pain & medical abortion at home

Pain&medicalabortionathome

TeresaBombas

MD.ObstetricianadGynecologistObstetricServiceA,MedicalUniversityHospitalofCoimbra

PortugueseSocietyofContraceptionPortugal

Concurrentsession2:Hottopicsinabortioncare

From:www.abort-report.eu.

FIAPAC13ºCongress,2018Pain&medicalabortionathome

Womenmaysafelyself-administermisoprostoloutsideofahealthfacility

From:www.abort-report.eu.


Adverseeffectsofmedicalabortion1


1.Clinicalpracticehandbookforsafeabortion.WHO,20142.Cavet S,Fiala C,Scemama A,PartoucheH.Assessment ofpainduringmedicalabortionwithhomeuseofmisoprostol.EurJContraceptReprod HealthCare2017;22(June(3)):207–11,.3.Saurel-CubizollesMJ,OpatowskiM,DavidP,bardy F,Dunbavand A.Painduringmedicalabortion:amulticentrestudy inFrance.Eur JObstet GynecolReprodBiol 2015;194:212–7.4.SchaffEA,FieldingSL,Weshoff C.Randomizedtrialoforalvsvaginalmisoprostol2daysaftermifepristone200mgforabortionupto63daysofgestation.

Contraception2002;66:247–50.

PainBleeding

FeverNausea and vomitingDiarrhoea

üPain is reported by 80-90%of women2,3,4

Mifepristone– prostaglandinsynergisticmechanismofaction

Misoprostol(24h-48h)

Mifepristone

From:Guiochon-Mantel A.Antiprogestatifs — mécanisme d’action.Reprod HumHorm 1999;12:248—53


Background• WomenfrequentlyexperiencepainduringMTOP,sometimesevensevere.

• Most recent guidelines from National, International Societies give ageneral recommendationfor:

Ø routine use of pain medication:• FrenchHealthAuthorities (HAS2010)• UKRoyalCollegeofObstetriciansandGynaecologists (RCOG2015)• Frenchnationalcollegeofobstetriciansandgynecologists (CNGOF2016)• InternationalFederationofGynecologyandObstetrics(FIGO2011)• WorldHealthOrganisation (WHO2014)

Ø onlyas-neededanalgesics:• ExecutiveandBoardoftheSocietyofObstetriciansandGynaecologists ofCanada


Problems• Thereisalackofclearandpracticalguidelinesonmanagementofpainassociatedwithfirst-trimestermedicalabortion

• Assessment ornotthepaininroutinepractice• Controlornottheriskfactors• Bestprotocolformanagementthepain(timingandtypeofanalgesicdrugsinuse)



Pain Assessment

• AccordingtotheWHO,painassessmentshouldbedoneinallcasesofpain,includinganinitialevaluationandongoingreassessment1.

1.WHONormative Guidelines on PainManagement,June 2007

Painduringmedicalabortion,theimpactoftheregimen:Aneglectedissue?Areview

CFiala,SCameron, Tbombas,MParachini,LSaya,KGemzell-Danielsson

TheEuropeanJournal ofContraceptionandReproductiveHealthCare,2014;EarlyOnline:1–17

ObjectivesToevaluatepainandotherearlyadverseeventsassociatedwithdifferent

Methods: The literature was searched for comparative studies of medical abortion usingmifepristone followed by the prostaglandin analogue misoprostol. Publications, whichincluded pain assessment were further analysed.

Results:• 1459 publication on medical abortion up to nine weeks of amenorrhoea only 23

comparative, prospective trials corresponded to the inclusion criteria.• Information on pain level was reported in 12/23 papers (52%),• information regarding systematic administration of analgesics in 12/23 (52%)• information concerning analgesia used was available for only 10/23 (43%).

Conclusion:Neither pain nor its treatment are systematically reported in clinical trials ofmedical abortion;


Painmanagementforupto9weeksmedicalabortion–AninternationalsurveyamongabortionprovidersCFiala,SCameron, T.Bombas,MParachini,AAgostini, RLertxundi,KGemzell-DanielssongEuropeanJournal ofObstetrics&GynecologyandReproductiveBiology225(2018)181–184

Objective:Performaninternationalsurveyamongmedicalabortion providerstodocument thecurrentclinicalpracticeformanagingpaininfirsttrimestermedicalabortion.

• 425providerswereinvitedbyemailtocompletethesurvey,• 362completedthequestionnaires (85%);• 283questionnaireswereanalyzed

Results:68%(n=173)ofrespondents didnotroutinelyassesspain

Forthosewhoroutinelyassessedpain,VisualAnalogue Scale(VAS)wasthemostcommonlyusedtool(n=46,58%).


Managementofpainassociatedwithup-to-9-weeksmedicalterminationofpregnancy(MToP)usingmifepristone-misoprostolregimensExpertconsensusbasedonasystematic literature reviewCFiala,SCameron, TBombas,AAgostini, RLertxundi,Mlubusky, MParachini,LSaya.Btrumbic,KGemzellDanielssonSubmittedforpublication, PLOSONE,august2018

QUESTIONEXPERTGROUPSTATEMENT


Q5.Shouldpainbeassessedduring first-trimester MToPprocess at all?

Itisgoodclinicalpracticetoassesspainduringabortionandbeforeandafter anypainintervention.Itshould alsobeformallyintegratedintomedicalabortionclinicalstudies.

Q6.Ifpainmustbeassessedduring first-trimester MToP,should this assessment besystematic or selective?

There was noagreement betweentheexpertsregardingtheneedforaformalassessment inclinical routine.Fordailypractice,painassessmentcouldbeusefulevenifnotsystematic.


Painmanagement:The value of risk factors ?


CFiala,SCameron, TBombas, AAgostini,RLertxundi, Mlubusky,MParachini, LSaya.Btrumbic, KGemzell DanielssonManagementofpainassociatedwithup-to-9-weeksmedicaltermination ofpregnancy(MToP)usingmifepristone-misoprostol regimensExpert consensusbasedonasystematic literature review Submittedforpublication, PLOSONE,august2018

- Highgestationalage- Youngerage- LowParity

• There is no difference between misoprostol at home and misoprostol athospital

ü the predictive value of these factors is insufficient to definespecial/individual pain management


From:Bettahar K, Pinton A, Boisramé T, Cavillon V, Wylomanski S, Nisand I, Hassoun D . Medical induced abortionJ Gynecol Obstet Biol Reprod (Paris). 2016 Dec;45(10):1490-1514..

Predictive factors forpain ocorrence /intensity

Painmanagementforupto9weeksmedicalabortion–AninternationalsurveyamongabortionprovidersCFiala,SCameron, T.Bombas,MParachini,AAgostini, RLertxundi,KGemzell-DanielssongEuropean Journal of Obstetrics & Gynecology and Reproductive Biology 225 (2018) 181–184

Results:

• 84%(n=220)didnotchangepainmanagementwithgestationalage• 67%(n=173)reportednochangeaccordingtotheplaceofmisoprostol

administration.

FIAPAC13ºCongress, 2018Concurrentsession2:HottopicsinabortioncarePain&medicalabortionathome

Pain duringmedicalabortion:amulticenter study inFranceSaurel-Cubizolles, MOpatowski,PDavid,FBardy,ADunbavandEuropeanJournalofObstetrics&GynecologyandReproductiveBiology194 (2015)212–217

Objective:Tocomparethelevelofpainreportedbywomenbydoseofmifepristone, 200or600mg, (inthe5daysafteramedicalabortion)Studydesign:Observationalstudyin11medicalcentersinFrancebetweenOctober2013andSeptember2014.

Theprotocolswere:Day1:200or600mgorallymifepristoneDay3:400,600or800mgorallymisoprostol

Womenreturnedaquestionnaire thattheycompletedduring5daysfollowing theabortion;painwasrecordedonavisualanalogscale(0–10)daily.



Results:453womenwereincluded;themeanagewas29years(range18–49years).Nodifferenceonpainlevelwith400µg,600µg,800µgofmisoprostol

Thepainduring the5dayswasmorefrequent forwomenwhohadearlyabortion (<5weeks)orlateabortion (>8weeks).


