Status:
TERMINATED
Antibiotics During Intrauterine Balloon Tamponade Placement
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Obstetric Complication
Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigat...
Detailed Description
The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade. Patients who are candidates for study enrol...
Eligibility Criteria
Inclusion
- Female
- Able to give consent
- Gestational age \> 24 weeks
- Postpartum
- Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours
- Primary obstetrician amenable to proceeding with either method of management during the study period.
Exclusion
- Age \< 18 years old
- IBT removed within 2 hours of placement
- Chorioamnionitis
- Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03478163
Start Date
March 8 2018
End Date
May 3 2021
Last Update
October 7 2021
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048