Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: A Multicenter Randomized Trial

What this Trial Is About

Researchers are conducting a randomized control trial to evaluate the Jada4 System, a novel vacuum-induced device designed to treat postpartum hemorrhage (PPH), a leading cause of maternal death worldwide, especially in low and middle income countries. The study aims to compare the effectiveness, safety, and cost-effectiveness of this device against standard care in women experiencing PPH, defined as significant blood loss or symptoms of hypovolemia after childbirth. PPH commonly results from uterine atony, where the uterus does not contract properly after delivery. The trial includes two groups: one group will receive the Jada4 System when initial medical treatments fail and blood loss reaches 1000 mL; this device uses low-level vacuum pressure to help the uterus contract and control bleeding rapidly. The other group will receive standard care which may include additional medications, tranexamic acid, condom catheter balloon tamponade, or surgical interventions if bleeding continues. The device remains in place for at least one hour during treatment, followed by monitoring before removal. Participants are enrolled at two hospitals in Ghana, a country with a high burden of PPH. Participants will be monitored from delivery until six weeks postpartum. Researchers will assess maternal survival without needing surgery, time to control bleeding, hemoglobin levels, blood transfusion rates, surgical procedures, maternal death rates, additional medication use, patient satisfaction, and any adverse events related to the device. The study also evaluates quality of life and cost-effectiveness. Safety and treatment outcomes will be closely followed during this period to determine the device's potential benefits compared to standard care.

Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage