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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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00790062
First received: November 12, 2008
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: May 30, 2012  
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
Conditions: Uterine Atony
Postpartum Hemorrhage
Intervention: Drug: Oxytocin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 1,798 women randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.

Reporting Groups
  Description
Oxytocin 10 Units/500cc No text entered.
Oxytocin 40 Units/500cc Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Oxytocin 80U/500cc No text entered.

Participant Flow:   Overall Study
    Oxytocin 10 Units/500cc   Oxytocin 40 Units/500cc   Oxytocin 80U/500cc
STARTED   659   481   658 
COMPLETED   659   481   658 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oxytocin 10 Units/500cc No text entered.
Oxytocin 40 Units/500cc Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
Oxytocin 80U/500cc No text entered.
Total Total of all reporting groups

Baseline Measures
   Oxytocin 10 Units/500cc   Oxytocin 40 Units/500cc   Oxytocin 80U/500cc   Total 
Overall Participants Analyzed 
[Units: Participants]
 659   481   658   1798 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Age (years)   23.9  (5.4)   23.9  (5.1)   24.4  (5.5)   24.2  (5.4) 
Gender, Customized 
[Units: Participants]
       
Female   659   481   658   1798 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian   143   97   156   396 
African American   404   278   379   1061 
Hispanic   106   101   120   327 
Other (not specified)   6   5   3   14 
Region of Enrollment 
[Units: Participants]
       
United States   659   481   658   1798 


  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage   [ Time Frame: Initial hospital discharge (2-3 days) ]

3.  Primary:   Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors   [ Time Frame: baseline to discharge (2-3 days) ]

4.  Secondary:   Change in Pre- to Post-delivery Hematocrit (%)   [ Time Frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit ]

5.  Secondary:   Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome   [ Time Frame: prior to discharge ]

6.  Secondary:   Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)   [ Time Frame: Initial hospital discharge (2-3 days) ]

7.  Secondary:   Number of Subjects With Hospital Stays Greater Than 4 Days   [ Time Frame: Initial hospital discharge (2 days or more) ]

8.  Secondary:   Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus   [ Time Frame: Initial hospital discharge (2-3 days or more) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alan T. N. Tita, MD
Organization: University of Alabama at Birmingham
phone: (205) 934-9616
e-mail: atit@uab.edu


Publications of Results:

Responsible Party: Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00790062     History of Changes
Other Study ID Numbers: F070910007
5K12HD001258-09 ( US NIH Grant/Contract Award Number )
Study First Received: November 12, 2008
Results First Received: May 30, 2012
Last Updated: March 8, 2016
Health Authority: United States: Institutional Review Board