Riskfactorsforpain: Riskfactorsforseverepain

• women<25yearsold,• gravidityandusualmenstrualpain

• primigravidawomen• womenwhohadpainful

menstruations


ü Theleadclinicalinvestigatorofthisstudyconsidersthat600mgmifepristonedoseisparticularlyofinterestforprimigravidawomenandwomenwhohaddysmenorrheaquotedabove5(i.e.painfulmenstruations).

Conclusions:Themeanpainseverityexperiencedbywomenundergoingmedicalabortionishigh;Itishigherwitharegimenof200mgmifepristone.Thefindingsemphasizetheneedtoimproveanalgesicstrategiesandinvitetooptforaprotocolof600mginsteadof200mgmifepristone.





Q4.Aretherepredictivefactorsforfirst-trimester MtoPassociatedpain occurrence orintensity?

Severalassociationsbetweenvariousfactorsandpaincanbefound.However,thepredictivevalueofthesefactorsisinsufficienttodefinepainmanagementforanindividualwoman.


Paintreatment


From:Clinical practicehandbook forsafeabortion.WHO,2014.

ü There is insufficient data to determine the optimalanalgesic to be used for pain associated with first- trimester

ü FIGO; WHO; RCOG, HAS and CNGOF recommend the use ofNSAIDs

ü NSAIDs were demonstrated nottohaveanynegativeimpactonefficacyofmedicalabortionorthedurationoftheprocedure


Results:• 94%(n=267) reportedanalgesicprescription forallwomen• 82%(n=233)beforepainonset• 6%(n=16)ofrespondents reported thattheyneverprovidedanalgesia

• 97%(226)prescribed-WHO-StepIanalgesics(NSAIDs,paracetamol)• 89,5%(205)Itwasinitiatedshortlybeforeoraftermisoprostol intake• themediantreatmentdurationwas2days[1–20days]


Conclusions:

• Most providers do provide analgesia routinely to women undergoing medicalabortion up to 9 weeks gestation.

• Therewere widespread variations in analgesic regimens used..




WHOanalgesic ladder

WHOModelListofEssentialMedicines,20th edition,2017Non-opioids: acetylsalicylic acid,ibuprofen, paracetamolWeak opioides:codeine,Strong Opioides:fentanyl,morphine,methadone




Q14.Whicharethemostappropriatepharmacologicalagents?

There was little evidence in the literature regarding themost appropriate pharmacological agents. Therefore, theexperts’ consensus is:− First line: prophylaxis: ibuprofen, 400 to 800 mg (useof second line in case of contraindications toNSAIDs)− Second line: opioids: codeine, dihydrocodeine, ormorphine.According to the WHO, patients with severe pain canstart with step 3, and morphine is still the first choice forsevere pain.



TangOS,etal.Misoprostol:pharmacokineticprofiles,effectsontheuterusandside-effects.IntJGynaecol Obstet 2007;99Suppl2:S160-7.

Misoprostol:Pharmacokinetic parameters according tothe route ofadministration

There are2periods of high pain:near the intake of misoprotoland at the expulsion

Should analgesic treatment beprophylacticorcurative?


Bledding and pain aftermisoprostol administration

Thereisapicofpainbetween1and3haftermisoprostol intake

JacksonAV,DayanandaI,FortinJM,etal.Canwomenaccuratelyassess theoutcomeofmedicalabortionbasedonsymptomsalone?Contraception2012;85:192—7.

Should analgesic treatment beprophylacticorcurative?


Drug Ibuprofen Opioid:Paracetamol+codeine

Tramadol

Posology 400mg-600mg(4-4h)max6perday

1-2cp(400mg/30mg)Max4perday

100mg(6-6h)max4perday

Contra-indication LESsevereCardiacdiseaseHepato-celulardisesaseGastriculcer

AsmaHipersensibilty tocodeine

LungdiseaseSevereHepato-celular disesase

Timeforclinicaleffect

90minutes 60minutesforcodeine

120minutes

Analgesic terapy formedicalabortion

From:Bettahar K, Pinton A, Boisramé T, Cavillon V, Wylomanski S, Nisand I, Hassoun D . Medical induced abortionJ Gynecol Obstet Biol Reprod (Paris). 2016 Dec;45(10):1490-1514..


