Skip to main navigation
Skip notifications
Access to POEMs and Essential Evidence Plus will no longer be included in CMA membership as of Dec. 1, 2023.
Search
Clindamycin in BV-positive women at low risk for preterm delivery does not prevent adverse outcomes
Clinical Question
Among women without a history of preterm delivery, does the treatment of bacterial vaginosis with oral clindamycin prevent pregnancy loss or preterm birth?
Bottom line
Among women without a history of preterm delivery, the identification and treatment of bacterial vaginosis (BV) in pregnancy, using a single course or multiple courses of oral clindamycin, was ineffective to prevent late miscarriage or early preterm birth (16 - 32 6/7 weeks). As a substudy, among women with a history of late miscarriage or preterm birth before 37 weeks' gestation there was no difference for the same pregnancy loss/preterm birth outcome whether they were treated with a single course or 3 monthly courses of oral clindamycin. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
This was a large and rigorously designed double-blind multicenter randomized controlled trial conducted in France. More than 84,000 pregnant women were screened for BV at less than 14 weeks' gestation. They were given a diagnosis of BV on the basis of a Nugent score of 7 to 10. The main focus of this study was the placebo-controlled trial of oral clindamycin to treat low-risk BV-positive women (n = 3105). Low risk was defined as without any history of late miscarriage or preterm birth (16 - 36 6/7 weeks' gestation). These women were randomized into 1 of 3 groups: an oral regimen of 3 courses of clindamycin 300 mg twice daily for 4 days; one course of clindamycin followed by 2 courses of placebo; or 3 courses of placebo. The analysis was a modified intention-to-treat analysis in which outcomes were assessed according to the group assignment, excluding the women lost to follow-up (n = 2869). There were no differences between the 3 groups for the main outcome of late miscarriage or very early preterm birth at 16 to 32 6/7 weeks' gestation (1.2% in the clindamycin groups vs 1.0% among the placebo group; relative risk 1.10; 95% CI 0.53 - 2.32; P = .82). The authors also analyzed many perinatal morbidity and mortality outcomes, none of which were statistically significant. The women who received clindamycin reported significantly more diarrhea and abdominal pain, but there were no severe adverse events in any group. In a substudy, the authors identified high-risk women who screened positive for BV and did have a history of late miscarriage or preterm birth (n = 236). As a pilot study, these women were randomized to receive one course or 3 courses of clindamycin, but not placebo. There were no differences in the rate of late miscarriage/early preterm birth between groups.
Reviewer
Linda Speer, MD
Professor and Chair, Department of Family Medicine
University of Toledo
Toledo, OH