Vaginal preparation with chlorhexidine at cesarean section to reduce endometritis and prevent sepsis: A randomized pilot trial (PREPS)

摘要

Abstract Introduction Cesarean sections are the most common major operation worldwide. One in 10 women develops a surgical‐site infection after cesarean section. The PREPS pilot trial was developed to assess the feasibility of a randomized controlled trial of vaginal cleansing with chlorhexidine before cesarean section, to reduce infectious morbidity. Material and methods A multi‐center, open‐label, parallel‐group pilot randomized controlled trial across 4 UK maternity units. Women aged ≥16?years, undergoing elective or emergency cesarean section, ≥34?weeks of gestation, and able to give informed consent were eligible. Women were randomized 1:1 to chlorhexidine 0.05% or no cleansing and were followed up until 6?weeks after cesarean section. The feasibility of a larger randomized controlled trial was assessed by the pilot trial’s recruitment, ability to use verbal consent in an emergency, adherence, follow‐up and withdrawal rates. The main clinical outcome collected was Center for Disease Control and Prevention (CDC) classification of endometritis at 30?days. Trial registration number is ISRCTN33435996. Results A total of 320 women (128% of target) were randomized. Of these, 93% (95% CI 89%‐95%) received their allocated intervention. Of the 88 women who had an emergency cesarean section, verbal consent was initially given by 32 (36%) women, with the remainder having sufficient time to give written consent. Endometritis (CDC definition) was collected from medical notes of 96% of women, 68% (95% CI 63%‐73%) were followed up at both 14 and 30?days by telephone, and we were able to collect patient‐reported outcomes. In the vaginal cleansing arm 2/152 (1.3%) women had endometritis compared with 1/155 (0.7%) in the no cleansing arm (RR 2.08, 95% CI 0.19‐22.31). Conclusions It is possible to perform a randomized controlled trial in women undergoing an elective or emergency cesarean section, using a verbal‐followed‐by‐written consent process, while maintaining high adherence and retaining women in the trial.