Handbook On Medical Methods Of Abortion
Handbook onMedical Methods ofAbortionby Government of Madhya Pradesh and Ipas to expandaccess to new technologies for safe abortion2013MMA Reference Manual.indd 105/07/13 5:56 PM
About IpasIpas works globally to increase women's ability to exercise their sexual and reproductive rights and toreduce abortion-related deaths and injuries. We seek to expand the availability, quality and sustainabilityof abortion and related reproductive health services, as well as to improve the enabling environment.Ipas believes that no woman should have to risk her life or health because she lacks safe reproductivehealth choices.Ipas India program, established in 2001, is partnering with 11 state Governments in advancing women'saccess to safe abortion services through strengthening of training systems; establishing service deliveryin primary health-care settings; promoting early abortion technologies such as MVA (Manual VacuumAspiration) and MMA (Medical Methods of Abortion); conducting research on abortion issues; andadvocating for policies that support women's health and rights.AcknowledgmentThis manual has been largely adapted from Woman centered abortion care: Reference Manual byAlyson G. Hyman and Laura Castleman, 2005. Chapel Hill, NC, IpasAndRevised edition of Guidelines for early Medical Abortion in India using Mifepristone and Misoprostol,WHO-CCR in Human Reproduction, AIIMS in collaboration with Ministry of Health & Family Welfare, GOIand Indian Council of Medial Research, 2007AndNational CAC Training and Service Delivery Guidelines by MOHFW, 2010MMA Reference Manual.indd 205/07/13 5:56 PM
Handbook onMedical Methods ofAbortionby Government of Madhya Pradesh and Ipas to expandaccess to new technologies for safe abortionMMA Reference Manual.indd 305/07/13 5:56 PM
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Table of ContentsTitlePage No.MessageForewordMedical Methods of Abortion: Technical Details1Bibliography24AnnexuresAnnexure 1: Medical Methods of Abortion Skills Checklist27Annexure 2: Pre and Post training Assessment Form31Annexure 3: Training Evaluation Form33iii
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National Rural Health MissionDirectorate of Health Services, MP3rd Floor, Bank of India BuildingArera Hills, Jail Road, Bhopal, MPDr. M GeethaI.A.S.Mission DirectorMessageUnsafe abortion is a significant yet preventable cause of maternal mortality across the country and in MadhyaPradesh. While we have been successful in reducing the maternal mortality rate of our state, concerted efforts andinnovative approaches are needed for us to meaningfully contribute to reaching the Millennium Development Goals.While under the National Rural Health Mission, we are constantly making endeavours to address the lack ofavailability of providers; one key area that also needs to be given attention is expanding availability of new and safetechnologies for abortion.In this regard, medical methods of abortion have proved to be a technology that is safe and affordable and if madeadequately available in the public sector, will go a long way in meeting the needs of women, augmenting servicesespecially in low resource settings.To further advance one of the key focus areas under NRHM- increasing access to safe abortion services- theDirectorate of Health Services, Government of Madhya Pradesh has developed this handbook with the objective ofimproving medical methods of abortion in the ongoing CAC trainings, thereby expanding their correct use andavailability in the public sector through the state.I hope this handbook will be extensively used by trainers as a resource and further by the providers as a reference,and will play a significant role in integrating medical methods of abortion into the public health system. I believethis will not only expand the choices for women in our state but also move forward the agenda of increasing accessto high quality safe abortion services.In our mission of improving women’s health, we look forward to working closely with Ipas that has been ourlong-term partner in increasing access to and quality of comprehensive abortion care services in the state.(Dr.Dr. M. Geetha)Bhopal01-07-2013vMMA Reference Manual.indd 705/07/13 5:56 PM
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Directorate of Health ServicesGovt. of Madhya Pradesh4th Floor, SatpuraBhawanBhopal, MPSanjay Goel (I.A.S.)DirectorForewordThe maternal mortality ratio (MMR) in Madhya Pradesh has declined from 379 per 100,000 live births in 2001-2003(RGI 2006) to 269 in 2007-2009 (RGI 2011). However, this is still higher than the national average and theGovernment of Madhya Pradesh is committed to reducing it further to achieve the Millennium Development Goals.One of the most easily preventable reasons for maternal deaths is unsafe abortions - although abortion has been legalin India for more than four decades, eight percent of all reported maternal deaths in the country (10% in EAG statesincluding Madhya Pradesh) are due to unsafe abortions.The