You are on page 1of 196

Reference Manual

for Doctors
on

Family Planning

September 2013

This material has been funded by UK aid from the UK Government,


however the views expressed do not necessarily reflect the UK
Government's official policies.
This document has been prepared by Project Ujjwal. Project Ujjwal is
funded by the UK aid from the UK Government under Contract No.
5926, Improved Family Planning and Reproductive Health Services in
India, beginning January 1, 2013. The project is implemented by a
consortium led by Futures Group International in partnership with
Public Health Foundation of India (PHFI), Hindustan Latex Family
Planning Promotion Trust (HLFPPT), Johns Hopkins University Center
for Communications Program and Oxford Policy Management
(OPM).
For further information, contact:
Futures Group International
DLF Building No. 10 B, 5th Floor, DLF Cyber City,
Phase II, Gurgaon-122 002, Haryana
Tel: +91-124-4702021

Reference Manual for Doctors on Family Planning and Reproductive Health

Reference Manual for Doctors


on Family Planning
Disclaimer
Although every effort has been made to provide correct and latest
information but considering the change due to scientific update, readers to
requested to check before applying or practicing it.

Project Ujjwal, 2013


All rights reserved. However, the module can be reviewed, abstracted and
reproduced, acknowledging the Project Ujjwal but are not for sale or
commercial purposes.

Foreword
The Federation of Obstetric & Gynaecological Societies of India

Model Residency CHS, 605, Bapurao Jagtap Marg, Jacob Circle,


Mahalakshmi (E), Mumbai-400011, INDIA
Tel: +91-22-2302 1648, 2302 1654, 2302 1343 / 32954564 Fax: +91-22-23021383
email: fogsi2007@gmail.com Web: www.fogsi.org

President : Dr. Hema Divakar

Tel: (022) 2302 1648, 2302 1654, 2302 1343, Fax (022) 2302 1383
Mobile: 09900154448 /09845819191
Email: drhemadivakar@gmail.com, presidentfogsi@gmail.com

Dr. Nozer Sheriar

Secretary General
Tel: 022-23620862, 26008740
Mobile: 09821097536
email: nsheriar@gmail.com

It gives me pleasure to note that Project Ujjwal has to published the Reference Manual for
Doctors on Family Planning and Reproductive Health for the private sector doctors under
the project on Reproductive Health Framework with technical support from Federation of
Obstetrics and Gynecological Societies of India (FOGSI).
It is expected that during capacity building exercise of private doctors, the key issues will be
discussed to improve their knowledge and help them to approach clients management in
most scientific way. Although there are plenty of documents available on different methods
of contraception both in Government and private sectors, these documents are special and
different , and are targeted to up gradation of insightful and practical knowledge of social
franchisee doctors who are otherwise a busy practitioners.
FOGSI always committed to support both public and private sectors through continuous
knowledge sharing in diverse field of maternal health though different approach like CMEs,
Distance learning, networking with different partners like PHFI, Jhepigo etc. In 2013 FOGSI
conducted series of CMEs, across the country and support number of initiatives. Our Vision
2022 initiatives under the banner of the ABCDE projects hope to see building of a healthy
generation next, with awareness and empowerment with knowledge of reproductive rights
and choices. Population stabilization, modern contraceptives prevalence, saving the girl child
are some of the major thematic areas where FOGSI is currently engaging their activities.

ii

Reference Manual for Doctors on Family Planning and Reproductive Health

When PHFI approached FOGSI to become their knowledge partner to develop the technical
materials especially for franchisee doctors, FOGSI immediately accepted the proposal. I am
thankful to Dr Saumendra Bagchi and other colleagues of PHFI to give us opportunity to
collaborate for this project. On 18th June, 2013 the eight members of FOGSI colleague across
the country was present in National Expert meet at Delhi to finalize the modules, with FAQs
and practicle problems addressed.
Beside finalization of the manual, the FOGSI commits its support for the project as State
Trainers in Bihar and Odisha, organizing CMEs, Supporting E learning platform, developing
Centre of Excellence in Family Planning etc.
The support from FOGSI Colleagues need special appreciation and FOGSI appreciates the
spirit of HOPE and BRIGHT FUTURE in the name of the project Ujjwal which symbolizes
optimism . On behalf of FOGSI , I am also thankful to other partners of the Project Ujjwal for
their active support in different thematic areas for the project.
Investment in Knowledge pays the best interest Benjamin Franklin
I am thankful to UK AID for supporting the project in Bihar and Odisha.

Best wishes

Dr. Hema Divakar


President, FOGSI

iii

Foreword

It gives me immense pleasure to note that The Public Health Foundation of India (PHFI) has
prepared a reference manual for doctors and their staff for the project Improving Family
Planning and Reproductive Health Services in India. The project will be implemented in the
states of Bihar and Odisha. PHFI, as a consortium project partner with Future Groups and
other organizations, is responsible for capacity building initiatives of franchisee doctors.
This initiative recognises the need for bridging capacity gaps that exist in the provision of
family planning services. The inclusion of private providers in service provision, counselling
and capacity building is intended to supplement and leverage the government resources for
achieving optimal results.
Provision of family planning services is one of the key strategies to reduce maternal
morbidity and mortality from unwanted pregnancies improves birth spacing and prevents
unsafe abortion. Government of India accords family planning services high priority and
encourages States to provide quality services to poor, low parity couple and youth. Recently
the Government of India launched the Reproductive, Maternal, Neonatal and Child Health
programme (RMNCH), where Family planning services have been given priority.
In the states of Bihar and Odisha, there is high unmet need for family planning services with
regard to both spacing and limiting methods. The critical gap in quality family planning
services needs to be addressed through planned and purposeful engagement of nongovernmental service providers. The project will address the involvement of private sector in
social franchisee mode.
As a partner on this important effort, we look forward to focusing on the theme of building
technical capacity of private service providers in the area of family planning and reproductive
health. Efforts will also focus on educating service providers on comprehensive abortion
care, the PC&PNDT Act and postpartum family planning.

iv

Reference Manual for Doctors on Family Planning and Reproductive Health

The capacity building strategy envisaged for the project will create a pool of skilled private
providers, in Odisha and Bihar, to provide efficient services and adherence to the standard
guidelines. The project will also facilitate collaborations with professional associations like
the Federation of Obstetric and Gynaecological Societies of India (FOGSI). I am thankful
to FOGSI for providing technical support for developing the training materials. My special
appreciation is to leading family planning experts from different professional organizations
and other individuals who made significant contribution to finalize the modules.
We are thankful to Futures Group for inviting the Public Health Foundation of India to be a
technical partner in this project. We look forward to their continued support in the capacity
building activities.
I would also like to thank the UK Aid for their support for this project.
I wish all the organisations and individuals engaged in this project success, measured through
both process and outcome indicators.

Prof. K. Srinath Reddy


President, Public Health Foundation of India

Preface

The National Rural Health Mission has intensified delivery of evidence based interventions
to achieve health related Millennium Development Goals. There is increasing recognition of
engaging with vast private service delivery sector and leverage their potential in addressing
unmet needs especially in matters of reproductive health including family planning.
The Improved Family Planning and Reproductive Health Services in India Project was awarded
by UK aid to a consortium partnership to Futures Group (lead partner) with Public Health
Foundation of India (PHFI), HLFPPT, John Hopkins Bloomberg Centre for communication
Programme (JHUCCP) and Oxford Policy management Asia (OPM). Intervention has been
planned to catalyze the private sector to scale-up choice of good quality, affordable FP and
reproductive health (RH) services for poor women in Bihar and Odisha
The present document is developed with the intention of fulfilling knowledge gaps amongst
private providers about recent developments in contraceptive technologies and other
Reproductive health interventions. The Pharmaceutical sector which reaches out to private
sector for detailing drugs also ignores sharing knowledge on newer contraceptives. In
the past, such documents have been developed and Government of India has also been
proactively updating the guidelines from time to time.
Being a consortium partners for the Project, Public Health Foundation of India has been given
specific responsibility for building capacity of the franchisee doctors in Bihar and Odisha. To
do so, PHFI initiated preparing technical guidelines on Family Planning and Safe Abortion
for private doctors. Development of such a technical document is a complex process. One
need to keep in mind information needs of the target group as well as available evidence and
best practices globally while at the same time does not deviate from Government guidelines.
There has to be vetting by the Reproductive Health Professionals as well as programme
managers and development partners. .
Several in house discussions and meetings with experts helped in finalizing the design of
the proposed trainings and what should go in to reference manual, which can be referred by
doctors in their regular practice. As the private doctors under social franchisee network are
supposed to be busy general practitioners in the rural belt of Bihar and Odisha, they may have
very specific questions, myths and misconceptions on different contraceptive methods and
safe abortion. Hence this document stresses on frequently asked questions in each section.
An attempt has been made to keep the language simple and ensure that document is reader
vi

Reference Manual for Doctors on Family Planning and Reproductive Health

friendly. Issues related to gender, rights, quality and equity are adequately emphasized at
appropriate places.
The document which you have in your hand is result of team work, steered by PHFI. FOGSI
is keenly engaged at the different steps in the development of this module and provided
useful suggestions on earlier drafts. FOGSI will be playing a critical role in capacity building
of franchisee doctors through national and state FOGSI members. We are thankful to Dr
Hema Diwakar, President FOGSI and her team of experts and we sincerely acknowledge the
great contribution of FOGSI and will continue our partnership in future.
Similarly we get tremendous support from consortium partners, Shuvi Sharma (Team leader
for RH Framework Project), Dr. Nidhi Chaudhuri and Lalitha Iyer from Futures Group, Dr. PC
Das and Dr. Minal Singh from HLFPPT , for their support and guidance and in preparation of
the module.
We express our sincere thanks to experts like Dr Alok Banerjee- Technical Advisor Parivar
Seva Sansthan, Dr BP Singh, President Enable Health Society, Dr Swasati Das-Senior Advisor
Jhpiego for their critical feedback.
Professor K. Srinath Reddy, President, PHFI is the guiding force for us and he always
encourage colleagues for significant contribution in the field of public health through quality
capacity building activities. Knowledge to action is the PHFI vision and we undertake these
initiatives to fulfill the PHFI vision. We are extremely thankful to Professor Srinath Reddy for
his constant encouragement and guidance.
Dr. Dinesh Agarwal, Senior Consultant for this project with PHFI, organized different chapters
and ensured that information is consistent with national guidelines as well as evidence based.
Finally, without the support of PHFI colleague, it would have been impossible to prepare
the module. My colleague Dr. Dinesh Jagtap and Ms. Nirmala Mishra Senior Programme
Manager, Surabhi Sharma- Junior Consultant, PHFI, actually work beyond human capacity
to make the module technically correct and incorporate so many suggestions from different
experts. It was a great team effort within PHFI to finalize the technical content.
We sincerely hope that, this document would fill the void in this area especially for private
providers and empower them to address unmet RH needs through provision of client
sensitive, need based and quality oriented services.

Dr. S. N. Bagchi
National Capacity Building & Quality Assurence Expert
RH Frame Work Project

vii

Abbreviations and Acronyms


AIDS Acquired Immuno Deficiency Syndrome
ANM

Auxillary Nurse Midwife

ART Antiretroviral Therapy


BP

Blood Pressure

BBT

Basal Body Temperature

BMD

Bone Mineral Density

CC

Cubic Centimetres

CEDAW

Convention on Elimination of All Forms of Discrimination Against Women

CES

Coverage Evaluation Survey

CICs

Combined Injectables Contraceptive

COC

Combined Oral Contraceptive

CPA

Cyproterone Acetate

CuT-220C

Copper Bearing IUDs

CVS

Cardiovascular System

DGO

Diploma in Obstetrics and Gynaecology

DHT

Di-Hydro Testosterone

DMPA

Depot-Medroxyprogesterone Acetate

DVT/PE

Deep Vein Thrombosis/ Pulmonary Embolism

ECP

Emergency contraceptive Pill

EE

Ethyle Estrodione

FAB

Fertility Awareness based Methods

FAM Fertility Awareness Methods


FAQs

Frequently Asked Questions

FC1

Female Condom 1

FC2

Female Condom 2

FOGSI

Federation of Obstetrics and Gynaecological societies of India

FP

Family Planning

FSH Follicle Stimulating Hormone

viii

Reference Manual for Doctors on Family Planning and Reproductive Health

GCC

Genetic Counselling Centre

GL

Genetic Lab

GOI Government of India


HBV

Hepatitis B Virus

HCG

Human Chorionic Gonadotropin

HCV

Hepatitis C Virus

HES

Heta Starch

HIV

Human Immuno Deficiency Virus

HLD

High Level Disinfectants

HPV

Human Papilloma Virus

HVB

Hepatitis B

ICMR

Indian Council of Medical Research

ICPD

International Conference on Population and Development

IMA Indian Medical Association


IPPF

International Planned Parenthood Federation

IUCD

Intrauterine Contraceptive Devices

IUD

Intrauterine Devices

IV

Intra venous

JSK

Jansankhya Sthirata Kosh

LAM

Lactational Amenorrhea Method

LH

Leutenising Hormone

LMP

Last Menstrual Period

MLCu- 375

Copper bearing IUDs

MoHFW

Ministry of Health and Family Welfare

MOU

Memorandum of Understanding

MPA

Medroxyprogesterone Acetate

MTP

Medical Termination of Pregnancy

NET-EN

Norethisterone Enanthate

NFHS-3

National Family Health Survey

NGO

Non Governmental Organization

NRHM

National Rural Health Mission


ix

NSAIDS

Non-steroidal anti-inflammatory drugs

NSSO

National Sample Survey Organization

NSV

Non Scalpel Vasectomy

OC

Oral Contraceptive

OPD Outpatients Department


OT

Operation Theatre

PC-PNDT

Pre-Conception and Pre- Natal Diagnostic Techniques

PGD

Pre- Implantation Genetic Diagnosis

PID

Pelvic Inflammatory Diseases

PLHIV

People Living with HIV

POPs

Progesterone- Only Pills

QAC

Quality Assurance Council

Rh

Rhesus Blood Group

RSS

Research Studies & Standards

SDM Standard Day Method


SOP

Standard Operating Procedures

SRB

Sex Ratio at Birth

STD Sexually Transmitted Disease


STI

Sexually Transmitted Infections

Tcu-380A

Copper bearing IUDs

UN

United Nations Population Fund

UNFPA

United Nations Population Fund

USG Ultrasonography
VTE

Venous Thrombosis

WHO

World Health Organization

Reference Manual for Doctors on Family Planning and Reproductive Health

National Experts
Dr. Hema Divakar, President FOGSI, completed her graduation and post-graduation
from Mumbai & now a leading Obstetrician & Gynecologist in Bengaluru,
Karnataka. She has a keen interest in High Risk Pregnancy Care. She as Technical
Expert contributed in numerous activities and documents of MoHFW, GoI. In FOGSI
she is a National Technical expert for EmOc Programme and also part of several
other task groups.

Dr. Indrani Ganguli Emeritus Consultant Professor GRIPMER. She is Head of


Department & Chairperson, Institute of Obstetrics & Gynaecology, Sir Ganga Ram
Hospital, New Delhi. Dr. Ganguli is Vice President Elect 2014 FOGSI and President
Elect All India NARCHI 2014-16. Colposcopy, Oncology, Endoscopic Surgery,
Geriatric Medicine and high-Risk Pregnancies are of special interest to her.

Dr. Jayam Kannan is a practicing Obstetrician & Gynecologist with more than 25
years of experience with government and private health care set ups. She is a merit
scholarship holder throughout her study and awarded gold medal in her medical
graduation and post-graduation. She has long list of awards and is a recipient of
President award also. Besides this received Life time achievement award by IMA in
2009. Presently she is Chairperson Adolescent Health Committee FOGSI.
Dr. Atul Ganatra is a practicing Obstetrician Gynecologist and Gynecological
Endoscopist. Presently he is Chairperson MTP Committee FOGSI and past VicePresident, Indian Medical Association. He is a Coordinator for Department of
Gynec Endoscopy Fortis Hospitals, Mumbai and Consultant at Fertility & IVF Clinic
Jupiter Hospital Thane, Hira Mongi Navneet Hospital, Mumbai and Guru Nanak
Hospital & Research Centre Mumbai
Dr. Shobha. N. Gudi is a Professor and head of the department of Obstetrics
and Gynaecology at St. Philominas Hospital, Bangalore. She is in teaching and
clinical practice for more than 20 years. She is Consultant at Excel Care hospital,
Bangalore and Manipal group of Hospitals, Bangalore. She has list of publications
in FOGSI Journals. Dr. Gudi has presented several papers at National, Regional
and International conferences.
Dr. Chandravati is a Prof. Emeritus -Department of Obstetrics & Gynaecology,
K.G. Medical College and a leading practitioners. She has published more than
50 papers in national journals and more than 15 papers in international journals.
Read over 40 papers, given many keynote address and orations. Dr. Chandravati
guided nearly 150 thesis. She is recipient of various awards from Central and State
Government for family planning work.
xi

Dr. Basab Mukherjee is a Consultant Gynaecologist & Laparoscopic Surgeon. He


completed his medical degree and post degree from CMC Vellore. He authored
20 chapters & edited numerous books. Dr. Basab has been faculty for 200 plus
workshops and conferences being held at local, National and International levels.

Dr. Parag Biniwale is a practicing Gynaecologists & a Post graduate teacher for
DNB, Pune. He is a National Website Editor, FOGSI (2011-2013). He also holds
the position of chairman, Young Talent Promotion Committee, FOGSI 2008-2010.
Dr. Biniwale as master trainer for Adolescent Friendly Health Services conducted
many workshops for FOGSI, WHO, UNFPA and GoI. He is an editor of book A
Gynaecological manual of adolescent girls & young women and contributed
chapters to FOGSI publications.
Dr. B. P. Singh completed his medical graduation and post- graduation from Uttar
Pradesh. Having over 40 years of experience he worked as clinician and hospital
administrator in Department of Health and Family Welfare, Uttar Pradesh. For more
than 13 years was associated with Engender Health in different capacity. Currently
Dr. B. P. Singh is president of Enable Health Society, an Indian National NGO. Dr. B.
P. Singh is also member of expert group to develop GoI Family Planning Guidelines.
Dr. Alok Banerjee an eminent medical person having more than 35 years
experiences in the field of Reproductive Health particularly on family planning,
abortion, infertility, adolescents sexuality etc. Graduated in Medicine from Calcutta
Medical College followed by post-graduation from AIIMS, New Delhi, he worked at
several organizations namely AIIMS, National Institute of Health & Family Welfare
(NIHFW), USAID etc. He was first in the country to bring NSV procedure. He has
several publications in both national & international journals. Dr. Banerjee serving
as member in various committees of Govt. of India.
Dr. P. C. Das is a medical graduate with more than 42 years of professional
experience. He retired as Deputy Commissioner, MOHFW and provided leadership
in RCH II, NRHM. Authored Protocols and Manuals in the Ministry, developed
curriculum in Health Education for SEARC countries. He was member secretary
for Health Education & IEC for tenth Five Year Plan. Presently, with HLFPPT for
capacity building, quality assurance and medical audit of both public and private
hospitals of the country and ICMR clinical monitor for the Biomedical Research.
Also examiner at IGNOU.
Dr. Dinesh Agarwal is a public health expert. He completed his medical education
from Jaipur, Rajasthan. Served as a faculty starting from junior lecturer to associate
professor at RNT Medical College Udaipur, Rajasthan. He was associated with
UNFPA for more than 15 years and retired as National Programme Officer
(Reproductive Health and HIV/AIDS), UNFPA. He has several publications on Family
Planning.
xii

Contents
Page No.
Chapter 1: Fertility scenario, Unmet Need
and Reproductive Rights

Chapter 2: Quality of Care in Family


Planning, Counselling and role of private
sector

Chapter 3: Reversible Contraceptives

17

Chapter 4: Irreversible Methods

85

Chapter 5: Natural Family Planning


Methods

105

Chapter 6: Termination of Pregnancy

115

Chapter 7: PC - PNDT Act: Salient


Features, Compliance and Protecting
access to Safe Abortion

131

Chapter 8: Accreditation of Private


Providers for Family Planning Services

141

Annexures

147

xiii

xiv

Chapter 1

Fertility Scenario,
Unmet Need and
Reproductive Rights

Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights

Introduction
Voluntary family planning is widely adopted throughout the world. More than half the couples
in developing countries now use a modern contraceptive method for timing, spacing or limiting
birth of children to achieve their reproductive intentions. In fact, few public health measures have
demonstrated such a vast impact on health, saving lives and promoting a healthier population, at
very low cost. A recent report in the medical journal Lancet, presents the most complete countryspecific information about trends between 1990 and 2010, with projections to 2015, in two key
family planning indicators for married or cohabiting women - the use of any contraceptive method
(contraceptive prevalence), and the non-use among women who want to avoid childbearing for at
least two years (unmet need). Worldwide, in the last two decades, contraceptive prevalence increased
from 55 percent to 63 percent, and unmet need decreased from 15 percent to 12 percent, but glaring
disparities between countries still remain. The success is not consistent across countries or even
within countries. It is estimated that in the developing world some 222 million women would like to
space or limit their children but are not using a contraceptive method for a variety of reasons. This
estimate supports the call, at the 2012 London Summit on Family Planning, for a focused effort to
bring contraception to people in countries where its use is still confined to a minority. It is estimated
that demand for family planning will go up by 40 percent as a record number of young people enter
child bearing age.
These two indicators (contraceptive prevalence and unmet need) respond to different agendas
but are complementary. Contraceptive prevalence is the main determinant of fertility; typically, an
increase of 1517 percentage points in prevalence reduces fertility (and thus population growth)
by one birth per woman. The total fertility rate at world level is expected to go down from 2.82 in
1995-2000 to 2.15 by middle of this century. In the past 50 years, most governments in developing
countries have enacted policies to reduce population growth through promotion of family planning
as an integral component of development. However, in contrast to demographic targets for death
reduction, targets for birth reduction have proved controversial because of concerns that couples
might be pressured or even coerced into use of contraception.
By responding to the human rights agenda of reproductive choice, unmet need avoids these
concerns. Unmet need has become a central rationale for donor support and advocacy and a crucial
guide for interventions, culminating in its addition, in 2007 as one of the indicators to monitor
progress in target 5b of the Millennium Development Goals to achieve, by 2015, universal access to
reproductive health.

Countries with high fertility rates also record high unmet need
There is good news on the population front in India as the sharpest decline in population growth rate
was registered in the 2011 census. More recently the Sample Registration Survey(by the Registrar
General of India) has estimated total fertility rate (TFR) as 2.4 (SRS 2011) and it is expected that
replacement level fertility of 2.1 will be achieved by 2017. Clearly, going forward, it will be important
for the family planning programme not only to address unmet contraceptive needs but also focus on
addressing regional/ social and income inequalities in access to contraception.

Reference Manual for Doctors on Family Planning and Reproductive Health

What are Indias population prospects in near future? A technical group constituted by the National
Population Commission has made some projections. It is assumed that TFR would reach replacement
level by 2017. However, different agencies dont have a consensus on the dates. Much would also
depend on how changes in age at marriage and contraceptive use are taking place. Given that India
has biggest ever cohort of young people, population momentum would continue to contribute
nearly 75 percent to total fertility. Additionally, as the recent Global Report Card on Adolescents
2012 states, adolescent girls in developing countries like India are more likely to have sex before
they turn 15, as compared to boys their age. The report also reveals that while three percent boys,
in the 15-19 year age category, had sex before reaching 15, almost eight percent girls in the same
age group had become sexually intimate. Although the fertility rate is declining, a large youth base
entering reproductive age is expected to lead to a substantive increase in population. Clearly the
solution lies in providing contraceptive options to this young population that are ideal for this age
group.
Changing age structure also has implications as how the family planning programme needs to
respond to the rising population of adolescents and young people. Although mean age at marriage
is going up, couples would need services to delay the first conception, and subsequently space
pregnancies. Obviously then, the programme would require a renewed focus on expanding spacing
contraceptive choices in a big way. In India, only 41.2 percent of second and high order births had a
birth interval of more than 36 months.

Unmet Need
Women with unmet need are those who are fecund and sexually active but are not using any method
of contraception, and report not wanting any more children or wanting to delay the birth of their
next child.
In India, an estimated 26 million women who want to delay or avoid pregnancy cannot exercise this
basic right because they lack access to modern contraceptive services. These couples may also cite
side effects of contraceptives, infrequent sex, fear of partner disapproval and religious beliefs as
reasons for not using contraceptives. Moreover, this results in thousands grappling with unintended
pregnancies and unsafe abortions. Over 60,000 women die due to pregnancy and childbirth
complications every year in the country. With access to quality reproductive health services and
supplies still remaining a privilege for many, the poorest and most vulnerable women are often left
on the fringes of accessibility.
Access to quality family planning services may be compromised for many reasons. In remote and
inaccessible areas, infrastructure for service delivery may be weak or contraceptive supplies could be
lacking at times. In certain cases, skilled providers are not available. In rural areas, especially where
health services are at a distance, conditional cash transfer schemes have helped to draw many more
women and their families for safe deliveries at institutions. Increasing footfalls to health centres
would be more beneficial if there is access to counseling in order to help women make informed
choices on the method of contraception during the postpartum (after delivery) period. Dispelling
myths and misconceptions about family planning methods would encourage individuals and couples
to opt for appropriate choices. India has a unique interface between the public health system and the

Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights

community, with every village having Accredited Social Health Activists, popularly known as ASHAs
who are trained to provide information on available contraceptive methods.
Alongside, prospects for scaling up social marketing and social franchising of existing programmes
must be explored. In addition, non-state actors should be brought into the fold through publicprivate-partnerships and increased corporate social responsibility.
For countries like India, universal access to quality family planning is a critical component for
development and the expected returns far outweigh the costs incurred. Providing contraceptive
information and services as part of sexual and reproductive health would lower maternal deaths by
a third. Research reveals that when a woman has access to voluntary family planning, she tends to
have fewer and healthier children and invests more in their health and education, and helps break
the vicious cycle of poverty.

Contraceptive Use
International Conference on Population and Development (ICPD), (1994) recognized that appropriate
methods for couples and individuals vary according to their age, parity, family size preference and
other factors, and thus the programme should ensure that both women and men have access to
information and effective family planning methods in order to exercise free and informed choice.
Current Use of Family Planning Methods in India
Male
Sterlization
1%

Pill
4% IUD 2%

Condom 6%
Any Traditional Method
7%

Female
Sterlization
34%
Non user 46%

(Source: DLHS-3 2007-08)

Reference Manual for Doctors on Family Planning and Reproductive Health

Indias programme is largely dominated by female sterilization. Mean age of sterilization among
women is around 25 years. Choices for spacing methods are very few. No new spacing method
has been included in the programme for the last 10 years, although injectables/vaginal rings are
available in the private sector.
Often newly married couples wish to delay pregnancy and subsequently opt for spacing between
births. It is more than obvious that young couples are not ideal candidates for sterilization services
because of its irreversible nature. With patriarchy being entrenched in the social fabric of the country,
male participation by accepting responsibility for contraception is abysmally low. Only one percent
males in India opt for sterilization as opposed to 37.3 percent females. In light of the fact that female
sterilization continues to be a predominant method of contraception in India, it is important to
promote the use of reversible methods such as oral pills, condoms and intrauterine devices (IUDs).
Additionally there is also a need to expand on the available contraceptive choices. For instance,
in Bangladesh, a major decline in fertility levels have been achieved by largely promoting spacing
methods and expanding the basket of contraceptive choices by including hormonal contraceptives
such as injectables and implants.
Substantial evidence indicates that a restricted choice of contraceptive methods has constrained
couples from using the method that best suits their needs, resulting in a lower level of contraceptive
prevalence and high unmet need. Freedom to choose from range of methods according to ones
need and preferences rests on the availability of methods.

Family Planning within Reproductive Rights Framework


Access to quality family planning is a non-negotiable human right. Governments that have ratified
international human rights agreements, have an obligation to honour their commitments in this
regard.
In the Programme of Action endorsed by almost 180 countries at the International Conference on
Population and Development in 1994 at Cairo, Governments resolved:
The principle of informed free choice is essential to the long-term success of family-planning
programmes. Any form of coercion has no part to play. In every society there are many social
and economic incentives and disincentives that affect individual decisions about child-bearing
and family size. Governmental goals for family planning should be defined in terms of unmet
needs for information and services and method specific targets should not be imposed...

Gender Issues in Family Planning


Gender refers to those characteristics of men and women that are socially and culturally determined.
These characteristics differ in different places and in every society they change over time. Gender is
relational and is often unequal and hierarchical.
The gender barriers in use of family planning services need to be addressed. Many women do not
have the autonomy to decide on the number of children they have, and when. They also do not have
any say in sexual relations and find it difficult to negotiate the use of contraceptives. Programmes
5

Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights

have perpetuated gendered stereotypes by promoting female sterilization and it is women who are
expected to shoulder the maximum burden of contraception. Lack of access to money also acts as
a barrier for accepting family planning methods. A providers judgmental attitude also places huge
barriers to access to contraceptive services.
High unwanted need for contraception indicates that many women either wish to space or do not
want to have more children, but are unable to use any family planning method. Women are less likely
to be informed about contraceptive methods and their sources of availability; they may fear spousal
or some other family members resistance to the contraceptive use. Additionally service providers
may not offer a full range of quality services such as IUD insertions under aseptic conditions which
may also create problems. Follow up protocols may not be adhered to in full and modalities for
management of complications may be missing. The absence of quality services could result in high
contraceptive morbidity.
In the context of family planning, as providers, we must always address the vulnerability of women
being burdened with unwanted pregnancies, their degree of autonomy for decision making and their
resources for seeking services as well as access to quality services.

Equity in Contraceptive use


Globally, many sexually active young people who want to avoid pregnancy are not using modern
family planning methods for various reasons, including a lack of access to services or disapproval by
health providers. A significant portion of unmet need is indicated by the high levels of abortion among
young women, as reported in surveys and inferred from hospitalizations after unsafe abortions, as
well as by estimates of out-of-wedlock pregnancies and young womens reports to interviewers
that their first or second births took place earlier than they desired (UNFPA, 2003).In most societies,
childbearing after marriage is expected and nearly universal and most newly married young people
want to begin childbearing soon after marriage.
Findings from the National Family Health Survey (NFHS) 3 suggest that the fertility rate in age group
of 15-19 years contributes to 17 percent of TFR. The Contraceptive Prevalence Rate amongst married
adolescents is very low at 13 percent. Contraceptive use increases with the education and wealth
indexes.
Data across three NFHS indicate no substantial change for unplanned births. Findings suggest that
young married are unable to access contraceptive options because there are strong social norms
around early child bearing which discourages contraceptive use soon after marriage.
There are marginalized population groups such as Sex workers and People Living with HIV (PLHIV) /
Antiretroviral Therapy (ART) users who also have high unmet need for contraceptives. Several studies
amongst sex workers indicate the need for effective method for dual protection. The Indian Network
of Sex Workers has been actively seeking the integration of reproductive health (RH) services within
the framework of targeted interventions being offered under the National AIDS Control Programme.
The Table below presents results from large scale coverage evaluation survey regarding contraceptive
use, both for any method and for modern methods, as per some demographic characteristics.

Reference Manual for Doctors on Family Planning and Reproductive Health

Coverage Evaluation Survey Report 2009 (CES 2009)


Background Characteristics

Any Method (%)

Any Modern Method (%)

Scheduled Castes

55.0

49.0

Scheduled Tribes

47.4

42.0

Other Backward Classes

53.3

47.5

Others

61.0

52.3

Lowest Wealth Index

40.1

34.0

Second Wealth Index

46.9

40.7

Middle Wealth Index

54.5

48.4

Fourth Wealth Index

59.2

52.8

Highest Wealth Index

64.0

56.4

India (15-49)

54.8

48.2

India (15-44)

54.0

47.1

Clearly one notices low contraceptive use in poor income quintiles and disadvantaged social groups.

Sexual and Reproductive Rights


What are Reproductive Rights?
Attaining the goals of sustainable, equitable development requires that individuals are able to
exercise control over their sexual and reproductive lives. This includes the rights to:
yy Reproductive and sexual health as a component of overall health, throughout the life cycle, for
both men and women.
yy Reproductive decision-making, including voluntary choice in marriage, family formation and
determination of the number, timing and spacing of ones children and the right to have access
to the information and means needed to exercise voluntary choice.
yy Equality and equity for men and women, to enable individuals to make free and informed
choices in all spheres of life, free from discrimination based on gender.
yy Sexual and reproductive security, including freedom from sexual violence and coercion, and the
right to privacy.

Protecting Reproductive Rights


During the 1990s a series of important United Nations conferences emphasized that the well-being
of individuals and respect for their human rights should be central to all development strategies.
Particular emphasis was given to reproductive rights as a cornerstone of development, and to
empowerment of women as being an important element in ensuring the exercise of these rights.
All major human rights treaties and consensus statements obligate countries to protect and
promote rights that relate to reproductive health. Of all human rights documents, the Convention
7

Chapter 1: Fertility Scenario, Unmet Need and Reproductive Rights

on Elimination of All Forms of Discrimination Against Women (CEDAW), a treaty binding on 165
countries, provides the strongest legal support for the right to reproductive health per se. In Article
12, CEDAW guarantees non-discrimination in access to health care, including affordable services and
information related to family planning, pregnancy, and the post-natal period.
The statements issued after the 1994 International Conference on Population and Development
(Cairo) Programme and the 1995 World Conference on Women (Beijing) are consensus statements
that confirm the centrality of reproductive rights in advancing the health of populations and the
status of women. Beijing, in particular, recognizes womens right to control their own sexuality and
sexual relations and to decide upon these matters on an equal basis.
Similarly, the International Planned Parenthood Federation (IPPF), Charter on Sexual and Reproductive
Rights is based on twelve rights that are grounded in core international human rights instruments
and additional rights that IPPF believes are implied by them. The Standards section draws heavily
on documents that won international consensus at four key UN conferences, which took place
between 1993 and 1995, namely the UN World Conference on Human Rights (Vienna, 1993); the
UN International Conference on Population and Development (Cairo, 1994); the UN World Summit
for Social Development (Copenhagen, 1995); and the UN Fourth World Conference on Women
(Beijing, 1995). The Charter represents IPPFs response to the challenge of interpreting human rights
language and applying it to sexual and reproductive health care issues. The classification of specific
issues under certain rights represents IPPFs judgment of where each issue should best appear; the
listing of any issue under any specific right does not preclude action being taken on that issue under
another right.
Over the years, there has been significant progress in increasing contraceptive use in India and this
is also reflected in the reduction of growth rates. However,gross inequities in use persist. Spacing
methods use is abysmally low. There are serious concerns on quality of care and limited method
choice. Providers need to be cognizant of these challenges in the programme and ensure that women
and couples achieve their reproductive goals without any fear and coercion.

Reference Manual for Doctors on Family Planning and Reproductive Health

Chapter 2

Quality of Care in
Family Planning,
Counseling and Role
of Private Sector

Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector

Overview
Growing use of contraception around the world has given couples the ability to choose the number
and spacing of their children and has tremendous life saving benefits. Despite this, unmet need for
contraception remains high, especially amongst the poorest people and those in rural areas.
Family Planning is considered a best buy among health investments, being one of the most cost
effective and high yield interventions that exist today. Family Planning could prevent many more
deaths, especially amongst the poor, if we are able to reduce unmet need. In following paragraphs is
a listing of the major benefits of family planning.

Saves womens lives


Nearly one third of maternal deaths could be prevented by delaying, spacing and avoiding unwanted
pregnancies and abortions to stop childbearing when the desired family size is achieved. Many
pregnancies are unintended and mistimed, and the risk of death associated with such events is high.
Health risks associated with close births are high in mothers below 18 years or older than 35 years.
Also women with more than five children are 1.5 to 3 times more likely to die from complications
during child birth. Women with more than three children are more likely to suffer from anaemia,
require blood transfusion and die of bleeding than women three or less children.

Saves children lives


Family planning helps women to space children thereby reducing newborn, infant and child deaths
significantly. About one third of all infant deaths occur because mothers had births too close or were
too young. Family planning helps women to delay pregnancy,and with spacing, more children are
likely to survive during infancy and are healthier.

Saves adolescents lives


Pregnancy amongst adolescents leads to health risks not only for babies but also young mothers,
particularly those under 18. Family planning can help them avoid social and economic consequences
of early child bearing. If girls get pregnant between the ages of 10 to 14 years they are five times
more likely to die of pregnancy related causes than women aged 20 to 25 years. Many unmarried
girls run the risk of pregnancy if they are sexually active. Providing contraception to them would save
lives. In addition, delaying pregnancy would allow them to complete their education and prepare to
join the workforce.

Reduces deaths from HIV/AIDS


Consistent and correct use of condoms can reduce the rate of new cases HIV infection. Additionally, by
averting unintended and high risk pregnancies, family planning reduces mother to child transmission
of HIV thus reducing the number of AIDS-affected babies whose life chances are seriously diminished.

10

Reference Manual for Doctors on Family Planning and Reproductive Health

Ensure environment sustainability


In many places, population growth strains natural resources and leads to water shortages, deforestation,
and animal extinction. Smaller families preserve essential resources which eases pressure on the
environment. Climate change discourses are also including discussions on addressing unmet need
as a strategy to reduce carbon footprints.
Millions of couples wish to plan their families but lack access to contraception. With smaller families,
parents can afford more for each childproviding better food, shelter, education, and health care.
Ultimately, this raises savings, boosts productivity, and leads to economic growth.

The Health Benefits of Family Planning


Family Planning has numerous health benefits for women, their sexual partners,
and their children. Family planning helps to:
Prevent unintended pregnancies and the number of unsafe abortions, thereby reducing:
yy Maternal deaths and disabilities
yy Infertility
Preventing high-risk pregnancies among:
yy Adolescents under age 18
yy Women over age 35
yy Women who have had many births or births spaced too closely together
yy Women with HIV/AIDS and other health conditions such as malaria and tuberculosis
Space births, resulting in:
yy Lower rates of newborn, infant, and child mortality
yy More time to breast feed, improving infant health
yy More time for women to recover physically and nutritionally between births
Adapted from: Susheela Singh et al., Adding it up. The Benefits of investing in Sexual and Reproductive Health Care (New York:
Guttmacher Institute and UNFPA, 2003):24

11

Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector

Quality of Care in Family Planning


Mere provision of contraceptive services is not enough to reduce unmet needs. Contraceptive
services should be of good quality. Indias family planning programme in the past was driven by
method specific targets by health workers with little focus on quality of care. Quality is also a rights
issue. The following element needs to be considered in organizing the quality of family planning
services.
Additional method choices:
If a provider provides access to wide range of contraceptive methods, this would increase usage by
yy Attracting new users
yy Attracting past users
yy Facilitating method switching
yy Reducing dropout rates.
Depending on many factors a client may prefer different contraceptive methods during the course of
her reproductive lifespan. Hence, to address unmet need more effectively, a basket of choices should
be offered.
Providers skills and behaviour are critical:
yy A provider should have the necessary clinical competence to offer particular methods to clients
as per the national protocols and standards.
yy A provider should be oriented on client-related issues which include initiation, use and
satisfaction.
yy A provider should not be judgmental and should allow,encourage or empower clients to make
own choices.
It is important to reduce dropout rates:
yy These are high now. Both at programme level and individual level this has been recognized as a
major challenge
yy It is important to focus on reduction in dropout rates as this increases efficiency, increases
contraceptive prevalence, reduces unintentional pregnancies and improves client satisfaction
yy It would be useful to improve the quality of client-provider interaction during contraceptive
provision so that the client can understand the specific issues relating to each method
yy A provider may need to counsel clients about long acting permanent methods (IUDs, Implants,
Sterilization).

12

Reference Manual for Doctors on Family Planning and Reproductive Health

Improved quality of client-provider intervention can take place in the following manner:
yy Help client in selecting the method appropriate to the desired reproductive intervention, i.e.
delay and spacing or stopping.
yy Provide information to client on potential side effects of method and how to manage these.
yy Focus should be on the client rather than the methods, hence changing the method and supply
source if necessary is highly encouraged.
Quality contraceptive supplies are available:
yy Providers should either provide these supplies or provide information about sources of quality
contraceptive commodities.
yy Providers should also provide information on alternate sources of supplies in case the client
runs out of supplies.

