Reference Manual for

Oral Contraceptive
Pills

March 2016

Family Planning Division

Ministry of Health and Family Welfare
Government of India
 Reference Manual for
Oral Contraceptive
Pills

March 2016

Family Planning Division

Ministry of Health and Family Welfare
Government of India
 Reference Manual for
Oral Contraceptive
Pills

March 2016

Family Planning Division

Ministry of Health and Family Welfare
Government of India
March 2016
Ministry of Health & Family Welfare
Government of India, Nirman Bhawan, New Delhi-110101

Any part of this document may be reproduced and excerpts from it may be quoted without
permission provided the material is distributed free of cost and the source is acknowledged.
Contents

MESSAGE

FOREWORD

PREFACE

ACKNOWLEDGEMENT

Chapter 1: Introduction 15

Section I: Technical Aspects of Oral Contraceptive Pills 19

Chapter 2: Overview of Oral Contraceptives 21

Chapter 3: Counselling 23

Chapter 4: Combined Oral Contraceptive Pills (COCs) 26

Chapter 5: Progestin-Only Pills (POPs) 33

Chapter 6: Centchroman (Ormeloxifene) Pills 39

Chapter 7: Emergency Contraceptive Pills (ECPs) 41

Chapter 8: Medical Eligibility Criteria (MEC) and Client’s Assessment 43

SECTION II: Managerial Aspects for Oral Contraceptive Services 49

Chapter 9: Program Determinants for Quality Services 51

SECTION III: Capacity Building of Service Providers on Oral Contraceptives 55

Chapter 10: Training and Skill Development 57

10.1: Assessment of Training Need 57

10.2: General Aspects of Training 57

10.3: Training Goal and Learning objectives 58

10.4: Number of Trainees per Batch 58

10.5: Training Duration 58

10.6: Training Approach and Methodology 58

10.7: Evaluation of Knowledge and Skills 59

10.8: Roadmap for Training 60

10.9: Curriculum and Schedule of Training on Oral Contraceptives 60

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SECTION IV: ANNEXURES 61

Annexure 1: Time of Initiation of Postpartum Family Planning Method 63

Annexure 2: Pregnancy Checklist 64

Annexure 3: Medical Eligibility Criteria for Oral Contraceptives 65

Annexure 4.1: Checklist: Family Planning Counselling 69

Annexure 4.2: Checklist: Method Specific Counselling on Combined 72

Oral Contraceptives (COCs)

Annexure 4.3: Checklist: Method Specific Counselling on Progestin-Only-Pills (POPs) 75

Annexure 4.4: Checklist: Method Specific Counselling on Centchroman (Ormeloxifene) 77

Annexure 5.1: Summary of Key Characteristics of COCs 79

Annexure 5.2: Summary of Key Characteristics of POPs 80

Annexure 5.3: Summary of Key Characteristics of Centchroman (Ormeloxifene) 81

Annexure 5.4: Summary of Key Characteristics of Emergency Contraceptive Pills 82

Annexure 6: Frequently Asked Questions (FAQs) and Clarifying Misconceptions 83

Annexure 7: Role Play and Case Studies 86

Annexure 8: Pre/Post -test questionnaire for OCPs 89

Annexure 8a: Pre/Post -test questionnaire (Answers) for OCPs 92

Annexure 9: Evaluation of Training 95

Annexure 10: Post Training Follow-up for OCPs 97

Annexure 11: Format of ASHAs Reporting under Home Delivery of Contraceptive Scheme 99

Annexure 11a: Format of Facility Register for contraceptive distribution 100

Annexure 12: Course Outline and Session Plan for Training 101

12
Abbreviations
AIDS Acquired Immunodeficiency Syndrome

ANM Auxillary Nurse Midwife

ASHA Accredited Social Health Activist

BCC Behaviour Change Communication

CDC Centre for Disease Control

CDRI Central Drug Research Institute

CHC Community Health Centre

CPR Contraceptive Prevelance Rate

DFWO District Family Welfare Officer

DH District Hospital

DLHS District Level Household Survey

DQAC District Quality Assurance Committee

ECP Emergency Contraceptive Pills

ELA Expected Level of Achievement

GMSD Government Medical Store Depot

Hb Haemoglobin

HIV Human Immunodeficiency Virus

HTSP Healthy Timing and Spacing of Pregnancy

IEC Information Education Communication

IIPS International Institute for Population Sciences

IUCD Intra Uterine Contraceptive Device

LHV Lady Health Visitor

LMP Last Menstrual Period

LNG Levonorgestrol

MEC Medical Eligibility Criteria

MO Medical Officer

MTP Medical Termination of Pregnancy

NCHS National Centre for Health Statistics

13
NHM National Health Mission

NSAID Non Steroidal Anti-Inflammatory Drug

OCP Oral Contraceptive Pills

PHC Primary Health Centre

POC Progestin Only Contraceptive

POP Progestin Only Pills

QA Quality Assurance

RCH Reproductive and Child Health

RTI Reproductive Tract Infections

SC SubCentre

SDH Sub District Hospital

SN Staff Nurse

SQAC State Quality Assurance committee

STI Sexually Transmitted Infections

UNFPA United Nation Population Funds

UNpop United Nations Population Division

WHO World Health Organization

14
 Chapter 1 Introduction

1.1 Background
India’s population of over 1.25 billion is slated to overtake that of China in the next decade. The
population size is more than the population of USA, Brazil, Bangladesh, Pakistan, Indonesia and
Japan put together. It is well known now that Family Planning is important not only for achieving
population stabilization but is also central to improve the maternal and new born health and
survival. Even though India has made considerable progress in reducing maternal mortality
ratio, it still contributes to 20% of maternal deaths worldwide, according to the 2012 report of
World bank, UNFPA, WHO. Family Planning can avert more than 30% of maternal deaths and
10% child mortality if couples spaced their pregnancies more than 2 years apart (Cleland J et al,
2006. Lancet).

In 1951, India was the world’s first nation to launch the Family Planning Programme. Over
the years India’s Family Planning Programme has evolved with the shift in focus from merely
population control to more critical issues of saving the lives and improving the health of mothers
and newborns. However, the unmet need for contraception at national level has been 20.5 percent
(DLHS 3, 2007-08).

Ensuring healthy timing and spacing of pregnancies is now one of the key interventions for
reproductive, maternal, neonatal, child and adolescent health (RMNCH+A) strategy. At the 2012
London Summit, the Government of India (GoI) made a commitment to increase access to family
planning services to 48 million additional users by the year 2020.

The renewed emphasis on use of reversible or spacing methods of contraceptives, which are
safe and effective for women, has brought the spotlight on improving women’s access to oral
contraceptive methods.

Oral contraception is a known and popular method of contraception and refers to birth control
methods taken orally, to prevent or delay pregnancy. The combined oral contraceptive pill was
the first oral contraceptive method and was marketed in 1960. In the following decades newer
methods of oral contraception such as, progestin-only pills and Centchroman (Ormeloxifene)
and emergency contraceptive pills have been popularised. Oral contraceptive methods are highly
effective when taken correctly and consistently

Combined Oral Contraceptives (COCs) contain low doses of the hormones progestin and estrogen
while Progestin-Only Pills (POPs), also called minipills, contain low dose of the progestin
hormone only, allowing breastfeeding women to use them. The first non-steroidal once a week
pill ‘Centchroman (Ormeloxifene)’ was developed indigenously by the Central Drug Research
Institute (CDRI), Lucknow.

Emergency Contraceptive Pills (ECPs) can reduce the risk of unintended pregnancy when taken
after unprotected sexual intercourse and offer women an important second chance to prevent
pregnancy when a regular method fails, no method was used or sex was forced. ECPs contain
either progesterone alone or progestin and estrogen combined together to prevent ovulation.

Documented evidence shows that expansion of the contraceptive method mix in low and middle-
income countries has a positive relationship with contraceptive use. Use of contraception may be
increased by extending the availability of current methods and by introducing new methods in
the existing basket of choices.

15
1.2 The Global Evidence for Use of Oral Contraceptives
According to the United Nations population data, 63% of partnered, reproductive-age women
worldwide, representing about 740 million couples practice some form of contraception. Almost
90 percent of them employ modern methods, which include oral contraceptives (“the pill”),
condoms, injections, intrauterine devices (IUDs) and sterilization. Worldwide, an estimated 8%
of all married women currently use the oral contraceptive pill. It is the number one contraceptive
method in Africa, Europe and Oceania (Australia, New Zealand and the South Pacific islands).
Oral Contraceptives (OCs) are an effective family planning method being used by over 100 million
women worldwide. Many more have used OCs at some time in their lives (Population Reports,
Oral Contraceptives: An Update, Series A, No. 9, Spring 2000). It is also the most prevalent form
of reversible contraception in the Americas. However, in India, the use of the Oral contraceptive
pill is relatively low (Source: EPI from UN Pop, Earth Policy Institute, 2012, Fig. 1).

50

45
Percent of Couples Using Modern Contraception

40

Earth Policy Institute - [Link]

35

30

25

20

15

10

0
Africa Asia Europe Latin Am. and Northern Oceania
Caribbean America

Fig. 1: Contraceptive Pill Prevalence by Region, Latest Year

Source: EPI from UNPoP

1.3 Global Evidences for Use of Emergency Contraceptive Pills

The use of ECPs is increasing worldwide. In United States, 2006–2010, among sexually experienced
women aged 15–44, roughly one in nine (11% or 5.8 million) women had ever used emergency
contraception, up from 4.2% in 2002. Most women who had ever used emergency contraception
had done so once (59%) or twice (24%). According to Euromonitor International’s report, India’s
market for emergency contraceptives jumped by 88% between 2009 and 2014, ranking the country
third in the world after the US and China. Young adult women aged 20–24 were most likely to
have ever used emergency contraception; about one in four had done so (23%) (Source: CDC,
NCHS Data Brief No. 112, February 2013).

1.4 Oral contraceptive usage in the National Family Planning Program of India
Despite the fact that oral contraception being safe and effective options for many women
worldwide, its use in India is very low, it is only 4% (Fig. 2).

16
 Fig. 2: Oral Pill Usage Versus Other Methods in India

Source: DLHS -3 (2007-2008), IIPS, Mumbai

1.5 Introduction of other Oral Pills in the National Family Planning Program
Considering the resurgence of interest and experience in postpartum family planning, as many
women come to health facilities for childbirth, oral contraceptives which are safe for breastfeeding
women, have good potential to improve use of family planning methods by postpartum women.
In addition to postpartum sterilization and postpartum IUCD currently available under the
National Programme, other postpartum family planning options can be – (i) Progestin only Pills
(POPs) which is a well-recognized non- invasive option for spacing births in the postpartum
period particularly for breastfeeding women and (ii) Centchroman (Ormeloxifene) as once-
a-week contraceptive, a promising non-hormonal option for spacing, as it is safe for lactating
women. Government has initiated efforts to expand oral contraceptive options by inclusion of
Progestin-Only Pills and Centchroman (Ormeloxifene) in the national programme and provide
them through the public health delivery system. Strategies to increase pill use include making
various oral contraceptive pills accessible to women at various stages of reproductive cycle,
giving women complete and easily understandable information, providing individual counseling
and giving follow-up messages to remind women about effective pill use. Making pills more
accessible by elimination of unnecessary restrictions to their safe use can also help women use the
pill more effectively.

1.6 Purpose of the Manual

This manual seeks to ensure that all providers have the latest and correct information on oral
contraceptive methods (Combined Oral Contraceptives (COCs), Progestin Only Pills (POPs),
Centchroman (Ormeloxifene) Pills and Emergency Contraceptive Pills (ECPs)) for providing
high quality services that are safe and client centred. It aims to revitalize the training aspects of
oral contraceptive methods and firmly establish it in the National Family Planning Program.

1.7 Target Audience

This comprehensive manual is meant to be used all over the country by all stakeholders,
including programme managers at the national, state, district and block level, trainers and service
providers at all level (medical doctors, nursing personnel and other paramedicals), faculty of
medical colleges as well as clients, who want to get acquainted with the program and be aware
of their rights and responsibilities. It will not only help in enhancing the knowledge and skills of
service providers in providing quality services, but also empower the programme managers in
scaling up the services in their states or districts which will in turn help to improve the acceptance
and continuation rates leading to user satisfaction.

17
18
Section I
Technical Aspects of Oral
Contraceptive Pills
 Chapter 2 Overview of Oral Contraceptives

An Oral Contraceptive method, both hormonal and non-hormonal ones, offer women and couples a
wide range of options for delaying, spacing and limiting births. Oral contraceptives are safe, effective,
reversible methods to prevent pregnancy and need to be taken regularly. They are an important part
of the National Family Planning Program’s contraceptive method mix.

They do not disrupt an existing pregnancy and do not interfere with sexual intercourse. However, they
do not protect a woman from HIV or other Sexually Transmitted Infections (STIs). Women using oral
contraceptives must use condoms to prevent HIV and other STIs.

2.1 Types of Oral Contraception

A. Hormonal
B. Non-hormonal

A. Hormonal: There are two main categories of hormonal contraceptives:

1. Combined hormonal contraceptives contain both an estrogen (usually ethinyl estradiol)
and a progestin
2. Progestin-only contraceptives contain only progesterone a synthetic analogue
(progestin).

Combined Oral Taken daily, irrespective of intercourse. Releases a low dose of

Contraceptive both estrogen and progestin into the bloodstream. Effectiveness
(COC) depends on regular intake.
Taken daily, irrespective of intercourse. Releases a low dose
Progestin-Only progestin into the bloodstream. Effectiveness depends on regular
Pill (POP) intake at the same time every day (within a window of 3 hours).
Safe for breastfeeding women.
A progestin-only method. Prevents pregnancy in emergency
Levonorgestrel situation (unprotected /accidental intercourse) to be taken within
Emergency 72 hours as a single dose (1.5 mg).
Contraceptive
Pill (ECP) Emergency contraceptive pills do not provide ongoing protection
against pregnancy.

B. Non-Hormonal: Centchroman (Ormeloxifene)

A non-steroidal, non-hormonal method, taken twice a week on

Centchroman
fixed days for the first three months, followed by once a week
(Ormeloxifene)
thereafter. Safe for breastfeeding women.

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 2.2 Contraceptive Effectiveness of Oral Contraceptives
Contraceptive effectiveness is described in two ways:

� Perfect use: Pregnancy rates (failure rates) during perfect use show how effective a method
is when it is used perfectly, consistently and exactly according to directions.
� Common (or typical) use: Pregnancy rates (failure rates) during common (or typical) use
show how effective a method is during actual use by the average person who does not
always use the method consistently and correctly.

The contraceptive effectiveness of various pills is detailed below.

Table 1 : Effectiveness of Oral Contraceptive Pills

Contraceptive Effectiveness
Method
With Perfect Use With Typical Use
Combined Oral yy0.3 pregnancy per 100 women yy8 pregnancy per 100 women
Contraceptive
Pills (COCs)
yyBreastfeeding women: 0.3 yyBreastfeeding women:
pregnancy per 100 women 1 pregnancy per 100 women
Progestin-only
Pills (POPs) yyNon-breastfeeding: 0.9 yyNon-breastfeeding:
pregnancy per 100 women 3-10 pregnancy per 100
women
Centchroman yy1-2 pregnancy per 100 women yyNo documented failure rate
(Ormeloxifene) with typical use available
yy ECPs are not a continuous form of birth control, hence annualized
pregnancy rate is not calculated.
yy If all 100 women used ECPs containing
Emergency
Contraceptive yy only progestin, 1 pregnancy per 100 women
Pills (ECPs)
yy Both estrogen and progestin, 2 pregnancy per 100 women
yy The sooner after unprotected sex that EC pills are taken, the more
effective they are.

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 Chapter 3 Counselling

3.1 Counselling
Counselling is defined as a helping process where a (skilled service provider) explicitly and
purposefully gives his/her time, attention and skills to assist a client to explore their situation,
identify and act upon solutions within the limitations of their given environment.

Counselling is a very essential component of Family Planning Services. Counselling is a client

centered approach that involves communication between a service provider/counsellor and
client. It enables the service provider/counsellor to understand clients’ perceptions, attitudes,
values, beliefs, family planning needs and preferences and accordingly can guide him/her
towards decision making. The provider/counsellor should be non-judgmental. Privacy (auditory
and visual) and confidentiality should be maintained during the process of counselling.

3.2 Benefits of Family Planning Counselling

� Increases acceptance
� Enhances continuation of methods
� Dispels rumours and corrects misunderstandings about contraceptive methods
� Promotes effective use
� Increases client’s satisfaction

3.3 Decision-Making
Counselling helps the client to make voluntary decision regarding:
� Whether to use contraception to delay, space or limit childbearing.
� Which method to use.
� Whether to continue using contraception if side effects occur.
� Whether to switch methods when the current method is unsatisfactory.
� Whether to involve one’s partner in reaching a decision.

3.4 Principles of FP Counselling

� Privacy.
� Confidentiality.
� Respectful, non-judgmental, accepting and caring attitude.
� Simple culturally appropriate language easy for client to understand.
� Good verbal and non-verbal interpersonal communication skills.
� Brief, simple and specific information with key messages.
� Opportunity for client to ask questions and express any concerns.
� Effective use of audio-visual aids, anatomic models and contraceptive samples.
� Repeat key information shared by the client, show and confirm that you have understood
correctly what they are saying.
� Voluntary Informed Decision making by client.

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3.5 Stages of Family Planning Counselling
3.5.1 Stage I: General Counselling
During this stage, the provider creates the conditions that help a client select a family
planning method.

yy Establish and maintain a warm, cordial relationship and listen to the client’s
contraceptive needs.
yy Rule out pregnancy using the Pregnancy Checklist (Annexure 2).
yy Display all the methods using flip charts, photographs, illustrations or posters.
Arrange by method type: Spacing (temporary/reversible methods) methods, Limiting
(Permanent) methods.
yy Set aside methods that are not appropriate for the client.
Keeping aside the methods helps to avoid taking time to provide information on methods
that are not relevant to the client’s needs.

