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PRACTICE GUIDELINES AIUM-—ACR-ACOG-SMFM-SRU Practice Parameter for the Performance of Standard Diagnostic Obstetric Ultrasound Examinations 4oi102002/pam.14831 Preamble he American Institute of Ultrasound in Medicine (AIUM) [ is a multdisciplinary association dedicated to advancing the safe and effective use of ultrasound in medicine through professional and public education, research, development of parameters, and accreditation. ‘The AIUM represents the entire range of clinical and basic science interests in medical diagnostic ultrasound, and, with un- ddreds of volunteers, the AIUM has promoted the safe and effective use of ultrasound in clinical medicine since 1952. This document and others like it will continue to advance this mission, Practice parameters of the AIUM are intended to provide the ‘medical ultrasound community with parameters for the performance and recording of high-quality ultrasound examinations. The parame- ters reflect what the AIUM considers the minimum criteria for a com- plete examination in each area but are not intended to establish a legal standard of care. AIUM-accredited practices are expected to generally follow the parameters with recognition that deviations from these parameters will be needed in some cases, depending on patient needs and available equipment. Practices are encouraged to go beyond the parameters to provide additional service and information as needed. Introduction ‘The clinical aspects contained in specific sections of this practice parameter (Introduction, Classification of Fetal Ultrasound Examina- tions, Specifications of the Examination, Equipment Specifications, and Fetal Safety) were revised collaboratively by the AIUM, the Amer- ican College of Radiology (ACR), the American College of Obstetsi- cans and Gynecologists (ACOG), the Society for Materal-Fetal Medicine (SMFM), and the Society of Radiologists in Ultrasound (SRU). Recommendations for Qualifications and Responsibilities of Personnel; Written Request for the Examination; Documentation; and Quality Control and Improvement, Safety, Infection Control, and \© 2018 by the Amica nsttute of Litasoune in Mecicine | J Ulasound Med 2018; 9989:1-12 | 0278-4297 | wnwalumorg AUM-ACR-ACOG-SMFM-SRU Practice Parameter forthe Performance of Standard Diagnostic Obstetric Uitasound Examinations Figure 1. Urasouns image of NT measurement Patient Education vary among the organizations and are auddressed by each separately This practice parameter has been developed for use by practitioners performing obstetric ultrasound studies. Obstetric ultrasound examinations should be performed only when there is a valid medical reason, and the lowest possible ultrasonic exposure settings should be used to gain the necessary diagnostic information." * While this practice parameter describes the key clements of standard ultrasound examinations in the first, second, and third trimesters of pregnancy, @ more detailed fetal anatomic examination may be nec essary in some cases, such as when an abnormality is found or suspected on the standard examination or in pregnancies at high risk for fetal anomalies.“ In some cases, other imaging may be necessary as well. While itis not possible to detect all structural con- genital anomalies with diagnostic ultrasound, adherence Figure 2 Diagram for the NT measurement, Figure 3. Transvaginal cervical engtn meas to the following practice parameter will increase the like- lihood of detecting many fetal abnormalities Classification of Fetal Ultrasound Examinations Standard First-Trimester Ultrasound Examination ‘A standard obstetric ultrasound examination in the first ‘trimester includes evaluation ofthe presence, size, loca- tion, and number of gestational sacs. The gestational sac is examined for the presence of a yolk sac and embryo/ fetus (a fetus is generally defined as 210 weeks’ gesta- tional age) When an embryo/fetus is detected, it should be measured, and the cardiac activity should be recorded by a 2-dimensional video elip or M-mode. The routine use of pulsed Doppler ultrasound to either doc: tument or “listen” to embryonie/fetal cardiac activity is discouraged.