetuses with platelet counts more than 50,000/µL
(31, 37).
Cesarean delivery has never been proven to prevent
intracranial hemorrhage reliably. Several reports indicate
that hemorrhagic complications in infants with thrombo-
cytopenia are unrelated to the mode of delivery (22, 31,
37, 38). In a review of 474 neonates born to mothers with
ITP, 29% of infants born vaginally with thrombocyto-
penia had a bleeding complication, compared with 30%
delivered by cesarean birth (31). In this study, the rate of
intracranial hemorrhage also was similar for both modes
of delivery: 4% after vaginal delivery and 3% after cesar-
ean delivery. In addition, it is unclear that intracranial
hemorrhage is an intrapartum phenomenon. The neonatal
platelet count often dramatically decreases after delivery.
Thus, intracranial hemorrhage during the neonatal period
could be mistakenly attributed to intrapartum events. No
case of intracranial hemorrhage has been proven defini-
tively to have occurred during labor (22, 23). Because
cesarean delivery does not clearly prevent intraventricu-
lar hemorrhage, many obstetricians choose the mode of
delivery in ITP based on obstetric considerations alone.
What tests or characteristics can be used to
s
predict fetal thrombocytopenia in pregnancies
complicated by ITP?
No maternal test or characteristic can reliably predict the
severity of thrombocytopenia in all cases of infants born
to mothers with ITP. Maternal characteristics and serol-
ogy, including prior splenectomy, platelet count, and the
presence of platelet-associated antibodies, all correlate
poorly with neonatal thrombocytopenia (39, 40). Fetal
thrombocytopenia is rare in the absence of circulating
antiplatelet antibodies (10), but exceptional cases have
been reported (41). Also, these assays are difficult to
perform and have a low positive predictive value (10).
PRACTICE BULLETINS
Is there any role for fetal platelet count deter-
s
mination in ITP?
At this time, most obstetricians do not obtain fetal plate-
let counts (42). Scalp sampling is fraught with inaccura-
cies and technical difficulties, and cordocentesis carries
a 1–2% risk of necessitating an emergent cesarean deliv-
ery for fetal indications (43). The low incidence of intra-
cranial hemorrhage and the lack of demonstrated differ-
ence in neonatal outcome between vaginal and cesarean
deliveries also supports the opinion that the determina-
tion of fetal platelet count is unwarranted for ITP (22,
23, 31, 37, 44). A substantial minority of perinatologists
(42) feel that the 5% risk of fetal thrombocytopenia
of less than 20,000/µL and the attendant theoretically
increased risk of an intracranial hemorrhage warrant
informing patients of the availability of cordocentesis
or scalp sampling during labor when choosing mode of
delivery (45–47).
What is the appropriate neonatal care for
s
infants born of pregnancies complicated by
ITP?
Regardless of the mode, delivery should be accom-
plished in a setting where an available clinician familiar
with the disorder can treat any neonatal complications
and have access to the medications needed for treatment.
Can a patient with thrombocytopenia be given
s
regional anesthesia?
The literature offers only limited and retrospective data
to address this issue. However, two studies (48, 49)
reported on a total of 184 patients with platelet counts
less than 150,000/µL. Of these, 113 patients received
epidural anesthesia without neurologic complication or
sequelae. In all of these patients, the diagnosis was gesta-
tional thrombocytopenia. Another study of patients with
platelet counts less than 100,000/µL due to preeclamp-
sia, ITP, or infection also received epidural anesthesia
without complication (50). Although the complication of
greatest concern is that of epidural hematoma, there are
only two cases in the literature of parturients who devel-
oped an epidural hematoma after regional anesthesia.
One patient had preeclampsia and a lupus anticoagulant
(51) and the other had an ependymoma (52). Cases
reported in nonparturients have almost always been asso-
ciated with anticoagulant therapy.
Although limited, data support the safety of epidural
anesthesia in patients with platelet counts greater than
100,000/µL. In women with gestational thrombocytope-
nia with platelet counts less than 99,000/µL but greater
than 50,000/µL, epidural anesthesia also may be safe, but
2013 COMPENDIUM OF SELECTED PUBLICATIONS 834
 its use in such patients will require a consensus among
the obstetrician, anesthesiologist, and patient. When
platelet counts are less than 50,000/µL, epidural anesthe-
sia should not be given.
When should an evaluation for possible neonatal
s
alloimmune thrombocytopenia be initiated, and
what tests are useful in making the diagnosis?
The most appropriate screening program incorporates
evaluation of patients with a history of infants with
otherwise unexplained bleeding or thrombocytopenia.
Neonatal alloimmune thrombocytopenia should be
suspected in cases of otherwise unexplained fetal or
neonatal thrombocytopenia, porencephaly, or intracra-
nial hemorrhage (either in utero or after birth). The
laboratory diagnosis includes determination of platelet
type and zygosity of both parents and the confirmation
of maternal antiplatelet antibodies with specificity for
paternal (or fetal–neonatal) platelets and the incom-
patible antigen. Platelet typing may be determined
serologically or by genotyping because the genes and
polymorphisms responsible for most cases of neonatal
alloimmune thrombocytopenia have been identified.
This is helpful when the father is heterozygous for the
pertinent antigen because fetal platelet antigen typing can
be performed using amniocytes (53). Chorionic villus
sampling should not be performed because of its poten-
tial increased sensitization to antiplatelet antibodies. The
laboratory evaluation of neonatal alloimmune throm-
bocytopenia can be complex, results may be ambigu-
ous, and an antigen incompatibility cannot always be
identified. Accordingly, testing for this disorder should
be performed in an experienced regional laboratory that
has special interest and expertise in neonatal alloimmune
thrombocytopenia.
There is a theoretical benefit from population-based
screening for platelet antigen incompatibility. However,
such a program has not been shown to be clinically use-
ful or cost-effective and is not currently recommended.
Another area of controversy is the patient whose sister
has had a pregnancy complicated by neonatal alloim-
mune thrombocytopenia. It may be worthwhile to evalu-
ate these patients for platelet antigen incompatibility
or human leukocyte antigen phenotype. However, the
theoretical advantages of testing these women must be
weighed against the potential for anxiety, cost, and mor-
bidity without proven benefit.
How can one determine the fetal platelet count
s
in pregnancies complicated by neonatal allo-
immune thrombocytopenia?
Unfortunately, as with ITP, there are no good indirect
methods to determine the fetal platelet count. Maternal
antiplatelet antibody titers correlate poorly with the sever-
PRACTICE BULLETINS
ity of the disease. Also, characteristics such as the out-
come of previously affected siblings (eg, birth platelet
count or intracranial hemorrhage recognized after deliv-
ery) do not reliably predict the severity of fetal throm-
bocytopenia (13). Currently, the only accurate means of
estimating the fetal platelet count is to sample the fetal
blood directly, although this may increase the risk of fetal
exsanguination.
What is the appropriate obstetric management
s
of neonatal alloimmune thrombocytopenia?
The primary goal of the obstetric management of preg-
nancies complicated by neonatal alloimmune thrombo-
cytopenia is to prevent intracranial hemorrhage and its
associated complications. In contrast to ITP, however,
the higher frequency of intracranial hemorrhage associat-
ed with neonatal alloimmune thrombocytopenia justifies
more aggressive interventions. Also, strategies intended
to avoid intracranial hemorrhage must be initiated ante-
natally because of the risk of in utero intracranial hemor-
rhage.
The optimal management of fetuses at risk for neo-
natal alloimmune thrombocytopenia (those testing posi-
tive for the incompatible antigen or those whose fathers
are homozygous for the antigen) remains controversial.
The management decisions for these cases should be
individualized and are best made after consultation with
obstetric and pediatric specialists familiar with the disor-
der as soon as the diagnosis is made. Several therapies
have been used in an attempt to increase the fetal platelet
count and to avoid intracranial hemorrhage, including
maternal treatment with IVIG, with or without steroids
(15, 54–60), and fetal platelet transfusions (59, 61, 62).
Intravenous immune globulin administered to the mother
appears to be the most consistently effective antepar-
tum therapy for neonatal alloimmune thrombocytopenia
(15). However, none of these therapies is effective in
all cases. Direct fetal administration of IVIG does not
reliably improve the fetal platelet count, although only a
few cases have been reported. Platelet transfusions with
maternal platelets are consistently effective in raising
the fetal platelet count. However, the short half-life of
transfused platelets requires weekly procedures and may
worsen the alloimmunization.
It is unknown whether it is necessary to determine
the fetal platelet count before initiating therapy. The risks
of cordocentesis in the setting of neonatal alloimmune
thrombocytopenia must be weighed against the ability to
determine the need for and the effectiveness of therapy.
Although unproven, the benefit of transfusing maternal
platelets at the time of cordocentesis may reduce the
risk of bleeding complications from the procedure (63).
The optimal time during gestation to first assess the fetal
platelet count also is controversial. When fetal blood
2013 COMPENDIUM OF SELECTED PUBLICATIONS 835
 sampling is indicated, performance at 22–24 weeks of
gestation may optimize medical therapy.
Most investigators recommend determination of
the fetal platelet count once fetal pulmonary maturity is
achieved, but before the onset of labor (eg, 37 weeks of
gestation). A trial of labor is permitted for fetuses with
platelet counts greater than 50,000/µL, while those with
severe thrombocytopenia are delivered by cesarean birth.
Although this strategy is of unproven efficacy, the high rate
of intracranial hemorrhage in neonatal alloimmune throm-
bocytopenia is considered to warrant these interventions.
Delivery should be accomplished in a setting equipped to
handle a neonate with severe thrombocytopenia.
What is appropriate obstetric management for
s
gestational thrombocytopenia?
Pregnancies with gestational thrombocytopenia are not at
risk for maternal bleeding complications or fetal throm-
bocytopenia (4, 9). Thus, such interventions as the deter-
mination of the fetal platelet count or cesarean delivery
are not indicated in patients with this condition. Women
with gestational thrombocytopenia do not require any
additional testing or specialized care, except follow-up
platelet counts.
Is it necessary to treat thrombocytopenia asso-
s
ciated with PIH?
The primary treatment of maternal thrombocytopenia
in the setting of PIH or HELLP syndrome is delivery.
Although antepartum reversal of thrombocytopenia has
been reported with medical therapy (64), this course of
treatment is not usual (65, 66). More importantly, the
underlying pathophysiology of PIH will only resolve
following birth. Thus, other than to allow for medical
stabilization, the effect of betamethasone on fetal pulmo-
nary maturity, or in special cases at preterm gestations,
severe thrombocytopenia due to PIH is an indication for
delivery (66).