Counseling in Family Planning


Why counseling?
A study in Egypt showed that client-centered counselling added only one minute to a consultation.
Clients are three times more likely to be satisfied and continue to use the method.
Key steps in family planning counselling:
yy Rapport building
yy Exploration
yy Decision making
yy Implementing the decision
In rapport building, there are four critical components:
yy Greet clients with respect
yy Make introductions
yy Assure confidentiality & privacy (visual and auditory)
yy Explain need to discuss sensitive and personal issues.
It is quite possible that many providers must be already doing these steps in their clinical settings.
However, it would be useful to take stock of possible challenges in following these steps.
Exploration: (New clients in OPD practice)
yy Explore in-depth clients reasons to visit
yy Probe reproductive health related plans, current situation and past experiences with
contraceptive use .
13

Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector

yy Discuss clients preferred method, if any or relevant options, provide complete information
as may be required, dispel myths and misconceptions.
yy Rule out pregnancy and explore factors related to menstrual bleeding, medical conditions
and any recent pregnancy/abortions.
Exploration: (Return clients)
yy Is client satisfied with methods? Any problems with the method?
yy Correct use of method.
yy Ask about reproductive intentions.
yy Explore reasons for dissatisfaction with accepted methods and possible options (Only for
dissatisfied clients).
Decision making
yy Identify decisions clients need to make.
yy Explore relevant options.
yy Help clients weigh benefits, disadvantages and consequences of each option.
yy Help client determine individual risks for sexually transmitted infections (STIs)/HIV
yy Encourage client to make his or her own decision
Implement decision making
yy Assist client in making a concrete and specific plan for carrying out decision.
yy Assist clients in developing skills to use his/her chosen method.
yy Identify any barrier in implementing the plan.
yy Develop strategies to overcome barriers.
yy Sources of supplies.
yy Make a plan for follow-up and for providers referrals.
Tips for Successful Counselling
yy Show every client respect, and help each client feel at ease.
yy Encourage the client to explain needs, express concerns, ask questions. There is no need to
rush during counselling.
yy Let the wishes and needs of the client guide the discussion.
yy Be alert to related needs such as protection from sexually transmitted infections including HIV,
and support for condom use.
yy Listen carefully. Listening is as important as giving correct information.

14

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Give just key information and instructions. Use the words the client knows.
yy Respect and support the clients informed decisions.
yy Bring up side effects, if any, and take the clients concerns seriously.
yy Check that the client understands about method and its use.
yy Invite the client to come back any time for any reason.
Counselling has succeeded when:
yy Clients feel they got the help they wanted.
yy Clients know what to do and feel confident that they can do it.
yy Clients feel respected and appreciated.
yy Clients come back when they need to do so.
yy And, most important, clients use their methods effectively and with satisfaction.
Role of Private Sector
In India the private sector dominates healthcare provision. Additionally, social marketing also
services a large number of clients with non-clinical contraceptive methods. Considering that there
is a huge network of private sector providers, there is scope to optimally engage the private sector
in provision of family planning services in a systemic manner. Leveraging the vast number of private
practitioners to provide family planning information, counselling and services is very much needed.
The Government of India scheme for public-private partnership and the proposed universal healthcare
coverage provides opportunities for enhancing this engagement.

15

Chapter 2: Quality of Care in Family Planning, Counseling and Role of Private Sector

Demand for Family Planning is going to increase in future:


yy It is estimated that the number of women in the reproductive age group (15-49
years) would increase by 10 percent by 2015 and another 8 percent by 2025, due to
population momentum.
yy Contraceptive needs are expected to rise as an increasing number of women want
to have smaller families.
yy Historically trends show that educated, urban and financially better off women have
begun to want smaller families and therefore need contraceptives earlier then their
less educated and poor peers. As education levels improve and media exposure
increases this would further boost demand for contraception.
yy Young people want to either delay or space the birth of children and hence
reversible methods are preferred compared to permanent methods. Hence there
would be more contacts with providers and method switching and replenishment of
supplies
As a private health care provider you can also add the provision of contraceptive services
to the other services which you offer.

16

Chapter 3

Reversible
Contraceptives
Barrier Methods
Intrauterine Devices (IUD)
Hormonal Methods
Combined Vaginal Rings

17

Chapter 3: Reversible Contraceptives

3.1. Barrier Methods


A variety of barrier methods suitable for both males and females are available. The aim of these
methods is to prevent live sperm from meeting the ovum.

3.1.1. Male Condoms


Male Condom is a sheath made to fit over a mans erect penis. Most condoms are made of latex
rubber and some are coated with a lubricant or spermicide. Condoms may be available in different
size, shapes, colours and textures.
Male Condoms are the most widely known and used barrier device by males all around the world.

How to use
1. Man should put the condom on the erect penis before penis touches the vagina:

Hold the pack at its edge and open by tearing from a ribbed edge.

Hold the condom so that the rolled rim is facing up, away from penis.

Place the condom on the tip of penis.

Unroll the condom all the way to the base of the penis. The condom should unroll easily. If
it does not, it is probably backwards. If more condoms are available, throw this one away
and use a new condom.

2. Most of the condoms are already lubricated; hence there is no need to apply any additional
lubricant. This may damage the condom.
3. Now they can have sexual intercourse.
4. After the sexual intercourse (ejaculation), hold the rim of the condom to the base of the penis
so it will not slip. The man should pull his penis out of the vagina before completely losing his
erection.
5. Move away from vagina and take off the condom without spilling semen on the vaginal
opening.
6. Tie a knot at the rim of the condom. A female condom should not be flushed. It can be
wrapped in paper and can go as household waste. Do not leave it where children will find it. Do
not use a male condom more than once.

18

Reference Manual for Doctors on Family Planning and Reproductive Health

Medical Eligibility for Male Condom Use


All men can safely use male condoms except those with severe allergic reaction to latex rubber.

Advantages of Using Male Condoms


yy Effective in preventing pregnancy: With typical use 14 pregnancies per 100 women in the first
year of use. With correct and consistent use every time, 3 pregnancies per 100 women in the
first year of use.
yy Male condoms can prevent sexual transmission of many diseases including HIV/AIDS,
Gonorrhoea, syphilis, Chlamydia and Trichomoniasis.
yy Can be used soon after childbirth.
yy No hormonal side effects.
yy Help prevent ectopic pregnancies.
yy No delay in returning to fertility after use of condoms is stopped.
yy Offer occasional contraception with no daily upkeep.
yy Easy to keep at hand in case sex occurs unexpectedly.
yy Can be used by men of any age.
yy Can be used without seeing a healthcare provider first.
yy Usually easy to obtain and sold at most places.
yy Enables a man to take responsibility for preventing pregnancy and disease.
yy Increased sexual enjoyment because no need to worry about pregnancy.
yy Often help to prevent premature ejaculation.

Limitations
yy Condoms probably protect somewhat, but not as well, against herpes, genital wart virus (HPV),
and other diseases that can cause sores on skin not covered by condoms.
yy Latex condoms may cause itching for a few people who are allergic to latex. Also, some people
may be allergic to the lubricant on some brands of condoms.
yy Couple must take the time to put the condom on the erect penis before sex.
yy Small possibility that condom might slip off or break during sexual intercourse.
yy If not properly stored or if used with oil based lubricants the condoms can become weak and
break.
yy When the female partner is using Miconazole or Econazole (for treatment of vaginal infections)
damage can be caused to the latex.
19

Chapter 3: Reversible Contraceptives

Side Effects
None

Managing Any Problem


If the condom breaks:
yy Washing both, penis and vagina with soap and water should reduce the risk of STIs and
pregnancy.
yy Best way would be to use emergency oral contraception to prevent pregnancy.
Condom or lubricant causes itching or rash on genitals
Suggest using water as lubricant. If itching continues, clients (both partners should be assessed for
infection). If there is no infection and allergy to latex seems likely, help the client choose another
method of contraception unless client is at risk of STIs.
Man cannot maintain an erection while putting on or using a condom
Discuss how to make condom use more enjoyable and less embarrassing. If the woman puts the
condom on for the man, this may make use more enjoyable. Explain that, with experience, more
couples are less embarrassed. Condoms are being positioned also as a sex pleasure enhancement
device.
Suggest a small amount of water or water based lubricant on the penis and extra lubricant on the
outside. This may increase sensation and help maintain erection.

Counselling
It is critical to counsel clients about condom use so that there is correct and consistent use. Use
of condom by male partner also promotes male involvement in reproductive health from gender
perspective as there is sharing of the contraceptive burden. Clients should be also counseled as what
needs to be done in the event of slippages/ breakage and alternative sources of supply in case the
regular sources run out.

Availability of Condom
Male condoms are being provided through a free distribution scheme and social marketing. In
addition, condoms are commercially sold by manufacturing companies under their brand names.

20

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked questions regarding Male Condoms


1. How effective are male condoms in preventing HIV?

On an average, male condoms are 80 to 95 percent effective in preventing HIV, when used correctly with
every act of sex.

2. Will using condoms reduce the risk of STI transmission during anal sex?

Yes. STIs can be passed from one person to another during anal sex act that inserts the penis into any part
of another persons body. Some sex acts are riskier than others. When using a latex condom for anal sex, a
water or silicone based lubricant is essential to help keep the condom from breaking.

3. Do condoms often break or slip off during sex? What can men and women do to reduce
this?

On an average, about two percent of condoms break or slip off completely during sex, primarily because
they were used incorrectly. Used properly, condoms seldom break.

If a condom slips or breaks, taking emergency contraceptive pills can reduce the risk that a woman will
become pregnant. However, it doesnt protect one from STIs, including HIV.

4. Can a man put two to three condoms on at once for more protection?

There is little evidence about the benefits of using two or more condoms. It is generally not recommended
because of concerns that friction between condoms could increase the chance of breakage.

5. Arent condoms used mainly in casual relationships or by people who have sex for money?

No. while many casual partners rely on condoms for STI protection, married couples all over the world use
condoms for pregnancy protection. In Japan, 42 percent of married couples use condoms- more than any
other family planning methods.

6. How to take care of male condoms?


Tips for caring for condoms:

Store condoms in cool, dark place, if possible. Excessive heat, light and humidity damage condoms.

Use lubricated, well packed condoms. Lubrication helps prevent tears. Handle condoms carefully.
Fingernail and rings can damage condoms. Do not unroll condom before use. This may weaken
them. Also, an unrolled condom is difficult to put on.

Do not use the condom if:

The packet is torn or damaged.

It is beyond expiry date or more than five years from the date of manufacture.

If it is uneven or has changed colour.

If it feels brittle, dried out or very sticky.

7. Can male condoms be re-used?


No. Male condoms should not be re-used.

21

Chapter 3: Reversible Contraceptives

3.1.2. Female Condoms


Female condom is a condom made of a soft, thin material that fits inside a womans vagina. Like the
male condom, the female condom is a barrier method, keeping the penis and sperm from contact
with the cervix and vagina.
The first generation female condom (FC1) was made from polyurethane- a thin, odourless material
that is hypoallergenic, stronger than natural rubber latex, and conducts heat.
The FC1 was launched in 1992 but it is no longer manufactured and has been replaced by a secondgeneration product, the FC2. The FC2 is made of nitrile rubber- a synthetic type of latex- and can be
used with any type of lubricant, including oil, silicone or water based products. The newer latex based
female condoms are also available commercially.

Mechanism of Action
The female condom can be inserted into the vagina prior to sexual intercourse, is not dependent on
the male erection and can remain in place after ejaculation. It has two flexible rings, an inner ring
at the closed end, used to insert the device inside the vagina and hold it in place, and an outer ring
which remains outside the vagina and covers the external genitalia. Before sex, the woman places the
closed end of the female condom high in her vagina. The closed end contains a flexible, removable
ring to help with insertion. A large flexible ring around the open end of the condom stays outside
covering external genitalia.

Medical Eligibility for Female Condom Use


Women who are allergic to latex are recommended to not use latex female condoms

Advantages of Female Condoms


yy Pregnancy rate is 21 percent if it is used in a less than correct and consistent manner, but if
used correctly and consistently about there is a five percent pregnancy rate.
yy Female controlled.
yy No medical condition appears to limit use.
yy More comfortable to men, less decrease in sensation than male latex condoms. As a result,
sensitivity of male partner may not be substantially reduced. It also offers ease of use by men
with erectile dysfunction.
yy Offer greater protection as it covers both internal and external genitalia.
yy Stronger (polyurethane is 40 percent more stronger than latex) therefore less frequent
breakage (1 percent compared to 4 percent for male condoms).
yy Longer shelf-life even under unfavourable storage conditions.

22

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Sex Workers found that female condom allowed them to continue their job without interruption
during menstruation.

Limitations of Female Condoms


yy Not aesthetically pleasing. The coverage of the female external genitalia had a decidedly
negative impact on the devices aesthetics and acceptance.
yy Difficulties in insertion and removal. Some participants noted difficulties associated with
insertion and removal of the female condom during initial period, discomfort, messiness and
inconvenience associated with use and movement of device during use.
yy A little more expensive than male condoms although with latex condoms prices may come
down further.

Counselling
The user must be counseled whenever the she wants. This should be done in the following steps.
Ensure that the client understands the correct use. Ask the client to explain the basic steps of using
the female condom while handling one. If a model is available, the client can practice inserting the
condom in the model and then taking it out.
yy Ask the client how many condoms she thinks will need until she can return. Assist with
information on availability of female condoms in the market.
yy Explain why using a new condom with every act of sex is important.
yy Explain about emergency contraceptive pills (ECPs). Explain ECP use in case of errors in
condom use- including not using a condom to help prevent pregnancy.
yy Discuss techniques and skills for negotiating condom use with partners.

Tips for New Users


yy Suggest to a new user that she practice putting in and taking out the condom before she next
has sex. Reassure her that correct usage becomes easier with practice. A woman may need to
use the female condom several times before she is comfortable with it.
yy Suggest she try different positions to see which way insertion is easiest for her.
yy The female condom is slippery. Some women find insertion easier if they put it in slowly,
especially the first few times.
yy If the client is switching from another method to the female condom, suggest she continues
with the previous method until she can use the female condom with confidence.

Reasons to Return
yy Assure every user that she is welcome to come back any time she has problems, questions

23

Chapter 3: Reversible Contraceptives

or wants another method; has any major change in health status or she thinks she might be
pregnant.
yy If she has difficulty using female condoms correctly.

Managing Any Problem


Penis does not enter the female condom, but slips between the sheath and the vagina wall
yy Man should withdraw penis and start over again with same female condom.
yy Add lubrication.
yy Woman or her partner can hold the outer ring.
yy Woman can hold her partners penis and guide it into the condom.
Outer ring slips inside the vagina or the condom is pushed into the vagina
If this occurs during sexual intercourse, STOP! And insert a new female condom.
Inner ring discomfort
Remove female condom and reinsert to position differently.
Condom riding out with penis
Use more lubrication inside the female condom or directly on the penis. If the female condom comes
out during sex, insert a new condom.
Condom slips out of hand during insertion
Remove excess lubrication.
Suspected pregnancy
Assess for pregnancy. A woman can safely use condoms during pregnancy for continued STI
protection.

24

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked questions regarding Female Condoms


1. Can female condoms prevent HIV?

Female condom is made of nitrile, a synthetic rubber, and has been tested to show that the HIV organism
cannot pass through it.

2. Should female and male condoms be used at the same time for double protection?

Female and male condoms should never be worn at the same time. Using both at the same time can cause
tearing or slipping in either condom.

3. Arent female condoms for sex workers and casual sex, and not married and long-term
partners?

Female condoms can prevent unintended pregnancy and HIV in marriages and long-term relationships.

4. Can female condoms only be used in one sexual position with the man on top and the
woman on the bottom?

They can be used in different sexual positions as long as it is inserted correctly and the outer ring remains
outside the vagina.

5. Are female condoms too big and baggy?


Female condoms are about the same length as the male condom but wider so they fit the inside of the
vagina more comfortably. Some men prefer the looseness of the female condom to the snugness of the
male condom.

6. Women will not be comfortable touching their vaginas in order to insert the female
condom?

People used to say the same thing when tampons were first introduced, but over time and with practice
these perceptions changed.

7. Do condoms reduce spontaneity?


Female condoms can be inserted some time before sexual intercourse so that sex can be spontaneous and
pleasurable.

8. Female condoms will get lost in the vagina or uterus?


The vagina is a small closed pouch and the female condom cannot get lost in it. The opening to the cervix
is far too small to allow a condom to pass through.

9. Can female condom be re-used?


No. It is not recommended to re-use male or female condoms.

10. Difficulty in persuading partner to use female condoms or not able to use a condom every
time?

Discuss ways to talk with her partner about the importance of condom use for protection from pregnancy
and STIs.

11. How to dispose female condom?


Female condom should not be flushed. It can be wrapped in paper and can go as household waste.

25

Chapter 3: Reversible Contraceptives

3.2. Intrauterine Devices (IUD)


Intrauterine contraceptive devices (IUDs or IUCDs) are small, flexible plastic devices that are inserted
into the womans uterus. The most common IUDs contain copper, and they work primarily by causing
a chemical change that damages sperm and egg before they can meet. Depending on the type, IUDs
can provide protection for 5 to 12 years.
Types of IUDs
The different types of IUD now available are:
I.

Copper-bearing IUDs: Made of plastic with copper sleeves and/or copper wire on the plastic,
such as TCu-380A, MLCu-375.

II. Hormone-releasing IUDs: Made of plastic, steadily released small amounts of hormone
progesterone or progestins such as levonorgestrol,

3.2.1 Copper-bearing IUD


Mechanism of Action of Copper-bearing IUDs
It works mainly by preventing the sperm and egg from meeting. The IUD makes it hard for sperm to
move through the womans reproductive tract, which reduces the ability of sperm to fertilize an egg,
or it prevents the egg from implanting in the wall of the uterus.
Effectiveness of Copper-bearing IUDs
Pregnancy rates for all major IUDs are less than one per 100 women per year. This means that of
every 1000 women using IUDs only six to eight may become pregnant. IUDs are as effective as
implants, injectable contraceptives and voluntary male and female sterilization. WHO trial suggests
that after 10 years of use the cumulative pregnancy rate for CuT-380A was 2.1 per 100 women and
for CuT-220C was 5.7.

Advantages
yy A single decision to use an IUD leads to effective long-term prevention of pregnancy up to 10
years.
yy Convenient to the user as no need of remembering anything once this is inserted.
yy No interference with sex and any hormonal side effects of copper-bearing IUDs.
yy Copper-bearing IUDs have no effect on quality or quantity of breast milk.
yy Can be inserted immediately after childbirth or after induced abortion.
yy Does not interfere with any medication.
yy Prevent ectopic pregnancy (less risk of ectopic pregnancy than in women not using any
contraceptive method).
26

Reference Manual for Doctors on Family Planning and Reproductive Health

yy No delay in return of fertility.

Limitations
yy Menstrual Irregularities in early months, but this is reduced after three months.
yy Does not protect against sexually transmitted diseases (STDs) including HIV/AIDS.
yy Requires skilled provider, including pelvic examination is needed to insert IUD.
yy Client cannot stop IUD use on her own. A skilled health care provider is required to remove the
device.
yy The IUD may come out of the uterus possibly without the woman knowing about it (more
common when the IUD is inserted soon after childbirth).
yy Does not protect against ectopic pregnancy.
In general, many women can use IUD safely and effectively. IUDs can be used in any
circumstances by women who:
yy Are of any age including adolescents and women over 40 years.
yy Have just had an abortion or miscarriage (if there is no evidence of infection or risk of infection).
yy Take antibiotics or anticonvulsants.
yy Are fat or thin or are breast feeding.
yy Have or do not have any children.
yy Are infected with HIV or are on ART.
yy Have anaemia.
Also, women with these conditions can use IUDs in any circumstances:
yy Benign breast disease and breast cancer.
yy Headaches.
yy Irregular vaginal bleeding (after evaluation).
yy Blood clotting problems and varicose veins.
yy Heart disease (disease involving heart valve may require treatment with antibiotics before IUD).
yy History of stroke, high blood pressure, diabetes, epilepsy.
yy Liver or gall bladder disease and thyroid disease.
yy Malaria and non-pelvic tuberculosis.
yy Past ectopic pregnancy.
yy Past pelvic surgery.
27

Chapter 3: Reversible Contraceptives

Medical Eligibility Criteria


The following conditions are included under category 3 (method not recommended for use unless
other more appropriate method is not available or not acceptable) and category 4 (method should
not be used at all)
yy Unexplained vaginal bleeding including endometrial, cervical cancer and ovarian cyst/tumours.
yy Cervical lacerations, cervical stenosis (Initiation).
yy Current STIs such as chlamydia and gonorrhoea (Initiation).
yy Current pelvic inflammatory diseases (PIDs), increased risk of STIs.
yy Pelvic tuberculosis.
yy Immediate post-septic abortion.
yy Clients on ART (Initiation).

IUD insertion
A provider who listens to a womans concern, answers her questions, and gives clear, practical
information about the side effects, especially probable bleeding changes and possible pain after
insertion, will help the woman use the IUD with success and satisfaction. Provider must counsel the
client about all available methods, share all information and allow the client to choose the method
of her choice. All women who choose IUDs must have access to IUD removal on demand.

Broad Steps in Procedure

Proper infection prevention measures should be followed when inserting a new, presterilized IUD.

No-Touch technique is preferred.: No-touch technique includes: (1) Loading the IUD
in the inserter while both parts are still in the sterile package; (2) Cleaning the cervix with
antiseptic before IUD insertion; (3) Being careful not to touch the vaginal wall or speculum
blades with the uterine sound or loaded IUD inserter; (4) Passing both, uterine sound and
IUD inserter only once through the cervical canal.

The woman is asked to tell the provider if she feels discomfort or pain at any time during
the procedure. Ibuprofen may be given 30 minutes before insertion to reduce cramping
and pain.

Conduct a careful pelvic examination (speculum and bi-manual) and check the position of
uterus to make sure that the woman can use an IUD safely and effectively.

The provider carefully cleans the cervix and vagina several times with an antiseptic solution
such as iodine.

Working slowly and gently, the provider inserts the IUD, following the manufacturers
instructions.
28

Reference Manual for Doctors on Family Planning and Reproductive Health

After the insertion, the provider asks client how she feels and, if she feels dizzy when
sitting, suggests that she lie quietly for 5 or 10 minutes. Any cramping probably will not last
long.

Postpartum insertion
Postpartum uterus is a hollow organ with its inner walls spread apart. Following delivery
cervix is dilated and flabby and outer margins are usually lacerated especially laterally.
Postpartum contraction of the lower part of uterus, such anatomical changes occur that
can cause a provider inserting IUD mistakenly and believe that fundus has been reached
and that IUD is properly placed when it is not. Such insertions result in expulsion.
Only providers who have special training should insert IUDs after childbirth. Proper
insertion technique is important to reduce the risk of expulsion. An IUD can be inserted
during
yy IUD can be manually inserted in first 10 minutes of delivery of placenta and
instrumentation is required for insertions up to 48 hour such a Kelly forceps. Inserter
should not be used as this may cause perforation.
yy Following an abortion, if there is no infection, bleeding or any other
contraindications
yy Insertion any time after 6 weeks postpartum
Follow-up visit of IUD user after a menstrual period, for check-up and pelvic examination
to see positioning of the device and any sign of infection. After this one return visit, no
further routine visits are required.

Removing the IUD


yy Removing IUD is usually simple. It can be done anytime throughout the menstrual cycle.
Removal may be somewhat easier during menstruation, when the cervix is dilated.
yy Proper infection-prevention procedures are followed.
yy The health care provider pulls the IUD strings slowly and gently with forceps.
yy If removal is not easy, the provider may dilate the cervix using a uterine sound or alligator
forceps or refer the client to a specially trained provider.

Common Side Effects


1. Some users may report changes in monthly bleeding including prolonged and heavy bleeding,
irregular bleeding and cramps. Women need to be counseled about these side effects during

29

Chapter 3: Reversible Contraceptives

pre-procedure counseling. She should be reassured that these problems would not last for
more than three months. If these continue she should be properly evaluated and advised
accordingly.
2. There is risk of PID if women have upper genital tract infections such as gonorrhea and
chlamydia at the time of insertion. IUD does not lead to PID.

Correcting Some Common Misunderstandings about IUDs


yy Does not increase risk of contracting STIs/HIV.
yy Does not increase risk of miscarriage if women get pregnant after IUD removal.
yy Do not make women infertile.
yy Do not cause birth defects.
yy Do not cause cancer.
yy Do not move to heart or brain.
yy Do not cause any pain during sex.

Counselling
A woman who chooses an IUD should know what will happen during the insertion procedure.
She also should understand the following:
She can expect:
yy Some cramping pain for first day or two after insertion. She can take Aspirin, Paracetamol
or Ibuprofen.
yy Some vaginal discharge for a few weeks after insertion. This is normal.
yy Heavier menstrual periods. Possible bleeding between menstrual periods, especially
during the first few months after IUD insertion.
yy Checking the IUD: Sometimes IUDs come out. This can happen especially in first month
or so after insertion or during a menstrual period. An IUD can come out without the
woman feeling it.

Follow up Schedules
Follow-up visit of IUD user in three to six weeks, after a menstrual period, for check-up and pelvic
examination to see positioning of the device and any sign of infection. After this one return visit, no
further routine visits are required.

30

Reference Manual for Doctors on Family Planning and Reproductive Health

Make sure she knows:


yy Exactly what kind of IUD she has and what it looks like.
yy When to have IUD removed or replaced (for CuT-380A IUD, 10 years after insertion and 5
years CuT 375). Discuss how to remember the year to return. If she wants a new IUD, it can be
inserted as soon as the old IUD is removed.
yy When she visits health care providers, she should tell them that she has an IUD.
yy Explain to her that she has right for removal of IUD if she is not happy with the method and
help her switch to other method if she decides so.
yy Provide the client with written record of month and year of IUD insertion and month and year
when it should be removed.

Management of Irregular Bleeding, or Heavy Bleeding


The prolonged bleeding means more than eight days and heavy bleeding implies twice as long or
twice as much as usual for her. Conduct a Pelvic Examination to look for cervical disease, ectopic
pregnancy, or PID. Refer for care if appropriate. She can continue using her IUD while condition is
being evaluated.

If there is no evidence of infection or other abnormalities and less than three months since
IUD insertion and bleeding is within normal and expected range.

Reassure her that changes in menstrual bleeding are normal and will probably lesson over time.
Suggest food containing iron to eat if possible. If possible, give her iron tablets (ferrous sulfate up to
200 mg 3 times a day for 3 months).
Ask if she wants to keep her IUD:

If she does, ask her to return in about three months for another check-up. If the bleeding
bothers her, you may give her ibuprofen or other non-steroidal anti-inflammatory drugs
(but not aspirin) to help her reduce it.

If not, remove the IUD and help her choose another method.

If there is no evidence of infection or other abnormalities and more than three months since IUD
insertion?

If the client wishes or if the bleeding or pain is severe, remove the IUD. Help her choose
another method.

If an abnormal condition is causing irregular or heavy bleeding, treat or refer for care.

If very heavy bleeding, check for signs of severe anaemiapale under fingernails and inside
eyelids.

If found:

Recommend IUD removal and help her choose another method.

31

Chapter 3: Reversible Contraceptives

Give her enough iron tablets for three months

If she wants to keep an IUD but has an inert IUD, replace it with a new copper-bearing IUD.
Ask her to come for a check-up in three to six weeks.

Management of Complications among IUD users


Management of lower abdominal pain that suggests pelvic inflammatory disease
Diagnose: Take history and perform abdominal and pelvic examinations. If pelvic exam is not
possible, do an external genital exam.
If one or more of the following is found, refer to a capable provider at once

Missed a menstrual period, her period is late, or she is pregnant.

Recently gave birth or had an abortion.

Pain or tenderness when pressure is put on the abdomen during examination.

A vaginal bleeding.

A pelvic mass.

If she has none of the above conditions, diagnose as PID if she has one or more of the following (the
more conditions she has, stronger the diagnosis)

Oral temperature of 38.30C (1010F) or higher.

Abnormal vaginal or cervical discharge.

Pain when moving the cervix during pelvic examination.

Tenderness in the area of fallopian tube or ovary.

Recent sex partner with urethral discharge or treated for gonorrhoea.

Note: Diagnosis may be difficult. PID signs and symptoms may be mild or absent. Also, the common signs and symptoms of PID often also
occur with other abdominal conditions such as ectopic pregnancy or appendicitis.

yy Treat or immediately refer for treatment. Treat for gonorrhoea, chlamydia, and trichomoniasis
all three.
yy General, remove the IUD if physical examination or laboratory tests point to PID. (Where PID
management and follow up are possible, some experienced clinicians may leave the IUD in
place). If diagnosis is uncertain and follow up is possible, treat with antibiotics without taking
out the IUD, and watch carefully for results of treatment. If diagnosis is uncertain and follow up
is not possible, take out the IUD and start antibiotics.
yy Follow-up: If the woman does not improve in two or three days after starting the treatment,
or if she develops a tubal abscess, she should be sent to hospital. Otherwise, schedule another
follow up for just after she has finished taking all of her medicine.
yy Urge the client to have her sex partner or partners come for STD treatment.
32

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked questions


1. How a woman should perform a self-check of her IUD is in place?

Once a week during the first month after insertion, women should do a self-check to know the presence
of IUD. In case of any symptoms of serious problems are noticed. IUDs are more likely to come out with
menstrual blood after a menstrual period; therefore self-check is required from time to time.

To check her IUD, a woman should

Wash her hands with soap and water.

Sit in squatting position.

Insert one or two fingers in her vagina as far as she can until she feels the strings. She should return
to the health care provider if she thinks the IUD might be out of place.

She should not pull on the strings. She might pull the IUD out of place.

Wash her hands again.

After postpartum insertion, the strings do not always come down through the cervix.

2. If a current IUD user has a sexually transmitted infection or has is at very high individual
risk of becoming infected with an STI, should her IUD be removed?

No. If a woman develops a new STI after her IUD has been inserted, she is not especially at risk of developing
PID because of the IUD. She can continue to use the IUD while she is being treated for the STI. Removing
the IUD has no benefit and may leave her at risk of unwanted pregnancy. Counsel her on condom use and
other strategies to avoid STIs in the future.

3. Does the IUD make a woman infertile?


No. A woman can become pregnant once the IUD is removed just as quickly as a woman who has never
used an IUD, although fertility decreases as women get older. Good studies find no increased risk of
infertility among women who have used IUDs, including young women and women with no children. If an
IUD user develops PID and it is not treated, there is some chance that she will become infertile.

4. Can a woman who has never had a baby use an IUD?


Yes. A woman who has not had children generally can use an IUD, but she should understand that the IUD
is more likely to come out because her uterus may be smaller than the uterus of a woman who has given
birth. Since insertion in nulliparous women as classified in category 2, it is advisable to have a qualified
doctor doing the procedure.

5. Can young women and older women use IUDs?


Yes. There is no minimum or maximum age limit. An IUD should be removed after menopause has
occurredwithin 12 months after her last monthly bleeding.

6. Should a woman have a rest period after using her IUD for several years or after the
IUD reaches its recommended time for removal?

No. This is not necessary, and it could be harmful. Removing the old IUD and immediately inserting a new
IUD poses less risk of infection than two separate procedures. Also, a woman could become pregnant
during a rest period before her new IUD is inserted.

33

Chapter 3: Reversible Contraceptives

7. Should antibiotics be routinely given before IUD insertion?


No, usually not. Most recent research done where STIs are not common suggests that PID risk is low with
or without antibiotics. When appropriate questions to screen for STI risk are used and IUD insertion is done
with proper infection-prevention procedures (including the no-touch insertion technique), there is little risk
of infection. Antibiotics may be considered, however, in areas where STIs are common and STI screening is
limited.

8. Must an IUD be inserted only during a womans monthly bleeding?


No. For a woman having menstrual cycles, an IUD can be inserted at any time during her menstrual cycle
if it is reasonably certain that the woman is not pregnant. Inserting the IUD during her monthly bleeding
may be a good time because she is not likely to be pregnant, and insertion may be easier. It is not as easy
to see signs of infection during monthly bleeding, however.

9. Do IUDs increase the risk of ectopic pregnancy?


No. On the contrary, IUDs greatly reduce the risk of ectopic pregnancy. Ectopic pregnancies are rare among
IUD users. The rate of ectopic pregnancy among women with IUDs is 12 per 10,000 women per year. The
rate of ectopic pregnancy among women in the United States using no contraceptive method is 65 per
10,000 women per year. On the rare occasions that the IUD fails and pregnancy occurs, six to eight of
every 100 of these pregnancies are ectopic. Thus, the great majority of pregnancies after IUD failure are
not ectopic. Still, ectopic pregnancy can be life-threatening, so a provider should be aware that ectopic
pregnancy is possible if the IUD fails.

3.2.2. Hormone releasing IUD: Levonorgestrel-20 IUDs (LNG-20 IUDs)


Levonorgestrel is a progestin widely used in implants and oral contraceptive pills. The levonorgestrel
intrauterine device (LNG-IUD) is a T-shaped plastic device that steadily releases small amounts of
levonorgestrel each day.
LNG 20 is one of the newest forms of hormone-releasing IUDs. It contains 52 mg of levonorgestrel
released at the rate of 20 micrograms per day and lasts for at least five years. It has been used
for 10 years in Europe and is now considered to be an ideal method of contraception. Apart from
preventing pregnancy, it also makes periods lighter, shorter and less painful. When it is removed,
fertility returns immediately.
LNG2 is particularly useful for two groups of women
yy Women who have been pregnant and do not want any more children in next few years and
yy Women their 30s and 40s who have completed their families and want a reliable long term
method of contraception which they can use and then forget about for five years at a time.

Mechanism of Action
The LNG IUD consists of plain device with a silastic reservoir attached to the vertical arm. The silastic
reservoir is impregnated with levonorgestrel and is covered with a rate-limiting silastic membrane.
The release rate of levonorgestrel is approximately 20 micrograms/24 hours for at least 5 years.
LNG IUD acts as contraceptive in two ways: it makes cervical mucous much thicker, preventing

34

Reference Manual for Doctors on Family Planning and Reproductive Health

sperm from getting through and it also thins out the endometrium hampering implantation. In
some women, it also prevents ovulation. This mechanism of LNG IUD appears to be at the level of
endometrium, where the high dose of local progestogen causes deciduation, epithelial atrophy and
direct vascular changes.

Effectiveness
The failure rate is low that it can be compared to sterilization. Long term studies show that among
100 women using LNG-20 IUD for one year, there will no more than two pregnancies. It is unique
method of contraception combining the main benefits of the pilleffective birth control with the
main appeal of sterilization, forget ability. It also has an advantage over copper IUD because it
tends to make periods lighter and shorter which the copper IUD does not.

Advantages
yy More effective than copper-bearing IUDs.
yy Most IUDs make womans period heavier, however the LNG IUD actual makes periods lighter
than usual.
yy Pelvic infection is less common with LNG IUD than copper-bearing IUDs.
yy The Dominican Republic study found that women who used LNG -20 for more than three years
were significantly less likely to have low serum ferritin or hematocrit than either women not
using IUDs or women using un-medicated or copper-bearing IUDs.
yy The studies have shown that the LNG-20 has had lower ectopic pregnancy rate than most
copper IUDs.
yy There are evidences that LNG IUD use among women with endometriosis decreased
dysmenorrhoea and pelvic pain.
yy Among women with heavy or prolonged bleeding, LNG IUDs are beneficial in treating
menorrhagia.

Limitations
yy It is costlier than copper-bearing IUDs.
yy Can cause irregular bleeding or spotting in the first six months of use.
yy Not suitable for women who are at risk of sexually transmitted infections or ectopic pregnancy.

Medical Eligibility Criteria


Most of the medical eligibility criteria for copper-bearing IUDs and LNG IUD are similar; however,
LNG IUD being the hormonal IUD the following are some of the major clarifications and additional
eligibility criteria:

35

Chapter 3: Reversible Contraceptives

yy In cases of cardiovascular disease and high blood pressure, there is some effect of hormone of
LNG IUD. Hence, though it can be used, it definitely is not as safe as copper-bearing IUDs.
yy In women with current deep vein thrombosis/pulmonary embolism, current history and
migraine with aura of ischemic heart disease, the LNG IUD should be used only if other
appropriate methods of contraception are not available or not acceptable.
yy Among women with fibroids, there were no adverse health events with LNG IUD use and there
was a decrease in symptoms and size of fibroids for some women.
yy Due to presence of hormone, LNG IUD is not found suitable for women with current breast
cancer. Even in women with past history of breast cancer, LNG IUD should be used only if other
appropriate methods of contraception are not available or not acceptable.
yy Due to hormone present in the LNG IUD in women with liverrelated diseases it should be used
only if other appropriate methods of contraception are either not available or not acceptable.

Timing of LNG IUD Insertion


LNG IUD is inserted within a week of beginning of a periodthis helps to reduce the chance of
expulsion and irregular bleeding. It may be inserted immediately after a medical termination of
pregnancy, but should be deferred until six weeks after delivery of a baby.
The hormone effect on the uterine endometrium is reversed within a month and normal periods and
fertility returns. The LNG IUD lasts for five years and if required, a new one could be inserted at the
same time the old one is removed.

3.3. Hormonal Methods


3.3.1. Combined Oral Contraceptive Pills (COCP)
Combined Oral Pills contains low doses of two hormonesa progestin and an estrogenlike the
natural hormones progesterone and estrogen in a womans body. Combined oral contraceptives
(COCs) are also called the Pill, low-dose combined pills, OCPs, and OCs.
Types of Oral Contraceptives
yy

Combined oral contraceptive pills

Low dose pills

Very low dose pills

yy Progestreone only pills/Minipills

Mechanism of Action
yy Inhibition of ovulation by suppressing FSH and LH.
yy Alternation of endometrium to make it unsuitable for implantation even if the ovum is fertilized.
36

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Changes in cervical mucus which make it hostile for sperm.

Effectiveness
Failure rate is 0.1 percent on correct and consistent use. Effectiveness depends on the user; risk of
pregnancy is greatest when a woman starts a new pill pack three or more days late, or misses three
or more pills near the beginning or end of a pill pack.
When no pill-taking mistakes are made, less than one pregnancy per 100 women using COCs over
the first year (3 per 1,000 women).
No delay in return of fertility after COC is stopped. Certain medicines and supplements may make
the pill less effective. These include:
yy The antibiotic rifampin other antibiotics do not make the pill less effective the antifungal
Griseofulvin other antifungals do not make the pill less effective.
yy Certain HIV medicines.
yy Certain anti-seizure medicines.

Medical Eligibility Criteria


Women who have the following known conditions should not initiate COCs (contraindications):
yy Breast feeding during the first six months postpartum.
yy First three weeks postpartum and not breast feeding (six weeks postpartum if other risk factors
for venous thromboembolism).
yy Age 35 or older and smoke 15 cigarettes per day or more.
yy Current breast cancer.
yy Severe cirrhosis; malignant liver tumours; or benign liver tumours, with the exception of focal
nodular hyperplasia (which is a tumour that consists of scar tissue and normal liver cells), gall
bladder disease.
yy Cardiovascular conditions (i.e., high blood pressure; diabetes with vascular complications;
history of or current deep venous thrombosis, stroke, or ischemic heart disease).
yy Migraine with aura or any migraine in women 35 or older.
yy Taking drugs that affect liver enzymes: Rifampicin or Rifabutin (for tuberculosis),
anticonvulsants (for Epilepsy), or Ritonavir (as part of an antiretroviral regimen).
yy Any planned major surgery which is likely to make client bed ridden for one week or more.

Side Effects
Generally not signs of a health problem; may diminish or change over time 37

Chapter 3: Reversible Contraceptives

yy Headaches, dizziness
yy Nausea
yy Changes in bleeding pattern including scanty, irregular, infrequent or no monthly bleeding or
spotting
yy Breast tenderness
yy Mood changes
yy Amenorrhea

Combined Oral Contraceptives for Women with HIV


yy Women can safely use COCs even if they are infected with HIV, have AIDS, or are on
antiretroviral (ARV) therapy unless their therapy includes ritonavir. Ritonavir may reduce the
effectiveness of COCs.
yy Urge these women to use condoms along with COCs. Used consistently and correctly, condoms
help prevent transmission of HIV and other STIs. Condoms also provide extra contraceptive
protection for women on ARV therapy.

Counseling
Women should be fully counseled about the method, how to take pills regularly, common side
effects, what to do when pills are missed and when to come for management of common side effects.
Additionally women should be made aware of the alternate sources of contraceptive supplies that
may be available in the area. These are women controlled methods and can be stopped anytime, do
not interfere with sex. Known health benefits include prevention of unwanted pregnancy, protection
against endometrial and ovary cancer. The protection against cancers continues for 15 years after
stopping use. The pills also reduce menstrual cramps, ovulation pain, excess hair on face, symptoms
of poly cystic ovarian syndrome and symptoms of endometriosis.

COCs are Safe and Suitable for Nearly all Women


yy Have or have not had any children.
yy Are not married, any age
yy Had an abortion.
yy Smoke cigarettes and less than 35 years.
yy Varicose veins

And Women can begin use COCs


yy Without any pelvic examination,without any blood tests.
yy Without cervical cancer screening.
38

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Without a breast examination.


yy Even if a women is not having monthly bleeding at the time if it is reasonably certain that she is
not pregnant.

