PErineal Assessment and Repair Longitudinal Study (PEARLS) protocol for a matched pair cluster trial 英文参考文献.docVIP

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PErineal Assessment and Repair Longitudinal Study (PEARLS) protocol for a matched pair cluster trial 英文参考文献.doc

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PErineal Assessment and Repair Longitudinal Study (PEARLS) protocol for a matched pair cluster trial 英文参考文献

Bicketal.BMCPregnancyandChildbirth2010,10:10 /1471-2393/10/10 STUDY PROTOCOL OpenAccess PErinealAssessmentandRepairLongitudinal Study(PEARLS):protocolforamatchedpair clustertrial DebraEBick1*,ChristineKettle2,3,SueMacdonald4,PeterWThomas5,RobertKHills6,KhaledMKIsmail3,7 Abstract Background:ThePerinealAssessmentandRepairLongitudinalStudy(PEARLS)isanationalclinicalquality improvementinitiativedesignedtoimprovetheassessmentandmanagementofperinealtrauma.Perinealtrauma affectsaround85%ofwomenwhohaveavaginalbirthintheUKeachyearandmillionsmoreworld-wide. Continuoussuturingtechniquescomparedwithtraditionalinterruptedmethodsaremoreeffectiveinreducing painandpostnatalmorbidity,howevertheyarenotwidelyusedbycliniciansdespiterecommendationsof evidencebasednationalclinicalguidelines.Perinealsuturingskillsandpostnatalmanagementoftraumaremain highlyvariablewithinandbetweenmaternityunitsintheUKaswellasworldwide.Implementationofa standardisedtrainingpackagetosupporteffectiveperinealmanagementpracticescouldreduceperinealpainand otherrelatedpostnatalmorbidityforasubstantialnumberofwomen. Methods/Design:PEARLSisamatchedpairclustertrial,whichisbeingconductedinmaternityunitsacrossthe UK.Unitswithinamatchedpairwillberandomisedtoimplementthestudyinterventioneitherearlyorlateinthe studyperiod.Theinterventionwillincludethecascadingofamulti-professionaltrainingpackagetoenhance midwiferyandobstetricskillsintheassessment,repairandpostnatalmanagementofperinealtrauma.Women whohavehadanepisiotomyorseconddegreeperinealtearwillbeeligibleforrecruitment.Priortodeveloping theinterventionanddecidingonstudyoutcomes,aDelphisurveyandaconsensusconferencewereheldto identifywhatwomen,whopreviouslysufferedperinealtraumaduringchildbirth,consideredtobeimportant outcomesforthem.Findingsfromthispreliminarywork(whichwillbereportedelsewhere)andotheroutcomes includingwomen’sexperiencesofperinealpainandpainonactivity,breastfeedinguptakeanddurationand psychologicalwell-beingasassessedusingtheEdinburghPostnatalDepressi