There has long been considered to be a causative association between bacterial vaginosis and preterm delivery – with increasing risk of delivery when BV is identified earlier in pregnancy. Clearly, of course, early antibiotic treatment would eradicate the pathology and improve pregnancy outcomes. It just makes sense.
But, no.
In this large, multicenter trial performed in France, 84,530 pregnant women were screened before 14 weeks gestation, resulting in 5,630 diagnoses of BV. Patients deemed “low-risk” for preterm delivery were treated with one of regimens of clindamycin or placebo, while those few deemed “high-risk” were excluded from placebo randomization. The primary outcome was late miscarriage or early preterm birth, a range of preterm delivery spanning 16-32 weeks gestation.
Approximately 2/5ths of those approached for enrollment declined to participate, leaving 2,869 for randomization into one of the three low-risk arms. There were no important baseline differences between the three cohorts. The results: no difference. About 1% of each group met the primary outcome, and there were no signals of even a small magnitude of benefit to treatment with clindamycin in the low-risk cohorts. Adverse events, of course, clearly favored placebo – as befitting clindamycin’s known propensity for gastrointestinal effects, but no effects on fetal outcomes were apparent.
This is not specifically relevant to Emergency Medicine other than to demonstrate the need to rigorously test even what seems obvious. Widespread screening and aggressive, proactive treatment – even when all signs point to an expected positive result – represented low-value, and potentially harmful care.
“Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial”
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31617-9/fulltext