Providing COCs
After birth.
If she is less than six months postpartum give her pills but also counsel her that pills should be
started only after her baby is six months old or when breast feeding is no longer babys main
food whichever is earlier.
If she is not breast feeding and less than four weeks after giving birth, she can start any time on
days 21-28. There is no need for any back up methods.

After abortion
Immediately if she is starting within seven days of abortion. Need to use back up method for seven
days if it is more than seven days after abortion.
Show and explain pill pack. With 28 pills pack explain that last seven pills are of different colour and
these do not contain hormones. She should take one pill each day until the pack is empty. She should
start the next pack on the very next day.
Sometime she may need to use a backup method if she misses a pill. Backup methods include
condoms, and withdrawal.

Management of Common Side Effects


Most side effects usually become less or stop within first few months. Skipping pills risks pregnancy
and can make some side effects worse. It is advised to take pill at the same time every day to help
reduce irregular bleeding and remember. Take pills with food or at bed time to avoid nausea.
Irregular Bleeding
Reassure the woman that this is not harmful and will stop after first few months of use. To reduce
irregular bleeding, she should take the pill at the same time, can use Ibuprofen three times a day.
If irregular bleeding continues for a long time or starts after several months of use, there may be
something wrong for other reasons and consider underlying conditions and evaluation.
No monthly bleeding
Reassure her that blood is not building inside her body. This is not harmful.

39

Chapter 3: Reversible Contraceptives

Ordinary Headaches
Suggest Aspirin, Paracetamol or Ibuprofen. Headaches getting worse should be evaluated.
Breast Tenderness
Recommend wearing a supportive bra, try hot and cold compresses and pain relievers.

Frequently asked questions


1. What does a doctor advise; if women forget to take the pill?

Alternate method of birth control to be suggested if the woman has vaginal intercourse during the seven
days after a missed pill. Some backup methods are the condom, female condom, diaphragm, or sponge.
One can also use emergency contraception (morning after pill) up to five days after unprotected intercourse.
Number of Pills
Missed

When Pills
Missed

What to do

Seven-Day
Backup Needed?

Beginning of
pack

Take a pill as soon as you remember.


Take the next pill at the usual time.
(This means you may take two pills in one day)

Yes

12 pills

Day 3day 21

Take a pill as soon as you remember.


Take the next pill at the usual time.
(This means you may take two pills in one day)

No

3 or more pills

First two
weeks

Take a pill as soon as you remember.


Take the next pill at the usual time.
(This means you may take two pills in one day)

Yes

3 or more pills

Third week

Do not finish pack. Throw away remaining pills.


Start next pack.

Yes

Throw away the missed reminder pill(s).


Take next reminder pill at the usual time.

No

First 12 pills

17 reminder pills Fourth week

2. Should a woman take a rest from COCs after taking them for a time?

No. There is no evidence that taking a rest is helpful. COCs can safely be used for many years without
having to stop taking them periodically. A woman is protected only as long as she takes her pills regularly.

3. How long does it take to become pregnant after stopping COCs?


Women who stop using COCs can become pregnant as quickly as women who stop non-hormonal methods.
The bleeding pattern a woman had before she used COCs generally returns after she stops taking them.
Some women may have to wait a few months before their usual bleeding pattern returns.

4. Do COCs cause abortion?


No. Research on COCs finds that they do not disrupt an existing pregnancy. They should not be used to try
to cause an abortion. They will not do so.

40

Reference Manual for Doctors on Family Planning and Reproductive Health

5. Do COCs cause birth defects? Will the fetus be harmed if a woman accidentally takes COCs
while she is pregnant?

No. Good evidence shows that COCs will not cause birth defects and will not otherwise harm the fetus if
a woman becomes pregnant while taking COCs or accidentally starts to take COCs when she is already
pregnant.

6. Do COCs cause women to gain or lose a lot of weight?


No. Most women do not gain or lose weight due to COCs. Studies find that, on average, COCs do not affect
weight. A few women experience sudden changes in weight when using COCs. These changes reverse after
they stop taking COCs. It is not known why these women respond to COCs in this way.

7. Do COCs change womens mood or sex drive?


Generally, no. Some women using COCs report these complaints. The great majority of COC users do not
report any such changes, however, and some report that both mood and sex drive improve. There is no
evidence that COCs affect womens sexual behavior.

8. What can a provider say to a client asking about COCs and breast cancer?

The provider can point out that both COC users and women who do not use COCs can have breast cancer.
In scientific studies breast cancer was slightly more common among women using COCs and those who
had used COCs in the past 10 years than among other women. Scientists do not know whether or not COCs
actually caused the slight increase in breast cancers. It is possible that the cancers were already there before
COC use but were found sooner in COC users.

9. Can COCs be used as a pregnancy test?


No. A woman may experience some vaginal bleeding (a withdrawal bleed) as a result of taking several
COCs or one full cycle of COCs, but studies suggests that this practice does not accurately identify who is
or is not pregnant.

10. Must a woman have a pelvic examination before she can start COCs or at follow-up visits?

No. Instead, asking the right questions usually can help to make reasonably certain that a woman is not
pregnant. No condition that could be detected by a pelvic examination rules out COC use.

11. Can women with varicose veins use COCs?


Yes. COCs are safe for women with varicose veins. Varicose veins are enlarged blood vessels close to the
surface of the skin. They are not dangerous. They are not blood clots, nor are these veins the deep veins in
the legs where a blood clot can be dangerous (deep vein thrombosis). A woman who has or has had deep
vein thrombosis should not use COCs.

12. Can a woman safely take COCs throughout her life?


Yes. There is no minimum or maximum age for COC use. COCs can be an appropriate method for most
women from onset of monthly bleeding (menarche) to menopause.

13. Can women who smoke use COCs safely?


Women younger than age 35 who smoke can use low-dose COCs. Women age 35 and older who smoke
should choose a method without estrogen or, if they smoke fewer than 15 cigarettes a day, monthly
injectables. Older women who smoke can take the progestin-only pill if they prefer pills. All women who
smoke should be urged to stop smoking.

41

Chapter 3: Reversible Contraceptives

14. What if a client wants to use COCs but it is not reasonably certain that she is not
pregnant after using the pregnancy checklist?

If pregnancy tests are not available, a woman can be given COCs to take home with instructions to begin
their use within five days after the start of her next monthly bleeding. She should use a backup method
until then.

15. Can COCs be used as emergency contraceptive pills (ECPs) after unprotected sex?

Yes. As soon as possible, but no more than five days after unprotected sex, a woman can take COCs as ECPs.
Progestin-only pills, however, are more effective and cause fewer side effects such as nausea and stomach
upset.

16. Is it important for a woman to take her COCs at the same time each day?

Yes, for two reasons. Some side effects may be reduced by taking the pill at the same time each day. Also,
taking a pill at the same time each day can help women remember to take their pills more consistently.
Linking pill taking with a daily activity also helps women remember to take their pills.

17. What are the health benefits of combined contraceptive pills?


Fertility related benefits:
yy

Prevention of pregnancy

yy

Offers protection against ectopic pregnancy

Menstrual benefits
yy

Menstrual cycle stabilization

yy

Lesser iron deficiency anaemia due to lighter menstrual cycles

yy

More regular menstrual cycles

yy

Less dysmenorrhea

Other possible health benefits


yy

Protection against pelvic inflammatory diseases

yy

Reduces risk of follicular cyst by 50% and corpus luteal cyst by 80%.

yy

Past contraceptive use protects women after they reach menopause where reduced risk of low bone
mineral density was documented

yy

Reduction in acne

Protection from some cancers


yy

Protection against cancers e.g. endometrial and ovarian cancer

yy

Protection against benign diseases e.g. benign breast diseases like fibrocystic and fibroadenomatosis
disease decreased by 50-70%

18. What are the facts to be considered for women with HIV and AIDS using COC?
yy

Women with HIV and AIDS can use COCs without restrictions.

yy

Women with AIDS who take antiretroviral drugs (ARVs) other than ritonavir can generally use COCs.

42

Reference Manual for Doctors on Family Planning and Reproductive Health

(There is some evidence that ritonavir reduces the blood levels of contraceptive hormones to a much
greater extent than other ARV drugs.)
yy

Women with HIV who choose to use COCs should be counseled about dual method use and consider
using condoms in addition to COCs. In addition to preventing the spread of HIV, condoms may be
especially beneficial to women on ARVs because condoms provide additional protection from pregnancy
in the event that COC effectiveness is reduced by ARVs.

3.3.2. Ultra Low dose COC Pills


(Also called Newer Pills)
Ethyle Estrodione (EE) + Drospirenone
It is an equivalent to 25 mg of spironolactone. The major effect is anti-mineralocorticoid activity.
By this property, drosiprenone decreases the salt and water retention, but it increases potassium
retention. EE + Drospirenoneachieves the contraceptive action by suppressing gonadotropins,
inhibiting ovulation and inducing changes in the cervical mucus and endometrium.

Advantages
yy As a contraceptive it is 99 per cent effective if used correctly.
yy It provides excellent cycle control.
yy Low incidence of breakthrough bleeding and spotting.
yy It is associated with lower incidence of symptoms associated with water retention such as
headache, breast tenderness and weight gain.
yy Suitable for females with features of hyper-androgenism.

Limitations
yy In women with renal, hepatic or adrenal problems could predispose to hyperkalemia as this
does not promote potassium excretion therefore associated with potassium retention.
yy Risk of venous thromboembolism is similar as that of COC pills.
The formulation is specifically beneficial for women susceptible to weight gain and rise in blood
pressure. The combination gives excellent cycle control, good tolerability and a level of weight loss
that may have a significant beneficial effect on compliance.
EE + Cyproterone Acetate (CPA)
Cyroproterone acetate is a synthetic progestogen derived from 17- alpha-hydroxy-progesterone with
anti-gonadotrophic and anti-androgenic peripheral activity. It was first used in men for treatment of
prostate cancer and was recognized in 1970 for its anti-androgenic property.

43

Chapter 3: Reversible Contraceptives

Phase
Having a menstrual
cycle

Recommended Guidelines
Within 5 days after start of her menstrual bleeding. No additional contraceptive
protection is needed.

In between 2 menstrual Any day if she is reasonably certain that she is not pregnant. If it has been more
cycles
than 5 days since menstrual bleeding started, she will need to abstain from sex or
use additional contraceptive protection for next 7 days
Amenorrhoea

She can start COCs at any time, if she is reasonably certain that she is not
pregnant. She will need to abstain from sex or use additional contraceptive
protection for next 7 days

Breast feeding

yy

If she is more than 6 months postpartum and amenorrhic, she can start COCs
as advised above for any other amenorrhic woman

yy

If she is more than 6 months postpartum and her menstrual cycles have
returned, she can start COCs as advised for other women having menstrual
cycles

yy

Women less than 6 weeks postpartum who are primarily breast feeding
should not use COCs. For women who are more than 6 weeks to 6 months
postpartum and primarily breast feeding, use of COCs is usually not
recommended unless other more appropriate methods are not available or
not acceptable

yy

She can start COCs immediately, if she has been using her hormonal method
consistently and correctly, or if it is reasonably certain that she is not
pregnant. There is no need to wait for her next menstrual period.

yy

If her previous method was an injectable, she should start COCs when repeat
injection would have been given. No additional contraceptive protection is
required.

Switching from nonhormonal method

yy

She can start COCs within 5 days after the start of her menstrual bleeding.

yy

She can also start immediately or at any other time, if it certain that she is
not pregnant. If it has been more than 5 days after the menstrual bleeding
started, she will need to abstain from sex or use additional contraceptive
protection for the next 7 days

Switching from IUD


(including hormonal)

yy

She can start COCs within 5 days after the start of her menstrual bleeding.
No additional contraceptive protection is required. The IUD can be removed
at that time.

yy

She can also start immediately or at any other time, if it reasonably certain
that she is not pregnant. If she has been sexually active during this menstrual
cycle, and it has been more than 5 days since menstrual bleeding started, it is
recommended that IUD should be removed at the time of her next menstrual
period.

yy

She can start the pills in the first 7 days after first or second trimetser
miscarriage or abortion

yy

Later at time when it is reasonably certain that she is not pregnant.

Switching to another
hormonal method

After miscarriage or
abortion

44

Reference Manual for Doctors on Family Planning and Reproductive Health

Advantages
yy Safe and reliable contraceptive.
yy Excellent cycle and endometrial control.
yy Additional benefit on hirsutism and acne.
yy Control of polycystic ovarian syndrome.
yy High psychological motivation due to its effect on androgenic skin disorders.
yy Favourable effect on lipid and carbohydrate metabolism.

Limitations
yy Nausea, headache and weight gain.
yy Risk of venous thromboembolism associated with CPA/EE use is equivalent to that associated
with the use of conventional COCs.
yy Risk of developing venous thromboembolism resulting in hospital admission associated with
anti-androgen oral contraceptive use is at least as high as with third generation use.
CPA inhibits testosterone and di-hydro testosterone (DHT) action by binding competitively
to intracellular receptors thus reducing nuclear concentration of free DHT. This also increases
testosterone clearance.
CPA is a potent anti-androgen hence is also used for treatment of women with acne/ hirsutism.
As a contraceptive pill this pill is safe and well tolerated with mild side effects and excellent cycle
control. This combination has also been used for the treatment of poly cystic ovarian syndrome.
There is high psychological motivation due to its effect on and rogenic skin disorders. There is also
favourable effect on lipid and carbohydrate metabolism.
Common side effects are similar to conventional OCPs such as nausea, vomiting and headache. Risk
of VTE is also similar to OCPs.
Pills with Levonorgesterol

It is monophasic Ethinylestradiol + Levonorgestrel and represents a formulation that extends


conventional oral contraceptive use from three weeks (21 tablets) of hormonal preparation and one
week of placebo to 12 weeks (84 tablets followed by one week off.) It is suitable for women who are
interested in just four periods a year for lifestyle or medical reasons.

Advantages
yy Works like typical monthly pill.
yy Ninety nine percent effective when used correctly.

45

Chapter 3: Reversible Contraceptives

yy Once daily pill to be started day five of the cycle.


yy Advantages of extended cycling and fewer scheduled periods especially suited for adolescents
with medical problems worsened by periods and women with hectic lifestyle.
yy Similar side-effects as conventional oral contraceptive pills.
Conditions benefitting from extended cycle

yy Dysmenorrhoea
yy Menorrhagia
yy Premenstrual syndrome
yy Iron deficiency anaemia
yy Endometriosis
yy Headaches
yy Epilepsy
yy Rheumatoid arthritis
yy Coagulopathies
yy Patients on anticoagulant therapy

Limitations
yy Higher incidence of breakthrough bleeding and spotting which subsequently settles.
yy Women need to be educated about pros and cons of suppression.
yy Some women will benefit from suppression and others will consider it unnatural control.
yy Newer pills have side effects similar to COCs apart from the specific ones mentioned earlier.

3.3.3. Progesterone-Only Pills (POPs) or Minipills


About Progestin-Only Pills
Pills that contain very low doses of a progestin like the natural hormone progesterone in a womans
body. Do not contain estrogen, and so can be used throughout breast feeding and by women
who cannot use methods with estrogen. Progestin-only pills (POPs) are also called minipills and
progestin-only oral contraceptives. Progestin-only oral contraceptives are the best oral contraceptives
for breast feeding women. They do not seem to reduce the milk production. The POPs can also be
used for emergency contraception after unprotected sex.
Mechanism of Action

yy Thickening of cervical mucous.


yy Suppression of ovulation.
46

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Involution of endometrium.
Effectiveness: 99.95 percent effective with correct and consistent use. Failure rate of only
0.5 percent in the first year in breast feeding women. The failure rates are higher in younger
women than in women over 40 years. There is no delay in return of fertility after POP stopped.

Advantages
yy Can be used by lactating mothers starting six weeks after childbirth. Quantity and quality of
breast milk does not seem to be affected.
yy No estrogen side effects. Do not increase risk of estrogen-related complications such as heart
attack or stroke.
yy Women take one pill every day with no break. Easier to understand than taking 21-day COCs.
yy Can be very effective during breast feeding.
yy Even less risk of progestin-related side effects, such as acne and weight gain, than with COCs.
yy May help prevent benign breast disease, endometrial and ovarian cancer and pelvic
inflammatory disease

Limitations
yy For women who are not breast feeding common side effects- changes in menstrual bleeding
are normal including irregular periods, spotting or bleeding between periods and amenorrhea
or missed periods, possibly for several months. A few women may have prolonged or heavy
periods.
yy Less common side effects include headaches and breast tenderness.
yy Need to be taken at about the same time each day to work best.
yy Do not prevent ectopic pregnancy.
The main comparative disadvantage of POPs-higher pregnancy rates than combined pills- is offset
by the protection against pregnancy that breast feeding itself provides; during breast feeding
ovulation is uncommon before menstruation resumes and may be irregular even after menstruation
has resumed.

Side Effects
yy Changes in bleeding patterns lengthened post partum amenorrhoea, irregular and frequent
bleeding, prolonged bleeding, no monthly bleeding.
yy Headaches, nausea and dizziness.
yy Breast tenderness and abdominal pains.

47

Chapter 3: Reversible Contraceptives

Medical Eligibility for POPs


In general, most women can use POPs safely and effectively. POP contraceptives can be used in any
circumstances by women who:
yy Are breast feeding (starting as soon as 6 weeks after childbirth)
yy Have no children
yy Are fat or thin
yy Are of any age, including adolescents and over 40
yy Smoke cigarettes
yy Have just had abortion or miscarriage
Also, women with following conditions can use POP contraceptives in any circumstances:
yy Benign breast disease
yy Heavy, painful menstrual periods or iron deficiency anaemia
yy Irregular menstrual periods
yy Diabetes without vascular, kidney, eye or nerve disease
yy Mild headaches
yy Varicose veins
yy Epilepsy
yy Malaria and Schistosomiasis
yy Sickle cell disease
yy Thyroid disease
yy PID & STD
yy Endometriosis
yy Benign ovarian tumour
yy Uterine fibroids
yy Past ectopic pregnancy
yy Tuberculosis unless taking Rifampin

48

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked questions


1. Can a woman who is breast feeding safely use POPs?

Yes. This is a good choice for a breast feeding mother who wants to use pills. POPs are safe for both the
mother and the baby, starting as early as six weeks after giving birth. They do not affect milk production.

2. What should a woman do when she stops breast feeding her baby? Can she continue
taking POPs?

A woman who is satisfied with using POPs can continue using them when she has stopped breast feeding.
However, she is less protected from pregnancy than when breast feeding. She can switch to another method
if she wishes.

3. Do POPs cause birth defects? Will the fetus be harmed if a woman accidentally takes
POPs while she is pregnant?

No. Good evidence shows that POPs will not cause birth defects and will not otherwise harm the fetus if a
woman becomes pregnant while taking POPs or accidentally takes POPs when she is already pregnant.

4. How long does it take to become pregnant after stopping POPs?


Women who stop using POPs can become pregnant as quickly as women who stop non-hormonal methods.
POPs do not delay the return of a womans fertility after she stops taking them. The bleeding pattern a
woman had before she used POPs generally returns after she stops taking them. Some women may have
to wait a few months before their usual bleeding pattern returns.

5. If a woman does not have monthly bleeding while taking POPs, does this mean that she
is pregnant?

Probably not, especially if she is breast feeding. If she has been taking her pills every day, she is probably
not pregnant and can keep taking her pills. If she is still worried after being reassured, she can be offered
a pregnancy test, if available, or referred for one. If not having monthly bleeding bothers her, switching to
another method may helpbut not to a Progestin-only injectable.

6. Must the POP be taken every day?


Yes. All of the pills in the POP package contain the hormone that prevents pregnancy. If a woman does
not take a pill every day especially a woman who is not breast feedingshe could become pregnant. (In
contrast, the last 7 pills in a 28-pill pack of combined oral contraceptives are not active. They contain no
hormones.)

7. Is it important for a woman to take her POPs at the same time each day?

Yes, for two reasons. POPs contain very little hormone, and taking a pill more than three hours late (more
than 12 hours late with POPs containing Desogestrel 75 mg) could reduce their effectiveness for women
who are not breast feeding. (Breast feeding women have the additional protection from pregnancy that
breast feeding provides, so taking pills late is not as risky.) Also, taking a pill at the same time each day
can help women remember to take their pills more consistently. Linking pill taking with a daily activity also
helps women remember to take their pills.

8. Do POPs cause cancer?


No. Few large studies exist on POPs and cancer, but smaller studies of POPs are reassuring. Larger studies

49

Chapter 3: Reversible Contraceptives

of implants have not shown any increased risk of cancer. Implants contain hormones similar to those used
in POPs, and, during the first few years of implant use, have about twice the dosage.

9. Can POPs be used as emergency contraceptive pills (ECPs) after unprotected sex?

Yes. As soon as possible, but no more than five days after unprotected sex, a woman can take POPs as ECPs.
Depending on the type of POP, she will have to take 40 to 50 pills. This is many pills, but it is safe because
there is a very small quantity of hormone in each pill.

10. Do POPs change womens mood or sex drive?


Generally, no. Some women using POPs report these complaints. The great majority of POP users do not
report any such changes, however, some report that both mood and sex drive improve. It is difficult to
tell whether such changes are due to the POPs or to other reasons. Providers can help a client with these
problems (see Mood changes or changes in sex drive, p. 39). There is no evidence that POPs affect womens
sexual behaviour.

11. What should be done if a POP user has an ovarian cyst?


The great majority of cysts are not true cysts but actually uid-filled structures in the ovary (follicles) that
continue to grow beyond the usual size in a normal menstrual cycle. They may cause some mild abdominal
pain, but they only require treatment if they grow abnormally large, twist, or burst. These follicles usually
go away without treatment.

12. Do POPs increase the risk of ectopic pregnancy?


No. On the contrary, POPs reduce the risk of ectopic pregnancy. Ectopic pregnancies are rare among POP
users. The rate of ectopic pregnancy among women using POPs is 48 per 10,000 women per year. The rate
of ectopic pregnancy among women in the United States using no contraceptive method is 65 per 10,000
women per year. On the uncommon occasions that POPs fail and pregnancy occurs, 5 to 10 of every 100
of these pregnancies are ectopic. Thus, the great majority of pregnancies after POPs fail are not ectopic.
Still, ectopic pregnancy can be life-threatening, so a provider should be aware that ectopic pregnancy
is possible if POPs fail. Pregnancies among POP users are few, especially during breast feeding. When
pregnancy occurs, however, as many as one in every 10 may occur outside the uterus.

13. When can a woman start POPs?


When she is:

Instructions for initiating use

Having menstrual cycle

She can start POPs within 5 days after the start of her menstrual bleeding. No
additional contraception is needed. She can also start POPs at any other time, it is
reasonably certain that she is not pregnant. If it has been more than 5 days since
menstrual bleeding started, she will need to abstain from sex or use additional
contraceptive protection for the next 2 days.

Amenorrhic

She can start POPs, if it is reasonably certain that she is not pregnant. She will need
to abstain from sex or use additional contraceptive protection for the next 2 days

Breast feeding

If she is between 6 weeks and 6 months postpartum and amenorrhic, she can
start POPs at any time. If she is fully or nearly fully breast feeding, no additional
contraceptive protection is needed. If she is more than 6 month postpartum and
her menstrual cycle has returned, she can start POPs as advised for any other
woman having their menstrual cycle. For women who are less than 6 weeks
postpartum and primarily breast feeding, use of POPs is not recommended unless
other appropriate contraceptive methods are not available or acceptable.

50

Reference Manual for Doctors on Family Planning and Reproductive Health

When she is:

Instructions for initiating use

Switching from another


hormonal method

She can start POPs immediately, if she has been using her hormonal method
consistently and correctly, or if she is otherwise reasonably certain that she is not
pregnant. There is no need to wait for her next menstrual period. If her previous
method was an injectable, she should start POPs when the repeat injection would
have been given. No additional contraceptive protection is needed.

Switching from a nonhormonal method


(Other than IUD)

She can start POPs within 5 days after start of her menstrual bleeding. No additional
contraceptive protection is needed. She can also start immediately or any other
time, if it is reasonably certain that she is not pregnant. If it has been more than
5 days since menstrual bleeding started, she will need to abstain from sex or use
additional contraceptive protection for the next 2 days.

Switching from IUD


(including hormonal)

She can start POPs within 5 days after start of her menstrual bleeding. No
additional contraceptive protection is needed. The IUD can be removed at
that time. She can also start immediately or any other time, if it is reasonably
certain that she is not pregnant. If she has been sexually active in this menstrual
cycle, and it has been more than 5 days since menstrual bleeding started, it is
recommended at the time of her next menstrual period. If she has not been
sexually active in this menstrual cycle and it has been more than 5 days since
menstrual bleeding started, she will need to abstain from sex or use additional
contraceptive protection for next 2 days. If that additional protection is to be
provided by the IUD she is using, it is recommended that this IUD be removed
at the time of her next menstrual period. If she is amenorrhic or has irregular
bleeding, she can start POPs as advised for other amenorrhic women.

14. What are the specific instructions to be given to the POP user?

The client should always take only one pill every day. If not breast feeding, it is best to take the pill at same
time each day if possible, even taking a pill more than few hours late increases the risk of pregnancy, and
missing two or more pills in a row greatly increases the risk.

Starting the next package


When she finishes one packet, she should take the first pill from the next package on the very next day. All
pills are active, hormonal pills. There is no wait between packets.

If a woman forgets one or more pills


She should take one pill as soon as she remembers and then keep taking one pill each day as usual.

A breast feeding woman using progestin-only pills for extra protection is still protected if she misses
pills.

If more than three hours late in taking a pill, a woman who is not breast feeding or who is breast
feeding but her menses have returned, should also use condoms or spermicide or else avoid sex for
two days. She should also take last missed pill as soon as she can. Then she should keep taking one
pill each day as usual.

Give advice on common problems


Describe the symptoms of problems that require medical attention. Serious complications of progestinonly pill are rare. Still a woman should see a doctor or nurse or return to the clinic if she has questions

51

Chapter 3: Reversible Contraceptives

or problems or any of the following possible symptoms of more serious problems. POPs may or may not
cause these problems:

Extremely heavy bleeding (twice as long as much as usual for her).

Any very bad headaches that start or become worse after she begins to take POPs.

Skin or eyes become unusually yellow.

Might be pregnant (for example, missed period after several regular cycles), especially if she also has
signs of ectopic pregnancyabdominal pain, tenderness, or faintness. A woman who develops these
signs must seek care at once.

Note on ectopic pregnancy


Pregnancies among POP users are few, especially during breast feeding. When pregnancy occurs,
however, as many as one in every 10 may occur outside the uterus. Ectopic pregnancy is lifethreatening and requires treatment at once.

Follow up POP users


Helping clients at any routine return visit

Same as in COCs.

If the client has developed active liver disease, if she has serious active liver disease, ask her to
stop the pills, do not provide any further pills. Refer for care. Help her to choose a method without
hormones.

If she is taking medicine for seizures, Rifampicin or Griseofulvin, provide condoms or spermicide
to use along with POPs. If she prefers, or if she is on long term treatment, help her choose another
effective contraceptive method.

If she has developed breast cancer, discontinue the pills and help her choose another non-hormonal
contraceptive.

3.3.4. Emergency Contraceptive Pills (ECP)


Emergency Contraception is a method of contraception that is used before missing a period to
preventun wanted pregnancy. It is also called morning after or post-coital pills. EC Pills are safe and
effective for the majority of women who may need these methods, as well as very simple to use.
EC is useful in preventing unwanted pregnancy amongst adolescents. There is no evidence that
knowledge and availability of this method has any effect on encouraging sexual activity. On the
other hand, ECs bring then in contact with health systems so that use of regular contraception can
be promoted.
EC pills have an important role in helping couples achieve their reproductive intentions.
Types of Emergency Contraception Pills

52

Reference Manual for Doctors on Family Planning and Reproductive Health

The following methods can be used for emergency contraception:


yy Emergency contraceptive pills (ECPs): Progestogen-only (0.75 mg LNG or 1.50 mg) or combined
Oestrogen / Progestogen oral contraceptives (Yuzpes regime)
yy In addition copper bearing IUDs also can be used as EC although this would require a skilled
provider.
Mechanism of Action
Mainly stops ovulation (release of eggs from ovary) just as OCs taken daily would do, but perhaps
also works in other ways. ECP does not interrupt an existing pregnancy. The probable mechanisms
are:
yy Inhibition or delay of ovulation.
yy Thickening of cervical mucous.
yy Direct inhibition of fertilization.
yy Histological and biochemical alteration in endometrium leading to impaired endometrial
receptivity to implantation of the fertilized egg.
yy Alteration in transport of egg, sperm and embryo.
yy Interference with corpus luteum function and luteolysis.
Effectiveness
Generally if no ECP is taken eight out of 100 women become pregnant. The sooner after
intercourse that it is taken the more effective it is. EC pills prevent about 75 percent of unwanted
pregnancies that would occur if no emergency contraception was used. Overall EC pills are little
less effective than regular pills.

Safety
Levonorgestrel-alone emergency contraception pills are very safe and do not cause abortion or
harm future fertility.

Side Effects
Side-effects are uncommon and generally mild. Nausea occurs among 20 percent clients using EC
pills. This does not last more than 24 hours. Taking pills with food or milk may reduce nausea. Routine
prophylactic anti-emetic is not recommended. Nearly five percent women may have vomiting. If
vomiting occurs within two hours,same dose should be repeated.
What pills can be used as Emergency Contraceptive Pills?
yy ECP with Levonorgestrel only (Several dedicated products are available).

53

Chapter 3: Reversible Contraceptives

yy Combined Estrogen and Levonorgestrel, or Ulipristal acetate.


yy Progestin-only pills with Levonorgestrel or Norgestrel.
yy Combined oral contraceptives with estrogen and a progestin Levonorgestrel, Norgestrel, or
Norethindrone (also called Norethisterone).
When to Take Them?
yy As soon as possible after unprotected sex. The sooner ECPs are taken after unprotected sex, the
better they prevent pregnancy.
yy Can prevent pregnancy when taken within 72 hours. These pills can be used for up to five days
of exposure to unprotected sex, but for best results it is advisable to use in 72 hours.
Who Needs Emergency Contraception?
Any woman of reproductive age may need emergency contraception at some point to avoid an
unwanted pregnancy.
In What Situations Should Emergency Contraception be used?
Emergency contraception can be used in a number of situations following sexual intercourse.
yy When no contraceptive has been used.
yy When there is a contraceptive failure or incorrect use, including:

Condom breakage, slippage, or incorrect use;

Three or more consecutively missed combined oral contraceptive pills;

The Progestogen-only pill (Mini pill) taken more than three hours late (or more than 12 hours late if
taking a 0.75mg desogestrel-containing pill);

Norethisterone Enanthate (NET-EN) Progestogen-only injection taken more than two weeks late;

Depot-medroxyprogesterone acetate (DMPA) Progestogen-only injection taken more than four


weeks late;

The combined Estrogen-plus-progestogen monthly injection taken more than seven days late;

Dislodging, delay in placing, or early removal of a contraceptive hormonal ring or skin patch;

Dislodging, breakage, tearing, or early removal of a diaphragm or cervical cap;

Failed withdrawal (e.g. ejaculation in the vagina or on external genitalia);

Failure of a spermicide tablet or film to melt before intercourse;

Miscalculation of the periodic abstinence method, or failure to abstain or use a barrier method on
the fertile days of the cycle;

Expulsion of an intrauterine contraceptive device (IUD) or hormonal contraceptive implant.

In cases of sexual assault when the woman was not protected by an effective contraceptive method.

54

Reference Manual for Doctors on Family Planning and Reproductive Health

Dosage
WHO recommends Levonorgestrel for emergency contraceptive pill use. Ideally, this Progestogenonly method should be taken as a single dose (1.5 mg) within (72 hours) of unprotected intercourse.
Alternatively, a woman can take the Levonorgestrel in two doses (0.75 mg each; 12 hours apart).

Medical Eligibility Criteria


All women can use ECPs safely and effectively, including women who cannot use ongoing hormonal
contraceptive methods. Because of the short-term nature of their use, there are no medical conditions
that make ECPs unsafe for any woman.

Contraindications
Emergency contraceptive pills should not be given to a woman who already has a confirmed
pregnancy. However, if a woman inadvertently takes the pills after she becomes pregnant, the
available evidence suggests that the pills will not harm either the mother or her fetus.
Emergency contraceptive pills are for emergency use only and are not appropriate for regular use as
an ongoing contraceptive method because of the higher possibility of failure compared with nonemergency contraceptives. In addition, frequent use of emergency contraception can result in sideeffects such as menstrual irregularities, although their repeated use poses no known health risks.

Counselling
As with any other contraceptive method, EC pills should be provided in a manner that is
respectful to clients and responsive to their need for information and care. The following points
should be considered:
yy Ensure visual and audio privacy. Confidentiality is critical. Provider should not make any
judgmental comments and indicate disapproval. Supportive attitudes would encourage
compliance and set the stage for follow up.
yy Clients may be under stress because of fear of pregnancy, rape related trauma and
concerns of STIs. Hence maintain a supportive environment.
yy Frequent use. Emphasize that pills are for emergency use only and not recommended
for routine use due to higher possibility of failures. Although frequent use is not
recommended, repeat use poses no health risks and not a reason for denying access.
yy Counsel that pills does not give any protection against STIs.
yy Counsel about other contraceptive methods.
yy Explain common side effects.
yy Does not protect from pregnancy if there is unprotected sex in following days and week.
yy Advise client to come back if menses are delayed for more than one week .

55

Chapter 3: Reversible Contraceptives

Frequently asked questions


1. Do ECPs disrupt an existing pregnancy?

No. ECPs do not work if a woman is already pregnant. When taken before a woman has ovulated, ECPs
prevent the release of an egg from the ovary or delay its release by five to seven days. By then, any sperm
in the womans reproductive tract will have died, since sperm can survive there for only about five days EC
Pills do not displace an implanted embryo and cannot terminate an existing pregnancy.

2. Do ECPs cause birth defects? Will the fetus be harmed if a woman accidentally takes ECPs
while she is pregnant?

No. Good evidence shows that ECPs will not cause birth defects and will not otherwise harm the fetus if a
woman is already pregnant when she takes ECPs or if ECPs fail to prevent pregnancy.

3. How long do ECPs protect a woman from pregnancy?


Women who take ECPs should understand that they could become pregnant the next time they have sex
unless they begin to use another method of contraception at once. Because ECPs delay ovulation in some
women, she may be most fertile soon after taking ECPs. If she wants ongoing protection from pregnancy,
she must start using another contraceptive method at once.

4. What oral contraceptive pills can be used as ECPs?


Many combined (estrogen-progestin) oral contraceptives and progestin only pills can be used as ECPs.
Any pills containing the hormones used for emergency contraception Levonorgestrel, Norgestrel,
Norethindrone, and these Progestins together with Estrogen (Ethinyl estradiol) can be used.

5. Are ECPs safe for women with HIV or AIDS? Can women on antiretroviral therapy safely
use ECPs?

Yes. Women with HIV, AIDS, and those on antiretroviral therapy can safely use ECPs.

6. Are ECPs safe for adolescents?


Yes. A study of ECP use among girls 13 to 16 years old found it safe. Furthermore, all of the study participants
were able to use ECPs correctly.

7. Can a woman who cannot use combined (estrogen-progestin) oral contraceptives or


progestin-only pills as an ongoing method still safely use ECPs?

Yes. This is because ECP treatment is very brief.

8. If ECPs failed to prevent pregnancy, does a woman have a greater chance of that
pregnancy being an ectopic pregnancy?

No. To date, no evidence suggests that ECPs increase the risk of ectopic pregnancy. Worldwide studies
of Progestin-only ECPs, including a United States Food and Drug Administration review, have not found
higher rates of ectopic pregnancy after ECPs failed than are found among pregnancies generally.

9. Why give women ECPs before they need them? Wont that discourage or otherwise affect
contraceptive use?

No. Studies of women given ECPs in advance report these findings:

Women who have ECPs on hand took them sooner after having unprotected sex than women who
had to seek out ECPs. Taken sooner, the ECPs are more likely to be effective.

56

Reference Manual for Doctors on Family Planning and Reproductive Health

Women given ECPs ahead of time were more likely to use ECPs than women who had to go to a
provider to get ECPs.

Women continued to use other contraceptive methods as they did before obtaining ECPs in advance.

10. Should women use ECPs as a regular method of contraception?


No. Nearly all other contraceptive methods are more effective in preventing pregnancy. A woman who uses
ECPs regularly for contraception is more likely to have an unintended pregnancy than a woman who uses
another contraceptive regularly. Still, women using other methods of contraception should know about
ECPs and how to obtain them if neededfor example, if a condom breaks or a woman misses three or
more combined oral contraceptive pills.

11. If a woman buys ECPs over the counter, can she use them correctly?

Yes. Taking ECPs is simple, and medical supervision is not needed. Studies show that young and adult
women nd the label and instructions easy to understand. ECPs are approved for over-the counter sales or
nonprescription use in many countries.

12. Women/couple may not use regular contraception if EC is available easily.


This is not true as per the studies.

13. Men would not use condoms if they know that their partners can use ECs.

Condom use prevents both unwanted pregnancy as well as infections. Men may be willing to rely on
condoms if they know that ECs are available as a backup in the event of breakage and slippages.

3.3.5. Progestin only Injectable (POI)


Progestin-only injectables contain a synthetic progestin like the natural hormone progesterone in
a womans body. They do not contain estrogen. (Combined injectables contain both progestin and
estrogen.) There are two types of POIs:
yy DMPA (Depot Medroxy-progestron acetate): 150 mg every three months
yy NET-EN (Norehisterone Enanthate): 200 mg every two months
DMPA is the most widely used progestin-only injectable. DMPA is also known as the shot, the jab, the
injection, Depo. These methods have been used by millions of women in more than 100 countries in
the world in the last decades.
Mechanism of Actions
Progestin-only injectables work primarily by preventing ovulation (the release of eggs from the
ovaries). Also,these thicken the cervical mucus, which prevents sperm from penetrating into the
uterus and fallopian tubes and meeting an egg, and suppress endometrial growth, making the
uterine lining unsuitable for implantation of a fertilized egg. DMPA has prolonged duration of action
since progestin in released slowly from muscles.
Who Can Use Progestin-Only Injectables?
Nearly all women can use progestin-only injectables safely and effectively, including women who:
yy Have or have not had children.
57

Chapter 3: Reversible Contraceptives

yy Are not married or women of any age, including adolescents and women over 40 years of age
yy Have just had an abortion or miscarriage.
yy Smoke cigarettes, regardless of a womans age or number of cigarettes smoked.
yy Are breast feeding (starting as soon as six weeks after childbirth).
yy Have HIV or AIDS, regardless of whether they are taking anti-retroviral therapy.
Health Risks and Benefits
There are no known health risks of using progestin-only injectables. Known health benefits of
progestin-only injectables include the following:
yy DMPA protects against cancer of the lining of the uterus (endometrial cancer).
yy DMPA protects against uterine fibroids.
yy DMPA may help protect against symptomatic pelvic inflammatory disease.
yy For women with sickle cell anaemia, DMPA reduces the frequency and pain of sickle cell crises.
yy For women with endometriosis, DMPA reduces pain during menstrual periods, pain during
intercourse, and pelvic pain and tenderness.
yy Both DMPA and NET-EN may help protect against iron-deficiency anaemia.
Effectiveness
yy A highly effective contraceptive method with a typical pregnancy rate of about three percent
during the first year of use (3 pregnancies per 100 women). In other words, 97 of every 100
women using Progestin-only injectables will not become pregnant during the first year of use.
Effectiveness depends on having injections on time.
Frequency and Timing of Injections
yy Women using DMPA have an injection every three months (four times a year) and women
using NET-EN have an injection every two months (six times a year).
yy DMPA injections can be as much as two weeks early or up to four weeks late. NET-EN injections
can be given as much as two weeks early or up to two weeks late.

Medical Eligibility Criteria


POIs should not be given if she is breast feeding a baby less than six weeks, severe cirrhosis of liver,
systolic blood pressure is more than 160 and diastolic more than 100 and diabetes for more than
20 years or damage to other systems, stroke, blood clots in legs, lungs heart attack or other serious
heart problems, unexplained vaginal bleeding, had or have breast cancer and in presence of multiple
risk factors for cardio-vascular diseases.

58

Reference Manual for Doctors on Family Planning and Reproductive Health

Return to Fertility
yy Fertility returns after a woman stops using injectables. However, return to fertility is often
delayed on an average of 10 months after the last injection.

Side Effects
yy Bleeding changes are common but not harmful. Most women have frequent or irregular
bleeding at first and then little or no monthly bleeding.
yy Gradual weight gain is common. Some women gain an average of one to two kilograms per
year. Some users lose weight or have no significant change in weight.
yy Some women who use progestin-only injectables report having headaches, dizziness,
abdominal bloating and discomfort, mood changes, and less sex drive.
yy There are some concerns abouthypo-oestrogenic effects of POIs in women below 18 years
because of possible decrease in bone mass/density. Any obvious risk of osteoporosis should
be taken in account (chronic Corticosteroid therapy) when advising them for POIs. POIs can be
generally safe amongst adolescents as risks associated with unwanted pregnancies are higher
than the oretical risk of osteoporosis later in life.