®” ‘The uterus, cervix, adnexa, and cul-de sac region should be examined. Standard Second- or Third-Trimester Ultrasound Examination ‘An obstetric ultasound examination in the second or third trimester includes an evaluation of the fetal number, cardiac activity, presentation, amniotic fluid volume, pla cental position, fetal biometry, and an anatomic survey. ‘The matemal cervix and adnexa should be examined. J Utrasoune Mec'2018; 9996 1-12 AIUMLACR-ACOG-SMFIM-SRU Practice Parameter forthe Perfomance of Standard Diagnostic Obstetic Utrasound Examinations Table 1. coer ea length measurement crea Bader emo, transvaginal sean (Cenc ls up 75% of avalable mage space, terior and aesteriorcenues are of equal thickness. intemal ans extemal cervical os ate Endocencal canals seen thoughout Calpe’ placed a the intemal and extemal os where the anterior ‘and pasteror was ofthe cervixmest Ifthe encocenca canal ‘cues, 2 or more near meacurements shouldbe used and aged together to ootan the cemeal length The shorestaest measurement shouldbe por Dynamic cenical shortening; examination te, 3-5 minutes andjor suprapubieluncal pressure Report shortest best measurement Limited Ultrasound Examination A limited obstetric ultrasound examination is per- formed to answer a specific, acute clinical question when an immediate impact on management is antic- pated and when time or other constraints make per- formance of a standard ultrasound examination impractical or unnecessary. Ifa limited obstetric ultra- sound examination is performed on a woman who has not previously had a standard or detailed ultra: sound examination, a subsequent standard or detailed ultrasound examination should be obtained where appropriate. In patients who require serial ultrasound examinations and have already had a standard or detailed scan, some will only need limited scans, whereas others will require standard or detailed follow-up examinations. Clinical judgement should be used to determine the proper type of ultrasound ‘examination to perform and the appropriate fre- quency for follow-up ultrasound examinations Specialized Ultrasound Examination A detailed anatomic examination is performed for ‘women at risk for fetal anatomic or karyotypic abnor malities (advanced maternal age, maternal medical complications of pregnancy, of pregnancy ater assisted reproductive technology) or when an anom- aly is suspected on the basis ofthe history, abnormal biochemical markers, or the results of either the lim- ited or standard scan (Other specialized ultrasound scans may include a fetal echocardiogram, biophysical profile, and fetal Doppler ultrasound or additional biometric measurements, incud- ing nuchal translucency (NT) and cervical length?" J urrasound Mes 2018, Qualifications and Responsibilities of Personnel See wwwaium.org for AIUM Official Statements, including Standards and Guidelines for the Accreditation of Ultrasound Practices and relevant Phy- sician Training Guidelines.'S Written Request for the Examination ‘The written or electronic request for an ultrasound examination should provide sufficient information to allow for the appropriate performance and interpreta- tion of the examination. The request for the examina- tion must be originated by a physician or another appropriately licensed health care provider or under the physician's or provider's direction. ‘The accompa- nying clinical information should be provided by a physician or other appropriate health care provider familiar with the patient's clinical situation and should be consistent with relevant legal and local health care facility requirements Specifications of the Examination Standard First-Trimester Ultrasound Examination 1 Indications for first-trimester’ ultrasound examinations include but are not limited to: a. Confirmation of the presence of an intrauterine pregnancy'*"”, Confirmation of cardiac activity’ Estimation of gestational age”* “5; L Diagnosis or evaluation of multiple gestations, including determination of chorionicity*® *, Evaluation of a suspected ectopic pregnancy”; Evaluation of the cause of vaginal bleeding; Evaluation of pelvic pain; Evaluation of suspected gestational trophoblastic disease; "Fore pupose ofthis document, ft tester represents I weak to 1 week Se AUM-ACR-ACOGSMFM-SRU Practice Parameter forthe Performance of Standard Diagnostic Obstetric Uitasound Examinations i. Assessment for certain fetal anomalies, such as anencephaly""*5; j. Measurement of the NT! when part of a sereening program for fetal aneuploidy; Ik, Imaging as an adjunct to chorionic villus sampling, embryo transfer, and localization and removal of an intrauterine device; and 1. Evaluation of maternal pelvic masses and/or uter: ine abnormalities 2, Imaging parameters Scanning in the first trimester may be performed either transabdominally or transvaginally. Ifa transab- dominal examination is not definitive, a transvaginal or transperineal scan is recommended. a. The uterus (including the cervix) and adnexa should be evaluated for the presence of a gesta tional sac. If a gestational sae is seen, its location should be documented. The gestational sac should be evaluated for the presence or absence of a yolk sac or embryo/fetus, and the crown-rump length should be recorded, when possible."”