A randomised controlled trial of vaginal clindamycin for early pregnancy bacterial vaginosis

Abstract

Objective To determine whether treatment of bacterial vaginosis (BV) with vaginal clindamycin affects pregnancy outcome. Materials and methodsMothers with singleton pregnancies and without previous preterm delivery in 17 health centres in Oulu from March 1996 Until March 1998, in whom BV was diagnosed by Gram stain of a vaginal swab at the first antenatal visit (at the 12th gestational week) were randomised at Oulu University Hospital to have a one-week course of vaginal clindamycin, or placebo. A follow up sample of Gram stain was taken two weeks after randomisation and at the 30th gestational weeks. Pregnancy outcome data was obtained from hospital records. Primary outcome was preterm birth, and puerperal infectious morbidity the other outcome measure.Results During the study period 1956 women were screened, of whom 143 (7.3%) were BV-positive. One hundred and one were randomised. The total preterm birth rate of BV+ women randomised was 9.9% (lO/lOl). Preterm birth occurred in 20.7% (6/29) vs 0% (0/26) according to whether BV persisted or not (P < 0-01). The preterm birth rate was 13.7% (7/51) in the clindamycin group vs 6.0% (3/50) in the placebo group (OR 2.5,95% CI 06-10). BV was cured just after treatment in 17 out of 51 (33%) of the clindamycin-treated patients vs 17 out of 50 (34%) of the placebo-treated patients (OR 1.0,95% CI 0.4-2.2). There was a difference in puerperal infectious morbidity in patients where BV persisted (31%, 9/29) compared with those in which BV did not persist (7.7%, 1/26) (OR 5.4, 95% CI 1-04-28). Infections were seen in 4/51 (8%) of the clindamycin treated vs 10/50 (20%) of the placebo treated cases, (OR 0.3,95% CI 0.1-1.2). ConclusionThe prevalence of BV was lower than expected in this low risk population, but nevertheless it increased the risk of preterm birth and puerperal infectious morbidity, the risk being highest in cases where BV persisted during pregnancy. Vaginal clindamycin treatment for BV in the fist trimester of pregnancy did not appear to reduce the risk of preterm birth or puerperal infections.

The Effect of Treating Bacterial Vaginosis on Preterm Labor

“…After randomization and treatment with clindamycin or placebo, the preterm birth rate in the clindamycin group was 13.7%, compared with 6.0% in the placebo group (OR, 2.5; 95% CI, 0.6-10). This study therefore supports the evidence that vaginal clindamycin treatment of BV in the first trimester does not reduce the risk of preterm birth 15 . In 1999, French et al 16 evaluated the association between BV, first-trimester vaginal bleeding and preterm labor in 1100 pregnant women who were enrolled in a prospective observational study (level II-II).…”

“…The results are similar to the conclusion of McGregor et al 13 that topical treatment in early pregnancy reduced vaginal fluid mucinase and sialidase, but failed to reduce the rate of preterm births 14 . A recent randomized controlled trial by Kurkinen-Raty et al 15 assessed the efficacy of vaginal clindamycin in reducing preterm birth (level I). Of the 1956 women without a history of preterm delivery who were screened at the first antenatal visit (gestational week 12), 143 women tested positive for BV.…”

“…14 Kurkinen-Raty et al 15 French et al Table 2 Studies that have evaluated the effect of treatment of bacterial vaginosis on the incidence of preterm labor…”

Autoprélèvement vaginal à la recherche d'une vaginose bactérienne pendant la grossesse : étude pilote

“…Dans les études menées jusqu'ici, elle varie entre 8 et 20 % des femmes enceintes. Elle serait plus élevée dans la population nord-américaine (14 à 35 % selon les séries [8,22]) que dans la population européenne (4 à 14 % selon les séries au Royaume-Uni [12,20], 8,6 % en Autriche [26], 7,3 % en Finlande [27], 15,6 % en Suède [16]). …”

Management of Abnormal Vaginal Flora as a Risk Factor for Preterm Birth

“…Even worse, Klebanoff's (Klebanoff et al, 2001) and Odendael's study (Odendaal et al, 2002) on the treatment of trichomoniasis and BV, respectively, rather demonstrated an increased risk of preterm birth after treatment with metronidazole, leading several authors to the compelling conclusion that metronidazole should not be used in pregnancy with the purpose to reduce the risk of preterm birth (Donders et al, 2009;Odendaal et al, 2002;Carey et al, 2003;Morency & Bujold, 2007). Investigators using broader spectrum antibiotics, also covering gram positive cocci and E coli, on the other hand, were successful in the reduction of preterm birth in several placebo controlled studies (Larsson et al, 2006;Lamont et al, 2003;Ugwumadu et al, 2003), although not all (Kekki et al, 2001;Kurkinen-Raty et al, 2000;Rosenstein et al, 2000). As most studies used a single treatment course of 5 to 7 days, and test of cure was not always done, one can ask whether a more intensive and repetitive treatment regimen would not be indicated, but studies are lacking.…”