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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00790062
First received: November 12, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Alabama at Birmingham:

Primary Outcome Measures:
  • Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment [ Time Frame: Prior to initial discharge from hospital ] [ Designated as safety issue: No ]
    The primary composite is defined as the number of subjects with any treatment of uterine atony or hemorrhage.


Secondary Outcome Measures:
  • The Primary Outcome in a Subgroup of Women With Risk Factors for Atony or Postpartum Hemorrhage [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
  • Change in Pre- to Post-delivery Hematocrit (%) [ Time Frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit ] [ Designated as safety issue: No ]
    change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)

  • Each Individual Treatment or Intervention in the Primary Outcome [ Time Frame: prior to discharge ] [ Designated as safety issue: No ]
    the number of individuals with each of the component treatments or individual outcomes in the primary composite.

  • Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) [ Time Frame: Initial hospital discharge (2-3 days) ] [ Designated as safety issue: No ]
    the number of individuals with a clinically estimated postpartum blood loss of 500cc or more

  • Hospital Stay > 4 Days [ Time Frame: Initial hospital discharge (2 days or more) ] [ Designated as safety issue: No ]
    Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge

  • Hypotension Warranting Pressor Agent or Fluid Bolus [ Time Frame: Initial hospital discharge (2-3 days or more) ] [ Designated as safety issue: Yes ]
    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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790062

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
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
Study First Received: November 12, 2008
Results First Received: May 30, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014