Efficacy of chlorhexidine vaginal preparation in reducing postoperative infections during emergency cesarean deliveries for women in labor: a randomized controlled trial

Postoperative infections are a leading cause of maternal morbidity after emergency cesarean delivery. This trial explores the effectiveness of preoperative vaginal cleansing via the use of chlorhexidine for reducing these complications in women in labor. This single-blinded superiority randomized controlled trial included 840 women in labor equally distributed to either immediate preoperative chlorhexidine gluconate 0.05% vaginal cleansing or no-cleansing; 826 were analyzed under a modified intention-to-treat approach. The co-primary outcomes were postcesarean endometritis and surgical site infection (SSI). Secondary outcomes included composite wound complications, postoperative fever, significant leukocytosis, hospital readmission, length of stay, and adverse drug reactions. Effects are expressed as risk ratios (RR) with 95% confidence intervals, with adjusted, sensitivity, and subgroup analyses for the co-primary outcomes. Chlorhexidine significantly reduced both co-primary outcomes; postcesarean endometritis (1.9% vs. 6.3%; RR 0.303, 95% CI 0.139–0.662; P = 0.001) and SSI (1.4% vs. 5.4%; RR 0.269, 95% CI 0.110–0.656; P = 0.002); both remained significant against a Bonferroni-adjusted threshold of 0.025. Other outcomes were also reduced, including composite wound complications (3.4% vs. 11.0%; RR 0.307, 95% CI 0.171–0.550; P < 0.001), and readmission for infection (1.4% vs. 6.3%; P < 0.001; RR 0.227, 95% CI 0.095–0.547). The co-primary outcome effects persisted after adjustment and in sensitivity analyses. Treatment effects were in the same direction across premature rupture of membranes (PROM) and obesity subgroups with no significant interaction, although the SSI reduction reached significance overall and in the non-obese stratum but not within the obese stratum. In this single-center trial, preoperative chlorhexidine vaginal cleansing produced lower rates of postcesarean endometritis and SSI and of related infectious morbidity. As a low-cost intervention that can be integrated into existing perioperative workflows, it is a promising strategy for reducing maternal infection; however, adverse events were not systematically solicited, and neonatal exposure was not assessed. Multicenter confirmation, systematic maternal and neonatal safety data, and cost-effectiveness analysis are required before routine adoption. ClinicalTrials.gov NCT04385680 submitted 9 May 2020, first posted 13 May 2020.