Investigators found no evidence for reduction in risk for late miscarriage or spontaneous very preterm birth as a result of systematic screening and treatment of bacterial vaginosis in women with low-risk pregnancies. These results from PREMEVA, a multicenter study conducted in 40 French centers, were published in the Lancet.
PREMEVA was a double-blind randomized controlled trial in which women aged ≥18 years with bacterial vaginosis and low-risk pregnancy were randomly assigned 2:1 to 1 of 3 groups: a single-course of 300 mg of clindamycin administered twice daily for 4 days, a triple course of the same treatment regimen, or placebo.
Over the trial duration, between April 1, 2006, and June 30, 2011, 84,530 women were screened and 5360 were found to have bacterial vaginosis. Of these, 943 were assigned to receive a single course of clindamycin, 968 were assigned to receive the triple course of clindamycin, and 958 were assigned to receive placebo—2 of whom were lost to follow-up.
The primary outcome of a composite of late miscarriage (16-21 weeks) or spontaneous very preterm birth (22-32 weeks) occurred in 1.2% of the 1904 patients receiving clindamycin and 1.0% of 956 participants receiving placebo (relative risk 1.10; 95% CI, 0.53-2.32; P =.82). Adverse events were also more common in the clindamycin groups than in the placebo group, occurring in 1.3% of the placebo group and in 3.0% of the clindamycin groups (P =.0035).
Investigators noted that compliance may have limited the study. Rates of treatment adherence were 80.4% and 83.7% for the treatment and placebo groups, respectively. The study also lacked a test-of-cure in the design but investigators observed “no difference in study outcomes between groups with single-course or triple course clindamycin, which is not in favor of mandatory rescreening for bacterial vaginosis treatment failure in preterm birth prevention.”
The results reported here led investigators to conclude that the use of antibiotics to prevent preterm delivery in women with low-risk pregnancies and bacterial vaginosis should be reconsidered because of growing concerns about antibiotic resistance.
Subtil D, Brabant G, Tilloy E, et al. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018;392(10160):2171-2179.