Question Does treatment with oral clindamycin for bacterial
vaginosis before 22 weeks' gestation lead to decreased premature births and
late miscarriages?
Synopsis Previous studies of screening for bacterial vaginosis in
pregnancy performed the screening late in the second trimester and treated
bacterial vaginosis with metronidazole. In this randomised controlled double
blinded trial, a general population of 6120 asymptomatic pregnant women in the
United Kingdom was screened in antenatal outpatients for bacterial vaginosis
by using Gram stain and Nugent scoring (0-10), and 494 (8.1%) women positive
for bacterial vaginosis with a Nugent score higher than 3 who were randomised
(allocation concealed) to oral clindamycin 300 mg twice a day for five days (n
= 249) or placebo (n = 245). By chance the treated group had a history of
fewer miscarriages (26% v 34%) but not fewer preterm deliveries (10%
v 9%). Spontaneous preterm deliveries (24-37 weeks' gestation) were
11/244 (5%) in the treated group versus 28/241 (12%) in the placebo group, and
late miscarriages (13-24 weeks) were 2/244 (1%) compared with 10/241 (4%) (P =
0.001 for the combined end point; number needed to treat = 10). The number
needed to screen to prevent one preterm birth or late miscarriage was
approximately 120. There were no differences in mean birth weight, low birth
weight, stillbirths, or mean gestational age at delivery. There was a trend to
increased gastrointestinal side effects in the treated group (7% v 3%; P = 0.10). Admissions to neonatal intensive care were 8% in the
clindamycin group compared with 10% in the placebo group (P = 0.41), which
would be clinically significant if the study had been large enough to show a
statistically significant difference.
Bottom line Women with asymptomatic bacterial vaginosis who were
treated with oral clindamycin before 22 weeks' gestation had fewer second
trimester miscarriages and preterm births, with a number needed to treat of
10. The study was not large enough to show a difference in neonatal admissions
to intensive care units. The Gram stain screening method and generic
antibiotic treatment are simple and inexpensive. The potential here for
getting a big bang for a buck in our use of healthcare dollars is very
attractive. Previous studies using metronidazole and treatment at later
gestational age have not found screening to be beneficial. This study needs to
be replicated in a larger trial before introducing widespread screening for
bacterial vaginosis in pregnancy.
Level of evidence 1b (see
www.infopoems.com/resources/levels.html);
individual randomised controlled trials (with narrow confidence interval).

