Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.

Objective: To 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.

Design: Randomised controlled trial.

Setting: Seven healthcare facilities in Cotonou, Benin and Bamako, Mali.

Population: Women 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.

Methods: Women 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 Measure: Proportion of women with invasive surgery or who died before hospital discharge.

Results: The 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 Number: ISRCT Registry Number 01202389; Post-results.