Sexually Transmitted Infections and HIV


yy Injectable contraceptives do not prevent transmission of STIs, including HIV. Women at risk for
STIs/HIV should also use condoms along with the injectables to prevent STI/HIV transmission.
yy Injectable contraceptives are safe and effective for women who have HIV, including those who
have AIDS and those taking antiretroviral medications.

When Can a Woman Begin Using Progestin-Only Injectables?


No tests are necessary for a woman to being using progestin-only contraceptives. She can begin:
yy Without a pelvic exam.
yy Without any blood tests or other routine laboratory tests.
yy Without cervical cancer screening.
yy Without a breast examination.
yy Even when she is not having monthly bleeding at the time, if it is reasonably certain a woman is
not pregnant.

59

Chapter 3: Reversible Contraceptives

Frequently asked questions


1. Can women who could get sexually transmitted infections use progestin-only injectables?

Yes. Women at risk for STIs can use progestin-only injectables. The few studies available have found that
women using DMPA were more likely to acquire chlamydia than women not using hormonal contraception.
The reason for this difference is not known. There are few studies available on use of NET-EN and STIs.
Like anyone else at risk for STIs, a user of progestin-only injectables who may be at risk for STIs should be
advised to use condoms correctly every time she has sex. Consistent and correct condom use will reduce
her risk of becoming infected if she is exposed to an STI.

2. If a woman does not have monthly bleeding while using progestin-only injectables, does
this mean that she is pregnant?

Probably not, especially if she is breast feeding. Eventually most women using progestin-only injectables
will not have monthly bleeding. If she has been getting her injections on time, she is probably not pregnant
and can keep using injectables. If she is still worried after being reassured, she can be offered a pregnancy
test, if available, or referred for one. If not having monthly bleeding bothers her, switching to another
method may help.

3. Can a woman who is breast feeding safely use progestin-only injectables?


Yes. This is a good choice for a breast feeding mother who wants a hormonal method. Progestin-only
injectables are safe for both the mother and the baby starting as early as six weeks after childbirth. They do
not affect milk production.

4. How much weight do women gain when they use progestin-only injectables?

Women gain an average of 12 kg per year when using DMPA. Some of the weight increase may be the
usual weight gain as people age. Some women, particularly overweight adolescents, have gained much
more than 12 kg per year. At the same time, some users of progestin-only injectables lose weight or have
no significant change in weight. Asian women in particular do not tend to gain weight when using DMPA.

5. Do DMPA and NET-EN cause abortion?


No. Research on progestin-only injectables finds that they do not disrupt an existing pregnancy. They
should not be used to try to cause an abortion. They will not do so.

6. Do progestin-only injectables make a woman infertile?


No. There may be a delay in regaining fertility after stopping progestin only injectables, but in time the
woman will be able to become pregnant as before, although fertility decreases as women get older. The
bleeding pattern a woman had before she used progestin-only injectables generally returns several months
after the last injection even if she had no monthly bleeding while using injectables. Some women may have
to wait several months before their usual bleeding pattern returns.

7. Does DMPA cause cancer?


Many studies show that DMPA does not cause cancer. DMPA use helps protect against cancer of the
lining of the uterus (endometrial cancer). Findings of the few studies on DMPA use and breast cancer are
similar to findings with combined oral contraceptives: Women using DMPA were slightly more likely to be
diagnosed with breast cancer while using DMPA or within 10 years after they stopped. It is unclear whether
these findings are explained by earlier detection of existing breast cancers among DMPA users or by a
biologic effect of DMPA on breast cancer. A few studies on DMPA use and cervical cancer suggest that

60

Reference Manual for Doctors on Family Planning and Reproductive Health

there may be a slightly increased risk of cervical cancer among women using DMPA for five years or more.
Cervical cancer cannot develop because of DMPA alone, however. It is caused by persistent infection with
human papillomavirus. Little information is available about NET-EN. It is expected to be as safe as DMPA
and other contraceptive methods containing only a progestin, such as progestin-only pills and implants.

8. Can a woman switch from one progestin-only injectable to another?


Switching injectables is safe, and it does not decrease effectiveness. If switching is necessary due to
shortages of supplies, the first injection of the new injectable should be given when the next injection of
the old formulation would have been given. Clients need to be told that they are switching, the name of
the new injectable, and its injection schedule.

9. How does DMPA affect bone density?


DMPA use decreases bone density. Research has not found that DMPA users of any age are likely to
have more broken bones. However, when DMPA use stops, bone density increases again for women of
reproductive age. Among adults who stop using DMPA, after two to three years their bone density appears
to be similar to that of women who have not used DMPA. Among adolescents, it is not clear whether the
loss in bone density prevents them from reaching their potential peak bone mass.

10. Do progestin-only injectables cause birth defects? Will the fetus be harmed if a woman
accidentally uses progestin-only injectables while she is pregnant?

No. Good evidence shows that progestin-only injectables will not cause birth defects and will not otherwise
harm the fetus if a woman becomes pregnant while using progestin-only injectables or accidentally starts
injectables when she is already pregnant.

11. Do progestin-only injectables change womens mood or sex drive?


Generally, no. Some women using injectables report these complaints, however the great majority of
injectables users do not report any such changes. It is difcult to tell whether such changes are due to
progestin only injectables or to other reasons. Providers can help a client with these problems (see Mood
changes or changes in sex drive, p. 76). There is no evidence that progestin-only injectables affect womens
sexual behaviour.

12. What if a woman returns for her next injection late?


Revised WHO guidance recommends giving a woman her next DMPA injection if she is up to four weeks
late, without the need for further evidence that she is not pregnant. A woman can receive her next NETEN injection if she is up to two weeks late. Some women return even later for their repeat injection. In
such cases providers should assess for pregnancy. Whether a woman is late for reinjection or not, her next
injection of DMPA should be planned for three months later, or her next injection of NET-EN should be
planned for two months later, as usual.

13. What are the procedures for injection?


Dose-DMPA: 150 mg for injections into the muscle (intramuscular injection 8). NET-EN: 200 mg for
injections into the muscle.

If possible, use single-dose vials. Check expiration date. If using an open multi-dose vial, check that the
vial is not leaking. DMPA: A 2 ml syringe and a 2123 gauge intramuscular needle. NET-EN: A 2 or 5 ml
syringe and a 19-gauge intramuscular needle. A narrower needle (2123 gauge) also can be used. For each
injection use a disposable auto-disable syringe and needle from a new, sealed package (within expiration
date and not damaged), if available.

61

Chapter 3: Reversible Contraceptives

Hand Wash
Wash hands with soap and water, if possible. If injection site is dirty, wash it with soap and water. No need
to wipe site with antiseptic.
Preparation of vial
DMPA: Gently shake the vial. NET-EN: Shaking the vial is not necessary. No need to wipe top of vial with
antiseptic. If vial is cold, warm to skin temperature before giving the injection. Pierce top of vial with
sterile needle and fill syringe with proper dose.
Inject formula
Insert sterile needle deep into the hip (ventrogluteal muscle), the upper arm (deltoid muscle), or the
buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the
syringe. Do not massage injection site.

14. How to dispose of disposable syringes and needles safely?


Do not recap, bend, or break needles before disposal. Place in a puncture-proof sharps container. Do not
reuse disposable syringes and needles. They are meant to be destroyed after a single use. Because of
their shape, they are very difficult to disinfect. Therefore, reuse might transmit diseases such as HIV and
hepatitis. If reusable syringe and needle are used, they must be sterilized again after each use.

15. What is the management of side effects?


Problems reported as side effects may or may not be due to the method.

Problems with side effects affect womens satisfaction and use of injectables. They deserve the
providers attention. If the client reports side effects, listen to her concerns, give her advice and, if
appropriate, treat.

Offer to help the client choose another method now, if she wishes, or if problems cannot be
overcome.

No monthly bleeding

Reassure her that most women using progestin only Injectables stop having monthly bleeding over
time, and this is not harmful. There is no need to lose blood every month. It is similar to not having
monthly bleeding during pregnancy. She is not fertile. Blood is not building up inside her. (Some
women are happy to be free from monthly bleeding)

If not having monthly bleeding bothers her, she may want to switch to monthly injectables, if
available.

Irregular bleeding (bleeding at unexpected times that bothers the client)

Reassure her that many women using progestin only injectables experience irregular bleeding. It is
not harmful and usually becomes less or stops after the first few months of use.

For modest short term relief, take 800 mg Ibuprofen three times daily or 500 mg Mefenamic acid two
times daily after meals for five days , beginning when irregular bleeding starts.

If irregular bleeding continues or starts after several months of normal or no monthly bleeding ,
or you suspect that something may be wrong for other reasons, consider underlying conditions
unrelated to method use.

62

Reference Manual for Doctors on Family Planning and Reproductive Health

Weight gain
Review diet and counsel as needed.
Abdominal bloating and discomfort
Consider locally available remedies.
Heavy and prolonged bleeding (twice as much as usual or longer than 8 days)

Reassure her that some women using progestin- only injectables experience heavy or prolonged
bleeding. It is not harmful and usually becomes less or stops after a few months.

For modest short term relief she can try (one at a time):

Combined oral contraceptives (COCs), taking one pill daily for 21 days, beginning when heavy
bleeding starts.

50umg of Ethinyl estradiol daily for 21 days, beginning when heavy bleeding starts.

If bleeding becomes a health threat or if the woman wants, help her choose another method. In the
meantime, she can take ethinyl estradiol or COCs as above to help reduce bleeding.

To help prevent anaemia, suggest she take iron tablets and tell her it is important to eat foods
containing iron, such as meat and poultry (especially beef and chicken liver), fish , green leafy
vegetables and legumes (beans, bean curd, lentils and peas).

If heavy or prolonged bleeding continues or starts after several months of normal or no monthly
bleeding, or you suspect that something may be wrong for other reasons, consider underlying
conditions unrelated to method use

Ordinary headaches (non-migrainous)

Suggest Aspirin (325-650 mg), Ibuprofen (200-400 mg), Paracetamol (325-1000mg), or other pain
reliever.

Any headaches that get worse or occur more often during use of injectables should be evaluated.

Mood changes or changes in sex drive

Ask about changes in her life that could affect her mood or sex drive, including changes in her
relationship with her partner. Give support as appropriate.

Clients who have serious mood changes such as major depression should be referred for care.

Consider locally available remedies.

Dizziness

Consider locally available remedies.

New problems that may require switching methods


May or may not be due to the method.
Migraine headaches

If she has migraine headaches without aura, she can continue to use the method if she wishes.

If she has migraine aura, do not give the injection. Help her choose a method without hormones.

63

Chapter 3: Reversible Contraceptives

Unexplained vaginal bleeding

Refer or evaluate by History and Pelvic examination. Diagnose and treat as appropriate.

If no cause of bleeding can be found, consider stopping Progestin- only injectables to make
diagnosis easier. Provide another method of her choice to use until the condition is evaluated and
treated (not implants or a copper bearing or hormonal IUD).

If bleeding is caused by sexually transmitted infection or pelvic inflammatory disease, she can
continue using progestin- only injectables during treatment.

Certain serious health conditions (suspected blocked or narrowed arteries, liver disease, severe
high blood pressure, blood clots in deep veins of legs or lungs, stroke, breast cancer, or damage to
arteries, vision, kidneys, or nervous system caused by diabetes.

Do not give next injection.

Give her a backup method to use until the condition is evaluated.

Refer for diagnosis and care if not already under care.

Suspected pregnancy

Assess for pregnancy.

Stop injections if pregnancy is confirmed.

There are no known risks to a fetus conceived while a woman is using injectables.

3.3.6. Combined Injectables Contraceptive (CIC)


Injectable contraceptives are a highly effective, long-acting, reversible method of contraception.
They contain synthetic steroid hormones that are usually given by injection into the muscle of a
womans hip, upper arm, or buttocks, which are then released slowly into the bloodstream from the
injection site. Injectable contraceptives include combined injectables and progestin-only injectables.

Combined Injectables
CICs contain a short-acting Oestrogen and long acting progesterone. Combined injectables are also
called monthly injectables, CICs, and the injection.
One formulation of combined injectables contains Medroxyprogesterone acetate (MPA) and Estradiol
Cypionate; another formulation contains Norethisterone Enanthate (NET-EN) and Estradiol Valerate.
MPA/estradiol Cypionate is marketed under the trade names Ciclofem, Ciclofemina, Cyclofem, CycloProvera. NET-EN/Estradiol Valerateis marketed under the trade names Mesigyna and Norigynon.

Mechanism of Action
Combined injectables work primarily by preventing ovulation (the release of eggs from the ovaries).
They also thicken the cervical mucus, preventing sperm from penetrating into the uterus and fallopian
tubes and meeting an egg, and suppress endometrial growth, making the uterine lining unsuitable
for implantation of a fertilized egg.
64

Reference Manual for Doctors on Family Planning and Reproductive Health

Health Risks and Benefits


Long-term studies of combined injectables are limited, but most researchers expect that
health benefits and risks are similar to those of COCs. Combined injectables will protect against
yy Endometrial cancer
yy Ovarian cancer
yy Pelvic inflammatory disease
yy Ovarian cysts
yy Iron-deficiency anaemia and will
yy Reduce menstrual cramps, menstrual bleeding problems, ovulation pain, excess hair on face or
body
yy Polycystic ovarian syndrome
yy Endometriosis

Health risks of combined injectables include


yy Deep vein thrombosis (Rarely)
yy Pulmonary embolism (Rarely)
A key difference between combined injectables and COCs is that combined injectables do not pass
through the liver first because they are not taken by mouth like COCs. Short-term studies have
shown that combined injectables have less effect than COCs on blood pressure, blood clotting, the
breakdown of fatty substances (lipid metabolism), and liver function.

Effectiveness
yy Ninety seven of every 100 women using injectables will not become pregnant during the first
year of use. Effectiveness depends on returning on time for injections.

Frequency and Timing of Injections


yy Women using combined injectables have an injection every month (12 times a year).
yy Injections of combined injectables can be as much as seven days early or up to seven days late.

Return to Fertility
Fertility returns after a woman stops using combined injectables. However, return to fertility is slightly
delayed. Women take one month longer, on average, to become pregnant after stopping combined
injectables than women who used methods other than injectables.

65

Chapter 3: Reversible Contraceptives

Side Effects
yy Bleeding changes are common but not harmful. Bleeding changes are less common among
users of combined injectables compared with users of progestin-only injectables. Most women
have frequent, irregular or prolonged bleeding during the first three months of use, but most
have regular bleeding patterns after one year of use. About two percent of users have no
monthly bleeding after one year of use.
yy Gradual weight gain is common. Some women gain an average of one kilogram per year. Some
users lose weight or have no significant change in weight.
yy Some women report headaches, dizziness, and breast tenderness.
yy Loss of bone mineral density is not a concern with combined hormonal methods, including
combined injectables.

Sexually Transmitted Infections and HIV


yy Injectable contraceptives do not prevent transmission of STIs, including HIV. Women at risk for
STIs/HIV should also use condoms along with the injectables to prevent STI/HIV transmission.
yy Injectable contraceptives are safe and effective for women who have HIV, including those who
have AIDS and those taking most antiretroviral medications.
Who can use Combined Injectables?
Nearly all women can use combined injectables safely and effectively, including women who:
yy Have or have not had children.
yy Are not married.
yy Are of any age, including adolescents and women over 40 years of age.
yy Have just had an abortion or miscarriage.
yy Smoke any number of cigarettes daily and are under 35 years old.
yy Smoke fewer than 15 cigarettes daily and are over 35 years old.
yy Have anaemia now or had anaemia in the past.
yy Have varicose veins.
yy Have HIV or AIDS, regardless of whether they are taking antiretroviral therapy.

Medical Eligibility Criteria


CIC should not be used in the presence of:
yy Breast feeding and less than six weeks postpartum.
yy Past or present evidence of deep vein thrombosis or pulmonary embolism.

66

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Current and history of ischemic heart disease or stroke or Complicated Valvular heart disease.
yy Major surgery with prolonged immobilization.
yy Hypertension with vascular disease; Diabetes mellitus with vascular complications.
yy Migraine with aura.
yy Breast cancer within the past five years.
yy Active viral hepatitis and malignant liver tumour and generally not used in presence of benign
tumour.
yy Smoking over 15 or more cigarettes daily aged 35 years or more.
yy Hyperlipidemia, severe decompressed cirrhosis.
When Can a Woman begin Using Combined Injectables?
No tests are necessary for a woman to begin using combined injectables. She can begin:
yy Without a pelvic exam
yy Without any blood tests or other routine laboratory tests
yy Without cervical cancer screening
yy Without a breast examination
Even when she is not having monthly bleeding at the time, if it is reasonably certain a woman is not
pregnant.
Injection technique
yy Use only sterile or high-level disinfected syringes and needles. Disposable syringes and needles
must not be re-used.
yy Shake the vial thoroughly. (If the vial has been cooled warm it to room temperature first).
yy Remove the protective the cap of vial carefully, so as not to contaminate the stopper.
yy Aspirate contents into a sterile syringe to the exact volume required.
yy Clean the injection site.
yy Insert the sterile needle deep into the gluteal (upper outer quadrant) or deltoid muscle. (Many
providers prefer to give oil-based injections only in the gluteal muscle to reduce any pain
associated with injections).
yy Do not massage the injection site.
yy Dispose of the disposable needles and syringes as appropriate.

67

Chapter 3: Reversible Contraceptives

Frequently asked questions


1. Who can provide CICs?

Any health care provider who has been trained in the education and counselling of clients and the
administration of injectables may provide this method, depending on local regulations and practice.

2. How to administer initial injection to the client?


Give the initial injection within the first seven days of the menstrual cycle,preferably the first day. The client
can also have the first injection at any other time, if it is reasonably certain that she is not pregnant. If it
has been more than seven days since menstrual bleeding started she will need to abstain from sex, or use
additional contraceptive protection for the next seven days.

For the amenorrhoeic client

The client can have the first injection at any time, if it is reasonably certain that she is not pregnant.
She will need to abstain from sex or use additional contraceptive protection for the next seven days.

For the postpartum client

If the client is breast feeding and she wishes to use an injectable contraceptive, recommend the
Progestogen-only injectable. CICs should not be used earlier than six months postpartum or before
weaning.

If the client is not breast feeding, she can receive the initial injection from three to six weeks
postpartum. If the client wishes to start the CIC after the sixth week postpartum and she has not
yet had the first postpartum period, rule out the possibility of pregnancy before giving the initial
injection.

3. How to deal with a woman who is switching from another method to CIC?
Switching from another hormonal method

The client can have the first injection immediately if she has been using her other hormonal method
consistently and correctly, or if it is reasonably certain that she is not pregnant. There is no need to
wait for her next menstrual period.

If her previous method was an injectable contraceptive, she should start the CIC when the repeat
injection would have been given. No additional contraceptive protection is needed.

Switching from a non-hormonal method (other than the IUD)

The client can have the first injection immediately if it is reasonably certain that she is not pregnant.
There is no need to wait for her next menstrual period.

If she is within seven days the start of her menstrual bleeding no other contraceptive protection is
needed.

If it has been more than seven days since menstrual bleeding started, she will need to abstain from
sex or use additional contraceptive protection for the next seven days.

Switching from an IUD (including a hormone-releasing IUD)

The client can have the first injection within seven days after the start of her menstrual bleeding. No
additional contraceptive protection is needed. The IUD can be removed at that time.

68

Reference Manual for Doctors on Family Planning and Reproductive Health

The client can also start the CIC at any time if it is reasonably certain that she is not pregnant.

If she has been sexually active in the current menstrual cycle, and it has been more than seven
days since menstrual bleeding started, it is recommended that the IUD be removed at the time
of her next menstrual period.

If she has not been sexually active in the current menstrual cycle and it has been more than
seven days since menstrual bleeding started, she will need to abstain from sex or use additional
contraceptive protection for the next seven days. If that additional protection is to be provided
by the IUD she is using, it is recommended that this IUD be removed at the time of her next
menstrual period.

If she is amenorrhoeic or has irregular bleeding she can start CICs as advised for other amenorrhoeic
women.

4. What is to be followed during repeat injection?


Regular repeat injections are essential if pregnancy is to be avoided. The client needs to have an injection
every four weeks (approximately every month). Advise the client to visit the clinic as soon as possible if she
islate for the next injection.

Re-injection interval

Provide repeat injections every four weeks (approximately monthly).

If the client is early for an injection

When the standard four-week re-injection interval cannot be adhered to for any reason, the repeat
injection can be given up to seven days early but may disrupt bleeding patterns.

If the client is late for an injection

The repeat injection can be given up to seven days late without any need for additional contraceptive
protection.

If the client is more than seven days late for an injection she can have the injection if it is reasonably
certain that she is not pregnant. She will need to abstain from sex or use additional contraceptive
protection for the next seven days.

She may wish to consider the use of emergency contraception if exposed to unprotected intercourse

5. What are the warning signs for a woman who is receiving CICs?

Advise the woman to consult or visit the clinic if pregnancy is suspectedor if any of the following problems
occur:

Severe abdominal pain.

Severe chest pain, cough or shortness of breath.

Severe headache.

Loss of vision or blurring.

Severe pain in calf or thigh.

Jaundice (yellowness of the eyes and skin).

Unusually heavy bleeding.

Unusual discomfort or problem at the injection site.

69

Chapter 3: Reversible Contraceptives

To prevent anxiety in the client, explain to her that serious complications are very rare. You can inform her
that her health will be better protected by use of this highly reliable method of contraception than if an
unintended pregnancy were to occur.

Combined Injectable is soon going to be available in the market in India.

3.3.7. Implants
Definition
Implants (small plastic rods or capsules) are placed sub-dermally and release progestogen at a
controlled rate, thus providing very small daily doses to achieve the desired contraceptive effect. A
specifically trained provider performs a minor surgical procedure to place the implant under the skin
on the inside of womens upper arm. These do not contain oestogen and hence can be used during
breast feeding.
Available proprietary implants include the six-capsule Norplant (Seven years protection) the two-rod
Jadelle (effective for five years). Sino implant, two rods and effective for four years and the one-rod
Implanon effective for three years. The Norplant implant system is a highly effective, long-acting,
reversible, low-dose progestogen-only contraceptive. The system consists of six slender, soft, silastic
(silicone rubber) capsules. Each capsule is 2.4 mm in diameter and 34 mm in length, and contains 36
mg levonorgestrel.
Approximately 30 g Levonorgestrel a day is released and the effective life of the implant is seven
years (unless the woman weighs more than 70 kg). Jadelle consists of two silastic rods which release
Levonorgestrel and is effective for up to five years. Each rod is 43 mm long and 2.5 mm in diameter,
and contains 75 mg levonorgestrel. Implanon is a single capsule which releases ethonogestrel and
has a life span of three years. It is 40 mm in length and 2 mm in diameter, and contains 68 mg
etonogestrel.
Implants are inserted sub-dermally in the womans upper arm or forearm by a minor surgical
procedure under local anaesthesia. After insertion, the implants are palpable but barely visible.
Contraceptive effect is achieved by a slow, steady release of progestogen by diffusion through the
silastic membrane into the bloodstream. Protection against pregnancy starts within 24 hours after
insertion and lasts approximately seven years in the case of Norplant, five years for Jadelle, and three
years for Implanon. Fertility is restored almost immediately after the implants are removed.

Mode of action
As with other progestogen-only contraceptives, implants have two modes of action:
yy The effect of the progestogen on cervical mucus is the main factor in its contraceptive efficacy.
The mucus becomes viscous and scanty, thus inhibiting sperm penetration.
yy The progestogen acts on the hypothalamus and pituitary and suppresses the LH surge
responsible for ovulation. Ovulation is prevented in at least half of the cycles.
In most cases the endometrium shows signs of suppression. However, this effect does not play an

70

Reference Manual for Doctors on Family Planning and Reproductive Health

important role in the efficacy of progestogen implants because the changes in cervical mucus and
anovulation would prevent fertilization.

Indications
Progestogen-only implants, where available, should be provided to any woman who requests this
method and who does not have any contraindication to its use, after appropriate counseling and
reaching an informed decision.
Progestogen-only implants are a suitable method for most women of reproductive age, but
particularly indicated for women who:
yy Want a highly effective method of contraception.
yy Want a long-term contraceptive method.
yy Desire a method that is not coitally related.
yy Prefer a method that is not taken daily nor requires frequent re-supply.
yy Have the desired number of children, but do not wish to be sterilized.
yy Are considering sterilization, but are not yet ready to make a final decision.
yy Should not use oestrogen-containing contraceptives.
yy Have problems remembering to take oral contraceptives.
yy Women with chronic problems whose health would be threatened with pregnancy.
Implants are safe for use in all age groups, nulliparous women. Fertility return is immediate.

Medical Eligibility Criteria


Historically, the contraindications to progestogen-only contraceptives were considered to be
the same as for COCs. However, progestogen-only implants have no effect on blood pressure or
coagulation factors (and therefore poses no risk of venous thrombosis), have a negligible effect on
lipid metabolism and have very little effect on liver function. Thus contraindications for progestogenonly implants may be considered separately from those for COCs.

Contraindications
Category 4
Progestogen-only implants should not be used in the presence of:
yy Breast cancer within the past five years.
Category 3
Do not advise the use of progestogen-only implants or provide them to women with:

71

Chapter 3: Reversible Contraceptives

yy Present evidence of deep vein thrombosis or pulmonary embolism (DVT/PE).


yy Active viral hepatitis.
yy Severe decompensated cirrhosis.
yy Benign or malignant liver tumour.
yy History of breast cancer with no evidence of disease for the last five years.
yy Breast feeding and less than six weeks postpartum.
yy Unexplained vaginal bleeding suggestive of a serious underlying condition (before evaluation).
yy Drug treatment affecting liver enzymes: rifampicin and certain anticonvulsants (Phenytoin,
Carbamazepine, Barbiturates, Primidone, Topiramate, Oxcarbazepine).
When any Category 3 condition is present explain to the client the potential risks and counsel
her about alternative methods. If the client chooses a progestogen-only implant because other
contraceptive options are not available or are unacceptable, it is particularly important that the
method should be provided by a properly qualified practitioner and that the woman is kept under
medical supervision.
Category 2
Progestogen-only implants can generally be used with precaution in the presence of:
yy Raised blood pressure (systolic 160 or diastolic 100 mmHg).
yy Any history of hypertension where the blood pressure cannot be evaluated.
yy Hypertension with vascular disease.
yy Current and history of Ischaemic heart disease or stroke.
yy Diabetes with or without complications (history of gestational disease is category 1).
When any of these conditions is present, careful screening and appropriate monitoring will allow the
benefits of using an implant to outweigh any potential risks. However, if a woman has more than
one of the first five conditions above, which may increase the risk of arterial cardiovascular disease; it
should be considered as category 3 of the medical eligibility criteria. If the client chooses an implant
because other contraceptive options are not available or acceptable, it is particularly important to
advise her that close medical follow-up is required.
If the method is provided, record the womans special condition in the clinical record and advise her
of warning signs relevant to her condition.

72

Reference Manual for Doctors on Family Planning and Reproductive Health

Counselling
Discuss the following points clearly with the client in language that she understands:
yy The physical characteristics of the implants, how they are inserted and in which part of the
body, and how they should feel under the skin.
yy Advantages and disadvantages of implants including effectiveness and length of
protection, risks and benefits, possible side-effects (particularly changes in menstrual
pattern), the procedures of insertion and removal and cost.
yy When implants should be removed.
yy The importance of follow-up visits.
yy After a client has chosen implants as her method of contraception make sure that she has
understood the following points before insertion:

Possible changes in her menstrual bleeding pattern and the fact that these usually
decrease with time.

Side-effects and complications to watch out for.

The importance of removal of the implant after its effective life span has expired
(7 years for Norplant, 5 years for Jadelle, and 3 years for Implanon).

Alternative family planning methods including information on effectiveness, risks and


benefits, side-effects and cost as appropriate.

Choice of Implant
The two newer sub-dermal implants Jadelle and Implanon are easier to insert and remove than
Norplant. In general, when renewing a sub-dermal implant, service programmes should replace
Norplant with Jadelle or Implanon. Selection of the implant will depend mainly on availability and
cost, besides other factors.

Insertion and Removal


Insertion
Insert the sub-dermal implant within the first seven days of the menstrual cycle. No additional
contraceptive protection is needed. The client can also have the implant inserted at any other time, if
it is reasonably certain that she is not pregnant. If it has been more than seven days since menstrual
bleeding started she will need to abstain from sex, or use additional contraceptive protection, for
the next seven days.
For the amenorrhoeic client
yy The client can have the implant inserted at any time, if it is reasonably certain that she is not
pregnant. She will need to abstain from sex or use additional contraceptive protection for the
next seven days.
73

Chapter 3: Reversible Contraceptives

For the postpartum client


yy If the client is breast feeding and she wishes to use a progestogen-only sub-dermal implant,
insert the implant from the sixth week postpartum, but not earlier. If she is between six weeks
and six months postpartum and amenorrhoeic, she can have the implant inserted at any time.
If she is fully or nearly fully breast feeding no additional contraceptive protection is needed.
yy If the client is not breast feeding she can have the implants inserted immediately or at any time
within the first six weeks postpartum. If the client requests the implant after the sixth week
postpartum and she has not yet had the first postpartum period, rule out the possibility of
pregnancy before inserting the initial implant.
Immediately or in first seven days after first or second trimester abortion
Basic principles for insertion and removal
yy Insertion and removal should only be performed by health personnel specially trained in these
procedures.
yy Proper insertion techniques are important to ensure ease of removal.
yy Perform insertion and removal only in a properly equipped clinical facility.
yy Maintain strict sterile techniques.
yy Before and during the insertion procedure, tell the woman what will happen during this
procedure and encourage her to ask questions.
yy Explain to her that she may feel some discomfort during some of the steps.

Indications for Removal of Sub-dermal Implants


yy User request: Remove the implants without unnecessary delay when the client makes a firm
request for it to be done.
yy Pregnancy: Remove the implants as soon as pregnancy is confirmed.
yy Medical reasons such as:

Heavy menstrual bleeding.

Repeated severe headache or migraine-type headache occurring for the first time.

Symptoms of acute liver disease.

Serious infection of insertion site not amenable to treatment with antibiotics and/or local
measures.

yy At the end of 7/5/3 years after insertion: If the woman wishes to continue with the method, you
can insert a new set of implants after removing the old set.

74

Reference Manual for Doctors on Family Planning and Reproductive Health

Instructions to the Client


Provide all instructions clearly and in a language appropriate to the background of the client.

Instructions after Insertion


yy After the effect of the local anaesthetic has worn off, there may be some discomfort and/or
swelling at the site of insertion for one to two days.
yy The woman must keep the site of insertion dry for four days.
yy The gauze should be removed after three days and the bandage removed on the fifth day.
yy The contraceptive effect of the implant starts soon after the capsules are inserted, so
intercourse can be resumed the day after insertion.

Side Effects
yy Advise the client about possible side effects, change in the menstrual bleeding, light spotting,
continuous and irregular bleeding or amenorrhea, headache, enlargement of ovaries dizziness,
skin rash and change in appetite
yy Most side effects would go away in one year.

Warning signs
Advise the client to make contact with the clinic or to return immediately if any of the following
problems occur:
yy Pain, pus or bleeding at the site of insertion.
yy Expulsion of the implant.
yy Unusually heavy vaginal bleeding.
yy Menstrual bleeding has not occurred within six weeks after the previous menstrual period.
yy Severe abdominal or pelvic pain.
yy New or severe headaches.
yy Yellow eyes or skin.
yy Shortness of breath or severe chest pains.
To prevent anxiety in the client, explain to her that serious complications are very rare. You can
mention that her health will be better protected by using this highly reliable method of contraception
than if an unintended pregnancy were to occur.

Follow-up
Give the client the date of the next visit (within 1 month). Explain that the implant should be removed
after 7/5/3 years and tell her the month and the year when it should be done. Also explain to her the
75

Chapter 3: Reversible Contraceptives

importance of another clinic where there is staff trained to perform the removal. This information,
the list of warning signs, and the name, address and telephone number of the clinic, can be put on
a card or leaflet and given to the client. This should be written and presented in such a way that the
client or somebody close to her (in case she cannot read) can readily understand it.

Removal
If the client has any problems with the subcutaneous implant or if she wishes its removal, she must
return to a clinic which provides implant removal services by trained providers.

Follow-up Care
The client should be seen within one month after insertion, mainly to check the insertion site and to
discuss any questions or concerns that she may have. Thereafter she should be seen at least annually.
The client should be given the option to attend the service delivery site most convenient to her,
provided that the site has staff properly trained in implant services.

Annual Follow-up Protocol


yy Update the clients address and how to make contact with her.
yy Assess the clients satisfaction with this method of contraception.
yy Determine if the client has had any problems or side effects and, if so,record them in the
clinical record. Update the medical history.
yy Perform a physical assessment including:

Blood pressure

Breast examination (with instruction for self-examination).

A bimanual pelvic examination, with a cervical smear if this is due and possible.

yy Provide appropriate counseling and/or treatment as required.


yy Review with the client the warning signs and instructions given at the previous visit, particularly
the need for removal (at 7 years if using Norplant, at 5 years if using Jadelle or at 3 years if using
Implanon), and the need to return to the same clinic or another competent clinic for removal
(give information on that clinic if applicable). Give instructions for annual follow-up.

Side Effects
yy The most frequent side-effect is disruption of the menstrual cycle. This includes prolonged
bleeding, spotting between periods or amenorrhoea. In general, the total monthly blood loss
is less than in a normal menstrual period, but some women may experience heavy bleeding.
yy Changes in menstrual bleeding patterns (breakthrough bleeding and spotting) are common,
especially during the first year of use. They are often temporary, and are rarely a risk to health.
Careful counseling of women starting to use sub-dermal implants has reduced the numbers
76

Reference Manual for Doctors on Family Planning and Reproductive Health

who discontinue this method because of these side effects. Clients who are fully informed
beforehand about what to expect will be better able to understand and cope with these and
other side effects, and this method usually results in a high degree of satisfaction among
women. If the problem persists or if bleeding becomes too heavy, gynaecological problems
should be excluded. If an STI or PID is diagnosed, the client can continue to use implants while
receiving treatment, and should be counseled on condom use. If no gynaecological problems
are found treatment with Ethinyl Oestradiol, low-dose combined oral contraceptives or nonsteroidal anti-inflammatory drugs may be tried. If this treatment is not effective and the
problem becomes a threat to the health of the woman or is not acceptable to her, the use of
implants should be discontinued. Help her to choose another method of contraception.
yy Headache is the second most frequent complaint. Less common side effects include
nervousness, nausea, dizziness, weight gain and skin side effects such as acne.
yy If any capsules are expelled (a rare problem), replace them with new capsules as soon as the
area is healed. Provide an interim back-up method of contraception.

Service Management
Progestogen-only sub-dermal implants require special attention by programme managers, mainly
because use of this method requires a surgical procedure, long-term follow-up and readily available
facilities for removal. Sexual Reproductive Health/family planning services therefore require the
availability of a well-designed information, education and communication system; suitable clinical
facilities; the establishment of training centres; and appropriate record-keeping and client follow-up
systems.

Client Records and Follow-up


A record-keeping system which assures an up-to-date clinical record for each implant user is
required. All client records should include findings from clinic assessment as well as insertion details.
The record-keeping system should include a register for scheduled removals, and a mechanism for
tracking clients so that the removal at 7/5/3 years may be accomplished in a timely fashion. The
programme should have a system to ensure proper follow-up of all clients, including procedures to
remind them to return to the clinic for check-ups and for removal at the end of the 7/5/3-year period.

Clinical Facilities
Facilities should:
yy Be sufficient for any demand which may be generated.
yy Ensure permanent access to removal on demand for users.
yy Have the essential equipment for insertion and removal.
yy Have access to steam autoclave and other facilities for decontamination, cleaning and
sterilization of equipment.
yy Have permanent availability of trained staff.
77

Chapter 3: Reversible Contraceptives

Storage, Shelf-life and Supplies


yy Store implants at room temperature away from excess heat and moisture.
yy Shelf-life is five years when stored as above.

Availability in India
The Indian Council of Medical Research (ICMR) has conducted trials with the single rod implant;
Implanon. The product is to be licensed for use in India soon.

Frequently asked questions


1. Why should family planning programmes consider providing implants?

Hormone-releasing sub-dermal implants are a highly safe, acceptable, effective, and reversible form of
contraception. Implants prevent pregnancy for an extended period of time after a single administration; no
regular action by the user and no routine clinical follow up are required. Implants have high continuation
and client satisfaction rates

2. What are contraceptive implants?


Contraceptive implants are small, thin, flexible plastic rods, each about the size of a matchstick, that are
inserted under the skin of a womans upper arm and release a progestin hormone into the body. The
most common types include Implanon (one rod containing 68 mg of progestin etonogestrel); Jadelle (two
rods, each containing 75 mg of levonorgestrel); and Sino-implant (II) (two rods, each containing 75 mg of
levonorgestrel), which is currently marketed as Zarin in much of Africa. Norplant (a six capsule system) is no
longer available as of 2008.

3. How do implants work?


The progestin hormone released by the implants prevents pregnancy by thickening the cervical mucus,
which blocks sperm from meeting an egg. Varying levels of ovulation suppression also occurs, depending
on the type of implant used.

4. Do implants interrupt a current pregnancy?


No. Implants do not interrupt an existing pregnancy, nor will they harm the fetus in the unlikely event that
pregnancy occurs during use

5. How effective are contraceptive implants?


Implants are one of the most effective reversible methods ever developed, comparable to intrauterine
devices (IUDs), as well as female and male sterilization. Overall, in three years of Implanon use, less than
one pregnancy per 100 users can be expected. In five years of Jadelle use, 1.1 pregnancies per 100 users
can be expected. In four years of use of Sino-implant (II), the cumulative pregnancy rate is 0.9-1.06 percent.
In general, long-acting methods, including implants, are more effective in practice than shorter acting
methods, including oral contraceptives and injectables, because compliance and continuation rates are
higher with methods that do not require regular action by the user

6. How effective are implants if they are kept in place beyond the time period of labelled
use?

Manufacturers decide on the duration of labelled use when they pursue product registration. However,

78

Reference Manual for Doctors on Family Planning and Reproductive Health

clinical evidence suggests implants still remain effective beyond these time periods. According to this
evidence, when use is extended by at least an additional year, pregnancy rates for Implanon, Jadelle and
Sino-Implant remain below 1-2 percent, depending on the type of implant. This compares favourably to
pregnancy rates associated with common use of other reversible methods of contraception, such as COCs
(8 percent), progestin-only injectables (3 percent) and condoms (15 percent).

7. Who can use contraceptive implants?


Implants can be used by women from menarche to menopause. Many women can safely use implants
including lactating mothers, HIV-positive women, cigarette smokers of any age, post-abortion women,
diabetic women, women at risk for cardiovascular disease (including those with high blood pressure), and
adolescents. Studies have shown that use of the implant has no impact on breast feeding or on the healthy
development of breast-fed babies. Implants can be initiated immediately after childbirth if a woman is not
breast feeding, and six weeks postpartum if a woman is partially or fully breast feeding (WHO, 2004).

8. What are the other major advantages of contraceptive implants?


Implants offer women a number of advantages that can suit their reproductive intentions and that make
continued use easy:

Convenience

Immediate return to fertility

Any side effects resolved immediately after removal

No known health risks

Suitable for nearly all women

9. What do good implant services include?


Good implant services require a competent and well-prepared staff that can perform insertion and removal
procedures and can help clients make an informed choice about implants. Programmes can prepare
providers to insert and remove implants through competency-based training. Providers can help clients
interested in implants by: counseling them about side effects with an emphasis on bleeding changes;
screening clients for conditions which may preclude safe use of implants; describing and answering
questions about insertion and removal; and determining whether the client can have implants inserted
immediately. Programmes should also ensure womens access to removal services (Ramchandran &
Upadhyay, 2007; WHO, 2007; WHO, 2009).

10. Who can provide implants?


Many different cadres of health care professionals can safely provide implants if they are thoroughly
trained. These include nurses, nurse-midwives, nurse-practitioners, midwives, physicians, and physicians
assistants and associates; in some countries, community health workers are also being trained to insert
implants (Chikamata, 2002; WHO, 2007).

11. How is Implanon inserted?


Implanon comes packaged in a specially designed applicator. The provider identifies the location for
insertion on the inner side of the upper arm. After injecting local anesthetic, the provider uses the needle
of the pre-loaded applicator to puncture the skin and places the single implant under the skin.

