Trial reportBJOG : an international journal of obstetrics and gynaecology2019
The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial.
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2021Pooled it
- Cost-effectiveness of uterine tamponade devices for the treatment of postpartum hemorrhage: A systematic review.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2020Pooled it
- Duration of Intrauterine Balloon Tamponade in Post-Partum Haemorrhage Management After Vaginal Delivery: A Secondary Cohort Analysis From the French TUB Trial.BJOG : an international journal of obstetrics and gynaecology · 2026Trial
- Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Trial
- Trial
- Suturing the placental bed in addition to intrauterine balloon tamponade, is it effective in placenta previa patients?BMC pregnancy and childbirth · 2026Article
- Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review.Frontiers in epidemiology · 2026Review
- Achieving Equitable Access to Obstetric Devices Through Innovation, Improvisation and Off-Label Use.BJOG : an international journal of obstetrics and gynaecology · 2025Review
- A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.PloS one · 2024Article
- Observational
- Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.PloS one · 2021Article
- Management of Postpartum Hemorrhage With a Mini-Sponge Tamponade Device.Obstetrics and gynecology · 2020Article
- Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data.BJOG : an international journal of obstetrics and gynaecology · 2020Article
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Abstract
objectiveTo assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings.
designStepped wedge, cluster-randomised trial.
settingEighteen secondary-level hospitals in Uganda, Egypt and Senegal. POPULATION: Women with vaginal delivery from October 2016 to March 2018.
methodsUse of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect).
main outcome measuresCombined IR of PPH-related invasive surgery and/or maternal death.
resultsThere were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods.
conclusionsIntroduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role. TWEETABLE ABSTRACT: Stepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death.
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