Mechanical properties of ESM-UBT: An ultra-low cost uterine balloon tamponade device

Abstract

Uncontrolled postpartum hemorrhage (PPH) is the most common cause of maternal morbidity and mortality worldwide, with most cases of death and disability mainly in resource poor settings. Placement of a uterine balloon tamponade (UBT) is a recognized life-saving intervention in these circumstances. A UBT device is a balloon attached to a semi-rigid large bore catheter that acts as both an introducer and as a channel to rapidly inflate the balloon once it is placed into the uterine cavity. Reports on patient outcomes associated with commercial UBT devices are encouraging, however, their high cost (up to$400 USD) is a barrier to implementation across resource-poor settings. The ESM-UBT device is an ultra-low-cost condom-catheter UBT designed to be a quality and affordable device for scale in resource poor areas (Figure 1). The purpose of this study was to comprehensively evaluate the mechanical properties of this device, in advance of Regulatory evaluation. The evaluated mechanical properties are expected to be effective on the function of the device in clinic.