Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study

Abstract

XXX OBJECTIVE: This study aimed to demonstrate that vaginal cleansing with a 4% chlorhexidine solution before cesarean delivery in patients with a history of rupture of membranes prevents postoperative infectious complications (endometritis, surgical site infections). A total of 204 patients with premature rupture of membranes or who were in labor for more than 6 hours after membranes ruptured were randomized before a cesarean delivery to preoperative vaginal cleansing with a chlorhexidine solution (n=97 patients) or to placebo cleansing with saline solution (n=107 patients). The management of the rupture of membranes and the cesarean delivery procedure were conducted according to standard local protocols for both groups, including the use of antibiotics. Vaginal cleansing with chlorhexidine reduced the risk for endometritis after cesarean delivery in patients with rupture of membranes when compared with placebo cleansing (chlorhexidine, 7.21% vs placebo, 18.8%; relative risk, 0.39; 95% confidence interval, 0.17-0.87; P=.015). Likewise, there was a statistically significant reduction in the number of cases of puerperal fever (chlorhexidine, 9.28% vs placebo, 19.8%; relative risk, 0.47; 95% confidence interval, 0.23-0.98; P=.037). There was a statistical difference between the groups in prolongation of hospitalization for >72 hours (chlorhexidine, 1.03% vs placebo, 7.55%; relative risk, 0.14; 95% confidence interval, 0.02-1.08; P=.02), although the confidence interval suggests that the effect was by chance. There were no statistical differences in surgical site infection at 7 days (chlorhexidine, 1.03% vs placebo, 0.94%; relative risk, 1.1; 95% confidence interval, 0.07-17.4; P=.94) and 15 days after the procedure (chlorhexidine, 1.03% vs placebo, 0%; relative risk, 3.31 [using a continuity correction]; 95% confidence interval, 0.14-80.21; P=.29). The use of chlorhexidine for vaginal cleansing before a cesarean delivery in patients with rupture of membranes reduced the risk for endometritis and puerperal fever. It also reduced the number of cases that required hospitalization for more than 3 days, but the confidence interval suggests that it could be by chance. It has no effect on the number of cases with surgical site infection.