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

• Published in: BMJ open Vol. 7; no. 9; p. e016590
• Main Authors: Dumont, Alexandre, Bodin, Cécile, Hounkpatin, Benjamin, Popowski, Thomas, Traoré, Mamadou, Perrin, René, Rozenberg, Patrick
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.09.2017; BMJ Publishing Group
• Subjects: Adult; Benin - epidemiology; Catheters; Combined Modality Therapy; Condoms; Consent; Demography; Evidence-based medicine; Female; Health care; Health facilities; Hemorrhage; Hospitals; Human health and pathology; Humanities and Social Sciences; Humans; Life Sciences; Mali - epidemiology; Misoprostol - therapeutic use; Mortality; Obstetrics and Gynaecology; Oxytocics - therapeutic use; Patients; Postpartum Hemorrhage - mortality; Postpartum Hemorrhage - therapy; Postpartum period; Pregnancy; Uterine Balloon Tamponade - methods; Womens health; Young Adult; Benin; Mali; low resource settings; post-partum haemorrhage; second line therapy; uterine balloon tamponade; misoprostol; randomized controlled trial; REGULATION DES NAISSANCES; CONTRACEPTION
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-016590

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.