Major hemorrhage is infrequent in patients with
PIH but minor bleeding such as operative site oozing
during cesarean delivery is common. Platelet transfu-
sions occasionally are needed to improve hemostasis in
patients with severe thrombocytopenia or DIC. However,
transfusions are less effective in these women because
of accelerated platelet destruction. Therefore, platelet
transfusions are best reserved for patients with severe
thrombocytopenia and active bleeding. An exception is
the patient undergoing cesarean delivery. Although of
uncertain benefit, many authorities recommend platelet
transfusions to increase the platelet count to more than
50,000/µL before cesarean delivery (66).
Platelet counts often decrease for 24–48 hours
after birth, followed by a rapid recovery (67–69). Most
patients will achieve normal platelet counts within a few
PRACTICE BULLETINS
days to a week postpartum (67, 69). However, although
rare, thrombocytopenia may continue for a prolonged
period, which often is associated with persistent mul-
tisystem dysfunction (68). Plasma exchange has been
reported to improve the platelet count in women with
HELLP syndrome (70), but the efficacy remains unprov-
en. Although thrombocytopenia associated with PIH or
HELLP syndrome may improve after treatment with
steroids or uterine curettage (71, 72), the clinical benefit
of these therapies also is uncertain.
Summary
The following recommendation is based on good
and consistent scientific evidence (Level A):
Neonatal alloimmune thrombocytopenia should be
s
treated with IVIG as the initial approach when fetal
thrombocytopenia is documented.
The following recommendations are based on lim-
ited or inconsistent scientific evidence (Level B):
The mode of delivery in pregnancies complicated
s
by ITP should be chosen based on obstetric consid-
erations alone. Prophylactic cesarean delivery does
not appear to reduce the risk of fetal or neonatal
hemorrhage.
Epidural anesthesia is safe in patients with platelet
s
counts greater than 100,000/µL.
Mild maternal thrombocytopenia (≥ 70,000/µL) in
s
asymptomatic pregnant women with no history of
bleeding problems is usually benign gestational
thrombocytopenia. These women should receive
routine prenatal care with periodic repeat platelet
counts (monthly to bimonthly).
The following recommendations are based pri-
marily on consensus and expert opinion (Level C):
Platelet counts of at least 50,000/µL rarely require
s
treatment.
Neonatal alloimmune thrombocytopenia should be
s
suspected in cases of otherwise unexplained fetal or
neonatal thrombocytopenia, hemorrhage, or poren-
cephaly.
s
Prior to initiating any plan of treatment for a woman
based on thrombocytopenia in her fetus, consultation
should be sought from a physician with experience
dealing with that problem.
Laboratory testing for neonatal alloimmune throm-
s
bocytopenia should be performed in a regional labo-
ratory with special interest and expertise in dealing
with the problem.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 836
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43. Ghidini A, Sepulveda W, Lockwood CJ, Romero R.
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159:1066–1068 (Level II-3)
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50. Rasmus KT, Rottman RL, Kotelko DM, Wright WC,
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52. Roscoe MWA, Barrington TW. Acute spinal subdural
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1984;9:672–675 (Level III)
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nucleotide probes. Blood 1991;78:2276–2282 (Level III)
54. Bussel JB, Berkowitz RL, McFarland JG, Lynch L,
Chitkara U. Antenatal treatment of neonatal alloimmune
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55. Lynch L, Bussel JB, McFarland JG, Chitkara U, Berkowitz
RL. Antenatal treatment of alloimmune thrombocytope-
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56. Marzusch K, Schnaidt M, Dietl J, Weist E, Hofstaetter
C, Golz R. High-dose immunoglobulin in the antenatal
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report and review. Br J Obstet Gynaecol 1992;99:260–262
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57. Mir N, Samson D, House MJ, Kovar IZ. Failure of ante-
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58. Bowman J, Harman C, Mentigolou S, Pollack J.
Intravenous fetal transfusion of immunoglobulin for allo-
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59. Nicolini U, Tannirandorn Y, Gonzalez P, Fisk NM,
Beacham J, Letsky EA, et al. Continuing controversy in
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Gynecol 1990;163:1144–1146 (Level III)
60. Zimmermann R, Huch A. In-utero fetal therapy with
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Lancet 1992;340:606 (Level III)
61. Kaplan C, Daffos F, Forestier F, Cox WL, Lyon-Caen
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62. Murphy MF, Pullon HW, Metcalfe P, Chapman JF,
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fusions. Vox Sang 1990;58:45–49 (Level III)
63. Paidas MJ, Berkowitz RL, Lynch L, Lockwood CJ,
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64. Clark SL, Phelan JR, Allen SH, Golde SR. Antepartum
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65. Weinstein L. Syndrome of hemolysis, elevated liver
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66. Sibai BM. The HELLP syndrome (hemolysis, elevated
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67. Katz VL, Thorp JM Jr, Rozas L, Bowes WA Jr. The
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68. Martin JN Jr, Blake PG, Lowry SL, Perry KG Jr, Files JC,
Morrison JC. Pregnancy complicated by preeclampsia-
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recovery? Obstet Gynecol 1990;76:737–741 (Level II-3)
69. Neiger R, Contag SA, Coustan DR. The resolution of
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70. Martin JN Jr, Files JC, Blake PG, Norman PH, Martin
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1990;162:126–137 (Level III)
The MEDLINE database, the Cochrane Library, and
ACOG’s own internal resources were used to conduct a lit-
erature search to locate relevant articles published between
January 1985 and January 1999. The search was restricted
to articles published in the English language. Priority was
given to articles reporting results of original research,
although review articles and commentaries also were
consulted. Abstracts of research presented at symposiums
and scientific conferences were not considered adequate
for inclusion in this document. Guidelines published by
organizations or institutions such as the National Institutes
of Health and ACOG were reviewed, and additional stud-
ies were located by reviewing bibliographies of identified
articles. When reliable research was not available, expert
opinions from obstetrician–gynecologists were used.
Studies were reviewed and evaluated for quality according
to the method outlined by the U.S. Preventive Services
Task Force:
I Evidence obtained from at least one properly
designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled
trials without randomization.
II-2 Evidence obtained from well-designed cohort or
case–control analytic studies, preferably from more
than one center or research group.
II-3 Evidence obtained from multiple time series with
or without the intervention. Dramatic results in
uncontrolled experiments also could be regarded as
this type of evidence.
III Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert
committees.

71. Magann EF, Martin JN Jr, Isaacs JD, Perry KG Jr, Martin Based on the highest level of evidence found in the data,
RW, Meydrech EF. Immediate postpartum curettage: recommendations are provided and graded according to the
accelerated recovery from severe preeclampsia. Obstet following categories:
Gynecol 1993;81:502–506 (Level I) Level A—Recommendations are based on good and con-
72. Magann EF, Bass D, Chauhan SP, Sullivan DL, Martin sistent scientific evidence.
RW, Martin JN Jr. Antepartum corticosteroids: disease
stabilization in patients with the syndrome of hemolysis, Level B—Recommendations are based on limited or incon-
elevated liver enzymes, and low platelets (HELLP). Am J sistent scientific evidence.
Obstet Gynecol 1994;171:1148–1153 (Level I) Level C—Recommendations are based primarily on con-
sensus and expert opinion.
Copyright © September 1999 by the American College of
Obstetricians and Gynecologists. All rights reserved. No part
of this publication may be reproduced, stored in a retrieval
system, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without
prior written permission from the publisher.
Requests for authorization to make photocopies should be di-
rected to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
ISSN 1099-3630
The American College of
Obstetricians and Gynecologists
409 12th Street, SW
PO Box 96920
Washington, DC 20090-6920

PRACTICE BULLETINS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 839


This Practice Bulletin was
developed by the ACOG Com-
mittee on Prac­tice Bulletins—
Obstetrics with the assistance
of Dwight J. Rouse, MD. The
in­for­ma­tion is de­signed to aid
practitioners in making deci-
sions about appropriate obstet-
ric and gynecologic care. These
guidelines should not be con-
strued as dic­tat­ing an exclusive
course of treatment or pro­ce­
dure. Variations in practice
may be warranted based on
the needs of the in­di­vid­u­al
pa­tient, resources, and limita-
tions unique to the institution
or type of prac­tice.
Reaffirmed 2012
PRACTICE BULLETINS
ACOG
PRACTICE
BULLETIN Clinical Management Guidelines for
Obstetrician–Gynecologists
Number 9, October 1999
(Replaces Technical Bulletin Number 188, January 1994)
Antepartum Fetal
Surveillance
The goal of antepartum fetal surveillance is to prevent fetal death. Antepartum
fetal surveillance techniques based on assessment of fetal heart rate patterns
have been in clinical use for almost three decades. More recently, real-time
ultrasonography and Doppler velocimetry have been used to evaluate fetal
well-being. Antepartum fetal surveillance techniques are now routinely used
to assess the risk of fetal death in pregnancies complicated by preexisting
maternal conditions (eg, type 1 diabetes mellitus) as well as those in which
complications have developed (eg, intrauterine growth restriction). This docu-
ment will review the current indications for and techniques of antepartum fetal
surveillance and outline management guidelines for antepartum fetal surveil-
lance, consistent with the best contemporary scientific evidence.
Background
Physiology of Fetal Heart Response and Fetal
Behavioral State Alteration
In both animals and humans, fetal heart rate pattern, level of activity, and degree
of muscular tone are sensitive to hypoxemia and acidemia (1–4). Redistribution
of fetal blood flow in response to hypoxemia may result in diminished renal per-
fusion and oligohydramnios (5). Surveillance techniques such as cardiotocog-
raphy, real-time ultrasonography, and maternal perception of fetal movement
can identify the fetus that is either suboptimally oxygenated or, with increasing
degrees of placental dysfunction, acidemic. Identification of suspected fetal
compromise provides the opportunity to intervene before progressive metabolic
acidosis can lead to fetal death. However, acute, catastrophic changes in fetal
status, such as those that can occur with abruptio placentae or an umbilical cord
accident, are generally not predicted by tests of fetal well-being. Therefore, fetal
deaths from such events are not as amenable to prevention.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 840
 In humans, the range of normal umbilical blood
gas parameters has been established by cordocentesis
performed in pregnancies in which the fetus ultimately
proved to be healthy, and ranges vary by gestational age
(6). Although the degree of hypoxemia and acidemia at
which various indices of fetal well-being become abnor-
mal is not known with precision, it can be estimated,
based on data from published studies. In one investiga-
tion, the fetal biophysical profile (BPP) was performed
immediately before cordocentesis. Fetuses with a non-
reactive nonstress test (NST) were found to have a mean
(± standard deviation) umbilical vein pH of 7.28 ± 0.11.
