Study of the Abdominal Aortic and Junctional Tourniquet Device for Severe Postpartum Hemorrhage Uncontrolled by Standard Treatments

What this Trial Is About

Researchers are evaluating the use of the Abdominal Aortic and Junctional Tourniquet - Stabilized AAJT-S device as a temporary treatment for severe postpartum hemorrhage PPH caused by uterine atony that does not respond to standard therapies like uterotonics and balloon tamponade. This multicenter, prospective study focuses on women experiencing heavy bleeding after childbirth in settings where surgical care and blood products may be delayed, such as conflict-affected regions in Ukraine. Participants will receive standard care for PPH initially. If bleeding continues uncontrolled, the AAJT-S device will be applied to the upper abdomen and inflated to 250 mmHg to temporarily block blood flow through the abdominal aorta and inferior vena cava. This device will be used for up to 60 minutes to reduce bleeding and provide time to prepare for surgery and blood transfusion. During the study, women will be closely monitored from device application until six weeks postpartum. Researchers will measure how quickly bleeding is controlled after device use and watch for any device-related side effects. Blood loss will also be estimated visually from delivery until the device is placed. This monitoring aims to assess the devices feasibility, safety, and effectiveness as a temporary intervention for severe PPH.

Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage