LevoplantLevonorgestrelSubdermal

ContraceptiveImplant

WhatisLevoplant?• Twosmall,flexiblerods

• eachaboutthesizeofamatchstick• Highlyeffectivecontraceptionfor3years• canbeinsertedanytimeaslongasthewomanisnotpregnant

• WorldHealthOrganizationprequalifiedcontraceptiveimplant

Implants

Nexplanon Jadelle Levoplant

Rods 1 2 2

Progestin Etonogestrel68 mg

Levonorgestrel75 mg/rod

Levonorgestrel75 mg/rod

Length 4 cm 4 cm 4 cmDiameter 2 mm 2.4 mm 2.4 mm

Plastic ethylene vinyl acetate Silastic* Silastic*

Approved duration of use 3 years 5 years 3 years

*Polidimetilsiloxanoycopolímero demetilvinilsiloxano

Effectiveness• Levoplant isoneofthemosteffectivecontraceptivemethodsavailable

• Sustainedreleaseofverylowdoseoflevonorgestrelintothebloodstream

• Fewerthan1pregnancyper100women(<1%)occursinthefirstyear

• Forheavierwomen(>80kg),effectivenessofLevoplantmaydecreaseneartheendofthedurationofuse.

• ConsiderreplacingtheirLevoplant implantssoonerthan3years

ModeofAction

Primarymodeofaction:• Productionofthickcervicalmucuswhichpreventsspermpenetration• Inhibitionofovulation– inabout50%ofmenstrualcycles

Othersecondaryactions:• Decreasenaturalprogesteroneproductionbytheovaryduringthepostovulatory(luteal)phaseeveninthosecyclesinwhichovulationoccurs

• Suppressionofendometrialgrowth(hypoplasia)

EfficacyYear Cumulative

Pregnancy Rate

1 0.0-0.1%

2 0.2-0.3%

3 0.0-0.3%

4 0.9-1.1%

5 0.7-2.1%

Steiner, Contraception, 2010

BenefitsofLevoplant• Long-lasting,safeandeffective• Effectivewithin24hoursofinsertion• Doesnotrequireanyfurtheractionafterinsertion• Almostimmediatereturntofertilityonceremoved• Limitedsideeffects• Convenient– doesnotinterferewithnormalactivities,sexualdesire,orintercourse

• Noroutinereturnvisitisrequireduntiltimeofremoval• Noestrogen

Disadvantages

• Needatrainedserviceproviderforinsertionandremoval• Changesinmonthlybleedingpatterns• Implantsmaybevisibleunderskin• Doesnotpreventsexuallytransmittedinfections(STIs)

WhocanuseLevoplant?• Levoplant issafefornearlyallwomen:

• Anyage– teenstoover40years• Withorwithoutchildren• Marriedorunmarried• Recentabortion,miscarriage,orectopicpregnancy• Smokers,regardlessofageornumberofcigarettessmoked• Breastfeeding(canuseLevoplant at6weeksafterchildbirth)• HIVpositive(whetheronantiretroviraltherapyornot)

WhocannotuseLevoplant?

• Levoplant isNOTsuitableforwomenwho:• Maybepregnant• Haveunexplainedvaginalbleeding• Haveasevereliverinfectionortumor• Areonspecialmedication• Haveahistoryofbreastcancer• AllergytolevonorgestrelorothercomponentofLevoplant

Precaution:DrugInteractions

Somedrugsdecreasetheeffectivenessofimplants:

• Anti-epilepsydrugs• Barbiturates(phenobarbital)

• Phenytoin• Carbamazepine• NOTvalproic acid

• Antibiotics:• Rifampin• Griseofulvin

Sideeffects:irregularbleedingpattern

• 800mgibuprofen3timesdailyaftermealsfor5days.• Giveclientcombinedoralcontraceptiveswithethinylestradiolandlevonorgestrel.

• Onepilldailyfor21days.• Or50μg ethinyl estradioldailyfor21days

TreatmentofBleedingEpisodes

Sideeffectsandtheirmanagement(1)SIDEEFFECTS MANAGEMENT

Changes inmenstrualbleedingpattern

800mgibuprofen3timesdailyaftermealsfor5days.Giveclientcombinedoralcontraceptiveswiththeprogestinlevonorgestrel.Askhertotakeonepilldailyfor21days.Or50μgethinyl estradioldailyfor21days

Nausea Try localremediesHeadaches Forregular,notmigraine,headaches,suggest:

• aspirin(325–650mg)• ibuprofen(200–400mg)• paracetamol(325–1000mg)Orotherpainreliever.

