lR;esot;rs - NHM

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lR;eso t;rs

Transcript of lR;esot;rs - NHM

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lR;eso t;rs

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Handbook on

Medical Methods of Abortion to Expand Access to New Technologies

for Safe Abortion

Ministry of Health & Family WelfareGovernment of India

lR;eso t;rs

JANUARY 2016

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List of Acronyms

AIDS AcquiredImmunodeficiencySyndrome

ANM AuxiliaryNurseMidwife

ACOG AmericanCongressofObstetriciansandGynaecologists

BP BloodPressure

CAC ComprehensiveAbortionCare

Gm Gram

HIV HumanImmunodeficiencyVirus

IEC InformationEducationCommunication

IUCD IntrauterineContraceptiveDevice

IV Intravenous

PC-PNDT PreConceptionandPreNatalDiagnosticTechniques

LMP LastMenstrualPeriod

MTP MedicalTerminationofPregnancy

MMA MedicalMethodsofAbortion

Mcg Microgram

NHM NationalHealthMission

POC ProductsofConception

P/S Per Speculum

P/V Per Vaginum

Rh Rhesus(Bloodgroup)

USG UltraSonography

VA VacuumAspiration

SRS SampleRegistrationSystem

LSCS LowerSegmentCaesareanSection

OPD OutPatientDepartment

WHO WorldHealthOrganization

RMP RegisteredMedicalPractitioner

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xvHandbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

List of Contributors

1. ShriC.K.Mishra AdditionalSecretary&MissionDirector(NHM),MoHFW

2. DrRakeshKumar JointSecretary(RMNCH+A),MoHFW

3. DrDineshBaswal DeputyCommissioner(InchargeMaternalHealth),MoHFW

4. DrVeenaDhawan AssistantCommissioner(MaternalHealth),MoHFW

5. ProfessorSuneetaMittal Director&Head,DepartmentofObstetrics&Gynaecology,FortisMemorialResearchInstitute

6. Dr.BelaGanatra Scientist,DepartmentofReproductiveHealth&Research,WorldHealthOrganization,Geneva

7. Dr.PratimaMittal Professor&Head,DepartmentofObstetrics&Gynaecology,VMMC&SafdarjungHospital,New-Delhi

8. Dr.PoonamVarmaShivKumar

Professor&Head,DepartmentofObstetrics&Gynaecology,MGIMS,Sewagram,Maharashtra

9. Dr.VidushiKulshrestha AssistantProfessorDepartmentofObstetrics&Gynaecology,,AIIMS,NewDelhi

10. Dr.VinitaDas Professor&Head,DepartmentofObstetrics&Gynaecology,KingGeorge’sMedicalUniversity,Lucknow,UttarPradesh

11. Dr.SudhaPrasad Professor&Head,DepartmentofObstetrics&Gynaecology,MaulanaAzadMedicalCollege&Hospital,New-Delhi

12. Dr.AbhaSingh DirectorProfessor,DepartmentofObstetrics&Gynaecology,LadyHardingMedicalCollege,NewDelhi

13. Dr. Sudha Salhan Professor,DepartmentofObstetrics&GynaecologyNDMCMedicalCollegeandHinduRaoHospital,NewDelhi

14. Dr.SangeetaBatra Senior Director (Health Systems), Ipas DevelopmentFoundation

15. DrPushkarKumar LeadConsultant,MaternalHealth,MoHFW

16. DrRajeevAgrawal SeniorManagementConsultant,MaternalHealth,MoHFW

17. Dr. Tarun Singh Sodha Consultant(MaternalHealth),MoHFW

18. Ms.JenitaKhwairakpam Consultant(MaternalHealth),MoHFW

19. Dr.AshishBanerjee Consultant(MaternalHealth),MoHFW

20. Dr.SalimaBhatia SeniorConsultant(MaternalHealth),MoHFW

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xviiHandbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Contents

Message ............................................................................................................................................... iii

Foreword .............................................................................................................................................. v

Preface ................................................................................................................................................vii

Acknowledgement ............................................................................................................................ ix

AbouttheHandbook ........................................................................................................................ xi

ListofAcronyms ............................................................................................................................. xiii

ListofContributors .......................................................................................................................... xv

IntroductiontoMedicalMethodsofAbortion(MMA) .................................................................1

Section 1: Medical Methods of Abortion - An Overview ..................................................................2

1.1:AdvantagesandLimitationsofMMA ......................................................................................2

Section 2: Law (MTP Act) and MMA ....................................................................................................3

2.1:EligibilityoftheProvider ............................................................................................................3

2.2:EligibilityofthePlace ..................................................................................................................3

2.3:DocumentationofMMAProcedure ..........................................................................................4

Section 3: Indications/Contraindications for MMA ...........................................................................5

3.1:IndicationsforMMA ...................................................................................................................5

3.2:ContraindicationsforMMA .......................................................................................................5

3.3:SpecialPrecautionsforMMA .....................................................................................................6

Section 4: MMA Drugs .............................................................................................................................7

4.1:DrugsusedinMMA ....................................................................................................................7

Section 5: MMA Protocol and Process ................................................................................................10

5.1:DrugProtocol ..............................................................................................................................10

5.2:ProcessofMMA..........................................................................................................................10

5.3:PostMMAContraception .........................................................................................................18

Section 6: Side Effects and Complications with MMA ...................................................................19

6.1:SideEffectsandtheirTreatment ..............................................................................................19

6.2:ComplicationsandtheirManagement ....................................................................................20

6.3.WarningSymptomsandSigns .................................................................................................22

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Section 7: Safety and Effectiveness .....................................................................................................23

Section 8: Comparison: VA and MMA Procedure ............................................................................24

Section 9: Suggested Agenda for MMA Reorientation ...................................................................26

References .................................................................................................................................................27

AnnexuresAnnexure1:MedicalMethodsofAbortionSkillsChecklist .............................................................28

Annexure2:EssentialEquipmentandSuppliesforMMA ................................................................31

Annexure3:MMA:DocumentationFormats ......................................................................................32

Annexure4:MMAFollow-upCard ......................................................................................................36

Annexure5:MedicalMethodsofAbortion(MMA)Reorientation PreandPost-trainingAssessment ..............................................................................................37

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Introduction to Medical Methods of Abortion (MMA)

Unsafeabortionsmakeasignificantcontributiontomaternalmorbidityandmortality.AsperSRS2001-03,abortion-relateddeathsaccountfornearlyeightpercentofallmaternaldeathsinIndia,whichtranslatestoabout3,520deathsannually.Numerousbarrierslimitaccesstosafeabortionservicesincludingshortageoftrainedproviders;lackofinfrastructureatthefacilities;andlackofinformationaboutlegalityandavailabilityofservicesamongwomenandthecommunity.

MedicalMethodsofAbortionisoneofthesafetechnologiesforabortioncarewhichoffersanopportunitytoincreaseaccesstoabortioncareservicesespeciallyinearlypregnancy.Itcanbeofferedatalllevelsofhealthcare,includingprimarylevels.Itcanalsobeprovidedonanoutpatientbasis.MMAisanon-invasivetechnologyandsimplifiestherequirementsofplaceandequipmentrequiredforvacuumaspirationprocedures.

