Background: Early-onset group B beta-hemolytic streptococcus (GBS) infection accounts for approximately 30% of neonatal infections, has a high mortality rate and is acquired through vertical transmission from colonized mothers. Several trials have demonstrated the efficacy of intrapartum chemoprophylaxis (IPC) for preventing early-onset disease (EOD). Vaginal disinfection with chlorhexidine during labour has been proposed as another strategy for preventing GBS EOD in the preterm and term neonate. Chlorhexidine has been found to have no impact on antibiotic resistance, is inexpensive, and applicable to poorly equipped delivery sites.
Objectives: To determine the effectiveness of vaginal disinfection with chlorhexidine during labour for preventing early-onset GBS infection in preterm and term neonates.
Search strategy: We searched the Cochrane Pregnancy and Childbirth trials register (October 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2003), MEDLINE (1966 to October 2003), EMBASE (1980 to March 2003), CINAHL (1982 to March 2003) and LILACS (1982 to September 2003).
Selection criteria: Randomized and quasi-randomized trials comparing vaginal disinfection with chlorhexidine to placebo, or no treatment.
Data collection and analysis: We extracted information from the results sections of the included studies. We reported relative risk (RR) and risk difference (RD) with 95% confidence intervals (CI) for dichotomous outcomes. We calculated the number needed to treat (NNT) with 95% CIs when a statistically significant RD was found. We used a chi square test (chi2) and the I2 analysis to test for heterogeneity, and applied a fixed or random effects model accordingly.
Main results: Five studies, including approximately 2190 term and preterm infants, met the inclusion criteria and reported on at least one of the outcomes of interest for this systematic review. When all studies were combined there was a statistically significant (p = 0.005) reduction in colonisation (RR 0.72, 95% CI 0.56 to 0.91); RD -0.16 (95% CI -0.26 to -0.05); NNT 6 (95% CI 4 to 20). There was no statistically significant between-study heterogeneity. There was no statistically significant between-study heterogeneity both for RR (chi(2) = 3.21 [p = 0.2], I(2) = 37.8%) and for RD (chi(2) = 1.66 [p = 0.44], I(2) = 0%). There was no statistically significant reduction in EOD including GBS infection, GBS pneumonia, GBS meningitis or mortality.
Reviewers' conclusions: Vaginal chlorhexidine resulted in a statistically significant reduction in GBS colonisation of neonates, but was not associated with reductions in other outcomes. The review currently does not support the use of vaginal disinfection with chlorhexidine in labour for preventing EOD. Results should be interpreted with caution as the methodological quality of the studies was poor.