government of Madhya Pradesh has taken many steps to address this, including training of doctors from the publichealth system, establishing comprehensive abortion care services at the primary health facilities and increasingawareness in the community about the legality and availability of these services. According to the state MTP data, weare serving 10% women with safe abortion services. Given this, we recognize that we can do more to keep pace withthe fast-evolving technologies for abortion to further expand access to safe services and provide these as a right forwomen in all parts of the state.One such potential lies in medical methods of abortion (MMA). It is a simple technology that is highly recommended fortermination of early pregnancies. Evidence from across the globe shows that it has significantly expanded women'soptions and improved clinicians' practices. It gains even more relevance in our context since it can be easilyincorporated in primary care settings.It is with this vision of harnessing the new and safe abortion technologies that I am introducing this reference manual– Handbook on Medical Methods of Abortion – that contains all required information for providing high-qualityabortion services through medical methods. This is a resource for certified abortion providers to guide them toadminister and manage early first trimester abortion through approved medication (Mifepristone & Misoprostol).I hope that providers of abortion services will extensively use this manual to further update their knowledge andcontinuously improve the quality of their services thus expanding the availability of medical methods of abortion, andgiving much-needed choices to women seeking to exercise their right to safe abortions.Sanjay Goel (I.A.S.)Bhopal26-06-2013viiMMA Reference Manual.indd 905/07/13 5:56 PM
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Medical Methods of Abortion (MMA)IntroductionThis module gives information and describes the skills required by providers to administerand manage first-trimester abortion procedures by medical methods. Medical Methods ofAbortion is also referred to as Medical Abortion.Course Objectives List eligibility criteria and contraindications for women seeking Medical Methods ofAbortion Compare relative benefits and risks of medical methods of abortion (MMA) andvacuum aspiration (VA) procedures Explain MMA protocol and describe/recognize side effects and complications Share experience of providing abortion services by medical methods post-CACtraining Recall essential information to be given to women availing MMAClimate SettingObjectivesContentClimate setting Registration Pre trainingassessmentMethodologyMaterials & Aids Individualexercise Registration sheet Presentation Introduction Courseobjectives Pre trainingassesment forms(one for eachtrainee) Objectives writtenon flip chartThis refresher course has been organized for gynecologists & medical officers who havesuccessfully completed the Comprehensive Abortion Care (CAC) training earlier. The courseseeks to update you for providing MMA services to women at your health centre in thefuture.This course has the following sections:1.Overview of Medical Methods of Abortion2.Protocols for administration of drugs for Medical Methods of Abortion, identifyingside effects and complications.1MMA Reference Manual 21-02-2014.indd 903/03/14 4:10 PM
3.Sharing of experience especially for MMA during service delivery at work site postCAC training4.Key information for women seeking Medical Methods of AbortionOverview for Administration, Comparison of MMA vs VAObjectivesDescribe the drugslisted for MedicalMethods ofAbortion in India;Eligibility criterionand contraindication for a womanseeking MedicalMethods ofAbortion; CompareMMA vs VAproceduresContentMethodology Overview Presentation Steps prior toprocedure Brainstorming Comparisonof MMA vs VA Recall,Questionsand Answers DiscussionMaterials & Aids Key points writtenon flipcharts Heading forcomparison tablewritten on flipchart Medical Methods of Abortion is a method for termination of pregnancy in a non-surgical,non-invasive way by using a drug or a combination of drugs. Medical Methods of Abortion provides women with a new option for termination ofpregnancy and should be offered in addition to other (or) aspiration abortion methodswhenever possible. Medical Methods of Abortion has the potential to increase access to safe abortionservices because it can be offered by providers in settings where Vacuum Aspiration(VA) or other methods of abortion may not be possible.Drugs UsedCommonly used drugs for Medical Methods of Abortion are a combination of Mifepristoneand Misoprostol. Drug Controller General of India approved the use of Mifepristone (inApril 2002) and Misoprostol (in December 2006) for termination of pregnancy upto 49days gestation period.In December 2008, Mifepristone Misoprostol (1 tab of mifepristone 200mg and 4 tabof misoprostol 200mcg each) Combipack was approved by the Central Drugs StandardControl Organization, Directorate General of Health Services for the medical terminationof intrauterine pregnancy (MTP) for up to 63 days gestation.2MMA Reference Manual 21-02-2014.indd 1003/03/14 4:10 PM