MMAcanbeusedatvariousstagesofpregnancyincludingsecondtrimester,butthefocusofthismanualisonearlypregnancyuptosevenweeks,asapprovedundertheMTPRules,2003.

Abortion should never be used as a method of family planning.

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MMAisanon-surgical,non-invasivemethodforterminationofpregnancybyusingadrugoracombinationofdrugs.Itprovideswomenwithanotheroptionforterminationofpregnancy,andshouldbeofferedinadditiontoothersafeabortionmethodswheneverpossible.

1.1: Advantages and Limitations of MMA

MMAisoneofthesafetechnologiesavailableforpregnancytermination.Itisanon-surgicalmethodforearlyabortionsandhasbothadvantagesaswellaslimitationsoverothermethodsofpregnancytermination.

Advantages of MMA

1. Abortioncanbeofferedatanearlystageofpregnancy

2. Potentiallymoreprivate,beingsimilartoanaturalmiscarriage

3. Non-surgicalmethodofabortion,andhencenon-invasive

4. Noanaesthesiarequired

5. Limitedinfrastructureneeded,canbeofferedinsettingswherevacuumaspirationmaynotbepossible

Limitations of MMA

1. AminimumofthreeclinicvisitsarerequiredduringtheMMAprocess

2. Bleedingmayoccurfor8-13days

3. Theremaybesideeffectsofthedrugs

4. OnceMMAdrugsaretaken,pregnancyhastobeterminated,sinceifpregnancycontinues,thereisariskoffoetalmalformation.

1Section

Medical Methods of Abortion - An Overview

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AlthoughMMAisnotasurgicalintervention,beingterminationofpregnancy,itfallsunderthepurviewoftheMTPAct1971.

2.1: Eligibility of the Provider

IncaseofterminationofpregnancyusingMifepristoneandMisoprostol,onlyaRegisteredMedicalPractitioner,asdefinedbytheMTPAct,canprescribethedrugs.

‘Registered Medical Practitioner (RMP)’meansamedicalpractitionerwhopossessesanyrecognizedmedialqualificationasdefinedinclause(h)ofsection2oftheIndianMedicalCouncilAct,1956(102of1956);whosenamehasbeenenteredinaStateMedicalRegister;andwhohassuchexperienceortrainingingynaecologyandobstetricsasmaybeprescribedbyRulesunderthisAct.

TheMTPRules,2003,requirethatanRMPshouldhaveoneormoreofthefollowingexperienceortrainingingynaecologyandobstetrics:

1. post–graduatedegreeordiplomainObstetricsandGynaecology.

2. completedsixmonthsasHouseSurgeoninObstetricsandGynaecology.

3. atleastoneyearexperienceinthepracticeofObstetricsandGynaecologyatanyhospitalthathasallfacilities.

4. assistedanRMPin25casesofmedicalterminationofpregnancyofwhichatleastfivehavebeenperformedindependentlyinahospitalestablishedormaintainedbythegovernmentoratraininginstituteapprovedforthispurposebythegovernment.

2.2: Eligibility of the Place

InaccordancewiththeMTPAct,noterminationofpregnancyshallbemadeatanyplaceotherthan–

a) ahospitalestablishedormaintainedbyGovernment,or

b) aplaceforthetimebeingapprovedforthepurposeofthisActbyGovernmentoraDistrictLevelCommittee(DLC)constitutedbytheGovernment,withtheChiefMedicalOfficerorDistrictHealthOfficerastheChairpersonofthesaidCommittee.

2Section

Law (MTP Act) and MMA

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ItshouldbenotedthattheDistrictLevelCommitteeshallconsistofnotlessthanthreeandnotmorethanfivemembersincludingtheChairperson,asspecifiedbytheGovernment.

IncaseofterminationofearlypregnancyuptosevenweeksusingMifepristoneandMisoprostol,RMPasundertheMTPAct,canprescribethedrugsathis/herclinicprovidedhe/shehasaccesstoaplaceapprovedforterminatingpregnancyundertheMTPAct.

The clinic should display a certificate to this effect from the owner of the approved place. In other words, the clinic where medical abortion drugs are prescribed by an RMP as under the MTP Act, does not need site approval as long as it has referral linkage to an MTP approved site.

2.3: Documentation/Reporting of MMA Procedure

SinceMMAcomesunderthepurviewofMTPAct,thedocumentationissimilartothatrequiredforvacuumaspirationprocedure.ItismandatorytofillandrecordinformationforabortioncasesperformedbyMMAinthefollowingforms:

1. FormC–ConsentForm

2. FormI–RMPOpinionForm

3. FormII–MonthlyReportingForm(tobesenttothedistrictauthorities)

4. FormIII–AdmissionRegisterforcaserecords

AlldocumentationformatsareattachedasAnnexure–3

Followingarethekeyconditions/requirementsofMTPusingmedicalmethods,undertheMTPAct:

• Itcanbeperformedonlybycertifiedabortionproviders

• It can be performed for gestation age up to sevenweeks, from approved sites aswell asclinicofaRMPwithreferrallinkages,providedacertificateofaccesstoanapprovedsiteisdisplayed

• Alldocumentationformats,filledforvacuumaspiration,aretobefilledforMMAalso.

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3.1: Indications for MMA

OptionforMMAshouldbegiventoallwomencomingtoahealthfacilityseekingterminationofpregnancyupto7weeksofgestation(49daysfromthefirstdayofthelastmenstrualperiodinwomenwithregularcyclesofapproximately28days)1

Figure 1: MMA Drugs (Mifepristone and Misoprostol)

3.2: Contraindications for MMA Women being prescribed MMA should be screened for the following common contraindications:

• Anaemia(haemoglobin<8gm%)

• Confirmedorsuspectedectopicpregnancy/undiagnosedadnexalmass

• UncontrolledhypertensionorBP>160/100mmHg

3Section

Indications/Contraindications for MMA

1InDecember2008,CombipackwithMifepristone+Misoprostol(1tabletofMifepristone200mgand4tabletsofMisoprostol200mcgeach)wasapprovedbytheCentralDrugsStandardControlOrganization,DirectorateGeneralofHealthServices,India,fortheterminationofintra-uterinepregnancyforupto63days/9weeksgestation.

CACTraining&ServiceDeliveryGuidelines,2010byMoHFW,GoIrecommendsitsuseupto49daysinpublicsectorsites,inlinewiththeMTPRules2003.

AproposedamendmenttotheMTPAct,1971,toincreasethegestationlimitforMMAto9weeksinpublicsectorsitesisunderprocess.Tilltheproposalisapproved,MMAinpublichealthfacilitywouldbeallowedonlyupto7weeks.