> 5 ‘A definitive diagnosis of intrauterine preg- rnaney can be made when an intrauterine gesta tional sac containing a yolk sac or embryo/fetus with or without cardiac activity is visualized, In very early intrauterine pregnancy, a small, eccentric intrauterine fluid collection with an echogenic rim can be seen before the yolk sac and embryo. In the absence of sonographic signs of ectopic pregnancy, the fluid collection is highly likely to represent an intrauterine gestational sac. Follow-up ultrasound and/or serial determination of maternal serum human chorionie gonadotropin levels are appropri ate in pregnancies of undetermined location to avoid inappropriate intervention in a potentially Viable early pregnancy.10!2° Caution should be used in making the pre sumptive diagnosis of a gestational sac in the absence of a definite yolk sac or embryo. If the embryo is not identified, the mean sac diameter may be useful for determining timing of ultrasound follow-up. However, the crown-rump length is a more accurate indicator of gestational age than the ‘mean gestational sac diameter. b, Presence or absence of cardiac activity should be documented with a 2-dimensional video clip or M mode.” With transvaginal scans, cardiac motion is ust- ally observed when the embryo is 2 mm or greater in length; if an embryo less than 7 mm in length is seen without cardiac activity, a subsequent sean in 1 week is recommended to ensure that the preg naney is nonviable."- «. Fetal number should be documented, Amnionicty and chorionicity should be documented for all multiple gestations."** 4. Appropriate fetal anatomy for the first trimester should be assessed and include the calvarium, fetal abdominal cord insertion, and presence of limbs when the fetus is of sufficient size. ¢. The nuchal region should be imaged, and abnor malities such as cystic hygroma should be docu: mented. For those patients desiring to assess their indi vidual risk of fetal aneuploidy, a very specific mea- surement of the NT during a specific age interval is necessary (as determined by the laboratory used). See the guidelines for this measurement below. Nuchal translucency measurements should be used (in conjunction with serum biochemistry) to determine the risk for having a fetus with anew ploidy or other abnormalities." In this setting, itis important that the practi tioner measure the NT according to established guidelines. A quality assessment program is recom: mended to ensure that false-positive and false negative results are kept to a minima.) Guidelines for NT measurement: i. The margins of the NT edges must be clear with the angle of insonation perpendicular to the NT line. ii. The fetus must be in the midsagittal plane. The tip of the nose, palate, and diencephalon should be seen, iil The image must be magnified so that itis filed by the fetal head, neck, and upper thorax iv, The fetal neck must be in a neutral postion, with the head in line with the spine, not flexed and not hyperextended, vy. The amnion must be seen as separate from the NT line, J Utrasoune Mec'2018; 9996 1-12 AIUMLACR-ACOG-SMFM-SRU Practice Parameter forthe Perfomance of Standard Diagnostic Obstetric Uirasound Examinations vi. The (+) calipers on the ultrasound screen must be used to perform the NT measurement. vii. Electronic calipers must be placed on the inner borders of the nuchal line with none of the hor- ‘zontal crossbar itself protruding into the space. vili, The calipers mast be placed perpendicular to the long axis ofthe fetus. ix. The measurement must be obtained at the wid- est space of the NT. The uterus, including the cervix, adnexal structures, and cul-de-sac, should be evaluated. Abnormalities should be imaged and documented. The presence, location, appearance, and size of adnexal masses should be documented. The pres: ence and number of leiomyomata should be docu- mented. ‘The measurements of the largest or any potentially clinically significant leiomyomata should be documented. The cul-de-sac should be evalu- ated for the presence or absence of fluid. Uterine anomalies should be documented. Standard Second- and Third-Trimester Ultrasound Examination"? 