NCT00790062

Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT

Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,798 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.

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 January of 2010 and their recommendations were implemented.

Conditions

• Uterine Atony
• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Oxytocin	See arms

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-11-13
• Last updated: 2016-04-08
• Results posted: 2014-01-30

Locations

1 site across 1 country: United States