Expired Study
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Birmingham, Alabama 35233


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - > 24 weeks, viable pregnancy, singleton or twins Exclusion Criteria: - No consent - Contraindication to oxytocin - Antepartum fetal demise - Intrapartum use of concentrated oxytocin - Planned cesarean - DIC or coagulopathy


NCT ID:

NCT00790062


Primary Contact:

Principal Investigator
Alan T Tita, MD, PhD
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35233
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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