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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790062
First Posted: November 13, 2008
Last Update Posted: April 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
  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.

Condition Intervention Phase
Uterine Atony Postpartum Hemorrhage Drug: Oxytocin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery

Resource links provided by NLM:


Further study details as provided by Alan Tita, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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)

  • 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.

  • 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

  • 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

  • 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)


Enrollment: 1798
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin 10 units/500cc
1 dose only for prophylaxis given over 1 hour
Drug: Oxytocin
See arms
Other Name: 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 Name: Pitocin
Experimental: Oxytocin 80U/500cc
1 dose only given over 1 hour
Drug: Oxytocin
See arms
Other Name: Pitocin

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790062


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
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
  More Information

Additional Information:
Publications:
Responsible Party: Alan Tita, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00790062     History of Changes
Other Study ID Numbers: F070910007
5K12HD001258-09 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: May 30, 2012
Results First Posted: January 30, 2014
Last Update Posted: April 8, 2016
Last Verified: March 2016

Keywords provided by Alan Tita, University of Alabama at Birmingham:
Uterine atony
Postpartum hemorrhage
clinical trial
Prophylactic oxytocin

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Dystocia
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs