Every day around the globe, more than 830 women die from preventable causes related to pregnancy and childbirth. Ninety-nine percent of these deaths occur in developing countries, where resources are limited and childbirth occurs outside of the health care system. Postpartum hemorrhage is one of the primary causes of maternal death and the leading cause of death for new mothers in developing countries. A major challenge in treating postpartum hemorrhage is that it is not possible to use tourniquets and other forms of wound compression to stop the bleeding.
A technique used to manage non-compressible wounds in battlefields and trauma settings is now being adapted by a team led by Maria I. Rodriguez, M.D., M.P.H., to treat severe postpartum hemorrhage. The trauma dressing and applicator device, XStat™ Mini Sponge Dressing, applies highly compressed medical sponges—similar to the ‘instant’ sponges sold in grocery stores—that stop high-flow arterial bleeding in about 20 seconds.
This device addresses a key gap in a major treatment for postpartum hemorrhage—uterine tamponade—by adapting it for use in low-resource settings. Tamponade, which physically stems bleeding, stabilizes hemorrhage while transporting a woman or preparing her for surgery. Current methods to deliver uterine tamponade include uterine balloons and packing the uterus with gauze. These methods can be helpful but are not ideal for low-resource settings—each requires specialized skill equipment.
Rodriguez’s adaptation of the XStat has a long, tapered applicator that can be deployed during vaginal examination by nonspecialists, and it administers three times the volume of the sponges contained in the trauma applicator. Unlike the trauma device, the design of the obstetrical applicator allows for the sponges to be removed without surgery. In initial testing, it demonstrated excellent uterine fill and higher average uterine pressure than gauze packing or the uterine balloon, suggesting it may be a more effective alternative. Animal testing also showed good uterine fill and no short-term signs of uterine trauma or infection. The next step for Rodriguez’s team is a Phase 1 clinical study.
In addition to Rodriguez, Jensen, Gregory, and Edelman, co-authors included Mary Bullard, Paul Longo, and Jerry Heidel.
This research was supported by Saving Lives at Birth partners: The United States Agency for International Development (USAID), the Government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the U.K. Government (AID-OAA-F-14-00007).