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

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Oxytocin 10 units/500cc	Oxytocin	1 dose only for prophylaxis given over 1 hour
Oxytocin 40 units/500cc	Oxytocin	One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Oxytocin 80U/500cc	Oxytocin	1 dose only given over 1 hour

Primary Outcome Measures

Name	Time	Method
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage	Initial hospital discharge (2-3 days)	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.
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment	baseline to discharge (2 - 3 days)	the number of subjects with any treatment of uterineatony or hemorrhage.
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors	baseline to discharge (2-3 days)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome	prior to discharge	the number of individuals with each of the component treatments or individual outcomes in the primary composite.
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus	Initial hospital discharge (2-3 days or more)	number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
Change in Pre- to Post-delivery Hematocrit (%)	During delivery hospitalization: Admission hematocrit - post-delivery hematocrit	change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)	Initial hospital discharge (2-3 days)	the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
Number of Subjects With Hospital Stays Greater Than 4 Days	Initial hospital discharge (2 days or more)	Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge