A Novel Agent for Management of Post Partum Hemorrhage: Adaptation of the Xstat Mini-Sponge Applicator for Obstetric Use
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries. The majority of these deaths occur outside the health care system, and so an intervention that could be used in any setting and with minimal training could save lives. We will use an animal model to demonstrate appropriate uterine fill, and a proof-of-concept study to show stoppage of post-delivery bleeding and test ease of removal. If our hypothesis is correct, we would then undertake a Phase I clinical trial to demonstrate feasibility in women followed by a Phase III randomized clinical trial of safety and efficacy. Standard care for treating PPH consists of massage, uterotonics, and tamponade (i.e., "holding pressure"). Devices used to treat PPH via tamponade are not easily adaptable to low-resource settings with diverse climates and providers. A novel agent, the XSTAT mini sponge dressing, has proven successful in the acute cessation of traumatic non-compressible bleeding analogous to PPH. This device utilizes pre-packaged, environmentally stable, compressed medical sponges soaked with a hemostatic agent and administered by a light-weight applicator. The sponges, once deployed, exert uniform pressure to address multiple sources of bleeding and are easily removable. We plan to adapt this device for obstetrical use in an effort to reduce deaths from PPH.