12. What are the most commonly used techniques for removal of implants?

There are two commonly used techniques for removing new implants. With the pop-out technique, the

79

Chapter 3: Reversible Contraceptives

provider first feels the site to ensure that the implant(s) can be located underneath the skin. The provider
then makes a small incision at the lower (distal) end of the implant, pushes the implant gently towards
the incision until the tip is visible, and then removes it with forceps. The U technique was developed for
use when Norplant proved difficult to remove and also to make routine removals easier. The technique
involves the use of an oval-ring-tipped forceps with an internal diameter of 2.2 mm to reach through a 4
mm incision to firmly grasp and remove each of the capsules (Rosenberg et al., 1997).

13. How important is it to counsel clients considering implants about bleeding changes?

It is very important to counsel clients about bleeding changes, in easily understandable,appropriate


language (and to ascertain that the client has understood what she is being told). Bleeding changes are
the most common reason that women cite for discontinuing implants. For example, in a Norplant study in
Senegal, women who perceived their counseling to be thoroughthat is, counseling included discussion
of side effects and of other contraceptive optionswere less likely than other women to discontinue use
of implants when bleeding changes did occur (Ba et al., 1999). Providers can explain that bleeding changes
are usually harmless and in most cases diminish over time. Every client should understand that she is
welcome to come back to consult with the provider at any time. If the bleeding changes are not acceptable
to the client, she should always have the option of switching to another, more acceptable method (WHO,
2007).

14. Why should clinics have a clear policy on removal?


Access to services for implant removal, or lack of access to removal, could strongly influence public
perceptions of implants. Providers and family planning programmes could be considered coercive if
women cannot have implants removed whenever they want to have them removed. Clinics that offer
implants should develop and communicate a clear policy on removal that states the following:

Whenever a woman wants her implant(s) removed, she should be able to have them removed
promptly free of charge or at an affordable price, without undue waiting, regardless of where or
when the implants were inserted.

A woman should not feel pressured to keep her implant(s). They should be removed whatever her
reason, whether it is personal or medical.

80

Reference Manual for Doctors on Family Planning and Reproductive Health

3.4. Combined Vaginal Rings


Combined Vaginal Ring a flexible ring placed in the vagina. Continuously releases two hormonesa
progestin and an estrogen, like the natural hormones progesterone and estrogen in a womans
bodyfrom inside the ring.
Its effectiveness depends on the user: Risk of pregnancy is greatest when a woman is late to start a
new ring. The combined vaginal ring is new, and research on effectiveness is limited. Effectiveness
rates in clinical trials of the vaginal ring suggests that it may be more effective than combined oral
contraceptives, both as commonly used and with consistent and correct use

Mechanism of Action
Hormones are absorbed through the wall of the vagina directly into the bloodstream. Over the
course of three weeks, the device releases a continuous low dose of estrogen and progestin. Higher
estrogen and progestin levels signal the brain not to release the hormones that cause egg maturation.
Without an egg ready to be released into the fallopian tube, ovulation cannot occur. The ring should
be removed three weeks after insertion, on the same day of the week as it was inserted.
Generally menstrual period will usually start two to three days after removal of Ring. After a oneweek break, a new ring is to be inserted. It is important that you insert a new ring on the same day
of the week as it was removed in the last cycle, even if your menstrual period has not stopped. The
ring is kept in place for three weeks, and then removed for the fourth week. During this fourth week
the woman will have monthly bleeding. Works primarily by preventing the release of eggs from the
ovaries

How to use
Explain how to insert the ring
yy She can choose the position most comfortable for herfor example, standing with one leg up,
squatting, or lying down.
yy She should press opposite sides of the ring together and gently push the folded ring entirely
inside the vagina.
yy The exact position is not important, but inserting it deeply helps it to stay in place, and she is
less likely to feel it. The muscles of the vagina naturally keep the ring in place.
Explain that the ring must be left in place for three weeks
yy She should keep the ring in place all the time every day and night for three weeks.
yy She can take the ring out at the end of the third week and dispose of it in a waste receptacle.
yy She should wash her hands clean and dry before taking out ring from the foil.

81

Chapter 3: Reversible Contraceptives

She should take out the ring for the fourth week
yy To remove the ring, she should hook her index finger inside it, or squeeze the ring between her
index and middle fingers, and pull it out.
yy She will probably have monthly bleeding this week.
yy If she forgets and leaves the ring in for as long as a fourth week, no special action is needed.
yy Never dispose of the ring in the toilet.
Ring should never be left out for more than three hours until the fourth week.
yy The ring can be removed for sex, cleaning, or other reasons, although removing it is not
necessary.
yy If the ring slips out, she should rinse it in clean water and immediately reinsert it.

Instructions for Late Replacement or Removal


yy Left ring out for more than three hours during weeks one or two

Put the ring back in as soon as possible. Use backup method* for the next seven days.

yy Left ring out for more than three hours during week three

Stop the current cycle and discard the ring.

Insert a new ring immediately and keep it in place for three weeks, starting a new cycle. Use
a backup method for the next seven days.

(Another option, if the ring was used continuously and correctly for the past seven days: Leave the
ring out and make the next seven days the week with no ring. After those seven days, insert a new
ring, starting a new cycle, and keep it in place for three weeks. Use a backup method for the first
seven days with the new ring.)
yy Waited more than seven days before inserting a new ring, or kept ring in longer than four weeks

Insert a new ring as soon as possible and begin a new four-week cycle. Use a backup
method for the first seven days of ring use.

Also, if a new ring was inserted three or more days late (ring was left out for 10 days
or more in a row) and unprotected sex took place in the past five days, consider taking
emergency contraceptive pills

Key points for providers & clients


yy Requires keeping a flexible ring in the vagina. It is kept in place all the time, every day and
night for three weeks, followed by a week with no ring in place.
yy Start each new ring on time for greatest effectiveness.

82

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Bleeding changes are common but not harmful. Typically irregular bleeding for the first few
months and then lighter a more regular bleeding.

Advantages of Vaginal Ring


yy Return of fertility after ring use is stopped: No delay
yy Protection against sexually transmitted infections: None

Disadvantages of Vaginal Ring


yy Vaginal Rings dont protect against HIV infection or STIs such as chlamydia, genital herpes,
genital warts, gonorrhea, hepatitis B and syphillis

Side Effects of Vaginal Ring


Some users report the following:
yy Changes in monthly bleeding, including:

Lighter bleeding and fewer days of bleeding

Irregular bleeding

Infrequent bleeding

Prolonged bleeding

No monthly bleeding

yy Headaches, dizziness
yy Irritation, redness, orinflammation of the vagina (vaginitis)
yy White vaginal discharge
yy Weight gain
yy Vomiting

Contraindications
All the contraindications for hormonal contraceptives are also to be considered.

83

Chapter 3: Reversible Contraceptives

Frequently asked questions


1. Can a Vaginal Ring get lost inside of me?

No. A Vaginal Ring cannot be pushed too far up or get lost in your body. In fact,it cannot go farther than
the cervix.

2. Will a Vaginal Ring dissolve?


No. A Vaginal Ring does not dissolve. It releases a low dose of hormones into your body over the course of
three weeks. After that time, you need to remove it, take a week off from vaginal ring and insert a new one
seven days after removal

3. Is a Vaginal Ring like a diaphragm?


No. it is not a barrier method. Just like the pill, it is a contraceptive that contains hormones for preventing
pregnancy.

4. What should one do if the Vaginal Ring is in it for too long?


If a Vaginal Ring has been left in for more than three weeks (but less than 4 weeks), remove it immediately
and insert a new ring after a one-week ring-free break.

If it has been left in place for more than four weeks, you may not be adequately protected from pregnancy
and must check to be sure you are not pregnant. If you are not pregnant, insert a new vaginal ring. You
must use an extra method of birth control (such as condoms or spermicide) until you have used the new
vaginal ring for seven days in a row. If you know or suspect you may be pregnant, do not use vaginal ring.
See your doctor as soon as possible.

5. Can there be an overdose when using the Vaginal Ring?


The Vaginal Ring is unlikely to cause an overdose because the ring holding the medicine releases a steady
amount of contraceptive hormones. Do not use more than one ring at a time. Overdose of combination
hormonal contraceptives may cause nausea, vomiting, or vaginal bleeding.

6. How should I store the Vaginal Ring?


After being dispensed by the pharmacy, a Vaginal Ring can be stored for up to four months at room
temperature (25C). Temperatures can be from (15 to 30C). Avoid direct sunlight or storing above (30C).

7. Can a woman use vaginal medications when using a Vaginal Ring?


Use of spermicides or vaginal yeast products will not reduce the contraceptive efficacy of a Vaginal Ring.

8. What happens when the Ring disconnects?


There have been reported cases of Vaginal Ring disconnecting at the weld joint causing the ring to change
shape and straighten out. This is not expected to affect the contraceptive effectiveness of a Vaginal Ring.
If the Vaginal Ring disconnects, expulsion (slipping out) is more likely to occur. If you discover the ring has
disconnected, you should discard the ring and replace it with a new ring.

84

Chapter 4

Irreversible Methods
Male Sterilization
Female Sterilization

85

Chapter 4: Irreversible Contraceptives

4.1. Male Sterilization


Male Sterilization
Vasectomy, a method of male sterilization, is a simple, minor surgical procedure that is performed by
entering the scrotum through a small incision or puncture, locating each vas deferens, and cutting
/blocking each of the vas to prevent sperm from passing. It usually takes 5-15 minutes to perform,
after 5-10 minutes for preoperative preparation and administration of local anaesthesia. It is also
called male sterilization or male surgical contraception.

Mechanism of Action
It works through closing of vas deference on either side. This keeps sperms out of his semen. The
man can still have erections and ejaculate semen. His semen, however, no longer makes a woman
pregnant because it has no sperm in it.

Effectiveness
This is one of the most effective and permanent methods but carries a small risk of failure as commonly
used0.15 pregnancies per 100 men in the first year after the procedure. The risk of failure is greater
if men get their semen examined within three months of the procedure as vasectomies are not
effective till three months after the procedure. Correct use means using condoms or another effective
family planning method consistently for at least for first three months or till the sperm completely
disappears from the semen.
If a partner of man becomes pregnant this may be because
yy Couple did not use any other method for three months after vasectomy
yy The provider made a mistake
yy Cut ends of vas regenerated
The procedure is intended to be permanent. A reversal of this surgery is possible but it involves
major surgery, is expensive difficult and may not be available and its success cannot be guaranteed.

Advantages
yy Nothing to remember except to use condoms or another family planning method for at least
the first three months or till the sperm completely disappears from semen.
yy No interference with sex. Does not affect the mans ability to have sex.
yy Increased sexual enjoyment because no need to worry about pregnancy.
yy No supplies to get, no repeated clinic visits required.
yy No apparent long term health risks.
86

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Compared with voluntary female sterilization, vasectomy is:

Probably slightly more effective

Slightly safer

Easier to perform. Less invasive

If there is a charge, often less expensive

Able to be tested for effectiveness at any time.

If pregnancy occurs in the mans partner, less likely to be ectopic than a pregnancy in a
woman who has been sterilized.

Complications
yy Common intra-operative complications:

Transient drop in BP or dizziness due to vaso-vagal attack. In such cases procedure should
be delayed and client allowed rest. An intravenous injection of atropine (0.6 mg) be given if
there is bradycardia. Oxygen should be administered simultaneously.

Convulsion and reactions to local anaesthesia. Maintain patency of airways and give 100
percent oxygen. If convulsion persists injection diazepam (5-10mg) IV can be given. Surgery
should be stopped and client allowed to recover.

Injury to testicular artery. This is rare, but if it occurs, pressure should be used to
tamponade both ends of the vessel. Subsequently both ends of artery should be ligated.

yy Immediate complications of surgery:

Minor complications such as swelling of scrotal tissue, bruising and pain. These often
disappear without any treatment. Ice packs, scrotal support and simple analgesics may
provide relief.

Hematoma. If this is small treat by scrotal support, analgesics and antibiotics. A large
hematoma may need evacuation and further treatment. If hematoma is detected remove
clots, look for bleeding and oozing points which should be tied. Referral should be
considered.

yy There can be stitch abscess, wound sepsis and orchitis. These conditions should be treated with
antibiotics, local dressing and analgesics.
yy Delayed complications:
There can be sperm granuloma at either side of vas occlusion. Majorities are symptomless and easily
respond to analgesics and anti-inflammatory drugs. There is no association of prostatic or testicular
and cardiovascular diseases with vasectomy.

87

Chapter 4: Irreversible Contraceptives

Medical Eligibility
Most men can have vasectomy.
Most men who want vasectomy can have safe and effective procedures in routine settings. This
includes men of any age, who have no children, who have sickle cell disease or hereditary anaemia;
or who are HIV positive or at high risk of HIV or other STIs (However, vasectomy does not prevent a
man from passing HIV or other STIs to others).
If he has the following, DELAY vasectomy and refer for treatment:
yy Active sexually transmitted infection.
yy Inflamed (swollen and tender) tip of penis, ducts or testicles.
yy Scrotal skin infection or mass in the scrotum.
yy Acute systemic infection or significant gastroenteritis.
yy Filariasis or elephantiasis.
If he has any of the following, REFER him to a centre with experienced staff and equipment that can
handle potential problems:
yy Hernia in the groin (provider if able, can perform vasectomy at the same time as repairing
hernia. If this is not possible, the hernia should be repaired first).
yy Undescended testicles- both sides.
yy Current-AIDS related illness.
yy Coagulation disorders.
If he has any of the following, use CAUTION: (means this can be done in routine settings but extra
precautions are needed):
yy Previous scrotal surgery or injury.
yy Large varicocoel or hydrocoele (swollen veins or membranes in the spermatic cord or
testes, causing swollen scrotum).
yy Undescended testicles one side only (vasectomy is performed on the normal side only.
Then if any sperm remains in the semen after three months, the other side must be done,
too).
yy If he has diabetes.
IMPORTANT: A man considering vasectomy needs good counseling.

88

Reference Manual for Doctors on Family Planning and Reproductive Health

Counseling
Since a vasectomy is intended to be a permanent method of contraception, it should be
provided only to men who have decided on their own that they do not want children any more.
Clients should be counseled about other available methods of contraception before deciding
on sterilization. Counseling should also include sharing information on the simplicity of the
procedure and how a man can also be responsible partner in matters of reproduction and
contraception.

Client assessment
Vasectomy is a safe and simple procedure when undertaken with proper screening. Prior to vasectomy,
a medical history should be taken and a limited physical examination should be done including
genital examination; the penis, scrotum, and inguinal region should be inspected visually; and the
scrotum should be palpated. Laboratory tests should not be routine but should be reserved for
specific cases in which the provider suspects a condition that would make it necessary to take extra
preparation or preparation.

Informed consent
The surgeon should verify that the client has signed the informed consent form before beginning the
procedure. Although the purpose of signing the form is to document informed consent, the principal
focus should be on confirming that the client has made an informed choice for a vasectomy as a
contraceptive method.

Infection prevention
Strict adherence to infection prevention practices all the times (before, during and after) is also crucial
to the safety of the procedure. Proper aseptic technique is essential to prevent both immediate and
long-term infectious morbidity and mortality. Inadequate infection prevention practices can lead to
surgical site infections, tetanus and infections such as HIV and hepatitis B, hepatitis C. Shaving of the
scrotum is no longer recommended, as this significantly increases colonization of micro-organisms
increasing the chance of surgical-site infection.

Anaesthesia
Good anaesthesia is essential for a pain-free vasectomy. The purpose of anaesthesia is to ensure
that the client is free from pain and discomfort during the operation. Both conventional and no
scalpel vasectomy are done under local anaesthesia. Premedication is commonly not required. Use
of regional or general anaesthesia is rarely needed and increases the risk and costs of the procedure.
However, general anaesthesia may be necessary when there are scrotal abnormalities (such as
large varicocele, large Hydrocoele or Chryptorchidism) or when vasectomy is performed along with
another surgical procedure. Men who need modest sedation (e.g. those who are extremely nervous)
may be given a small dose of an oral tranquilizer, such as diazepam.
89

Chapter 4: Irreversible Contraceptives

Instructions to client
Men undergoing vasectomy should receive clear instructions about post-operative care, anticipated
side effects, actions to be taken if complications occur, sites where they can access emergency care,
the need for post-operative semen analysis, use of condoms and the time and place for making a
follow-up visit.

Requirements for a Safe Procedure


Essential elements of quality sterilization include counseling, client assessment and screening,
informed consent, infection prevention, selection of appropriate procedures, safe anaesthesia
regimens and post-operative care and instructions.

Providing Vasectomy
Learning to perform vasectomy takes training and practice under direct supervision. Therefore,
this description is a summary and not detailed instruction. All family planning providers should
understand these procedures and be able to discuss with clients, both men and women.

The vasectomy procedure


yy The provider uses proper infection prevention procedures at all times.
yy The man receives injection of local anaesthetic in his scrotum to prevent pain. He stays awake
throughout the procedure.
yy The health care provider feels the skin of the scrotum to find each tube (vas deferens). The
provider makes a small incision in the skin with a scalpel or else uses a special instrument to
make a puncture (the no-scalpel technique).
yy The provider lifts each vas out of the incision. Most providers cut each vas and tie one or both
ends closed with thread. Some close off the vas with heat or clip. The incision may be sewn
shut or just covered with an adhesive bandage. The procedure is over. Some providers also
use facial transposition for better results. With fascial transposition, the fascial sheath (the thin
layer that surrounds the vas) is sutured over one end of the cut vas. Fascial interposition places
a tissue between two cut ends of vas. Ligation without division is not recommended, as the
potential for failure due to recanalization is more. Division with facial interposition increases
effectivity.
yy After the procedure the client should rest for 15-30 minutes.
yy The man receives instructions on how to care for the wound. If his wife is not using an effective
contraceptive, he receives and uses condoms until sperm is cleared from his system. They
should wait three months till the semen shows no sperm before relying on his vasectomy for
contraception. During this period, the man should resume sexual activity, but he or his partner
will need to use additional contraceptive protection. Semen analysis, where available, can
confirm contraceptive effectiveness after the threemonth waiting period.
90

Reference Manual for Doctors on Family Planning and Reproductive Health

yy He leaves the clinic within a few hours, often in less than one hour.
Preliminary results from randomized controlled trials found that use of fascial interposition
with ligation and excision of vas during vasectomy lead to more rapid decrease in sperm count
than when ligation and excision were used alone.

Explaining Self-care
Before the procedure, the man should:
yy Bathe thoroughly, especially genital area and upper inner thighs.
yy Wear clean and loose fitting clothing to the health facility.
yy Not take any medicines for 24 hours prior to the procedure, unless heath care provider
performing the procedure tells him to do so.

After the procedure, the man should:


yy Rest for two days. He should not do any heavy work or vigorous exercise for a few days.
yy Keep the incision clean and dry for two to three days. He can use a towel to wipe his body
clean but should not soak in water.
yy Wear snug underwear or pants for two to three days to help support the scrotum. This will
lessen swelling, bleeding and pain.
yy Take Paracetamol or another safe, locally available pain-relief medication as needed. He should
not take aspirin or ibuprofen, which slow blood clotting.
yy Use condoms or another effective family planning method for three months or more after
the procedure till azoospermia is achievedClient can have sex within two to three days after
the procedure if it is not uncomfortable but needs to use condoms. He can expect his sexual
performance to be unchanged. Vasectomy does not affect mans ability to have sex.
In most cases, using good surgical technique to minimize the trauma and limit bleeding,
practicing aseptic techniques, and giving clients good post-operative instructions can prevent
bleeding, hematoma, and infection
Explain specific reasons to see a doctor or health care provider
A man who has undergone vasectomy should return to the clinic for any of these reasons:
For a follow-up, as per the national guidelines for vasectomy:
yy All clients who undergo vasectomy should be visited by a health worker within 48 hours. In
non-scalpel vasectomy (NSV) cases, the client should also be seen 48 hours after operation.
yy First follow-up: seven days after the surgery, the client should go for removal of stitches (in cases
of incisional vasectomy), to have the wound examined and to have his questions answered if any.
91

Chapter 4: Irreversible Contraceptives

yy Second follow-up: the client should undergo semen analysis after three months.
yy Emergency follow-up: this can be done at any time after the surgery.

His wife misses her menstrual period or thinks she is pregnant.

He has questions or problems of any kind.

Return at once, if he has:


High fever (greater than 380C) in the first four weeks and especially in the first week, or
Bleeding or pus from the wound, or
Pain, heat, swelling, or redness at an incision that becomes worse or does not stop
(signs of infection)

If the clinic cannot be reached quickly, he should go to another doctor or health care provider
at once.

Helping client at any routine return visit


IMPORTANT: Follow-up within seven days or at least within two weeks is strongly recommended. A
heath care provider checks the site for any signs of complications, and removes stitches in incisional
vasectomy. This can be done in the clinic, in the clients home (by a trained provider), or at any other
health centre. No man should be denied a vasectomy because follow up would not be possible.
A man may want to come back to have his semen examined, if feasible, at least three months
after vasectomy. This microscopic examination can make sure his semen contains no sperm, or his
vasectomy is working.

Ask questions
At any routine visit
yy Ask if the client has any questions or anything to discuss.
yy Ask the client about his experience with vasectomy, whether he is satisfied, whether he has any
problems. Give him any information or help that he needs, and invite him to return any time he
has questions or problems.
Problem

Provide treatment

Pain

Check for blood clots in the scrotum.


yy Small, uninfected blood clots require rest and pain-relief
medication such as Paracetamol
yy Large blood clots may need to be surgically drained
yy Infected blood clots require antibiotics and hospitalization

92

Reference Manual for Doctors on Family Planning and Reproductive Health

Problem
Infection (Pus, heat, pain or
redness caused by bacteria or
other germs)
Abscess

Provide treatment
yy Clean site with soap and water or antiseptic
yy Give 7 to 10 day course of antibiotics
yy Clean site with antiseptic
yy Incise and drain abscess
yy Perform wound care

Fear of impotence

yy If significant skin infection involved, give 7 to 10 day


course of antibiotics
In counseling before the procedure, the health care
provider should assure the client that vasectomy does not
physically change sexual desire, functioning, or pleasure. This
information can be repeated at any follow up visits.

Managing any problems


During recovery and healing, if a man experiences strong pain, heat, swelling or redness at or around
the incision, he should come back to the clinic. If this happens, a health care provider should check
for clots, pus, infection or abscess.

Certificate of Sterilization
A certificate of sterilization should be issued only after the semen analysis shows no sperm.
yy Tell client that he should report to the clinic for semen analysis after three months.
yy If sperm is still present in semen after three months then client is tested every month till six
months.
yy Do not declare failure of vasectomy till six months.
yy If sperm is still present after six months consider re-vasectomy

Frequently asked questions on Vasectomy


1. Will vasectomy make a man lose his sexual ability, make him weak or fat?

No. After vasectomy, the male sexual physiology remains unaffected (aside from the desired change in
fertility). The nerves involved in erection are not involved during the vasectomy procedure. Seminal fluid
continues to be produced and the tubes that carry seminal fluids remain intact. The male sex drive, ability
to have an erection and ejaculation of semen will be unaffected by a vasectomy and will remain the same
as before. Testicles will continue to create sperm.

After vasectomy, unused sperm cells will be absorbed into the body instead of leaving in the semen. With
sperm making up less than five percent of semen, there will be no noticeable differences in ejaculation.

93

Chapter 4: Irreversible Contraceptives

After vasectomy, the fluid volume, colour and texture of ejaculation remain the same. The person can work
as hard as before. He will not gain weight because of the vasectomy.

For some couples, the ability to have sex without worrying about conception can even improve their sex
life

2. Does a man need to use another contraceptive method after vasectomy?


Vasectomy does not immediately work. After a vasectomy, the male will still have active sperm in his semen
for about three months or more. Not using another method for the first three months is the main cause of
pregnancies among couples relying on vasectomy. Over the next few months the semen will be tested to
ensure there is no active sperm and that the vasectomy is complete.

Besides that, vasectomy does not protect against STIs, including HIV. All men at risk of STIs, including HIV,
whether or not they have had vasectomies, need to use condoms to protect themselves and their partners
from infection.

3. Is it possible to check if a vasectomy is working?


Yes. A provider can examine a semen sample under a microscope to see if it still contains sperm. If the
provider sees no moving (motile) sperm, the vasectomy is working. A semen examination is recommended
at any time after three months following the procedure. If there is less than one non-motile sperm per 10
high-power fields (less than 100,000 sperm per milliliter) in the fresh semen sample, then the man can rely
on his vasectomy and stop using a backup method for contraception. If his semen contains more moving
sperm, the man should continue to use a backup method and return to the clinic monthly for a semen
analysis. If his semen continues to have moving sperm, he may need to have a repeat vasectomy.

4. What if a mans partner gets pregnant after vasectomy?


Every man having a vasectomy should know that vasectomies sometimes fail and his partner could become
pregnant. He should not make the assumption that his partner was unfaithful, if she becomes pregnant.
Remind the man that for about three months, they needed to use another contraceptive method. It takes
20 or more ejaculations to empty the seminal vesicles. Semen analysis should be conducted and, if sperm
is found, a repeat vasectomy is required.

Rarely failure occurs due to occlusion of a structure other than the vas deferens, reattachment of the cut
vas deferens ends, and recanalization. The risk of early failure is about 1-2 per 1000 vasectomy procedures.

5. Will the vasectomy stop working after a time?


Generally not. Vasectomy is intended to be permanent. In rare cases recanalization may occur. The risk of
this is about 1-4 per 5000 vasectomies. Recanalization occurs when the vas deferens ends are reconnected
by sperm being pushed up through the healing tissue and forming many small channels which connect
with the cut vas deferens upstream from the occlusion site.

6. Can a man have his vasectomy reversed, if he decides that he wants another child?

Vasectomy is intended to be permanent and men considering vasectomies should not think of them as
reversible. Clients must be told that a reversal of this surgery is possible, but the reversal involves a major
surgery and its success cannot be guaranteed. People who are not ready for a permanent method of
sterilization, who may want more children, should choose a different family planning method. Surgery to
reverse vasectomy is possible for only some men and reversal often does not guarantee a pregnancy. The
reversal procedure is difficult and expensive, and there are very few providers who are able to perform such
surgery. Vasectomy causes a breakdown in the blood-testes barrier that leads to increased levels of serum
anti-sperm antibodies in most men. If a man has a vasectomy reversal, the presence of these antibodies
can inhibit pregnancy, even if the vasa are successfully reconnected.

94

Reference Manual for Doctors on Family Planning and Reproductive Health

7. Is it better for the man to have a vasectomy or for the woman to have female sterilization?

Each couple must decide for themselves which method is best for them. Both are very effective, safe,
permanent methods for couples who know that they will not want more children. Ideally, a couple should
consider both methods. If both are acceptable to the couple, vasectomy would be preferable because it is
simpler, safer, easier, less invasive and less expensive than female sterilization.

8. Does vasectomy have long term health risk?


Over the years, there have been concerns about possible negative health consequences resulting from
vasectomy. However, results of large, well-designed studies have consistently shown no adverse effects of
vasectomy on the risks of heart disease, testicular or prostate cancer, immune system disorders, and a host
of other conditions. Men requesting the procedure can thus be reassured that there is no substantial longterm health risk associated with the procedure.

9. Can a man who has a vasectomy transmit or become infected with sexually transmitted
infections including HIV, HVB and HCV?

Yes. Vasectomy does not protect against STIs, including HIV, HVB and HCV. All men at risk of STIs, including
HIV, HVB and HCV, whether or not they have vasectomies, need to use condoms correctly and consistently
to protect themselves and their partners from STI infections.

10. Are there risks undergoing vasectomy?


As with any surgical procedure, there is a small risk of infection. Complications are unusual, but may occur
in the form of inflammation or light bleeding and are typically treated with medication and rest.

11. How effective is a vasectomy?


A vasectomy is 99% effective.

12. How soon can person return to work after a vasectomy?


Most clients can return to work two to three days after the vasectomy surgery, if they feel comfortable.
After the vasectomy procedure a person can continue doing household chores the same day. Strenuous
work should be avoided for 48 hours. After 48 hours of the NSV procedure one he can resume strenuous
work like lifting heavy bags, ploughing etc. if he feels comfortable. The acceptor should avoid cycling for
one week (because testicles and vas rub against seat of the bicycle while pedaling).

13. When can one resume intercourse after the vasectomy?


After the vasectomy procedure, a client can have intercourse as soon as it is comfortable for him, which
usually takes about two to three or more days. The client or his partner will need to use another method
of contraception for three or more months following vasectomy, to avoid an unplanned pregnancy, as the
man can still cause a pregnancy until the sperm count is zero. Clients should not have unprotected sex until
the semen has been tested and a zero sperm count has been confirmed. Every client should be offered the
opportunity to have a semen analysis. Ideally, one or two sperm-free semen specimens should be obtained
from the client after vasectomy, to be reasonably sure that the vasectomy operation has been successful.

95

Chapter 4: Irreversible Contraceptives

4.2. Female Sterilization


Female sterilization is the most widely used family planning method in the world and one of the
most effective. Female sterilization is one of the options available to couples who have decided to
end childbearing. Information and guidance about sterilization should be part of a broad discussion
about family planning options.
Female sterilization is an attractive option for many women because it is a single procedure that
provides protection without the need for future involvement by the woman. Given the permanence
of this option, however, it is essential that the decision to undergo sterilization is made thoughtfully
and voluntarily, on the basis of complete information about the procedure, including its risks, benefits
and alternatives.

Mechanism of Action
Female sterilization is the surgical procedure used to end a womans ability to become pregnant.
This procedure involves blocking (commonly referred to as occluding) the fallopian tubes (also called
uterine tubes or oviducts) so that the egg and sperm cannot meet. This is done during a relatively
simple operation, which varies according to:
yy Surgical approach used to reach the tubes
yy The technique used to block the tubes
yy The timing of the procedure.
The timing factor whether or not the procedure will be performed just after a woman gives birth
influences the choice of both the surgical approach and the blocking technique. It will also have
an important influence on the type of counselling issues that need to be discussed.

Effectiveness
Women who choose sterilization benefit from highly effective protection from pregnancy. With less
than one in 100 women getting pregnant after one year, female sterilization is one of the most
effective contraceptive options available today.

Eligibility Criteria
Female sterilization is suitable for most women who are certain that they want no more children and
need a reliable contraceptive. From a medical perspective, the procedure is most appropriate for
women who have no contraindications to surgery or anaesthesia. Women who have a current pelvic
infection should not undergo the procedure until treated and fully recovered. When the procedure is
to be done immediately after child delivery, it is best performed when there are no signs of infection
or other complications associated with delivery

96

Reference Manual for Doctors on Family Planning and Reproductive Health

Counselling
Female sterilization should be presented as one of many options available to women interested
in permanent contraception. Potential clients should receive complete information about all
available family planning methods with no undue emphasis on sterilization. The health provider
should carefully screen potential clients for sterilization to ensure that each has a desire to
end childbearing and has a full understanding of the risks and benefits of the method. Various
factors, especially the clients age and the number of living children, may be warning signals that
a client will become dissatisfied later with her decision. This regret appears to be more common
among women with certain characteristics or situations, such as:
yy Young age
yy Few or no children
yy Marital instability
yy Partner who doesnt agree with decision
yy Uncertain about wanting more children
These warning signs are useful for identifying women who may need special counselling but should
not be used arbitrarily to deny the procedure to a woman who has made an informed and voluntary
decision.

Timeline for Female Sterilization


The sterilization procedure can be done at most times during a womans reproductive life. It is usually
performed during:
yy The immediate postpartum period, immediately following or up to 48 hours after a vaginal
delivery, or during a caesarean section delivery.
yy The post-abortion period, immediately following an induced or spontaneous abortion, or
yy The interval period, when the woman has not recently been pregnant or at least six weeks
since a womans last delivery (when the uterus has returned to its normal size).
Female sterilization should not be performed when a women is pregnant or during days 8 to 41 after
delivery. With special care, sterilizations can be performed during three to seven days after delivery
(the postpartum period).

Common Surgical Approaches or Procedures


Two common approaches, both through the abdomen, are used to reach the fallopian tubes:
yy Mini-laparotomy involves a small abdominal incision through which a surgeon usually lifts
the fallopian tubes out of the abdomen to block them. The incision is 2-5 cm above the pubic
hairline when a woman has not recently been pregnant or 1.5-3 cm just below the navel or
umbilicus for postpartum procedures. This procedure is appropriate for women during interval,
post-abortion and immediate postpartum periods. During interval mini-laparotomy, the
97

Chapter 4: Irreversible Contraceptives

provider may use a uterine elevator, a metal instrument which is inserted into the vagina to
raise the uterus. This makes it easier to move the pelvic structures so that the tubes are near
the incision site.
yy Laparoscopy uses a laparoscope, a narrow lighted tube through which a surgeon is able to
see into the abdominal cavity and pelvic structure. This optical instrument is inserted through
a small puncture near the navel, or umbilicus. The same opening, or sometimes a second
puncture, is used to manipulate the organs and block the tubes. It is recommended only for
women in the interval period or following first-trimester abortion (when gestation is less than
12 weeks). Laparoscopy should not be performed on women during the postpartum period
because of the orientation and the vascular nature of the postpartum uterus.
Table 1: Comparison of mini-laparotomy and laparoscopy for female sterilization
Mini-laparotomy

Laparoscopy

Instruments
and
equipment

Requires a few inexpensive,


standard surgical instruments.

Requires sophisticated and expensive


endoscopic equipment that is difficult to
maintain.

Surgical skills
and expertise

Can be performed by health


workers with basic surgical ability
and skills, after training in the
technique.
Suitable for postpartum, postabortion and interval periods.

Restricted to specially trained surgeons,


usually obstetricians and gynaecologists.
Requires regular practice to maintain skills.

Setting

May be performed in maternity


centres and basic health facilities
with surgical capacity.

Fully equipped operating room and


anaesthetist required.

Time
necessary for
the operation

Depending on the experience of


the operator, takes on average
10-20 minutes.

Depending on the experience of the


operator, takes on average 5 -15 minutes
and so most appropriate for services with
large daily case-loads.

Precautions

Difficult to use for obese women


(especially for interval procedures)
and those with pelvic scarring and
adhesions.
Complications are rare. Slight risk
of bowel and bladder injuries,
uterine perforation and wound
infection.
Recommended local anaesthesia.

Not recommended for postpartum


women or for women with previous lower
abdominal surgery or pelvic infections.

Side-effects

Short-term abdominal pain may


occur.

Postoperative chest and shoulder pain


resulting from abdominal insufflation may
occur.

Effectiveness

Highly effective; failure rates less


than 1% after 12 months.

Highly effective; failure rates less than 1%


after 12 months.

Timing

Complications

Anaesthesia

98

Most suitable for interval period and


following first trimester abortion.

Complications are rare. Slight risk of


vascular injury, bowel injury and insufflation
accidents. Some complications may require
use of general anaesthesia.
Local, spinal or general anaesthesia.

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked questions on Female Sterilization


How does timing affect choice of surgical approach?
Mini-laparotomy can be used to reach the tubes at any time (during the interval, post-abortion or
postpartum periods), whereas laparoscopy should only be performed during the interval period or
following an early induced (first-trimester) abortion. Laparoscopy is not otherwise recommended
for use postpartum because of the possibility of injury to the large, vascular uterus of postpartum
women.

What are the common techniques for blocking the fallopian tubes?
The choice of the blocking method depends upon several factors, including type of surgical approach
(mini-laparotomy or laparoscopy), the timing of the sterilization (postpartum or interval), providers
training, and availability of supplies. Once the provider reaches the uterine tubes, the tubes can be
blocked) by two commonly used methods:
yy Ligation and division (cut and section). Ligation is used only with mini-laparotomy (both
postpartum and interval cases), this method involves tying each fallopian tube with suture
material and then cutting and removing a section. The most common method is the Pomeroy
technique, in which a segment of the fallopian tube is tied in a loop and then the top portion
of the loop is cut and removed. Another method the Parkland technique involves tying
the tube at two points and removing the intervening segment.
yy Mechanical devices. The preferred choice for use with laparoscopy, this involves placing a device
(hinged or spring clips or a small ring or band made of silicone rubber), to close and seal each
tube. The various mechanical methods, which are suitable for interval cases using laparoscopy,
require a specialist surgeon trained in laparoscopy. The rates of failure and complications may
increase if training is inadequate or skills not maintained by routine practice of the procedure.
yy Electrical methods. Electrocoagulation is used with a laparoscope to burn and block the tubes.
This method is no longer recommended because research shows a greater risk for internal
burns during the procedure and for ectopic pregnancy after the operation.

How does the surgical approach and the timing factor affect choice of the
blocking technique?
The timing of the procedure, whether a woman wants to have the procedure immediately after
delivery or not, influences the choice of both the surgical approach and the blocking method. During
the interval period (when a woman has not recently been pregnant or it has been at least six weeks
since delivery), either surgical approach (mini-laparotomy or laparoscopy) can be used along with
either blocking method (ligation or a mechanical device). For immediate postpartum sterilization,
mini-laparotomy is the recommended surgical approach, with ligation, using clips, rings or bands.
During caesarean surgery, ligation is the most common method. For post-abortion sterilization, both
surgical approaches and blocking methods may be used (although the mechanical devices require
extra care because of the somewhat enlarged tubes).

99

Chapter 4: Irreversible Contraceptives

What are the health benefits of female sterilization?


Given the considerable health risks associated with unspaced pregnancies, the use of contraceptives
provides a significant health benefit to women at risk of unwanted pregnancy. Also in contrast to
temporary methods, it does not require continuous involvement by the woman. A woman who
has undergone sterilization is spared the common worries linked to temporary methods partner
compliance, inconvenience, side effects, supply problems, and the consequences of forgetfulness.
In addition to its benefit as a contraceptive, recent research suggests that sterilization may reduce a
womans risk of ovarian cancer.

What are the possible complications of female sterilization?


Short-term. Complications are rare. The types of complications vary by the type of surgical procedure.
Mini-laparotomy complications include wound infection, uterine perforation with uterine elevator,
and bladder or intestinal injury. Laparoscopy complications may involve anaesthesia problems, tears
and transections of the tubes, and injuries to organs from instruments such as the uterine elevator,
insufflation needle or trocar. Although the complications with laparoscopy are not more common
than with mini-laparotomy, some are more severe and require general anaesthesia. The rate of
complications is highly dependent on the level of surgical skill and experience.
The chance of having these problems is largely limited to the time of surgery or shortly thereafter.
Most of these problems can be prevented with attention to careful screening, use of local anaesthesia
with light sedation, careful surgical technique, good asepsis, and appropriate post-operative care. The
seriousness of these problems can be minimized if they are recognized early and treated promptly.
Oral and written post-operative instructions (with illustrations where needed for low and non-literate
women) should direct women to return to the clinic one week after the procedure to ensure that no
infection has occurred.
Long-term. Failure of sterilization is rare. However, when pregnancy occurs in a woman who has
undergone sterilization, it is likely to be an ectopic (tubal) pregnancy, which is potentially fatal.
Women should be counselled about the importance of getting medical attention immediately if
they believe that they might be pregnant.
Subsequent regret about the sterilization decision is another possible consequence. Research results
underscore the importance of counselling women considering sterilization about the permanent
nature of sterilization and the possibility of regret.

What are the considerations regarding immediate postpartum sterilization?


The period immediately after childbirth is a popular time for women to undergo sterilization by
mini-laparotomy. It offers advantages from both the mothers and providers perspective. It is often
less painful and recovery time is shorter than with interval mini-laparotomy. It is convenient for the
mother because it eliminates the need for a separate visit for the sterilization procedure and having
the procedure done immediately postpartum does not prolong the normal hospital or maternity
stay.

100

Reference Manual for Doctors on Family Planning and Reproductive Health

From the providers viewpoint, a smaller incision is possible because of the enlarged postpartum
uterus, and it is easier to reach the fallopian tubes. With less extensive abdominal manipulation,
less instrumentation is necessary. The engorged fallopian tubes in postpartum women can be more
difficult to block, however, so that mechanical devices such as rings and clips are usually not suitable.
One device, the Filshie Clip, is an exception.
Immediate postpartum sterilization may have some advantages, but the chance that a woman will
regret her previous decision after undergoing sterilization is higher with women who undergo the
procedure at this time, especially in cases of a childs illness or death or a change in marital status.
Proper counselling is very important.
As pregnancy and childbirth may influence a womans decision to have no more children, it is critical
that counsellors encourage careful thought about the decision. The choice should be made well in
advance of delivery or abortion and never when postpartum and abortion clients are sedated or in
labour. Stress, pain and sedatives may influence a decision that later will be the wrong choice. Research
suggests that regret after postpartum sterilization may be more common among younger women
(less than 30 to 35 years old), women with few children, and those having caesarean sections. For
postpartum clients with medical problems or for those who do not wish a permanent method, other
long-term options exist. The IUD and Norplant may be inserted during the immediate postpartum.
Women who have a caesarean delivery may choose to undergo sterilization during the same
procedure. Furthermore, sterilization should be performed at the time of caesarean section only with
the womans full consideration and informed decision well before the procedure.