Cessation of fetal movement appears to occur at lower
pH levels; fetuses with abnormal movement were found
to have an umbilical vein pH of 7.16 ± 0.08 (7). Thus,
a reasonable correlation between certain measurable
aspects of fetal heart rate and behavior and evidence of
fetal metabolic compromise can be inferred.
However, when abnormal antepartum fetal surveil-
lance results are compared with evidence of hypoxia
or acidemia, the degree of acid–base disturbance may
range from mild to severe. Furthermore, factors other
than acid–base and oxygenation status (eg, prematurity,
fetal sleep–wake cycle, maternal medication exposure,
and fetal central nervous system abnormalities) can
adversely affect biophysical parameters. Finally, neither
the degree nor the duration of intrauterine hypoxemia
and acidemia necessary to adversely affect short- and
long-term neonatal outcome has been established with
any precision.
Antepartum Fetal Surveillance
Techniques
Several antepartum fetal surveillance techniques (tests)
are in use. These include fetal movement assessment,
NST, contraction stress test (CST), BPP, modified BPP,
and umbilical artery Doppler velocimetry.
Fetal Movement Assessment
A diminution in the maternal perception of fetal move-
ment often but not invariably precedes fetal death, in
some cases by several days (8). This observation pro-
vides the rationale for fetal movement assessment by the
mother (“kick counts”) as a means of antepartum fetal
surveillance.
Although several counting protocols have been
employed, neither the optimal number of movements
nor the ideal duration for counting movements has been
defined. Thus, numerous protocols have been reported
and appear to be acceptable. In one approach, the woman
lies on her side and counts distinct fetal movements (9).
Perception of 10 distinct movements in a period of up to
PRACTICE BULLETINS
2 hours is considered reassuring. Once 10 movements
have been perceived, the count may be discontinued. In
another approach, women are instructed to count fetal
movements for 1 hour three times per week (10). The
count is considered reassuring if it equals or exceeds the
woman’s previously established baseline count. In the
absence of a reassuring count, further fetal assessment
is recommended.
Contraction Stress Test
The CST is based on the response of the fetal heart rate
to uterine contractions. It relies on the premise that fetal
oxygenation will be transiently worsened by uterine
contractions. In the suboptimally oxygenated fetus, the
resultant intermittent worsening in oxygenation will, in
turn, lead to the fetal heart rate pattern of late decelera-
tions. Uterine contractions also may provoke or accen-
tuate a pattern of variable decelerations caused by fetal
umbilical cord compression, which in some cases is
associated with oligohydramnios.
With the patient in the lateral recumbent position,
the fetal heart rate and uterine contractions are simul-
taneously recorded with an external fetal monitor. If
at least three spontaneous contractions of 40 seconds’
duration each or longer are present in a 10-minute
period, no uterine stimulation is necessary. If fewer
than three contractions of at least 40 seconds’ duration
occur in 10 minutes, contractions are induced with either
nipple stimulation or intravenous administration of dilute
oxytocin.
Nipple stimulation usually is successful in inducing
an adequate contraction pattern and allows comple-
tion of testing in approximately half the time required
when intravenous oxytocin is given (11). In one nipple
stimulation technique, the woman is instructed to rub
one nipple through her clothing for 2 minutes or until a
contraction begins (11). If by that time the contraction
frequency has not become adequate (as defined previ-
ously), stimulation is stopped and restarted again after 5
minutes. If nipple stimulation is unsuccessful, or if the
use of oxytocin is preferred, an intravenous infusion of
dilute oxytocin may be initiated at a rate of 0.5 mU/min
and doubled every 20 minutes until an adequate contrac-
tion pattern is achieved (12).
The CST is interpreted according to the presence
or absence of late fetal heart rate decelerations (13),
which are defined as decelerations that reach their nadir
after the peak of the contraction and that usually persist
beyond the end of the contraction. The results of the
CST are categorized as follows:
• Negative: no late or significant variable decelera-
tions
2013 COMPENDIUM OF SELECTED PUBLICATIONS 841
 • Positive: late decelerations following 50% or more
of contractions (even if the contraction frequency is
fewer than three in 10 minutes)
• Equivocal–suspicious: intermittent late decelerations
or significant variable decelerations
• Equivocal–hyperstimulatory: fetal heart rate decel-
erations that occur in the presence of contractions
more frequent than every 2 minutes or lasting longer
than 90 seconds
• Unsatisfactory: fewer than three contractions in 10
minutes or an uninterpretable tracing
Relative contraindications to the CST generally
include conditions associated with an increased risk of
preterm labor and delivery, uterine rupture, or uterine
bleeding. These include the following (12):
• Preterm labor or certain patients at high risk of pre-
term labor
• Preterm membrane rupture
• History of extensive uterine surgery or classical
cesarean delivery
• Known placenta previa
Nonstress Test
The NST is based on the premise that the heart rate of the
fetus that is not acidotic or neurologically depressed will
temporarily accelerate with fetal movement. Heart rate
reactivity is thought to be a good indicator of normal fetal
autonomic function. Loss of reactivity is associated most
commonly with a fetal sleep cycle but may result from
any cause of central nervous system depression, including
fetal acidosis.
With the patient in the lateral tilt position, the fetal
heart rate is monitored with an external transducer.
Ideally, the patient should not have smoked recently,
because this may adversely affect test results (14). The
tracing is observed for fetal heart rate accelerations that
peak (but do not necessarily remain) at least 15 beats per
minute above the baseline and last 15 seconds from base-
line to baseline. It may be necessary to continue the tracing
for 40 minutes or longer to take into account the variations
of the fetal sleep–wake cycle. Acoustic stimulation of the
nonacidotic fetus may elicit fetal heart rate accelerations
that appear to be valid in the prediction of fetal well-being.
Such stimulation offers the advantage of safely reducing
overall testing time without compromising detection of
the acidotic fetus (15–17). To perform acoustic stimula-
tion, an artificial larynx (ideally one of the commercially
available models especially designed for this purpose) is
positioned on the maternal abdomen and a stimulus of
1–2 seconds is applied. This may be repeated up to three
PRACTICE BULLETINS
times for progressively longer durations of up to 3 sec-
onds to elicit fetal heart rate accelerations.
Nonstress test results are categorized as reactive or
nonreactive. Various definitions of reactivity have been
used. Using the most common definition, the NST is
considered reactive (normal) if there are two or more fetal
heart rate accelerations (as defined previously) within a
20-minute period, with or without fetal movement dis-
cernible by the woman (18). A nonreactive NST is one
that lacks sufficient fetal heart rate accelerations over a
40-minute period. The NST of the noncompromised pre-
term fetus is frequently nonreactive: from 24 to 28 weeks
of gestation, up to 50% of NSTs may not be reactive (19),
and from 28 to 32 weeks of gestation, 15% of NSTs are
not reactive (20, 21).
Variable decelerations may be observed in up to 50%
of NSTs (22). If nonrepetitive and brief (<30 seconds),
they indicate neither fetal compromise nor the need for
obstetric intervention (22). Repetitive variable decelera-
tions (at least 3 in 20 minutes), even if mild, have been
associated with an increased risk of cesarean delivery for a
nonreassuring intrapartum fetal heart rate pattern (23, 24).
Fetal heart rate decelerations during an NST that persist
for 1 minute or longer are associated with a markedly
increased risk of both cesarean delivery for a nonreassur-
ing fetal heart rate pattern and fetal demise (25–27).
Biophysical Profile
The BPP consists of an NST combined with four observa-
tions made by real-time ultrasonography (28). Thus, the
BPP comprises five components:
1. Nonstress test (which, if all four ultrasound compo-
nents are normal, may be omitted without compro-
mising the validity of the test results) (28)
2. Fetal breathing movements (one or more episodes of
rhythmic fetal breathing movements of 30 seconds or
more within 30 minutes)
3. Fetal movement (three or more discrete body or limb
movements within 30 minutes)
4. Fetal tone (one or more episodes of extension of a
fetal extremity with return to flexion, or opening or
closing of a hand)
5. Determination of the amniotic fluid volume (a single
vertical pocket of amniotic fluid exceeding 2 cm is
considered evidence of adequate amniotic fluid) (29,
30)
Each of the five components is assigned a score of
either 2 (normal or present as defined previously) or 0
(abnormal, absent, or insufficient). A composite score of
8 or 10 is normal, a score of 6 is considered equivocal, and
2013 COMPENDIUM OF SELECTED PUBLICATIONS 842
 a score of 4 or less is abnormal. Regardless of the com-
posite score, in the presence of oligohydramnios (largest
vertical pocket of amniotic fluid volume ≤ 2 cm), further
evaluation is warranted (30).
Modified Biophysical Profile
In the late second- or third-trimester fetus, amniotic fluid
reflects fetal urine production. Placental dysfunction
may result in diminished fetal renal perfusion, leading to
oligohydramnios (5). Amniotic fluid volume assessment
can therefore be used to evaluate long-term uteroplacen-
tal function. This observation fostered the development
of what has come to be termed the “modified BPP” as a
primary mode of antepartum fetal surveillance. The modi-
fied BPP combines the NST (with the option of acoustic
stimulation), as a short-term indicator of fetal acid–base
status, with the amniotic fluid index (AFI), which is the
sum of measurements of the deepest cord-free amniotic
fluid pocket in each of the abdominal quadrants, as an
indicator of long-term placental function (15). An AFI
greater than 5 cm generally is considered to represent an
adequate volume of amniotic fluid (31). Thus, the modi-
fied BPP is considered normal if the NST is reactive and
the AFI is more than 5, and abnormal if either the NST is
nonreactive or the AFI is 5 or less.
Umbilical Artery Doppler Velocimetry
Doppler ultrasonography is a noninvasive technique
used to assess the hemodynamic components of vascular
impedance. Umbilical artery Doppler flow velocimetry
has been adapted for use as a technique of fetal sur-
veillance, based on the observation that flow velocity
waveforms in the umbilical artery of normally growing
fetuses differ from those of growth-restricted fetuses.
Specifically, the umbilical flow velocity waveform
of normally growing fetuses is characterized by high-
velocity diastolic flow, whereas with intrauterine growth
restriction, there is diminution of umbilical artery dia-
stolic flow (32–34). In some cases of extreme intrauter-
ine growth restriction, flow is absent or even reversed.
The perinatal mortality rate in such pregnancies is quite
high (35). Abnormal flow velocity waveforms have been
correlated histopathologically with small-artery oblitera-
tion in placental tertiary villi (36) and functionally with
fetal hypoxia and acidosis (37), as well as with perinatal
morbidity and mortality (35). Commonly measured flow
indices, based on the characteristics of peak systolic fre-
quency shift (S), end-diastolic frequency shift (D), and
mean peak frequency shift over the cardiac cycle (A),
include the following:
• Systolic to diastolic ratio (S/D)
PRACTICE BULLETINS
• Resistance index (S-D/S)
• Pulsatility index (S-D/A)
Randomized studies (38–44) of the utility of umbili-
cal artery Doppler velocimetry generally have defined
abnormal flow as either absent end diastolic flow, or a
flow index greater than two standard deviations above the
mean for gestational age. To maximize interpretability,
multiple waveforms should be assessed, and wall-filter
settings should be set low enough (typically <150 Hz) to
avoid masking diastolic flow.