Tip: Use visual materials such as brochures, photos and actual samples of different
choices during counselling.

3.5.2 Stage II: Method Specific Counselling

yy Give information about the methods that have not been set aside, including
their effectiveness. Remove myths/misconceptions and address the queries
(Please refer Annexure 6).
yy Ask the client to choose the method that is most convenient for her/him.
yy Determine client’s medical eligibility for the chosen method.
yy Give the client complete information about the method that she/he has chosen.
yy Check the client understands and reinforce key information.
yy Make sure the client has made a definite decision. Give client the selected method or
a referral and back-up method depending on the method selected.
yy Encourage the client to involve her/his partner(s) in decisions about contraception,
either through discussion or a visit to the clinic.
yy Assess STI/HIV risk. If the client has STI symptoms, refer or treat her/him with
syndromic approach (if needed HIV counselling). Discuss dual protection. Offer
condoms and instruct the client in correct and consistent use.
yy Provide follow-up instructions for the method chosen.
yy Invite the client to return at any time. Thank client for the visit and complete the
session.

3.5.3 Follow up Counselling

yy Elicit client experience and satisfaction with the method

yy Discuss problems, side effects and manage, if any.
yy Encourage continuation unless major problems exist.
yy Repeat key instructions.
yy Answer questions and address clients’ concerns.
yy Encourage satisfied clients to talk to other couples to adopt this method.

24
3.6 Counselling for Special Groups
yy Young people (15- 24 years of age): Young people need youth-friendly services and service
providers/counsellor should address the specific needs and concerns of this group.
yy Men: Involving men in family planning is particularly important. Addressing men’s
interests and concerns helps couples reach healthy decisions jointly and removes a common
barrier to women’s use of family planning.
yy Clients affected by gender based violence: women who are affected by violence and
rape victims are at risk of unintended pregnancy. Emergency contraception is particularly
important in these groups.

For general and method specific counselling on COCs, POPs or Centchroman

(Ormeloxifene), please refer Annexure 4.1, 4.2, 4.3, 4.4

25
 Chapter 41 Combined Oral Contraceptive Pills (COCs)

4.1 What are COCs?

Combined Oral Contraceptives pills (COCs) contain low doses of two synthetic hormones-
progestin and an oestrogen which are similar to the natural hormones in woman’s body.

4.2 Key Points

yyCOCs are safe and effective.
yyCOCs have several non-contraceptive benefits, like protection against endometrial
and ovarian cancer, iron deficiency anaemia, polycystic ovarian syndrome and
endometriosis.
yyCOCs should not be given to breast feeding women till 6 months postpartum.
yyOne pill is to be taken every day. For greatest effectiveness, a woman must take pills
daily without any break (28 pills packet).
yyMissing pills increases the risk of unwanted pregnancy.

Fig. 3: COCs in the Public Sector - (a) ASHA Supply (b) Free Supply

The available COC pills in the public sector is Mala-N (Fig. 3)

yy Mala N contains Levonorgestrel (0.15mg) + Ethinyl estradiol (30 micrograms). Mala-N is

supplied free of cost through government health centres and hospitals.
yy Each strip of Mala-N contains 21 hormonal tablets and 7 non hormonal (iron) tablets.

4.3 When to Start COCs?

A woman can start using COCs, any time she wants, if it is reasonably certain that she is not
pregnant. Use the Pregnancy Checklist (Annexure 2).

26
Woman's situation When to start
Having menstrual yy Any time, within 5 days after the start of her monthly bleeding. No need
cycles for a backup method.
yy Any time, after 5 days of start of her monthly bleeding, if it is reasonably
certain that she is not pregnant. A backup method (e.g. Condom) is needed
for the first 7 days of taking pills (if pregnancy cannot be ascertained give
her COCs now and tell her to start taking them during her next monthly
bleeding and use condoms till then).
Breast Feeding
Less than 6 months yy Not recommended in less than 6 months after giving birth. Prescribe the
after giving birth alternative methods like POPs, Centchroman (Ormeloxifene) and Injectable
Contraceptives.
More than 6 months yy Any time, if her monthly bleeding has not returned and if it is reasonably
after giving birth certain that she is not pregnant. A backup method (e.g. Condom) is needed
for the first 7 days of taking pills (if pregnancy cannot be ascertained give
her COCs now and tell her to start taking them during her next monthly
bleeding and use condoms till then).
yy If her monthly bleeding has returned, COCs can be started as advised for
women having menstrual cycles.
Not breastfeeding
Less than 4 weeks yy Any time on days 21–28 after giving birth.
after giving birth yy Give her pills any time to start during these 7 days. No need for a backup
method. (If additional risk for venous thromboembolism exists, wait until
6 weeks).
More than 4 weeks yy Any time, if her monthly bleeding has not returned and if it is reasonably
after giving birth certain that she is not pregnant. A backup method (e.g. Condom) is needed
for the first 7 days of taking pills (if pregnancy cannot be ascertained give
her COCs now and tell her to start taking them during her next monthly
bleeding and use condoms till then).
yy If her monthly bleeding has returned, COCs can be started as advised for
women having menstrual cycles.
After miscarriage or yy Immediately, within 7 days after first- or second-trimester miscarriage or
abortion abortion, no need for a backup method.
yy Any time, if it is more than 7 days after first or second trimester miscarriage
or abortion and it is reasonably certain that she is not pregnant. A backup
method (e.g. Condom) is needed for the first 7 days of taking pills (if
pregnancy cannot be ascertained give her COCs now and tell her to start
taking them during her next monthly bleeding and use condoms till then).
yy In case of medical abortion, COCs can be started on the day of misoprostol
use or within five days after taking it.
No monthly yy Any time, if it is reasonably certain that she is not pregnant. A backup
bleeding (not related method (e.g. Condom) is needed for the first 7 days of taking pills.
to childbirth or
breastfeeding)
Switching from yy If she is switching from Cu-IUCD:
a non-hormonal yy Immediately, within 5 days of her monthly bleeding. No need of backup
method method.
yy If it is more than 5 days after start of monthly bleeding-start COCs along
with a backup method (e.g. Condom).

27
Woman's situation When to start
Switching from a yy Immediately, if she has been using the hormonal method consistently and
hormonal method correctly or if it is otherwise reasonably certain that she is not pregnant.
No need to wait for her next monthly bleeding and no need for a backup
method.
yy At the time of repeat Injection, if switching from injectable contraceptive.
No need for a backup method.
After taking yy Same day, there is no need to wait for her next monthly bleeding to start
Emergency her pills.
Contraceptive Pills yy A new COC user should begin a new pill pack.
(ECPs)
yy A continuing user who needed ECPs due to pill-taking errors can continue
where she left off with her current pack.
yy A backup method (e.g. Condom) is needed for the first 7 days of taking
pills.

4.4 How to Use COC Pills?

� One pill should be taken every day, even if there is no intercourse, until the pack is empty.
� Linking pill intake to a daily activity such as after dinner may help her remember and
reduce some side effects.
� 28-pill packs: When she finishes one pack, first pill from the next pack should be taken on
the very next day. Bleeding occurs when woman is on the tablets given in the last row of
the pack (iron tablets). However, pills should be continued, irrespective of bleeding.
� It is very important to start the next pack on time. There is risk of pregnancy, if pack is
started late.
� If she vomits within 2 hours of taking a pill, another pill from the pack should be taken as
soon as possible and rest of the pills should be continued as scheduled.

4.5 How to Increase Compliance of COC Use?

� Assure every client that she is welcome to come back or ask question any time to the
provider, if she has problems, wants another method, has any major change in health
status or thinks that she might be pregnant.
� Encourage her to come back for more pills before her supply is finished.
� Whenever client comes back to the provider, ask:
� How she is doing with the method, whether she is satisfied and has any questions or
anything to discuss.
� Especially if she is concerned about bleeding changes. Give her any information or
help that she needs (see Management of Side Effects, missing of pills and Problems
Requiring Switching Methods in Section 4.6).
� If she often has problems remembering to take a pill every day. If so, discuss ways to
remember making up for missed pills, ECPs or choosing another method.
� If there are major life changes that may affect her needs particularly plans for having
children and STI/HIV risk. Follow-up as needed.
� If possible, get her blood pressure checked every year.

28
4.6 How to Manage Side Effects, Missing of Pills and Problems Requiring Switching
Methods?
Problems with side effects affect woman’s satisfaction and use of COCs. They deserve providers’
attention. If she reports side effects or problems, listen to her concerns, give advice and if
appropriate, provide treatment. Encourage her to keep taking a pill every day even if she has
side effects as missing pills can risk pregnancy. Explain that many side effects will subside after
a few months of use. Offer help to choose another method if she wishes or cannot overcome the
problems.

4.6.1 Problems Reported as Side Effects

Side Effects How to Manage

Irregular and yy Reassure her that many women using COCs experience
unexpected bleeding irregular bleeding. It is not harmful and usually becomes
less or stops after the first few months of use.
yy Other possible causes of irregular bleeding: Missed pills,
taking pills at different times every day; vomiting or
diarrhoea, taking anticonvulsants or Rifampicin.
yy To reduce irregular bleeding:
yy Take a pill each day and at the same time.
yy Make up for missed pills properly, including after
vomiting or diarrhoea.
yy For modest short-term relief, take 800 mg Ibuprofen/
Mefenamic acid/Tranexamic acid 3 times daily
after meals for 5 days or another nonsteroidal anti-
inflammatory drug (NSAID), when irregular bleeding
starts.
yy If taking pills for more than a few months and NSAIDs
do not help, give a different COC formulation, if
available. Ask to try the new pills for at least 3 months.
yy If irregular bleeding continues or starts after several
months of normal or no monthly bleeding or some
other conditions unrelated to method use is suspected,
consider further evaluation.
No monthly bleeding yy Ask her any spotting (which she may not recognise as a
monthly bleeding) or no bleeding at all. Reassure and tell
her that some women using COCs stop having monthly
bleeding and this is not harmful. It is similar to not having
monthly bleeding during pregnancy. She is not infertile.
Blood is not building up inside her.
yy Ask if she has been taking a pill every day. If so, reassure
that she is not likely to be pregnant and can continue
taking COCs as before.
yy If she skipped the 7 non-hormonal pills (28-day pack),
reassure that she is not pregnant and can continue using
COCs.
yy If she has missed hormonal pills or started a new pack late,
COCs can be continued.
yy Ask her to return for checkup if she has signs and
symptoms of early pregnancy after missing 3 or more pills
or starting a new pack 3 or more days late.

29
 Side Effects How to Manage
Ordinary headaches yy Try the following (one at a time):
(non-migrainous) yy Suggest Ibuprofen (200–400 mg), Paracetamol (500–1000
mg) or other pain relievers.
yy Some women get headache during the hormone-free week
(those 7 days when a woman does not take hormonal pills).
yy Any headaches that gets worse or occurs more often
during COC use should be evaluated.
Nausea or Dizziness yy For nausea, suggest taking COCs at bedtime or with food.
yy If symptoms continue consider locally available remedies.
Breast tenderness yy Recommend to wear a supportive bra (including during
strenuous activity and sleep).
yy Try hot or cold compresses.
yy Suggest Ibuprofen (200–400 mg), Paracetamol (500–1000
mg) or other pain reliever.
Weight change yy Review diet and counsel as needed.
Mood changes or yy Some women have changes in mood during the hormone-
changes in sex drive free week (those 7 days when a woman does not take
hormonal pills).
yy Ask about changes in her life that could affect her mood
or sex drive (including changes in relationship with her
partner). Give her support as appropriate.
Acne yy Acne usually improves with COC use. It may worsen for
a few women. If she has been taking pills for more than
a few months and acne persists give a different COC
formulation, if available. Ask her to try the new pills for at
least 3 months.
yy Women who have serious mood changes such as major
depression should be referred for care.

4.6.2 Problems Associated with Missing of Pills

Missed Pills How to Manage

Missed 1 or 2 pills/ yy Take one hormonal pill as soon as possible or two pills at
started new pack 1 or scheduled time.
2 days late? yy There is little or no risk of pregnancy.
Missed 3 or more yy Take one hormonal pill as soon as possible and continue
pills in the first or the scheduled pill.
second week/started yy Use a backup method for the next 7 days.
new pack 3 or more
yy Also can consider taking ECPs, if she had sex in the past
days late? 72 hours.
Missed 3 or more yy Take one hormonal pill as soon as possible and finish all
pills in the third hormonal pills in the pack as scheduled. Throw away the 7
week? non-hormonal pills in a 28-pill pack.
yy Start a new pack the next day.

30
 Missed Pills How to Manage
yy Use a backup method for the next 7 days.
yy Also can consider taking ECPs, if she had sex in the past
72 hours.
Missed any non- yy Discard the missed non-hormonal pill(s).
hormonal pills? (last yy Keep taking COCs, one each day. Start the new pack as
7 pills in 28-pill pack) usual.
Severe vomiting or yy If she vomits within 2 hours after taking a pill, she should
diarrhoea take another pill from pack as soon as possible and
continue taking the scheduled pills.
yy If she has vomiting or diarrhoea for more than 2 days,
follow instructions for 1 or 2 missed pills above.

4.6.3 Problems Requiring Switching Methods

Problems reported by the client may or may not be due to the method.

Problems How to Manage

Unexplained vaginal yy Refer or evaluate by history and pelvic examination.
bleeding (that Diagnose and treat, as appropriate. She can continue using
suggests a medical COCs while her condition is being evaluated.
condition not related yy If bleeding is caused by sexually transmitted infection or
to the method) or pelvic inflammatory disease she can continue using COCs
heavy or prolonged during treatment.
bleeding
Starting treatment yy Barbiturates, Carbamazepine, Oxcarbazepine, Phenytoin,
with anticonvulsants Primidone, Topiramate and Rifampicin may make COCs
or rifampicin less effective. If using these medications long-term, she
may want a different method, such as progestogen-only
injectables or a copper-bearing IUCD.
yy If using these medications short-term, she can use a backup
method (e.g. Condom) along with COCs.
Migraine headaches yy Regardless of her age, a woman who develops migraine
headaches, with or without aura or whose migraine
headaches become worse while using COCs should stop
using COCs. Help her choose a method without oestrogen.
In non-ambulatory yy If she is having major surgery or her leg is in a cast or for
condition (one week other reasons she will be unable to move about for several
or more) weeks, tell her to:
yy Stop taking COCs and use a backup method (e.g.
Condom) during this period.
yy Restart COCs 2 weeks after she can move about again

31
 Problems How to Manage
Certain serious health yy Tell her to stop taking COCs.
conditions (suspected yy Give her a backup method (e.g. Condom) to use until the
heart or liver disease, condition is evaluated.
high blood pressure,
yy Refer for diagnosis and care, if not already under care.
blood clots in deep
veins of legs or lungs,
stroke, breast cancer,
damage to arteries,
vision, kidneys or
nervous system due
to diabetes or gall
bladder disease)
Suspected pregnancy yy Assess for pregnancy.
yy Tell her to stop taking COCs if pregnancy is confirmed.
yy Assure her there are no known risks to a foetus conceived
while taking COCs.

32
 Chapter 5 Progestin-Only Pills (POPs)

5.1 What are POPs?

Progestin-only pills contain very low doses of a synthetic hormone known as progestin which is
like the natural hormone progesterone in a woman’s body. POPs are also called “Minipills”. The
available product is Levonorgestrol (LNG) and Desogestrel.

5.2 Key Points

yyPOPs are safe and effective.
yyPOPs are safe for breastfeeding women as they do not affect quality and quantity of milk.
yyPOPs can be started in breast feeding women earlier than 6 weeks.
yyBleeding changes are common but not harmful.
yyOne pill to be taken every day at the same time without any break.

5.3 When to Start POPs?

A woman can start using POPs any time if it is reasonably certain that she is not pregnant. Use
the Pregnancy Checklist (Annexure 2).

Woman's situation When to start

Having regular yy Any day within 5 days of menstrual cycle with no need for a backup
menstrual cycles method.
or switching from yy Any time after 5 days of menstrual cycle if it is reasonably certain
a non-hormonal that she is not pregnant. A backup method (e.g. Condom) is needed
method (Condoms, for the first 2 days of taking pills (if pregnancy cannot be ascertained
Centchroman give her POPs now and tell her to start taking them during her next
(Ormeloxifene), monthly bleeding and use condoms till then).
IUCDs) yy Immediately, if switching from an IUCD.
Switching from a yy Immediately, if she has been using the hormonal method consistently
hormonal method and correctly or if it is otherwise reasonably certain that she is not
(COCs, DMPA) pregnant. No need to wait for her next monthly bleeding and also
no need for a backup method.
yy At the time of repeat injection, if switching from injectables. No
need for a backup method.
Breast Feeding
Less than 6 months yy Any time, if her monthly bleeding has not returned. No need for a
after giving birth backup method.
yy If the monthly bleeding has returned, POPs can be started as
advised for women having menstrual cycles.

33
 Woman's situation When to start
More than 6 months yy Any time, if her monthly bleeding has not returned and if it is
after giving birth reasonably certain that she is not pregnant. A backup method (e.g.
Condom) is needed for the first 2 days of taking pills (if pregnancy
cannot be ascertained give her POPs now and tell her to start taking
them during her next monthly bleeding and use condoms till then).
yy If her monthly bleeding has returned, POPs can be started as
advised for women having menstrual cycles.
Not breastfeeding
Less than 4 weeks yy Any time, no need for a backup method.
after giving birth
More than 4 weeks yy Any time, if her monthly bleeding has not returned and if it is
after giving birth reasonably certain that she is not pregnant. A backup method (e.g.
Condom) is needed for the first 2 days of taking pills (if pregnancy
cannot be ascertained give her POPs now and tell her to start taking
them during her next monthly bleeding and use condoms till then).
yy If her monthly bleeding has returned, POPs can be started as
advised for women having menstrual cycles.
No monthly yy Any time if it is reasonably certain that she is not pregnant. A backup
bleeding (not related method (e.g. Condom) is needed for the first 2 days of taking pills.
to childbirth or
breastfeeding)
After miscarriage or yy Immediately, if she is starting within 7 days after first or second
abortion trimester miscarriage or abortion. No need for a backup method.
yy Any time, if it is more than 7 days after first or second trimester
miscarriage or abortion and if it is reasonably certain that she is not
pregnant. A backup method (e.g. Condom) is needed for the first
2 days of taking pills (if pregnancy cannot be ascertained give her
POPs now and tell her to start taking them during her next monthly
bleeding and use condoms till then).
After taking yy Same day, there is no need to wait for her next monthly bleeding to
Emergency start her pills.
Contraceptive Pills yy A new POP user should begin a new pill pack.
(ECPs)
yy A continuing user who needed ECPs due to pill-taking errors can
continue where she left off with current pack.
yy A backup method (e.g. Condom) is needed for the first 2 days of
taking pills.

5.4 How to Use POPs?

� Explain that all pills in POP packs are of same color and are active pills containing a
hormone that prevents pregnancy.
� One pill should be taken every day and at the same time until the pack is empty. Delayed
intake of the pill may increase failure/risk of pregnancy.
� Linking pill intake to a daily activity such as after dinner may help her remember and
reduce some side effects.
� It is very important to start the new pack on the next day at the same time as starting a pack
late risks pregnancy.
� When breastfeeding is stopped continue taking POPs but its effectivity reduces marginally.

34
5.5 How to Increase Compliance of POP Use?
Assure every client that she is welcome to come back or ask question anytime to the provider, if
she has problems, wants another method, has any major change in health status or thinks that she
might be pregnant.

� Encourage her to come back for more pills before supply is finished.
� Whenever client comes back to the provider ask:
� How she is doing with the method, whether she is satisfied and ask if she has any
questions or anything to discuss.
� Especially if she is concerned about bleeding changes. Give her any information or
help that she needs (see Management of Side Effects, Missing of Pills and Problems
Requiring Switching Methods in Section 5.6).
� If she often has problems remembering to take a pill every day. If so, discuss ways to
remember making up for missed pills, ECPs or choosing another method.
� If there are major life changes that may affect her needs particularly plans for having
children and STI/HIV risk, follow-up as needed.

5.6 How to Manage Side Effects, Missing of Pills and Problems Requiring Switching
Methods?
Problems with side effects affect women’s satisfaction and use of POPs. They deserve providers’
attention. If the client reports side effects or problems, listen to her concerns, give advice and if
appropriate, provide treatment. Encourage her to keep taking a pill every day even if she has
side effects as missing pills can risk pregnancy. Explain that many side effects will subside after
a few months of use. Offer help to choose another method if she wishes or cannot overcome the
problems.

5.6.1 Problems Reported as Side Effects

Side Effects How to Manage

No monthly bleeding yy Breastfeeding: Reassure her that this is normal during
breastfeeding and is not harmful.
yy Non breastfeeding: Reassure her that some women using
POPs stop having monthly bleeding and is not harmful.
It is similar to not having monthly bleeding during
pregnancy. She is not infertile.
Irregular and yy Reassure her that many women using POPs experience
Unexpected bleeding irregular bleeding whether breastfeeding or not.
Breastfeeding itself can also cause irregular bleeding and
is not harmful and usually becomes less or stops after
the first few months of use. Some women have irregular
bleeding the entire time they are taking POPs, however,
other possible causes of irregular bleeding may be due
to vomiting or diarrhoea or taking anticonvulsants or
Rifampicin etc.
yy To reduce irregular bleeding:
yy Teach her to make up for missed pills properly, including
after vomiting or diarrhoea.
yy If irregular bleeding continues or starts after several
months of normal or no monthly bleeding or if some
other conditions, unrelated to method use is suscepted,
consider further evaluation.

35
 Side Effects How to Manage
Heavy or prolonged yy Reassure her that some women using POPs experience
bleeding (Twice as heavy or prolonged bleeding. It is generally not harmful
much as usual or and usually becomes less or stops after a few months.
longer than 8 days) yy Additionally when heavy bleeding starts Tranexamic acid
500 mg 8 hourly can be given.
yy To help prevent anaemia, suggest taking iron tablets and
taking foods containing iron such as meat, egg, fish, green
leafy vegetables and legumes (beans, bean curd, lentils
and peas).
yy If heavy or prolonged bleeding continues or starts after
several months of normal or no monthly bleeding or
if some other conditions, unrelated to method use is
suscepted, consider further evaluation.
Ordinary headaches yy Suggest Ibuprofen (200–400 mg), Paracetamol (500 mg) or
(Non-migrainous) other pain relievers.
yy Any headache that gets worse or occurs more often during
POP use should be evaluated.
Mood changes or yy Ask about changes in her life that could affect her mood or
changes in sex drive sex drive (including changes in her relationship with her
partner). Give her support as appropriate.
yy Some women experience depression in the year after
giving birth. This is not related to POPs. Women who have
serious mood changes such as major depression should be
referred for care.
Breast Tenderness yy Recommend to wear a supportive bra (including during
(Women not strenuous activity and sleep).
breastfeeding) yy Try hot or cold compresses.
yy Suggest Ibuprofen (200–400 mg), Paracetamol (500 mg) or
other pain reliever.
Severe pain in lower yy Many conditions can cause severe abdominal pain. Be
abdomen (Suspected particularly alert for additional signs or symptoms of
ectopic pregnancy ectopic pregnancy (rare but can be life-threatening).
or enlarged ovarian yy In the early stages of ectopic pregnancy, symptoms may
follicles or cysts) be absent or mild but eventually they will become severe.
A combination of following signs or symptoms should
increase suspicion of ectopic pregnancy:
yy Unusual abdominal pain or tenderness
yy Abnormal vaginal bleeding or no monthly bleeding
especially if this is a change from her usual bleeding
pattern
yy Light-headedness or dizziness
yy Fainting
yy A woman can continue to use POPs during evaluation and
treatment.

36
 Side Effects How to Manage
yy Abdominal pain may be due to other problems such as
enlarged ovarian follicles or cysts. There is no need to
treat enlarged ovarian follicles or cysts unless they grow
abnormally large, twist or burst. Reassure that they usually
disappear on their own. Advice followup in 6 weeks to
ascertain that the problem is resolving.
yy If ectopic pregnancy or another serious health condition is
suspected, refer at once for immediate diagnosis and care.
Nausea or dizziness yy Suggest her to take POPs at bedtime or with food.

5.6.2 Problems Associated with Missing of Pills

Missed Pills How to Manage

3 or more hours late yy Take a pill as soon as possible.
taking a pill or misses yy Keep taking pills as usual, one each day. (She may take 2
one completely pills at the same time or on the same day). For breastfeeding
women, missing a pill puts her at risk of pregnancy
depending on whether or not her monthly bleeding has
returned.
If she has monthly yy A backup method should be used for the next 2 days.
bleeding yy Also, can consider taking ECPs, if she had sex in the past
72 hours.
If she has severe yy If she vomits within 2 hours after taking a pill, she should
vomiting or diarrhoea take another pill from the pack as soon as possible and
continue with the schedule pill as usual.
yy If her vomiting or diarrhoea continues, follow the
instructions for making up for missed pills above.

5.6.3 Problems Requiring Switching Methods

Problems reported by the client may or may not be due to the method.

Problems How to Manage

Unexplained vaginal yy Refer or evaluate by history and pelvic examination.
bleeding or heavy or Diagnose and treat as appropriate. She can continue using
prolonged bleeding POPs while her condition is being evaluated.
yy If bleeding is caused by sexually transmitted infection or
pelvic inflammatory disease, she can continue using POPs
during treatment.
Starting treatment yy Barbiturates, Carbamazepine, Oxcarbazepine, Phenytoin,
with anticonvulsants Primidone, Topiramate and Rifampicin may make POPs
or rifampicin less effective. If using these medications long-term, she
may want a different method such as progestogen-only
injectables or a copper-bearing IUCD.
yy If using these medications short-term, she can use a backup
method (e.g. Condom) along with POPs.

37
 Problems How to Manage
Migraine headaches yy If she has migraine headaches without aura, she can
continue to use POPs if she wishes
yy If she has migraine with aura, stop POPs. Help her choose
a method without hormones.
Certain serious health yy Tell her to stop taking POPs.
conditions (suspected yy Give her a backup method (e.g. Condom) to use until the
blood clots in deep condition is evaluated.
veins of legs or lungs,
yy Refer for diagnosis and care if not already under care.
liver disease or breast
cancer)
Heart disease due to yy A woman who has one of these conditions can start POPs.
blocked or narrowed If however the condition develops after she starts using
arteries (ischemic POPs then it should be stopped. Help her choose a method
heart disease) or without hormones.
stroke yy Refer for diagnosis and care if not already under care.

Suspected pregnancy yy Assess for pregnancy, including ectopic pregnancy.

yy Tell her to stop taking POPs if pregnancy is confirmed.
yy Assure her that there are no known risks to a foetus
conceived while taking POPs and pregnancy can be
continued.

38
 Chapter 6 Centchroman (Ormeloxifene) Pills

6.1 What are Centchroman (Ormeloxifene) Pills?

Centchroman (Ormeloxifene) is a non steroidal, non- hormonal once a week oral contraceptive
pill. It acts as selective estrogen receptor modulator (SERM). In some tissues/organs of the body,
it has weak oestrogenic action (e.g, bones) while in others it has strong anti-estrogenic action (e.g,
uterus, breasts etc).

6.2 Key Points

yyCentchroman (Ormeloxifene) is safe and effective.
yyCentchroman (Ormeloxifene) is safe for breast feeding women.
yyApart from prolongation of menstruation cycle in some women, it is not known to cause
any side effects.
yyOne pill is taken twice a week for first three months, followed by once a week thereafter.

Fig. 3: Centchroman (Ormeloxifene) in the Public Sector - (a) ASHA Supply (b) Free Supply

6.3 When to Start and How to Use Centchroman (Ormeloxifene)?

� For initiation of the Centchroman (Ormeloxifene), the first pill is to be taken on the first
day of period (as indicated by the first day of bleeding) and the second pill three days later.
This pattern of days is repeated through the first three months.
� Starting from fourth month, the pill is to be taken once a week on the first pill day and
should be continued on the weekly schedule regardless of her menstrual cycle. Refer table
below to decide for fixed day(s).

Table 2: Schedule of Centchroman (Ormeloxifene)

If the first Day of pill is First 3 Months After 3 Months

taken on
Pill to be taken on to be taken on
Sunday Sunday and Wednesday Sunday
Monday Monday and Thursday Monday
Tuesday Tuesday and Friday Tuesday
Wednesday Wednesday and Saturday Wednesday

39
 If the first Day of pill is First 3 Months After 3 Months
taken on
Pill to be taken on to be taken on
Thursday Thursday and Sunday Thursday
Friday Friday and Monday Friday
Saturday Saturday and Tuesday Saturday

6.4 How to Increase Compliance of Centchroman (Ormeloxifene) Use?

� Assure every client that she is welcome to come back or ask question any time to the

provider, if she has problems, wants another method, has any major change in health
status or thinks that she might be pregnant.
� Encourage her to come back for more pills before her supply is finished.
� Whenever client comes back to the provider ask:

� How she is doing with the method, whether she is satisfied and has any questions or
anything to discuss.
� Especially if she is concerned about bleeding changes. Give any information or help

that she needs (See Management of Side Effects, Missing of Pills in Section 6.5) . Assure
her that these changes get normalized with continuing usage.
� If she often has problems remembering to take pills. If so, discuss ways to remember,
making up for missed pills, ECP or choosing another method.
� If there are major life changes that may affect her needs particularly plans for having
children and STI/HIV risk, follow-up as needed.

6.5 How to Manage Side Effects, Missing of Pills?

� Centchroman (Ormeloxifene) causes delayed periods in few women. But this occurs in
around 8% of users and usually in the first three months. The periods tend to settle down
to a rhythm once the body gets used to the drug.
� Periods can get scanty over time in some women.

Counsel and reassure her that some women using Centchroman (Ormeloxifene) have such
problem. This is not harmful and will subside on its own.

6.5.1 How to Manage Missed Pills?

� Take a pill as soon as possible after it is missed.

� If pill is missed by 1 or 2 days but lesser than 7 days, the normal schedule should
be continued and client needs to use a back-up method (e.g. Condoms) till the next
period starts.
� If pill is missed by more than 7 days, client needs to start taking it all over again
like a new user that is twice a week for 3 months and then once a week.

6.5.2 If Period is Missed with Centchroman (Ormeloxifene)

With Centchroman (Ormeloxifene), occasionally the menstrual cycle may get prolonged
in some users. The contraceptive makes the periods lighter and the interval longer,
which is not harmful and can actually be helpful for anaemic women, as user loses lesser
amount of blood. However, if periods are delayed by more than 15 days, pregnancy
needs to be ruled out.

40
 Chapter 7 Emergency Contraceptive Pills (ECPs)

7.1 What is Emergency Contraceptive Pill?

� Emergency contraceptive pill is used to prevent pregnancy after unprotected sexual
intercourse, sex was coerced or contraceptive accidents like condom rupture or missed
pills.
� In the National Program, EC pills contains only progestin - Levonorgestrel (1.5 mg
per tablet). However, combined oral contraceptive pills containing an oestrogen and a
progestin can also be used as EC pills.
� ECPs are also called “morning-after pills” or post coital contraceptives.

7.2 Key Points

yyECPs are safe for all women even women who cannot use combined hormonal contraceptive
methods.
yyECPs do not disrupt an existing pregnancy.
yyECPs provide an opportunity for women to start using a regular contraceptive method
yyECPs help to prevent pregnancy when taken up to 3 days (72 hours) after unprotected sex.
The sooner they are taken the better.

Fig. 4: ECPs in the Public Sector - (a) ASHA Supply (b) Free Supply

Emergency contraceptive pills are meant to be used for emergency only. These are not
appropriate for regular use as a contraceptive method because of the higher possibility of
failure compared to other contraceptive method. In addition, frequent use of emergency
contraception can result in side-effects such as menstrual irregularities. The repeated use
poses no known health risks but is less effective than a regular method in preventing
pregnancy.

7.3 How to Use?

yy Take the pill immediately after unprotected/accidental intercourse or as soon as possible
within next 3 days (72 hours).
yy If 2 pills of Levonorgestrol or COCs are used as an emergency contraceptive, second dose
to be taken after 12 hours of first dose.

41
7.4 How to Manage Side Effects?
Side effects are minor and they are not signs of illness. The common ones are:
yy Nausea: Routine use of anti-nausea medication is not recommended. If user have had
nausea with previous ECP use or with the first dose of a 2-dose regimen, can take anti-
emetic 1½ to 1 hour before taking ECP.
yy Vomiting: If woman vomits within 2 hours after taking ECP, she should take another
dose (she can take an anti-emetic with the repeat dose). If vomiting occurs more than
2 hours after taking ECPs, she does not need to take extra pills. If vomiting continues,
she can take the repeat dose by placing the pills high in her vagina.
yy Slight bleeding or change in timing of monthly bleeding, which gradually subsides.

� Explain that ECPs can at the most avert pregnancy resulting from the episode of
unprotected/accidental sex after which pill was taken. It cannot protect her from future
pregnancy, if unprotected sex occurs again any time. Therefore, it should not be used as
a regular contraceptive method.
yy Counsel the client to choose a family planning method to start using after the emergency
contraception, if she does not plan for pregnancy immediately.
yy Advise the client to start a contraceptive after ECP use as most contraceptive methods
can be started on the same day of ECP use.
yy If she does not want to start a contraceptive method now, give her condoms or COCs
and ask her to use them if she changes her mind. Give instructions on use. Invite her
to come back any time, if she wants another method or has any questions or problems.

yy Tell her that ECP does not protect from STIs/HIV.

yy Explain that ECP will not harm an existing pregnancy.
yy Advise the client to return if her next monthly bleeding:

yy Is unusually light (possible pregnancy)

yy Period is delayed beyond one week of expected date of cycle.
yy Is unusually painful (possible ectopic pregnancy)

Copper IUCD can also be used as an emergency contraceptive method if inserted

within 5 days of unprotected intercourse/contraceptive accident.

42
 Chapter 8 Medical Eligibility Criteria (MEC) and Client’s
Assessment

8.1 Medical Eligibility Criteria (MEC) Categories

The Medical Eligibility Criteria (MEC) forms the scientific foundation for client assessment
regarding family planning methods. It gives a detailed guidance regarding whether a family
planning method can safely be given to a woman with a certain medical condition.

The criteria has been adapted and modified according to the Indian situation, based on the skills,
knowledge and availability of resources in the health delivery system.
The MEC has four categories.

Category With Clinical With Limited Clinical

Judgement Judgement
1. A condition for which there is Use method in any Yes
no restriction for the use of the circumstances (Use the Method)
contraceptive method.
2. A condition where the advantages Generally use the
of using the method generally method
outweigh the theoretical or proven
risks.
3. A condition where the theoretical or Use of method not No
proven risks usually outweigh the usually recommended (Do not use the method)
advantages of using the method. unless other more
appropriate methods
are not available or not
acceptable
4. A condition which represents an Method not to be used
unacceptable health risk if the
contraceptive method is used.

8.2 MEC Wheel for Contraceptive Use (2015)

MEC Wheel for Contraceptive Use – India (2015)
is available. This is a very useful job-aid, which
tells family planning providers if a woman
presenting with a known medical or physical
condition can use various contraceptive methods
safely and effectively or not. This wheel is based
on medical eligibility criteria for starting use
of selected contraceptive methods. Ministry of
Health and Family Welfare, Government of India,
has adapted the wheel from WHO MEC wheel
for contraceptive use (2015 update). The wheel
should be used by family planning providers to
decide if COCs and POPs can be given to women
with specific medical and physical conditions or
not. MEC for Oral Contraceptives is given in the
Annexure 3.

43
8.3 Client Assessment
This section describes client assessment prior to provision of oral contraceptive methods. The
primary objectives of this assessment or screening are to determine whether the family planning
client
� Is pregnant,
� Has any condition that affect the client’s medical eligibility to start or continue using a
particular method,
� Has any special problem that require further assessment, treatment or regular follow-up.

These objectives usually can be accomplished by asking a few key questions. Unless specific
problems are identified, the safe provision of oral contraceptive methods does not require
physical or pelvic examinations or any laboratory test.

8.3.1 How to Be Reasonably Sure a Client is Not Pregnant

Provider can be reasonably sure a client is not pregnant if she has no signs or symptoms of
pregnancy (e.g. breast tenderness or nausea) and she answers “Yes” to at least one of the
questions on the Pregnancy Checklist. This checklist, “How to be reasonably sure a client
is not pregnant,” is highly effective and has been validated in Kenya, Guatemala, Senegal,
Mali and Egypt. When used correctly, it is more than 99% effective in ruling out pregnancy.

Before starting any method Pregnancy checklist should be used (Annexure 2). It is also
given in Medical Eligibility Criteria (MEC) Wheel for Contraceptive Use – India (2015).

8.3.2 Client Assessment for Combined Oral Contraceptives (COCs):

After ruling out pregnancy (Annexure 2), ask the client the questions below about known
medical conditions. Examinations and tests are not necessary.

NO YES
1. Are you breastfeeding a baby less than 6 months old?
yy If fully or nearly fully breastfeeding: Give her COCs and
tell her to start taking them 6 months after giving birth
or when breast milk is no longer the baby’s main food—
whichever comes first
yy If partially breastfeeding: She can start COCs as soon as 6
weeks after childbirth
2. Have you had a baby in the last 3 weeks and you are not
breastfeeding?
yy Give her COCs now and tell her to start taking them 3
weeks after childbirth. (If there is an additional risk that
she might develop a blood clot in a deep vein (deep vein
thrombosis or VTE), then she should not start COCs at 3
weeks after childbirth, but start at 6 weeks instead.
3. Do you smoke cigarettes?
yy If she is 35 years of age or older and smokes, do not provide
COCs. Urge her to stop smoking and help her choose
another method.

44
NO YES
4. Do you have cirrhosis of the liver, a liver infection or liver
tumor? (Are her eyes or skin unusually yellow? [signs of
jaundice]) Have you ever had jaundice when using COCs?
yy If she reports serious active liver disease (jaundice, active
hepatitis, severe cirrhosis, liver tumor) or ever had jaundice
while using COCs, do not provide COCs. Help her choose
a method without hormones.
5. Do you have high blood pressure?
Check blood pressure if possible:
yy If her blood pressure is below 140/90 mm Hg, provide
COCs.
yy If her systolic blood pressure is 140 mm Hg or higher or
diastolic blood pressure is 90 or higher, do not provide
COCs. Help her choose a oral method without estrogen.
(One blood pressure reading in the range of 140–159/90–99
mm Hg is not enough to diagnose high blood pressure.
Give her a backup method ([Link]) to use until she
can return for another blood pressure check or help her
choose another method now if she prefers. If her blood
pressure at next check is below 140/90, she can use COCs).
6. Have you had diabetes for more than 20 years or damage to
your arteries, vision, kidneys or nervous system caused by
diabetes?
yy Do not provide COCs. Help her choose a method without
estrogen but not progestin-only injectables.
7. Do you have gallbladder disease now or take medication for
gallbladder disease?
yy Do not provide COCs.
8. Have you ever had a stroke, blood clot in your legs or lungs,
heart attack or other serious heart problems?
yy Do not provide COCs, help her choose an oral method
without estrogen or help her choose a method without
hormones.
9. Do you have or have you ever had breast cancer?
yy Do not provide COCs, help her choose a method without
hormones.
10. Do you sometimes see a bright area of lost vision in the
eye before a very bad headache (migraine aura)? Do you
get throbbing, severe head pain, often on one side of the
head that can last from a few hours to several days and
can cause nausea or vomiting (migraine headaches)? Such
headaches are often made worse by light, noise or moving
about.
yy If she has migraine aura at any age, do not provide COCs.
If she has migraine headaches without aura and is age 35
or older, do not provide COCs. Help these women choose
a method without estrogen. If she is under 35 and has
migraine headaches without aura, she can use COCs.

45
 NO YES
11. Are you taking medications for seizures? Are you taking
rifampicin or rifabutin for tuberculosis or other illness?
yy If she is taking barbiturates, carbamazepine, lamotrigine,
oxcarbazepine, phenytoin, primidone, topiramate,
rifampicin or rifabutin do not provide COCs. They can
make COCs less effective. Help her choose another
method but not progestin-only pills. If she is taking
lamotrigine, help her choose a method without estrogen.
12. Are you planning major surgery that will keep you from
walking for one week or more?
yy If so, she can start COCs 2 weeks after the surgery. Until
she can start COCs, she should use a backup method.
13. Do you have several conditions that could increase your
chances of heart disease (coronary artery disease) or
stroke, such as older age, smoking, high blood pressure or
diabetes?
yy Do not provide COCs. Help her choose a method without
estrogen but not progestogen-only injectables.

If she answers “no” to If she answers “yes” to

all of the questions, then a question, follow the
she can start COCs if she instructions.
wants.

8.3.3 Client Assessment for Progestin-Only Pills

After ruling out pregnancy (Annexure 2), ask the client the questions below about known
medical conditions. Examinations and tests are not necessary.

NO YES
1. Are you breastfeeding a baby less than 6 months old?
yy She can start taking POPs earlier than six weeks
2. Do you have cirrhosis of the liver, a liver infection or liver
tumor? (Are her eyes or skin unusually yellow? [signs of
jaundice])
yy If she reports serious active liver disease (jaundice, active
hepatitis, severe cirrhosis, liver tumor), do not provide
POPs. Help her choose a method without hormones.
3. Do you have a serious problem now with a blood clot in your
legs or lungs?
yy Help her choose a method without hormones.

46
 NO YES
4. Are you taking medication for seizures? Are you taking
rifampicin or rifabutin for tuberculosis or other illness?
yy If she is taking barbiturates, carbamazepine, oxcarbazepine,
phenytoin, primidone, topiramate, rifampicin or rifabutin
do not provide POPs. They can make POPs less effective.
Help her choose another method but not COCs.
5. Do you have or have you ever had breast cancer?
yy Do not provide POPs, help her choose a method without
hormones.

If she answers “no” to all If she answers “yes” to

of the questions, then she a question, follow the
can start POPs if she wants. instructions.

8.3.4 Client Assessment for Centchroman (Ormeloxifene)

After ruling out pregnancy (Annexure 2), if the client is identified with a medical
condition in which hormonal contraceptive cannot be started, she can start Centchroman
(Ormeloxifene), if she wants. Centchroman (Ormeloxifene) should not be given if client has
any of the following condition:

� Polycystic ovarian disease

� Cervical hyperplasia
� Recent history of jaundice or liver disease
� Severe allergic state
� Chronic illness, like tuberculosis or renal disease

8.3.5 Client Assessment for EC Pills

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

ECPs can be used any time a woman is exposed to unprotected sex

For example, if unprotected sex has occurred because:
� sex was coerced
� no contraceptive was used during sex
� contraceptive accident occurred, such as:
� Condom was used incorrectly, slipped or broke
� Missed more than two hormonal pills
� Couple incorrectly used fertility awareness method
� Man failed to withdraw, as intended, before ejaculation
� IUCD was expelled
� Client comes more than 4 weeks late for her repeat injection of DMPA

47
48
Section II
Managerial Aspects for
Oral Contraceptive Services
 Chapter 9 Program Determinants for Quality services

9.1 Determinants of Services

The provision of adequate, appropriate and sustainable services determines the client satisfaction.
It is thus imperative that the service providers are skilled on various technical aspects. Also the
program managers need to understand all the managerial aspects to deliver quality services to
the clients.

9.1.1 Service Delivery Points

Oral Contraceptive Pills should be available as a contraceptive choice in all public health
facilities. Oral pills available under the National Family Planning Program are - Combined
Oral Contraceptives, Progestin Only Pills, Centchroman (Ormeloxifene) and Emergency
Contraceptive Pills.

In addition to public health facilities ASHAs also serve as a service delivery point for oral
pills. Under the scheme for ‘Home Delivery of Contraceptives’, ASHAs distribute the Oral
pills and condoms at the doorstep of the beneficiary.

9.1.2 Eligibility of Providers

Doctors (MBBS and above, AYUSH), SN/LHV/ANM are eligible to prescribe oral
contraceptive pills to the client after obtaining proper history and examination.

For ‘Home Delivery of contraceptives’ through ASHA it is mandatory that the first dose
will be prescribed by doctors (MBBS and above, AYUSH), SN/ LHV/ANM after proper
screening of the client.

9.1.3 Capacity Building of Service Providers

Skill building of provider is an essential component for quality service delivery. A situational
analysis of the current status of service providers at different levels of health facilities in the
district will help in identifying training needs. The training needs assessment along with
the training process and schedule has been detailed in Chapter 10.

ASHAs should also be oriented from time to time during the monthly meetings on the
important aspects of contraceptive service delivery.

9.1.4 Ensuring Regular Supply

Good quality reproductive health care requires a continuous supply of contraceptives
and other commodities. Contraceptive logistics management requires accurate and timely
reports.

Clinic staff members do their part when they properly manage contraceptive inventory,
accurately record and report what commodities are used and promptly order new supplies.

Family planning staff members need to be familiar with and work within whatever systems
are in place at their worksites to make certain that they have the supplies that are needed.

51
 [Link] Logistics Responsibilities for Family Planning Providers
Workers at all levels of the health system, including those at the central, state,
district, block and community levels play a role in ensuring that the contraceptives
logistics system functions effectively. While specific supply chain procedures can
vary across settings, medical officers, store in-charges, nurses, lady heath visitors,
ANMs and ASHAs are specifically responsible for the following common
activities:

1. Receive and store contraceptives in the health center according to

recommended storage guidelines.
2. Record all issues and receipts of health commodities on the stock register.
3. Issue products to service providers according to FEFO (First-to-Expire, First-
Out) system of distribution.
4. Conduct a physical inventory of commodities monthly and update the stock
register.
5. Consolidate data on usage of commodities by all user units affiliated to the
health centre.
6. Complete monthly report and send to the designated District/State authority
by the scheduled date of every month.
7. Send requisition of each item based on scientific calculation timely (before
the stock gets exhausted).

[Link] Demand Estimation

The quantity of various oral contraceptives required for a specific period of time
at a health facility or with community health worker can be calculated based on
estimated users.
The table below shows the method of demand estimation for various oral pills:

[Link]. Oral Contraceptive pills Method for calculation

1 Combined Oral Contraceptives Estimated COC Users x 15 cycles +
(In Cycles) 10% Buffer Stock
2 Emergency Contraceptive Pill Estimated ECP users (average of last 3
(in tablet) years) + 10% Buffer Stock
3 Centchroman (Ormeloxifene) Estimated Centchroman
(weekly pills) (In strips) (Ormeloxifene) users x 9 strips + 10%
Buffer Stock
4 Progestin Only Pills (POPs) (In For Post-partum women - Estimated
Cycles) Users x 7 cycles + 10% Buffer Stock

[Link] Distribution
Supplies reach from manufacturer/supplier to the state warehouse based on the
consignee list provided by the Family Planning Division, MoHFW, GoI. State has
to ensure further distribution to the district level stores, block level stores and
further to the service delivery points.
The replenishment/further supply of the oral contraceptive pills should be on
consumption basis only. Demand estimation at state has to be an outcome of an
indent submitted by district/block based on the consumption and stock in hand
at facility.

52
 [Link] Storing Procedure
Proper storage of health commodities helps ensure that products are always
available, accessible and in good condition. It protects the quality of the
contraceptives and other supplies and preserves the integrity of the packaging to
make supplies available for use.

yy The storage area should be dry, away from water, direct sunlight and fire.
yy The storage area should be cleaned regularly to prevent harmful insects and
rodents from entering it.
yy The cartons should be stacked at least 10 cm off the floor, 30 cm away from
the walls and other stacks and no more than 2.5m high.
yy The cartons should be arranged with arrows pointing up with identification
labels, expiry dates and manufacturing dates clearly visible.
yy To make sure that the commodities do not expire before they are dispensed,
First-to-Expire, First-Out (FEFO) system should be followed. With this
system, the commodities with the shortest remaining shelf life are used first.
yy The commodities should be stored away from insecticides, chemicals,
flammable products, hazardous materials, old files, office supplies and
equipment.

9.1.5 Records and Reporting System

Timely and accurate reporting is essential for smooth implementation of program. The
progress of oral contraceptive acceptors should be documented in a standardized manner
for program effectiveness. The documented information should be reported in time and
regularly by the concerned provider and facilities.

The purpose is to collect relevant information to:

1. Document and know relevant details of acceptors by contraceptive methods.

2. Follow-up with acceptors of the methods.

3. Collect and report information to other levels of the system in order to make decisions
regarding the quantity and time to distribute contraceptives and related supplies.

Relevant records of contraceptive distribution should be maintained at different service

delivery points and reported on monthly basis by ASHAs to the respective ANMs for
incorporation in the Subcenter level HMIS. ASHAs will maintain a beneficiary list for
the distribution of contraceptives under ‘Home Delivery of Contraceptives’ scheme. The
information to be captured by ASHAs is placed at Annexure 11.

At facility level the relevant socio-demographic information need to be recorded from all
the clients who have chosen to receive oral pills as per details given in Annexure 11a.

Apart from service delivery reports, stock information contraceptive wise should be
regularly updated at the facility level and submitted to the district and state who in turn
would communicate the same to GoI on a quarterly basis.

53
54
Section III
Capacity Building of
Service Providers on Oral
Contraceptives
 Chapter 10 Training and Skill Development

10.1 Assessment of Training Need

A situational analysis of the current status of service providers at the different level of health
facilities in the district will help in identifying training needs. This will help to determine and
plan the most appropriate interventions such as ‘Training of Trainers’ to develop a core group of
‘trainers’ and competent service providers at various levels.

The State Program Managers need to coordinate with the District Chief Medical Officer to identify
the availability of service providers required for providing regular oral contraceptive pills. Based
upon the need of the districts the doctors/ Staff Nurses/ LHV/ANM can be trained. The training
load can be calculated using the following RAG analysis.

Calculation of the Training Load - for various categories of providers

(Doctors, Nurses, LHVs, ANMs etc.)

DH / SDH CHC PHC

Oral Contraception R A G R A G R A G

R- Required; A- Available; G – Gap

10.2 General Aspects of Training

10.2.1 Training Site Selection

• The facility for training should have a comfortable clean training hall to
accommodate about 35 persons.
• Availability of chairs, tables, light source, fans/AC, audio-visual facility and
alternate source of power.
• Space for providing refreshments and also toilet facilities.
• Availability of at least two trainers for the respective training site.

Identification and designation of these training centres at State and District level will
be the responsibility of SQAC/Director Family Welfare and DQAC/CMO whichever
is applicable.

10.2.2 Criteria for Designation of ‘Trainers’

• Trained service providers (MBBS and above, AYUSH, Staff Nurses) with some
training experience, good communication skills, well-versed with training skills
and technique of adult learning principles. They should have competency/
proficiency in the skills of counselling.
• Can spare time and willing to conduct training and follow-up monitoring visits
for on-site support/hand-holding, if required,
• Can be designated as a trainer by SQAC/Director Family Welfare at State level and
by DQAC/CMO at District level.

57
 10.2.3 Selection of ‘Trainees’
The intended trainees for this course are - Medical Officer (MBBS/AYUSH), Staff Nurse
(SN), Lady Health Visitor (LHV), Auxiliary Nurse Midwife (ANM) committed to
provide the above methods after completion of the training.
When selecting trainees, priority should be given to service providers from institutions
that are committed to provide FP Services. Facilities nominating trainees should be
able to include new oral pills in basket of FP Services.

10.2.4 Equipment and supplies for training sites

• Reference Manual for Oral Contraceptive Pills.

• Samples of all contraceptive methods including injectable contraceptive.
• Summary of Key characteristics of OCPs (Annexure 5.1,5.2,5.3,5.4)
• Formats with role plays and case studies (Annexure 7 )
• Pre/Post-Test Questionnaire (Annexure 8, 8a), Training evaluation formats
(Annexure 9)
• LCD Projector and screen for Power point Presentation, extension board, power
back up, flip chart, flip stands, coloured markers.

10.3 Training Goal and Learning objectives

The goal of training is to assist service providers in learning to provide safe quality oral
contraceptives through improved service delivery. At the end of the training participants should
be able to fulfill following objectives:
� Demonstrate appropriate counselling skills for oral contraceptive methods.
� Assess the eligibility and provide oral contraceptive methods as per standard procedure
and guidelines.
� Describe the follow-up care of clients using oral contraceptive methods.
� Describe management of side effects/ other issues related to oral contraceptive methods.
� Demonstrate correct record keeping and reporting of clients using oral contraceptive
methods.

10.4 Number of Trainees per Batch

Approximately 25 to 30

10.5 Training Duration

One full working day

10.6 Training Approach and Methodology

All training activities in this course should be conducted in an interactive, participatory manner
as suggested in the course outline. To accomplish this, the trainer should change roles throughout
the course. For example, the trainer is an instructor when presenting a classroom session, a
facilitator when conducting small group discussions or role plays. Finally, when objectively
assessing performance, the trainer serves as an evaluator.
Following training methodology will be used in this training course:
� Interactive presentations and group discussion
� Demonstration
� Individual and group exercises

58
 � Role plays and case studies
� Counselling practice with real clients
A suggestive course outline (session plan) of training has been provided in Annexure 12.

10.6.1 Important Tips for the Trainers

yy Familiarize with the content of all Sections and Annexures in the ‘Reference
Manual for Oral Contraceptive Pills, Pre/Post Test Questionnaires, Checklist on
Family Planning and Method Specific Counselling for Oral Contraceptives, role
plays and case studies etc.
yy Make necessary preparations in advance, as per the facilitator guide.
yy Plan meeting with co-facilitators before each workshop for assigning responsibilities
and to clarify any doubts, concerns or reservations.
yy Work together as a team subtly supporting each other in every session.
yy Conduct wrap-up session at the end of each training day and start the next day
with a re-cap session to provide continuity in the training.
yy Arrange a seating arrangement which is informal, preferably in a semi-circle,
without any podium for the trainers.
yy Adopt a warm and friendly attitude towards the participants to make the training
very effective and take care not to ridicule any trainee.
yy Explain, demonstrate, answer questions, talk with participants about their answers
to exercises, get role plays conducted and analyse them, lead group discussions,
organize and supervise clinical practice in outpatient facility and generally give
participants any help they need to successfully complete the course.
yy Using leading questions draw the relevant information related to the session
from participants and fill in the gaps, where necessary. This will help trainees to
assimilate the knowledge and experiences.

10.6.2 Adapt the Curriculum to Reflect the Participants’ Expectations

Use the results of the small group exercise about participants’ expectations. Although
trainers may not always be able to meet all of the participants’ needs, knowing
expectations helps in tailoring the training and add relevant information and examples
to the training sessions.

Language: Use non-technical simple language during the sessions so that participants
can understand and gain practice with simple terminology that can be used during
their work.

10.7 Evaluation of Knowledge and Skills

Evaluation is a fundamental part of training. Proper evaluation helps ensure that the training is
not merely a one-time intervention but part of a broader strategy to develop participants’ skills
and to help them apply those skills upon return to their work-sites. Evaluation can also help to
improve future training activities. Evaluation of training includes:
� A pre and post-test of participants’ knowledge: this pre-test and post-test is designed to
be given at the beginning and end of the training course. The trainer can use the results to
customize the training to best suit the trainees.
� Continuous assessment of the training.
� An assessment of the trainees by the trainer (Checklist on Family Planning and Method
Specific Counselling ; Annexure 4.1,4.2,4.3,4.4).
� An assessment of the training by the participants (Evaluation of Training; Annexure 9)

59
 10.7.1 Training Follow-up
For training to be truly successful, trainees must be able to use their new skills and
knowledge and apply them when they return to their jobs. Practice on job helps in
gaining competency and gradually proficiency in the skills. The follow up should be
conducted within 2 to 3 months by District Training Coordinator/CMO (Annexure 10).

10.7.2 Certification
Certificate of attendance may be given to participants who have attended training.

10.8 Roadmap for training

The training strategy is to start with orientation of Trainers and Program managers at the national
level and state level followed by facility level training of service providers at district/sub district
level. This process would ultimately build a sustainable self-renewing system of DH/CHC based
Trainers responsible for developing the capacity of competent service providers for FP services

10.9 Curriculum and Schedule of Training on Oral Contraceptives

Time Duration Topics / Activities
9:30-10:00 30 Min yy Introductions of Participants
yy Participants’ Expectations, Group Norms
10:00-10:20 20 Min yy Course Goal and Objectives
yy Review the Course Agenda, Components of the Training
Package and Course Materials Given to Participants.
10:20-10:40 20 Min yy Pre Course Knowledge Assessment
10:40-11:00 20 Min yy National Family Planning Program and Need for Expanding
Contraceptive Choice, Global Use of Oral Contraceptives
and in the National Family Planning Program
Working Tea
11:00-12:00 60 min yy Technical Update on Combined Oral Pills, Pops & Ecpills
12:00-12:30 30 Min yy Technical Update on Centchroman (Ormeloxifene)
12:30-1:15 45 Min yy Medical Eligibility Criteria and Client Assessment for Oral
Contraceptives(Ocps, Pops, Centchroman (Ormeloxifene),
Ecps)
1:15-2:00 45 Min Lunch
2:00-3:00 60 Min yy Counselling for Ocps
yy Role-Play
3:00-3:30 30 Min yy Helping Continuing Users and Managing Side Effects and
Problems of Oral Contraceptives
3:30-4:00 30 Min yy Addressing Misconceptions on Oral Contraceptives
Working Tea
4:00-4:45 45 Min yy Skill Practice Using Checklist on Counselling Skills
4:45-5:15 30 Min yy Contraceptive Logistics and Record Keeping for Oral
Contraceptives
5:15-5:35 20 Min yy Post Course Knowledge Assessment Questionnaire , Course
Evaluation formats and Course Closure

60
Section IV
Annexures
 Delivery 48 hr 1wk 3 weeks 4 weeks 6 weeks 6 months 12 months
Annexure 1

Condom

All IUCD IUCD

Women Female Sterilization Female Sterilization

Emergency Contraceptive Pill (ECP)*

Male Sterilizatiion

Lactational Amenorrhea Method (LAM)

Breast-Feeding Injection DMPA

Planning Method

Women
Progestin-Only Pill (POP)
Combined
Contraceptive
(COC) Pill

Centchroman

Progestin-Only Methods (POP/Injection DMPA)

Non-breast
Feeding Women Combined Oral Contraceptive (COC) Pill

Centchroman

* This is to be used only in emergency. For a regular contraceptive use, take advice from ANM/Doctor at government health centre.
Time of Initiation of Postpartum Family

63
 Annexure 2 Pregnancy Checklist

Before starting any method, ask the client, questions 1-6. As soon as the client answers “yes” to any
question, stop and follow the instruction given below.

1. Ask for the following 3 criteria for LAM

(All 3 must be met)
yy The baby is less than 6 months old
yy Menstrual period has not returned after last childbirth
yy The baby is fully or nearly fully breastfed, fed often, day and night at least 8-10
times a day, at least once in 4 hours and at least once at night (at least 85% of
feeding should be breast milk).
NO 2. Have you abstained from sexual intercourse since your last monthly bleeding YES
or delivery?
3. Have you had a baby in the last 4 weeks?
4. Did the first day of your monthly bleeding start within the past 7 days (or within
the past 12 days if the client is planning to use an IUCD)?
5. Have you had a miscarriage or abortion in the last 7 days (or within the past 12
days if the client is planning to use an IUCD)?
6. Have you been using a reliable contraceptive method consistently and correctly?

If the client answered “no” to all If the client answered “yes” to

questions, pregnancy cannot be at least one of the questions and
ruled out. The client should wait she has no signs or symptoms of
for her next monthly bleeding or pregnancy, you can give her the
do a Urine Pregnancy Test for method she has chosen.
Confirmation.

64
 Annexure 3 Medical Eligibility Criteria for Oral
Contraceptives

The table below is the quick reference chart of MEC for Oral Contraceptives adapted from the latest
recommendations of WHO MEC 2015:

� Women with conditions listed under WHO Category 1 and 2 can use hormonal contraceptives
� Women with conditions listed under WHO category 3 and 4 should not use hormonal contraceptives.
� 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.

Condition Combined Oral Progestin Only

Contraceptives Pills (POPs)
(COCs)
Age and parity
a) Women from menarche to 40 years of age 1 1
b) Nulliparous or parous 1 1

Smoke cigarettes/bidi
a) Age < 35 Years 2 1
b) Age ≥ 35 Years 3 or 4 1
Anemia now or had in the past 1 1
Breastfeeding
a) < 6 weeks postpartum 4 2
b) ≥ 6 weeks to < 6 months (primarily breastfeeding) 3 1
c) ≥ 6 months postpartum 2 1
Postpartum
(non-breastfeeding women)
a) < 21 days
(i) without other risk factors for VTE 3 1 (For all
(ii) with other risk factors for VTE 4 conditions
given)
b) ≥ 21 days to 42 days
(i) without other risk factors for VTE 2
(ii) with other risk factors for VTE 3
c) ≥ 42 days 1

Post-abortion
Immediate post-septic 1 1
Superficial venous disorders
a) Varicose veins 1 1
b) Superficial venous thrombosis 2 1
Known dyslipidaemias without other known cardiovascular 2 2
risk factors
*I= Initiation; C= Continuation

65
 Condition Combined Oral Progestin Only
Contraceptives Pills (POPs)
(COCs)
Hypertension
a) History of (where BP can’t be evaluated) 3 2
b) BP is controlled and can be evaluated 3 1
c) Elevated BP (Systolic 140-159 or diastolic 90-99) 3 1
d) Elevated BP (Systolic ≥ 160 or diastolic ≥ 100) 4 2
e) Vascular disease 4 2

Deep venous thrombosis

a) History of DVT/PE 4 (in all 2
b) Acute DVT/PE conditions 3
c) DVT/PE, established on anticoagulant therapy given) 2
d) Major surgery with prolonged immobilization 2

Ischemic heart disease

(current or history of) or stroke (history of CVA) 4 I* 2; C 3
Complicated valvular heart disease 4 1
Headaches
a) Non-migranous (mild or severe) *I 1; C 2 *I 1: C 1
b) Migraine without aura (age <35 years) *I 2; C 3 *I 1; C 2
c) Migraine without aura (age ≥35 years) *I 3; C 4 *I 1; C 2
d) Migraines with aura (at any age) *I 4; C 4 *I 2; C 3
PID/STIs
a) Current purulent cervicitis or chlamydial infection or 1 (in all 1 (in all
gonorrhoea conditions conditions
b) Other STIs (excluding HIV and hepatitis) given) given)
c) Vaginitis (including Trichomonas vaginalis and bacterial
vaginosis)
d) Increased risk of STIs
HIV/AIDS 1 (in all 1 (in all
a) High risk of HIV conditions conditions
b) Asymptomatic or mild HIV clinical disease (WHO stage given) given)
1 or 2)
c) Severe or advanced HIV clinical disease (WHO stage 3
or 4)
Antiretroviral Therapy
a) Nucleoside reverse transcriptase inhibitors (NRTIs): 1 1
Abacavir/Tenofovir/Zidovudine/Lamivudine/
Didanosine/Emtricitabine/Stavudine
b) Non-nucleoside reverse transcriptase inhibitors (NNRTIs) 1 for ETR and 1 for ETR and
Etravirine (ETR) RPV RPV
Rilpivirine (RPV) 2 for EFV and 2 for EFV and
Efavirenz (EFV) NVP NVP
Nevirapine (NVP)
c) Protease inhibitors (PIs)
2 2
Ritonavir-boosted atazanavir (ATV/r)
Ritonavir-boosted lopinavir (LPV/r)
Ritonavir-boosted darunavir (DRV/r)
Ritonavir (RTV)

*I= Initiation; C= Continuation

66
 Condition Combined Oral Progestin Only
Contraceptives Pills (POPs)
(COCs)
d) Integrase inhibitors 1 1
Raltegravir (RAL)
Unexplained vaginal bleeding 2 2
Cancers
b) Cervical 2 1
c) Endometrial 1 1
d) Ovarian 1 1
Breast disease
a) Undiagnosed mass 2 2
b) Current cancer 4 4
c) Past, no evidence of current disease for last 5 years 3 3
Tuberculosis (pelvic and non-pelvic) 1 1
Diabetes
a) H/o gestational diabetes 1 1
b) Nephropathy/retinopathy/neuropathy 3/4 2
c) Diabetes for >20 years 3/4 2
Symptomatic gall bladder disease (current or medically 3 2
treated)
Hepatitis
a) Acute or flare 4 1
b) Chronic or client is carrier 1 1
Cirrhosis
a) Mild 1 1
b) Severe 4 3
Drug interactions
a) Rifampicin or rifabutin 3 3
b) Anticonvulsant therapy 3 3

* I = Initiation, C = Continuation

The table below shows the MEC for EC Pills

Condition COC Progestin only Ulipristal acetate

Pregnancy ECP use is not applicable
Breastfeeding 1 1 2
Past ectopic pregnancy 1 1 1
Obesity 1 1 1
H/O severe cardiovascular disease 2 2 2
Migraine 2 2 2
Severe liver disease (including jaundice) 2 2 2

67
Condition COC Progestin only Ulipristal acetate
CYP3A4 inducers (e.g. rifampicin, 1 1 1
phenytoin, phenobarbital, carbamazepine,
efavirenz, fosphenytoin, nevirapine,
oxcarbazepine, primidone, rifabutin, St
John’s wort/Hypericum perforatum)
Repeated ECP use 1 1 1
Rape 1 1 1

Medical Eligibility Criteria for Centchroman (Ormeloxifene):

� Women with following conditions should not use Centchroman (Ormeloxifene):
yy Polycystic ovarian disease
yy Cervical hyperplasia
yy Recent history of clinical evidence of jaundice or liver disease
yy Severe allergic states, chronic illnesses such as tuberculosis, renal disease
� Centchroman (Ormeloxifene) possesses no effect on platelet aggregation, lipid profile and HDL
cholesterol.
� Centchroman (Ormeloxifene) can be safely used by lactating mothers.

68
 Annexure Checklist: Family Planning Counselling
(4.1)

(To be used for practicing and assessment of the FP counselling skill)

This checklist is for counselling woman/couple at any time on various methods of family planning.

Place a “” in case box if step/task is performed satisfactorily, an “X” if it is not performed
satisfactorily or N/O if not observed.

Satisfactory: Performs the step or task according to the standard procedure or guidelines

Unsatisfactory: Unable to perform the step or task according to the standard procedure or guidelines

Not Observed: Step or task not performed by participant during evaluation by trainer

Participant ________________________________________Date of Observation ____________________

(Some of the following steps/tasks should be performed simultaneously)

STEP/TASK CASES
Preparation for Counselling 1 2 3 4 5 Comments
1. Ensures room/counselling corner is well lit and there is
availability of chairs and table.
2. Prepares equipment and supplies.
3. Ensures availability of writing materials and job-aids
(eg. client file, daily activity register, FP job-aids, client
education material, flip book).
4. Ensures privacy.
SKILL/ACTIVITY PERFORMED SATISFACTORILY
General Counselling Skills
5. Greets the woman with respect and kindness. Introduces
self.
6. Uses body language to show interest in and concern for the
woman.
7. Asks the woman the purpose of her visit. Reassures the
woman that the information in the counselling session will
be confidential.
8. Tells the woman that this session is going to help client to
take decision on her own as per her needs and for ensuring
good health for woman and her children (if any). Responds
to the woman’s questions/concerns.
9. Uses language that the woman can understand.
10. Discusses the health benefits to mother and baby of waiting
at least two years after the birth of her last baby before she
tries to conceive again.

69
STEP/TASK CASES
General Counselling Skills 1 2 3 4 5 Comments
11. Rules out pregnancy by asking the 6 questions to be
reasonably sure that the woman is not pregnant
yy Have you had a baby in last 4 weeks
yy Did you have a baby less than 6 months ago? If so, are
you fully or nearly fully breastfeeding? Have you had
no monthly menstrual bleeding since giving birth?
yy Have you abstained from sexual intercourse since your
last menstrual period or delivery?
yy Did your last menstrual period start within past 7 days
(or 12 days if you plan to use IUCD)?
yy Have you had a miscarriage or abortion in the last 7
days?
yy Have you been using a reliable contraceptive method
consistently and correctly?
(If client’s response to any of the above question is “Yes”
and she is free of signs and symptoms of pregnancy,
pregnancy is unlikely.)
12. Displays the counselling kit/flip book page/samples of
contraceptives showing all the FP methods and
yy If client has a method in mind, provides method specific
counselling on that method.
yy If client does not have any specific method in mind,
asks the following 4 questions and eliminates methods
according to client’s response:
i. Do you want more children in the future?
(If yes, does not discuss male and female sterilization)
ii. Are you breastfeeding an infant of less than 6 months
old?
(If yes, does not discuss combined oral contraceptive
pills)
iii. Will your partner use condoms?
(If yes, discusses about condoms. Also, irrespective of
client’s response, assesses woman’s risk for STIs and
HIV and explains that condoms are the only method
that can protect from STI and HIV)
iv. Have you not tolerated an FP method in the past?
(If yes, asks which method. Does not discuss the
method used if the problem experienced was really
related to the method)

70
STEP/TASK CASES
General Counselling Skills 1 2 3 4 5 Comments
13. Briefly provides general information about those
contraceptive methods that are appropriate for woman
based on her facts to questions asked in step 12.
yy How to use the method
yy Effectiveness
yy Common side effects
yy Need for protection against STIs including HIV/AIDS
14. Clarifies any misconception the woman may have about
family planning methods.
15. Asks which method interests the woman. Helps the woman
choose a method.
Method-Specific Counselling – once the woman has chosen a method, please provide method specific
counselling for the method chosen (Please refer to checklists for method specific counselling of oral
contraceptives 4.2, 4.3, 4.4)

71
 Annexure Checklist: Method Specific Counselling on
(4.2) Combined Oral Contraceptives (COCs)

(To be used for practicing and assessment of the method specific contraceptive counselling skill on
COCs)

This checklist is for counselling woman/couple at any time on combined oral contraceptives.

Place a “” in case box if step/task is performed satisfactorily, an “X” if it is not performed
satisfactorily or N/O if not observed.