Where can sterilization be performed?


In the case of mini-laparotomy, the procedure can be performed in maternity centres and basic
health facilities with surgical capacity, including both permanent and temporary facilities with access
to referral care. Laparoscopy requires a fully-equipped hospital, where laparoscopy is performed on
a regular basis and an anaesthetist is available.

Who can perform the procedure?


Only empaneled providers as per GOI guidelines can perform. As per these guidelines a post graduate
qualification obstetrics/gynaecology is necessary for laparoscopic sterilization.

How do health workers help couples with decision-making?


The purpose of family planning counselling is to assist couples with information and guidance
about selection of a family planning method. In addition to providing complete and accurate
information about methods of contraception (filling in gaps in the clients knowledge and correcting
misconceptions), a counsellor focuses on how these choices relate to a womans specific needs and
circumstances. Couples wishing to maintain the option of having children should be counselled not
to undergo sterilization. A womans right to make an informed and free choice is compromised when
strong emphasis is placed on particular methods of contraception. Women should feel no pressure
to choose sterilization.

101

Chapter 4: Irreversible Contraceptives

Counselling is particularly important in the case of sterilization because the procedure is permanent
and it requires surgery. A counselling session with a woman considering sterilization should focus
on the clients needs and desires. Whenever possible, a woman should be encouraged to include her
partner in the counselling process. However, except where it is a legal requirement, partner consent
should not be mandatory.

The counselling session should


yy Discuss the range of options. Information about sterilization must be part of a general
discussion about family planning and the range of available choices. No strong emphasis
should be placed on any particular method, such as sterilization.
yy Clarify misconceptions. Attention should be given to identifying and counteracting
rumours and myths about female sterilization and other methods of contraception.
Research suggests misconceptions are a major obstacle to contraceptive use in some
countries. Common misinformation about sterilization for example, that sterilization will
make a woman stop menstruating or affect her sexuality can discourage a woman from
choosing the method and should be addressed. It is generally agreed that sterilization
does not affect female hormones and that it does not change sexual desire or satisfaction.
yy Emphasize the permanence of sterilization. Family planning providers should emphasize the
permanence of sterilization and the availability of alternative reversible methods. Providers
involved in counselling should be trained to identify clients who are likely to change their
mind about sterilization after the procedure has been performed. Younger women are at
greatest risk of later regretting their decision. Age and other factors linked to heightened
risk of future regret should be seen as warning signs but should not be used to deny the
procedure to women who make a carefully considered decision.
yy Discuss the sterilization procedure. Clients need to know the benefits and risks of surgical
sterilization, including the rare but possible serious complications and the consequence of
failure. They need to know what they can expect during and after surgery.

Counsellors should encourage a sufficient time interval between counselling and the procedure, and
emphasize that clients are free to change their mind at any time before the procedure.

What is informed consent?


After counselling and careful consideration, a woman may decide that sterilization is the right choice
for her. She will be asked to sign an informed consent form indicating that she has made an informed
and free choice. However, the informed consent form should not be dismissed as merely a legal
requirement or a protection of the provider. A signed form does not guarantee that a decision
was made freely or based on clear, complete and accurate information, but it can provide useful
guidelines for family planning programmes offering sterilization services. After careful screening and

102

Reference Manual for Doctors on Family Planning and Reproductive Health

counselling, the form can serve as a final step in the informed consent process. It provides a reminder
to both provider and client and helps to ensure that a client:
yy Knows that this is a surgical procedure and it is intended to permanently prevent the client
from having more children.
yy Has been informed about alternative family planning methods.
yy Is aware of the benefits and risks of the procedure.
yy Has made a voluntary choice.
yy Knows that she may change her mind at any time before surgery without loss of medical or
financial benefits.

What are the common restrictions on obtaining sterilization?


Regulations regarding sterilization vary, but most of them are designed to protect the client from
coercion and to minimize the incidence of regret by women after sterilization. Some countries
require a minimum age (usually varying between 30 and 35 years) and insist women already have
a minimum number of children, sometimes specifying the sex. Many countries require women to
wait for a specified period of time between making the decision to undergo sterilization and the
procedure. Consent of the spouse or partner may be required, although it is generally recognized
that the focus should be on counselling and not consent of the partner or spouse.

What pre-operative care is required?


Medical histories and physical examinations should include information regarding possible pregnancy,
pelvic disease, previous abdominal surgery and other conditions that may increase a womans risks.

What do women need to know before the surgery?


A woman who has decided to undergo sterilization must be advised to use temporary contraceptives
until the procedure has been performed. A counselling session before the surgery should provide
instructions on how to prepare for surgery and what to expect during and after the operation.
Simple, non-technical explanation of the surgical steps and the anaesthesia to be used will inform
and reassure the client. Sample client instructions for both pre-operative and post-operative care
should include simple and clear illustrations for use with low and non-literate populations.

What follow-up care and information is necessary?


Most women can be discharged on the same day following mini-laparotomy and laparoscopy,
since recovery problems are minor and most complications are recognized either during or shortly
after surgery. At that time, providers should again give women instructions on what to do after the
surgery, including how to care for the wound and how to treat any pain that might occur, and what to
expect (for instance, a small but visible scar will remain). Women should be advised to seek medical
attention immediately if they experience any increase in abdominal pain.

103

Chapter 4: Irreversible Contraceptives

A follow-up visit should occur within seven days of surgery. A woman who has undergone sterilization
during the interval period can expect to return to normal activities within three to five days and
sexual relations within a week or when she feels comfortable thereafter. For women who undergo
the procedure immediately after delivery, the procedure does not extend the normal recovery period
for childbirth.
A woman who has undergone sterilization has a less than one percent chance of becoming pregnant.
However, providers and clients alike need to be aware of the possible consequences of pregnancy
after sterilization. Among those women who do become pregnant after sterilization, there is a marked
increase in risk of ectopic (tubal) pregnancy, which is potentially fatal. Women must be advised to
watch for these signs of tubal pregnancy: lower abdominal pain, missed periods, and abnormal
uterine bleeding.
Despite careful screening, some clients may experience difficulty in adjusting to being sterilized,
especially in the event of remarriage or loss of a child. For these women, counselling and support
should be offered and appropriate information on centres of excellence where reversal services are
available.

Is reversal possible?
Most women who choose sterilization feel that they have made the right choice, but some women
later regret their decision. For some of these women, surgery to restore fertility may be an option.
Although reversal is sometimes possible, sterilization should never be considered a reversible
procedure. Women considering sterilization must be counselled about the intended permanence
and the possibility of future regret.
Women should know that surgery to attempt to reverse sterilization is available only in some
countries. Counselling should emphasize the following:
yy Sterilization is intended to be permanent.
yy Reversal procedure involves complex and lengthy surgery, highly trained surgeons and
specialized equipment. It also often requires general anaesthesia. Risks are greater and
recovery time is longer than for sterilization.
yy A large number of reversal procedures are unsuccessful.
yy Reversal surgery increases the chance that a woman will have a tubal pregnancy.

What other advice about sterilization should health workers give?


Female sterilization and breast feeding. The procedure does not interfere with a mothers milk
production or adversely affect the health of the child.
Female sterilization and sexually transmitted diseases. Women who undergo sterilization do not have
any protection against sexually transmitted diseases (STDs), including HIV. Even if not at any risk
of pregnancy, women who may be at risk of STDs must be counselled to use protection. For these
women, condoms used correctly and at every intercourse is the best available protection. Other
barrier methods (diaphragm, cap, sponge, and vaginal spermicides) provide limited protection.

104

Chapter 5

Natural Family
Planning Methods
Standard Day Methods (SDM)
Sympto-thermic Method
Lactational Amenorrhoea
Method (LAM)

105

Chapter 5: Natural Family Planning Methods

Natural methods for prevention of pregnancy are mainly of two types. These are
Fertility Awareness Based Methods (FAM) and Lactational Amenorrhoea Method
(LAM).
Fertility Awareness Based Methods
Fertility Awareness Based Methods of family planning help women identify their fertile window- the
days of cycle in which they are most likely to get pregnant. If they wish to prevent pregnancy they
need to avoid unprotected sex on these days.

Physiology of Menstruation
Changes in the uterus, called The Menstrual Cycle. At the menarche, hypothalamic maturation leads
to onset of cyclic ovulation that is release of ovum from ovary at periodic interval, while atresia
continues. During each cycle, some 10-15 follicles enlarge to become secondary follicles, under the
influence of FSH from the anterior pituitary. Fluid accumulation occurs in these follicles proceeds to
the stage of Ovulation. After ovulation, capillaries from the theca interna invade the rapidly dividing
granulosa layer and the clotted blood is replaced with yellowish, lipid rich luteal cells, forming the
Corpus Luteum. This enlarges for 8-9 days during which the luteal cells secrete oestrogen and
progesterone and:
yy If fertilization has not occurred , the corpus Luteum regresses and eventually becomes Corpus
Albicans
yy If pregnancy occurs the Corpus Luteum continues to grow for several months and begins to
degenerate at approx. the 6th month
The time of Ovulation is the time of Maximum fertility, therefore, for pregnancy to occur, the coitus
(intercourse) should take place within a day or two on either side of the Ovulation (fertile period). The
rest of the menstrual Cycle constitutes a more or less Safe Period.
There are commercial products available in the markets which help in determining the ovulation. Just
prior to ovulation, Lutenizing Hormone is released. This kit detects release and helps determine and
anticipate ovulation. A positive test is indicated by a test that is equal or greater intensity (darker)
than the control band. A negative test result is indicated when the test band is lesser intensity (lighter)
than the control band or cannot be seen.
Users of FAM may not have unprotected sex whenever they wish, because for some days in each
cycle they have to avoid sex or use a barrier method. Hence using FAB methods is amount to timing
of sexual activity.
Also generally couples perceive intercourse during menses as unhealthy, unclean and un-pleasurable.
Fertility Awareness means that a woman learns how to tell when the fertile time of her menstrual
cycle starts and ends. The following two methods qualify for inclusion in fertility awareness based
methods:

106

Reference Manual for Doctors on Family Planning and Reproductive Health

5.1. Standard Day Methods (SDM)


Most women using the SDM use a device called Cycle Beadsa string of colour-coded beads that
help women identify the days of their cycles when they can become pregnant and the days when
pregnancy is very unlikely. The white beads, which represent the end of the cycle, indicate the
time when the woman has a high probability of becoming pregnant if she has unprotected sexual
intercourse.
Mechanism of Action
yy On the day that your menstrual period starts, hold the Cycle Beads and move the rubber ring
onto the first red bead.
yy Each day, move the rubber ring onto the next bead, moving in the direction of the arrow.
yy Avoid sexual intercourse or unprotected sexual intercourse on the days when the rubber ring is
on any of the white beads.
SDM users who have two or more cycles outside the 26-32 day range, within any one year of
use
yy Advise her that the method may not be appropriate for her because of a higher risk of
pregnancy. Help her consider another method.
Initial provision of SDM for women whose menstrual cycles are within the 26-32 day range
yy Provide another method of contraception for protection on days 8-19 if she desires. Give
supplies in advance.
SDM users who have unprotected intercourse between days 8-19
yy Consider the use of emergency contraception if appropriate
Cyclebead Method

Image source: www.irh.org Institute for Reproductive Health, Georgetown University

107

Chapter 5: Natural Family Planning Methods

5.2. Sympto-thermic Method


Symptom-thermic method
The symptom-thermal method is a means of natural family planning that involves abstaining from
sexual intercourse on days that a woman is fertile, or capable of getting pregnant.

Mechanism of Action
To use the symptom-thermal method, a woman needs to learn about her bodys natural fertility signs
and also take her temperature every morning. Daily temperature readings are performed using a
basal thermometer, a special thermometer that will determine the bodys temperature within a few
hundredths of a degree. This level of precision is necessary to detect the slight temperature increase
that marks the end of the fertile period. The woman keeps a chart where she records her daily
temperature and also other body signs that indicate when ovulation will occur. Other body signs
include cervical mucus consistency, cervical position, mid-cycle cramping, and mood. To use this
method, couples should receive training from a certified natural family planning instructor.
Unlike the calendar-rhythm method or standard days method, a women can use this method no
matter how long her cycles are. The couple avoids unprotected sex between the first day of monthly
bleeding and either the fourth day after peak cervical secretions or the third full day after the rise in
temperature (BBT), whichever happens later.

Effectiveness of symptom-thermal method


Among experienced users, the symptom-thermal method has an overall annual failure rate of 13
to 20 percent. That means each year about one in seven users of this method experience a surprise
pregnancy. For perfect users, the method has a failure rate of only two to three percent, but this
method is completely ineffective if used incorrectly. For women who feel uncomfortable touching
their bodies, this method can be used without recording information about cervical position or
cervical mucus, but this will make the method less effective. Such women should consider the
standard days method instead.

Side-effects and health risks of the symptom-thermal method


Like other methods of natural family planning, there are no side effects or health risks because the
user does not put anything into her body. There are no hormones, chemicals, or surgical procedures
involved.

Advantages of FAM
yy No chemical agents or physical devices.
yy No side effects.
yy Efficient when well taught and motivated.
108

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Low cost for methods based on observation.


yy Not dependent on medical personnel after initial instruction.
yy Promotes fertility awareness.
yy Encourages shared responsibility and increases spousal communication as well as promotes
male responsibility.
yy Ethically acceptable .
yy Can be used to plan or avoid pregnancy.

Limitations of FAM
yy Takes time to learn 3-6 cycles.
yy Some women find charting difficult.
yy Requires commitment from both partners.
yy More difficult at times of stress or hormonal change.
yy No protection against STIs.
yy Cannot be used without co-operation of partner.

Side Effects
No known side effects

Managing any Problem


Problems with use
yy Problems with fertility awareness methods affect a womans satisfaction and the use of the
method. If the client reports any problems, listen to her concern and give her advice. Help the
client choose another method.
Inability to abstain from sex during the fertile time
yy Discuss the problem openly with the couple and help them feel at ease, not embarrassed.
yy Discuss possible use of condoms, diaphragms, withdrawal or spermicides or sexual contact
without vaginal sex during the fertile time.
yy If she has had unprotected sex in the past five days, she can consider Emergency Contraceptive
Pills.
Difficulty in recognizing different types of secretions for the ovulation method
yy Counsel the client and help her learn how to interpret cervical secretions. Suggest she can use
the Two day Method, which does not require the user to tell the difference among types of
secretions.

109

Chapter 5: Natural Family Planning Methods

Frequently asked Questions


1. Can only educated couples use FAM?

No couples with little or no formal schooling can do use FAM effectively. Couples must be highly motivated,
well trained in their method and committed to avoiding unprotected sex during the fertile time.

2. Are Fertility Based Methods reliable?


For many couples, these methods provide reliable information about the fertile days. If the couple avoids
vaginal sex or uses condoms or a diaphragm during the womans fertile time, FAM can be very effective.
Using withdrawal or spermicides during the fertile time is less effective.

5.3. Lactational Amenorrhoea Method


(LAM)
What is Lactational Amennorhea Method?
Lactational Amenorrhea Method (LAM) is the use of breast feeding as a temporary family planning
method. LAM provides natural protection against pregnancy and encourages starting another
method at the proper time.

Mechanism of Action
LAM delays return of ovulation and menstruation in postpartum women. The most important factors
controlling ovarian activity during lactation is the strength of sucking stimulus. It has been well
established that duration of lactation amenorrhea and assumption of ovarian suppression is longer
among fully breast feeding mothers than partially breast feeding mothers. The mothers with the
highest sucking frequencies have higher prolactin levels, longest lactational amenorrhea and ovarian
suppression. During lactation prolactin directly act on hypothalamus to prevent surge of lutenising
hormone which stimulates ovulation.

Medical Eligibility for LAM


Following conditions needs to be satisfied for successful LAM:
yy The baby gets at least 85% of his or her feeding as breast milk. And the mother breast feeds
often, both day and night.
yy The mothers menstrual periods have not returned.
yy The baby is less than 6 months old.
If any of these three is not true, the woman should use another method for effective family planning
one that does not interfere with breast feeding
110

Reference Manual for Doctors on Family Planning and Reproductive Health

Also, women with following conditions can use LAM in any circumstances:
yy Benign breast disease
yy Breast cancer
yy Headaches
yy High blood pressure
yy Varicose veins
yy Vulvular heart disease
yy Diabetes
yy Iron deficiency anaemia
yy Malaria
yy Sickle cell disease
yy Gallbladder disease
yy Thyroid disease
yy Uterine fibroid

Advantages of LAM
yy Effectively prevents pregnancy for at least six months and may be longer if a woman keeps
breast feeding often, day and night.
yy Encourages the best breast feeding patterns.
yy Can be used immediately after childbirth.
yy No need to do anything at the time of sexual intercourse.
yy No direct cost for family planning or for feeding the baby.
yy No supplies or procedure required to prevent pregnancy.
yy No hormonal side effects.
yy Counselling on LAM encourages starting a follow on method at the proper time.
yy Breast feeding practices required by LAM have other health benefits for mother and baby

Provides the healthiest food for baby

Protects the baby from life-threatening diarrhoea

Helps protect the baby from diseases like measles and pneumonia by passing mothers
immunities to baby

Helps develop close bondage between mother and baby


111

Chapter 5: Natural Family Planning Methods

Disadvantages of LAM
yy Effectiveness after six months is not certain.
yy Frequent breast feeding may be inconvenient or difficult for some women, especially working
mothers.
yy No protection against STIs including HIV.
yy If the mother has HIV, there is a small chance that breast milk will pass HIV to the baby.

Contraindications for LAM


There are no medical contraindications for LAM. All breast feeding women can use LAM, but women
in the following circumstances may want to consider other contraceptive methods:
yy Has HIV infection including AIDS.
yy Is using certain medications during breast feeding (including mood altering drugs, reserpine,
ergotamine, antimetabolites, cyclosporine, high dose of Corticosteroids, Bromocriptine,
radioactive drugs, Lithium and certain anticoagulants.
yy Newborn has a condition that makes it difficult to breastfed (including being small-for-date
or premature and needing intensive neonatal care, unable to digest food normally or having
deformities of the mouth, jaw or palate.

Side Effects
There are no known side effects for LAM

Managing any Problem


yy Problems with breast feeding or LAM affect womens satisfaction and use of the method. If the
client reports any problem, listen to her concerns, give her advice and if appropriate, treat.
yy Offer to help the client chose another method now, if she wishes, or if problems cannot be
overcome.
yy HIV transmission through breast milk is more likely among mothers with advanced disease
or who are newly infected. Women taking antiretroviral therapy during first weeks of breast
feeding may reduce the risk of HIV transmission through breast milk. HIV women should be
urged to use condoms with LAM.

112

Reference Manual for Doctors on Family Planning and Reproductive Health

Frequently asked Questions


1. Can replacement feeding help reduce the risk of HIV?

Replacement feeding poses no risk of HIV transmission. If available replacement feeding is acceptable,
feasible, affordable, sustainable and safe then exclusive breast feeding for the first six months is the safest
way to feed the baby and it is compatible with LAM.

2. Can LAM be used for six months without worry that woman will run out of milk?

LAM can be used for six months without worry. Womans milk will be continued to be produced through
six months and longer in response to the babys suckling or the mothers expression of her milk.

3. Can LAM be used for fat or thin women?


LAM can be used by women with normal nutrition. No special foods are required. It can be used for a full
six months without the need for supplementary foods. Mothers milk alone can fully nourish a baby for the
first six months of life.

113

114

Chapter 6

Termination of
Pregnancy
Medical Methods for
Termination of Early Pregnancy
Vacuum Aspiration

115

Chapter 6: Termination of Pregnancy

Terminate of Pregnancy
By a registered medical practitioner who possesses a recognized medical qualification as defined in
the Indian Medical Council Act, 1956 whose name has been entered in a state medical register and
who has such experience or training in Gynaecology and Obstetrics as prescribed by the MTP rules
made under this Act.
The rules further prescribe that only those persons having the following experience or training can
perform MTPs.

Up to 12 weeks gestation
A practitioner who has assisted a registered medical practitioner in the performance of 25 cases
of MTP of which at least five have been performed independently in a hospital establishment or
maintained by the government or training institute approved for this purpose by the government.

Up to 20 weeks gestation
yy A practitioner who hold a post graduate degree or diploma in Obstetrics and Gynaecology
yy A practitioner who has completed six months of house surgery (residency) in Obstetrics and
Gynaecology.
yy A practitioner who has at least one year experience in the practice of Obstetrics and
Gynaecology at any hospital that has all facilities.

Counselling
Counselling is a structured interaction in which a person voluntarily receives emotional support and
guidance from a trained person in an environment that is conducive to open sharing of thoughts,
feelings and perceptions. Every woman who seeks MTP services must be counselled.
Providers, nursing staff/ paramedical staff, counsellors (where available) may be appropriately trained
to offer abortion related counselling services. Counselling is an integral part of safe abortion services
and is important as performing the procedure correctly.
Pre- procedure Counselling
yy It helps the woman to decide about the termination of pregnancy.
yy It ensures that the consent for the procedure is given after receiving the complete information
about the procedure and understanding its implications.
yy It helps the woman to adopt a contraceptive method after procedure.
Following are the critical steps in pre-procedure counselling
yy Ensure that privacy and confidentiality are maintained during counseling.

116

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Be non-judgemental while interacting with woman and be sensitive towards her needs.
yy Establish a rapport with the woman and gain her confidence as abortion is a very sensitive
issue and the woman may be reluctant to discuss it. Building rapport is also critical for finding
out whether there have been any attempts to terminate the present pregnancy as this is
important for predicting likely problems and may affect management.
yy Make the woman feel comfortable mentally and physically. The former is extremely important
as the woman may have strange feelings about terminating the pregnancy.
yy Identify the reason for termination of pregnancy by asking relevant questions related to
personal, social , family and medical history and past use of contraceptive methods.
yy Use simple language and allow the woman to clarify doubts.
yy If the woman is convinced about termination of pregnancy, assess the woman for the MTP
procedure.
yy If found eligible for MTP, explain the following in simple language

Range of available options of MTP procedures based on gestation

Procedure chosen by her

Likely risks associated with the procedure

Care after the procedure

Immediate risks associated with pregnancy (within 2-6 weeks) if no contraceptive method is
used

When to return to follow up

yy Involve the husband / accompanying person if the woman is comfortable.


yy Help the woman sign the consent form.
yy Discuss various contraceptive methods- mechanism, advantages and disadvantages.
yy Help the woman to choose a contraceptive method and assess whether the method is
appropriate (based on history and examination).
If the chosen method is not appropriate, explain the reason and help her choose another method.
If the method is appropriate, provide the method specific information. In case the method is not
available at the centre, provide information and other assistance for getting the appropriate service
elsewhere. If a woman is not willing to accept a contraceptive method:
yy Do not refuse MTP, as the woman is likely to go elsewhere, probably to an illegal abortion
provider and suffer complications.
yy Assure the woman that she wont be refused MTP.
yy Wait for an opportunity to counsel her after the procedure. If she is still not willing to accept a
contraceptive method, call her for follow up in a weeks time and counsel again. Encourage her
to bring her spouse.

117

Chapter 6: Termination of Pregnancy

yy Record the assessment findings, procedure, contraception or refusal to accept contraception


and advice given (including referral).
Post abortion counselling
Important notes for counsellors on post - abortion contraception
yy Roughly 75 percent women ovulate and six percent conceive within two to six weeks after
abortion, if they are not using contraception.
yy All modern contraceptive methods can be safely provided immediately after the first trimester
MTP (caution to be taken for second trimester abortions).
yy The continuation rate for postpartum abortion insertion of IUD is good. Insertion of IUD
immediately after the first trimester MTP is not associated with higher risk of expulsion,
infection or bleeding.
yy Abdominal tubectomy can be safely performed concurrently with MTP. Laparoscopic ligation
should be done after first trimester MTPs.
Post abortion Counsellingis an integral part of the post-procedure care. It is as important as the pre
abortion counselling because:
yy It ensures that the woman has understood post-abortion care and what action to be taken in
case of complications.
yy It re-enforces the need for continuing the use of the contraceptive method chosen.
yy It provides an opportunity to counsel for contraception in cases where the woman is not sure
about accepting a contraceptive method.
Important steps are:
yy Ensure privacy and confidentiality and an empathetic attitude.
yy Enquire from the woman how she is feeling and reassure in case of any problems.
yy Repeat the information about post procedure care and ensure that the woman understands it
fully.
yy Repeat the potential effects / warning signs and what to do then.
yy Call the woman for follow up in a weeks time and counsel again if the woman does not accept
any form of contraception. Encourage her to bring her spouse.

Clinical Assessment
Clinical assessment for eligibility to undergo termination of pregnancy is critical to avoid complications
while providing services. It provides the following information:
yy Confirmation of pregnancy
yy Exact period of gestation

118

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Womans general health condition


yy Associated gynaecological disorders and infection
yy Associated medical problems
Components of clinical assessment
1. History Taking

The following should be included:1.1 Personal details


- Age, religion, address
1.2. Menstrual history: length and duration of cycle, flow (excess or normal), LMP
1.3. Obstetric history: Parity, live births, abortion (induced and spontaneous), previous caesarean
section (if any), last child birth / abortion
1.4. History of any interference/ drugs taken in this pregnancy to attempt termination
1.5. Contraceptive history: type of contraceptive used, how long
1.6. Status of tetanus immunization: last dose received
1.7. Psychological assessment to assess family support
1.8. Sexual / domestic violence
1.9. Medical history should include the following:
-

Hypertension

Heart disease

Renal disease

Diabetes mellitus

Epilepsy

Asthma

Drug allergies

Bleeding disorders

2. Physical Examination
2.1. General Examination
-

Check pulse, blood pressure and temperature if indicated

Look for pallor/ icterus

2.2. Systemic Examination


-

Examine chest and cardiovascular system

Examine abdomen for abdominal mass, scars and distension. Check for rigidity and
rebound tendernes

119

Chapter 6: Termination of Pregnancy

3. Pelvic Examination

Before starting the pelvic examination, inform the woman and take verbal consent from her. Also
ensure that:

Privacy is maintained

Equipment is ready

Woman has emptied her bladder

3.1 Examination of external genitalia

Inspect the external gene Talia: labia major, minor and introits for redness, ulcer, growth, warts,
swelling and discharge

3.2 Speculum Examination


o Inspect the vagina and cervix for ulcer, foul smelling discharge and bleeding
o If there is an erosion, cervix bleeds on touch or a growth, refer to a specialist
o If there is any evidence of infection , perform the procedure under antibiotic cover
3.3. Bimanual Examination

There is one of the critical steps, helpful in comparing the size of the uterus to the period of
amenorrhea. During bimanual examination:
o Feel the cervix for consistency and tenderness on movement. A soft cervix is indicative
of pregnancy. Tenderness on movement is indicative of pelvic inflammatory disease or
ectopic pregnancy
o Feel the position of the uterus and assess the size of the uterus .Also feel the shape ,
consistency and mobility of the uterus
o Feel through the furnaces for adnexa (ovary and fallopian tube). Tenderness in the adnexa
or mass felt in the adnexa is indicative of PID or ectopic pregnancy. Such cases should be
referred / treated in appropriate higher level of facilities.
Uterine Size
Bigger than expected
but has smooth and soft
surface

Possible Conditions
- Molar pregnancy
- Multiple pregnancy

Line of Action
USG if available or refer to an
appropriate centre

- Wrong dates
Bigger than expected,
irregular and firm

Pressure of Fibroids with


Pregnancy

USG if available or refer to an


appropriate centre

Smaller than expected

- Wrong dates

USG if available or refer to an


appropriate centre

- Non- pregnant uterus


- Ectopic Pregnancy

120

Reference Manual for Doctors on Family Planning and Reproductive Health

Establishing the period of gestation may be difficult in cases of:

The woman does not remember date of last menstrual period.

Conception during Lactational Amenorrhoea.

Wrong dates provided intentionally by the woman.

Missed or incomplete abortion.

4. Laboratory Test

Ultrasound may be helpful for accurate dating when there is a discrepancy in the size of
the uterus by LMP and bimanual examination. However, this test is not a mandatory. It can
detect ectopic pregnancies

Haemoglobin

Urine for albumin and sugar

Blood group/ RH (wherever possible). All women and primi gravid for second trimester
MTPs must be tested for ABO and Rh blood grouping. For multigravidas it should be done
wherever feasible. All Rh vet women should preferably be advised/ administered anti-D
immediately after the abortion procedure or within 72 hours of the procedure , the dose of
which for first trimester MTP will be 50 mcg and second trimester MTP will be 300mcg

Methods of abortion
There are a number of different methods of abortion. The method recommended will depend on
how many weeks pregnant the lady is. This is usually calculated by counting the number of weeks
from the first day of her last period.

6.1. Medical Abortion


Early medical abortion (up to nine weeks of pregnancy)
After the woman is found suitable to undergo pregnancy termination with medical methods, the
following clinical protocol is followed:
First Visit, Day 1
yy Mifepristone (200 mg) is administered orally
yy Anti D (50 mug) is given to Rh negative woman
Before the woman leaves the facility:
yy Instruct her to maintain a record of her symptoms in the client card given to her.
yy Provide her with address and phone numbers of back up facility where she can contact in case
of emergency.

121

Chapter 6: Termination of Pregnancy

yy Ask her to return to the clinic after 48 hours.


yy A small percentage of women (3%) may expel products of conception with mifepristone alone,
but total drug dosage schedule with misoprostol must be completed.
yy Home administration of misoprostol may be advised at the discretion of the provider in
certain cases where the woman has an access to 24 hour. emergency services. In case of home
administration of misoprostol, the woman needs to be provided with:
yy Antiemetics
yy Analgesics
yy Additional dose of misoprostol to be repeated in the conditions mentioned below
Second Visit, Day 3
On her second visit, note any history of bleeding or other side effects and proceed with the following:
yy Administer misoprostol 400 mcg orally / vaginally for gestation age up to seven weeks.
yy Observe the woman for four hours in the clinic / hospital and monitor:

Pulse and blood pressure

Time of start of bleeding and expulsion of products (if it occurs)

Side effects of the drugs

yy Perform a pelvic examination before the woman leaves the clinic and if cervical so is open and
products are partially expelled, remove them digitally.
yy Prescribe drugs for pain relief, if required. Non-narcotic and narcotic analgesic such as
Paracetamol (Acetaminophen) with or without codeine, or Ibuprofen should be provided. Nonsteroidal anti anti-inflammatory drugs (NSAIDS) dont interfere with Misoprostol.
Before the woman leaves the facility:
yy Instruct her to take adequate rest and avoid travelling
yy Tell her that she should report in case of excessive pain or bleeding; (bleeding heavy enough to
completely soak two pads an hour for two consecutive hours or more)
yy Tell Her to use a contraceptive method if she has intercourse
Provide her with:

Analgesics

Anti-emetics

Additional dose of misoprostol, to be repeated in the case of vomiting within half an hour
of taking tablets.

Condoms

122

Reference Manual for Doctors on Family Planning and Reproductive Health

Third Visit, Day 15


During her visit on day 15:
yy A clinical history is taken and pelvic examination is done to ensure the complete expulsion of
the products of conception.
yy Ultrasonography is required if history and examination do not confirm expulsion of products of
conception
Before the woman leaves the facility:
yy Tell her that her next period may be delayed but should come for a check-up if she does not
menstruate in six weeks.
yy Counsel her for contraception and provide her the chosen contraceptive method, if she has not
started it.
Protocols for Mifepristone and Misoprostol
Gestational age
Up to 49 days

Mifepristone on Day 1
200 mg (one 200 mg tablet),
orally

Misoprostol on day 3
400 mcg (two 200 mcg tablets),
orally / vaginal

(For MTP for gestation between 49-63 days the central drugs standard control organization has approved a comb pack of one 200mg
tablet of mifepristone and four 200mcg tablets of misoprostol)

Advantages of medical methods of abortion


Abortion can be offered at early stage with minimum technical assistance. There is more privacy
and less overall complication rate. Since no instrument/anaesthesia is required and hence this is not
invasive. There is no effect on future fertility.

Contraindications
Medical Methods of abortion are contraindicated in women with:
yy Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass, as mifepristone is
not an effective treatment for ectopic pregnancy.
yy Anaemia (Haemoglobin <8 gm. %)
yy Uncontrolled hypertension with B.P. > 160/100 mmHg:
yy Cardiovascular disease such as angina, alular disease, arrhythmia
yy Coagulopathy or women on anti-coagulant therapy
yy Chronic adrenal failure or current long term use of systemic corticosteroids

123

Chapter 6: Termination of Pregnancy

yy Severe renal, liver or respiratory disease


yy Uncontrolled seizure disorder
yy Inherited Porphyria
yy Glaucoma
yy Allergy or intolerance to mifepristone/ misoprostol or other prostaglandins
Psychosocial situation unsuitable for medical methods of abortion
yy Women who are unable to adhere to the protocol due to social and personal reasons
yy Women who want quick abortion
yy

Language or comprehension barrier

6.2. Vacuum Aspiration


In this, contents of uterus are evacuated through a plastic/ metal cannula that is connected to a
vacuum source. Hand held syringes are used to aspirate products of conception. Electric operated
suction instruments are also used for suction. This method is also suitable for early termination of
pregnancy. This is safe up to 12 weeks of pregnancy.
Several studies have demonstrated safety and effectiveness of these methods. Specific benefits
include reduced need for cervical dilatation, reduced risk of cervical injury, reduced infections and
blood loss.
Major complications are two to three times higher in conventional D and C procedures. It is important
that all efforts are made to replace Dand C with safer methods.

Complications and Management


A large number of women undergo unsafe abortions and almost one woman dies every two hours
due to complications. Therefore, proper case selection, adequate counselling and appropriate referral
are the key to the success of medical methods of abortion. Also, the woman should be informed
about the possible complications and where /whom to contact for emergency services.
a. Failure of the method
Failure of the method of abortion is when vacuum aspiration is performed for any reason including
clinicians decision, patients choice or a true drug failure. True drug failure is defined as the
presence of gestational cardiac activity two weeks following the administration of mifepristone and
misoprostol. It occurs in less than onepercent of women and pregnancy should be terminated by
vacuum aspiration.

124

Reference Manual for Doctors on Family Planning and Reproductive Health

b. Heavy Bleeding
Bleeding is likely to be heavier than regular menses, comparable to that of a miscarriage. She should
be told that soaking two pads per hour for two hours in a row is all right at the time of peak cramping
which is often the case during the expulsion of the products of conception. However, if this persists
and /or the woman is dizzy, she should consult the doctor. Severe bleeding necessitating surgical
evacuation is reported in less than one percent of patients. If needed it may be done depending on:

The clinicians assessment blood loss

Presence of circumstances that make it difficult for the woman to obtain emergency help
later

Womans preference

c. Abdominal Cramps
Crimpy abdominal pain is experienced by most women for a short time. Pain relief is an important
part of the therapy. Often, women are relieved by Paracetamol. A mild opioid such as oxycodone
is often added to Paracetamol if required. Pain usually subsides once the products are expelled.
Persistent pain, with failure to respond to these drugs for several hours, warrants evaluation for other
causes such as ectopic pregnancy, infection or incomplete abortion
d. Fever or a feeling of warmth
It is thought to be a component of the prostaglandin analogy used. It is usually short lived and
resolves spontaneously. Acetaminophen (Paracetamol) given for pain relief also takes care of fever,
but if temperature exceeds 100.4 F (38 degrees) or persists for several hours despite antipyretics,
infection should be ruled out.
e. Incomplete abortion
Women having persistent gestational sac without cardiac activity two weeks after the administration
of mifepristone and misoprostol are diagnosed to have incomplete abortion. Such women usually do
not have pregnancy related symptoms and often spontaneously expel the products of conception.
Blood, blood clots and decidua present in the uterus despite expulsion of gestation sac may appear
as hyper echoic tissue on ultrasonography and may be interpreted as incomplete abortion. In the
absence of excessive bleeding, these patients should be followed conservatively.
f. Risk of Teratogens
It is advisable to terminate pregnancy surgically if it continues after drugs for medical abortion have
been taken, due to the risk of possible teratogenicity. A written statement signed by the woman must
be kept on record if surgical termination is refused.
g. Delayed onset of next menses
There might be a delay in the following menstrual period. Next menstruation can occur from 3-6
weeks after the abortion and is usually normal.

125

Chapter 6: Termination of Pregnancy

For 24 hours after the procedure, the client should not do any of the following:
yy Drink alcohol
yy Drive
yy Operate machinery
yy Use appliances that could cause injury
yy Make any major decisions

Frequently asked question


1. What factors should be taken into account when counselling a woman about her choice
between medical and surgical abortion?

There is little, if any, difference between medical and surgical abortion in terms of safety and efficacy. Thus,
both methods are similar from a medical point of view and there are only very few situations where a
recommendation for one or the other method for medical reasons can be given. Two studies have found
that women are more likely to find a method of abortion acceptable if they have chosen it themselves. Being
provided with a choice of methods is seen as extremely important by the majority of women undergoing
abortion. Many studies suggest that women who choose medical abortion find it more acceptable at
earlier than later gestations.

Medical abortion may be preferred:


yy

If it is the womans preference;

yy

In very early gestation; up to 49 days of gestation, medical abortion is considered to be more effective
than surgical abortion, especially when clinical practice does not include detailed inspection of aspirated
tissue

yy

If the woman is severely obese (body mass index greater than 30) but does not have other cardiovascular
risk factors as surgical treatment may be technically more difficult;if the woman has uterine
malformations or a fibroid uterus, or has previously had cervical surgery (which may make surgical
abortion technically more differ cult);

yy

If the woman wants to avoid a surgical intervention.

Surgical abortion may be preferred:


yy

If it is the womans preference, or if she requests concurrent sterilization;

yy

If she has contraindications to medical abortion

yy

If time or geographical constraints preclude the follow-up needed to confirm that abortion is complete.

2. What are the contraindications to medical abortion?


There are very few absolute contraindications to medical abortion. They include:
yy

Previous allergic reaction to one of the drugs involved;

yy

Inherited porphyria;

126

Reference Manual for Doctors on Family Planning and Reproductive Health

yy

Chronic adrenal failure;

yy

Known or suspected ectopic pregnancy.

Caution is required in a range of circumstances including:


yy

If the woman is on long-term corticosteroid therapy (including those with severe, uncontrolled asthma);

yy

If she has a haemorrhagic disorder;

yy

If she has severe anaemia;

yy

If she has pre-existing heart disease or cardiovascular risk factors (e.g. hypertension and smoking).

3. Do any other characteristics of the woman need to be taken into account in providing
medical abortion?
yy

Age - Neither adolescence nor older age (e.g. over 35 years) should be regarded as a contraindication to
medical abortion.

yy

Anaemia - This need not be regarded as a contraindication. However, anaemia detected at the time of
abortion should be treated. Average blood loss in medical abortion may be more than that in surgical
abortion, and the incidence of heavy bleeding may be higher.

yy

Breast feeding - It is likely that mifepristone passes into breast milk. Studies investigating the endocrine
effects of mifepristone on the foetus have found increased levels of adrenocorticotropic hormone and
cortisol. The clinical implications of these changes are unclear. Small amounts of misoprostol also enter
breast milk soon after administration, but it is not known whether this could have any effect on the
infant. As misoprostol levels decline rapidly, it has been recommended that misoprostol should be taken
immediately after a feed and the next feed given after four hours in case of oral administration. After
vaginal Administration, misoprostol levels stay high for longer, and the feed should preferably be given
more than six hours later. Unfortunately, the available data do not allow a precise recommendation on
optimum timing.

yy

Insulin - dependent diabetes or thyroid disorder. There is no evidence that medicalabortion causes
particular problems in women with these disorders. However, mifepristone has been shown to alter
insulin sensitivity in vitro and these effects may or may not be reflected in blood sugar and insulin levels.

yy

Multiple pregnancies - There is no evidence that the failure rate of medical abortion is increased or that
a different dosage regimen is required in the case of multiple pregnancies.

yy

Obesity - There is no evidence that the failure rate of medical abortion is increased or that a different
dosage regimen is required in obese women.

yy

Previous Caesarean section - There is evidence from one study that the safety and efficacy of early
medical abortion are unaffected by previous Caesarean section.

yy

Smoking - There is no evidence of interaction between the risks of smoking and medical abortion.
However, smoking contributes to cardiovascular risk and this factor should be considered when assessing
a womans overall suitability for medical abortion.

yy

Uterine malformations, congenital and acquired; previous cervical surgery. There is no evidence that
these represent contraindications.

