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

Abstract

Background: 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).

Study design: 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.

Results: 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).

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT03442218.

Keywords: antisepsis; cesarean; chlorhexidine; endometritis; latency period; prevention; puerperal fever; rupture of membranes; surgical site infection; vaginal cleansing.