Status:
NOT_YET_RECRUITING
Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06996808
Start Date
September 1 2025
End Date
January 1 2029
Last Update
June 4 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.