Randomized Trial to Compare Chitosan Gauze vs. Bakri Balloon for Refractory Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is a leading cause of maternal mortality globally, particularly in low- and middle-income countries. Initial management involves uterotonics like oxytocin, but a significant subset of patients remains unresponsive. Current second-line interventions, such as the Bakri intrauterine balloon, have a failure rate of 20-40%, especially in cases of coagulopathy or diffuse atony. There is a critical clinical need for alternative, effective second-line treatments to avoid invasive procedures like uterine artery embolization or hysterectomy.

This study proposes a head-to-head, randomized controlled trial comparing two second-line interventions for postpartum hemorrhage (PPH) refractory to medical treatment. The interventions are the Bakri intrauterine balloon and chitosan gauze (Celox PPH©). Patients with blood loss exceeding 1000 mL after delivery, unresponsive to uterotonics (oxytocin, methylergometrine, tranexamic acid), will be randomized. The study aims to assess the relative efficacy and safety of these two mechanical methods in controlling uterine bleeding.