Satisfactory: Performs the step or task according to the standard procedure or guidelines

Unsatisfactory: Unable to perform the step or task according to the standard procedure or guidelines

Not Observed: Step or task not performed by participant during evaluation by trainer

Participant __________________________________________Date of Observation ____________________

(Some of the following steps/tasks should be performed simultaneously)

STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
1. Ensures that client has chosen COC voluntarily after getting
information on various contraceptive options
2. Ensure that the client is not pregnant (Annexure 2)
3. For assessing the medical eligibility of clients for COC,
provider asks questions to ensure that the following
conditions are not present, in which COC cannot be used
by the woman:
yy Breastfeeding her baby less than 6 months of age.
yy Smoking cigarettes and more than 35 years of age.
yy Breast cancer.
yy Stroke, blood clot in legs or lungs or heart attack.
yy Repeated severe headaches, often on one side and/or
pulsating, causing nausea and which are made worse by
light, noise or movement
yy Taking any pills for tuberculosis (TB) or seizures (Fits)
regularly
yy Gall bladder disease or serious liver disease or jaundice
yy High blood pressure
yy Diabetes
yy Two or more conditions that could increase the chances
of a heart attack or stroke, such as smoking, obesity or
diabetes

72
STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
4. If client is eligible for COC, tells the woman following points
about the COC:
yy How to take pills and what to do if she misses the pills
yy How does it work
yy Effectiveness
yy Advantages
yy Disadvantages including side effects
yy When to come for follow up- (The client can come back
any time-……………..)
5. Provides the packets of COC
6. Asks to repeat the instructions:
yy How to use the method
yy Side effects
yy When to get the next supply of the pills (before her pills
are finished)
7. Asks and responds, if the she has any questions or concerns.
8. Records the relevant information.
Information on Other Services
9. Educates the woman about prevention of STIs and HIV/
AIDS. Informs her that COC does not protect from STIs
including HIV/AIDS.
10. Using information collected in earlier steps, determines
client’s needs for postpartum, newborn and infant care
services.
yy If client reported giving birth recently, discuss or refer
for postpartum care, newborn care
yy For clients with children less than 5 years of age, discuss
and arrange or refer for immunizations and growth
monitoring services
SKILL/ACTIVITY PERFORMED SATISFACTORILY
Follow-up Counselling
1. Greets the woman and asks her the purpose of visit
2. Checks whether the woman is satisfied with the method and
is still using it.
3. Asks if she has any questions, concerns or problems with
COC.
4. Explores changes in the woman’s health status or lifestyle that
may mean she needs a different family planning method.

73
STEP/TASK CASES
Follow-up Counselling 1 2 3 4 5 Comments
5. Reassures about side effects.
6. Refers to the doctor for any physical examination, if needed.
7. Schedules return visit for providing more pills before supply
finishes

74
 Annexure Checklist: Method Specific Counselling on
(4.3) Progestin-Only-Pills (POPs)

(To be used for practicing and assessment of the method specific contraceptive counselling skill on
POPs)

This checklist is for counselling woman/couple at any time on POPs.

Place a “” in case box if step/task is performed satisfactorily, an “X” if it is not performed
satisfactorily or N/O if not observed.

Satisfactory: Performs the step or task according to the standard procedure or guidelines

Unsatisfactory: Unable to perform the step or task according to the standard procedure or guidelines

Not Observed: Step or task not performed by participant during evaluation by trainer

Participant __________________________________________Date of Observation ____________________

(Some of the following steps/tasks should be performed simultaneously)

STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
1. Ensures that client has chosen POPs voluntarily after getting
information on various contraceptive options
2. For assessing the medical eligibility of clients for POPs,
provider asks questions to ensure that the following
conditions are not present, in which POPs cannot be used
by the woman:
yy Jaundice/Cirrhosis of liver/liver infection/ liver tumour
yy Blood clot in her legs or lungs
yy Client taking medication for seizures
yy Client taking Rifampicin/Rifabutin for tuberculosis
yy Breast cancer or history of breast cancer
3. If the client is eligible for POPs, tells the woman following
points about the POPs:
yy How to take pills and what to do if she misses pills?
yy How does it work?
yy Effectiveness (Explains the woman that the breastfeeding
increases the effectiveness of POPs)
yy Advantages
yy Disadvantages including side effects especially
unscheduled bleeding.
4. Provides the packets of POPs

75
STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
6. Asks and responds if she has any questions or concerns
7. Records the relevant information
Information on Other Services
8. Educates the woman about prevention of STIs and HIV/
AIDS Informs her that POPs do not protect from STIs
including HIV/AIDS
9. Using information collected in earlier steps, determines
client’s needs for postpartum, newborn and infant care
services
yy If client reported giving birth recently, discuss or refer for
postpartum care, newborn care
yy For clients with children less than 5 years of age, discuss
and arrange or refer for immunizations and growth
monitoring services
SKILL/ACTIVITY PERFORMED SATISFACTORILY
Follow-up Counselling
1. Greets the woman and asks her the purpose of visit
2. Checks whether the woman is satisfied with the method and
is still using it. Asks if she has any questions, concerns or
problems with the method.
3. Explores changes in the woman’s health status or lifestyle
that may mean she needs a different family planning method
4. Reassures the woman about side effects especially menstrual
changes
5. Refers to the doctor for any physical examination, if needed
6. Schedules return visit for providing more pills before supply
finishes

76
 Annexure 4 Checklist: Method Specific Counselling on
(4.4) Centchroman (Ormeloxifene)

(To be used for practicing and assessment of the method specific contraceptive counselling skill on
Centchroman (Ormeloxifene))

This checklist is for counselling woman/couple at any time on Centchroman (Ormeloxifene).

Place a “” in case box if step/task is performed satisfactorily, an “X” if it is not performed
satisfactorily or N/O if not observed.
Satisfactory: Performs the step or task according to the standard procedure or guidelines
Unsatisfactory: Unable to perform the step or task according to the standard procedure or guidelines
Not Observed: Step or task not performed by participant during evaluation by trainer

Participant __________________________________________Date of Observation ____________________

(Some of the following steps/tasks should be performed simultaneously)

STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
1. Ensures that client has chosen Centchroman (Ormeloxifene)
voluntarily after getting information on various
contraceptive options. If the client is identified with a
medical condition in which hormonal contraceptives cannot
be started, she can start Centchroman (Ormeloxifene), if
she wants
2. For assessing the medical eligibility of clients for
Centchroman (Ormeloxifene), provider asks questions to
ensure that the following conditions are not present, in
which Centchroman cannot be used by the woman:
yy Polycystic ovarian disease
yy Cervical hyperplasia
yy Recent history of clinical evidence of jaundice or liver
disease
yy Severe allergic states
yy Chronic illness such as tuberculosis or renal disease
3. If client is eligible for Centchroman (Ormeloxifene), tells
the woman following points about the Centchroman
(Ormeloxifene):
yy How to take the pills and what to do if she misses the
pills
yy How does it work
yy Effectiveness
yy Advantages
yy Disadvantages including side effects

77
STEP/TASK CASES
Information on the Method 1 2 3 4 5 Comments
5. Asks the woman to repeat the instructions about Centchroman
(Ormeloxifene):
yy How to use the method
yy Side effects
yy When to get the next supply (before her pills are finished)
6. Asks and responds if the woman has any questions or
concerns
7. Record the relevant information
Information on Other Services
8. Educates the woman about prevention of STIs and HIV/
AIDS. Informs her that Centchroman (Ormeloxifene) does
not protect from STIs including HIV/AIDS
9. Using information collected in earlier steps, determines
client’s needs for postpartum, newborn and infant care
services.
yy If client reported giving birth recently, discuss or refer for
postpartum care, newborn care
yy For clients with children less than 5 years of age, discuss
and arrange or refer for immunizations and growth
monitoring services
SKILL/ACTIVITY PERFORMED SATISFACTORILY
Follow-up Counselling
1. Greets the woman and asks her the purpose of visit
2. Checks whether the woman is satisfied with Centchroman
(Ormeloxifene) and is still using it
3. Check whether the woman has missed any pill (Biweekly
schedule in first three months and once a week pill schedule
thereafter)
4. If yes show her the way of taking pill with help of an example
and discuss the way to remember.
5. Asks if she has any questions, concerns or problems with the
method
6. Explores changes in the woman’s health status or lifestyle
and offer her other methods if she has issues with current
method (compliance and bleeding)
7. Reassures and counsel about side effects
8. Refers to the doctor for any physical examination, if needed
9. Schedules return visit for providing more pills before supply
finishes

78
 HOW DOES HOW TO WHO CAN WHO SHOULD NOT USE EFFECTIVENESS LIMITATIONS/ FAILURE RATE
IT WORK USE THE USE THE THE METHOD AND BENEFITS SIDE EFFECTS
METHOD METHOD
yy Works by yy One pill to yy Women yy Breastfeeding women < 6 yy Highly effective, yy Must be taken (Expressed in no.
5.1

yy Preventing be taken and couples months postpartum. reversible, easy to every day. of pregnancies per
the release every day, who want yy Non-breastfeeding women < 3 use and safe for yy Require regular/ 100 women using
Annexure

of eggs from irrespective of an effective, weeks postpartum. most women. dependable the method over
the ovaries intercourse. reversible yy Regulate the supply. the first year)
method. yy Women who smoke >15 yy Perfect Use*:
(ovulation) yy After a pack cigarettes/day and ≥35 years old. menstrual cycle yy May cause
by of 28 pills yy Women and reduces 0.3
yy Women with the following side effects in
suppressing pills is over, of any age menstrual flow some women, yy Typical Use*: 8
follicle the next pack including conditions: (which is useful such as nausea,
stimulating needs to be adolescents yy Deep vein thrombosis (DVT) to anaemic headache,
hormone started from and women women) bleeding
yy Heart disease
(FSH) and next day itself, over 40 years yy Decrease the risk between menses
luteinizing without any of age. yy Bleeding disorders
of ovarian and or weight gain.
hormone break. yy Women yy Liver disease or tumours uterine cancer,
(LH). yy Do not protect
having yy Recurrent migraine benign breast against STIs
yy Preventing anaemia due headaches with focal disease and and HIV.
implantation. to heavy neurological symptoms incidence of acne.
menstrual yy Risk of
yy Causing yy Unexplained vaginal yy Do not interfere developing
thickening bleeding and with sexual
menstrual bleeding cardiovascular
of cervical intercourse. disease in
mucus, cramps. yy Breast cancer
yy Pelvic exam not women over 35
which makes yy Women with yy Currently taking mandatory before years of age and
it difficult for an irregular. anticonvulsants for use. who smoke.
sperm to pass menstrual epilepsy or Rifampicin for
through. cycle tuberculosis yy Immediate return
of fertility on
yy HIV positive However can also be used under discontinuation.
women, following conditions with expert
whether or advice:
not on ARV yy Women with hypertension (BP
140/90 or more)
yy Diabetes (advanced or long
standing) with vascular
Summary of Key Characteristics of COCs

problems or central nervous

system (CNS), kidney or visual
disease.

79
*Perfect use – when use is consistent and exact according to directions.
**Typical use – when use is not always consistent and correct.
80
HOW DOES HOW TO WHO CAN WHO SHOULD EFFECTIVENESS LIMITATIONS/ FAILURE RATE
IT WORK USE THE USE THE NOT USE THE AND BENEFITS SIDE EFFECTS
METHOD METHOD METHOD
yy Works by yy One pill to yy Who want yy History of breast yy Highly effective yy Effectiveness (Expressed in no. of
(5.2)

yy Thickening be taken an effective, cancer in breastfeeding decreases when pregnancies per 100
cervical every day reversible yy Acute blood clot women (99%), breastfeeding stops women using the
Annexure

mucus (this and at the method in deep veins of reversible, easy yy Require regular/ method over the first
blocks sperm same time. yy Breastfeeding legs. to use dependable supply year)
from meeting women yy Severe liver yy Can be started yy May cause side
an egg) (can start as soon after Breastfeeding women:
disease, infection effects in some yy Perfect Use*: 0.3
yy Preventing soon as after or tumor. childbirth women, such as
the release childbirth). yy Can be changes in bleeding yy Typical Use**: 1
yy Taking medicines
of eggs from yy Women of any for seizures. used while patterns including:
the ovaries age including breastfeeding yy Irregular/Prolonged yy Not breastfeeding
(ovulation) adolescents and yy Safe for most bleeding/ No women:
yy Thinning of women over 40 women bleeding yy Perfect Use*: 0.9
endometrial years of age.
yy Do not interfere yy Postpartum yy Typical Use**: 3-10
lining yy Women just with sexual Amenorrhoea
after abortion, intercourse may be prolonged
miscarriage in breastfeeding
or ectopic yy Can be provided
by trained non- women
pregnancy.
medical staff yy Some may have
yy Women having side effects like
anaemia. yy Immediate return
of fertility on headaches, dizziness,
yy Women, who discontinuation mood changes,
have varicose breast tenderness,
veins. abdominal pain,
yy HIV positive nausea
women, yy Other possible
whether or not change- In non-
on ARV. breast feeding
women, ovarian
follicle may be
enlarged.
Summary of Key Characteristics of POPs

yy Do not protect
against STIs, HIV
*Perfect use – when use is consistent and exact according to directions.
**Typical use – when use is not always consistent and correct.
 HOW DOES IT HOW TO WHO CAN WHO SHOULD EFFECTIVENESS AND LIMITATIONS/ FAILURE
WORK USE THE USE THE NOT USE THE BENEFITS SIDE EFFECTS RATE
METHOD METHOD METHOD
yy Works by yy One tablet yy Women Women with yy Highly Safe and effective, yy Require (Expressed in no.
(5.3)

creating (30 mg) who want yy Polycystic ovarian non-steroidal non-hormonal regular/ of pregnancies
asynchrony twice a week an effective, disease. reversible method dependable per 100 women
Annexure

between on fixed reversible yy Cervical yy Easy to use orally twice a week supply using the
developing days for 3 method. hyperplasia. for first three months and once yy Prolongation of method over the
zygote and months (for yy Women who a week thereafter menstruation first year)
endometrial instance, if yy Recent history of yy PerfectUse*:
want oral clinical evidence yy Can be used safely by lactating cycle in some
maturation one takes the contraception women 1.63
leading to first pill on a of jaundice or liver mothers
but not disease. yy Do not protect
prevention of Sunday, she hormonal pills. yy Safe for most women. Free
implantation should take yy Severe allergic from side effects commonly against STIs
(Asynchrony the second yy Women states, chronic associated with hormonal oral and HIV
in the form of one on who are illnesses such as contraceptives (such as nausea,
slight increase Wednesday). breastfeeding. tuberculosis, renal dizziness, weight gain, etc.)
in transport of From the yy Women of any disease etc. yy Does not interfere with sexual
zygote through 4th month age including intercourse
oviducts, onwards, adolescents and
acceleration only one women over 40 yy Can be started without a
of Blastocyst tablet once years of age. pelvic examination. it can be
formation and a week.(first provided by trained health
yy Women having provider
suppression of day of week
anemia.
endometrial i.e. Sunday yy Immediate return of fertility on
proliferation in the given yy Women just discontinuation
and example) after abortion,
decidualization) miscarriage yy Has no effect on platelet
It does not or ectopic aggregation, lipid profile and
Centchroman (Ormeloxifene)

alter basal or pregnancy. HDL cholesterol.

peak FSH/LH yy HIV positive yy No teratogenic effect.
levels and also women, yy Effective in managing
no effect on
Summary of Key Characteristics of

whether or not dysfunctional uterine bleeding

the production on ARV.
of estrogen or yy Can prevent breast cancers,
progesterone. uterine cancers and protection
against demineralisation of
bone.

81
*Perfect use – when use is consistent and exact according to directions.
82
HOW DOES IT HOW TO WHO CAN WHO SHOULD EFFECTIVENESS LIMITATIONS/ FAILURE RATE
WORK USE THE USE THE NOT USE THE AND BENEFITS SIDE EFFECTS
METHOD METHOD METHOD
yy Action of ECP yy To be taken yy All women yy There are no yy Moderately yy Possibility of (Expressed in no.
(5.4)

depends on the time as soon as who have had medical conditions effective, if taken side effects of pregnancies per
in the menstrual cycle possible unprotected that make ECPs within 3 days of like nausea, 100 women using
Annexure

when the intercourse or within intercourse/ unsafe for any unprotected sex/ vomiting, the method over
has occurred and 3 days) of accidental act woman. accidental act headache, the first year)
when ECP is taken. unprotected for any reason. yy Pregnant women yy 1-3% women dizziness, yy If 100 women
yy ECP causes intercourse yy Women should not use may still conceive fatigue each had
inhibition or delay Taking who are ECP, however if despite taking and breast unprotected
of ovulation when it sooner contraindicated accidentally taken ECP tenderness. sex once in
used prior to is more for hormonal it will not cause These side menstrual cycle,
ovulation. effective. contraceptive abortion. effects generally yy With no
can take ECP do not last more ECPs, eight
yy It also acts by than few hours
thickening of can become
cervical mucus yy Next menstrual pregnant
resulting in bleeding may be yy With Progestin-
trapping of earlier or later only ECP, one
sperms, direct than expected in can become
inhibition of some women pregnant
fertilization, yy It does not yy With Combined
histological and provide estrogen-
biochemical contraception progestin ECPs,
alterations in from subsequent two can become
the dometrium, unprotected pregnant
alteration in the intercourse
transport of egg, yy Does not protect
sperm or embryo, against STIs and
interference with HIV
corpus luteum
function and
Summary of Key Characteristics of

luteolysis.
yy EC is not effective
Emergency Contraceptive Pills (ECPs)

once the process of

implantation has
begun.
 Annexure 6 Frequently Asked Questions (FAQs) and
Clarifying Misconceptions

Responding to common queries asked about oral contraceptives by clients and clarification of
misconceptions are essential in improving acceptability of these important family planning methods
for many women. Providers should try to respond to clients’ queries and correct misconceptions
through counselling.

A. Questions and Answers (Correcting Common Misconceptions) about COCs

Question 1: Should I take “rest” from COCs after taking them for some time?
Answer: No, taking rest is not needed. In fact, taking a “rest” from COCs can lead to unintended
pregnancy. COCs can be used for many years without having to stop them periodically.

