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

Hodgetts-Morton, V and Hewitt, CA and Wilson, A and Farmer, N and Weckesser, Annalise and Dixon, E and Brocklehurst, P and Hardy, P and Morris, RK (2019) Vaginal preparation with chlorhexidine at cesarean section to reduce endometritis and prevent sepsis: A randomized pilot trial (PREPS). Acta Obstetricia et Gynecologica Scandinavica, 99 (2). pp. 231-239. ISSN 1600-0412

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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.

Item Type: Article
Identification Number: https://doi.org/10.1111/aogs.13737
Date: 20 September 2019
Uncontrolled Keywords: cesarean section,chlorhexidine, endometritis, pilot projects, sepsis,surgical wound infection, vaginal cleansing, vaginal douching
Subjects: A900 Others in Medicine and Dentistry
Divisions: Faculty of Health, Education and Life Sciences > Centre for Social Care, Health and Related Research (C-SHARR) > Family Health
Depositing User: Annalise Weckesser
Date Deposited: 16 Oct 2019 07:14
Last Modified: 20 Sep 2020 03:00
URI: http://www.open-access.bcu.ac.uk/id/eprint/8189

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