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

March 8, 2016 updated by: Alan Tita, University of Alabama at Birmingham

Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1798

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin 10 units/500cc
1 dose only for prophylaxis given over 1 hour
Drug: Oxytocin
See arms
Other Names:
  • Pitocin
Experimental: Oxytocin 40 units/500cc
One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Drug: Oxytocin
See arms
Other Names:
  • Pitocin
Experimental: Oxytocin 80U/500cc
1 dose only given over 1 hour
Drug: Oxytocin
See arms
Other Names:
  • Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
the number of subjects with any treatment of uterineatony or hemorrhage.
baseline to discharge (2 - 3 days)
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
Time Frame: 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.
Initial hospital discharge (2-3 days)
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
Time Frame: 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.
baseline to discharge (2-3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pre- to Post-delivery Hematocrit (%)
Time Frame: 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)
During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Time Frame: prior to discharge
the number of individuals with each of the component treatments or individual outcomes in the primary composite.
prior to discharge
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
Time Frame: Initial hospital discharge (2-3 days)
the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
Initial hospital discharge (2-3 days)
Number of Subjects With Hospital Stays Greater Than 4 Days
Time Frame: Initial hospital discharge (2 days or more)
Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
Initial hospital discharge (2 days or more)
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
Time Frame: 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)
Initial hospital discharge (2-3 days or more)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F070910007
  • 5K12HD001258-09 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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