The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage
Use of uterine balloon tamponade is a recommended approach for managing postpartum hemorrhage that is uncontrolled by uterotonics. The condom-catheter UBT is considered a low-cost alternative to pre-fabricated UBT devices (such as the Bakri balloon) and use of condom-catheter UBT could help expand access to UBT in low- and middle-income countries (LMICs). This study assessed the effectiveness of introducing condom-catheter UBT on reducing overall PPH‐related morbidity and mortality among hospital populations in LMICs using a stepped‐wedge, cluster‐randomized trial design. Prior to this research, evidence on UBT use in LMIC was largely comprised of case series with a key limitation of no comparison group. Our study was designed to address this evidence gap and to better understand the specific impact that UBT introduction may have as a public health intervention aimed at improving PPH‐related outcomes in LMIC. This study showed that introduction of UBT did not reduce PPH-related deaths and invasive procedures during the study period. Rather, there was a statistically significant increase in the composite outcome of PPH-related deaths and invasive procedures following UBT introduction; however, the increase was not statistically significant after excluding two sites (identified as outliers in sensitivity analysis) and there were some indications that the observed increase may be due to underlying temporal trends in clinical practices that are unrelated to UBT introduction.
The study revealed contextual factors that help explain why UBT introduction did not result in declines in PPH-related morbidity and mortality. For example, over half of women who had invasive procedures or PPH-related death had factors beyond uterine atony that complicated management, including obstetric trauma (which UBT is not designed to address). Further, blood shortages were a problem for over half of PPH-related deaths in the study. Taken together, these findings suggest that interventions such as UBT may have limited effectiveness in improving maternal outcomes when introduced into resource‐constrained health systems with unreliable access to other essential components of emergency care. Efforts to strengthen PPH care must include prioritizing continued access to uterotonics, blood products, and qualified and available health providers.