Clinical trial of chlorhexidine vaginal irrigation to prevent peripartal infection in nulliparous women.

Abstract

The purpose of this study was to determine whether intrapartum chlorhexidine vaginal irrigations prevent peripartal infection in nulliparous women at >or=32 weeks of gestation. This was a double-blinded, placebo-controlled randomized clinical trial. Vaginal irrigations were performed with 200 mL of 0.2% chlorhexidine solution or sterile saline solution placebo every 6 hours during labor. The primary study outcome was clinically diagnosed maternal peripartal infection: chorioamnionitis or endometritis. Analysis was by intent to treat. One thousand forty-one women were assigned randomly to one of two groups (chlorhexidine therapy, 525 women; placebo, 516 women). The two groups were balanced for risk factors for infection. Rates of peripartal infection were 19.3% in the chlorhexidine group and 17.3% in the placebo group (relative risk 1.1; 95% CI, 0.9-1.4). Major and minor neonatal morbidities were similar between the groups. No major and one minor adverse reaction was attributed to chlorhexidine irrigation. Under the conditions of this trial, chlorhexidine vaginal irrigation lacked efficacy in the prevention of clinically diagnosed maternal and neonatal infectious morbidity.