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Bacterial vaginosis - Evidence
Evidence on preventing adverse outcomes of pregnancy
The evidence regarding the prevention of adverse outcomes in pregnant women with bacterial vaginosis (BV) is conflicting. Some evidence suggests that treatment of high-risk women (those who have already had a pre-term birth) and treatment of women before 20 weeks' gestation may have a beneficial effect on some adverse outcomes, but further evidence is needed to confirm this.
A Cochrane systematic review (search date: to May 2006) considered the use of antibiotics to prevent adverse outcomes associated with BV in pregnancy [McDonald et al, 2007]. The review included 15 RCTs of good quality (n = 5888); five trials used oral metronidazole alone, one used oral metronidazole plus erythromycin, one used oral clindamycin, one used ampicillin, one used vaginal metronidazole gel, and six used intravaginal clindamycin:
- The risk of pre-term birth less than 37 weeks' gestation was not significantly decreased with any antibiotic compared with no treatment or placebo (odds ratio [OR] 0.91, 95% CI 0.78 to 1.06; 15 trials of 5888 women). There was also no evidence of an effect on pre-term pre-labour rupture of membranes (OR 0.88, 95% CI 0.61 to 1.28; four trials of 2579 women), nor on the incidence of low-birthweight deliveries (OR 0.95, 95% CI 0.77 to 1.17; seven trials of 4107 women).
- As there were sufficient trials in the review, the comparisons were stratified, to explore the effect of the intervention on the outcomes, by the following factors: oral versus vaginal antibiotics, women with a previous pre-term birth, clindamycin compared with placebo treatment; and treatment before 20 weeks' gestation:
- Oral versus intravaginal antibiotics: the route of administration appeared to make no difference to the outcomes.
- Women with a previous pre-term birth: the use of antibiotics was associated with a significant decrease in the risk of pre-term pre-labour rupture of membranes (OR 0.14, 95% CI 0.05 to 0.38; two trials of 114 women) and low birthweight (OR 0.31, 95% CI 0.13 to 0.75; two trials of 114 women) but not of subsequent pre-term birth less than 37 weeks' gestation (OR 0.83, 95% CI 0.59 to 1.17; five trials of 622 women). All five studies compared oral metronidazole (various doses) with placebo.
- Clindamycin (oral or intravaginal) versus placebo: there was no significant difference in pre-term birth less than 37 weeks' gestation (OR 0.80, 95% CI 0.60 to 1.05; six trials of 2406 women), pre-term pre-labour rupture of membranes (OR 2.52, 95% CI 0.69 to 9.25; one trial of 100 women), or low birthweight (OR 1.03, 95% CI 0.73 to 1.45; four trials of 1648 women).
- Treatment before 20 weeks' gestation: antibiotic treatment was associated with a significant decrease in risk of pre-term birth less than 37 weeks' gestation (OR 0.72, 95% CI 0.55 to 0.95; five trials of 2287 women) and pre-term pre-labour rupture of membranes (OR 0.14, 95% CI 0.04 to 0.44; one trial of 80 women), but not low birthweight (OR 0.79, 95% CI 0.44 to 1.41; two trials of 489 women).
- Two earlier systematic reviews produced similar findings [Riggs and Klebanoff, 2004; Okun et al, 2005].
- One RCT has investigated oral metronidazole for the prevention of pre-term birth in women designated to be at high risk for pre-term delivery on the basis of clinical history and a positive test for cervicovaginal fetal fibronectin [Shennan et al, 2006]. The study was stopped early owing to difficulty in recruitment.
- Among the 100 women randomized to treatment, there were significantly more pre-term deliveries in those treated with metronidazole (33/53) than those who received placebo (18/46) (RR 1.6, 95% CI 1.05 to 2.4). However, only 13 of 96 women (14%) initially tested positive for BV. Further, appropriately powered studies are needed to confirm or refute these results in women with BV.
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