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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,798
See arms
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
the number of subjects with any treatment of uterineatony or hemorrhage.
Time frame: baseline to discharge (2 - 3 days)
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
Time frame: Initial hospital discharge (2-3 days)
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.
Time frame: baseline to discharge (2-3 days)
Change in Pre- to Post-delivery Hematocrit (%)
change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
Time frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
the number of individuals with each of the component treatments or individual outcomes in the primary composite.
Time frame: prior to discharge
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
Time frame: Initial hospital discharge (2-3 days)
Number of Subjects With Hospital Stays Greater Than 4 Days
Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
Time frame: Initial hospital discharge (2 days or more)
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
Time frame: Initial hospital discharge (2-3 days or more)
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