Clinical validation of a novel, affordable uterine balloon tamponade, developed in Africa, to reduce maternal deaths due to postpartum hemorrhage.

Organization: 
PATH
Organization Location: 
Seattle, Washington

Postpartum hemorrhage (PPH) continues to be the leading cause of maternal deaths worldwide resulting in an estimated 125,000 maternal deaths per year. Women who survive PPH suffer from severe anemia and are more likely to die within the following year. Most of these deaths are preventable with timely management of the bleeding, yet in low-resource settings (LRS), especially in rural areas, women have little access to proper care during delivery. Evidence to support the use and efficacy of uterine balloon tamponade (UBT) for PPH is growing, as is awareness and demand. The need for an affordable, ready-to-use medical device is well documented. We propose to conduct a clinical validation study of a novel affordable UBT, designed and manufactured in South Africa by Sinapi Biomedical for the management of PPH in LRS. The UBT is a fully integrated system with a gravity-fed filling mechanism making it easier and faster to use. Introduction and wide-scale use would have measurable impact if introduced at points of care where treatment options are currently limited because of lack of skilled providers or equipment. We will develop a sustainable commercialization strategy to ensure adoption and global access of this lifesaving device in low- and middle- income countries. PATH, Sinapi, Stellenbosch University, and Tygerberg Hospital will collaborate, providing strong technical and clinical skills and a deep understanding of sustainable commercialization and introduction strategies.

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