Mifepristone It was commonly called RU-486, however, the term Mifepristone is more commonnow. It was invented in 1980. RU is the initials of pharmaceutical company Roussel-Uclaf which manufactured it and 486 is a random laboratory serial number. Mechanism of action: It is an antiprogestin, which blocks the progesteronereceptors in the endometrium and decidua causing the necrosis of uterine lining and detachment of implanted embryo. Italso causes cervical softening and increased production ofprostaglandins, causing uterine contractions. It sensitizes theuterus to the effect of prostaglandins. It is more effective in early pregnancy when progesterone ispresent in lower concentrations due to limited production by thecorpus luteum. As the placenta takes over the production ofprogestrone, the progesterone is produced in large quantitiesIt is available as 200 mg tablet. Dosage: 200 mg orally on day 1 (first visit)When used with prostaglandin, complete abortion rate is 95-99%.Side-effects: Serious side effects are rare. However, women may oeaMisoprostol It is a synthetic prostaglandin E1 analogue In December 2006, Drug Controllor General of India approved its use in gyneacologicalindications for cervical ripening, prevention of post partum hemorrhage and withMifepristone, for early abortions up to 7 weeks. Mechanism of action: It binds to myometrial cells causing strong uterine contractions,cervical softening and dilatation. This leads to expulsion of conceptus from the uterus.3MMA Reference Manual 21-02-2014.indd 1103/03/14 4:10 PM
Dosage:Dose is variable, depending on gestation age and route of administration. Approvedprotocol in India is 400 mcg given orally or vaginally on day 3 (second visit) for gestationperiod upto 49 days and 800 mcg sublingually or vaginally for gestation period upto 63days. Depending on the woman and the clinician's decision, even home use of Misoprostol on day 2 or 3 may be tried to reduce one follow-up visit. It is economical and stable at room temperature. It gets absorbed fairly well in gastrointestinal tract and vaginal mucosa.Through vaginal route, it has lesser side effects, is absorbed slowly and is effective fora longer time whereas by oral route it leads to more gastrointestinal side effects, isabsorbed quickly and is effective for a shorter time. Sublingual and buccal routes alsoshow very promising results. There is no problem if the tablets do not completelydissolve on vaginal administration. It has fewer side effects as compared to other prostaglandins. Being selective for PGE1receptors, it has no significant effect on bronchi and blood vessels. Originally it was developed for prevention and treatment of gastric ulcer. Side-effects:– Nausea– Vomiting– Diarrhoea– Fever (sometimes with shivering)4MMA Reference Manual 21-02-2014.indd 1203/03/14 4:10 PM
EffectivenessA combination of Mifepristone and Misoprostol has the following efficacy for terminationof early pregnancy:ConditionEffectiveness*Complete abortion95 - 99%Heavy bleeding requiring vacuum aspiration1 - 2%Incomplete abortion requiring other methodsof evacuation1 - 2%Heavy bleeding requiring blood transfusion0.1 - 0.2%*(Source: Use of RU-486 with Misoprostol for early abortions in India. Guidelines for Medical Officers, WHO-CCR in Human Reproduction, All India Institute of Medical Sciences,Ministry of Health and Family Welfare, Government of India and Indian Council of MedicalResearch, 2003).FailureMedical Methods of Abortion is said to be a failure when the clinician has to resort to othermethods of abortion. It could be from: Heavy bleeding/Hemorrhage True drug failure/continuing pregnancySometimes, it may be due to Clinician's / woman's decision: For heavy bleeding, blood loss is estimated taking into account the number ofnormally used average sized pads soaked at a given time (described later). If indicated,VA is done as soon as possible. True drug failure is presence of gestational cardiac activity 2 weeks after Mifepristoneand Misoprostol administration leading to continuing pregnancy. This has to beterminated by VA. Incomplete Abortion:–Some women have a persistent gestation sac without cardiac activity 2 weeksafter the Misoprostol administration. This is called incomplete abortion.–Sometimes gestation sac is expelled but women keep bleeding due to bloodclots/ decidual bits in the uterine cavity. This can be managed conservatively asmostly it is expelled spontaneously. But if bleeding is profuse, VA may have tobe done.5MMA Reference Manual 21-02-2014.indd 1303/03/14 4:10 PM