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• Knowncasesof:

• Heartproblemssuchasangina,valvulardisease,arrhythmiawhichcanleadtosuddencardiovascularcollapse

• Renal, liver or respiratory disease (Bronchial asthma is not a contraindication sinceMisoprostolisabronchodilator)

• Currentlong-termsystemiccorticosteroidtherapy

• Uncontrolledseizuredisorder

• Chronicadrenalfailure

• HypersensitivitytoMifepristone/Misoprostolorotherprostaglandins

• Inheritedporphyrias

3.3: Special Precautions for MMA

Besides absolute contraindications for MMA, there are conditions where caution has to be exercised. Such conditions are enumerated below:

1. WomennotsureaboutLMPorwithlactationalamenorrhea

2. Pregnancy with IUCD in situ: IUCDtoberemovedbeforegivingMMAdrugs

3. Pregnancy with uterine scar: Althoughsafe,exercisecautionwithhistoryofLSCS,hysterotomyormyomectomy

4. Pregnancy with fibroid: Large fibroid encroaching on endometrial cavity can cause heavybleedingandcaninterferewithuterinecontractility

5. Women on anti-tubercular drugs:Rifampicinisaliverenzymesinducingdrug,whichcanleadtoincreasedmetabolismandhencedecreasedefficacyofMMAdrugs

6. Breastfeeding: WomenhavetowithholdfeedingforfourhoursafterMisoprostoladministration

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4.1: Drugs Used in MMA

RecommendeddrugsforMMAareMifepristoneandMisoprostol.

MMA drugs are Schedule H drugs and are to be sold by retail on the prescription of a Registered Medical Practitioner only.

Mifepristone isanantiprogestin,whichblockstheprogesteronereceptorsintheendometrium,causingthenecrosisofuterinelininganddetachmentofimplantedembryo.Itcausescervicalsofteningandanincreasedproductionofprostaglandins,causinguterinecontractions.Asmallpercentageofwomen(3%)mayexpelproductsofconception(POC)withMifepristonealone.

Misoprostol isasyntheticprostaglandinE1analogue.Itbindstothemyometrialcells,causingstronguterinecontractions,cervicalsofteninganddilatation.ThisleadstotheexpulsionofPOCfromtheuterus.Misoprostolhasanadvantageoverotherprostaglandinsasitiswellabsorbedfromdifferentroutesofadministration,iseconomical,andstableatroomtemperaturesincomparisontoPGF2alphaderivatives.

Itwasearlierusedforpreventionandtreatmentofgastriculcer.

Action of Misoprostol through different routes of administration:

Sublingual: Rapidonsetofaction(likeoralroute)andlongerdurationofaction(likevaginalroute);

Figure 2: Sublingual administration of Misoprostol

4Section

MMA Drugs

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Buccal: Onsetanddurationofactionisquitesimilartothevaginalroutealthoughtheserumlevelsachievedarelower.

Figure 3: Buccal administration of Misoprostol

Vaginal: Gradualonsetbutlongerdurationandsustainedaction.Misoprostoltabletsonvaginaladministrationmaynotcompletelydissolve.Asthecoreofthetabletisnon-medicated,thisdoesnotaffectitsefficacy.Moisteningthetabletbeforevaginaladministrationdoesnotimproveefficacy(ACOG,2009)

Figure 4: Vaginal administration of Misoprostol

Oral: Rapidonsetbutshorttotaldurationofaction

Figure 5: Oral administration of Misoprostol

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Figure 6: Graph comparing pharmacokinetics of Misoprostol administered by different routes

Table 1: Effectiveness of Misoprostol administered by different routes

Route of Administration

Onset of Action

Duration of Action Preferred/Recommended Route

Sublingual Fastest Highestplasmalevelsandprolongedaction

Mostrecommended

Buccal Quick Prolongedaction RecommendedVaginal Quick Prolongedaction Recommended Oral Quick Leastduration Leastrecommendedbutstillcanbegiven

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Thestepsoftheprocedurearedividedbelowonthebasisofthedayofthevisit.Typicallyitrequiresthreevisits(Day1,3and15)whentheMMAdrugsareusedbythewomanandtoconfirmthecompletionoftheabortionprocess.

5.1: Drug Protocol

Table 2: MMA Drug Protocol

Visit Day Drugs usedFirst One • 200mgMifepristoneoral;

• Anti D 50 mcg, if Rh negative (give 300 mcg if 50mcg notavailable

Second Three • 400mcgMisoprostol(twotabletsof200mcgeach)sublingual/buccal/ vaginal /oral;

• Analgesics(Ibuprofen);

• Antiemetic;

• OffercontraceptionThird Fifteen • Confirmandensurecompletionofabortion;

• Offercontraception,ifnotalreadydoneso

5.2: Process of MMA

First Visit/Day 1/Day of Mifepristone Administration

Firstvisitstartswithassessingthesuitabilityofthewomantoundergomedicalmethodsofabortion.Suitabilityisjudgedbyconductingaclinicalexamination,necessaryinvestigationsandexcludingthecontraindications.

FirstvisitmaysometimesnotbethedayofMifepristoneadministration.ItisthedayofMifepristoneadministrationwhichistakenasDay1.

5Section

MMA Protocol and Process

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1. Detailed History

a) Demographicprofile:age,religion,addresstobenoted

b) Menstrualhistory:length&durationofcycle,flow(excessornormal),LMP

c) Obstetrichistory:parity,livebirths,abortion(inducedandspontaneous),previouscaesareansection(ifany),lastchildbirth/abortion,presentlylactatingornot

d) Historyofpre-existingmedical/surgicalconditions:

• Hypertension

• Heartdisease

• Diabetesmellitus

• Epilepsy

• Asthma-notacontraindicationwithPGE1

• Renaldisease

• Drugallergies

• Bleedingdisorders

• Currentmedication

• Previousuterine/tubal/abdominalsurgery/ectopicpregnancy

• Treatmentforinfertility/Tuberculosis/pelvicinflammatorydisease

e) Historyofanyinterference/drugstakeninthispregnancytoattempttermination

f) Contraceptivehistory:typeanddurationofcontraceptiveused

g) Statusoftetanusimmunization:lastdosereceived

h) Psychosocialassessment–toassessfamilysupport

i) Historyofsexualassaultanddomesticviolence

2. Counselling: General and Method-specific Counselling

General Counselling

While counselling, attention must be paid to the following points:

• Tellheraboutallthemethodsavailableforabortionandhoweachmethoddiffersfromtheother.

• Askaboutherexistingknowledgeandbeliefsaboutabortionoptions.

• Discusshercontraceptiveneedsandcounselheraccordinglyforcontraceptionafterabortion.

• Discussinfectionpreventionaspectslikelocalhygiene,handwashinganduseofcleansanitarynapkins,etc.

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Figure 7: Counselling on MMA procedure

Method-specific Counselling

IfthewomanchoosesMMA,sheshouldbeprovidedthefollowinginformation:

a) Itisanon-invasiveandnon-surgicalmethod

b) Theprocessissimilartoanaturalmiscarriage

c) Sheneedstomakeaminimumofthreevisitstothefacility(day1,3,&15).HomeadministrationofMisoprostolisallowedonprovider’sdiscretion.Insuchcases,thenumberoffacilityvisitswillreducetotwo.

d) Shehastofollowadefinitedrugprotocol

e) Counsellingaboutdifferentroutesofadministration

f) ShehastobereadyforVAprocedureincaseoffailureofthemethodorexcessivebleeding(soakingtwoormorethickpadsperhourfortwoconsecutivehours)

g) Shehastostaywithintheaccessiblelimitsoftheappropriatehealthcarefacility.Sheshouldnotbeleftunattendedathome

h) Explainthesymptomsthatwouldbeexperiencedbyher,forexample:

• Bleeding per vaginum is an essential part of the MMA process since it is similar tomiscarriage. Bleeding is usually heavier thanwhat is experiencedduring amenstrualperiod.Bleedingoftenlastsfor8to13days.SoakingoftwothickpadswithinonetotwohoursaftertakingMisoprostol,butdecreasingovertimeisconsiderednormal.

