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The Use of Progesterone to Reduce Preterm Birth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Morrison, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00830765
First received: December 16, 2008
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
Results First Received: May 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Preterm Birth
Interventions: Drug: Progesterone (OHP17)
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1 Placebo The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
2 Progesterone The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.

Participant Flow:   Overall Study
    1 Placebo     2 Progesterone  
STARTED     73     71  
COMPLETED     70     69  
NOT COMPLETED     3     2  
Protocol Violation                 3                 2  



  Baseline Characteristics
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Reporting Groups
  Description
1 Placebo The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
2 Progesterone The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
Total Total of all reporting groups

Baseline Measures
    1 Placebo     2 Progesterone     Total  
Number of Participants  
[units: participants]
 		  73     71     144  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     73     71     144  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25.4  ± 5.0     23.3  ± 5.8     24.4  ± 5.1  
Gender  
[units: participants]
 		     
Female     73     71     144  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     73     71     144  



  Outcome Measures

1.  Primary:   Weeks Gestation at Birth Among Patients Receiving the Active Drug.   [ Time Frame: Through delivery, until discharge up to 40 weeks gestation ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Dr John Morrison
Organization: UMississippi
phone: 601-984-5300
e-mail: jmorrison@umc.edu


No publications provided by University of Mississippi Medical Center

Publications automatically indexed to this study:


Responsible Party: John Morrison, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00830765     History of Changes
Other Study ID Numbers: 2003-0239
Study First Received: December 16, 2008
Results First Received: May 22, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board