Subtil D, et al. - Researchers conducted this PREMEVA (a double-blind randomized controlled trial) trial in 40 French centers to determine if treatment of bacterial vaginosis reduces late miscarriages or spontaneous very preterm birth. No evidence of risk reduction of late miscarriage or spontaneous very preterm birth was found by systematic screening and subsequent treatment for bacterial vaginosis in women with low-risk pregnancies. In this patient population, physicians should reconsider the use of antibiotics to prevent preterm delivery.

Methods

• Eligibility criteria for inclusion included women aged 18 years or older with bacterial vaginosis and low-risk pregnancy and were randomly assigned (2:1) to three parallel groups: single-course or triple-course 300 mg clindamycin twice-daily for 4 days, or placebo.
• In a high-risk subtrial, women with high-risk pregnancy outcomes were eligible for inclusion and were randomly assigned (1:1) to either single-course or triple-course clindamycin.
• A composite of late miscarriage (16–21 weeks) or spontaneous very preterm birth (22–32 weeks) was the primary outcome, which researchers evaluated in all patients with delivery data (modified intention to treat).
• Adverse events were systematically reported in this analysis.

Results

• As per data, 84,530 pregnant women before 14 weeks' gestation were screened between April 1, 2006, and June 30, 2011.
• It was observed that 5,630 had bacterial vaginosis, of whom 3,105 were randomly assigned to groups in the low-risk trial (n=943 to receive single-course clindamycin, n=968 to receive triple-course clindamycin, and n=958 to receive placebo) or high-risk subtrial (n=122 to receive single-course clindamycin and n=114 to receive triple-course clindamycin).
• The primary outcome occurred in 22 (1,2%) of 1,904 study participants receiving clindamycin and 10 (1,0%) of 956 participants receiving placebo (relative risk [RR] 1,10, 95% CI 0,53–2,32; p=0,82).
• The primary outcome occurred in 5 (4.4%) participants in the triple-course clindamycin group and 8 (6,0%) participants in the single-course clindamycin group (RR 0,67, 95% CI 0,23–2,00; p=0,47).
• Adverse events were more common in the clindamycin groups than in the placebo group (58 [3.0%] of 1,904 vs 12 [1,3%] of 956; p=0,0035) in the low-risk trial.
• Findings revealed that the most commonly reported adverse event was diarrhea (30 [1,6%] in the clindamycin groups vs 4 [0.4%] in the placebo group; p=0.0071); abdominal pain was also observed in the clindamycin groups (9 [0.6%] participants) vs none in the placebo group (p=0.034).
• In any group, no severe adverse event was reported.
• In the high-risk subtrial, adverse fetal and neonatal outcomes did not vary significantly between groups.