A single dose of intravenous co-amoxiclav, given after the umbilical cord is clamped, could halve the rate of maternal infection following forceps or ventouse delivery. Around one in eight women in the UK who give birth vaginally need an assisted delivery with forceps or a ventouse cup. These procedures carry a higher risk of infection than unassisted birth, yet there is no clear evidence on whether giving antibiotics preventatively—before infection sets in—is effective or safe. Current practice varies, and clinicians lack a robust trial to guide them. This randomised, double-blind, placebo-controlled trial will recruit women at full term across consultant-led maternity units. Half will receive the antibiotic, half a saline placebo. The primary outcome is confirmed or suspected infection within six weeks of delivery, including endometritis or systemic infection. Secondary outcomes cover pain, wound healing, hospital stays, breastfeeding, and side effects such as anaphylaxis. If the trial shows that a single prophylactic dose reduces infections by the expected margin, it could change national guidelines. That would mean fewer women needing additional antibiotics, fewer GP visits or hospital readmissions, and less disruption to early motherhood—a straightforward intervention with the potential to improve recovery for tens of thousands of women each year.
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Design: Randomised, double-blind, placebo-controlled trial Setting: Consultant-led maternity units Target population: Pregnant women undergoing delivery by forceps (any type) or ventouse (any type) at 37+0 weeks or greater gestation Health technology being assessed: A single dose of intravenous co-amoxiclav (1g amoxycillin/200mg clavulanic acid) following clamping of the cord, versus placebo (normal saline). Measurement of outcomes: The primary outcome will be confirmed or suspected maternal infection within 6 weeks of delivery, as defined by the prescription of antibiotics, endometritis or confirmed systemic infection on culture. Secondary outcome measures, evaluated at six weeks post-delivery will include severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital / GP visits, need for additional perineal care, dyspareunia, patient reported outcomes including the ability to sit comfortably to feed the baby, maternal general health, breast feeding and wound breakdown, as well as any potential side effects of antibiotic usage such as anaphylaxis. Standard measurement tools from previous studies will be used alongside specific questions. Sample size: Existing literature suggests a conservative estimate of the background rate of maternal infection following operative delivery of 4% and an estimated reduction of 50% in this rate with antibiotic prophylaxis. To conduct a study with 90% power and a two-sided 5% level of significance, with 5% loss to follow-up gives 1,712 per group, or a total of 3,424 women. Project timetable: Planned duration 38 months, recruitment over 2 years assuming a conservative 1 in 3 women will be accessed, agree to participate and provide complete outcome data, greater than observed in previous trials of antibiotic prophylaxis for caesarean section. March-August 2015: Obtain approvals and set-up the study sites; train local personnel in trial procedures. September 2015-August 2017: Recruitment in study sites. October 2017: Completion of follow-up. November 2017-April 2018: Analysis, reporting and dissemination of results. Expertise in team: The team has extensive experience of conducting clinical trials in the maternity field, as well as other studies of severe pregnancy complications, and includes members with key expertise in obstetrics, statistics, microbiology, epidemiology, public health and midwifery.
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