Progestogens to prevent preterm birth in twin pregnancies an individual participant data meta-analysis of randomized trials 英文参考文献.docVIP
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Progestogens to prevent preterm birth in twin pregnancies an individual participant data meta-analysis of randomized trials 英文参考文献
Schuitetal.BMCPregnancyandChildbirth2012,12:13
/1471-2393/12/13
STUDY PROTOCOL
OpenAccess
Progestogenstopreventpretermbirthintwin
pregnancies:anindividualparticipantdatameta-
analysisofrandomizedtrials
EwoudSchuit1*,SarahStock2,RolfHHGroenwold1,KimberlyMaurel3,CAndrewCombs4,ThomasGarite5,
CathyYSpong6,ElizabethAThom7,DwightJRouse8,SteveNCaritis9,GeorgeRSaade10,JuliaMZachary7,
JaneENorman2,LineRode11,KatharinaKlein12,AnnTabor11,El?in?eting?z13,JohnCMorrison14,
EverettFMagann15,ChristianMBriery16,VicenteSerra17,AlfredoPerales18,JuanMeseguer19,AnwarHNassar20,
ArianneCLim21,KarelGMMoons1,AnnekeKwee22 andBenWillemJMol21
Abstract
Background:Pretermbirthistheprincipalfactorcontributingtoadverseoutcomesinmultiplepregnancies.
Randomizedcontrolledtrialsofprogestogenstopreventpretermbirthintwinpregnancieshaveshownnoclear
benefits.However,individualstudieshavenothadsufficientpowertoevaluatepotentialbenefitsinwomenat
particularhighriskofearlydelivery(forexample,womenwithapreviouspretermbirthorshortcervix)orto
determineadverseeffectsforrareoutcomessuchasintrauterinedeath.
Methods/design:Weproposeanindividualparticipantdatameta-analysisofhighqualityrandomized,double-
blind,placebo-controlledtrialsofprogestogentreatmentinwomenwithatwinpregnancy.Theprimaryoutcome
willbeadverseperinataloutcome(acompositemeasureofperinatalmortalityandsignificantneonatalmorbidity).
Missingdatawillbeimputedwithineachoriginalstudy,beforedataoftheindividualstudiesarepooled.The
effectsof17-hydroxyprogesteronecaproateorvaginalprogesteronetreatmentinwomenwithtwinpregnancies
willbeestimatedbymeansofarandomeffectslog-binomialmodel.Analyseswillbeadjustedforvariablesusedin
stratifiedrandomizationasappropriate.Pre-specifiedsubgroupanalysiswillbeperformedtoexploretheeffectof
progestogentreatmentinhigh-riskgroups.
Discussion:Combiningindividualpatientdatafromdifferentrandomizedtrialshaspotentialtoprovidevaluable,
clinicallyusefulinformationregardingthebenefitsandpotentialharmsofprogestogensinwomenwithtwin
preg
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