Introduction of the Ellavi Uterine Balloon Tamponade into the Kenyan and Ghanaian maternal health care package for improved postpartum hemorrhage management: an implementation research study

   Objectives: Use of intrauterine balloon tamponades (UBTs) for management of refractory postpartum hemorrhage (PPH) has triggered recent debate. Research suggests that UBT use is associated with improved PPH-related outcomes but effectiveness studies have yielded conflicting evidence. Implementation research is needed to identify factors influencing the successful integration of UBTs into maternal health care packages. The Ellavi UBT (Ellavi) is a new low-cost, preassembled device used to treat refractory PPH. Methods: We conducted a longitudinal, mixed-methods, implementation research study to determine the adoption, sustainability, acceptability, feasibility, and fidelity of introducing the Ellavi into maternal health care packages. Obstetric staff (n=451) were trained across six hospitals in Ghana and Kenya and administered cross-sectional surveys post-training and post-use of the Ellavi over 10 months.</p