• AbdominalpainisexperiencedasapartoftheMMAprocess.Refrainfromdescribingcramping pain as similar to labour pains. Instead, it can be compared with severemenstrualcramps.SometimesthepainbeginsfollowingingestionoftabletMifepristone,butmostoftenitstartsonetothreehoursafterMisoprostoladministrationandisheaviestduringtheactualabortionprocess,oftenlastinguptofourhours.Ifthepainispersistent,thepossibilityofectopicpregnancyshouldalwaysberuledout.

• Nausea,vomiting,diarrhoea,etc.arenormalsideeffectsofdrugs.

i) Therecouldbeteratogenic(harmful)effectonthefetus,ifpregnancycontinues

j) Asmallpercentageofwomen(3%)mayexpelproductswithMifepristonealone,but totaldrugschedulewithMisoprostolmustbecompleted

k) Duringtheabortionprocess,itisidealtoavoidintercoursetopreventinfection,orusebarriermethods

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l) Womenwithnosupportathome:arrangementsshouldbemadefor transportation to thehospital,incaseofemergencyorshouldbeadmittedfortheMMAprocedure.

3. General Physical, Systemic, Abdominal and Pelvic Examination

a) Check for pallor: if pallor exists, heavy bleeding during the procedure may worsen theconditionandincreasetheriskofshockandillhealth.

b) Bloodpressure;cardiovascular;andrespiratorysystemforanypre-existingdisease

c) Lookforanymass,rigidity,tendernessinabdominalexamination

d) CarryoutPelvicexamination(P/SandP/V)

Figure 8: Performing bimanual examination

• P/Sexamination:lookforinfection,cervicalerosion,polyp

• P/Vexamination:checkthesize,shape,regularityandconsistencyofuterustoconfirmtheperiodofgestationandadenexalmass

• Ruleoutectopicpregnancy2,incaseofadenexalmass/fullnessortendernessinadenexaorcervicaltenderness.

2Ectopicpregnanciescanbediagnosedwithacarefulhistory,examinationandUSG.SinceitisanobstetricUSG,itmustbedoneinaccordancewithPCPNDTAct.

Symptoms during ectopic pregnancy might include:•Amenorrhea•Nausea,vomiting•Lowerabdominalpain,usuallyone-sided,thatmaybesuddenandintense,persistent,orcramping• Irregularvaginalbleedingorspotting• Faintingordizzinessthatpersistsformorethanafewsecondsispossiblyindicativeofinternalbleeding.Internalbleedingisnotnecessarilyaccompaniedbyvaginalbleeding

Signs•Uterinesizethatissmallerthanexpected•Palpableadenexalmass•Tendercervicalmovements Inadditiontotheabovesymptomsandsigns,ruleoutectopicpregnancywhileperformingvacuumaspirationifnoPOCevacuatedaftertheprocedure

Whenectopicpregnancyissuspected,referthewomanassoonaspossibletoahigherfacilityforconfirmationofdiagnosisandinitiatingtreatment.Uterine evacuation methods whether vacuum aspiration or medical methods using Mifepristone and Misoprostol, cannot terminate an ectopic pregnancy and hence should not be attempted in case of suspicion.

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4. Contraceptive Options

Woman’sacceptanceforcontraceptivemethodshouldnotbeapre-conditionforprovidingabortionservices.Allpostabortioncontraceptiveoptionsshouldbediscussedwithherandsheshouldbehelpedtochoosetheappropriatecontraceptionforherself.

5. Investigations (Recommended)

• Haemoglobin

• Routineurineexamination

• BloodGroup:ABORhespeciallyinprimigravida.

• Pregnancytest

Investigations (Optional)

Ultrasonography (USG): ItisnotmandatorytoperformUSGforallwomenundergoingterminationofpregnancywithmedicalmethods.Itcan,however,beperformedunderfollowingconditions:

• WomenunsureofLMPorhaveconceivedduringlactationalamenorrhea

• Womenwithdiscrepancybetweenhistoryandclinicalfindings

• Womenwithsuspicionofectopicpregnancy

• Provideruncertainafterbimanualexamination,or inabilitytomeasureuterinesizeduetoobesity,pelvicdiscomfort,oranuncooperativewoman

6. Informed Consent

Gettheconsentofthewoman/guardianinFormC.AlsofillintheRMPOpinionForm(FormI),beforeprescribingMMAdrugs.

7. Tablet Mifepristone (200mg) is administered orally

Anti-D(50mcg)giventoRhnegativewoman.

8. Iron and Folic Acid Tablets

180tablets(tobetakenfornextsixmonths)shouldbegiventoallwomenundergoingMMAprocedure.

9. Sanitary Napkins

TwopacketsofsanitarynapkinscouldbeprovidedtoallwomenundergoingMMA.

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10. Antibiotics

Routineuseofprophylacticantibioticsisnotindicatedexceptincasesofnulliparouswomen.Antibioticsshouldalsobegiventowomenwithvaginalinfections.RecommendedantibioticsareDoxycycline100mg,twiceadayforfivedaysfornon-lactatingwomen,andAzithromycin500mg,onceadayforthreedaysforlactatingwomen.

11. Give contact address and phone number oftheserviceprovider/facilitywherewomancangoincaseofanemergency.

12. Complete the MMA follow-up card

ExplaintheMMAfollow-upcard(Annexure4)tothewomanandinstructhertonotedownhersymptomsonit.

Atthesolediscretionoftheserviceprovider,awomancanbegivenMisoprostoltobetakenathome.Insuchcases,athoroughcounsellingonwhatisexpectedaftertakingMisoprostol,shouldbedone.Sheshouldbecalledbackon15thdayforfollowup.

ThetablebelowsummarizesthetasksforDay1oftheMMAprotocol:

Table 3: Tasks for Day 1/Day of Mifepristone Administration

Provider’s task Instructions to the woman• Detailed history, rule out contraindications and

notespecialprecautions

• Generalcounselling

• MMAspecificcounselling

• Discusscontraceptiveoptionswithher

• Completephysicalandpelvicexamination

• ObtaininformedconsentinForm-C.

• FillinFormI.

