Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen

Launched by UNIVERSITY OF ROMA LA SAPIENZA · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat severe postpartum hemorrhage (PPH), which is heavy bleeding that can happen after childbirth. The trial compares the use of an intrauterine balloon (called Bakri©) that applies pressure to stop the bleeding, with a special type of gauze (Celox PPH©) that helps form clots to control the bleeding. This study is important because some women do not respond to standard medical treatments, and finding effective alternatives can help reduce complications and improve recovery.

To participate in this trial, women aged 18 and older who have experienced significant bleeding (more than 1000 mL) after giving birth, either vaginally or by cesarean section, may be eligible. They should have already tried standard medications without success and be stable enough to undergo one of these treatments. Participants can expect to receive either the Bakri balloon or the Celox gauze to see which method works better in controlling their bleeding. This research aims to improve treatment options for women facing severe bleeding after childbirth, potentially leading to better outcomes and shorter hospital stays.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria: Participants must meet all of the following criteria to be eligible for inclusion:
• • Women aged 18 years or older who have delivered either vaginally or via cesarean section.
• • Diagnosis of postpartum hemorrhage, defined as an estimated blood loss (EBL) greater than 1000 mL within the first 24 hours postpartum.
• • Refractory to first-line medical therapy, specifically high-dose oxytocin (≥40 IU total administered intravenously or intramuscularly), a full dose of methylergometrine (0.2 mg IM or IV), and administration of tranexamic acid (1 g IV).
• • Hemodynamically stable at the time of enrollment, allowing time for the application of a mechanical or topical intervention.
• Exclusion Criteria: Patients will be excluded if they meet any of the following conditions:
• • Clinical or radiological suspicion of placenta accreta spectrum (PAS), including placenta increta or percreta, which may necessitate immediate surgical management.
• • Known pre-existing or newly diagnosed coagulopathy, including but not limited to thrombocytopenia (\<50,000/μL), von Willebrand disease, hemophilia, or disseminated intravascular coagulation (DIC), which may compromise the safety or efficacy of the interventions.
• • Hemodynamic instability defined by persistent hypotension (systolic BP \<90 mmHg or MAP \<65 mmHg) despite resuscitation, or active decision to proceed to surgical intervention (e.g., laparotomy, uterine artery embolization, or hysterectomy) without delay.