Question 2: Will the COCs make me infertile, after I stop taking them? Or, How long will I take to
become pregnant, after stopping COCs?
Answer: A woman is protected from pregnancy as long as she takes the pill regularly. Women who
stop using COCs can become pregnant quickly. It only takes 1 to 3 months for woman’s
fertility to come back to normal after stopping the pill.

Question 3: Do COCs cause abortion?

Answer: No, COCs do not disrupt an existing pregnancy. They should not be used to try to cause an
abortion. They will not do so.

Question 4: Getting pregnant while on the pill will lead to birth defects?
Answer: A baby will not have birth defects if a woman becomes pregnant while on pills or accidentally
starts to take COCs, when she is already pregnant.

Question 5: Will the pill make me gain weight?

Answer: Most women do not gain or lose weight due to COCs. Weight changes naturally as life
circumstances change and as people age. 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 in this way.

Question 6: Will the pill change my mood or sex drive?

Answer: Although some women often blame the pill for mood swings, depression-like symptoms
and irritability, studies have found no evidence that COCs affect woman’s sexual behavior.
Majority of COC users do not report any such change, however, some women report that
both mood and sex drive improve.

Question 7: Will COCs increase the chances of cancer?

Answer: COCs actually reduces the risks of ovarian cancer and endometrial cancer. In addition,
there is a greater decrease in ovarian cancer risk in people who use the pill longer. Although
some studies show breast cancer slightly more common in women using COCs and those
who had used COCs in the past 10 years than among other women. It is possible that the
breast cancers were already there before COC use but were found sooner in COC users.

83
B. Questions and Answers (Correcting Common Misconceptions) about POPs
Question 1: Are POPs safe for me, as I am breastfeeding my child?
Answer: Yes, this is a good choice for a breastfeeding mother who wants to use pills. POPs are safe
for both the mother and the baby, starting as early as possible after giving birth. They do
not affect milk production. They do not cause diarrhea in baby.

Question 2: Can I continue taking POPs, when I stop breastfeeding my baby?

Answer: A woman who is satisfied with using POPs can continue using them when she has stopped
breastfeeding. However, she can switch to another method if she wishes.

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

Question 4: How long does it take to become pregnant after stopping POPs?
Answer: POPs do not delay the return of a woman’s 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.

Question 5: I did not have my monthly bleeding and I am on POPs, does this mean that I am
pregnant?
Answer: Probably not, especially if a woman is breastfeeding. 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

Question 6: Do POPs cause cancer?

Answer: No, only a few studies are available on POPs and cancer. Studies of Injectable (used in other
countries), which contain similar hormones, have not shown any increased risk of cancer.
(Refer Reference Manual for Injectable Contraceptive (DMPA))

Question 7: Will the pill change my mood or sex drive?

Answer: Generally, no. some women using POPs report these complaints. The great majority of
POP users do not report any such changes, It is difficult to tell whether such changes are
due to the POPs or to other reasons. There is no evidence that POPs affect women’s sexual
behavior.

Question 8: Do POPs increase the risk of ectopic pregnancy?

Answer: No, still, ectopic pregnancy can be life-threatening, so a provider should be aware that
ectopic pregnancy is possible if POPs fail.

C. Questions and Answers (Correcting Common Misconceptions) about Centchroman

(Ormeloxifene)
Question 1: Is Centchroman (Ormeloxifene) safe for me, as I am breastfeeding my baby?
Answer: Yes, this is a good choice for a breastfeeding mother who wants to use pills. It is a non-
hormonal, non-steroidal pill and safe for breastfeeding mothers.

Question 2: Does Centchroman (Ormeloxifene) cause birth defects? Will the foetus be harmed if a
woman becomes pregnant (method failure), while on Centchroman (Ormeloxifene)?
Answer: Centchroman (Ormeloxifene) does not cause congenital anomalies and babies born to user
failures present normal milestones.

84
Question 4: Will Centchroman (Ormeloxifene) cause any serious side effect?
Answer: Apart from prolongation of menstruation cycle in some women, intake of this non-hormonal
contraceptive pill, is not known to cause any side-effect, such as nausea, weight gain, fluid
retention, hypertension etc commonly seen with other combined Oral Contraceptives

Question 5: Does Centchroman (Ormeloxifene) cause vaginal discharge, spotting, breakthrough

bleeding or menorrhagia?
Answer: No. Centchroman (Ormeloxifene) does not cause vaginal discharge, spotting, breakthrough
bleeding or menorrhagia.

Question 6: Does Centchroman (Ormeloxifene) cause any abnormal change in my genital tract?
Answer: No. Centchroman (Ormeloxifene) does not cause any abnormal change of female genital
tract (vagina, cervix, uterus and ovaries).

D. Questions and Answers (Correcting Common Misconceptions) about EC pills

Question 1: Do ECPs cause abortion?
Answer: No. ECPs do not work if implantation has occurred or a woman is already pregnant. .
ECPs do not cause abortion.

Question 2: Do ECPs cause birth defects? Will the fetus be harmed if a woman accidentally takes
ECPs while she is pregnant??
Answer: No. evidence shows that ECPs will not cause birth defects and will not in anyway harm
the fetus if a woman is already pregnant when she takes ECPs or if ECPs fail to prevent
pregnancy.

Question 4: How long do ECPs protect a woman from pregnancy?

Answer: ECPs only protect the women from current unprotected sex.

Question 5: Are ECPs safe for adolescents?

Answer: 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.

Question 6: Can a woman who cannot use combined (estrogen-progestin) oral contraceptives or
progestin-only pills as an ongoing method still safely use ECPs?
Answer: Yes. This is because ECP is for a brief duration.

Question 7: If ECPs failed to prevent pregnancy, does a woman have a greater chance of that
pregnancy being an ectopic pregnancy?
Answer: No. There is no evidence 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.

Question 8: Can ECPs be used as a regular method of contraception?

Answer: No, they are meant for emergency use only. Nearly all other contraceptive methods are
more effective in preventing pregnancy than ECP, however if a women has failed to initiate
a regular method she can use again without any medical side effects

Question 9: If a woman buys ECPs over the counter, can she use them correctly?
Answer: Yes. Taking ECPs is simple and medical supervision is not needed. Studies show that young
and adult women find the label and instructions easy to understand. ECPs are approved
for over-the-counter sales or nonprescription use in many countries including India.

85
 Annexure 7 Role Play and Case Studies

7.1 Role Play

In a role-play two or more individuals enact parts in a scenario related to a training topic. The
role-play technique allows participants to ‘play’ the role of one or more individuals in a real
life situation. The role-play directly involves the individuals in the training session. When the
role-play involves situations that individuals are likely to encounter, the methods can build self-
confidence in training situation hence are better prepared to deal with such incidents.

Since participants have a chance to put themselves in the other person’s position. By doing so,
they can empathize and at the end of the exercise is typically a practical doable answer and a
real world solutions. It provides an opportunity for learners to see how others might feel/behave
in a given situation helps to change participant’s attitude and enables participants to see the
consequences of their actions on others. It is stimulating and fun. It engages the group’s attention
and simulates the real world.

The role-play is not without its disadvantages as it is done in an unreal or artificial atmosphere
and some participants may have difficulty visualizing themselves in an imaginary situation. The
trainees may feel very uncomfortable portraying any type of role. Without proper knowledge
and understanding in advance, the role-play is nothing more than a game. This method is much
more time consuming than other types of training. Role-plays may be made more effective if the
participants are given time to prepare.

7.2 Process of Conducting Role Play

Select any three participants for the role play – one to enact the role of a ‘client’, another as a
‘counsellor’ and the third person to be the ‘observer’. Select any of the sample role plays to be
enacted out from the options given below. Prepare the participants to understand the situation
and their respective roles, allowing only the ‘client’ to read through the case study.

Arrange the stage for optimal viewing and ensure that actors speak loudly and clearly. The
‘counsellor’ should enact the situation by assisting the client in the decision making process.
Respect, care, honesty and confidentiality should be emphasized and form the basis of the
interaction with the client.

The appointed ‘observer’ should share their observations about the role play which has been
enacted. Thank the actors and ask for their feedback. Finally ask the audience for their observations
of the role play and highlight the key principles as evinced from the play.

7.3 Sample role plays are given below.

Counselling of Client

7.3.1 Role Play - 1

A 20 year old lactating woman wants to postpone her next pregnancy. Her sister uses
some pills and she likes that method very much. Client says she wants to use that type of
pill. The health provider counsels her.

86
 7.3.2 Role Play – 2
A 24 year old women comes to see her service provider because she has heavy menstrual
periods lasting for 7-8 days each month. She feels run down since birth of her last child.
She has two children, a boy of 7 months and a daughter of 3 years. She has never used a
contraceptive method and she and her husband want to have one more child. The health
provider counsels the couple.

Switching Methods

7.3.3 Role Play – 3

A young couple, woman age 18 years and the man age 22 years, married for 7 weeks come
to see the FP Service provider because they want to postpone their first child until they
both complete their university studies in two years. They are currently using condoms
but neither like this method. She has heard about that some pills are available and wants
to use them. Her husband is against this as he has heard that it could cause his wife to
become sterile. The health provider counsels the couple.

7.3.4 Role Play – 4

A 41 year old woman with three teen age boys and one 6 months year old girl (who was
a surprize baby following removal of an IUCD) wants contraceptive protection. She has
used an IUCD in the past but had it removed because of heavy bleeding, cramping and
pain. She is afraid and absolutely refuses to consider a tubectomy or IUCD. She has heard
that she is too old to take the contraceptive pills. How health provider will respond?

7.4 Case Study

A case study is a written description of a hypothetical situation that is used for analysis, discussion,
and problem solving. It can be used to discuss common problems in a typical situation. It provides
a safe opportunity to develop problem-solving skills and promote group discussion and group
problem-solving.

The case study is another important technique that trainers should become familiar with and
know how to use properly. The case study is an actual presentation, either written or verbal, of an
incident that either did or could happen in related areas.

After having read or being given the case, small groups typically spend a prescribed period of
time discussing it and its possible solutions fully. Since the case should be an incident of relevance
to the training situation, its “real world” application is obvious. The case study should be realistic
so that learner can relate to the situation .The trainers can select or write cases that are of relevance
and concern to the group at hand. If the case study does not reflect a real-life situation, trainees
may view the case as being too theoretical.

7.5 Process of Discussing Case Studies

• Introduce the case study
• Give the participants time to familiarize themselves with the case
• Present questions for the discussion or the problem to be solved
• Give participants time to solve the problem/s
• Have some participants present their solutions/answers
• Ask the participants what they have learned from the exercise
• Ask them how the case might be relevant to their own environment, to their job experience
• Summarize

87
7.6 SAMPLE OCP CASE STUDIES
Counselling of Client

7.6.1 Case Study – 1

A 23 year old men and her 19 year old wife six weeks post-partum brings their baby
for immunization. She is breast feeding the child. She uses this visit to ask how she can
prevent another pregnancy for a year or two. She would like to try OCPs but her husband
is not in favour of this because he believes it will harm the baby through the mother’s
milk.

Discussion Questions:
1. What will the health provider say to the couple regarding his belief that OCPs pills
will harm the baby?
2. Is Combined Oral Pill an appropriate method for this woman?
3. Is Centchroman (Ormeloxifene) pill or POP an appropriate method for this woman?
4. What guidance regarding the effectiveness, safety, advantages, disadvantages/possible
side effects health provider discuss with the couple.

7.6.2 Case Study – 2

A young married women age 20 years comes to the clinic and is accompanied with her
mother –in-law. She has two children under age 5. She wants to use the OCPs but her
mother-in-law is very much opposed to this because she has heard that the OCPs cause
cancer.

Discussion Questions:
1. How will the health provider responds to the mother-in-law with regard to the OCPs
causing cancer?
2. What will the service provider say regarding the effectiveness, safety, advantages,
disadvantages/possible side effects of OCPs available when dealing with woman and
mother-in-law?
3. What specific instructions will the health provider give in regards to the use of the
OCPs?

7.6.3 Case Study – 3

A young couple, woman age 20 and the man age 24, married for 2 months come to see
the FP Service provider because they were currently using condoms, but last night some
how during the sexual contact the condom bursts and they are afraid that this may result
in pregnancy. They absolutely want to postpone their first child for at least one year until
they both complete their studies. Now they do not want to use the condom.

Discussion Questions:
1. How will the health provider responds to their concern regarding getting pregnant?
2. What instructions will health provider give for use of ECPs?
3. What will service provider suggest regarding future postponement of pregnancy?
4. What will the service provider say regarding the effectiveness, safety, advantages,
disadvantages/possible side effects of methods?
5. What specific instructions will the health provider give in regards to the use of the
method?

88
 Annexure 8 Pre/Post-Test Questionnaire for OCPs

Name: Time: 15 min

Designation:
Place of posting:
Date:

Pretest/ Posttest (please encircle)

Please encircle most appropriate choice/choices. Please do not encircle more than one choice

1. What is the earliest time when breastfeeding women can start taking Progestin only Pills (POPs)
after delivery?
a. After 6 weeks postpartum
b. Immediately after giving birth
c. After 6 months postpartum
d. Cannot start POPs while breastfeeding

2. When can a breastfeeding woman start combined COCs?

a. Immediately after delivery
b. 3 weeks postpartum
c. 6 months postpartum
d. 6 weeks postpartum

3. The primary mechanism of action of the COCs is:

a. Preventing ovulation by suppressing FSH and LH
b. Destroying the ovum
c. Helping prevent implantation by suppressing development of the endometrium
d. Hampering sperm transport by thickening cervical mucus
e. Destroying the sperm

4. POPs may not be an appropriate choice for:

a. Women who have breast cancer
b. Women who are breastfeeding
c. Women who have estrogen related side effects from COCs
d. Women who are over 35 and smoke

5. Which is the most popular method of contraception used in India:

a. Condoms
b. Oral pills
c. Female sterilization
d. Intra Uterine Contraceptive Device

89
6. If a client forgets to take 1 pill of COC, she should:
a. Take the pill as soon as possible and continue taking rest of the pills as scheduled
b. Discard the forgotten pill
c. Take 2 pills as soon as she remembers
d. Start a new pack of pills

7. Advantages of the COCs include the facts that:

a. It is highly effective if taken correctly
b. It protects against HIV/AIDS
c. It protects against ovarian and endometrial cancer
d. It decreases risk of ectopic pregnancy
e. It protects against breast cancer

8. POPs can be given to women who:

a. Have unexplained vaginal bleeding
b. Have breast cancer
c. Are over 35 and smoke
d. Have high blood pressure

9. Which is true for combined pills

a. Increases hair on face and body
b. Not helpful in relieving symptoms of endometriosis
c. Helps protect against Iron Deficiency Anaemia
d. Increases risk of ovarian and endometrial cancers

10. Combined pills should not be used by

a. Women suffering from chronic head aches
b. Heavy smokers
c. Women having 3 month old child and breast feeding
d. All of the above

11. EC Pill is most effective when taken within __ hours of last unprotected sex
a. 72 hours
b. 96 hours
c. 120 hours
d. Any time till the expected date of next menstrual period

12. EC Pills contain

a. High dose oestrogens
b. Low dose oestrogens
c. High dose progestins
d. Low dose progestins

13. Dosage of Centchroman is

a. Once a week
b. Twice a week
c. Once a week for 12 weeks followed by twice a week from the 13th week onwards
d. Twice a week for 12 weeks followed by once a week from the 13th week onwards

90
14. Centchroman is composed of
a. Estrogen and progesterone
b. Synthetic progestin
c. Norethindrone enanthate
d. Synthetic estrogen
e. Ormeloxifene

15. Who should NOT take Centchroman?

a. Women breastfeeding their babies
b. Women with anemia
c. Women with varicose veins
d. Women with polycystic ovarian disease

16. Which of the following is advised, if a woman misses a Centchroman pill?

a. To take the missed pill as soon as possible
b. If pill is missed by less than 7 days, she should continue normal schedule and no need of back
up
c. If pill is missed by more than 7 days, woman needs to continue the usual schedule and back
up for 7 days is advised ,
d. All of the above

17. Informed written consent signed by client is required for providing

a. COC Pill
b. POP
c. Emergency contraceptive Pill
d. Injection DMPA
e. Centchroman
f. IUCD
g. All of the above
h. None of the above

18. Which of the following is advised, if a woman misses a Progestin Only Pill (POP) or is more
than 3 hours late?
a. Take the pill as soon as possible and continue taking rest of the pills as scheduled
b. Discard the forgotten pill
c. Start a new pack of pill
d. None of the above

19. In the National Family Planning Program EC pills are available as

a. 1 pill pack containing Levonorgestrol (1.5 mg per tablet)
b. 2 pill pack containing Levonorgestrol (0.75 mg per tablet)
c. Both a) & b)
d. None of the above

20. Which is not true for ECPs?

a. It is known as ‘morning after pills‘
b. It is known as ‘post-coital pill‘
c. It is taken within 72 hrs of unprotected intercourse.
d. It can be used as regular contraceptive method.

