Prophylactic and Resuscitative Endovascular Balloon in Gynecology & Obstetrics (PREGO) TRIAL
This multicenter observational study examines the use of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct in the management of peri-partum and post-partum hemorrhage (PPH). REBOA has been increasingly used in trauma and acute care surgery to control non-compressible hemorrhage, and some institutions have begun applying the technique to severe obstetric hemorrhage. However, indications, protocols, and outcomes associated with its use in this setting are not well defined.
The study will collect prospective observational data on pregnant and postpartum patients experiencing peri-partum hemorrhage before delivery or within 12 weeks after delivery. Outcomes will be compared between patients who receive REBOA as part of hemorrhage management and those who do not.
The primary objective is to evaluate the impact of REBOA use on outcomes such as blood transfusion requirements, estimated blood loss, and uterine preservation. Secondary outcomes include procedure timing, maternal and neonatal intensive care utilization, complications related to vascular access or systemic effects, and maternal and neonatal mortality. The findings are intended to inform recommendations regarding the role of REBOA in the management of peri-partum hemorrhage.