Dizziness Suggestirontablets,multivitamins

Sideeffectsandtheirmanagement(2)SIDEEFFECTS MANAGEMENT

Abdominal pain Mildabdominalpain,youcansuggest:• aspirin(325–650mg)• ibuprofen (200–400mg)• paracetamol(325–1000mg),orotherpainreliever.Forsevereabdominalpain:• Investigateforectopicpregnancy• Referatonceforimmediatediagnosisandcare.

Weightchange Reviewdietandexercisepracticesandchanges andcounselaccordingly

Breasttenderness Wearingasupportive bra(dayandnight).Suggest: aspirin(325-650mg), ibuprofen (200-400mg),paracetamol(325-1000mg),orotherpainreliever

Moodchange Ifectopic pregnancyorotherserioushealthcondition issuspected, referatonceforimmediatediagnosisandcare.

Levoplant vsJadelle (1)Levoplant Jadelle

Activeingredient Levonorgestrel Levonorgestrel

Numberof rods 2 2

Durationofuse WHOqualified for3yearsofuse WHOqualified for5yearsofuse

Insertion Sub-dermal insertion inVshapewithtrocar Sub-dermal insertion inVshapewithtrocar

Removal Suggested touseCrile/Kellyforcepsforbothstabilizationandremoval;howeveruseofMosquito forcepsisalsoacceptable

Suggested touseMosquito forcepstostabilizeandCrile/Kellyforcepstoremovetherods

Howitworks 1. Prevents ovulation, sonoeggcanbefertilized

2. Thickenscervicalmucus(blockssperm)

1. Prevents ovulation, sonoeggcanbefertilized

2. Thickenscervicalmucus(blockssperm)

Levoplant vsJadelle (2)Levoplant Jadelle

Howwellitworks Very effective.<1pregnancyper100usersovertimeused

Very effective.<1pregnancyper100usersovertimeused

Sideeffects Bleeding irregularities:noneatall,regular,infrequent, heavyorprolonged orirregularlasting8daysormoreespeciallyinfirstyear

Other: Headaches,abdominalpain,breasttenderness

Bleeding irregularities:noneatall,regular,infrequent, heavyorprolonged orirregularlasting8daysormoreespeciallyinfirstyear

Other: Headaches,abdominalpain,breasttenderness

Usein women>80kg Yes,though replacementbeforemaximumtimemayassurecontinuedeffectiveness

Yes,though replacementbeforemaximumtimemayassurecontinuedeffectiveness

Useduringbreastfeeding

Yes Yes

Questions?

LevoplantMedicalEligibilityClientScreeningandTimeofInsertion

Objectivesofthesession

Bytheendofthesession,participantswillbeableto:• DescribemedicaleligibilityofclientsintendedtouseLevoplant• Screenclientsusingchecklist• Useclinicaljudgmentinspecialcases• AdvisewhenappropriatetoinsertLevoplant

MedicalEligibilityinClientScreeningAsktheclientthefollowingquestions:1. Areyoubreastfeedingababylessthan6weeksold?2. Doyouhavecirrhosisoftheliver,aliverinfection,orlivertumor?3. Doyouhaveaproblemnowwithabloodclotinyourlegsorlungs?4. Doyouhavevaginalbleedingthatisunusualforyou?5. Doyouhaveorhaveyoueverhadbreastcancer?IftheanswerisNO toallofthese,thenproceedforfurtherstepsinscreening.

ClinicalJudgmentinSpecialCasesWomenwithanyoftheconditionsbelowshouldNOTuseLevoplant:1. Breastfeedingandlessthan6weekssincechildbirth2. Severeliverdisease,infection,ortumor3. Acutebloodclotindeepveinsoflegsorlungs4. Unexplainedvaginalbleeding5. Hadbreastcancermorethan5yearsagoandithasnotreturned6. SystemicLupusErythematosuswithpositive(orunknown)anti-

phospholipidantibodies

WhentoInsertLevoplant

IMPORTANT:AwomancanstartusingLevoplant anytimeshewantsifitisreasonablycertainsheisnotpregnant.UsethePregnancyRule-OutChecklisttobereasonablycertainsheisnotpregnant.

Woman’ssituation Whentostart

Havingmenstrual cyclesorswitchingfromanon-hormonalmethod

Ifsheisstartingwithin7daysafterthestartofhermonthlybleeding, noneedforabackupmethod.