91
 Annexure Pre/Post-Test Questionnaire (Answers) for
8(a) OCPs

Name: Time: 15 min

Designation:
Place of posting:
Date:
Pretest/ Posttest (please encircle)
Please encircle most appropriate choice. Please do not encircle more than one choice

1. What is the earliest time when breastfeeding women can start taking Progestin only Pills (POPs)
after delivery?
a. After 6 weeks postpartum
b. Immediately after giving birth
c. After 6 months postpartum
d. Cannot start POPs while breastfeeding

2. When can a breastfeeding woman start combined COCs?

a. Immediately after delivery
b. 3 weeks postpartum
c. 6 months postpartum
d. 6 weeks postpartum

3. The primary mechanism of action of the COCs is:

a. Preventing ovulation by suppressing FSH and LH
b. Destroying the ovum
c. Helping prevent implantation by suppressing development of the endometrium
d. Hampering sperm transport by thickening cervical mucus
e. Destroying the sperm

4. POPs may not be an appropriate choice for:

a. Women who have breast cancer
b. Women who are breastfeeding
c. Women who have estrogen related side effects from COCs
d. Women who are over 35 and smoke

5. Which is the most popular method of contraception used in India:

a. Condoms
b. Oral pills
c. Female sterilization
d. Intra Uterine Contraceptive Device

92
6. If a client forgets to take 1 pill of COC, she should:
a. Take the pill as soon as possible and continue taking rest of the pills as scheduled
b. Discard the forgotten pill
c. Take 2 pills as soon as she remembers
d. Start a new pack of pills

7. Advantages of the COCs include the facts that:

a. It is highly effective if taken correctly
b. It protects against HIV/AIDS
c. It protects against ovarian and endometrial cancer
d. It decreases risk of ectopic pregnancy
e. It protects against breast cancer

8. POPs can be given to women who:

a. Have unexplained vaginal bleeding
b. Have breast cancer
c. Are over 35 and smoke
d. Have high blood pressure

9. Which is true for combined pills

a. Increases hair on face and body
b. Not helpful in relieving symptoms of endometriosis
c. Helps protect against Iron Deficiency Anaemia
d. Increases risk of ovarian and endometrial cancers

10. Combined pills should not be used by

a. Women suffering from chronic head aches
b. Heavy smokers
c. Women having 3 month old child and breast feeding
d. All of the above

11. EC Pill is most effective when taken within __ hours of last unprotected sex
a. 72 hours
b. 96 hours
c. 120 hours
d. Any time till the expected date of next menstrual period

12. EC Pills contain

a. High dose oestrogens
b. Low dose oestrogens
c. High dose progestins
d. Low dose progestins

13. Dosage of Centchroman is

a. Once a week
b. Twice a week
c. Once a week for 12 weeks followed by twice a week from the 13th week onwards
d. Twice a week for 12 weeks followed by once a week from the 13th week onwards

93
14. Centchroman is composed of
a. Estrogen and progesterone
b. Synthetic progestin
c. Norethindrone enanthate
d. Synthetic estrogen
e. Ormeloxifene

15. Who should NOT take Centchroman?

a. Women breastfeeding their babies
b. Women with anemia
c. Women with varicose veins
d. Women with polycystic ovarian disease

16. Which of the following is advised, if a woman misses a Centchroman pill?

a. To take the missed pill as soon as possible
b. If pill is missed by less than 7 days, she should continue normal schedule and no need of back
up
c. If pill is missed by more than 7 days, woman needs to continue the usual schedule and back
up for 7 days is advised,
d. All of the above

17. Informed written consent signed by client is required for providing

a. COC Pill
b. POP
c. Emergency contraceptive Pill
d. Injection DMPA
e. Centchroman
f. IUCD
g. All of the above
h. None of the above

18. Which of the following is advised, if a woman misses a Progestin Only Pill (POP) or is more
than 3 hours late?
a. Take the pill as soon as possible and continue taking rest of the pills as scheduled
b. Discard the forgotten pill
c. Start a new pack of pill
d. None of the above

19. In the National Family Planning Program EC pills are available as

a. 1 pill pack containing Levonorgestrol (1.5 mg per tablet)
b. 2 pill pack containing Levonorgestrol (0.75 mg per tablet)
c. Both a) & b)
d. None of the above

20. Which is not true for ECPs?

a. It is known as ‘morning after pills‘
b. It is known as ‘post-coital pill‘
c. It is taken within 72 hrs of unprotected intercourse.
d. It can be used as regular contraceptive method.

94
 Annexure 9 Evaluation of Training

Name------------------------------------------------------------------ Designation--------------------------------------------

Date---------------------------------------------------------------------District--------------------------------------------------

Put (√ ) in front of the your response

S. No. Item Excellent Very Good Satisfactory Poor

Good
1. Organization of the workshop
2. Subject matter covered
3. Duration of workshop
4 Effectiveness of facilitators
5 Overall evaluation of workshop

6. Please share with us the sessions you found most useful (include reasons why)

7. Please share with us the sessions that you found least useful (include reasons why):

8. Please share any suggestions on how to improve the workshop or a particular session?

95
9. Please share how you will be using the knowledge gained in workshop to include Oral Contraceptive
Services in your work place?

10. What support you will need to provide Oral Contraceptive Services in your work place?

11 Other Comments

96
 Annexure 10 Post Training Follow-up for OCPs

Instructions to trainer:
� Complete one form per trainee during follow up (Telephonic / Visit). Form has three parts: Part
I-General assessment, Part II-Clinical Performance Assessment and Part III-Action Plan
� At the end of assessment review gaps identified with trainee and share the actions recommended.

Part I: General Assessment

State: District: Facility Name:

Facility type Date of Training Date of follow up
No. of this Follow up 1 /2 /3
st nd rd

(Tick (√ ) one Choice)

Name of the person conducting follow up:
Designation of the person conducting follow up:
Name of the Trainee Designation:
For services that are being provided, what are the numbers of services/procedures that were
performed?
Procedure Last month Last quarter
Counseling
COC provision
POP provision
Centchroman (Ormeloxifene)
provision
ECP provision

If services are not provided what difficulties have prevented you? (Tick (√ ) response that applies)
1 Lack of confidence in skill
2 Service is not provided in the facility
3 Lack of demand or clients seeking for the service
4 Time constraint due to excess workload
5 Lack of supplies and equipment
6 Other (specify)
If services are provided, have you experienced any difficulties during service provision? If yes,
tick (√ ) accordingly
1 Shortage of Supplies
2 Low case load
3 High case load
4 Periodic stock out of supplies
5 Other (specify)

97
Part II:
Assessment of Clinical Performance: (applicable for follow up visit)

Following the observation of procedures and based on the corresponding observation checklist
(4.1/4.2/4.3/4.4)results, (in case a client is available) rate trainee’s performance by checking in the
appropriate box for each procedure.

Part III: Action Plan

Table below should be utilized by trainer for developing action plan based on gaps identified from
above assessment for remedial actions and share with the trainee.

Trainers Action Plan

S. No. Gaps identified Support required Timeline Remarks
1
2
3
4
5
Signature of the trainer

98
99
S
No
No. Name Age
Number

Children
ECR Client’s Client's of Living

Date
Apr

No. of cycles
Date
May

No. of cycles
Date
Jun

No. of cycles
Date
Jul

No. of cycles
Date
Aug

No. of cycles
Date
Sep

No. of cycles
Date
Oct

No. of cycles
Date
Nov

No. of cycles
Date
Dec

No. of cycles
Date
Jan

No. of cycles
Date
Number of cycles/strips distributed and date on which the cycle/strip was given to the client
Feb

No. of cycles
Date
Mar

No. of cycles
Home Delivery of Contraceptive Scheme
Annexure 11 Format of ASHAs Reporting under
 Facility Register for Contraceptive Distribution

100
Monthly ECR No./ Client’s Client’s Client’s No. of Last Type of contra-ceptive method preferred (Tick Quantity of Remarks
[Link] OPD No. Name Age Address living Child the appropriate option) contraceptive given
and Children Birth COCs Centchroman POPs Condom (Condom- write
Telephone number of pieces;
11A

(Mala N) (Ormeloxifene)
Number Oral Pills- write
Annexure

number of cycles/
strips)
Contraceptive Distribution
Format of Facility Register for
 Time Topics / Activities Session Plan Methodology/ Resource Materials
DAY 1: Morning
30 Minutes yy Introductions of yy Open course with welcome of participants by yy Prepared welcome sign
Participants organizers, lead trainers yy Flipchart and markers
yy Participants’ yy Facilitate the introductions of all participants and yy Name badges
Expectations, Group trainers.
Norms yy Explore participants’ expectations for the course by
brain storming. Brainstorm the norms to be followed
during workshop
20 Minutes yy Course Goal and yy Review the course goals and objectives; the course yy Flipchart with Course Objectives
Objectives design and expected outcomes. yy Copies of course agenda
yy Review the Course yy Review which expectations of participants can be met yy Training folder for each
Agenda, Components and which cannot be. participant, containing:
of the Training yy Review the course agenda, including starting and
Package and Course yy Reference Manual on Oral
ending times and times for breaks and lunch Contraceptives
Materials Given to
Participants. yy Review the materials to be used in the course and yy Job-aids
given to participants. Ensure that participants
understand the use of the different materials.
20 Minutes yy Pre Course Knowledge yy Distribute the Pre-Test Questionnaire to each yy Copies of Pre-Test Questionnaire
Assessment participant. one for each Participant
yy Assign a number to each participant and ask them to yy Small pieces of paper with
write the number on the Pre-Test sheet and remember numbers
the number till the end of the training. Ask them to
answer each question. Allow 20 minutes for the Pre-
Test Questionnaire.
Annexure 12 Course Outline and Session Plan for Training

101
102
Time Topics / Activities Session Plan Methodology/ Resource Materials
20 Minutes yy National Family yy Use the power-point slides to present information. yy PPT on Global use of oral
Planning Program and yy Ask questions to the participants and engage them in contraceptives in India; Inclusion
Need for Expanding the discussion on the updated information . of new oral contraceptives
Contraceptive Choice, in National Family Planning
Global Use of Oral yy Use the power point slides to present information on Program.
Contraceptives and in impact of pregnancy spacing on maternal, newborn
and child health. yy Sample of all contraceptives
the National Family
Planning Program
60 Minutes yy Technical Update yy Discuss Global evidence for use of oral contraceptives. yy Power point slides on POP
on Combined Oral yy Review Oral contraceptive usage in National FP yy Handouts of key characteristics
Contraceptives, Program. of different oral contraceptives
(Cocs), Progestin (COCs, POPs, ECPs)
Only Pills (Pops) yy Share Technical information including mechanism
& Emergency of action, effectiveness, who should use and who
Contraceptive Pills should not, advantage and limitations (side effects)
(EcPs) in participatory manner. Trainer may design some
questions on following.
yy Combined Oral Contraceptives (COCs)
yy Progestin Only Pills (POPs)
yy Emergency Contraceptive Pills (EC Pills)
At the end trainer may give handouts of Summary
of Key characteristics of COCs, POPs, ECPs for easy
reference.
 Time Topics / Activities Session Plan Methodology/ Resource Materials
30 Minutes yy Technical Update yy Share Technical information including mechanism of yy Power point slides on
on Centchroman action, effectiveness, who should use and who should Centchroman (Ormeloxifene)
(Ormeloxifene) not, advantage and limitations (side effects) in a yy handouts of key characteristics of
participatory manner. different oral contraceptives
yy Centchroman (Ormeloxifene) yy Reference Manual for Oral
yy Volunteers to share their answers on following points Contraceptive Pills
for each oral contraceptive method:
yy Mechanism of action
yy Contraceptive effectiveness
yy Benefits
yy Possible side effects
yy Limitations
yy Who should and who should not use the method
Tea: 15 minutes
45 Minutes yy Medical Eligibility yy Recap on how to use the MEC. yy MEC wheel
Criteria and Client yy Discuss from the reference manual what questions yy Client assessment for oral
Assessment for Oral need to be asked for screening clients for different oral contraceptives given in the
Contraceptives contraceptives. Reference Manual for Oral
yy Ask participants to collect one or two VIPP Contraceptive Pills
(Visualisation in Participatory Programme) cards per yy PowerPoint slides
person, without seeing what is written on the card/s. yy VIPP cards containing
Each card contains a name of a medical condition questions whether specific oral
and question asking specific oral contraceptive can be contraceptive can be given in the
given in this medical condition or not? given medical condition/s.
yy Now, ask the participants to write their answer on the
VIPP card by using the MEC wheel. Collect all the
cards. Ask participants to open the annexure of MEC
in reference manual on oral contraceptives.
yy Read out from VIPP card (without taking the name
of participant, who has written) what participant

103
has written and discuss the correct response for each
question.
104
Time Topics / Activities Session Plan Methodology/ Resource Materials
60 Minutes yy Counselling for OCPs yy Demonstrate a role-play on counselling with method yy Copies of counselling role-plays
specific counselling for different oral contraceptives. and Case studies
yy Project Role Play situation on FP counselling. Get yy Counselling checklists and
volunteers to enact in front of all the participants. Reference Manual for Oral
Remaining participants and trainer to observe the Contraceptive Pills
role-play through checklist and after the role-play,
facilitate a discussion about what was done well, what
was not done and what could be done differently.
yy Ask participants to observe the role-play through
checklist and after the role-play, facilitate a discussion
about what was done well, what was not done and
what could be done differently.
yy Trainer observes and uses the counselling checklist to
ensure that the counselling approach and technical
information discussed in the role-plays is accurate.
yy Should address client assessment issues.
yy 3 Case Studies: Divide participants into small groups
Give one case study (out of 3) to each group. Give 5-7
min to discuss case.
yy Trainer to discuss each case one by one and add when
necessary
yy End the session by emphasizing that for side effects,
reassurance and correct management can help clients
to continue using the method and decrease drop outs.
management of common side effects
30 Minutes yy Helping Continuing yy Recap the possible side effects/problems of each oral yy Power point slides
Users and Managing contraceptives
Side Effects and yy Discuss in detail how to manage them.
Problems of Oral
Contraceptives yy Synthesize the session by emphasizing the importance
of being able to manage side effects and complications
related to the use of oral contraceptives
 Time Topics / Activities Session Plan Methodology/ Resource Materials
Lunch: 45 Minutes
30 Minutes yy Addressing yy Facilitate questions and answers on misconceptions yy Quiz questions (or Quiz session
Misconceptions on on Oral contraceptives- COCs, POPs, Centchroman on computer)
Oral Contraceptives (Ormeloxifene), EC Pills yy Annexure in Reference Manual for
Oral Contraceptive Pills
45 Minutes yy Skill Practice yy Skill assessment of participants on counselling skills yy Counselling checklist
Using Checklist on by using skill assessment checklist for yy Method specific counselling
Counselling Skills yy FP checklist for COCs, POPs,
yy Method specific counselling on Oral contraceptives Centchroman (Ormeloxifene)
(COCs, POPs, Centchroman (Ormeloxifene))
30 Minutes yy Contraceptive yy Discuss data collection records maintenance yy Power point slides
Logistics and Record yy Share the samples of records yy Samples of clients’ cards and
Keeping for Oral record/register
Contraceptives yy Discuss how to fill them and report to higher
managers
yy Discuss how to procure and maintain stock of oral
contraceptives
20 Minutes yy Post Course yy Grade the Post-Test Questionnaire during the breaks yy Post-Test Questionnaire
Knowledge yy Use the answer sheets to prepare the Post-course
Assessment and Knowledge Matrix and then return the sheets.
Course evaluation
Formats yy Discuss the correct answers of the assessment
questions, for which some participants have written
incorrect responses.
yy Course Closure
yy Explain that the feedback of participants on the
course evaluation form is very important and it will
help in improving quality of future training on oral
contraceptives.
yy Have participants fill-out and submit the course
evaluation forms.
yy Closing remarks by training organizers.

105
106
List of Experts
Dr. Alok Banerjee Dr. B. P. Singh Dr. Ravi Anand
Technical Advisor President Director, Technical &
Parivar Sewa Sanstha Enable Health Society Operations
New Delhi New Delhi Abt Associates
New Delhi

Dr. Sunita Singal Dr. Saswati Das Dr. Vivek Yadav

Senior Clinical Advisor Director, Clinical Services and Associate Director
Engender Health Training Jhpiego Jhpiego
New Delhi New Delhi New Delhi

Dr. Abha Singh Dr. Suneeta Mittal Dr. Basab Mukherjee

Director & Professor Director and HOD, O & Chairperson, Family Welfare
Dept of Obstertric and GFortis Memorial Research Committee FOGSI
Gynaec Institute Kolkata, West Bengal
LHMC, New Delhi Gurgaon

Dr. Malabika Roy Dr. Bulbul Sood Dr. Jyoti Vajpayee

Scientist G & Head Country Director FP Head
ICMR Jhpiego BMGF
New Delhi New Delhi New Delhi

Dr. Brinda Frey Dr. Loveleen Johri Dr. Vasanthi Krishnan

Director Clinical Services Senior Health & Policy Project Director
Engender Health Advisor Comprehensive Contraceptive
Lucknow Department of Health and Care Project IPAS, New Delhi
Human Services, New Delhi

Dr. Shubhra Phillips Dr. Jyoti Sachdeva Dr. Minati Rath

Country Director Programme Officer Senior Clinical Officer
PCI New Delhi Jhpiego
New Delhi New Delhi

Dr. Pratima Mittal Dr. Ashim Ghatak Dr. Rupali Dewan

HOD, Dept. of O & G Chief Scientist & Head Dept. of O & G
Safdarjang Hospital CSIR- CDRI, Lucknow Safdarjang Hospital
New Delhi New Delhi

Dr. Rashmi Kukreja Dr. Rajkumar Dr. Shikha Srivastava

Health Advisor Programme Officer Advisor Technical Services
DFID Karnataka PSI
New Delhi Lucknow

Dr. Roli Seth Dr. Ajit K Mohanty Dr. Anita Verma

Deputy Director (CBQA) State Programme Officer CMO, NFSG
Abt Associates Odisha Family Welfare
Lucknow RML Hospital, New Delhi

Dr. S R Kulkarni Dr. Teja Ram Dr. S. K. Sikdar

Scientiest DC, FP DC, FP (I/C)
CSIR- CDRI MOHFW MOHFW
Lucknow

109
Support Extended By

Dr. Nidhi Bhatt Ms. Shilpa John Mr. Nadeem Akhtar Khan
Program Officer Consultant Program Manager
NTSU, FP FP Division NTSU, FP
MoHFW MoHFW MoHFW

Dr. Pragati Singh Ms. Shikha Bansal Dr. Upasna Naik

Lead Consultant Program Officer Program Officer
FP Division NTSU, FP NTSU, FP
MoHFW MoHFW MoHFW

110
March 2016
Family Planning Division
Ministry of Health and Family Welfare
Government of India