The Effectiveness and Safety of Introducing Condom-catheter Uterine Balloon Tamponade for Postpartum Hemorrhage at Secondary Level Hospitals in Uganda, Egypt, and Senegal: A Stepped Wedge, Cluster-randomized Trial

Abstract

(BJOG. 2019;126:1612–1621) The World Health Organization has recommended uterine balloon tamponade (UBT) as one intervention for postpartum hemorrhage (PPH), a leading cause of maternal mortality worldwide. This is important for low- and middle-income countries (LMICs), where uterotonics, blood products, and skilled surgical teams may not be readily available. A few studies have reviewed the use of condom-catheter UBT in LMICs, but they have demonstrated conflicting findings or lacked robust evidence on its effectiveness. The aim of this study was to examine if condom-catheter UBT reduced maternal morbidity and mortality associated with PPH in LMICs.

Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review

“…The experimental study by Anger et al, which used a stepped-wedge design, suggests a four-fold statistically significant increase in surgical interventions or maternal deaths associated with introducing improvised UBTs (RR 4.08, 95% CI 1.07-15.58). 20 In contrast, two nonrandomised studies showed unclear effects on the composite outcome after the inclusion of the Bakri balloon (RR 0.33, 95% CI 0.11-1.03) and Bakri/Ebb balloon (RR 0.95, 95% CI 0.32-2.81). 21,23 Three studies reported hysterectomy rates and were graded as low-certainty evidence.…”

“…21,23 Three studies reported hysterectomy rates and were graded as low-certainty evidence. The Anger et al trial used the condom-catheter device and found unclear results (RR 4.38, 95% CI 0.47-41.81), 20 as did both non-randomised studies that assessed purpose-designed UBT (RR 0.49, 95% CI 0.04-5.38 and RR 1.84, 95% CI 0.44-7.69, respectively). 21,23 Regarding the subsequent need for conservative surgical interventions (artery ligation, compressive sutures), the RCT (Anger et al) suggests a statistically significant increase in the risk of additional conservative interventions associated with improvised devices (RR 2.82, 95% CI 1.03-7.71), 20 whereas the non-randomised studies evaluating purpose-designed devices showed unclear results (RR 0.29, 95% CI 0.08-1.06 21,23 and RR 0.21, 95% CI 0.02-1.82 23 ).…”

“…The Anger et al trial used the condom-catheter device and found unclear results (RR 4.38, 95% CI 0.47-41.81), 20 as did both non-randomised studies that assessed purpose-designed UBT (RR 0.49, 95% CI 0.04-5.38 and RR 1.84, 95% CI 0.44-7.69, respectively). 21,23 Regarding the subsequent need for conservative surgical interventions (artery ligation, compressive sutures), the RCT (Anger et al) suggests a statistically significant increase in the risk of additional conservative interventions associated with improvised devices (RR 2.82, 95% CI 1.03-7.71), 20 whereas the non-randomised studies evaluating purpose-designed devices showed unclear results (RR 0.29, 95% CI 0.08-1.06 21,23 and RR 0.21, 95% CI 0.02-1.82 23 ). For other secondary outcomes, the RCT assessing the condom-catheter device found unclear results for maternal deaths (RR 2.23, 95% CI 0.35-14.07), blood transfusion (RR 1.24, 95% CI 0.86-1.80) and transfer to a higher level of care (RR 3.05, 95% CI 0.79-11.70).…”

“…Twenty-six studies were eligible according to our selection criteria. Four out of 26 compatible citations were ultimately included [20][21][22][23] (Figure S1). The excluded studies and the reasons for exclusion are described in Table S4.…”

“…One study conducted in Benin and Mali assessed UBT devices' effectiveness for refractory postpartum haemorrhage after vaginal birth by comparing the condom-catheter balloon against standard care. 22 Three studies evaluated the effects at the facility-level of including UBT devices as a treatment option for refractory PPH after vaginal birth, including one stepped-wedge cluster RCT conducted in Uganda, Senegal and Egypt introducing condom or glove catheter 20 and two non-randomised studies conducted in France: one comparing outcome rates at the hospital-level before and after the introduction of the Bakri balloon 21 and the other comparing outcomes between one perinatal network using the Bakri/EBB â and one control network. 23 To assess the included studies' validity, we rated individual criteria for each study, which were specific for randomised and non-randomised studies.…”