Conditions: Uterine Atony Postpartum Hemorrhage
Keywords: Uterine atony Postpartum hemorrhage clinical trial Prophylactic oxytocin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1798
Healthy volunteers: no

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 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.

Arms:
arm 1: 1 dose only for prophylaxis given over 1 hour arm 2: One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. arm 3: 1 dose only given over 1 hour

Interventions: intervention 1: Oxytocin
Intervention descriptions: intervention 1: See arms

Protocol document: