For women with low-risk pregnancies who have bacterial vaginosis in their first trimester, the use of oral clindamycin does not reduce the risk of late miscarriage or preterm delivery, according to a study published in Lancet.
Investigators for the Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis (PREMEVA, ClinicalTrials.gov Identifier: NCT00642980) project conducted a double-blind randomized controlled trial in 40 French centers to determine if late miscarriages or spontaneous very preterm births can be prevented by treating bacterial vaginosis with clindamycin.
The primary outcome measured was the combination of late miscarriage (16-21 weeks) or spontaneous very preterm birth (22-32 weeks).
Women aged ≥18 years with bacterial vaginosis who were pregnant (median gestational age at randomization, 12.4 weeks) were eligible for participation in the study.
Women with low-risk pregnancies (n = 2869) were randomly assigned (2:1) to receive either single-course clindamycin 300 mg (n = 943), triple-course clindamycin 300 mg (n = 968), or placebo (n = 958). Single-course treatment consisted of clindamycin 300 mg twice daily for 4 days and 2 courses of placebo for 4 days. Triple-course treatment consisted of 3 cycles of clindamycin 300 mg twice daily for 4 days.
For ethical reasons, women with high-risk pregnancies (n = 236) were randomly assigned to receive either single-course (n = 122) or triple-course (n = 114) treatment without the option for placebo-only treatment.
For women with low-risk pregnancies, late miscarriage or spontaneous very preterm birth occurred in 1.2% of those treated with clindamycin and 1.0% of those treated with placebo (relative risk [RR], 1.10; P =.82). For women with high-risk pregnancies, the primary outcome occurred in 4.4% of women receiving triple-course treatment and 6.0% of participants receiving single-course treatment (RR, 0.67; P =.47).
No severe adverse events were reported in any of the groups; however, adverse events were more common among women receiving clindamycin treatment vs those receiving placebo (3.0% vs 1.3%, respectively).
“In the context of increasing recognition that indiscriminate antibiotic use increases the risk of resistance and might be associated with long-term risks, antibiotic prevention of preterm delivery in women with low-risk pregnancies who have bacterial vaginosis should be reconsidered,” the investigators wrote. “In high-risk pregnancies, there was no benefit of triple-course compared with single-course clindamycin,” they continued. “One option could be to study antibiotic prevention in high-risk pregnancies through a dose-escalation study.”
Subtil D, Brabant G, Tilloy E, et al. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial [published online October 12, 2018]. Lancet. doi:10.1016/S0140-6736(18)31617-9