Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings 英文参考文献.docVIP

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Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings 英文参考文献.doc

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Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings 英文参考文献

Mehtaetal.BMCPregnancyandChildbirth2012,12:89 /1471-2393/12/89 STUDY PROTOCOL OpenAccess Protocolforadrugsexposurepregnancyregistry forimplementationinresource-limitedsettings UshmaMehta1,ChristineClerk2,ElizabethAllen3,MackensieYore4,Esperan?aSevene5,JanSinglovic6, MaxPetzold7,VivianaMangiaterra8,ElizabethElefant9,FrankMSullivan10,LewisBHolmes11andMelbaGomes8* Abstract Background:Theabsenceofrobustevidenceofsafetyofmedicinesinpregnancy,particularlythoseformajor diseasesprovidedbypublichealthprogrammesindevelopingcountries,hasresultedincautiousrecommendations ontheiruse.WedescribeaprotocolforaPregnancyRegistryadaptedtoresource-limitedsettingsaimedat providingevidenceonthesafetyofmedicinesinpregnancy. Methods/Design:Sentinelhealthfacilitiesarechosenwherewomencomeforprenatalcareandarelikelytocome fordelivery.Staffcapacityisimprovedtoprovidebettercareduringthepregnancy,toidentifyvisiblebirthdefects atdeliveryandreferinfantswithmajoranomaliesforsurgicalorclinicalevaluationandtreatment.Consenting womenareenrolledattheirfirstantenatalvisitandcarefulmedical,obstetricanddrug-exposurehistoriestaken; medicalrecordlinkageisencouraged.Enrolledwomenarefollowedupprospectivelyandtheirhistoriesare updatedateachsubsequentvisit.Theenrolledwomanisencouragedtodeliveratthefacility,wheresheandher babycanbeassessed. Discussion:InadditiontodatapoolingintoacommonWHOdatabase,theWHOPregnancyRegistryhasthree importantfeatures:Firstistheinclusionofpregnantwomencomingforantenatalcare,enablingcomparisonof birthoutcomesofwomenwhohavebeenexposedtoamedicinewiththosewhohavenot.Secondisits applicabilitytoresource-poorsettingsregardlessofdrugordisease.Thirdisimprovementofreproductivehealth careduringpregnanciesandatdelivery.Facilitydeliveryenablesbetterhealthoutcomes,timelyevaluationand managementofthenewborn,andthecollectionofreliableclinicaldata.TheRegistryaimstoimprovematernal andneonatalcareandalsoprovidemuchneededinformationonthesafetyofmedicinesinpregnancy. Keywords:PregnancyRegistry,Congenital