Ifitismorethan7daysafterthestartofhermonthlybleeding, shecanhaveLevoplant insertedifreasonablycertainsheisnotpregnant.Shewillneedabackupmethod forthefirst7daysafterinsertion.

IfswitchingfromanIUD,shecanhaveLevoplant inserted immediately.

Switchingfromahormonalmethod

Immediately,ifshehasbeenusingthehormonalmethodconsistentlyandcorrectlyorifitisotherwisereasonablycertainsheisnotpregnant.Noneedtowaitforhernextmonthlybleeding.Noneed forabackupmethod.

Ifsheisswitchingfrom injectables,shecanhaveLevoplant insertedwhentherepeatinjectionwouldhavebeengiven.Noneedforabackupmethod.

Woman’ssituation Whentostart

Fully ornearlyfullybreastfeeding• LESS than6monthsafterchildbirth

Ifshegavebirth lessthan6weeksago,delayinsertionuntilatleast6weeksaftergivingbirth.

IfhermonthlybleedinghasNOT returned, Levoplant canbeinsertedanytimebetween6weeksand6months.Noneed forabackupmethod.

Ifhermonthlybleedinghasreturned, shecanhaveLevoplantinsertedasadvisedforwomenhavingmenstrualcycles (onpreviouspage).

Fullyornearlyfullybreastfeeding• MORE than6months afterchildbirth

IfhermonthlybleedinghasNOTreturned, shecanhaveLevoplantinsertedanytimeitisreasonablycertainsheisnotpregnant.Shewillneedabackupmethod forthefirst7daysafterinsertion

Ifhermonthlybleedinghasreturned, shecanhaveLevoplantinsertedasadvisedforwomenhavingmenstrualcycles

PregnancyRule-OutChecklistforLevoplant

NO 1.Didyourlastmenstrual periodstartwithin thepast7days? YES

NO 2.Haveyouabstainedfrom sexualintercoursesinceyour lastmenstrualperiodordelivery? YES

NO 3.Haveyoubeenusingareliablecontraceptive methodconsistentlyandcorrectlysinceyourlastmenstrualperiodordelivery?

YES

NO 4. Haveyouhadababyinthelast4weeks? YES

NO 5.Didyouhaveababylessthan6monthsago, areyoufullyornearly-fullybreastfeeding,andhaveyouhadnomenstrualperiodsincethen?

YES

NO 6.Haveyouhadamiscarriage orabortion inthepast7days? YES

IftheclientanswerNO toallofthequestions,pregnancycannotberuledoutusingthechecklist.Ruleoutpregnancybyothermeans.

IftheclientansweredYES toatleastoneofthequestions andsheisfreeofsignsorsymptomsofpregnancy,youcanbereasonablysuresheisnotpregnant.

Questions?

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Levoplantcontraceptive

implant

StepsforInsertionandRemoval

BeforeYouBegin

• Alwaysusesterileglovesorforcepswhenhandlingtherods.

• IfaLevoplant rodiscontaminated(forexample,fallsonthefloor),LEAVEITforlaterdisposalandOPENANEWPACKAGEandcontinuewiththeprocedure.

RequiredEquipment

• Anexaminationtable• Sterilesurgicalcloth/drapesandgloves• Antisepticsolution• Localanesthetic,needles,andsyringe• Trocar,forceps• Scalpel(optional)• Skinclosure,sterilegauze,andcompresses

PropertimingforInsertion• Within7daysfromtheonsetofmenstrualbleeding

• Immediatelyorwithin7dayspost-abortion

• Immediatelyorwithin3weekspost-partumifthewomanisnotbreastfeeding

• From6weekspostpartumifthewomanisbreastfeeding

Levoplant withDisposableTrocar&Cannula

• Levoplant isprovidedwithadisposabletrocar

• sharpenoughtopenetratetheskindirectly

• Disposabletrocarcanbeusedtopuncturetheskinandinserttherods

• Noneedforincision

StepsofInsertion(1)1. Washthenon-dominantarm2. Allowtheclienttoliedownonthe

proceduretablewithhernon-dominantarmextendedonasterileorcleanclothontheothertable,atarightangletoherbody

3. Theimplantswillbeinsertedsub-dermallyusingthedisposabletrocar,intheshapeofanarrowV,openingtowardsthearmpit

StepsofInsertion(2)4. Confirmtheabsenceofknownallergiestoanestheticagentor

relateddrugs5. LocatethesiteofLevoplant insertionattheinnersideoftheupper

arm,6-8cmabovetheelbow6. Useaspongeforcepstoholdacottonorgauzeswabsoakedwith

antiseptic(betadineorchlorhexidine)• Beginbywipingattheinsertionsiteandmoveoutwardinacircularmotionfor8to13cm(3to5in.).