• Recordinvestigations

• TabletMifepristone200mg,tobetakenorally

• CompleteMMAfollow-upcard

• Give contact address and phone number for anyemergency

• Give180tabletsofIronandFolicAcid

• Give2packetsofsanitarynapkins

• RecorddetailsinAdmissionRegister

• ExplainwhattoexpectaftertakingtabletMifepristone

• She must return for Misoprostoladministration after two days(unless the service providerdecidesforhomeadministrationofMisoprostol)

• She may have pain and bleedingduringthesetwodays

• TaketabletIbuprofentorelievethepain

• Avoid intercourse or use barriermethod,suchascondoms

• Report to the center/provider incase of excessive bleeding/acuteabdominalpain

• RecordanyexperienceofsideeffectsontheMMAfollow-upcard

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16 Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Second Visit/Day 3/Day of Misoprostol Administration

1) Note any history of bleeding/pain or any other side effects after tablet Mifepristone: Some womenwillstartbleedingaftertheadministrationoftabletMifepristone.

2) Administer Misoprostol:Askthewomantoemptythebladder.Give/inserttwotabletsof200mcgMisoprostol(total400mcg)bysublingual/buccal/vaginal/oralroute.Askhertolieinbedforhalfanhouraftervaginalinsertion.

Ifshevomitstabletmisoprostolwithinhalfanhourofitsintake,thesamedosage(400mcgmisoprostol)shouldberepeated.

3) Observe the woman for four hours after Misoprostol administration in the clinic/hospital and monitor:

i. Pulseandbloodpressure

ii. Timeofstartofbleedingandexpulsionofproducts(ifitoccurs)

iii. Sideeffectsofthedrugs(e.g.chills)

4) Medication for pain relief: Usually the pain starts within one to three hours of takingMisoprostol,soanalgesiccanbetakenwell intimebeforepainbecomesintolerable.Tablet Ibuprofen 400 mg is recommended.ParacetamolisnotrecommendedforpainreliefduringtheprocessofMMA.Ifpaindoesnotsubsideontakingdrugs,thepossibilityofectopicpregnancyshould be ruled out. Receiving complete informationduring counselling and reassuranceduringtheprocesshelpsthewomantotoleratepainbetter.

5) Perform pelvic examinationbeforethewomanleavestheclinicandifcervicalosisopenandproductsarepartiallyexpelled,removethemdigitally.SheshouldbeobservedforanotherfewhoursortilltheexpulsionofthePOCiscomplete

6) In case the woman does not abort at the health centre or takes Misoprostol at home, inform her about:

• Reporting back to the center/service provider in case of excessive bleeding/acuteabdominalpain

• Warningsignsandsymptoms(givenonpage22)

• Usingcleansanitarynapkins

• Avoidingtamponsanddouche

• Reportingback if there isnobleedingeven24hoursafter takingMisoprostol (refer tofigure9fornextsteps)

• Sideeffectssuchasnausea,vomiting,diarrhoea(usuallymild),headache,fever,dizziness

• Returningforfollow-uponthe15thday

• KeepfillingtheMMAfollowupcard

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17Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Figure 9: Plan of action if there is no bleeding 24 hours after administration of Misoprostol

The table below summarizes the tasks for Day 3 of the MMA protocol:

Table 4: Tasks for day 3/Day of Misoprostol administration

Provider’s task Instructions to the woman• Note bleeding/pain or other side

effectsaftertabletMifepristone

• Give two tablets of Misoprostol (400mcg) sublingual/buccal/vaginal/oral

• Observeherforfourtosixhoursintheclinic

• Prescribe tablet Ibuprofen for painrelief

• Bimanual examination just beforedischargefromthefacility

• Antiemetic and anti-diarrhoeal drugs could be prescribed

• Explain what to expect after takingMisoprostol

• OCP can be started, if chosen as acontraceptivemethod

• Lieinbedfor30minutesaftervaginalinsertionofMisoprostol

• She can have side effects such as nausea,vomiting,diarrhoea,headache,fever,dizziness,fatigue

• Avoidintercoursetillbleedingstops

• Usecleansanitarynapkinsandavoid tamponsand douche

• Avoidgoingoutofstationtillthirdvisit

• She should report in case of:

• Nobleeding24hoursafterMisoprostolintake

•Excessive bleeding, i.e. soaking twoormorethickpadsperhourfortwohourscontinuously

• Fever more than 24 hours after Misoprostoladministration

• Returnforfollow-uponthe15thday

• KeepfillingtheMMAfollow-upcard

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18 Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Third Visit/Day 15/Follow-up Visit

1) Noterelevanthistory/checkMMAfollow-upcard

2) Carry out pelvic examination to ensure completion of abortion process/continuation ofpregnancy

3) Reiteratecontraceptivecounsellingandservices

4) AdviseUSGif

• completeexpulsionofPOCnotconfirmed

• continuationofpregnancysuspected

• bleedingcontinues

5) Askthewomantoreportbackiftherearenoperiodswithinsixweeks

ThetablebelowsummarizesthetasksforDay15oftheMMAprotocol:

Table 5: Tasks for Day 15/Follow up visit

Provider’s task Instructions to the woman• Note history of bleeding/pain in abdomen/

expulsionofPOC

• Pelvic examination to rule out continuation ofpregnancy.USG,ifindicated

• Reiteratecontraceptivecounsellingandservices

• Contraceptiveadviceasperthemethodchosen

• Report back if there are no periodswithin sixweeksof the completionoftheabortionprocess

5.3: Post MMA Contraception• Hormonalmethods,whethercombined(estrogenandprogestogen)orprogestin-only,canbe

startedonthedayoftheMisoprostoladministration(day3)orday15oftheMMAregimen.InjectablehormonalmethodslikeDepotMedroxyProgesteroneAcetate(DMPA)canalsobestartedonday3or15oftheMMAregime.

• IUCDcanbeinsertedafterconfirmedcompleteabortion,providedthepresenceofinfectionisruledout,onday15.

• Condomscanbeusedassoonassheresumessexualactivityafterabortion

• Tuballigationcanbedoneafterthefirstmenstrualcycle.However,ifdesirousofconcurrenttuballigation,vacuumaspirationispreferred

• Vasectomy,ifchosen,canbedoneindependentoftheprocedure

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19Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

6.1: Side Effects

Figure 10: Side effects with MMA drugs – headache, vomiting

Common side effects experienced with MMA are:

a) Gastrointestinalsideeffects

b) Fever,warmthandchills

c) Headacheanddizziness

• Gastrointestinal Side Effects: Diarrhoea,nauseaandvomitingarecommonlyreportedbywomenfollowingtheuseofMisoprostol.Thesesideeffectsaremildandself-limitingandpassoffwithoutanytreatment.Antiemeticandanti-diarrhoealmedicinesmaybeprescribedwhenneeded.ORScanbegivenifvomitingordiarrhoeaissevere.Tab.Loperamidemaybeprescribedfordiarrhoea.(butwithcaution)

• Fever, Warmth and Chills: Fever, feeling of warmth and chills are short-lived and self-limitingsideeffects.Treatmentisgenerallynotrequiredbutthewomanshouldknowthatshemayexperience thesesymptoms.Post-abortion infection is rareafterMMA.Persistentfever(>38°cfortworeadingsfourhourapart)mayindicateinfectionandmustbeevaluatedandtreatedaccordingly.

6Section

Side Effects and Complications with MMA and their Management

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• Headache and Dizziness: SomewomenduringtheprocessofMMAreportheadacheanddizziness. Headache is treated with non-narcotic analgesics and mild dizziness of shortduration is managed by hydration. Advise the woman to take plenty of fluids, rest andexercisecautionwhilechangingposition.