Clinical Considerations and
Recommendations
Is there compelling evidence that any form of
s
antepartum fetal surveillance decreases the
risk of fetal demise or otherwise improves peri-
natal outcome?
There is a dearth of evidence from randomized controlled
trials that antepartum fetal surveillance decreases the
risk of fetal death (45). Moreover, in one comprehensive
review, antepartum fetal surveillance was categorized as a
form of care “likely to be ineffective or harmful” (46). In
spite of its unproven value, antepartum fetal surveillance
is widely integrated into clinical practice in the developed
world. Therefore, a definitive evaluation of antepartum
fetal surveillance (which would require the random allo-
cation of gravidas to prenatal care that included some
form of antepartum fetal surveillance versus prenatal care
that did not include any form of antepartum fetal surveil-
lance) is unlikely to be conducted in a setting that can
be generalized to current U.S. obstetric practice. In the
absence of a definitive, relevant randomized clinical trial,
evidence for the value of antepartum fetal surveillance
will remain circumstantial and rest principally on the
observation that antepartum fetal surveillance has been
consistently associated with rates of fetal death that are
substantially lower than the rates of fetal death in both
untested (and presumably lower-risk) contemporaneous
pregnancies from the same institutions (15, 16, 47) and
pregnancies with similar complicating factors that were
managed before the advent of currently employed tech-
niques of antepartum fetal surveillance (historic controls).
However, these perceived benefits of antepartum fetal
surveillance may be influenced by the low incidence of
adverse fetal outcome in the general population. The
lower the incidence of adverse outcomes, the more likely
favorable outcomes will be achieved regardless of test
performance.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 843
 s
What are the indications for antepartum fetal
surveillance?
Because antepartum fetal surveillance results have not
been definitively demonstrated to improve perinatal
outcome, all indications for antepartum testing must be
considered somewhat relative. In general, antepartum
fetal surveillance has been employed in pregnancies in
which the risk of antepartum fetal demise is increased.
Accordingly, some of the conditions under which testing
may be appropriate include the following:
• Maternal conditions
—Antiphospholipid syndrome
—Hyperthyroidism (poorly controlled)
—Hemoglobinopathies (hemoglobin SS, SC,
or S-thalassemia)
—Cyanotic heart disease
—Systemic lupus erythematosus
—Chronic renal disease
—Type 1 diabetes mellitus
—Hypertensive disorders
• Pregnancy-related conditions
—Pregnancy-induced hypertension
—Decreased fetal movement
—Oligohydramnios
—Polyhydramnios
—Intrauterine growth restriction
—Postterm pregnancy
—Isoimmunization (moderate to severe)
—Previous fetal demise (unexplained or recurrent occurring within 1 week of a normal test result. The still-
risk)
—Multiple gestation (with significant growth dis - unpredictable causes of demise, was 1.9 per 1,000 in the
crepancy)
When during gestation should antepartum
s
fetal surveillance be initiated?
Choosing the appropriate point in gestation to begin
antepartum testing depends on balancing several consid-
erations, including the prognosis for neonatal survival,
the severity of maternal disease, the risk of fetal death,
and the potential for iatrogenic prematurity complica-
tions resulting from false-positive test results. The
importance of the last consideration is illustrated by the
experience of one large center, in which 60% of infants
delivered because of an abnormal antepartum test result
had no evidence of short-term or long-term fetal com-
promise (16). Both theoretic models (48) and large
clinical studies (49, 50) confirm that initiating testing
at 32–34 weeks of gestation is appropriate for most at-
risk patients. However, in pregnancies with multiple or
particularly worrisome high-risk conditions (eg, chronic
hypertension with suspected intrauterine growth restric-
PRACTICE BULLETINS
tion), testing might begin as early as 26–28 weeks of
gestation.
What is the proper frequency of testing?
s
How frequently to perform fetal testing depends on sev-
eral factors, including clinical judgment. If the indica-
tion for testing is not persistent (eg, a single episode of
decreased fetal movement followed by reassuring testing
in an otherwise uncomplicated pregnancy), it need not be
repeated. When the clinical condition that prompted test-
ing persists, the test should be repeated periodically until
delivery to monitor for continued fetal well-being. If the
maternal medical condition is stable and CST results are
negative, the CST is typically repeated in 1 week (12).
Other tests of fetal well-being (NST, BPP, or modified
BPP) are typically repeated at weekly intervals (16), but
in the presence of certain high-risk conditions, such as
postterm pregnancy, type 1 diabetes, intrauterine growth
restriction, or pregnancy-induced hypertension, some
investigators have performed twice-weekly NST, BPP,
or modified BPP testing. Any significant deterioration in
the maternal medical status requires fetal reevaluation,
as does any acute diminution in fetal activity, regardless
of the amount of time that has elapsed since the last test.
How reassuring is a normal test result?
s
In most cases, a normal test result is highly reassuring,
as reflected in the false-negative rate of antepartum
fetal surveillance, defined as the incidence of stillbirth
birth rate, corrected for lethal congenital anomalies and
largest series of NSTs (5,861) versus 0.3 per 1,000 in
12,656 CSTs (13), 0.8 per 1,000 in 44,828 BPPs (51),
and 0.8 per 1,000 in 54,617 modified BPPs (16). Based
on these data, the negative predictive value of the NST
is 99.8%, and greater than 99.9% for the CST, BPP,
and modified BPP. Although similar data from a large
series are not available for umbilical artery Doppler velo-
cimetry, in one randomized clinical trial among women
with pregnancies complicated by intrauterine growth
restriction (38), no stillbirths occurred in 214 pregnancies
in which umbilical artery Doppler velocimetry was the
primary means of antepartum fetal surveillance (negative
predictive value of 100%). The low false-negative rate
of these tests depends on an appropriate response to any
significant deterioration in the maternal clinical status,
including retesting of the fetal condition. As mentioned
previously, these tests generally do not predict stillbirths
related to acute changes in maternal–fetal status, such as
those that occur with abruptio placentae or an umbilical
cord accident. Moreover, recent, normal antepartum fetal
2013 COMPENDIUM OF SELECTED PUBLICATIONS 844
 test results should not preclude the use of intrapartum fetal
monitoring.
How should one respond to an abnormal test
s
result?
An abnormal fetal test result should always be consid-
ered in the context of the overall clinical picture, taking
into account the substantial possibility that the test result
is falsely positive. Certain acute maternal conditions
(eg, diabetic ketoacidosis, pneumonia with hypoxemia)
can result in abnormal test results, which generally will
become normal as the maternal condition improves. In
these circumstances, stabilizing the maternal condition
and retesting the fetus may be appropriate.
In cases where an abnormal test result is not asso-
ciated with any clinical evidence of worsening in the
maternal status, a sequenced approach to the investiga-
tion of the fetal condition should be undertaken. Such an
approach takes advantage of the high negative predictive
value generally exhibited by all commonly used ante-
partum tests (see above), and minimizes the potential
for unnecessary delivery based on a false-positive (ie,
abnormal) test result. False-positive rates, in contrast to
false-negative rates, have typically not been calculated
using the outcome of stillbirth. This is because most ante-
partum tests were introduced into clinical practice before
an unbiased evaluation of their sensitivity and specific-
ity. In clinical practice, abnormal test results usually are
followed by another test or delivery is effected, which
obscures the relationship between a positive test result
and the subsequent risk of stillbirth. Therefore, in the
absence of unbiased evaluations, the positive predictive
value of antepartum tests has been estimated using sur-
rogate markers, such as the rate of positive follow-up
test results when the primary test result is positive. For
example, it has been observed that up to 90% of nonreac-
tive NSTs are followed by a negative CST result (18).
Based on this observation, the positive predictive value of
an NST is only 10%. Another way that the false-positive
rate of fetal testing has been estimated is to calculate the
incidence of abnormal test results that prompt delivery
but are not associated with evidence of fetal compromise,
as manifested by a nonreassuring intrapartum fetal heart
rate, meconium-stained amniotic fluid, 5-minute Apgar
scores of less than 7, or birth weight greater than the 10th
percentile for gestational age. By this latter definition,
in one large series, a testing scheme in which abnormal
modified BPPs were followed by full BPPs had a false-
positive rate of 60% (positive predictive value = 40%)
(18). In another study in which the physicians were
blinded to test results, a CST was found to have a positive
predictive value of less than 35% (52).
PRACTICE BULLETINS
Therefore, the response to an abnormal test result
should be tailored to the clinical situation. Maternal
reports of decreased fetal movement should be evaluated
by an NST, CST, BPP, or modified BPP; these results, if
normal, usually are sufficient to exclude imminent fetal
jeopardy. A nonreactive NST or an abnormal modified
BPP generally should be followed by additional testing
(either a CST or a full BPP). A positive CST result sug-
gests that NST nonreactivity is a consequence of hypoxia-
induced acidosis, whereas a negative result implies that
the NST nonreactivity exists for another reason, such as
a premature fetus, maternal exposure to certain drugs or
medications, a fetal sleep cycle, or preexisting neurologic
damage. In many circumstances, a positive CST result
generally indicates that delivery is warranted. However,
the combination of a nonreactive NST and a positive
CST result is associated frequently with serious fetal
malformation and justifies ultrasonographic investigation
for anomalies whenever possible (53). Indeed, evaluation
for grossly abnormal fetal anatomy should precede any
intervention for suspected fetal compromise whenever
possible.
A BPP score of 6 is considered equivocal; in the term
fetus, this score generally should prompt delivery, where-
as in the preterm fetus, it should result in a repeat BPP
in 24 hours (30). In the interim, maternal corticosteroid
administration should be considered for pregnancies of
less than 34 weeks of gestation. Repeat equivocal scores
should result either in delivery or continued intensive sur-
veillance. A BPP score of 4 usually indicates that delivery
is warranted, although in extremely premature pregnan-
cies, management should be individualized. Biophysical
profiles less than 4 should result in expeditious delivery.
Regardless of the overall score, oligohydramnios always
requires further evaluation.
In the absence of obstetric contraindications, delivery
of the fetus with an abnormal test result often may be
attempted by induction of labor, with continuous monitor-
ing of both the fetal heart rate and contractions.
Are there clinical circumstances in which one
s
test is distinguished by its utility or lack thereof?
