CHLORHEXIDINE VAGINAL IRRIGATION FOR THE PREVENTION OF PERIPARTAL INFECTION - A PLACEBO-CONTROLLED RANDOMIZED CLINICAL-TRIAL

OBJECTIVE: Our purpose was to determine whether chlorhexidine vaginal irrigation prevents maternal peripartal infection. STUDY DESIGN: A dou ble-blinded, placebo-controlled, randomized trial was performed. Singl e 200 ml irrigations of either 0.2% chlorhexidine solution or sterile water placebo were given in active labor or before planned cesarean de livery. The primary outcome measure was the combined rate of chorioamn ionitis and endometritis (which were mutually exclusive diagnoses). RE SULTS: A total of 1024 patients were enrolled: 508 in the chlorhexidin e group and 516 in the placebo group. The two groups were generally we ll balanced on important clinical factors but differed (p < 0.05) in r ates of nulliparity (chlorhexidine 42%, placebo 52%), intrauterine pre ssure catheter usage (chlorhexidine 65%, placebo 72%), and presence of meconium (chlorhexidine 17%, placebo 22%). There were no recognized a dverse maternal or neonatal reactions to irrigation. Rates of infectio n (chorioamnionitis + endometritis) did not differ significantly betwe en the groups, chlorhexidine 10% versus placebo 13% (relative risk 0.8 , 95% confidence interval 0.5 to 1.1). Stratified and logistic regress ion analyses supported the primary univariate analysis. Neonatal outco mes, including sepsis rates of 0.4%, were equivalent for the groups. C ONCLUSION: As used in this trial, chlorhexidine lacked efficacy in the prevention of maternal peripartal infection.