Chlorhexidine vaginal preparation versus standard treatment at caesarean section to reduce endometritis and prevent sepsis—a feasibility study protocol (the PREPS trial)

Hodgetts Morton, V and Wilson, A and Hewitt, C and Weckesser, Annalise and Farmer, N and Lissauer, D and Hardy, P and Morris, K (2018) Chlorhexidine vaginal preparation versus standard treatment at caesarean section to reduce endometritis and prevent sepsis—a feasibility study protocol (the PREPS trial). Pilot and Feasibility Studies, 4 (84). pp. 1-10. ISSN 2055-5784

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Abstract

Background
Worldwide caesarean section (CS) delivery is the most common major operation. Approximately 25% of pregnant women undergo a CS in the UK for delivery of their babies. Sepsis and post-natal infection constitute significant maternal mortality and morbidity. Infection following a CS has a number of primary sources including endometritis occurring in 7–17% of women. Sepsis reduction and reduction in antibiotic use have been identified as a national and international priority. The overarching aim of this research is to reduce infectious morbidity from caesarean sections.

Methods
This is a parallel group feasibility randomised controlled trial comparing vaginal cleansing using chlorhexidine gluconate versus no cleansing (standard practice) at CS to reduce infection. Women will be recruited from four National Health Service maternity units. Two hundred fifty women (125 in each arm) undergoing elective or emergency CS, who are aged 16 years and above, and at least 34 weeks pregnant will be randomised. Allocation to treatment will be on a 1:1 ratio. The study includes a qualitative aspect to develop women centred outcomes of wellbeing after delivery.

Discussion
The success of the feasibility study will be assessed by criteria related to the feasibility measurements to ascertain if a larger study is feasible in its current format, needs modification or is unfeasible, and includes recruitment, adherence, follow-up and withdrawal measures.

Trial registration
The PREPS trial has been registered with ISRCTN (ISRCTN 33435996).

Item Type: Article
Subjects: A300 Clinical Medicine
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: 10 Aug 2018 10:59
Last Modified: 10 Aug 2018 10:59
URI: http://www.open-access.bcu.ac.uk/id/eprint/6228

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