Status:
COMPLETED
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Uterine Atony
Postpartum Hemorrhage
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorr...
Detailed Description
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in Januar...
Eligibility Criteria
Inclusion
- \> 24 weeks, viable pregnancy, singleton or twins
Exclusion
- No consent
- Contraindication to oxytocin
- Antepartum fetal demise
- Intrapartum use of concentrated oxytocin
- Planned cesarean
- DIC or coagulopathy
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1798 Patients enrolled
Trial Details
Trial ID
NCT00790062
Start Date
November 1 2008
End Date
June 1 2010
Last Update
April 8 2016
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233