protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [actrn12610000607077]协议的随机对照试验治疗无症状的念珠菌病的预防早产(actrn12610000607077).pdfVIP

Roberts et al. BMC Pregnancy and Childbirth 2011, 11:19 /1471-2393/11/19 STUDY PROTOCOL Open Access Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077] 1,2*† 2,3† 1,3 1,3 4 Christine L Roberts , Jonathan M Morris , Kristen R Rickard , Warwick B Giles , Judy M Simpson , George Kotsiou5, Jennifer R Bowen6 Abstract Background: Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. Methods/Design: Using a prospective, randomised, open-label, blinded-endpoint (PROBE) study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care 20 weeks gestation with singleton pregnancies are eligible for inclusion. The intervention is a 6-day course of clotrimazole vaginal pessaries (100 mg) and the primary outcome is spontaneous preterm birth 37 weeks gestation. The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone) to open-label treatment or usual care (screening result is not revealed, no treatment, routine a