1, These examinations are commonly performed to assess fetal anatomy and biometry. Other indica- tions include but are not limited to: a. Screening for fetal anomalies*™**; i, Evaluation of fetal anatomy”, ¢ Estimation of gestational age"; 4. Evaluation of suspected multiple gestation; ¢. Evaluation of cervical length!?"™*""*1, £ Evaluation of fetal growth®?*, g Evaluation ofa significant discrepancy between uterine size and clinical dates; 1h, Determination of fetal presentation; i. Evaluation of fetal well-being; j. Suspected amniotic fluid abnormalities k Evaluation of premature rupture of membranes and/or premature labor; | Evaluation of vaginal bleeding; 1m. Evaluation of abdominal or pelvie pain; 1, Suspected placental abruption; 0. Suspected fetal death; p. Follow-up evaluation of a fetal anomaly; 4, Evaluation/follow-up of placental appearance and location, including suspected placenta 66-68, J utrasound Mes 2018, previa, vasa previa, and abnormally adherent placenta; +. Adjunct to amniocentesis or other procedure; s. Adjunct to external cephalic version; t. Evaluation of suspected gestational trophoblas- tic disease; u. Evaluation of a pelvic mass; and v. Suspected uterine anomalies, In certain clinical circumstances, a more detailed examination of fetal anatomy may be indicated.* Imaging parameters for a standard fetal examination a. Fetal cardiac activity (by video clip or M- mode), fetal number, and presentation should be documented ‘An abnormal heart rate and/or chythm should be documented Multiple gestations require the documen. tation of addtional information: chorionicity, amnionicity, comparison of fetal sizes, evaluat tion of amniotic uid volume in each gesta tional sac, and fetal genitalia (when visualized). b. A qualitative or semiquantitative estimate of amniotic fluid volume should be documented. Although it is acceptable for experienced examiners to qualitatively estimate amniotic fluid volume, semiquantitative methods have also been described for this purpose (eg, amniotic fluid index (AFI, single deepest pocket, and 2-diameter pocket). In assessing oligohydramnios, the deepest vertical pocket (<2cm) is preferred over AFI (<5 cm) because it results in fewer obstetric interven tions without a significant diference in the Perinatal outcome, and the single deepest pocket should be at least 1 cm wide®™® Polyhydramnios (deepest vertical pocket 28 em or AFI 224 em) may be associated with other pregnancy complications.” «. The placental location, appearance, and relation- ship with the intemal cervical os should be docu- mented, The umbilical cord should be imaged and the number of vessel in the cord documen- ted. The placental cord insertion site should be documented wien technically possible”*”* Ie is recognized that the apparent placen- tal position early in pregnancy may not AUM-ACR-ACOG-SMFM-SRU Practice Parameter forthe Performance of Standard Diagnostic Obstetric Uitasound Examinations correlate well with its location at the time of delivery. ‘A transvaginal or transperineal ultrasound, examination should be performed if the rela- tionship between the cervix and the placenta cannot be assessed. Ayyelamentous (also called membranous) placental cord insertion that crosses the inter nal os of the cervix is suspicious for a vasa pre- via, a condition that has a high risk of fetal mortality if not diagnosed prior to labor.” ”* Color and pulsed Doppler ultrasound should bbe used to assess vasa previa or abnormal pla cental cord insertion. Gestational age assessment First-trimester crown-rump measurement is the most accurate means for sonographic dating of pregnancy. Beyond this period, a variety of sonographic parameters such as biparietal diameter, abdominal circumference, and femoral diaphysis length can be used to estimate gestational age. It should be noted that abdominal cir cumference is the least reliable of these measurements for estimating gestational age."*” The variability of ges tational age estimation, however, increases with advanc- ing pregnancy. Significant discrepancies between gestational age and fetal measurements may suggest the possiblity ofa fetal growth abnormality. ‘The pregnancy should not be redated after an accurate earlier scan has been performed and is avail able for comparison.” i. The biparietal diameter is measured atthe level of the thalami and cavum septi pellucii."” The cere- bellar hemispheres should not be visible in this scanning plane, The measurement is typically taken from the outer edge of the proximal skull to the inner edge ofthe distal skull ‘The head shape may be elongated (dolicho- cephaly) or rounded (brachyeephaly) as a normal variant. Under these circumstances, certain vari ants of normal fetal head development may make