Status:
ACTIVE_NOT_RECRUITING
Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage
Lead Sponsor:
Denver Health and Hospital Authority
Conditions:
Postpartum Hemorrhage, Immediate
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little i...
Eligibility Criteria
Inclusion
- Women at Denver Health and Hospital Authority (DHHA) who have an IUBT placed for postpartum hemorrhage due to uterine atony will be approached for enrollment in the study.
Exclusion
- Women will be excluded from the study if they: are less than 18 years of age; had a cesarean delivery; are unable to consent for themselves; have a preexisting or acquired clotting factor disorder such as von Willebrand or hemophilia, disseminated intravascular coagulation, or therapeutic anticoagulation at time of delivery; would refuse blood product transfusion; have a fetal demise or birth of a previable fetus; or are incarcerated at the time of delivery. Women who do not speak English or Spanish will be offered enrollment if a phone interpreter is available to review the consent, but will be excluded from the survey portion of the study.
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04467996
Start Date
October 19 2020
End Date
January 1 2026
Last Update
November 21 2025
Active Locations (1)
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1
Denver Health Hospital
Denver, Colorado, United States, 80204