127

Chapter 6: Termination of Pregnancy

4. How should pregnancy be confirmed and gestation estimated?


In most cases, pregnancy can be confirmed and its length estimated on the basis of the womans history and
a physical examination. Occasionally, laboratory tests may be needed when the typical signs of pregnancy
are not clearly present and the health-care provider is unsure whether the woman is pregnant. Ultrasound
scanning is not necessary for the provision of early abortion. Where ultrasound equipment is available, a
scan can help identify an intrauterine pregnancy and exclude an ectopic one after about six weeks. It also
helps determine gestational age and diagnose Pathologies or non-viability of a pregnancy.

5. What clinical assessment and laboratory investigations are required prior to medical
abortion?

As for any method of abortion, clinical history-taking should serve to identify contraindications and to
identify risk factors for complications. History-taking should include: personal and family history of relevant
diseases; current use of medications and known allergies; obstetric and gynaecological history, including
ectopic pregnancies; any bleeding tendencies; and history of sexually transmitted infections. Social history
should include risk assessment for STIs, taking into account local STI prevalence rates. The clinician must
be alert to the possibility of violence or coercion in the context of the unwanted pregnancy.

Basic routine observations (pulse, blood pressure, and temperature) are useful as a baseline. There are
no laboratory tests that are essential before medical abortion. However, tests such as haemoglobinlevel,
blood group and rhesus (Rh) typing, and screening for hepatitis,HIV and STIs, may be offered on the basis
of individual risk factors or available resources. Ideally, services should offer testing for pathogens in the
lower genital tract, and treat women found positive.

Rhesus status - The prevalence of Rh-negative status varies markedly with ethnicity, being highest among
Caucasians. For pregnancies up to 63 days gestation, the theoretical risk of maternal Rh sensitization is
very low; there is no evidence that sensitization occurs at this stage of pregnancy. Thus, determination of
blood group and Rh status and the offer of anti-D prophylaxis to Rh-negative women are not considered
prerequisites for early medical abortion. In settings where the prevalence of Rh-negative status is high, and
where resources permit, the offer of Rh typing and anti-D prophylaxis could be worth while as precautionary
components of medical abortion care.

6. Is the interval between administration of mifepristone and prostaglandin crucial?


The licensed and most commonly used interval, of 3648 hours, corresponds to the time when the uterus
is most sensitive to prostaglandin after priming with mifepristone; hence the therapeutic dose can be
reduced to the minimum. This interval was also found to be the most effective in initial studies when uterine
contractility was measured at different times between administration of mifepristone and of prostaglandin.
It has been shown recently, however, that the interval can be shortened to 24 hours or lengthened to
72 hours, without loss of efficacy, when Mifepristone is used in combination with 0.8 mg of vaginally
administered misoprostol. If misoprostol is given as an oral dose of 0.4 mg, the interval of 3648 hours
should be adhered to. Other time intervals are currently being studied.

7. What pain relief should be available to women during medical abortion?


Pain is caused both by the abortion process and as a side-effect of the prostaglandin. It is most likely to
be felt in the few hours after administration of the prostaglandin, when the gestational sac/embryo is
being expelled from the uterus. Studies have shown that women feel less pain if they are older, have been
pregnant before or are in the early stages of pregnancy. However, none of these factors is sufficiently
predictive to be useful in the management of individual cases. The perception of pain and request for relief
vary greatly from one individual to another and among cultures. In any case, health-care providers should
make adequate analgesia easily available to all women who request it during medical abortion. Examples

128

Reference Manual for Doctors on Family Planning and Reproductive Health

of commonly used preparations are: Paracetamol 5001000 mg or nonsteroidal anti-inflammatory drugs


(NSAIDs), such as ibuprofen 200 mg. In cases of severe pain, codeine 3040 mg may be added to either of
the above-mentioned treatments.

8. If a woman has an incomplete abortion, is it necessary to evacuate the uterus surgically?


On average, vaginal bleeding gradually diminishes over about two weeks after a medical abortion, but in
individual cases spotting can last up to 45 days. Generally, bleeding after medical abortion lasts longer
than after vacuum aspiration. If the woman is well, neither prolonged bleeding nor the presence of tissue
in the uterus (as detected by ultrasound) is an indication for surgical intervention. Remaining products of
conception will be expelled during subsequent vaginal bleeding. Surgical evacuation of the uterus may be
carried out on the womans request or if the bleeding is heavy or prolonged, or causes anaemia, or if there
is evidence of infection. In the latter case, antibiotic treatment should be initiated.

9. How should the success of medical abortion be confirmed?


For all women who undergo medical abortion, it is important to confirm that the pregnancy has indeed
been terminated. If expulsion of the products of conception was confirmed by a qualified person in the
hours after administration of the prostaglandin, further follow-up is not absolutely necessary. Otherwise,
a follow-up visit should be arranged about two weeks after the administration of mifepristone, at the
convenience of the patient. At the follow-up visit, complete abortion should be confirmed clinically, either
by bimanualpelvic examination or, if available, pelvic ultrasound. If serial measurements of human chorionic
gonadotropin (HCG) in blood or urine are used, it should be remembered that in some cases low HCG
levels can be detectable for up to four weeks after successful expulsion. Women who continue to have
symptoms of pregnancy or who have minimal bleeding are most likely to be still pregnant.

10. Is there a risk of fetal abnormality after an unsuccessful medical abortion?


Only one anomaly has been reported after the use of mifepristone alone. This case,described as a
Sirenomelia, could not be related to the drug intake. Indeed, this typeof anomaly occurs at a very early
stage of pregnancy at about four weeks of embryo development while the treatment was taken in
the fifth week of pregnancy. Thirteen other cases of malformation have been reported: all occurred in
pregnancies in which mifepristone was administered at 79 weeks of amenorrhoea, followed in eight cases
by gemeprost and in five cases by misoprostol. None of the events could be conclusively related to the
treatment.

It is not possible to determine whether the reported anomalies were caused by the treatment, since the
incidence of birth defects in a normal population is around 2 per 100 births. Some prostaglandins have
been classified as teratogenic, although misoprostol did not induce such effects in embryotoxicology
studies. Mifepristone is not a Teratogenicity agent but, when used in combination with a prostaglandin,
may induceuterine contraction, which could account for some of the observed defects. Since the available
data are limited and inconclusive, there is no need to insist on termination of an exposed pregnancy if the
woman wishes to continue it. Women should,nevertheless, be informed that because of the unknown risk
of abortifacient drugs to the foetus, follow-up is important.

11. Which methods of contraception can a woman use after medical abortion?

Most women who have an induced abortion for an unwanted pregnancy do not want to get pregnant
again immediately. In a few cases, there may be medical reasons for avoiding immediate pregnancy. Postabortion family planning is therefore an integral part of comprehensive abortion care. Women who have
had an early abortion are almost immediately at risk of becoming pregnant again. Ovulation may occur as
early as day 10 after a first-trimester abortion. Up to 78 percent of women in one study had ovulated by

129

Chapter 6: Termination of Pregnancy

the time of the six-week follow-up. Women who have had a medical abortion can use any modern method
of contraception afterwards. When the woman is counselled about the abortion, the opportunity should
be taken to review her contraceptive needs. Ideally, she should be provided with an effective contraceptive
method immediately after the abortion. Combined oral contraceptive pills can be started on the day that
misoprostol is administered, when expulsion usually occurs. Two prospective randomized controlled studies
evaluated the effects of immediate use of combined oral contraceptive pills versus placebo following
medical abortion and found no difference in complete abortion rates, side-effects and duration of bleeding.
Progestogen-only methods are commonly associated with breakthrough bleeding, which may be confused
with an incomplete abortion. Depot-Medroxy progester one injections and implants are often associated
with amenorrhoea, or irregular bleeding, which may make it difficult to determine whether pregnancy
has been terminated. It may therefore be preferable to start using these methods only after it has been
confirmed that the pregnancy has been terminated. Sterilization and insertion of an intrauterine device
should be deferred until confirmation that the abortion is complete. Women who choose a contraceptive
method that cannot be started immediately should be encouraged to use condoms in the meantime. Other
methods, such as caps, sponges, diaphragm, spermicidal foams, jellies and vaginal tablets, can be used as
soon as sexual intercourse is resumed, preferably when bleeding has stopped. Methods of natural family
planning can be resumed only after the return of regular cycles.

130

Chapter 7

PC-PNDT Act

131

Chapter 7: PC-PNDT Act

Sex Selection?
Sex selection is the practice of determining the sex of the unborn foetus and eliminating it if found
to be female. In recent years, the use of ultrasound technology has become the most common mode
of sex determination followed by elimination of the female.

Child Sex Ratio and Sex Ratio at Birth


The child sex ratio reflects the imbalance between the number of girls and boys, indicating that the
practice of sex selection (along with other factors such as selective neglect of girls) have led to a
drastic decline in the number of girls compared to the number of boys.
When the ratio is calculated at birth (i.e. the number of girls born per 1000 boys), it provides a clearer
indication of sex selection, which happens before birth. Though sex ratio at birth is a better indicator
of pre-natal sex selection, the child sex ratio is still most widely quoted because of its easy availability
at the district level and throughout the country.
Child Sex Ratio is calculated as the number of girls per 1000 boys in the 0-6 year age group. In India,
the ratio has shown a sharp decline from 976 girls to 1000 boys in 1961 to 914 as per the 2011
census. The decline has been the sharpest from 1981 onwards. The fall to 927 in the 2001 census is
alarming, especially since the country seems to be registering an upward growth in other areas. This
clearly indicates that economic prosperity and education have no bearing on the sex ratio or in
other words, in changing the traditional preference for sons over daughters.
The sex ratio at birth for the country for 2007-09 is estimated as 906 girls born for every 1000 boys.
Today, the north-western states, where the sex determination clinics first made their presence felt,
have the lowest child sex ratios. In Punjab and Haryana, there are less than 900 girls for every 1000
boys.

Root cause of sex selection and son preference in India


In India, gender based sex selection in favour of boys is a symptom of pervasive social, cultural,
political and economic injustices against women and a manifest action of gender discrimination. This
issue needs to be seen in the context of a male-dominated social and family structure and a value
system based on son preference. Further, the practice of dowry and the tag of parayadhan translate
into daughters being seen as liabilities.
Discrimination and neglect of the girl child could be in terms of inadequate nutrition, denial or
limited access to education and health, and domestic violence. In one of its worst forms, it leads
to complete rejection of daughters even before birth, as practiced through sex selection. In recent
years, it has been perpetuated by the illegal use of diagnostic technologies coupled with unethical
medical practices.

Impact of sex selection


The adverse child sex ratio can severely impact the delicate equilibrium of nature and damage the
moral and social fabric. Contrary to what many believe, fewer girls in a society will not enhance its
132

Reference Manual for Doctors on Family Planning and Reproductive Health

status. Instead, it could lead to increased violence against women, rape, abduction, trafficking and a
resurgence of practices such as polyandry (more than one man marrying one woman). In some parts
of the country, women are already being bought as brides, making commodification of women a
real threat.

PCPNDT Act
The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act regulates
sex selection, before or after conception. The law was first enacted in 1994 and amended in 2003. Its
purpose is to prevent misuse of technologies such as ultrasound that enable testing the sex of the
foetus and eliminating girls.
It is illegal to test the sex of the foetus for non-medical reasons. The law provides for imprisonment,
which may extend to three years and fine up to Rs. 10,000 for the first conviction.
Key steps for complying with PCPNDT Act
yy Register the facility including the machine and display the registration certificate.
yy Inform the appropriate authority of any change in the machine, facility or qualified staff.
yy Maintain transparent and complete records.
yy Preserve records for up to two years.
yy They have to be made available at the time of inspection.
Under what circumstances can pre-natal diagnostic techniques to be offered to pregnant
woman?
yy Age > 35 years: Since it is known that after the age of 35 years the incidence of congenital
foetal malformations increases.
yy Previous two or more spontaneous abortions/foetal loss.
yy Exposure to potential teratogenic agents such as radiation, drugs, infection, chemicals.
yy Family history of mental retardation or physical deformities such as, spasticity or any other
genetic disease.

Abortion rights
In India, abortion is legal under certain circumstances as defined by the Medical Termination of
Pregnancy Act, 1971. The law does not permit abortion for the reason of sex selection. It is important
to recognize this fact and not consider that abortion per se is illegal. A woman needs to have rightful
access to safe and legal abortion services as per the MTP Act.
From a gender equality perspective, sex selection is a reflection of discrimination against girls and
subordination of women as a group. Equally important is to remember that not providing women
access to safe abortion services for legally valid reasons further deepens their subordination. Access
to safe and legal abortion is also necessary to prevent maternal death and related ill health.
133

Chapter 7: PC-PNDT Act

Punishments under the Act


Offence/ Offender

Punishment

Breach of any provision of the Act by any service 3 years imprisonment and / or fine of Rs. 10,000
providers
For subsequent offence

5 Years imprisonment and/ or fine of Rs. 50,000

Medical Professionals

The AA will inform the State Medical Council


and recommend suspension of the offenders
registration. Removal of name from register
for 5 years on first conviction
Imprisonment extending upto 3 years and / or
fine of Rs. 50,000.

Persons seeking to know the sex of the foetus.


(A woman will be presumed to have been
compelled to undergo sex determination tests
by her husband and relatives. If the presumption
is not dispelled, then the person concerned will
be punishable for abetment of the offence)
For subsequent offence

Imprisonment upto 5 years and / or fine of Rs


1,00,000

Persons connected with advertisement of sex


selection / sex determination services

Imprisonment upto 3 years and / or a fine of


Rs. 10,000 with additional fine of continuing
contravention at the rate of Rs. 500 per day

Contravention of provisions of the Act or rules


for which specific punishment is provided with
Act/ Rule

Imprisonment upto 3 months and /or fine of


Rs. 1,000 with additional fine of continuing
contravention at the rate of Rs. 500 per day.

Persons to be punished:
yy Person who performs the test.
yy Every person in charge of and responsible for the conduct of business of the Genetic Centre
(GC), Genetic Counselling Centre (GCC) or Genetic Laboratory (GL).
yy Owner, director or the manager of the company , which runs the Genetic Centre , Genetic
Counselling Centre or Genetic Laboratory.
yy Mediator who is responsible for directing the pregnant woman to such a unit.
yy Husband / Family of the pregnant woman.
yy All other relatives of the pregnant woman who are responsible for forcing her or helping her
undergo pre-natal sex detection.
yy The pregnant woman herself is considered innocent under the Act, unless and until proved
otherwise. If it is proved that she approached the unit for pre-natal sex detection without any
compulsion, then she is considered guilty.
The code of conduct to be followed by all persons employed in GCC, GL, Ultasound Clinics,
Imaging Centres registered under the Act / Rules

134

Reference Manual for Doctors on Family Planning and Reproductive Health

Code of conduct by Ultrasound and Imaging clinics under the Act


yy Display information at the clinic: Registration certificate, copy of the Act and a display board in
English and a local language saying DISCLOSURE OF THE SEX OF THE FOETUS IS PROHIBITED
UNDER LAW RULE 17(1)
yy Maintain Records as Prescribed by Law
Mandatory Records
Register showing in serial order
yy Name and addresses of men or women given genetic counselling and/or subjected to prenatal
diagnostic procedure or test.
yy Names of their spouses of fathers;
yy Date on which they first reported for such counselling
For every case
yy The referrals of the doctor recommending the scan
yy A declaration by the doctor that he/she has neither detected nor disclosed the sex of the
foetus to anybody in any manner
yy A declaration from the pregnant women regarding her non-interest in knowing the sex of the
foetus
Maintain forms as prescribed by Rules of the Act
yy Maintain Form D (Records for genetic Counselling Centre), E (Records for genetic Laboratory)
and F (Record for the pregnant women by ultrasound clinics, etc)
yy Multiple copies of forms can be photocopied from the PCPNDT Handbook on Act and Rules
yy Send complete report based on above forms statutorily by 5th of the succeeding month (for
the previous month) to the Appropriate Authority or any officer so authorized.
Other Medical Records: Other records that are kept by the clinic include:
yy Case Record
yy Forms of consent for invasive procedures (form G)
yy Laboratory results, microscopic pictures and sonographic plates or slides
yy Recommendations and letters from referring doctor
(i) Not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus
in any manner.
(ii) Not employ or cause to be employed any person not possessing qualifications necessary
for carrying out pre-natal diagnostic techniques/ procedures, techniques and tests including
ultrasonography.

135

Chapter 7: PC-PNDT Act

(iii) Not conduct or cause to be conducted or aid in conducting by himself or through any other
person any techniques or procedure for selection of sex before or after conception or for
detection of sex of foetus except for the purposes specified in sub- section (2) of section 4 of
the Act.
(iv) Not conduct or cause to be conducted or aid in conducting by himself or through any other
person any techniques or test or procedure under the Act at a place other than a place
registered under the Act / these Rules.
(v) Ensure that no provision of the Act and these Rules are violated in any manner.
(vi) Ensure that the person conducting any techniques, test or procedure leading to detection of
sex of foetus for purposes not covered under section 4(2) of the Act or selection of sex before
or after conception, is informed that such procedures lead to violation of the Act and these
Rules which are punishable offences.
(vii) Help the law enforcing agencies in bringing to book the violators of the provisions of the Act
and these Rules.
(viii) Display the medical professionals name and designation prominently on their dress.
(ix) Write his/her name and designation in full under his/her signature.
(x) On no account conduct or allow/cause female foeticide to be conducted.
(xi) Not commit any other act of Professional misconduct.
Responsibility of the Medical Professionals
1. To say No to requests for performing sex selection, sex detection and gender-specific MTPs
and to discourage colleagues from doing so.
2. To register Genetic Centres.
3. To counsel women/couples and their families and dissuade them from knowing the sex of the
foetus.
4. To enlighten society about erring doctors who conduct prenatal sex detection and female
specific MTPs.

To regularly have stocktaking on the prevalence of sex determination and sex selection
by professional bodies such as the Indian Medical Association and to publish articles and
statements on the subject to give prominent focus to the issue.

6. To himself/herself sincerely abide by the Act and its spirit.


7. To blow the whistle on those in the fraternity who are conducting these tests and practices.
They should be immediately reported to the concerned Appropriate Authority.

136

Reference Manual for Doctors on Family Planning and Reproductive Health

Amendments in the Act in 2012


Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994), the Central Government hereby
makes the following further amendments to the Pre-conception and Pre-natal Diagnostic Techniques
(Prohibition of Sex Selection) Rules, 1996 namely:
1. (1) These rules may be called the Pre-conception and Pre-natal Diagnostic Techniques(Prohibition
of Sex Selection) Amendment Rules, 2012.(2) They shall come into force on the date of their
publication in the Official Gazette.
2. In the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules,
1996 (hereinafter referred to as the said rules), after rule 3, the following shall be inserted, before
rule 3A, namely: (3) Each medical practitioner qualified under the Act to conduct ultrasonography
in a genetic clinic/ultrasound clinic/imaging centre shall be permitted to be registered with a
maximum of two such clinics/centres within a district. The consulting hours for such medical
practitioner, shall be clearly specified by each clinic/centre.
3. In the said rules, in rule 5 in sub-rule (1), the following sub-rule,- In item (a) for the letters and
figure Rs. 3,000.00, the words rupees twenty five thousand shall be substituted. In item (b) for
the letters and figure Rs 4,000.00, the words rupees thirty five thousand shall be substituted.
4. In the said rules, in rule 13, for the words within a period of thirty days of such change, the
words at least thirty days in advance of the expected date of such change, and seek re-issuance
of certificate of registration from the Appropriate Authority, with the changes duly incorporated
shall be substituted.

Frequently asked Question


1. Is the act against technology?

The Act and the campaign for its implementation are not against the technology per se, but demand the
ethical use of pre-natal diagnostic technology. If technology is used to only selectively eliminate the female
foetus, then doctors need to question the use of this technology.

2. What are the commonly used techniques for sex selection?


I. Pre- conception Techniques


a. Pre- Implantation Genetic Diagnosis (PGD)

b. Sperm sorting and sperm separation

II. Pre- natal diagnostic Techniques (PNDT)


a. Amniocentesis

b. Chorion Villus Biopsy

c. Sonography

III. Other methods include Ayurvedic Therapies

137

Chapter 7: PC-PNDT Act

3. Where can these tests be conducted? And who can conduct these tests?

These tests can be conducted at the following premises

Genetic Counselling Centres (GCC) including maternity clinics, nursing homes, gynaecological clinics

Genetic Clinics

Genetic Laboratories

Ultrasound Clinics and Imaging Centres

These tests can be conducted by

Registered Medical Practitioner with six months training or one year experience with any recognized
medical qualification under the Indian Medical Council Act, 1956 and whose name is entered in the
State Medical Register

Gynaecologist possessing a post graduate degree in Gynaecology and Obstetrics

Medical Geneticist possessing a degree or diploma in genetic science

Paediatrician possessing a post graduate degree in Paediatrics.

4. Can a medical Professional perform pre-natal diagnostic technique on a pregnant woman


without her consent?

The Act gives full right to the pregnant woman to know: what procedure is to be performed; good and bad
effects of such a test on her and her foetus; types of results expected of such a test; type of information
that will not be looked for and conveyed to her with this test; what will be the advantages of taking the test
and disadvantages of not taking the test.

5. Is there any test where informed consent is not required?


After the amendments to the Act, there has been a bifurcation of procedures adopted for invasive and
non-invasive tests. Invasive tests are those which have the risk of causing miscarriage- for example,
amniocentesis, CVS and Foetal blood sampling. Non-invasive tests such as Ultrasound do not carry a risk;
hence consent of the pregnant woman need not be taken. However, before taking the test, the woman has
to give a declaration stating that she does not want to know the sex of the foetus. Similarly, the medical
professional conducting the test has to declare that he/she will neither detect nor disclose the sex of the
foetus to any person.

6. What is the procedure for registering a Genetic Clinic, Counselling Centre or a Laboratory?

The owner has to apply to the Appropriate Authority (the chief Medical Officer at the district where the unit
is situated or the officer appointed in the sub district). All applications are to be made in duplicate in Form
A and must be accompanied by enclosures containing details of equipment available, the make and model
of each piece of equipment and the names, qualifications, registration number and experience of medical
professionals.

The registration fee for a Genetic Clinic is Rs. 3,000. However,Genetic Clinic is Rs. 3,000. However, if the
centre is providing more than one service as a Genetic Counselling Centre, Genetic Laboratory and Genetic
Clinic then it is Rs. 4,000. This fee is non-refundable and irrespective of the number of USG machines in the
centre.

138

Reference Manual for Doctors on Family Planning and Reproductive Health

7. Can non- allopathic medical professionals perform USG?


No non-allopathic medical professionals cannot perform USG.

8. What is validity of the registration certificate? How does the owner renew the
registration?

Five years, provided there is no violation under the Act. An application for renewal should be made in
duplicate through Form A to the AA 30 days before the expiry date of the registration. The registration
would be renewed after conducting an enquiry and with suggestions from the Advisory committee. The
renewal fee is half of the original fee.

9. What should the scan Centres do under the Act?


Display

Registration certificate, PNDT board and Pamphlets;

Records

Mandatory records

Register showing in serial order:

Name and address of men/women given genetic counselling and / or subjected to prenatal
diagnostic procedure or test.

Names of their spouses or fathers.

Dates on which they first reported for such counselling.

The scan centre shall send consolidated report on Form F statutorily by the 5th of the following month
for the previous month, to the Appropriate Authority or any officer so authorized. Other kinds of records
include:

Case records

Forms of consent

Laboratory results

Microscopic pictures

Sonographic plates or slides

Recommendations and letter

10. If the owner is convicted under the Act and undergoes punishment, what is the status of
registration of his unit?

In such a case, when charges are framed against him, the registration of his unit is suspended or cancelled,
prohibiting any pre-natal diagnostic or counselling from being carried out there. In such an event, the
Appropriate Authority can grant the registration, depending on whether the units meet the requirements
laid down in the Act and the Rules.

11. Who can be punished under the Act?

Person who performs the test.


139

Chapter 7: PC-PNDT Act

Every person in charge of and responsible for the conduct of business of the Genetic
Centre, Genetic Counselling Centre or Genetic Laboratory.

Owner, director or the manager of the company which runs the Genetic Centre, Genetic
Counselling Centre or Genetic Laboratory.

Mediator who is responsible for directing the pregnant woman to such a unit.

Husband / Family of the pregnant woman.

All other relatives of the pregnant woman who are responsible for forcing her or helping
her undergo pre-natal sex detection.

The pregnant woman herself is considered innocent under the Act, unless and until proved
otherwise. If it is proved that she approached the unit for pre-natal sex detection without
any compulsion, then she is considered guilty.

12. Is sex selection caused by poverty and illiteracy?


No this is a myth. This practice is prevalent right across the country, even in regions which are prosperous
and people are literate.

13. Does the mother have the right to choose the sex of her future child?

Fear of violence and desertion and desire to establish ones value in the family mean that woman feels
pressured to have sons and therefore opt for sex selection. This can hardly be called as a couples choice.
As per the law, the right to bring into existence a life in future with a choice to determine the sex of that life
cannot in itself be a right. The view is that sex selection cannot be treated as a matter of right and choice
as it promotes discrimination.

140

Chapter 8

Accreditation of
Private Providers
for Family Planning
Services

141

Chapter 8: Accreditation of Private Providers for Family Planning Services

8.1. Accreditation under Government


of India Public-Private Partnership
Scheme
Understanding Public Private Partnership
Public-Private Partnership or PPP in the context of the health sector is an instrument for improving
the health of the population. PPP is to be seen in the context of viewing the whole medical sector as
a national asset with health promotion as goal of all health providers, private or public. The Private
and Non-profit sectors are also very much accountable for the success of the overall health systems
and services of the country. Therefore, synergies where all the stakeholders feel they are part of the
system and do everything possible to strengthen national policies and programmes need to be
emphasized, with a proactive role from the Government.
However for definitional purpose, Public would define government or organizations functioning
under State budgets, Private would be the Profit/Non-profit/Voluntary sector and Partnership
would mean a collaborative effort and reciprocal relationship between two parties with clear terms
and conditions to achieve mutually understood and agreed upon objectives following certain
mechanisms.
PPP however would not mean privatization of the health sector. Partnership is not meant to be
a substitution for lesser provisioning of government resources nor an abdication of government
responsibility but as a tool for augmenting the public health system.1
Although it varies between regions and states, more than two thirds of health care activity in India
takes place in the private sector, which is currently expanding more rapidly than the government
sector. Though the economic weight of this sub-sector and the part of household budgets devoted
to private health care are substantial, it remains largely unregulated.2
Over the years the private health sector in India has grown markedly. Today the private sector provides
58 percent of the hospitals, 29 percent of the beds in the hospitals and 81 percent of the doctors.
(The Report of the Task Force on Medical Education, Ministry of Health and Family Welfare)
The private providers in treatment of illness are 78 percent in the rural areas and 81 percent in the
urban areas. The use of public health care is lowest in the states of Bihar and Uttar Pradesh. The
reliance on the private sector is highest in Bihar. Seventy seven percent of out-patient department
(OPD) cases in rural areas and 80 percent in urban areas are being serviced by the private sector in
the country (60th round of the National Sample Survey Organisation [NSSO] Report.
Branding of healthcare institutions as government certified etc. and with a specific brand name
would help create a ready market of clients willing to go an extra mile to avail of services from such
providers.3
Draft Report on Recommendation of Task Force on Public Private Partnership for the 11th Plan
National Plan for RCH II 2005
3
The Principles and Evidence Base for RCH Phase II PIPs
1

142

Reference Manual for Doctors on Family Planning and Reproductive Health

Objectives of PPP in Family Planning


Universal coverage and equity for family planning services should be the main objective of the PPP
mechanism besides:
yy Improving quality, accessibility,availability, acceptability and efficiency.
yy Exchange of skills and expertise between the public and private sector.
yy Mobilization of additional resources.
yy Improve the efficiency in allocation of resources and additional resource generation.
yy Widening the range of services and number of service providers.
yy Clearly defined sharing of risks.
yy Community ownership.

Santushti Scheme
Santushti is a Scheme of Jansankhya Sthirata Kosh (JSK) for the highly populated states of India viz
Bihar, Uttar Pradesh, Madhya Pradesh, Rajasthan, Jharkhand, Chhattisgarh and Odisha. Under this
scheme, JSK, invites private sector gynaecologists and vasectomy surgeons to conduct operations in
Public Private Partnership mode.
According to this Scheme, an accredited private Nursing Home/ Hospital (Quality assurance manual
for Sterilization services), can sign a MOU with JSK. Upon signing the MOU the private Hospital/
Nursing Home shall be entitled for an incentive, whenever it conducts 10 or more Tubectomy/
Vasectomy cases in a month.
To participate in this scheme, Private Hospitals/Nursing Homes may contact either the District Chief
Medical & Health Officer or JSK. The quality assurance manual can also be accessed on mohfw.nic.in.
Following terms regarding the Santushti Strategy will become applicable:
1. Accredited Private Hospitals/Nursing Homes, who conduct 10 Tubectomy (Female Sterilization)
and Vasectomy (Male Sterilization) operations in a month, will be eligible for payment under
the Santushti Strategy.
2. Private facilities conforming to the aforesaid criteria are entitled to claim Rs. 1500/- per case
from National Rural health Mission (NRHM) funds while an additional amount of Rs. 500/- per
case will be paid by JSK.
3. Now there is also a provision for payment of wage compensation to the clients undergoing
sterilization operations equal to the sum paid to them in the public facility. i.e. Rs. 600/- for
Tubectomy and Rs 1100/- for Vasectomy clients.

143

Chapter 8: Accreditation of Private Providers for Family Planning Services

Wage
Motivators
compensation to
(Rs.)
the beneficiaries
(Rs.)

Type of
Service

Type of
facility

Incentive
to the
Providers

Tubectomy

Private

1850/-

150/-

600/-

2600/ (1500/- from


NRHM Fund &the rest will
be provided by JSK)

Vasectomy

Private

1800/-

200/-

1100/-

3100/- (1500/- from


NRHM Fund &the rest will
be provided by JSK)

Total (Rs.)

4. To streamline the functioning there will be a Tripartite MOU will be between the Private Health
Provider, the State Health Society and JSK.
5. NGOs working in the state may also be eligible to participate in the Scheme if they will fulfil
requisite criteria for quality assurance.
The Scheme is currently available in following districts:
Uttar-Pradesh: Bijnour, Gorakhpur, Farrukhabad, Barabanki, Aligarh, Badaun, Bareilly
Rajasthan: Bharatpur, Ajmer, Tonk, Pali, Jodhpur
Bihar: PurbiChamparan, Sitamarhi, Purnea, Katihar, Kishanganj
Madhya Pradesh: Sagar, Jabalpur, Neemuch
Accreditation of private hospital for Sterilization Services
Qualification requirements for service providers4
yy Female sterilization by mini-laptubectomy should be performed by a trained MBBS/ post
graduate doctor.
yy Laparoscopic sterilization for females should be performed by a gynaecologist with DGO/
MD/MS qualification or by a surgeon with an MS degree; these doctors should be trained in
laparoscopic sterilization.
yy The male sterilization procedures, both conventional vasectomy and no-scalpel vasectomy
(NSV), should be performed by a trained MBBS doctor/or a post graduate doctor.
Empanelment of doctors for performing sterilization3
yy Approved panel of doctors: Each state will prepare a district-wise list of doctors (both from
government and accredited private centres/NGOs) who are qualified to perform sterilization
operations as per the prescribed eligibility criteria.
4

Quality Assurance Manual for Sterilization Services

144

Reference Manual for Doctors on Family Planning and Reproductive Health

Eligibility/Qualification of Doctors for Conducting Sterilization Procedures


Female Sterilization
An MBBS Doctor trained to carry out Minilap
Tubectomy may perform mini-laptubectomy.

Male Sterilization
Conventional Vasectomy can be performed
by an MBBS Doctor trained in conventional
Vasectomy.

Or
Laparoscopic Tubectomy can be performed
either by a Gynaecologist with DGO/MD/MS
Degree and trained in Laparoscopic sterilization
or by a surgeon with MS (Surgery) Degree and
trained in Laparoscopic sterilization

An MBBS doctor trained in no-scalpel


vasectomy may perform no-scalpel vasectomy.

yy Only those doctors whose names appear on the panel will be entitled to carry out sterilization
procedures in the government and/or government-accredited institutions and will be covered
under indemnity insurance. The panel will be updated quarterly.
Compensation to private providers for IUD insertion
For each IUD insertion at an accredited private facility Rs. 75 inclusive of the cost of the IUD would
be admissible.

145

146

Annexures

147

148

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 1: References
1. Ministry of Health and Family Welfare. 2010.Comprehensive Abortion Care Guidelines.[Online].
[Accessed on 15 April 2013]. Available from: http://mohfw.nic.in/NRHM/Documents/MH/
Comprehensive%20Abortion%20Care%20Training%20&%20Service%20Delivery%20Guidelines.
pdf
2. Ministry of Health and Family Welfare. 2008.Guidelines for Administration of emergency
contraceptive pills by Health care providers.[Online].[Accessed on 15 April 2013]. Available from
http://mohfw.nic.in/NRHM/FP/ECP_Book_Final.pdf
3. National Consortium for Medical Abortions in India (2010).Guidelines for early Medical abortions
in India using Mifepristone and Misoprostol. New Delhi.
4. The Federation of Obstetrics and Gynaecologists Societies in India 2006. Contraception: Past,
Present and Future: 2006. India. United Nations Population Fund.(2006). Contraceptive Updates:
2006.[Online].[Accessed on 16 April2013]. Available from:http://mohfw.nic.in/NRHM/FP/
reference_material.pdf
5. USAID and Family Health International, 360. Facts for family Planning. [Online].[Accessed on 15
April 2013]. Available from: http://www.fphandbook.org/sites/default/files/familyplanning_web.
pdf
6. WHO/USAID and Johns Hopkins (2011) Family Planning: Global hand book,revised 2011 update.
Geneva, Switzerland: WHO Press.
7. Government of India: Standards for Sterlisation, Quality Assurance, Intra Uterine Devices, Minilap
and NSV.
8. Family Planning Association of India. Injectable Contraceptives: Technical Guide for Service
providers:
9. Population Services International.2012. Intrauterine Uterine Devices: Reference Manual for
Doctors. India.
10. Smith R., L. Ashford., J. Gribble and D. Clifton. 2012. Family planning saves lives. PopulationReference
Bureau. 4th ed.Washington.
11. United Nations Population Fund.2013.Gender Biased sex selection and Access to safe abortion.
IPAS and UNFPA publication.
12. Trends and Differentials in fertility and FP indicators of EAG states in India : A policy paper from
Policy project 2012.
13. United Nations Population Fund.2009.Doctors for daughters: An information kit for Doctors
on PC-PNDT Act 2009.[online].[Accessed on 20 April 2013]. Available from:http://india.unfpa.
org/?publications

149

Annexures

Annexure 2
Infection Prevention in the Clinics/facilities
Infection prevention procedures are simple, safe, effective and inexpensive. infectious organisms
of concern in the clinics include bacteria (such as staphylococcus), viruses (particularly HIV and
Hepatitis B and Hepatitis C), fungi and parasites. In the clinic, infectious organisms can be found in
blood and body fluids with visible blood or tissue. The organisms can be passed through mucous
membranes or broken skin, such as cuts and scratches and by needlesticks with used needles and
other puncture wounds. Infectious organisms can pass from clinics to communities when waste
disposal is not proper or staff members do not wash their hands properly before leaving the clinic.
Basic Rules of Infection Prevention:
These rules are to apply the universal standard precautions for infection prevention for all hosital
procedures at all times with all clients to decrease the risk of transmission of infection, including the
Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), and Hepatitis B (HBV).
Standard universal precautions of infection prevention include:
Washing hands
1. Ensuring self-protection by wearing gloves and employing other physical barriers
2. Adopting safe work practices (to prevent injuries from sharps/instruments)
3. Maintaining proper methods of environmental cleanliness
4. Ensuring the proper processing of instruments and other reusable items
5. Following proper waste-disposal practices and handling, transporting, and processing used and/
or soiled linens in the recommended and prescribed manner.
Hand Washing
yy Hand washing may be the single most important infection prevention procedure.
yy Wash hands before and after examining or treating each client. (Hand wasing is not necessary
if clients do not require an examination or treatment.)
yy Use clean water and plain soap, and rub hands for at least 10 to 15 seconds. Be sure to follow
six steps of hand washing to clean thumbs, tips of fingers, between the fingers and under
fingernails, back of the hand and wrists.
yy Wash hands after:

arriving for work

handling soiled instruments and other items

touching mucous membranes, blood, or other body fluids

before putting on gloves and after removing gloves

150

Reference Manual for Doctors on Family Planning and Reproductive Health

before and after eating food

after you use the toilet or latrine

when you leave

Dry hands with a paper towel or a clean, dry cloth towel that no one else uses, or air-dry.
Practices such as using a common basin where a number of people or even one person washes or
dips his/her hand(s) repeatedly is dangerous and must be abandoned.

Surgical scrub
a) The surgeon and his/her assistant must scrub both their hands and forearms up to the elbows
thoroughly with soap and running water or antiseptic agents. The entire procedure should be
repeated at least three times so that the scrub lasts for at least 3 minutes. The hands and forearms
should be air dried. Do not dry hands with sterile surgical gown which you are going to wear for
surgical procedure.
b) A small nail brush should be used for cleaning fingernails.

Ideally, the surgeon and the assistant should scrub thoroughly between each procedure. In camp
settings, in order to prevent re-colonization of the skin by micro-organisms, the surgical staff should
do a three-minute surgical scrub every hour or after every five cases (whichever is earlier) or if the
surgeon (and/or the surgical staff) goes out of the operation theatre (OT), or touches any infected
item or if the glove is torn. In between antiseptic alcohol scrub should be done.
Six steps of effective hand wash
1. Wash palms & fingers

4. Wash finger tips

2. Wash back of hands

3. Wash fingers & interdigital space

5. Wash thumbs

6. Wash wrists

151

Annexures

Process instruments that touch tissues beneath the skin,and will be re-used, preferably after
sterilization or high level disinfection. Do the following:
yy Wear gloves for any procedure that risks touching blood, other body fluids, mucous
membranes, broken skin, soiled items, dirty surfaces or waste
yy Wear sterilized surgical gloves for surgical procedures such as insertion of implants
yy Wear single use examination gloves for procedures that touch intact mucous membranes or
generally to avoid exposure to body fluids
yy Gloves are not necessary for giving intramuscular injections
yy Change gloves between procedures on the same client and between clients
yy Do not touch clean equipment or surfaces with dirty gloves or bare hands
yy Wash hands before putting on and after removing gloves. Put gloved hand in 0.5% chlorione
solution before removing them. Do not wash gloved hands instead of changing gloves. Gloves
are not a substitute for hand washing
yy Wear clean utility gloves when cleaning soiled instruments and equipment, handling waste and
cleaning blood or body fluid spills
Do Pelvic Examination only when needed
Pelvic examinations are not needed for most family planning methods- needed only for female
sterilization and the IUD. Pelvic examinations should be done only when there is a reason such
as suspicion of sexually transmitted infections, when the examination could help with diagnosis or
treatment.
For injections, use new auto disable syringes and needles
Auto disable syringes and needles are safer and more reliable than standard single use disposable
syringes and needles and any disposable syringes and needles are safer than sterilizing re-usable
syringes and needles. Reusable syringes and needles should be considered only when single use
injection equipment is not available and if programmes can document the quality of high level
disinfection (HLD)/sterilization
Cleaning the clients skin before the injection is needed when the skin is dirty. If it is washed with soap
and water with a clean towel. Wiping with an antiseptic has no added benefit.
Asepsis in OT/Procedure room/client care area
Wipe examination tables, bench tops, and other surfaces that come in contact with unbroken skin
with 0.5% chlorine solution after each client.
A. Before Surgery
yy Clean the operating table, table/counter top and light handles with a cloth soaked in 0.5%
chlorine solution and detergent

152

Reference Manual for Doctors on Family Planning and Reproductive Health

yy Clean the floor with a mop soaked in 0.5% chlorine solution


B. After Surgery
yy Decontaminate all operating room surfaces that come into contact with the patient (such as
table) between procedures by scrubbing and wiping them with 0.5% chlorine solution
yy The operating table, counters/table tops, and light handles should be wiped with a detergent
and 0.5% chlorine solution
Dispose of single use equipment and supplies properly and safely
Handling bio-medical waste
yy Use personal protective equipment googles, mask , apron and closed protective plastic shoes
when handling wastes.
yy Needles and syringes meant for single use must not be reused. Do not take apart the needle
and syringe. Used needles should not be broken, bent or recapped. Put used needles and
syringes immediately into a puncture proof container for disposal. (If needles and syringes will
not be incinerated , they should be decontaminated by flushing with 0.5% chlorine solution
before they are put into the puncture proof container).The puncture proof sharps container
should be sealed and deeply buried when threefourths full.
yy Dressings and other soiled solid waste should be collected in plastic bags and, within 2 days,
buried in a deep pit. Liquid wastes should be poured down a utility sink drain or a flushable
toilet or poured into a deep pit and buried.
yy Clean waste containers with detergent and rinse with water.
yy Remove utility gloves and decontaminate and clean them whenever they are dirty and at least
once every day.
yy Wash hands before putting on and after removing utility gloves for disposing of soiled
equipment and waste.
Wash Linens
Wash linens (for example bedding, caps, gowns, and surgical drapess) by hand or machine and line
dry or machine dry. When handling soiled linens, wear gloves and other protective attire , hold linens
away from your body and do not shake them.
Little risk of HIV Infection in the clinic
yy Health care providers may be exposed to HIV through needle sticks, mucous membranes , or
broken skin, but the risk of infection is low.
yy Needle sticks or cuts cause most infections in health care settings. The average risk of HIV
infection after a needle stick exposure to HIV infected blood is 3 infections per 1,000 needle
sticks but risk of Hep. B infection is 10% to 30 % and Hep. C risk of infection is 3% to 10% .

