Oral Progesterone for Prevention of Preterm Birth

This study has been completed.
Sponsor:
Information provided by:
Fetal Medicine Foundation
ClinicalTrials.gov Identifier:
NCT01180296
First received: August 10, 2010
Last updated: March 2, 2012
Last verified: March 2012
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Preterm Birth
Interventions: Drug: oral micronized progesterone
Drug: Identical Placebo tablet

  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
No text entered.

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
Progesterone Group 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
Placebo Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery

Participant Flow:   Overall Study
    Progesterone Group     Placebo  
STARTED     20     16  
COMPLETED     19     14  
NOT COMPLETED     1     2  
Protocol Violation                 1                 2  



  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.
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Reporting Groups
  Description
Progesterone Group 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
Placebo Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Total Total of all reporting groups

Baseline Measures
    Progesterone Group     Placebo     Total  
Number of Participants  
[units: participants]
  20     16     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     16     36  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.3  ± 4.7     27.2  ± 4.9     28  ± 4  
Gender  
[units: participants]
     
Female     20     16     36  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     20     16     36  



  Outcome Measures

1.  Primary:   Rate of Recurrent Preterm Birth   [ Time Frame: Prior to 37 weeks' gestation ]

2.  Secondary:   Serum Progesterone Levels   [ Time Frame: At approximately 28 weeks' gestation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   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
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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.


Results Point of Contact:  
Name/Title: David McKenna
Organization: Fetal Medicine Foundation?USA
phone: 937-208-4005
e-mail: dsmckenna@mvh.org


No publications provided


Responsible Party: David S. McKenna, Fetal Medicine Foundation/USA
ClinicalTrials.gov Identifier: NCT01180296     History of Changes
Other Study ID Numbers: MVH-MP-Pilot-RCT
Study First Received: August 10, 2010
Results First Received: June 22, 2011
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board