A large-scale, definitive randomized trial comparing the
relative efficacy of one technique of antepartum fetal test-
ing to another has not yet been performed. Accordingly,
in most clinical situations, no single antepartum fetal test
can be considered superior to any other.
As mentioned previously, in certain clinical situa-
tions, the CST is considered relatively contraindicated
(increased risk of preterm labor and delivery, uterine
rupture, and uterine bleeding), although even in these
situations the value of the information provided by the
test may outweigh its potential risks.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 845
 When should oligohydramnios prompt delivery? in the Doppler group were significantly less likely to
s

undergo obstetric intervention, including antepartum hos-

Amniotic fluid volume is estimated using ultrasonogra-
pital admission, labor induction, and emergency cesarean
phy. One widely used definition of oligohydramnios is
delivery for nonreassuring fetal status. On average, wo-
no measurable vertical pocket of amniotic fluid greater
men in the Doppler group underwent antenatal testing
than 2 cm (29), and another is an AFI of 5 cm or less
less frequently (4 times) than women in the cardiotocog-
(31). Nevertheless, from a clinical standpoint, an ideal
raphy group (8 times). Other perinatal outcomes, such as
cutoff level for intervention using the AFI has yet to be
gestational age at birth, birthweight, Apgar scores, and
established. Determining when to intervene for oligo-
cesarean birth rates, did not differ between the groups.
hydramnios depends on several factors, including ges-
Subsequent trials (56, 57) have supported the find-
tational age, the maternal and fetal clinical condition as
ings of less frequent antenatal monitoring (56) and
determined by other indices of fetal well-being, and the
shorter durations of maternal hospitalization (56, 57) in
actual measured AFI value. Because rupture of the fetal
the Doppler group. However, rates of obstetric interven-
membranes can cause diminished amniotic fluid volume,
tions, such as antepartum admission and labor induction,
an evaluation for membrane rupture may be appropriate.
were not lower in the Doppler groups, and perinatal out-
In postterm pregnancy, oligohydramnios is common
come was not improved. On balance, the available evi-
and is associated with an increased risk of meconium
dence suggests that primary antepartum surveillance of
staining of the amniotic fluid and cesarean delivery for
suspected intrauterine growth restriction with umbilical
nonreassuring fetal heart rate (54, 55). Thus, oligohy-
artery Doppler velocimetry can achieve at least equiva-
dramnios has been considered an indication for delivery
lent (and possibly better) fetal and neonatal outcomes
of the postterm pregnancy (15), although the effective-
as primary antepartum surveillance based on results of
ness of this approach in improving perinatal outcome has
the NST. Furthermore, frequency of antepartum testing
not been established by randomized investigation.
and certain aspects of obstetric intervention are reduced
In a term pregnancy complicated by oligohydram-
with use of Doppler (58). If umbilical artery Doppler
nios, delivery often is the most appropriate course of
velocimetry is used, decisions regarding timing of deliv-
action. However, management should be individualized,
ery should be made using a combination of information
and in certain situations, delivery may be safely post-
from the Doppler ultrasonography and other tests of fetal
poned (eg, an uncomplicated pregnancy with an AFI
well-being, such as amniotic fluid volume assessment,
of 5 cm but otherwise reassuring fetal testing and an
NST, CST, and BPP, along with careful monitoring of
unfavorable cervix at 37 weeks of gestation).
maternal status.
In the preterm fetus, depending on the maternal and
No benefit has been demonstrated for umbilical
fetal condition, expectant management may be the most
artery velocimetry for conditions other than suspected
appropriate course of action (eg, with preterm premature
intrauterine growth restriction, such as postterm gesta-
rupture of membranes or in the presence of fetal anoma-
tion, diabetes mellitus, systemic lupus erythematosus,
lies). Once oligohydramnios is diagnosed, if delivery is
or antiphospholipid syndrome. Doppler ultrasonography
not undertaken, follow-up amniotic fluid volume and
has not been shown to be of value as a screening test for
fetal growth assessments are indicated. If the oligohy-
detecting fetal compromise in the general obstetric popu-
dramnios is persistent, close monitoring of the maternal
lation, and its use for this purpose cannot be recommend-
condition and ongoing antepartum fetal surveillance
ed (59). In addition to the umbilical artery, it is possible to
should be performed to guide further management. If the
evaluate blood flow in major fetal vessels. Multiple inves-
oligohydramnios results from fetal membrane rupture,
tigators have observed a correlation between increased
follow-up amniotic fluid volume assessment often may
flow resistance (elevated S/D ratio) in the umbilical
be safely omitted.
artery and decreased resistance to flow (reduced S/D
ratio) in the middle cerebral artery. This phenomenon
What is the role of Doppler velocimetry?
s

has been attributed to a “brain sparing” adaptive response

At least three randomized trials (38, 56, 57) have evaluat-
ed the utility of umbilical artery Doppler velocimetry as a
technique of antepartum fetal surveillance in pregnancies
complicated by suspected intrauterine growth restriction.
In the first and largest of these trials (38), 214 pregnancies
were allocated to Doppler umbilical artery velocimetry as
the primary technique of fetal surveillance, and 212 were
allocated to cardiotocography (NST). Overall, women
to fetal hypoxemia, and it has been suggested that the
ratio of middle cerebral artery S/D ratio to umbilical
artery S/D ratio might serve as a useful predictor of fetal
compromise (60). However, the only randomized clini-
cal trial of middle cerebral artery Doppler velocimetry
failed to demonstrate any clinical benefit to assessing
this parameter (61). Moreover, women in this trial who
were allocated to standard fetal evaluation plus assess-

PRACTICE BULLETINS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 846

 ment of the ratio of middle cerebral artery or umbilical
artery Doppler flow, or both, were delivered on average
5.7 days earlier after the institution of fetal testing than
women who were allocated to standard fetal evaluation
without assessment of middle cerebral artery blood flow.
This suggests that incorporation of middle cerebral artery
Doppler flow assessment into clinical practice might
increase unnecessary intervention. Therefore, at present,
middle cerebral artery Doppler flow measurement should
be considered investigational.
Should all women perform daily fetal move-
s
ment assessment?
Whether programs of fetal movement assessment actu-
ally can reduce the risk of stillbirth is not clear. Only two
randomized trials have addressed this issue. The first was
conducted in a mixed high-risk (39%) and low-risk (61%)
population of 3,111 Danish women who, after 32 weeks
of gestation, were randomly assigned to an experimental
(counting) group or a control group (10). Women in the
experimental group were asked to count fetal move-
ments for 1 hour three times a week and to contact their
hospital immediately if they detected fewer movements
than their previously established baseline. The control
group of women were given no special fetal movement
assessment instructions but were asked about fetal move-
ment at their prenatal visits. Of the 1,583 women in the
counting group, three experienced stillbirths of normally
formed infants weighing more than 1,500 g, versus 12
stillbirths among the 1,569 women in the control group
(P<0.05). Of women allocated to the counting group,
80% complied well with the protocol for counting, and
4% were evaluated for decreased fetal movement. The
rates of operative vaginal birth and cesarean delivery did
not differ significantly between the groups.
The second randomized study to evaluate fetal
movement allocated 68,000 women at 28–32 weeks of
gestation to a counting policy (in which normal fetal
movement was defined as the perception of 10 move-
ments within 10 hours) or to routine care in which no
special counting policies were employed (62). Women
in the counting group with fewer than 10 movements in
10 hours for two successive days were instructed to alert
their care provider, at whose discretion further evaluation
was undertaken. Overall fetal death rates were low in
this trial and did not differ significantly between the two
groups (2.9/1,000 in the counting group versus 2.7/1,000
in the control group). More women in the counting
group (7% versus 5%) underwent fetal heart rate testing,
and more (5% versus 4%) were admitted antenatally to
the hospital. However, the rates of labor induction and
elective cesarean delivery did not differ significantly
between the two groups. It should be noted that in the
PRACTICE BULLETINS
counting group, only 46% of women with decreased fetal
movement alerted their care providers. Compliance for
both recording fetal movements and reporting when they
were diminished was even lower for women who experi-
enced a stillbirth.
Consistent evidence that a formal program of fetal
movement assessment will result in a reduction in fetal
deaths is lacking. Moreover, whether fetal movement
assessment adds benefit to an established program of
regular fetal surveillance has not been evaluated. One of
the two randomized studies of fetal movement assess-
ment suggests that its use may reduce stillbirths; the other
does not. Formal movement assessment may increase,
by a small degree, the number of antepartum visits and
fetal evaluations. In the randomized trials, however, this
increased surveillance did not result in a higher rate of
intervention (10, 62).
Summary
The following recommendations are based on lim-
ited or inconsistent scientific evidence (Level B):
Women with high-risk factors for stillbirth should
s
undergo antepartum fetal surveillance using the NST,
CST, BPP, or modified BPP.
Initiating testing at 32–34 weeks of gestation is
s
appropriate for most pregnancies at increased risk of
stillbirth, although in pregnancies with multiple or
particularly worrisome high-risk conditions, testing
may be initiated as early as 26–28 weeks of gestation.
When the clinical condition that has prompted test-
s
ing persists, a reassuring test should be repeated
periodically (either weekly or, depending on the test
used and the presence of certain high-risk conditions,
twice weekly) until delivery. Any significant dete-
rioration in the maternal medical status or any acute
diminution in fetal activity requires fetal reevalua-
tion, regardless of the amount of time that has elapsed
since the last test.
An abnormal NST or modified BPP usually should
s
be further evaluated by either a CST or a full BPP.
Subsequent management should then be predicated
on the results of the CST or BPP, the gestational age,
the degree of oligohydramnios (if assessed), and the
maternal condition.
Oligohydramnios, defined as either no ultrasono-
s
graphically measurable vertical pocket of amniotic
fluid greater than 2 cm or an AFI of 5 cm or less,
requires (depending on the degree of oligohydram-
nios, the gestational age, and the maternal clinical
2013 COMPENDIUM OF SELECTED PUBLICATIONS 847
 condition) either delivery or close maternal or fetal
surveillance.
In the absence of obstetric contraindications, delivery
s
of the fetus with an abnormal test result often may
be attempted by induction of labor with continuous
monitoring of the fetal heart rate and contractions. If
repetitive late decelerations are observed, cesarean
delivery generally is indicated.
Recent, normal antepartum fetal test results should
s
not preclude the use of intrapartum fetal monitoring.
Umbilical artery Doppler velocimetry has been found
s
to be of benefit only in pregnancies complicated by
intrauterine growth restriction. If used in this setting,
decisions regarding timing of delivery should be made
using a combination of information from the Doppler
ultrasonography and other tests of fetal well-being,
along with careful monitoring of maternal status.
