Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth an open-label pilot randomized controlled trial 英文参考文献.docVIP

Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth an open-label pilot randomized controlled trial 英文参考文献.doc

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Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth an open-label pilot randomized controlled trial 英文参考文献

Robertsetal.BMCPregnancyandChildbirth2011,11:18 /1471-2393/11/18 RESEARCH ARTICLE OpenAccess Treatmentofasymptomaticvaginalcandidiasisin pregnancytopreventpretermbirth:anopen- labelpilotrandomizedcontrolledtrial ChristineLRoberts1,2*,KristenRickard2,GeorgeKotsiou3,JonathanMMorris1,2 Abstract Background:Althoughtheconnectionbetweenascendinginfectionandpretermbirthisundisputed,research focusedonfindingeffectivetreatmentshasbeendisappointing.HoweverevidencethateradicationofCandidain pregnancymayreducetheriskofpretermbirthisemerging.Weconductedapilotstudytoassessthefeasibilityof conductingalargerandomizedcontrolledtrialtodeterminewhethertreatmentofasymptomaticcandidiasisin earlypregnancyreducestheincidenceofpretermbirth. Methods:Weusedaprospective,randomized,open-label,blinded-endpoint(PROBE)studydesign.Pregnant womenpresentingat20weeksgestationwithsingletonpregnanciesself-collectedavaginalswab.Thosewho wereasymptomaticandculturepositiveforCandidawererandomizedto6-daysofclotrimazolevaginalpessaries (100mg)orusualcare(screeningresultisnotrevealed,notreatment).Theprimaryoutcomesweretherateof asymptomaticvaginalcandidiasis,participationandfollow-up.Theproposedprimarytrialoutcomeofspontaneous pretermbirth37weeksgestationwasalsoassessed. Results:Of779womenapproached,500(64%)participatedincandidiasisscreening,and98(19.6%)had asymptomaticvaginalcandidiasisandwererandomizedtoclotrimazoleorusualcare.Womenwerenot inconveniencedbyparticipationinthestudy,laboratorytestingandmedicationdispensingwereproblem-free,and thefollow-upratewas99%.Therewasatendencytowardsareductioninspontaneouspretermbirthamong womenwithasymptomaticcandidiasiswhoweretreatedwithclotrimazoleRR=0.33,95%CI0.04-3.03. Conclusions:Alarge,adequatelypowered,randomizedtrialofclotrimazoletopreventpretermbirthinwomen withasymptomaticcandidiasisisbothfeasibleandwarranted. Trialregistration:AustraliaandNewZealandClinicalTrialsRegister(ANZCTR):ACTRN12609001052224 Background (15-19weeks)andtreatmentforasymptomaticbacteria

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