6.2: Complications and their Management

Potential complications associated with MMA are:

A. Excessivevaginalbleeding

B. Incompleteabortion

C. Continuationofpregnancy

D. Infection

Table 6: Incidence of complications in MMA

Complications IncidenceHeavybleedingrequiringvacuumaspiration 1–2%Incompleteabortionrequiringothermethodsofevacuation 1–2%Continuationofpregnancy 1–2%Heavybleedingrequiringbloodtransfusion 0.1–0.2%

A. Excessive Vaginal Bleeding

• Soakingtwoormorethickpadsperhourfortwoconsecutivehoursneedclosemonitoringofthewoman.Inthiscondition,sheshouldreporttothefacility.Conductexamination,includingbimanualexamination,toruleoutincompleteabortionandassessforhypovolemia.

• Fluidreplacement:IVinfusionwithRingersLactatesolution30dropsperminuteshouldbestarted.Simultaneously,prepareforevacuationoftheuterus.Insomecases,bloodtransfusionmayberequired.

B. Incomplete Abortion

• Generally,thereisexcessive/continuedbleedinginthecaseofincompleteabortion.Assesshervitalparameters:

1. Ifherconditionisunstable,resuscitateandstabilize.Stabilizationshouldbefollowedbyexaminationandfurthermanagement.

2. Ifherconditionisstable,proceedwiththeexamination:

a. IfPOCisfeltattheos,managewithdigitalevacuationorwithovumforcepsfollowedbyvacuumaspiration

b. Ifnoproductsarefeltattheos,decidethelineofmanagementbasedontheclinicalsymptoms,pelvicexaminationandUSGfindings:

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i. If the gestation sac is visible but is non-viable, then an additional dose of Misoprostol (dosage given below) may be offered to the woman. Wait for the pregnancy to be expelled with time. The woman should be counselled to return to the clinic after one week to ensure that the abortion is complete.

One dose of Misoprostol 600 mcg oral or 400 mcg sublingual can be repeated in such cases of incomplete abortion. If bleeding continues even after an additional dose of Misoprostol, perform vacuum aspiration.

ii. If no gestation sac is visible on USG but bleeding continues due to decidual bits in the uterine cavity, manage conservatively, without any medication or intervention as these are expelled spontaneously in most cases. An additional visit after seven days will have to be planned to ensure completion of the process.

If bleeding is profuse at any time during this process, vacuum aspiration may have to be done.

iii. If USG shows viable gestation sac, pregnancy should be terminated by vacuum aspiration.

Treatment of Incomplete Abortion

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C. Continuation of Pregnancy

IfthepregnancycontinuestogrowdespitetakingdrugsforMMA,itindicatesthatthedrugswereineffective.Insuchcases,thepregnancyhastobeterminatedbyvacuumaspirationinviewoftheteratogeniceffectofthedrugs3.

D. Infection

InfectionofuterusisrareintheprocessofMMA.Ifthewomanhassymptomssuchasfever,chills,foul-smellingdischargeorbleedingandpaininlowerabdomen,uterineinfectionmaybesuspected.StartbroadspectrumantibioticsassoonaspossibleandremovethePOC,usingvacuumaspiration.TherecommendedantibioticsareDoxycycline100mg,twiceadayforfivedaysfornon-lactatingwomen,andAzithromycin500mg,onceadayforthreedaysforlactatingwomen.

6.3: Warning Symptoms and Signs

ThewarningsymptomsandsignsduringtheMMAprocess,forwhichsheshouldimmediatelycontacttheserviceproviderorfacilityshouldbeexplainedtothewoman.Signsandsymptomsareasbelow:

• Excessivebleeding,soakingtwothickpadsinanhourfortwoconsecutivehours

• Persistentseverepainabdomen

• Faintingattacks

• No/minimalbleedingaftertheadministrationofMisoprostol

• NoperiodsaftersixweeksofthecompletionofMMAprocess

3DataoncontinuingpregnancyafterMifepristoneexposurewithoutMisoprostolarelimited.TheassociationbetweenMisoprostolandcongenitalanomaliesisbetterestablished.ThemosttypicalmalformationsassociatedwithMisoprostoluseareMöbiussyndrome,araredisorderofcranialnervepalsiesassociatedwithlimbanomaliesandcraniofacialdefects,andterminaltransverselimbdefects.Althoughnotclearlyestablished,theproposedmechanismisvasculardisruptionduetouterinecontractionsleadingtodisorderedfetaldevelopment

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7.1: Safety

MifepristoneandMisoprostolaresafedrugsforterminatingpregnancyaslongasthewomandoesnothaveanycontraindicationsfortheiruse.

7.2: Effectiveness

AcombinationofMifepristoneandMisoprostolhasaneffectivenessof95–99%forterminationofearlypregnancyuptosevenweeks.

Failed abortion:Womenwithcontinuedsignsofpregnancyorclinicalsignsoffailedabortionshouldbeofferedvacuumaspirationasexpeditiouslyaspossible.

Vacuumaspirationmaybeneededincasesof:

• Ongoingpregnancy

• Excessivebleeding

• Ifabortionprocessisincompleteatthetimeoffollowupvisitandtheserviceproviderorthewomandoesnotwanttowaitanylonger

7Section

Safety & Effectiveness

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24 Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Though,bothvacuumaspirationaswellasmedicalmethodsaresafetechnologies,bothhavetheirdistinctfeatures.Keyfeaturesareenumeratedbelow:

Table 7: Comparison of VA and MMA

Feature Vacuum Aspiration Medical Methods of AbortionTechniqueused POCevacuatedthrougha

cannulaattachedtovacuumsource(manualorelectric)

POCexpelledwithdrugs(Mifepristone&Misoprostol);anon-surgicalmethod

Gestationlimitofthetechnique

Usedupto12weeksofpregnancy

Usedupto7weeksofpregnancy(forpublicsectorsites)

Effectiveness Morethan98%effective 95-99%effectiveTimetakenforprocedurecompletion

5-15minutes Inmajorityofcases,processofabortiongetscompletedwithin4–6hoursofMisoprostoladministration.However,thebleedingmaycontinueupto8–13daysinsomecases.

POC Check POC are examined and confirmedimmediately

POCmaybeexpelledathome

Mandatoryvisitsfortheprocedure

Onevisit Requireminimum3visits(2visitsincaseofhomeadministrationofMisoprostol)

Paincontrolmedicationused

Localanaesthesia&oralanalgesics

Ibuprofengivenorally

Proceduredoneby Trainedhealthcareprovider

Drugsprescribedbytrainedhealthcareprovider

Riskofcervicalanduterineinjury

Possiblebutrare Noriskofinjurytocervixanduterussincenoinstrumentationisdone

Post-procedurebleeding

Minimal* Post–medicationbleedingcouldbeheavy(esp.afterMisoprostol)*

8Section

Comparison: VA and MMA Procedure

*ThoughbleedingisheavyafterMisoprostoladministrationinMMA,overallbloodlossiscomparableinVAandMMA.