Middle cerebral artery Doppler velocimetry should
s
be considered an investigational approach to antepar-
tum fetal surveillance.
References
1. Boddy K, Dawes GS, Fisher R, Pinter S, Robinson JS.
Foetal respiratory movements, electrocortical and car-
diovascular responses to hypoxaemia and hypercapnia in
sheep. J Physiol 1974;243:599–618 (Level III) Antepartum fetal heart rate testing. I. Evolution of the non-
2. Manning FA, Platt LD. Maternal hypoxemia and fetal
breathing movements. Obstet Gynecol 1979;53:758–760
(Level III)
3. Murata Y, Martin CB Jr, Ikenoue T, Hashimoto T, Taira
S, Sagawa T, et al. Fetal heart rate accelerations and late
decelerations during the course of intrauterine death in
chronically catheterized rhesus monkeys. Am J Obstet
Gynecol 1982;144:218–223 (Level III)
4. Natale R, Clewlow F, Dawes GS. Measurement of fetal
forelimb movements in the lamb in utero. Am J Obstet
Gynecol 1981;140:545–551 (Level III)
5. Seeds AE. Current concepts of amniotic fluid dynamics.
Am J Obstet Gynecol 1980;138:575–586 (Level III)
6. Weiner CP, Sipes SL, Wenstrom K. The effect of fetal age
upon normal fetal laboratory values and venous pressure.
Obstet Gynecol 1992;79:713–718 (Level III)
7. Manning FA, Snijders R, Harman CR, Nicolaides K,
Menticoglou S, Morrison I. Fetal biophysical profile
score. VI. Correlation with antepartum umbilical venous
fetal pH. Am J Obstet Gynecol 1993;169:755–763 (Level II-2)
8. Pearson JF, Weaver JB. Fetal activity and fetal wellbeing: an
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 26. Druzin ML, Gratacos J, Keegan KA, Paul RH. Antepartum
fetal heart rate testing. VII. The significance of fetal bra-
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I. The relationship of marginal and decreased amniotic
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SM, Lange IR, Johnson JM. Fetal assessment based
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31. Rutherford SE, Phelan JP, Smith CV, Jacobs N. The four-
quadrant assessment of amniotic fluid volume: an adjunct
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32. Erskine RL, Ritchie JW. Umbilical artery blood flow
characteristics in normal and growth-retarded fetuses. Br J
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33. Gudmundsson S, Marsal K. Umbilical and uteroplacental
blood flow velocity waveforms in pregnancies with fetal
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34. Reuwer PJ, Bruinse HW, Stoutenbeek P, Haspels AA.
Doppler assessment of the fetoplacental circulation in
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Reprod Biol 1984;18:199–205 (Level II-2)
35. Karsdorp VH, van Vugt JM, van Geijn HP, Kostense PJ,
Arduini D, Montenegra N, et al. Clinical significance of
absent or reversed end diastolic velocity waveforms in
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36. Giles WB, Trudinger BJ, Baird PJ. Fetal umbilical artery
flow velocity waveforms and placental resistance: patho-
logical correlation. Br J Obstet Gynaecol 1985;92:31–38
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37. Nicolaides KH, Bilardo CM, Soothill PW, Campbell S.
Absence of end diastolic frequencies in umbilical artery:
a sign of fetal hypoxia and acidosis. BMJ 1988;297:
1026–1027 (Level III)
38. Almstrom H, Axelsson O, Cnattingius S, Ekman G,
Maesel A, Ulmsten U, et al. Comparison of umbilical-
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936–940 (Level I )
39. Johnstone FD, Prescott R, Hoskins P, Greer IA, McGlew
T, Compton M. The effect of introduction of umbili-
cal Doppler recordings to obstetric practice. Br J Obstet
Gynaecol 1993;100:733–741 (Level I)
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40. Newnham JP, O’Dea MR, Reid KP, Diepeveen DA.
Doppler flow velocity waveform analysis in high risk
pregnancies: a randomized controlled trial. Br J Obstet
Gynaecol 1991;98:956–963 (Level I)
41. Omtzigt AM, Reuwer PJ, Bruinse HW. A randomized
controlled trial on the clinical value of umbilical Doppler
velocimetry in antenatal care. Am J Obstet Gynecol 1994;
170:625–634 (Level I)
42. Pattinson RC, Norman K, Odendaal HJ. The role of
Doppler velocimetry in the management of high risk
pregnancies. Br J Obstet Gynaecol 1994;101:114–120
(Level I)
43. Trudinger BJ, Cook CM, Giles WB, Connelly A,
Thompson RS. Umbilical artery flow velocity waveforms
in high-risk pregnancy. Randomised controlled trial.
Lancet 1987;1(8526):188–190 (Level I)
44. Tyrrell SN, Lilford RJ, Macdonald HN, Nelson EJ, Porter
J, Gupta JK. Randomized comparison of routine vs highly
selective use of Doppler ultrasound and biophysical scor-
ing to investigate high risk pregnancies. Br J Obstet
Gynaecol 1990;97:909–916 (Level I)
45. Thacker SB, Berkelman RL. Assessing the diagnostic
accuracy and efficacy of selected antepartum fetal surveil-
lance techniques. Obstet Gynecol Surv 1986;41:121–141
(Level III)
46. Enkin M, Keirse MJNC, Renfrew M, Neilson J. A guide to
effective care in pregnancy and childbirth. 2nd ed. Oxford:
Oxford University Press, 1995:410 (Level III)
47. Nageotte MP, Towers CV, Asrat T, Freeman RK. Perinatal
outcome with the modified biophysical profile. Am J
Obstet Gynecol 1994;170:1672–1676 (Level I)
48. Rouse DJ, Owen J, Goldenberg RL, Cliver SP.
Determinants of the optimal time in gestation to initiate
antenatal fetal testing: a decision-analytic approach. Am J
Obstet Gynecol 1995;173:1357–1363 (Decision Analysis)
49. Lagrew DC, Pircon RA, Towers CV, Dorchester W,
Freeman RK. Antepartum fetal surveillance in patients
with diabetes: when to start? Am J Obstet Gynecol
1993;168:1820–1826 (Level III)
50. Pircon RA, Lagrew DC, Towers CV, Dorchester WL,
Gocke SE, Freeman RK. Antepartum testing in the hyper-
tensive patient: when to begin. Am J Obstet Gynecol
1991;164:1563–1570 (Level III)
51. Manning FA, Morrison I, Harman CR, Lange IR,
Menticoglou S. Fetal assessment based on fetal biophysi-
cal profile scoring: experience in 19,221 referred high-risk
pregnancies. II. An analysis of false-negative fetal deaths.
Am J Obstet Gynecol 1987;157:880–884 (Level II-3)
52. Staisch KJ, Westlake JR, Bashore RA. Blind oxyto-
cin challenge test and perinatal outcome. Am J Obstet
Gynecol 1980;138:399–403 (Level II-2)
53. Garite TJ, Linzey EM, Freeman RK, Dorchester W.
Fetal heart rate patterns and fetal distress in fetuses with
congenital anomalies. Obstet Gynecol 1979;53:716–720
(Level II-2)
54. Leveno KJ, Quirk JG Jr, Cunningham FG, Nelson SD,
Santos-Ramos R, Toofanian A, et al. Prolonged pregnan-
cy. I. Observations concerning the causes of fetal distress.
Am J Obstet Gynecol 1984;150:465–473 (Level III)
2013 COMPENDIUM OF SELECTED PUBLICATIONS 849
 55. Phelan JP, Platt LD, Yeh SY, Broussard P, Paul RH. The
role of ultrasound assessment of amniotic fluid volume in
the management of the postdate pregnancy. Am J Obstet
Gynecol 1985;151:304–308 (Level II-2)
56. Haley J, Tuffnell DJ, Johnson N. Randomised controlled
trial of cardiotocography versus umbilical artery Doppler
in the management of small for gestational age fetuses. Br
J Obstet Gynaecol 1997;104:431–435 (Level I)
57. Nienhuis SJ, Vles JS, Gerver WJ, Hoogland HJ. Doppler
ultrasonography in suspected intrauterine growth retar-
dation: a randomized clinical trial. Ultrasound Obstet
Gynecol 1997;9:6–13 (Level I)
58. Neilson JP, Alfirevic Z. Doppler ultrasound for fetal
assessment in high risk pregnancies (Cochrane Review).
In: The Cochrane Library, Issue 3, 1999. Oxford: Update
Software (Meta-analysis)
59. Mason GC, Lilford RJ, Porter J, Nelson E, Tyrell S.
Randomised comparison of routine versus highly selective
use of Doppler ultrasound in low risk pregnancies. Br J
Obstet Gynaecol 1993;100:130–133 (Level I)
60. Mari G, Deter RL. Middle cerebral artery flow velocity
waveforms in normal and small-for-gestational-age fetus-
es. Am J Obstet Gynecol 1992;166:1262–1270 (Level
II-2)
61. Ott WJ, Mora G, Arias F, Sunderji S, Sheldon G.
Comparison of the modified biophysical profile to a “new”
biophysical profile incorporating the middle cerebral
artery to umbilical artery velocity flow systolic/diastolic
ratio. Am J Obstet Gynecol 1998;178:1346–1353 (Level I)
62. Grant A, Elbourne D, Valentin L, Alexander S. Routine
formal fetal movement counting and risk of antepar-
tum late death in normally formed singletons. Lancet
1989;2(8659):345–349 (Level I)
The MEDLINE database, the Cochrane Library, and
ACOG’s own internal resources and documents were used
to con­duct a lit­er­a­ture search to lo­cate rel­e­vant ar­ti­cles
pub­lished be­tween January 1985 and February 1999. The
search was re­strict­ed to ar­ti­cles pub­lished in the English
lan­guage. Pri­or­i­ty was given to articles re­port­ing results of
orig­i­nal re­search, although re­view ar­ti­cles and com­men­tar­
ies also were consulted. Ab­stracts of re­search pre­sent­ed at
sym­po­sia and sci­en­tif­ic con­fer­enc­es were not con­sid­ered
adequate for in­clu­sion in this doc­u­ment. Guide­lines pub­
lished by or­ga­ni­za­tions or in­sti­tu­tions such as the Na­tion­al
In­sti­tutes of Health and the Amer­i­can Col­lege of Ob­ste­
tri­cians and Gy­ne­col­o­gists were re­viewed, and ad­di­tion­al
studies were located by re­view­ing bib­liographies of identi-
fied articles. When re­ li­
able research was not available,
expert opinions from ob­ste­tri­cian–gynecologists were used.
Studies were reviewed and evaluated for qual­it­y ac­cord­ing
to the method outlined by the U.S. Pre­ven­tive Services
Task Force:
I Evidence obtained from at least one prop­ er­ly
de­signed randomized controlled trial.
II-1 Evidence obtained from well-designed con­trolled
tri­als without randomization.
II-2 Evidence obtained from well-designed co­ hort or
case–control analytic studies, pref­er­a­bly from more
than one center or research group.
II-3 Evidence obtained from multiple time series with or
with­out the intervention. Dra­mat­ic re­sults in un­con­
trolled ex­per­i­ments also could be regarded as this
type of ev­i­dence.
III Opinions of respected authorities, based on clin­i­cal
ex­pe­ri­ence, descriptive stud­ies, or re­ports of ex­pert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and grad­ed ac­cord­ing to the
following categories:
Level A—Recommendations are based on good and con­
sis­tent sci­en­tif­ic evidence.
Level B—Recommendations are based on limited or in­con­
sis­tent scientific evidence.
Level C—Recommendations are based primarily on con­
sen­sus and expert opinion.

Copyright © October 1999 by the American College of Ob­ste­tri­cians

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be reproduced, stored in a re­triev­al sys­tem, or transmitted, in any form
or by any means, elec­tron­ic, me­chan­i­cal, photocopying, recording, or
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PRACTICE BULLETINS 2013 COMPENDIUM OF SELECTED PUBLICATIONS 850


This Practice Bulletin was
developed by the ACOG Com-
mittee on Prac­tice Bulletins—
Obstetrics with the assistance
of Susan M. Cox, MD. The
in­for­ma­tion is de­signed to aid
practitioners in making deci-
sions about appropriate obstet-
ric and gynecologic care. These
guidelines should not be con-
strued as dic­ tat­
ing an exclu-
sive course of treatment or
pro­ce­dure. Variations in prac-
tice may be warranted based
on the needs of the in­di­vid­ua­ l
pa­tient, resources, and limita-
tions unique to the institution
or type of prac­tice.
Reaffirmed 2010
PRACTICE BULLETINS
ACOG
PRACTICE
BULLETIN Clinical Management Guidelines for
Obstetrician–Gynecologists
Number 12, January 2000
Intrauterine Growth
Restriction
Intrauterine growth restriction (IUGR) is one of the most common and complex
problems in modern obstetrics. Diagnosis and management are complicated
by the use of ambiguous terminology and a lack of uniform diagnostic criteria.
In addition, some authors do not make a clear distinction between suspected
prenatal growth restriction and confirmed IUGR in the perinatal period.
Furthermore, size alone is not an indication of a complication. As a result of
this confusion, underintervention and overintervention can occur. This bulletin
will focus on the etiology, diagnosis, and management of intrauterine growth
restriction.
Background
Definitions
Several factors have contributed to the confusion in terminology associated
with IUGR:
• By definition, 10% of infants in any population will have birth weights
at or below the 10th percentile. Intrauterine growth restriction could be
manifest at a weight above the population determined at the 10th percentile
(eg, an undernourished infant born at the 15th percentile whose genetic
makeup would have placed it at the 90th percentile). Distinctions between
normal and pathologic growth often cannot reliably be made in clinical
practice, especially prior to birth.
• Although defining a pathologic condition using a 10th percentile cutoff
makes statistical sense, it may not be clinically relevant. One study sug-
gests that adverse perinatal outcome generally is confined to those infants
with birth weights below the 5th percentile, and in most cases below the
3rd percentile (1).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 851
 • Although specific ethnic- and geographic-based
growth curves are increasingly used to evaluate birth
weight, it remains unclear whether this is appropri-
ate. These distinctions become even more difficult in
ethnically heterogeneous and geographically mobile
populations, such as those in the United States. Birth
weight also is related to maternal height, parity,
paternal height, and the fetus’ sex.
The use of the terms “small for gestational age”
(SGA) and “intrauterine growth restriction” has been
confusing, and the terms often are used interchangeably.
For the purpose of this document, SGA will be used only
in reference to the infant and IUGR to the fetus.
Small for Gestational Age
Infants with a birth weight at the lower extreme of the
normal birth weight distribution are termed SGA. In the
United States, the most commonly used definition of
SGA is a birth weight below the 10th percentile for ges-
tational age (2, 3).
Intrauterine Growth Restriction
Intrauterine growth restriction is a term used to describe
a fetus whose estimated weight appears to be less than
expected, usually less than the 10th percentile, which
is the convention this document will adopt. The term
IUGR includes normal fetuses at the lower end of the
growth spectrum, as well as those with specific clinical
conditions in which the fetus fails to achieve its inherent
growth potential as a consequence of either pathologic
extrinsic influences (such as maternal smoking) or intrin-
sic genetic defects (such as aneuploidy).
Etiology
Several conditions have been found to be associated with
IUGR (see the box). These antecedents can be divided
into several broad categories: maternal, fetal, or placen-
tal. Maternal behavioral conditions include substance use
(including smoking and alcohol use) (4–6), extremes of
reproductive age (younger than 16 years and older than
35 years), little maternal weight gain (7), malnutrition,
and low prepregnancy weight (7). In addition, low socio-
economic status is associated with IUGR (7).
Maternal Medical Conditions
Medical complications that affect the microcirculation
causing fetal hypoxemia or vasoconstriction or a reduc-
tion in fetal perfusion also are significantly associated
with IUGR (8). These include hypertension, both chronic
and acute (as in preeclampsia) (9), and severe chronic
diseases, such as renal insufficiency (10), systemic lupus
PRACTICE BULLETINS
Risk Factors for Intrauterine Growth Restriction
• Maternal medical conditions
—Hypertension
—Renal disease
—Restrictive lung disease
—Diabetes (with microvascular disease)
—Cyanotic heart disease
—Antiphospholipid syndrome
—Collagen-vascular disease
—Hemoglobinopathies
• Smoking and substance use and abuse
• Severe malnutrition
• Primary placental disease
• Multiple gestation
• Infections (viral, protozoal)
• Genetic disorders
• Exposure to teratogens
erythematosus, antiphospholipid antibody syndrome,
chronic anemia, and pregestational diabetes (especially
White’s classifications C, D, F, and R). Growth restric-
tion may be preceded by defective maternal volume
adaptation in early pregnancy (11, 12).
Placental association with IUGR is unique in that
it can be the primary cause (eg, mosaicism) or merely
involved in an adaptive process of a pregnancy compli-
cation. The placenta and impaired placental perfusion
are the most common cause of SGA in nonanomalous
infants (13), as seen in early-onset preeclampsia, which
produces the most severe IUGR (14). Intrauterine growth
restriction also is related to other placental abnormalities,
including partial abruptions, previa, infarcts, and hema-
tomas (15). In unexplained IUGR, placental mosaicism
may be identified in up to 25% of patients (16). Factors
not associated with IUGR include caffeine use in non-
smokers (6, 17) and passive smoking (18).
Substance Use and Abuse
Maternal alcohol abuse is associated with impaired fetal
growth; virtually all neonates with fetal alcohol syndrome
will exhibit significant growth restriction (6, 19). It is
unknown whether a threshold effect exists for alcohol,
but effects on the fetus are related to the amount con-
sumed.
Women who smoke have a 3.5-fold increase of SGA
infants, compared with nonsmokers (9). Newborns of
2013 COMPENDIUM OF SELECTED PUBLICATIONS 852
 smokers are smaller at every gestational age. Women
who stop smoking before 16 weeks of gestation have
infants with birth weights similar to those of babies of
women who never smoked (20), and women who quit as
late as the seventh month have mean birth weights higher
than those who smoked during the entire pregnancy (21).
The incidence of IUGR is markedly increased in
pregnant women who use illicit drugs, but it is difficult
to differentiate the drug effect from the effects of other
behaviors associated with drug use. The incidence of
SGA infants in mothers with heroin addiction is as high
as 50% (22) and is reported to be as high as 35% in
patients managed with methadone (23). Cocaine abuse in
pregnancy is associated with delivery of an SGA neonate
in 30% or more of cases (24).
Malnutrition
There is a common belief that severe maternal malnutri-
tion will result in fetal growth restriction. The data from
studies of the Siege of Leningrad during World War II
(25) and the Dutch famine of the same period (26) sug-
gest that maternal intake must be reduced to below 1,500
kilocalories per day before a measurable effect on birth
weight becomes evident. In these studies, it is not entirely
clear, however, how much of the effect on birth weight
was the result of IUGR and how much the result of pre-
term delivery.
Although low prepregnancy weight and low mater-
nal weight gain have been positively associated with
an increase in IUGR (7, 27, 28), and increased weight
gain has been associated with decreased IUGR in some
populations (29), there is as yet no demonstration that
altering dietary recommendations or habits can affect
birth weight in a positive manner. Rather, although there
are associations between maternal prepregnancy weight,
maternal weight gain, and birth weight, there has been
no trial showing that any intervention to alter pregnancy
weight gain has a beneficial effect on fetal weight gain.
Placental Disease
Primary placental disease (such as chorioangioma) is
a rare but recognized cause of growth restriction (30).
Placenta previa has been associated with an increase in
growth restriction, presumably secondary to abnormal
placental implantation. Confined placental mosaicism has
been identified three times more frequently from placen-
tas of SGA infants than in infants of normal growth (16).
Multiple Gestation
Intrauterine growth restriction is a common complication
of multiple gestation. It is more pronounced in higher
order multiple gestations when compared with twin ges-
PRACTICE BULLETINS
tations (31). Investigators have reported a greater likeli-
hood of IUGR among surviving fetuses after multifetal
reduction (32, 33). The growth restriction is a result of
placental reserve inadequate to sustain the normal growth
of more than one fetus. Growth restriction can occur in
dizygotic twin gestations but is more common and severe
in monozygotic twins. It is evident that equal sharing of
functional placental mass is not the norm; rather, one
twin is more likely to have a larger share of functional
placental mass than the other (31).
Infections
Viral infections have been estimated to be etiologic in less
than 5% of all growth-restricted fetuses (34). However,
when evaluated in documented cases of in utero viral
infection, the frequency of IUGR can be strikingly high.
Fetal rubella infection is associated with growth restric-
tion in up to 60% of cases (35). Cytomegalovirus also
is a recognized cause of growth restriction (36). In one
study, approximately 40% of fetuses with varicella syn-
drome exhibited growth restriction (37). Bacterial infec-
tions have not been shown to cause growth restriction.
Some protozoal infections, such as Toxoplasma gondii,
Trypanosoma cruzi (Chagas disease), and syphilis, are
associated with growth restriction (38, 39).
Genetic Disorders
Chromosome anomalies are a major cause of IUGR (40,
41). Many fetal structural anomalies also are associated
with an increased risk of growth restriction, with a rela-
tive risk ranging from as high as 24.7 with anencephaly
to as low as 1.2 with pyloric stenosis (42).