measurement of the head circumference more reliable than the biparietal diameter for estimating gestational age. fi The head circumference is measured at the same level asthe biparietal diameter, around the outer perimeter of the bony calvarium, excluding subcutaneous tissues of the skull. This measurement is not affected by head shape. iii, The femoral diaphysis length can be reliably used after 14 weeks’ gestational age. The long axis of| the femoral shat is most accurately measured with the beam of insonation being perpendicular to the shaft, excluding the distal femoral epiphysis. iv. The abdominal circumference or average abdominal diameter should be determined at the skin Tine om a true transverse view at the level of the june- tion of the umbilical vein, portal sinus, and fetal stom: ach when visible, Fetal weight estimation Fetal weight can be estimated from measurements such as the biparietal diameter, head circumference, abdominal circumference or average abdominal diam- eter, and femoral diaphysis length." Results from various prediction models can be subsequently com: pared to fetal weight percentiles from published TE previous studies have been performed, appro priateness of growth should also be documented. Scans for growth evaluation can typically be per formed at least 3 weeks apart. A shorter scan interval may result in confusion as to whether measurement changes are truly due to growth as opposed to varia tions in the technique itsele*°" Currently, even the best fetal weight prediction ‘methods can yield errors as high as +1586." ‘Maternal anatomy Evaluation of the uterus, adnexal structures, and cer- vi should be performed. ‘The presence, location, and size of adnexal masses and the presence of at least the largest and potentially clinically significant leiomyomata should be documen: ted, It is not always possible to image the normal mater: nal ovaries during the second and third trimester. If the cervix appears abnormal (shortened or fan- ricled) or is not adequately visualized during the transabdominal ultrasound examination, a transvagi nal or transperineal scan is recommended when eval uation of the cervix is needed," ™"*57* Ifa referring health provider desires a precise cer vical length measurement, a transvaginal measure: ment of the cervix should be performed. 147-6 J Utrasoune Mec'2018; 9996 1-12 AIUMLACR-ACOG-SMFM-SRU Practice Parameter forthe Perfomance of Standard Diagnostic Obstetric Uirasound Examinations ‘A. midline lower uterine segment contraction may obscure the internal os, giving the false impres- sion of a longer endocervical canal. Excessive manual pressure with the ultrasound transducer may also falsely clongate the cervix. Fetal anatomic survey Fetal anatomy, as described in this document, may be adequately assessed by ultrasound after approximately 18 weeks’ gestational age. It may be possible to docu- ment normal structures before this time, although some structures can be dificult to visualize because of fetal size, position, movement, abdominal sears, and increased matemal abdominal wall thickness." °? A second- or third-trimester scan may pose technical limitations for an anatomic evaluation due to imaging artifacts from acoustic shadowing. When this occurs, the report of the ultrasound examination should doc- tument the nature of this technical limitation. A follow-up examination may be helpful The following areas of assessment represent the minimal elements of a standard examination of fetal anatomy. A more detailed fetal anatomic examination may be necessary if an abnormality or suspected abnormality is found on the standard examination. i. Head, face, and neck: Lateral cerebral ventricles; Choroid plexus; Midline fax; Cavum septi pellucidis Cerebellum; Cisterna magna; and Upper lip. A measurement of the nuchal fold may be helpful during a specific age interval (approximately 16 to 20 weeks’ gestational age) to assess the risk of aneuploidy?” ii Chest: Heart™* Four-chamber view, heart size, and position; Left ventricular outflow tract; Right ventricular outflow tract; and Three-vessel view and 3-vessel trachea view, if technically feasible.