Timing of birth for women with a twin pregnancy at term a randomised controlled trial 英文参考文献.docVIP

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Timing of birth for women with a twin pregnancy at term a randomised controlled trial 英文参考文献.doc

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Timing of birth for women with a twin pregnancy at term a randomised controlled trial 英文参考文献

Doddetal.BMCPregnancyandChildbirth2010,10:68 /1471-2393/10/68 STUDY PROTOCOL OpenAccess Timingofbirthforwomenwithatwinpregnancy atterm:arandomisedcontrolledtrial JodieMDodd1*,CarolineACrowther1,RossRHaslam2,JeffreySRobinson1 Abstract Background:Thereisawellrecognizedriskofcomplicationsforbothwomenandinfantsofatwinpregnancy, increasingbeyond37weeksgestation.Pretermbirthpriorto37weeksgestationisarecognizedcomplicationofa twinpregnancy,however,upto50%oftwinswillbebornafterthistime. Theaimsofthisrandomisedtrialaretoassesswhetherelectivebirthat37weeksgestationcomparedwith standardcareinwomenwithatwinpregnancyaffectstheriskofperinataldeath,andseriousinfantcomplications. Methods/Design:Design:Multicentredrandomisedtrial. InclusionCriteria:womenwithatwinpregnancyat366weeksormorewithoutcontraindicationtocontinuationof pregnancy. TrialEntryRandomisation:Followingwritteninformedconsent,eligiblewomenwillberandomisedfrom36+6 weeksgestation.Therandomisationscheduleusesbalancedvariableblocks,withstratificationforcentreofbirth andplannedmodeofbirth.Womenwillberandomisedtoeitherelectivebirthorstandardcare. TreatmentSchedules:Womenallocatedtotheelectivebirthgroupwillbeplannedforelectivebirthfrom37 weeksgestation.Wheretheplanisforvaginalbirth,thiswillinvolveinductionoflabour.Wheretheplanisfor caesareanbirth,thiswillinvolveelectivecaesareansection.Forwomenallocatedtostandardcare,birthwillbe plannedfor38weeksgestationorlater.Wheretheplanisforvaginalbirth,thiswillinvolveeitherawaitingthe spontaneousonsetoflabour,orinductionoflabourifrequired.Wheretheplanisforcaesareanbirth,thiswill involveelectivecaesareansection(after38andascloseto39weeksaspossible). PrimaryStudyOutcome:Acompositeofperinatalmortalityorseriousneonatalmorbidity. SampleSize:460womenwithatwinpregnancytoshowareductioninthecompositeoutcomefrom16.3%to 6.7%withadjustmentfortheclusteringoftwininfantswithinmothers(p=0.05,80%power). Discussion:Thisisaprotocolforarandomisedtrial,thefindingsofwhichwillcontributeinformationaboutthe