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Vaginal dysbiosis (characterized by an imbalance of microbiota; commonly termed bacterial vaginosis) is a risk factor for preterm birth, but studies of treatment during pregnancy have been inconclusive. Now, investigators in France randomized 2869 pregnant women at <15 weeks' gestation with vaginal dysbiosis (Nugent score >7) and low risk for preterm delivery to receive a single course of 300-mg clindamycin twice daily for 4 days, three courses of the same regimen spaced 1 month apart, or placebo. In an ancillary trial of high-risk pregnancies, 236 women were randomized to single- or triple-course clindamycin. The primary outcome was spontaneous miscarriage between 16 and 21 weeks or delivery between 22 and 32 weeks.
Rates of the primary outcome in low-risk pregnancies were 1.2% with clindamycin treatment (0.8% with single course; 1.5% with triple course) and 1.0% with placebo. Among women with high-risk pregnancies, rates were 6.0% (single course) and 4.4% (triple course). Abdominal pain or diarrhea was more common with clindamycin than placebo.
Subtil D et al. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): A multicentre, double-blind, randomised controlled trial. Lancet 2018 Oct 12; [e-pub]. (https://doi.org/10.1016/S0140-6736(18)31617-9)
Comment
These results indicate that treatment of vaginal dysbiosis during low-risk pregnancy is unlikely to affect risk for late miscarriage or very preterm birth. However, it's important to note that only 7% of women in this study population had vaginal dysbiosis, limiting the ability to draw inferences about pregnant women in the U.S. (25% of whom have the condition; http://www.cdc.gov/std/bv/stats.htm). The trial is also limited by the diagnostic method for vaginal dysbiosis (which identified replacement of optimal microflora with anaerobes, but lacked specificity regarding individual bacterial species or communities that might raise risk for poor outcomes) and the absence of repeat diagnostics (which are important, given that vaginal dysbiosis is typically recurrent).