Prophylactic ComparedWith Therapeutic Ibuprofen AnalgesiainFirst TrimesterMedicalAbortion:ARandomized Controlled TrialElizabeth G. Raymond, MD, MPH, Mark A. Weaver, PhD, Karmen S. Louie, MS, MPH, Gillian Dean, MD, MPH, Lauren Porsch, MPH, E. SteveLichtenberg, MD, MPH, Rose Ali, PA-C, MS, and Michelle Arnesen, MPAS, PA-COBSTETRICS& GYNECOLOGY, VOL. 122, NO. 3, SEPTEMBER 2013

Randomizedparticipants:250• Prophylacticgroup123(follow-updata:111(90%)(1hbeforemisoprostol, Take800mgibuprofen, and one additionaltabletevery4–6hours for48hours)

• Therapeuticgroup:127(follow-updata:117(92%)(every 4–6hoursasneededstartingattheonsetofpain):Max4tablesperday

200 mg mifepristone orally in the clinic followed by 800 micrograms 1–2 days later at home


Prophylactic ComparedWith Therapeutic Ibuprofen AnalgesiainFirst TrimesterMedicalAbortion:ARandomized Controlled TrialElizabeth G. Raymond, MD, MPH, Mark A. Weaver, PhD, Karmen S. Louie, MS, MPH, Gillian Dean, MD, MPH, Lauren Porsch, MPH, E. SteveLichtenberg, MD, MPH, Rose Ali, PA-C, MS, and Michelle Arnesen, MPAS, PA-COBSTETRICS& GYNECOLOGY, VOL. 122, NO. 3, SEPTEMBER 2013

Results:The mean maximum pain scores:

theprophylactic7.1(standarddeviation2.5)therapeuticgroupswere7.3(standarddeviation 2.2),ns

No evidence that pretreatment with high-dose ibuprofen followed by around-the-clockadministration offered any advantage over ibuprofen as needed in reducing pain in first-trimester medical abortion in duration of pain, average daily pain, recalled maximumpain, qualitative pain description, acceptability of pain, and use of alternative analgesicagents




Q11. Should analgesictreatmentbe systematic or selective?

Treatment for pain associated with first-trimester MToPshould be systematic. In addition, women should haveeasy access to additional stepwise pain treatment.

Q12.Should analgesictreatmentbeprophylacticorcurative,andatwhattimeshoulditbetaken?

Limited data suggest that prophylactic treatment is notbetter than only curative, ….. But, expert’srecommendation is that best principles would advisegiving prophylactic analgesia



Nonpharmacological strategies

• Givingdetailedinformationtowomenontheprocedure

• Respectful,non-judgmentalcommunication• Verbalsupportandreassurance

• Thepresenceofasupportpersonwhocanremainwithherduringtheprocess(onlyifshedesiresit)

• Allowinghomeintakeofmisoprostol• Ensuringarelaxingandsupportingenvironment

• Hotwaterbottleorheatingpad

1.Safe Abortion:Technical andPolicyGuidance forHealthSystems.2nded.Geneva:WorldHealthOrganization;20122. Bettahar K, Pinton A, Boisramé T, Cavillon V, Wylomanski S, Nisand I, Hassoun D . Medical induced abortion J Gynecol Obstet Biol Reprod (Paris). 2016 Dec;45(10):1490-1514..


Takehomemessages

• Thereisaclearneedforstandardizedevidencebasedregimensformanagementofpainassociatedwithfirsttrimestermedicalabortion

• Goodcounsellingisimportant

• Theuseofanalgesicbyroutine• Prophylacticuseorattimeofmisoprostolintake• Steptheneeds

• 1ºline:ibuprofen• 2ºline:codeine/tramadol• 3ºlinemorphine

• Includenon-pharmacologicstrategies

Thankyou


From Coimbra,Portugal

pain & medical abortion at home

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