Exposure to Teratogens
Maternal ingestion of certain medications is a recognized
cause of growth restriction; the incidence and severity
vary by substance, gestational age at exposure, duration
of exposure, and dosage. Therapeutic agents known to
be associated with growth restriction include anticon-
vulsants (eg, trimethadione, phenytoin) (43–45), folic
acid antagonists (eg, methotrexate) (46), and warfarin
(47, 48).
Morbidity and Mortality
Fetal Morbidity and Mortality
Perinatal morbidity and mortality is significantly
increased in the presence of low birth weight for ges-
tational age, especially with weights below the 3rd per-
centile for gestational age (1). One study found that 26%
of all stillbirths were SGA (49). The risk of death in the
2013 COMPENDIUM OF SELECTED PUBLICATIONS 853
 presence of IUGR also is affected by gestational age and
the primary etiology and may be further modified by the
severity and progression of associated maternal etiologic
factors (eg, hypertension) (50) (see Table 1).
Both intrapartum and neonatal complications are
increased in the presence of IUGR. During labor, up to
50% of growth-restricted fetuses exhibit abnormal heart
rate patterns, most often variable decelerations, and such
fetuses have an increased cesarean delivery rate (51, 52).
Oligohydramnios is a common finding in growth-restrict-
ed fetuses and may render the umbilical cord vulnerable
to compression (53–55). Sustained antepartum cord com-
pression in growth-restricted fetuses is a presumed cause
of sudden fetal death (51, 55). Incidences of low Apgar
scores and cord blood acidemia increase significantly in
SGA neonates (56).
Neonatal Morbidity
Neonatal complications in the SGA infant include poly-
cythemia, hyperbilirubinemia, hypoglycemia, hypother-
mia, and apneic episodes (57, 58), as well as low Apgar
scores, umbilical artery pH less than 7.0, need for intu-
bation in the delivery room, seizures, sepsis, and neona-
tal death (1). It is uncertain whether IUGR accelerates
fetal pulmonary maturity. One study found a decreased
incidence of both respiratory distress syndrome and
intraventricular hemorrhage in infants with SGA com-
pared with a control group of infants of appropriate size
for their gestational age (59). In contrast, other stud-
ies failed to document a difference in lung profile in a
matched series (60) and found no difference in the need
for ventilatory support in newborns with SGA when
compared with controls. The use of glucocorticoids in
Table 1. Corrected Perinatal Mortality Rates (Excluding Lethal
Anomaly) Among Low-risk and High-risk (Screened/Unscreened)
Pregnancies and Among SGA Fetuses (Screened/Unscreened),
Manitoba Experience
Corrected Perinatal
  Mortality Rates
Category Number of Cases (per 1,000 live births)
All cases 144,786 5.6
All low risk 101,350 3.8
All high risk 43,436 9.8
Screened high risk 31,740 2.2
All SGA (7% total population) 10,135 17.8
Unscreened SGA 7,460 21.3
Screened SGA* 2,675 8.4
* Serial fetal assessment management by fetal biophysical profile score.
Manning FA. Intrauterine growth retardation, etiology, pathophysiology, diag-nosis,
and treatment. In: Fetal medicine: principles and practice. Norwalk, Connecticut:
Appleton & Lange, 1995:372
PRACTICE BULLETINS
fetuses with IUGR has not been studied, but current rec-
ommendations are to give glucocorticoids to women with
complicated pregnancies who are likely to deliver before
34 weeks of gestation (61).
Long-term development of infants born with SGA
depends in part on the cause of the growth failure. In
infants with karyotype abnormalities or viral infection,
the etiology rather than the weight percentile ultimately
will determine the outcome. There are conflicting data
on whether infants catch up in growth. Most otherwise
normal infants with SGA secondary to placental insuffi-
ciency will exhibit normal catch-up growth by the age of
2 years, although this pattern may not be seen universally
in severely affected infants (58, 62–64) or in preterm
growth-restricted infants (65). A comparison of 714 neo-
nates of appropriate size for age with 347 SGA neonates,
derived from several studies, indicated a twofold increase
of major neurologic sequelae among SGA infants (54).
There is no evidence to suggest that any specific manage-
ment scheme or delivery route prevents neurologic injury
in such fetuses. Long-term follow-up of infants with SGA
shows that they are more prone to develop adult-onset
hypertension and cardiovascular complications (66). It is
important to note that IUGR and SGA both have a multi-
tude of etiologies, and there is a danger in grouping them.
There may be no consequences of low birth weight under
some circumstances; under others, it may be devastating.
Antenatal Diagnosis of Intrauterine
Growth Restriction
There are two essential steps involved in the antenatal
recognition of growth restriction. The first step involves
the elucidation of maternal risk factors associated with
growth restriction and the clinical assessment of uter-
ine size in relation to gestational age. The second step
involves the ultrasonographic assessment of fetal size and
growth, supplemented by invasive fetal testing for aneu-
ploidy or viral infection in select cases.
Clinical Evaluation
The key physical finding in IUGR is a uterine size that is
smaller than expected for gestational age. Several methods
are available for clinical determination of uterine size,
the most common of which is an objective measurement
of fundal height. Such techniques, however, are prone to
considerable inaccuracy and should be used for screening
only, not as a sole guide to obstetric management in the
presence of risk factors for or suspicions of IUGR. These
inaccuracies are revealed in clinical studies suggesting that
growth restriction is undetected in about one third of cases
and is incorrectly diagnosed about 50% of the time (3, 67).
2013 COMPENDIUM OF SELECTED PUBLICATIONS 854
 Prior to birth, the diagnosis of IUGR is not precise.
Currently, the use of ultrasonographically estimated fetal
weight, head- or femur-to-abdomen ratios, or serial obser-
vation of biometric growth patterns (growth velocity)
are all acceptable and widely used methods to diagnose
IUGR (68–72). This document does not address the con-
cept of asymmetrical versus symmetrical IUGR, because
it is unclear whether the distinction is important with
respect to etiology or neonatal outcome.
Four standard fetal measurements generally are
obtained as part of any complete obstetric ultrasound
examination after the first trimester: 1) fetal abdomi-
nal circumference, 2) head circumference, 3) biparietal
diameter, and 4) femur length (73). Fetal morphologic
parameters can be converted to fetal weight estimates
using published formulas and tables (74). An abdominal
circumference within the normal range reliably excludes
growth restriction with a false-negative rate of less than
10% (71). A small abdominal circumference or fetal
weight estimate below the 10th percentile suggests the
possibility of growth restriction, with the likelihood
increasing as the percentile rank decreases (71). When
IUGR is suspected, serial measurements of fetal biomet-
ric parameters provide an estimated growth rate. Such
serial measurements are of considerable clinical value in
confirming or excluding the diagnosis and assessing the
progression and severity of growth restriction. Given the
high incidence of genetic and structural defects associated
with IUGR, a detailed ultrasound survey for the presence
of fetal structural and functional defects may be indicated.
Amniotic fluid volume is an important diagnostic
and prognostic parameter in fetuses with IUGR (75, 76).
Oligohydramnios is highly suggestive of growth failure
and indicates an increased risk of fetal death. Oligohy-
dramnios is diagnosed ultrasonographically in approxi-
mately 77–83% of pregnancies with growth-restricted
fetuses (75–77). In contrast, amniotic fluid volume often
is normal even in a fetus with significant growth restric-
tion; thus, the absence of oligohydramnios should not
detract from the diagnosis of IUGR.
Although Doppler velocimetry of the umbilical arter-
ies is not useful as a screening technique for IUGR (78,
79), it has been demonstrated to be useful once IUGR
has been diagnosed. Not only are Doppler velocimetry
findings normal in growth-restricted fetuses with chro-
mosomal or other structural etiologies (80) but Doppler
velocimetry has been shown to both reduce interventions
and improve fetal outcome in pregnancies at risk for
IUGR (81). Thus, once IUGR is suspected or diagnosed,
Doppler velocimetry may be useful as a part of fetal
evaluation. Fetuses with normal flow patterns seem less
likely to benefit from consideration of early delivery than
do their counterparts with abnormal studies.
PRACTICE BULLETINS
Clinical Considerations and
Recommendations
s
Which pregnancies should be screened for
intrauterine growth restriction, and how is
screening accomplished?
Unfortunately, approximately one half of growth-restrict-
ed fetuses are not diagnosed until delivery. In essence, all
pregnancies are screened for IUGR using serial fundal
height measurements. A single measurement at 32–34
weeks of gestation is approximately 70–85% sensitive
and 96% specific for detecting the growth-restricted fetus
(82). A third-trimester ultrasound examination, with a
single measurement of abdominal circumference, detects
about 80% of IUGR fetuses (70). Even so, this does not
justify ultrasonography as a screening tool, because fun-
dal height measurement performs comparably (70). All
pregnancies should be screened with serial fundal height
assessments, reserving ultrasonography for those with
risk factors, lagging growth, or no growth (69, 83, 84).
Women who have previously given birth to an
SGA infant are at an increased risk for this condition in
subsequent pregnancies (9). Physicians should consider
an early ultrasound examination to confirm gestational
age, as well as subsequent ultrasonography to evaluate
sequential fetal growth, in women with significant risk
factors.
What are the best ways to evaluate and moni-
s
tor a pregnancy complicated by suspected
intrauterine growth restriction?
Once IUGR is suspected (ie, lagging fundal height), it
should be confirmed using multiple ultrasonographic
parameters, such as estimated weight percentile, amniotic
fluid volume, elevated head circumference and abdomi-
nal circumference ratio, and possibly Doppler criteria (ie,
elevated systolic–diastolic ratio or reversed or absent end-
diastolic flow) (85). Identification of IUGR is improved
by recording growth velocity or through two sets of
examinations generally 2–4 weeks apart.
The diagnosis of IUGR as the fetus approaches term
may be an indication for delivery (86). If pregnancy is remote
from term or if delivery is not elected, the optimal mode of
monitoring has not been established. Periodic fetal assess-
ment (approximately weekly) using Doppler velocimetry,
contraction stress test, traditional biophysical profile (BPP),
modified BPP, or nonstress test (NST) are all accepted moni-
toring techniques. Randomized controlled trials have demon-
strated that monitoring with Doppler velocimetry reduces the
risk of perinatal morbidity (81). Comparable studies for the
other methods have not been done.
2013 COMPENDIUM OF SELECTED PUBLICATIONS 855
 Serial ultrasonograms to determine the rate of growth ment are the usual courses of action at present. Overall
should be obtained approximately every 2–4 weeks. experience with the NST confirms that with a reactive
Measurements at shorter intervals (<2 weeks) may over- NST the fetus is not likely to die in utero immediately.
lap with measurement errors.