Objective To test the hypothesis that intravenous antibiotics given intra-operatively reduce the failure rate of vesico-vaginal fistula repair.
Design A single blind, randomised controlled trial.
Setting A district hospital in Benin, West Africa.
Population Seventy-nine women undergoing repair of an obstetric vesico-vaginal fistula by a single surgeon at Hopital Evangelique; two women had repeat operations.
Methods Participants in the treatment group (n = 41) received ampicillin 500 mg intra-operatively. Controls (n = 40) received no prophylactic antibiotics.
Main outcome measures Failure of fistula closure and objective incontinence (a positive pad test) at hospital discharge. Secondary outcomes included febrile morbidity, other antibiotic use and urinary infection.
Results Antibiotic prophylaxis did not reduce the odds of failed repair (OR 2.1 95% CI 0.75–6.1) or of objective incontinence (OR 1.9; 95% CI 0.72–5.1). The women in the antibiotic prophylaxis group received less post-operative antibiotics and had less urinary infections at day 10.
Conclusions Prophylactic antibiotics should not be used in vesico-vaginal fistulae repair in the developing world outside randomised controlled trials.