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25Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Feature Vacuum Aspiration Medical Methods of AbortionPost–procedurepain

Remainsforaveryshortperiod

Paincouldbeintenseduringtheactualprocessofexpulsion

Hospitalstay Fewhours FewhoursoneachvisitRiskoffetalmalformation

None Potentialriskexists,ifthemethodfailsandpregnancycontinues

Acceptabilitytowomen

• doneasadaycare-procedure

• womanawakeduringtheprocedure

• non-invasivetechnology

• moreprivate;closetonaturalmiscarriage

• nohospitalization

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26 Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Reorientation on Medical Methods of Abortion

Suggested Agenda

Time Topic9.30–10.00a.m. Registration,Pretest10:00–10:15a.m. Objectiveoftheworkshop

BriefontheMMAhandbook10.15–10.45a.m. OverviewofMMA10.45–11.15a.m. MTPAct&MMA11.15–12.00Noon MMAprocessandprotocol

Sideeffectsandfollow-up12.00–12.45p.m. Counsellingandeligibilityscreening12.45–13.30p.m. Casestudiesformanagementofcomplications13.30–14.15p.m. Demonstration ofMMA follow-up card,MMA ready reckoner,MMA

sitesignage,Documentationformats14.15–14.30p.m. Posttest14.30 p.m. Discussion&Questions

9Section

Suggested MMA Reorientation Schedule (For MTP certified providers)

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References

• WorldHealthOrganization(WHO)2012.Safeabortion:Technicalandpolicyguidanceforhealthsystems.Geneva,WHO.

• Ministry of Health & Family Welfare (MoHFW), Government of India: ComprehensiveAbortionCareTrainingandServiceDeliveryGuidelines2010(2ndedition2014).MoHFW.

• Ministry of Health & Family Welfare (MoHFW), Government of India: ComprehensiveAbortionCareTrainingPackage,2014.MoHFW.

• World Health Organization (WHO) 2014: Clinical practice handbook for Safe Abortions.GenevaWHO.

• Prof Suneeta Mittal, Director in charge, WHO CCR in Human Reproduction, All IndiaInstitute of Medical Sciences, MoHFW, Government of India, 2007: Guidelines for earlymedicalabortioninIndiausingMifepristoneandMisoprostol.

• ShaguftaPraveenetal:Comparisonofsublingual,vaginal,andoralmisoprostolincervicalripeningforfirsttrimesterabortion.IndianJPharmacol.2011Apr;43(2):172–175.

• SOGSclinicalpracticeguidelinesNo.133,September2003.

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Annexure – 1Medical Methods of Abortion: Skills Checklist

Day 1: Skills for first visit to clinic (Mifepristone administration) Yes NoPre-procedure tasksGreetsthewomaninafriendly,respectfulmanner;ensuresprivacyConfirmswithherthatshewantstoterminateherpregnancyExplainswhattoexpectduringtheclinicvisitAsksifshehascomewithsomeone,andifshewouldlikethatpersontojoinherinthecounsellingAsksabouthergeneralandreproductivehealthandmedicalhistoryExplainswhichabortionmethodsareavailable,includingcharacteristics,effectivenessandthevisitsrequiredConfirmsthatsheiseligibleforMMA(pregnancyuptosevenweeks)IfthewomanchoosesMMA,providesmoreinformationonthemethodinsimpletermsClarifiesthewoman‘sfeelingsonthepossibilityofhavingtheabortionathomeandaskswhatsupportshehasathomeEnsuresthatsheunderstands:

•Commonsideeffectsandsymptoms

•Importanceofattendingrequiredclinicvisits

•WarningsignsindicatingtheneedtoreturntotheclinicExplainshowMifepristoneandMisoprostolwillbeadministeredandwhattoexpectaftertakingitExplainsthatiftheMMAfails,vacuumaspirationwillbenecessarytoterminatethepregnancyAsksthewomanwhethershehasadditionalquestionsObtainswritteninformedconsentProvides first dose for MMAProvidesMifepristone(onetablet200mg)orallyPost-procedure tasksExplainshowtotakepainmanagementmedication(Ibuprofen)ExplainswhattodoincaseofproblemsExplainshowtorecordthesideeffectsexperienced,ifany,ontheMMAfollow-upcardGivesthewomantheaddressandtelephonenumberoftheclinicwhereshemaygoincaseofanemergencyAskshertoreturntotheclinicfortheseconddoseaftertwodays

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Day 3: Skills for second visit to clinic (Misoprostol administration) Yes NoPre-procedure tasksGreetsthewomaninafriendly,respectfulmanner;ensuresprivacyEnquires about her experience after taking Mifepristone (bleeding,passageofPOC,discomfort,sideeffects).Checksthefollow-upcardExplainswhattoexpectduringthisvisitProvides second dose for MMAAdministers Misoprostol in clinic : two tablets of 200 mcg each,sublingual/buccal/vaginal/oralPost-procedure tasksAsksthewomantorestintheclinicforfourhoursObservesthewomanforbleeding,cramping,expulsionofPOCIfthewomanleavestheclinicbeforesheaborts,givesherinstructionsand supplies (pain medication, written instructions) for aborting athomeExplainshowtorecordherexperienceofanysideeffectonthefollow-upcardandremindsheroftheaddressandcontactnumberoftheclinictovisitincaseofanemergencyRecords the date of Misoprostol administration and counsels thewomantocomeforafollow-upvisitonday15Reviewsafter-careinstructionsandprovidesinformationonwarningsignswhich indicate theneed to return to the clinicor seekmedicalassistanceAsksthewomanifshehasanyadditionalquestionsandclarifiesthemDay 15: Skills for third visit to clinic (Follow-up visit) Yes NoGreetsthewomaninafriendly,respectfulmanner;ensuresprivacyEnquiresaboutherexperienceoftheabortionprocess,asksherifshesawtheexpulsionofanyPOCandfeelsthattheabortioniscompleteAskswhethersheisstillhavingsymptomsofpregnancyExplainswhattoexpectduringthisfollow-upvisitAssessment to ensure abortion is completeAssessesthecompletenessoftheabortionby:

• Takingahistoryof theabortionprocess (amountanddurationofbleeding,sideeffects,cramping,anyvisiblepartsofPOCexpelled)

• Conducting a physical examination (pelvic examination to assessthesizeandconsistencyoftheuterus)

• Advising/performinganultrasound, for thepresenceofgestationsac,ifitisstillunclearwhethertheabortioniscomplete

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• Iftheabortionisnotcomplete,discussestreatmentoptions:

• Expectantmanagement; additionalMisoprostol administration;orvacuumaspiration

• Ifthepregnancyiscontinuing:

• Discussesneedforvacuumaspirationtoterminateit

• ArrangestocompletetheprocedurebyVAIftheabortioniscomplete:

• Providesinformationaboutreturntofertility

• Explainsrisksofrepeatedinducedabortions

• CounselsregardingcontraceptivemethodsAsksthewomanifshehasanyadditionalquestionsandclarifiesthemTellsher that she cancomeback to the clinicwhenever shehasanyproblemordoesnothaveherperiodswithin6weeks

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Annexure – 2Essential Equipment, Instruments, Drugs and