• Ifaniodophor (e.g.,Betadine)isused,allowtoairdryforabout2minutesbeforeproceeding(iodophors requireupto2minutestocontacttimetoreleasefreeiodine).

StepsofInsertion(3)7. Fillthesyringewith2-4mlof

1%localanestheticwithoutadrenaline

8. Anaesthetizetwoareasabout4.5cmlong,tomimictheVshapeoftheinsertionarea

9. Gentlytouchtheinsertionsitewithforcepstomakesuretheanestheticisworking

StepsofInsertion(4)10. Introducethetrocarjustbeneath

theskinatanesthetizedarea11. Oncethetipofthetrocaris

beneaththeskin,advancethetrocaralongtheskinhorizontallytothemarkclosesttothehandleofthetrocar,pointingslightlyupwardsraisingtheskin(tenting)tokeeptheimplantinthesubdermalplane

StepsofInsertion(5)

Note:• Donotforcethetrocar,andifyoufeelanyresistance,tryanotherdirection

• Itisimportanttokeepthetrocarsubdermalbytentingtheskinwiththetrocar,asfailuretodosomayresultindeepplacementoftheimplantscausingamoredifficultremoval

• Throughouttheinsertionprocedure,thetrocarshouldbeorientedwiththebevelup

StepsofInsertion(6)12. Removetheplungerwhenthe

trocarisadvancedtothemarknearestthehub

13. Loadthefirstimplantintothetrocareitherwithtweezersorglovedfingers

14. Pushtheimplantgentlywiththeplungertothetipofthetrocaruntilyoufeelresistance

15. Neverforcetheplunger

StepsofInsertion(7)

16. Holdtheplungersteadyandpullthetrocarbacktothemarknearthetip

NOTE:• Itisimportanttokeeptheplungersteadyandnottopushtheimplantintothetissue

• Thetrocariswithdrawnafterinsertionofthe1st rodonlytothemarkclosesttoitstip.DONOTwithdrawcompletely

StepsofInsertion(8)

17. Fixthepositionofthefirstimplantwiththeleftfore-fingerandadvancethetrocartoformaVshapealongthesideofthefinger.TheVshouldbeabouta30-degreeangle.Insertthesecondimplantnexttothefirstone

NOTE:• Leave5mmbetweenthepunctureandthetipoftheimplantstoavoidspontaneousexpulsions.

StepsofInsertion(9)18. Aftertheinsertion,presstheedges

oftheincisiontogetherandclosetheinsertionpointwithasterilebutterflyadhesive

19. Covertheinsertionareawithacompressandwrapenoughgauzearoundthearmtoensurehemostasis

20. Observethepatientattheclinicfor15minutesforsignsofsyncopeorbleedingfromtheincisionbeforesheisdischargedaftercounseling

Removal:RequiredEquipment

• Anexaminationtable• Sterilesurgicalcloth/drapesandgloves• Antisepticsolution• Localanesthetic,needles,andsyringe• Sterile#11scalpel,forceps(twoCrile/Kellyforcepsrecommended,thoughoneCrile/KellyandoneMosquitoacceptable)

• Skinclosures,sterilegauzeandcompresses

Removal(1)• Foroptimalreadiness,implantremovalshouldpreferablybedoneoncertainscheduleddays

• Theimplantsshallberemovedverygently,andthiswillusuallytakemoretimethantheirinsertion

• Implantsmaysometimesbenicked,cutorbrokenduringremoval.Ifremovalprovesdifficult,closetheincisionandbandagethewound,andhavethepatientreturnforanotherattempt

• Theremainingimplant(s)willbeeasiertoremoveaftertheareaishealed.Anon-hormonalmethodofcontraceptionshouldbeuseduntilbothimplanthavebeenremoved

Removal(2) • Thepatientshallbeinasimilarposition,andasimilaraseptictechniqueshallbeappliedasforinsertion

