BackgroundTreatment for bacterial vaginosis in pregnant women to reduce risk of spontaneous very preterm birth and late miscarriage remains controversial. We conducted a randomized control trial to determine whether bacterial vaginosis treatment could decrease spontaneous very preterm births and late miscarriages. MethodsThe PREMEVA trial was a multicenter randomized control double-blinded trial performed in 40 French centers. A total of 84,530 pregnant women were screened for bacterial vaginosis before 14 weeks of gestation. Women with bacterial vaginosis in the first trimester of pregnancy were randomly assigned to three similarly sized parallel arms: one four-day course of 600 mg oral clindamycin daily, three four-day courses of 600 mg daily a month apart or placebo. The primary outcome was a composite of late miscarriage (16-21 weeks) or spontaneous very preterm delivery (22-32 weeks) according to clindamycin treatment or placebo. Secondary outcomes included spontaneous preterm delivery before 37 weeks (22-36 weeks). FindingsBetween 04/01/2006 and 06/30/2011, 84,530 pregnant women were screened before 14 weeks of gestation, 5630 (6•7%) had bacterial vaginosis and 2869 were randomized. The primary outcome did not differ significantly between the groups (1•2% in the clindamycin group and 1.0% in the placebo group, relative risk, 1.10; 95% confidence interval [CI], 0•53 to 2•32), nor in the rate of spontaneous preterm delivery before 37 weeks (4•8% and 4•1%, respectively; relative risk, 1•17; 95% CI, 0•81 to 1•69). Side effects were more common in the clindamycin group (3•0% vs 1•3%, p=0•003) but not severe. InterpretationSystematic screening and subsequent treatment for bacterial vaginosis in low-risk pregnant women does not decrease late miscarriage, spontaneous very preterm birth, or spontaneous preterm birth.

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