Consumables for MMA

Item PHC

2 MMA

CHC

3 MMA

SDH/RH

3 MMA

DH

10 MMA1 Equipment 1.1 Gynaeexaminationtable 1 1 1 11.2 Screen/curtainforprivacy 1 1 1 11.3 Footstep 1 1 1 11.4 Autoclave 1 1 1 11.5 Boiler 1 1 1 12 Instruments 2.1 Cusco’sspeculum(medium&largesize) 3 3 4 10 3 Drugs 3.1 Analgesics–TabIbuprofen 20 20 20 1003.2 TabMisoprostol(200mcg) 8 12 12 403.3 TabMifepristone(200mg) 2 3 3 103.4 TabDoxycycline(100mg) 20 20 20 403.5 CapAzithromycin(500mg) 3 6 6 123.6 5%Dextrose 2 2 5 103.7 Ringerlactate 5 10 10 203.8 Normalsaline 5 10 10 204 Consumables 4.1 Utilitygloves 2 2 2 34.2 Cotton/gauze(packets) 2 2 2 2 4.3 I/Vsets 2 3 3 104.4 I/Vcannula/scalpveinsets 2 3 3 20104.5 PovidoneIodinesolutionbottles 2 4 4 104.6 Bleachingpowder 4.7 Disposablesyringes(2ml) 4 10 10 254.8 Surgicalgloves(pairs) 10 15 15 50

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Annexure – 3Documentation Formats

CONSENT FORM

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tick (3) the one which is appropriate.

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only)

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Form III(Seeregulation5)

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36 Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

Annexure – 4

MMA Follow up Card

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Annexure – 5

Medical Methods of Abortion (MMA) Reorientation

Pre-training Assessment

Statement True False1. MMA is a safe alternativemethod to vacuumaspiration to terminate

earlypregnancy.2. MMAmayaffectthewoman'sfuturefertilityadversely.3. Physical examination of thewoman is not required before providing

MMAservices.4. Awrittenconsentofthewomanseekingmedicalmethodsofabortionis

mandatoryontheprescribedformat.5. AminimumoffourvisitsarerecommendedtocompletetheGovernment

ofIndia’sstandardMMAdrugprotocol.6. Only a Registered Medical Practitioner, as under the MTP Act can

prescribeMMAdrugs7. Fertilitycanreturnwithin10daysofanabortion.8. After MMA, most of the contraceptive methods can be started

immediatelyafterconfirmingthattheabortioniscomplete.9. MMAdrugscancausecongenitalanomalies.10. SaleofMMAdrugsoverthecounterislegallyallowedinIndia.

Please encircle the correct answer in the following questions:

11.WhichofthefollowingisrecommendedforpainmanagementduringMMA?

a) TabletParacetamol

b) TabletIbuprofen

c) InjectionDiazepam

d) Paracervicalblock

12.WhichofthefollowingistheLEASTeffectiverouteforMisoprostoladministrationduringtheMMAprocess:

i. Sublingual

ii. Vaginal

iii. Oral

iv. Buccal

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13. WhichcontraceptivemethodscanbestartedonthedayoftakingMisoprostol?

a) Oralpills

b) Tubectomy

c) IUCDs

d) Vasectomy

14.OnlywaytomanageanincompleteabortionduringtheprocessofMMAis:

• Vacuumaspiration

• RepeatdoseofMisoprostol

• Eitherofthetwodependingontheseverityofbleeding

15. IfpregnancycontinuesafterMMA,itshouldbeterminatedbyarepeatdoseofMMAdrugs:

• True

• False

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Medical Methods of Abortion (MMA) Reorientation

Post-training Assessment

Please encircle the correct answer in the following questions:

1. Whatare thepreferredmethods foruterineevacuation in thefirst trimesterofpregnancyaccordingtotheWorldHealthOrganization(WHO)?

a) Medicalabortiononly

b) Sharpcurettage

c) VacuumAspirationandMedicalAbortion

d) Uterotonicinstillation

2. EffectivenessofMedicalMethodsofAbortionforpregnancyuptosevenweeksis:

a. 95-99%

b. 80%

c. 82-83%

3. InIndia, it is legaltobuytabletsofMifepristoneandMisoprostolover-the-counterfromachemistshop:

a. True

b. False

4. WhichofthefollowingarecontraindicationstoMMA?

a) Suspectedectopicpregnancy

b) HIV/AIDS

c) Breastfeeding

d) Multiplepregnancy

5. InformationtowomenonMMAshouldinclude:

a) Therangeofexpectedbleeding

b) PossiblesideeffectsaftertakingMisoprostol

c) Warningsignsforwhichthewomanshouldcontactherprovider

d) Alloftheabove

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6. GovernmentofIndia’sstandardMMAdrugprotocol(forgestationupto49days)is:

a) 600mgMisoprostolfollowed2dayslaterby400mcgMifepristonevaginal/sublingual

b) 200mgMifepristoneorally followed2days laterby400mcgMisoprostol sublingual/buccal/vaginal/oral

c) 600mgMifepristoneorallyfollowed2dayslaterby400mcgMisoprostoloral/vaginal

d) 200mgMisoprostolorallyfollowed2dayslaterby800mcgMifepristonevaginal/buccal

7. WhichofthefollowingistheLEASTeffectiverouteforMisoprostoladministrationduringtheMMAprocess:

i. Sublingual

ii. Vaginal

iii. Oral

iv. Buccal

8. WhichofthefollowingisrecommendedforpainmanagementduringMMA?

a. TabletParacetamol

b. TabletIbuprofen

c. InjectionDiazepam

d. Paracervicalblock

9. AfterMisoprostoladministration,mostwomenabortwithin:

a.4hours

b.½hour

c. 1 hour

d.oneday

10. AftergivingMisoprostol,thewomanshouldbecalledforfollow-uponwhichday:

a.5th

b.15th

c.7th

d.10th

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41Handbook on Medical Methods of Abortion to Expand Access to New Technologies for Safe Abortion

11.WhichcontraceptivemethodscanbestartedonthedayoftakingMisoprostol?

a. Oralpills

b. Tubectomy

c. IUCDs

d. Vasectomy

12.WhatarethesymptomssuggestiveofcomplicationsduringMMAprocess?

a) Excessivebleeding,soakingmorethantwothickpadsperhourfortwoconsecutivehours

b) FeveranydayafterthedayMisoprostolisused

c) Unusualorfoul-smellingvaginaldischarge

d) Alloftheabove

13.PossiblecomplicationswithMMAinclude:

a) Mildcramping

b) Uterineperforation

c) Continuationofpregnancy

d) Injurytocervixanduterus

14.MMAdrugshavebeendesignatedbytheDrugControllerGeneralofIndiaas:

a. Schedule K

b. ScheduleH

c. Schedule X

d. Schedule G

15.DocumentationoftheMMAprocedureisdoneinthefollowingformats:

a. FormC

b. RMPOpinionForm

c. Admissionregister

d. Alloftheabove

.

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ThehandbookisdisseminatedbyIpasDevelopmentFoundationaspartofoureffortstoimprovequalityofcomprehensiveabortioncareservicesinIndia.

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