*¥$* iii Abdomen: Stomach (presence, size, and situs); Kidneys; Urinary bladder; J utrasound Mes 2018, ‘Umbilical cord insertion site into the fetal abdomen; and ‘Umbilical cord vessel number. iv. Spine: Cervical, thoraci lumbar, and sacral spine. v. Extremities: Presence of legs and arms; and Presence of hands and feet. vi, External genitalia In multiple gestations and when medically indicated. Documentation Adequate documentation is essential for high-quality patient care, There should be a permanent record of the ultrasound examination and its interpretation, Images of all appropriate areas, both normal and abnormal, should be recorded. Variations from nor- mal size should be accompanied by measurements. Images should be labeled with the patient identifica tion, facility identification, examination date, and side (right or let) of the anatomic site imaged. An offical interpretation (final report) of the ultrasound findings should be included in the patient's medical record, Retention of the ultrasound examination should be consistent both with clinical needs and with relevant legal and local health care facility requirements.”® Reporting should be in accordance with the AIUM Practice Parameter for Documentation of an Uttrasound Examination ® Equipment Specifications These studies should be conducted with real-time scanners, using a transabdominal and/or transvaginal approach. A transducer of appropriate frequency should be used. Real-time ultrasound is necessary to confirm the presence of fetal life through observation of cardiac activity and active movement. The choice of transducer frequency is a trade-off between beam penetration and resolution. With mod- em equipment, =3-MHz abdominal transducers allow sufficient penetration in most patients while providing adequate resolution. During early pregnancy, AUM-ACR-ACOG-SMFM-SRU Practice Parameter forthe Performance of Standard Diagnostic Obstetric Uitasound Examinations transvaginal ultrasound may provide superior resol tion while still allowing adequate penetration. Fetal Safety Diagnostic ultrasound studies of the fetus are gener- ally considered safe during pregnancy.!*°”! ‘This diagnostic procedure should be performed only when there isa valid medical indication, and the lowest pos- sible ultrasonic exposure setting should be used to gain the necessary diagnostic information under the ieasonably (ALARA) as low as achievable principle. ‘A thermal index for soft tissue (Is) should be used at before 10 weeks’ gestation, and a thermal index for bone (Tib) should be used at or after 10 weeks’ gesta- tion when bone ossification is evident? In keeping with the ALARA principle, spectral Doppler ultrasound should not be used unless clinically indicated.°"” ‘The promotion, selling, oF leasing of ultrasound equipment for making “keepsake fetal videos" is con: sidered by the US Food and Drug Administration to bbe an unapproved use of a medical device.1°"-! Use of a diagnostic ultrasound system for these purposes, without a physician's order, may be in violation of state laws or regulations. Quality Control and Improvement, Safety, Infection Control, and Patient Education Peles and procedures related to quality control 3t education, infection control, and safety should be developed and implemented in accordance wth the AIUM Standards and Guidelines for the Accreditation of Ultrasound Practices Equipment performance monitoting should be in accordance with the AIUM Standards and Guidelines Jor the Accreditation of Ultrasound Practices. ALARA Principle ‘The potential benefits and risks of each examination should be considered. The ALARA principle should be observed with adjusting controls that affect the acoustic output and by considering transducer dwell times. Further details on ALARA may be found in the AIUM publication Medial Ulrasound Safety, ‘Third Edition, Acknowledgments ‘This parameter was revised by the AIUM in collabo- ration with the ACR, ACOG, the SMFM, and the SRU according to the process described in the AIUM Clinical Standards Committee Manual Collaborative Subcommittee ‘Members represent their societies in the initial and final revision of this practice parameter. ACR. ACOG Marcela MO, cha Oksana H.Batarowich, MD John? MeCahan, MD on “Anthony Siscione, MD “AM si MFM Brann Biomey, Peter Dowie. MD, Wesley Lee, MD Pn Mo Lymn Simpson. MD. RUIhB. Goldstein, MD Joseph Wax, MD AIUM Clinical Standards Committee John Pellerito, MD, chair Bryann Bromley, MD, vice chair Sandra Allison, MD Anil Chauhan, MD Stamatia Destounis, MD Eitan Dickman, MD, RDMS Beth Kline-Fath, MD Joan Mastrobattista, MD ‘Marsha Neumyer, BS, RVT ‘Tatjana Rundek, MD, PhD Khaled Sakhel, MD James Shwayder, MD, JD ‘Ants Toi, MD. J Utrasoune Mec'2018; 9996 1-32 AIUM-ACR-ACOS-SMFM-SRU Practice Parameter ‘othe Performance of Standard Diagnostic Obstetric Utrasound Examinations Joseph Wax, MD Isabelle Wilkins, MD Original copyright 1985; revised 2018, 2013, 2007, 2003, 1996, 1995, 1991, 1990. Renamed 2015. 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