• Locatetheimplantsbypalpation,possiblymarkingtheirpositionwithamarkerpen

• Iftheycannotbepalpated,theymaybelocatedbyultrasoundorsofttissueX-ray

Removal(3)• Injectasmallamountoflocalanestheticundertheendsoftheimplantthatareclosertoeachother– thiswillraisetheendsoftheimplants

• Anestheticinjectedovertheimplantsmayobscuretheirpositionandmakeremovalmoredifficult

• Ifnecessary,moreanestheticcanbegiveninsmallamountsatatime

Removal(4)

• Makea4-mmincisionwiththescalpelclosetotheendsoftheimplants(belowthebottomoftheV)

• Keeptheincisionsmall

Removal(5)• Pusheachimplantwithyourfingersgentlytowardstheincision

• Whenthetipisvisibleorneartotheincision,graspitwithCrile/Kellyforceps.Mosquitoforcepscanalsobeused

Removal(6)• StabilizetheimplantwiththeCrile/Kellyforceps.Mosquitoforcepscanalsobeused

• Useascalpelandverygentlyopenthetissuesheatharoundtheimplant

Removal(7)• Grasptheendoftheimplantwiththesecondforceps(Crile/Kellyforceps)

Removal(8)

• Releasethestabilizing(first)forceps

• Usethesecondforcepsholdingtheendoftheimplanttogentlyremovetheimplant

Removal(9)

• Repeattheprocedureforthesecondimplant

• MeasurethelengthoftheremovedimplantstomakesurethepatienthadtwoLevoplantimplantsandnotothercontraceptiveimplants

• Thelengthshouldbe44mm

Removal(10)

• Aftertheprocedureiscompleted,closetheincisionandbandageitasafterinsertion.Thearmshouldbekeptdryforafewdays

WishtocontinueLevoplant

• Iftheclientwishestocontinueusingthemethod,anewsetofLevoplant canbeinsertedthroughthesameincision,inthesameortheoppositedirection

• Iftheclientprefers,Levoplant canalsobeinsertedinherotherarm

Questions?

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Levoplant

Pre&PostInsertionCareandCounseling:ClientFollow-Up

BeforeInsertion

• Counselclientonwhattoexpect,bothduringandafterinsertionincludingcommonsideeffects

• Beclearandconcise• Reassurethatcommonsideeffectsarenotharmful• Projectprofessionalism,clinicalconfidence,andreceptivitytoquestions

• Ifpossible,alsoprovideprintedmaterials

Managementafterinsertion• Beopentopatientquestion• Practiceactivelistening• Ruleoutothercausesofanycomplaints• Giveadviceaboutmanagingthesideeffects• Trymedicalmanagementbeforeremovalfirstforsideeffects• Honorthewishesofthewoman• Ifremovalischosen,contraceptiveand/orpregnancycounseling

Post-insertioncare(1)• Instructclientregardingwoundcareandmakereturnvisitappointment,ifneeded

• Sheshouldkeeptheinsertionareadryfor4days.Shecantakeofftheelasticbandageorgauzeafter2daysandtheadhesivebandageafter5days.

• Seekaclinicianifanyirritationoccursatthesiteofinsertion• Aftertheanestheticwearsoff,herarmmaybesoreforafewdays.Shemayalsohaveswellingandbruisingattheinsertionsite.Thisiscommonandwillgoawaywithouttreatment.

Post-insertioncare(2)

• Observeclientforatleast15to20minutesandaskherhowshefeelsbeforesendingherhome

• Discusswhattodoifclientexperiencesanyproblemsfollowinginsertionorsideeffects

• Asktheclienttorepeatinstructions• Answerclient’squestions

Follow-up

“Comebackanytime”• Assureeveryclientsheiswelcometocomebackanytime– forexample,when:

• Shehasproblems,questions,orwantsanothermethod• Shehasamajorchangeinhealthstatus• Shethinksshemightbepregnant

• Remindhertobringthefollow-upcardduringeachvisittotheclinic

WarningsignsorproblemsTheclientshouldreturntotheclinicifshehasanyofthefollowingproblems(DISCUS):• Delayedmenstrualperiodafterseveralmonthsofregularcycles(maybeasignofpregnancy)

• Infection– pusorbleedingattheinsertionside• Severelowerabdominalpain(maybeasymptomofectopicpregnancy)• Capsule(expulsionofarod)• Unexplainedheavyvaginalbleeding(eithertwiceaslong/heavyasnormal)• Severeheadache– migraine(vascular)headaches,repeatedverypainfulheadachesorblurredvision

Questions?

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