Safety Using Mifepristone and Misoprostol is a safe method to terminate pregnancy as longas the woman does not have any contraindications for its use.Advantages and Limitations of Medical Methods of AbortionAdvantagesLimitationsAbortion can be offered at an early stageAt least three clinic visits requiredPotentially more private, similar to anatural miscarriageTakes longer than VA, mean durationof bleeding being 9.5 daysLess invasive than VA. No instrumentsare usedUnpredictable outcome: may end in acomplete/ incomplete abortion/continuedpregnancyNo anestheisaPossibility of side effects of drugsRisk of fetal malformation if preganancycontinues6MMA Reference Manual 21-02-2014.indd 1403/03/14 4:10 PM
Eligibility CriteriaEligibility of the Provider Medical Methods of Abortion is not a surgical intervention. However, it is a termination of pregnancyand, therefore, falls under the purview of the MTPAct 1971. In case of termination of pregnancy usingMifepristone and Misoprostol, the registered medicalpractitioner, as defined by the MTP Act, can onlyprescribe the drugs.Eligibility of the Place Medical Methods of Abortion , asper the amended MTP Rules 2003,can be provided from approvedsites as well as non-approvedclinics with referral linkage toapproved MTP site. The lawrequires that a certificate of accessto a registered place (i.e. showingthat a referral link has been established) from the owner of theapproved site must be displayed inthe clinic where MMA is beingprovided.Medical Methods of Abortion and the LawThe key conditions/requirements of MTP using themedical methods are: Can be provided only by certified abortion providers Can be provided from approved sites as well as nonapproved clinics with referral linkages provided acertificate of access to a registered place is displayed7MMA Reference Manual 21-02-2014.indd 1503/03/14 4:10 PM
Women seeking Medical Methods of AbortionOption for Medical Methods of Abortion should be given to all women coming toa health facility seeking termination of pregnancy up to 7 weeks of gestation (49days from the first day of the last menstrual period in women with regular cyclesof approximately 28 days) provided that the following aspects have beenassessed and found appropriate: Frame of mind of the woman–Acceptability of minimum three follow-up visits–Ability to understand the instructions and give informed consent Agrees for vacuum aspiration procedure, if failure or excessivebleeding occurs Support from family or others Consent of guardian in case of minor as per MTP Act 1971 Easy access to appropriate health care facility in an emergency8MMA Reference Manual 21-02-2014.indd 1603/03/14 4:10 PM
ContraindicationsWomen with following conditions and factors are not eligible for Medical Methods ofAbortion:Contraindications to Medical Methods of Abortion Ectopic pregnancy either confirmed orsuspected.Or undiagnosed adnexal mass Hemorrhagic disorder Allergy to Misfepristone, Misoprostol orother Prostaglandins Current anticoagulant therapy Current use of long term corticosteroid Uncontrolled hypertension, BP 160/100 Uncontrolled seizure disorder Inherited porphyria Anemia (Hemoglobin 8 gm%)Special precautions (where drug need to be used cautiously) Pregnancy with fibroid-big symptomatic Intrauterine device in place (removebefore giving Mifepristone)fibroids encroaching on endometrialcavity can have heavy bleeding andmay interfere with uterine contractility Bronchial asthma - prostaglandinsother than Misoprostol should not beused. Misoprostol is a weakbronchodilator If on anti tubercular drugs, efficacy ofthe drugs may decrease and there aremore chances of failure requiringsurgical abortion Pregnancy with uterine scar (previouscaesarean section, hystertomy ormyomectomy) caution should be exercisedPsycho - Social Situations (unsuitable for MMA) Woman unable to take responsibility for Anxious women wanting quick abortionher condition Language or comprehension barrier,inability to give informed consent Not willing for VA abortion in case offailure9MMA Reference Manual 21-02-2014.indd 1703/03/14 4:10 PM
Comparison: VA and MMA procedureFeatureVacuum AspirationMedical Methods ofAbortionTechnique usedUterine contents evacuatedthrough a cannula attachedto vacuum source (manualor electric)Uterine evacuation withdrugs (Mifepristone &Misoprostol), a nonsurgical methodGestation limit ofthe techniqueCan be used upto 12weeks of pregnancyCan be used upto 7 weeksof pregnancyEffectivenessMore than 98% effective93-98% effectiveTime taken for theprocedure completion5-15 minutesMay take 9-16 daysPOC CheckPOC are examined andconfirmed immediatelyPOC may be expelled athomeNumber of visits forthe procedureOne visitRequire minimum 3 visitsFollow up visitNot mandatoryMust to ensure completionAnaesthesia usedLocal Anaesthesia & oralanalgesicsOral pain controlmedicationProcedure done byHealth care providerProcess similar to amiscarriageRisk of cervical and uterineinjuryPossible but rareNo risk of injury to cervixand uterus since noinstrumentation is donePost - procedure
4. Key information for women seeking Medical Methods of Abortion Overview for Administration, Comparison of MMA vs VA Medical Methods of Abortion is a method for termination of pregnancy in a non-surgical, non-invasive way by using a drug or a combination of drugs. Medical Methods of Abortion
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