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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
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  
Number of Participants  
[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
  Show All Outcome Measures

1.  Primary:   Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment   [ Time Frame: Prior to initial discharge from hospital ]

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

3.  Secondary:   Each Individual Treatment or Intervention in the Primary Outcome   [ Time Frame: prior to discharge ]

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

5.  Secondary:   Hospital Stay > 4 Days   [ Time Frame: Initial hospital discharge (2 days or more) ]

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

7.  Secondary:   The Primary Outcome in a Subgroup of Women With Risk Factors for Atony or Postpartum Hemorrhage   [ Time Frame: Initial hospital discharge (2-3 days) ]
Results not yet reported.   Anticipated Reporting Date:   12/2012   Safety Issue:   No


  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
No text entered.


  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
Study First Received: November 12, 2008
Results First Received: May 30, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board