ObjectiveTo assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings.DesignRandomised controlled trial.SettingSeven healthcare facilities in Cotonou, Benin and Bamako, Mali.PopulationWomen delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics.MethodsWomen were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol.Main outcome measureProportion of women with invasive surgery or who died before hospital discharge.ResultsThe proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059).Trial registration numberISRCT Registry Number 01202389; Post-results.

Decrease in the delays in oxytocin administration is a key determinant to improve maternal outcomes related to PPH in this context.