153

Annexures

yy The risk after exposure of the eye, nose or mouth to HIV infected blood is estimated to be
about 1 infection per 1,000 exposures. A small amount of 0.00000001 CC of blood is sufficient
to infect.
yy Following universal precautions is the best way that providers can avoid workplace exposure to
HIV and other fluid borne infections.
Make Infection Prevention a Habit
With each and every client and each and every procedure on a client, a health care provider should
think, What infection prevention procedure is needed? Any client or provider may have an infection
without knowing it and without obvious symptoms.
Infection prevention is a sign of good health care that can attract clients. For some clients cleanliness
is one of the most important signs of quality.
The 4 steps of processing reusable equipment are
yy Decontaminate to kill infectious organisms such as HIV and Hepatitis B and C and to make
instruments, gloves, and other objects safer for people who clean them. Soak in 0.5% chlorine
solution for 10 minutes. Rinse with clean water or clean immediately.
yy Clean to remove body fluids, tissue and dirt. Wash or scrub with a brush ( a toothbrush is a
good option) with detergent and water. Avoid bar soap or powdered soap, which form a sticky
substance with blood and body tissues and can stay on the equipment. Rinse and dry. While
cleaning, wear utility gloves and personal protective equipment- goggles, mask, apron and
enclosed shoes.
yy High level disinfection or sterilization

High level disinfection kills all infectious organisms except some bacterial endospores (a
dormant, resistant form of bacteria) by boiling, steaming or with chemicals. Instruments
or supplies that touch intact mucous membranes or broken skin, such as vaginal specula,
uterine sounds and gloves for pelvic examinations should be high level disinfected or
sterilized. Sterilization is the preferred method while HLD is an acceptable alternative.
HLD can be achieved either by boiling or by soaking in a high-level disinfectant (like 2%
glutaraldehyde) for 20 minutes.

Sterilization kills all infectious organisms including bacterial endospores, with a high
pressure steam autooclave, a dry heat oven, chemicals, or radiation. It can be done by
using steam (autoclaving) at 15lb pressure for 30 minutes or soaking in a chemical solution
(2% gluteradehyde) for 10 hours.

Store instruments and supplies to protect them from contamination. They should be stored
in a dry high level disinfected or sterilized container in a clean area away from clinic traffic.
The equipment used to sterilize and high level disinfect instruments and supplies also must
be gaurded against contamination.

154

Reference Manual for Doctors on Family Planning and Reproductive Health

Some procedures/equipment which are ineffective and obselete ( which may still be used at clinics/
hospitals) are:
yy Fumigation of OT
yy Using Ultravoilet lamps for asepsis in OT
yy Flaming of trays with spirit to sterilize instrument tray
yy Putting instruments in formaline chamber for sterilization

155

Annexures

Annexure 3
FORM F
[See Proviso to Section 4(3), Rule 9(4) and Rule 10(1A)]
Form for Maintenance of Record in Respect of Pregnant Woman by
Genetic Clinic/Ultrasound Clinic/Imaging Centre
1. Name and address of the Genetic Clinic/Ultrasound Clinic/Imaging Centre.
2. Registration No.
3. Patients name and her age.
4. Number of children with sex of each child.
5. Husbands/Fathers name.
6. Full address with Tel. No., if any.
7. Referred by (full name and address of Doctor(s)/Genetic Counseling Centre (Referral note to be
preserved carefully with case papers)/self-referral.
8. Last menstrual period/weeks of pregnancy.
9. History of genetic/medical disease in the family (specify).

Basis of diagnosis: (a) Clinical (b) Bio-chemical (c) Cytogenetic (d) Other (e.g. Radiological,
ultrasonography etc. specify).

10. Indication for pre-natal diagnosis.


A. Previous child/children with:

Chromosomal disorders metabolic disorders Congenital anomaly Single gene disorder

Mental retardation Haemoglobinopathy Sex linked disorders. Any other (specify)

B. Advanced maternal age (35 years).


C. Mother/father/sibling has genetic disease (specify).
D. Other (specify).
11. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered

Medical Practitioner) who performed it.

Non-Invasive

(i) Ultrasound

(Specify purpose for which ultrasound is to done during pregnancy)

[List of indications for ultrasonography of pregnant women are given in the important Notes]

Invasive

156

Reference Manual for Doctors on Family Planning and Reproductive Health

Amniocentesis Chorionic Villi aspiration Foetal biopsy Cordocentesis. Any other (specify).

12. Any complication of procedure please specify.


13. Laboratory tests recommended [Strike out whichever is not applicable or not necessary]

Chromosomal studies Biochemical studies.

Molecular studies Pre-implantation genetic diagnosis.

14. Result of

(a) Pre-natal diagnostic procedure (give details).

(b) Ultrasonography Normal/Abnormal

(Specify abnormality detected, if any)

15. Date(s) on which procedures carried out.


16. Date on which consent obtained. (In case of invasive).
17. The result of pre-natal diagnostic procedure was conveyed to ....on .
18. Was MTP advised/conducted?
19. Date on which MTP carried out

Date: Name, Signature and Registration number of the

Place Gynaecologist/Radiologist/Director of the Clinic.

Declaration of Pregnant Woman


I, Ms. ________________ (name of the pregnant woman) declare that by undergoing ultrasonography
/image scanning etc. I do not want to know the sex of my foetus.

Signature/Thumb impression of pregnant woman

Declaration of Doctor/Person Conducting Ultrasonography/Image Scanning

I, __________________ (name of the person conducting Ultrasonography/image scanning) declare


that
while conducting ultrasonography/image scanning on Ms. ___________ (name of the
pregnant woman), I have neither detected nor disclosed the sex of her foetus to anybody in any
manner.

Name and signature of the person conducting Ultrasonography/image scanning/Director or


owner of genetic clinic/ultrasound clinic/imaging centre.

Important Note:(i) Ultrasound is not indicated/advised/performed to determine the sex of foetus except for
diagnosis of sex-linked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B etc.
(ii) During pregnancy Ultrasonography should only be performed when indicated.
157

Annexures

The following is the representative list of indications for ultrasound during pregnancy.
1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
2) Estimation of gestational age (dating).
3) Detection of number of fetuses and their chorionicity.
4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/
MTP failure.
5) Vaginal bleeding / leaking.
6) Follow-up of cases of abortion.
7) Assessment of cervical canal and diameter of internal os.
8) Discrepancy between uterine size and period of amenorrhoea.
9) Any suspected adenexal or uterine pathology / abnormality.
10) Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and
their follow-up.
11) To evaluate foetal presentation and position.
12) Assessment of liquor amnii.
13) Preterm labour / preterm premature rupture of membranes.
14) Evaluation of placental position, thickness, grading and abnormalities (placenta praevia,
retroplacental haemorrhage, abnormal adherence etc.).
15) Evaluation of umbilical cord presentation, insertion, nuchal encirclement, number of vessels
and presence of true knot.
16) Evaluation of previous Caesarean Section scars.
17) Evaluation of foetal growth parameters, foetal weight and foetal well being.
18) Colour flow mapping and duplex Doppler studies.
19) Ultrasound guided procedures such as medical termination of pregnancy, external cephalic
version etc. and their follow-up.
20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling
(CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnioinfusion, intrauterine
infusion, placement of shunts etc.
21) Observation of intra-partum events.
22) Medical/surgical conditions complicating pregnancy.
23) Research/scientific studies in recognized institutions. Person conducting ultrasonography on
pregnant women shall keep complete record thereof in the clinic/centre in Form F and any
deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5
or section 6 of the Act, unless contrary is proved by the person conducting such ultrasonography.

158

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 4
MTP Consent Form
Form C
(Refer rule 9 MTP, 2003)

I______________________________________________Daughter/Wife of ______________________aged
about_________ years at present residing at _____________________________do hereby give my
consent to termination of my pregnancy at ________________________________________________

Place __________________

Signature

Date __________________

(To be filled in by guardian where the woman is a mentally ill person or a minor

I _____________________________Son/Daughter/wife of ______________________aged
about_________years at present residing at ___________________________________________________________
give my consent to the termination of the pregnancy of my ward __________________________who is a
minor/ mentally ill person at _____________________________________________________________

Place_____________

Signature

159

Annexures

Annexure 5
Client Card for Medical Method of Aborton
In case of emergency, please contact:
Doctor:___________________________________________________

Phone Number: _________________________

Hospital Address:_______________________________________________________________________________________
_________________________________________________________________________________________________________

Details of the Patient:


Name:________________________________________________________Phone Number:__________________________
Residential Address: ___________________________________________________________________________________
_________________________________________________________________________________________________________
Date of visit:__________________________________ Date of second visit:_____________________________________
Date of third visit:_________________________________________________

160

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 6
Gender Biased Sex-Selection and Access to Safe Abortions
Frequently Asked Questions
The declining child sex ratio
Recent census (2011) data reveal a dismal child sex ratio of 914 females per 1000 males. This is down from 927
in 2001; and 945 in 1991. However, the Sex ratio at birth at the national level increased from 892 in 2000-2002
to 906 in 2007-2009 though this is still a far cry from normal sex ratio at birth.
Gender biased sex selection in favour of boys is a symptom of pervasive social, cultural, political and economic
injustices against women, and a manifest action of gender discrimination. In recent times, it has been perpetuated
by the illegal use of diagnostic technologies coupled with unethical medical practices. Such injustices must be
addressed and resolved without exposing women and children to the risk of death or serious injury through
denying them access to needed services and thus further violating their rights (Dickens et al, 2005).
The Pre-natal Diagnostic Techniques Regulations and Prevention of Misuse Act came into force in 1994 to curb
selective sex determination. With rapid improvements in diagnostic technology the Act was amended in 2003
to make it more comprehensive and was renamed the Preconception and Pre-natal Diagnostic Techniques
(Prohibition of Sex Selection) Act. While the Act can be successful in hindering any further worsening of the
gender imbalancei, there are challenges in its effective implementation.
Policy makers and programme managers at national, state and district levels are seriously concerned with the
decline in the child sex ration and grappling with solutions to arrest this decline.
Unsafe Abortions: A continuing problem
Forty years ago, the Medical Termination of Pregnancy Act (1971) entitled women in India access to abortion
services under certain specified conditions. However, it is a well-documented fact that abortions are not
available to millions of women in India who need them. It is estimated that 6.4 million abortions take place in
India each year. Half of these (around 3.6 million) are unsafe performed in unhygienic conditions by untrained
providersii. More than 80 percent of women in the country still do not know that abortion is legal and availableiii.
Add to this the fact that abortion is highly stigmatized in the socio-cultural context, leading many women who
seek an abortion to visit unsafe backstreet providers.
Unsafe abortion is the third leading cause of maternal deaths in India, contributing to eight percent of all
maternal deaths annually - morbidity attributable to unsafe abortions is much more.
Inter-linkages
Though the reasons for the skewed sex ratio stem from multiple deep-rooted social and cultural issues, the
most common reason given to explain it is the purported easy availability of ultrasound technologies and
abortions in the country. This is a flawed assumption precisely because sex selection is first about determination
of the sex of the fetus At times, an instant reaction based on a flawed understanding leads to restrictions on
access to second trimester abortions, seen as an easy solution to fix the problem of sex selection.
This already has and will continue to have unfortunate side-effects: in some cases, attempts to combat gender
biased sex selection have made it more difficult for all women to access abortion. Many women who seek
abortions in India do so through backstreet practitioners. Administrative action that puts curbs on abortion will

161

Annexures

tend to further drive women to unsafe services as already being seen in some states and a woman who requires
an abortion in the second trimester for whatever reason may be assumed to be guilty of asking to terminate the
pregnancy for sex-selection reasons.
Given the current environment and ad-hoc measures to curb gender biased sex selection, there is always a
threat of restriction to the womens access to abortion, especially second trimester abortion in India. Various
United Nations human rights treaty monitoring bodies have established that the rights of women and girls to
life, health and development are violated when they undergo an unsafe abortion because safe services are
denied to them. Ensuring access to services for safe abortion to the full extent of the law at all times is crucial, as
is working with communities to address the social norms and practices that increase the vulnerability of women
and girls to the health risks associated with unsafe abortions.
It can be challenging for policymakers to envision approaches that simultaneously address the serious issue
of gender biased sex selection while protecting womens access to safe, legal abortion services. Below are
responses to some frequently asked questions that attempt to clarify the differences between the two issues
and provide helpful information to states across the country that are attempting to address the two issues with
equal regard for their importance to the lives of women and girls.

Q. What is ultrasonography (USG) used for during pregnancy?


Ultrasonography for pregnant women is conducted to monitor fetal health and for specific maternal
conditions like bleeding or excessive pain. In the first trimester of pregnancy, USG helps to diagnose and
determine the viability of the pregnancy. In the second trimester, it helps to identify congenital abnormalities
in the fetus. It is also in the second trimester, that the sex of the fetus can be determined through
ultrasonography. However, the use of ultrasonography for non-medical reasons such as to determine the
sex of the fetus is not permitted under law.

Q. Is increased availability of USG the only reason for gender biased sex selection?

No. While studies point to a link between higher availability of sonography centres and a decline in
child sex ratio. it will be wrong to solely associate the increasing availability of USG to the increase in sex
selection. Technology itself has its positives and USG has played an important role in improving maternal
and newborn health outcomes across the country. Analysis of the National Family Health Survey (NFHS-3)
data shows that among women who had at least one USG for any of their pregnancies, 80 percent had
one or more live births without any pregnancy lossiv. Equally, it is the misuse of technology by the medical
community that has made it possible for parents to act out their preference for sons.

Q. Is pre natal sex-selection the only reason for the skewed child sex ratio?

No. The main reason for skewed child sex ratio is son preference this manifests itself not only in the prenatal period but in practices that discriminate against females even after birth. Girls killed shortly after birth
or adopted outside the family are sometimes unaccounted for. Discriminatory feeding and health care
practices leading to neglect cause an increase in post-natal mortality in girls which is visible in the gender
gap in infant and under five mortality rates of some states. The ratio can be also affected by the under
counting of girls in census enumerationsv.

Q. Do women seek abortions only to terminate a pregnancy when the fetus is female?

No. Most women who opt for an abortion do so because they cannot afford another child, because
contraception has failed, because they are unmarried, or because they have been raped. Estimates indicate
that two to four percent of all abortions in the country are son selective abortionsvi. According to estimates
for 2001-2008, 4.6 percent of all female births did not occur because of pre- natal sex selection. (UNFPA;
Trends in SRB and estimates of girls missing at birth in India, 2011) .

162

Reference Manual for Doctors on Family Planning and Reproductive Health

Q. What makes an abortion legal in India?


Abortion is legal if it fulfills the following conditions:

Performed by a registered medical practitioner as defined in the MTP Act.

Performed in a place approved under the Act.

Other requirements such as gestation period, consent and opinion of registered medical practitioners
are fulfilled.

In India many private providers, including well-qualified private providers, may provide safe abortion
services, although the fact that facilities where they perform abortion are not approved makes them illegal.
Therefore, facilities capable of providing safe abortion services need to be able to get a registration under
the MTP act in a timely and a systematic matter. It is only when access to safe abortion improves that
woman will not need to resort to backstreet and unsafe services.

Q. What are the legal requirements for offering abortion services?

The MTP Act clearly spells out requirements in order to provide legal and safe abortion services.

The Act lays out the qualifications for providers who wish to offer abortion services.

The Act also spells out facility requirements for clinics that wish to be eligible for approval to offer
abortion services in the first and second trimesters.

For second trimester abortions opinion of two registered medical practitioners as defined in the Act
is mandatory.

Q. Is sex-selective abortion illegal under the MTP Act?


Yes. Sex determination is not a permitted condition for seeking legal abortion under the MTP Act. Under
the MTP Act abortion in India is legal for the following conditions:

When continuation of a pregnancy involves risk to the life of the pregnant woman or of grave injury
to her physical or mental health taking into account the pregnant womans actual or reasonable
foreseeable environment.

When there is substantial risk that if the child were born, s/he would suffer from such physical or
mental abnormalities as to be seriously handicapped.

In cases of rape.

When the device or method used by any married woman or her husband for the purpose of limiting
the number of children has failed.

Q. Are all second-trimester abortions sex selective? Why do women seek abortions in the
second trimester?

Not all second-trimester abortions are sex selective. In fact, while sex determination takes place mostly in
the second trimester of pregnancy, 80 to 90 percent of reported abortions in India take place in the first
trimester.

In India, some women delay pregnancy termination until they are in the second trimester of pregnancy for
reasons other than sex selection. Cases of delay in abortion seeking are common amongst poor, young, and
unmarried women in particular, who are often poorly informed on many fronts: they may not understand
the signs of pregnancy, the possibility or legality of obtaining an abortion, the importance of seeking early
abortion (in the first trimester) and the location of safe services.

163

Annexures

Q. What can be the consequences of restricting access to abortions for women?


Restriction on safe abortion services will have long-term consequences on the health of women especially
if they are poor and less educated and may also violate their human and reproductive health rights
(Ganatra 2008). Evidence shows that if women do not have access to safe abortion services they often
turn to unsafe options (WHO, 2007). Placing limitations on second-trimester abortions and/or increasing
unnecessary reporting requirements for abortions will discourage providers from offering abortion services.
Any immediate actions to curb access to abortions by government will add to the already widespread belief
that abortion in India is illegal, pushing women to risk their lives, when they are in need of early and safe
abortion services.

Q. What are some steps that can lead to a balanced approach to address both issues of sex
selection and lack of access to abortions?

Educating policymakers, government officials and other stakeholders on the ways in which both
MTP and PCPNDT Acts are implemented in fulfilling their intents, that is to prevent unsafe abortion
and to prevent sex selection respectively. Using one law to fulfill the intent of the other is in fact
counterproductive and does not help fulfill the objectives of both Acts.

Encouraging dialogue among the NGOs that work to implement the PCPNDT Act and the MTP Act
to reach consensus on strategies that address both issues without hindering either; and to ensure
strengthened implementation of both Acts with clear understanding of the intent of each.

Operationalizing District Level Committees under the MTP Act so that private abortion providers are
brought into the legal framework of the MTP Act. This will ensure regular reporting of MTP cases,
including second-trimester abortions.

Focussing communication campaigns on the issue of sex determination and selection.

Clearing up public misconceptions by emphasizing that sex determination is illegal, while abortion is
legal (for certain conditions) in the country.

Using communication campaigns to emphasize the importance of seeking early and safe abortion, in
order to discourage abortions in the second trimester when chances of sex selection are higher.

Ensuring better regulation and vigilance to stem illegal and unethical practices instead of imposing
additional restrictions such as not allowing sale of abortion drugs or redistricting on registration of
facilities for MTP.

Supporting implementation of programmes and initiatives that seek to reduce gender discrimination.

Seeking and implementing behavior-change campaigns to address the underlying social causes of
sex selection and discrimination against the female child.

Q. How can improved implementation of the MTP Act prevent sex-selective abortions?

The MTP Act clearly defines the approval requirements for private-sector facilities and reporting mechanisms
for both public- and private-sector facilities. However, implementation of the MTP Act is poor across the
country, and data for abortion services is often missing in both the public and private sectors. Improved
implementation of the MTP Act will contribute to better reporting of cases of abortion in the country
and provide information on trends of abortion, the gestational age at which abortions are sought, and
number and location of private-sector facilities offering abortions. This will lead to improved access to safe,
legal abortion services for conditions approved by the Act and will make realistic data available for better
analysis and policymaking.

164

Reference Manual for Doctors on Family Planning and Reproductive Health

Q. What steps can be taken to improve implementation of the MTP Act?


Some steps that can be urgently taken to improve the implementation of MTP Act include:

Setting up of the district-level MTP committees

Putting in place systematic inspection of facilities and monitoring of MTP records

Expediting registration of facilities that fulfill the criteria set under the Act to qualify for providing
MTP services

Gender biased sex selection further undervalues women and girls, it perpetuates gender discrimination
and should be addressed through effective enforcement of the PC-PNDT Act as well as other actions
required to promote the value of girls and overall gender equality. However, we must ensure that in doing
so, womens right to safe abortion services is not compromised in any manner.

i
Arindam Nandi & Anil Deolalikar. Does a Legal Ban on Sex Selective Abortions Improve Child Sex Ratios? Evidence from a Policy
Change in India, April 2011. Accessed online at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1824420&http://papers.ssrn.
com/sol3/papers.cfm?abstract_id=1824420
ii
Duggal R, Ramachandran V. The Abortion Assessment Project-India; Key Findings and Recommendations. Reproductive Health
Matters, Volume 12, Issue 24, 2004. 122-129
iii
Banerjee et al. 2009.Knowledge and Care seeking behavior in four selected districts of Bihar and Jharkhand. India. Presented
at Population Association of America (PAA). April-May 2009. Available online at paa2009.princeton.edu/sessionViewer.
aspx?SessionId=153

Banerjee et al. 2011.Understanding the Role of Ultrasound (USG) in improving maternal care in India

iv

Jha P. et al. Trends in selective abortion of girls: Analysis of nationally representative birth histories from 1990 to 2005 and census
data from 1991 to 2011. Published online May 24, 2011 www.thelancet.com
v

Ibid

vi

165

Annexures

Annexure 7
Chart on Effectiveness of contraceptives

Source - Family Planning - A Global Handbook for Provider - Revised 2011 update

166

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 8
WHO statement on hormonal contraception and bone health
(http://whqlibdoc.who.int/wer/WHO_WER_2005/80_297-304(no35).pdf)
Steroid hormonal contraceptives, including oral contraceptives, injectables and implants, are
highly effective and widely used. These contraceptives have important health benefits, including
contraceptive and non-contraceptive benefits, and some health risks. For most women, the health
benefits of use clearly exceed the health risks. Questions have been raised regarding the association
between use of one particular hormonal contraceptive, depomedroxy-progesterone acetate (DMPA),
and the risk of bone loss. In response, WHO convened a consultation in Geneva, Switzerland, on
2021 June 2005, to assess current evidence on the relationship between the use of steroid hormonal
contraceptives and bone health.
Bone health may be influenced by many factors including pregnancy, breastfeeding and use of
hormonal contraceptives. The principal clinical outcome of interest with regard to bone health
is the occurrence of fracture. Bone mineral density (BMD) measurements are commonly used to
assessfracture risk, but the accuracy of measurements can be influencedby changes in body
composition, including changes in lean body mass and fat. Furthermore, fracture risk is related to
many factors, BMD being only one of them. The relationship between decrease in BMD and increase
in fracture risk has been best studied in postmenopausal women, among whom the risk of any
fracture increases approximately 1.5- fold for each standard deviation decrease in BMD. There is little
information on the impact of BMD changes in young age groups on fracture risk later in life.
Progestogen-only methods of contraception
With regard to Progestogen-only methods, data on Levonorgestrol implants suggest no adverse
effect on BMD. Other low-dose Progestogen-only contraceptives such as pills, other implants and
the Levonorgestrol-releasing intrauterine device do not appear to have an effect on BMD, although
data for these methods are limited. The use of DMPA for contraception produces a hypo-estrogenic
state in women; some studies have shown that this is associated with a decrease in BMD. The weight
of data indicates that DMPA use reduces BMD in women who have attained peak bone mass, and
impairs the acquisition of bone mineral among those who have not yet attained peak bone mass.
The magnitude of the effect on BMD is similar across a variety of studies. Cross-sectional studies
show lower BMD in longer-term DMPA users by approximately 0.5 standard deviation at the hip and
spine compared with non-users. In longitudinal studies, adults (18 years) and adolescents (menarche
to<18 years) both lost around 57% (approximately 0.5 standard deviation) of BMD at the same sites,
after 2 years of continuous use of DMPA. The rate of loss appeared to decrease over time. When
DMPA use is discontinued, BMD increases again in women, regardless of age, except for those who
have reached menopause. Among adults, BMD values appear to return tothose of comparable nonDMPA users over a period of 2 to 3 years. It is not clear whether the loss in BMD among adolescent
users of DMPA prevents attainment of potential peak bone mass. There remains a concern that older
women who reach the menopause while still using DMPA may no longer have the opportunity to
regain BMD before entering the period of bone loss normally associated with menopause. Absolute
fracture risk is low during the reproductive years, and insufficient data exist to assess whether
DMPA use modifies this risk. There are also insufficient data to assess whether DMPA use during

167

Annexures

the reproductive years affects the risk of fracture in future postmenopausal life. Since the effect on
BMD is largely reversible, any lifetime increase infracture risk is likely to be small. Data regarding the
use of the other Progestogen-only injectable contraceptive, NorethisteroneEnanthate (NETEN), are
insufficient to determine whether there is any effect of NET-EN on bone health. In the absence of
evidence, the concerns regarding DMPA and bone health also apply to NET-EN.
DMPA is a highly effective and widely available method of contraception, which plays an important
role in the contraceptive method mix. This is particularly so in regions with a high unmet need
for contraception and where maternal morbidity and mortality are high. Any decisions regarding
choice of a contraceptive method should also take this fact into consideration. WHO will continue
to monitor research in this area and will review the recommendations listed below as and when new
evidence becomes available. WHO also encourages relevant research in this area to fill key evidence
gaps.
Recommendations, with regard to bone metabolism
yy There should be no restriction on the use of DMPA, including no restriction on duration of use,
among women aged 18 to 45 years who are otherwise eligible to use the method.
yy Among adolescents (menarche to <18 years) and women over 45 years, the advantages of
using DMPA generally outweigh the theoretical safety concerns regarding fracture risk. Since
data are insufficient to determine if this is the case with long-term use among these age
groups, the overall risks and benefits for continuing use of the method should be reconsidered
over time with the individual user.
yy Recommendations regarding DMPA use also pertain to use of NET-EN. There should be no
restriction on the use of other Progestogen- only contraceptive methods among women
otherwise eligible to use these methods, including no restrictions on duration of use.
yy There should be no restriction on the use of combined hormonal contraceptive methods
among women who are otherwise eligible to use these methods, including no restrictions on
duration of use.

168

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 9
FOGSI Policy Statement - Injectable Contraception - September 2003
yy FOGSI confirms the WHO Guidelines and believes that injectable hormonal contraceptives are
a safe, effective and convenient form of contraception particularly for lactating and oestrogen
sensitive women.
yy Extensive trials have proven that the method is reversible with additional health benefits.
yy Proper counselling regarding menstrual irregularity will improve the compliance.
yy FOGSI advises its members to use injectable hormonal contraceptives within the WHO
Guidelines.

169

Annexures

Annexure 10
Criteria for Empanelment of a Doctor /Accreditation of a Health Facility for Sterilization
Physical Infrastructure
Standards for physical infrastructure for static services have been laid down in the documents
Standards for Male and Female Sterilization and Standard Operating Procedures (SOP) on Camps/
Mobile Services, which provide details about input, requirements, and processes for camps. These
documents can be accessed from the Research Studies & Standards (RSS) Division of the Ministry
of Health and Family Welfare (MOHFW), Government of India or from the MOHFW website (www.
mohfw.nic.in)
Processes
The processes include technical and interpersonal dimensions and encompass a range of elements.
The protocols for the following procedures are detailed in the Standards for Male and Female
Sterilization, 2006.
yy Counselling
yy Minilaptubectomy
yy Laparoscopic tubectomy
yy Conventional vasectomy
yy No-scalpel vasectomy
yy Anaesthesia/analgesia/premedication
yy Follow-up protocols
yy Infection-prevention practices
Complications
All cases of failure and complications, major or minor, arising during surgery or post-surgery
must be documented and a copy sent to the district QAC. The major complications that required
hospitalization and all cases of failure must be reported to the district QAC. The district QAC will
in turn be responsible for communicating such information to the concerned insurance service
providers for compensation.

170

Reference Manual for Doctors on Family Planning and Reproductive Health

Personnel Requirement
Female Sterilization
1. One MBBS Doctor trained to carry out
MinilapTubectomy OR

One Gynaecologist with DGO/MD/MS


qualification or

A surgeon with MS Degree and trained in


Laparoscopic sterilization.

Male Sterilization
1. One MBBS doctor trained in Vasectomy
2. One Staff Nurse LHV/ ANM /
3. One OT Assistant / Helper
4. One Male worker for counseling and
administrative work

2. One OT Staff Nurse/ LHV/ ANM


3. One OT Assistant/ Helper
4. One Anaesthetist can be hired if necessary.

Infrastructure requirement
Female Sterilization
Facilities

Male Sterilization

yy

Well ventilated, fly proof room with


concrete/tiled floor which can be
cleaned thoroughly

yy

Well ventilated, fly proof room with


concrete/tiled floor which can be
cleaned thoroughly

yy

Running water supply through tapor


bucket with tap

yy

Running water supply through tapor


bucket with tap

yy

Electricity supply with a stand by


generator and other light source
necessary.

yy

Electricity supply with a stand by


generator and other light source.

171

Annexures

Female Sterilization
Space
required

Male Sterilization

yy

Area for reception

yy

Area for reception

yy

Waiting area

yy

Waiting area

yy

Counselling area which offers privacy


and ensures avoidance of any
interruptions.

yy

Counseling area which offers privacy and


ensures avoidance of any interruptions.

yy

yy

Laboratory for blood & urine


examination

Laboratory for blood & urine


examination

yy

Clinical examination room for initial


assessment and follow up

yy

Pre-operative preparation room for


trimming of hair, washing,changing of
clothes and premedication

yy

Hand washing area near the OT for


scrubbing

yy

Sterilization room, near the OT for


autoclaving, washing and cleaning
equipment,preparation of sterile packs.

yy

Operation theatre should be isolated


and away from the general thoroughfare
of the clinic, if should be large enough
to allow operating staff to move freely
and to accommodate all the necessary
equipment. Lighting should be
adequate.

yy

Recovery room must be spacious and


well ventilated,number of beds will
be determined by the available space,
should be adjacent to the OT

yy

Adequate number of toilets: sufficient


number of sanitary type toilets with
running water for the clients and the
staff.

yy

Storage area

yy

Office area for keeping records

yy

Clinical examination room for initial


assessment and follow up

yy

Pre-operative preparation room fort


rimming of hair, washing, changing of
clothes and premedication

yy

Hand washing area near the OT for


scrubbing

yy

Sterilization room, near the OT for


autoclaving, washing and cleaning
equipment, preparation of sterile packs.

yy

Operation theatre should be isolated


and away from the general thorough
fare of the clinic, if should be large
enough to allow operating staff to
move freely and to accommodate all
the necessary equipment. Lighting
should be adequate.

yy

Recovery room must be spacious


and well ventilated, number of beds
will be determined by the available
space,should be adjacent to the OT

yy

Adequate number of toilets: sufficient


number of sanitary type toilets with
running water for the clients and the
staff.

yy

Storage area

yy

Office area for keeping records

172

Reference Manual for Doctors on Family Planning and Reproductive Health

Female Sterilization
Examination
room
requirement

Laboratory

Sterilization
room

Cleaning
Room

Male Sterilization

yy

Examination table

yy

Examination table

yy

Foot stool

yy

Foot stool

yy

Blood Pressure apparatus

yy

Blood Pressure apparatus

yy

Thermometer

yy

Thermometer

yy

Stethoscope

yy

Stethoscope

yy

Examination light

yy

Weighing scale

yy

Instrument for pelvic examination

yy

Haemoglobinometer and accessories

yy

Haemoglobinometer and accessories

yy

Apparatus to estimate albumin and


sugar in urine

yy

Apparatus to estimate albumin and


sugar in urine

yy

Reagents

yy

Reagents

yy

Autoclave

yy

Autoclave

yy

Boiler

yy

Boiler

yy

Surgical drums

yy

Autoclave drums

yy

SS Tray

yy

Glutaraldehyde Solution 2%

yy

Glutaraldehyde solution 2%

yy

Hand Brushes

yy

Hand Brushes

yy

Utility gloves

yy

Utility gloves

yy

Basins

yy

Basins

yy

Detergents

yy

Detergents

yy

Chlorine solution 0.5%

yy

Chlorine solution 0.5%

173

Annexures

Female Sterilization
Operation
Theatre

yy

Operating table capable of


Trendelenburgs position

yy

Step up stool

yy

Spotlight in OT

yy

Instrument trolley

yy

Mini Laparotomy Kit

yy

Laparoscopy Kit

yy

Blood Pressure Instrument

yy

Stethoscope

yy

Syringe with needles

yy

Emergency equipment & Drugs

yy

Room heater

yy

IV stand

yy

Waste basket, storage cabinet,buckets, yy


basins for decontamination
yy
Box for used linen
yy
Puncture proof box for needles

Box for used linen

yy

Patients cot with mattress, sheet,


pillow, pillow cover and blankets

yy

Patients cot with mattress, sheet, pillow,


pillow cover and blankets

yy

BP Instrument

yy

Thermometers

yy

Stethoscope

yy

Stethoscope

yy

Thermometers

yy

Blood pressure instrument

yy

IV stand

yy

IV stand

yy

Emergency equipment and drugs as


per list

yy

Emergency equipment and drugs as per


list

yy
yy

Recovery
room

Male Sterilization

174

yy

Operating table

yy

Step up stool

yy

Spotlight in OT

yy

Instrument trolley

yy

Conventional Vasectomy Kit

yy

No- Scalpel Vasectomy Kit

yy

Emergency equipment &Drugs

yy

Room heater

yy

Blood Pressure Instrument

yy

Stethoscope

yy

Syringe with needles

yy

Waste basket, storage cabinet,buckets,


basins for decontamination

Puncture proof box for needles


IV stand

Reference Manual for Doctors on Family Planning and Reproductive Health

Female Sterilization
Emergency
equipment &
supplies

Male Sterilization

yy

Stethoscope

yy

Stethoscope

yy

BP instruments

yy

BP instruments

yy

Oral Airways guedel size 3,4,5

yy

Oral Airways guedel size 3,4,5

yy

Nasopharyngeal airways size 6,6.5,7.0

yy

Nasopharyngeal airways size 6,6.5,7.0

yy

Suction machine with tubing & two


straps

yy

Suction machine with tubing & two


straps

yy

Ambu bag with mass size 3,4,5

yy

Ambu bag with mass size 3,4,5

yy

tubing and oxygen nipple

yy

tubing and oxygen nipple

yy

Oxygen cylinder with reducing valve


and flow meter

yy

Oxygen cylinder with reducing valve and


flow meter

yy

Blanket

yy

Blanket

yy

Gauge pieces

yy

Gauge pieces

yy

Kidney tray

yy

Kidney tray

yy

Torch

yy

Torch

yy

Syringes and needles, including


butterfly sets, IV Cannula

yy

Syringes and needles, including butterfly


sets, IV Cannula

yy

Intravenous infusion sets and fluids

yy

Intravenous infusion sets and fluids

yy

Sterile laparotomy instruments

yy

Sterile laparotomy instruments

yy

Endotrachael tube size 6, 6.5, 7, 7.5,


8.0

yy

Endotrachael tube size 6, 6.5, 7, 7.5, 8.0

yy

Laryngeal mask airway size 3,4,5

yy

Combitube

yy

Cricothyroidectomy set

yy

Laryngeal mask airways

175

Annexures

Female Sterilization
Emergency
drugs

Male Sterilization

yy

Injection Adrenaline

yy

Injection Adrenaline

yy

Injection Atropine

yy

Injection Atropine

yy

Injection Hydrocortisone (Dexamethasone)

yy

yy

Injection Physostigmine

Injection Hydrocortisone
(Dexamethasone)

yy

Injection Aminophylline

yy

Injection Physostigmine

yy

Injection Diazepam

yy

Injection Diazepam

yy

Injection Deriphyline

yy

Injection Deriphyline

yy

Injection Pheniramine Maleate

yy

Injection Pheniramine Maleate

yy

Injection Promethazine

yy

Injection Promethazine

yy

Injection Ranitidine

yy

Injection Ranitidine

yy

Injection Metoclopramide

yy

Injection Metoclopramide

yy

Injection Xylocard

yy

Injection Xylocard

yy

Injection Pentazocine

yy

Injection Pentazocine

yy

Injection Sodium Bicarbonate

yy

yy

Injection Calcium Gluconate/ Calcium Chloride

Injection Sodium Bicarbonate


(7.5 %)

yy

Injection Frusemide

yy

yy

Injection Methergine

Injection Calcium Gluconate/


Calcium Chloride

yy

Injection Dopamine

yy

Injection Frusemide

yy

Injection Mephentermine

yy

Injection Dopamine

yy

Injection Oxytocin

yy

Injection Mephentermine

yy

Electorde jelly

yy

Electorde jelly

yy

Water soluble jelly IV fluids

yy

Water soluble jelly.

yy

Dextrose 5%

IV fluids

yy

Glucose 25%

yy

Dextrose 5%

yy

Ringer Lactate solution.

yy

Glucose 25%

yy

0.9% sodium chloride (normal saline)

yy

Ringer Lactate solution.

yy

Heta Starch (HES 6 %) (7.5 %)

yy

yy

Injection Calcium Gluconate/ Calcium Chloride

0.9% sodium chloride (normal


saline)

yy

Injection Frusemide

yy

Heta Starch (HES 6 %)

yy

Injection Methergine

yy

Injection Dopamine

yy

Injection Mephentermine

yy

Injection Oxytocin

IV fluids
yy

Dextrose 5%

yy

Glucose 25%

yy

Ringer Lactate solution.

yy

0.9% sodium chloride (normal saline)

176

Reference Manual for Doctors on Family Planning and Reproductive Health

Annexure 11
Commonly available brands of contraceptives
Product

Manufacturer

1. Male Condoms
yy Ahsaas

yy Bliss

yy Deluxe Nirodh

PSI

yy Masti

yy Mauj

yy Milan

yy Mithun

yy New Lubricated Nirodh

yy Pick Me

yy Sangam

yy Sawan

yy Super Deluxe Nirodh

yy Ustad

yy Zaroor

yy Sathi

yy Sparsh

yy Thrill
2. Female Condoms
yy FC 2R Also known as
Femidon, Protective Care
yy VA w.o.w

Female Health Company


Medtech Products Ltd
Cupid

yy CupidTM
3. Common IUD brands in India

Organon

yy ParaGard Interuterine Device


(Cu T380a/ Multiload)
yy Freedom 5
177

Drug Formulation

Annexures

Product

Manufacturer

4. Common LNG IUD brands in


India

Zydus

yy Mirena

5. Vaginal Ring

Drug Formulation
Levonorgestrel USP, 13-Ethyl17-hydroxy-18,19-dinor-17
alpha-pregn-4-en-20-yn-3one

Organon

yy Nuva ring
Organon

6. Ultra Low dose COCs


yy Femilon

Wyeth Ltd

yy Loette
7. Minipills
yy Norethindrone(Micronan)

Genetic Pharma/ Symbiosis/


Novartis
VHB (Gen Biotech)

yy Livonorgestel (Neogest)

Ethinyl Estradiol
0.02mg/0.15mg
Levonorgestrel 0.10mg
ethinylestradiol 0.02mg
0.75 mg Levongestrel
19-nor-17aethnyltestosterone
30ug levonorgestrel)

yy Norgestrel (microval)
8. Injectables
yy Depo Provera

Pfizer

(1ml in prefilled syringe)

yy Depo Provera (1ml vial)

Pfizer (Wyeth) / DKT

yy Depo Progestin (1ml vial)

Harshen Lab / DKT

yy Paree

Famy care, SDRL / Janani

yy Petogen (1ml vial)

HLL

yy Procosteron 150 (1ml vial)

Star Drugs and Research Labs


/ PSI

yy Myone Depot

Sun Pharmaceuticals Ind. L td.

yy Khushi (1ml vial with Disposable Star Drugs & Research Labs
syringe & needle)
(SDRL) / PHSI
9. SDM cycle Beads

HLL

yy Mala chakra

HLL

yy Ritumala

178

Depot medroxyprogesterone
acetate

Project Ujjawal
Futures Group International India
5th Floor, Building No. 10 B, DLF Cyber City,
Phase II, Gurgaon 122002, Haryana

Implementing Partners
OWLEDG
KN
E

TO

ACTION

PUBLIC
HEALTH
FOUNDATION
OF INDIA

Printed by Mehra Impressions (www.mehraimpressions.com)

Published by