Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome 英文参考文献.docVIP

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Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome 英文参考文献.doc

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Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome 英文参考文献

Normanetal.BMCPregnancyandChildbirth2012,12:79 /1471-2393/12/79 STUDY PROTOCOL OpenAccess TrialprotocolOPPTIMUM–Doesprogesterone prophylaxisforthepreventionofpretermlabour improveoutcome? JaneENorman1*,AndrewShennan2,PhillipBennett3,StevenThornton4,StephenRobson5,NeilMarlow6, JohnNorrie7,StavrosPetrou8,NeilSebire9,TinaLavender10andSoniaWhyte11 Abstract Background:Pretermbirthisaglobalproblem,withaprevalenceof8to12%dependingonlocation..Several largetrialsandsystematicreviewshaveshownprogestogenstobeeffectiveinpreventingordelayingpreterm birthinselectedhighriskwomenwithasingletonpregnancy(includingthosewithashortcervixorprevious pretermbirth).Althoughanimprovementinshorttermneonataloutcomeshasbeenshowninsometrialsthese havenotconsistentlybeenconfirmedinmeta-analyses.Additionallydataonlongertermoutcomesislimitedtoa singletrialwherenodifferenceinoutcomeswasdemonstratedatfouryearsofageofthechild,despitethosein the“progesterone”grouphavingalowerincidenceofpretermbirth. Methods/Design:TheOPPTIMUMstudyisadoubleblindrandomizedplacebocontrolledtrialtodetermine whetherprogesteroneprophylaxistopreventpretermbirthhaslongtermneonatalorinfantbenefit.Specificallyit willstudywhether,inwomenwithsingletonpregnancyandathighriskofpretermlabour,prophylacticvaginal naturalprogesterone,200mgdailyfrom22–34weeksgestation,comparedtoplacebo,improvesobstetric outcomebylengtheningpregnancythusreducingtheincidenceofpretermdelivery(before34weeks),improves neonataloutcomebyreducingacompositeofdeathandmajormorbidity,andleadstoimprovedchildhood cognitiveandneurosensoryoutcomesattwoyearsofage.Recruitmentbeganin2009andisscheduledtoclosein Spring2013.AsofMay2012,over800womenhadbeenrandomizedin60sites. Discussion:OPPTIMUMwillprovidefurtherevidenceontheeffectivenessofvaginalprogesteroneforpreventionof pretermbirthandimprovementofneonataloutcomesinselectedgroupsofwomenwithsingletonpregnancyat highriskofpretermbirth.Additionallyitwilldeterminewhetheranyreductionintheincidenceofpretermbirthis accompaniedby