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

Status

Completed

Phase

Phase 4

Enrollment

1,798 participants (actual)

Sponsor

University of Alabama at Birmingham · Other

Design

Randomized · Quadruple masking

Countries

1 country

United States

Start

Nov 2008

Primary completion

Jun 2010

Completion

Jun 2010

First posted

13 Nov 2008 (estimated)

Last update posted

8 Apr 2016 (estimated)

Conditions

Uterine Atony · Postpartum Hemorrhage

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.

• Active comparator

  Oxytocin 10 units/500cc

  1 dose only for prophylaxis given over 1 hour

• Experimental

  Oxytocin 40 units/500cc

  One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

• Experimental

  Oxytocin 80U/500cc

  1 dose only given over 1 hour

1. Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment

   Time frame · baseline to discharge (2 - 3 days)

   Registry description

   the number of subjects with any treatment of uterineatony or hemorrhage.

2. Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage

   Time frame · Initial hospital discharge (2-3 days)

   Registry description

   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.

3. Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors

   Time frame · baseline to discharge (2-3 days)

   Registry description

   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.