Abstract
BackgroundWorldwide 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.MethodsThis 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.DiscussionThe 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 registrationThe PREPS trial has been registered with ISRCTN (ISRCTN 33435996).
Highlights
Worldwide caesarean section (CS) delivery is the most common major operation
Risk factors for endometritis following CS include in labour caesarean section and ruptured membranes with or without vaginal colonisation with group B streptococcus
A single swab/sponge mounted on a sponge holder soaked in the antiseptic will be used to clean the vagina prior to CS at the time of urinary catheter insertion, for guidance, we suggest the vaginal cleansing should take 30 s
Summary
Worldwide caesarean section (CS) delivery is the most common major operation. 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. 25% of pregnant women undergo a CS in the UK for delivery of their babies This equates to approximately 171,000 caesarean sections per year in England alone. Infection following a CS has numerous primary sources including endometritis, occurring in 7–17% of women; this equates to approximately 27,000 cases of infection per year in England only. Sepsis reduction and reduction in antibiotic use have been identified as national and international priorities, improving maternal health and neonatal wellbeing through the facilitation of ongoing breast feeding
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