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Oral Progesterone for Prevention of Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180296
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : July 21, 2011
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
David S. McKenna, Fetal Medicine Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Preterm Birth
Interventions Drug: oral micronized progesterone
Drug: Identical Placebo tablet
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Progesterone Group Placebo
Hide Arm/Group Description 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Period Title: Overall Study
Started 20 16
Completed 19 14
Not Completed 1 2
Reason Not Completed
Protocol Violation             1             2
Arm/Group Title Progesterone Group Placebo Total
Hide Arm/Group Description 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery Total of all reporting groups
Overall Number of Baseline Participants 20 16 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
16
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 16 participants 36 participants
29.3  (4.7) 27.2  (4.9) 28  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
Female
20
 100.0%
16
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 16 participants 36 participants
20 16 36
1.Primary Outcome
Title Rate of Recurrent Preterm Birth
Hide Description Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
Time Frame Prior to 37 weeks' gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Group Placebo
Hide Arm/Group Description:
400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Overall Number of Participants Analyzed 19 14
Measure Type: Number
Unit of Measure: participants
5 8
2.Secondary Outcome
Title Secondary Outcomes
Hide Description Serum progesterone levels
Time Frame Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Group Placebo
Hide Arm/Group Description:
oral micronized progesterone: 400 mg oral micronized progesterone nightly from 16 to 34 weeks vs placebo
Identical Placebo tablet: placebo taking nightly from 16 to 34 weeks
Overall Number of Participants Analyzed 15 8
Mean (Standard Deviation)
Unit of Measure: pg/mL
122.6  (61.8) 90.1  (38.7)
Time Frame From trial entry until delivery of the infant, average (+/- std dev) gestational age at randomization was 18.2 +/- 2.7 weeks for placebo group and 16.9 +/- 2.6 weeks for progesterone group; Average gestational age at delivery was 35.9 +/- 3.8 weeks for placebo group, and 37.0 +/- 2.7 weeks for progesterone group. The average duration adverse events were collected was 17.7 weeks for the placebo group, and 20.1 weeks for the progesterone group.
Adverse Event Reporting Description All subjects were queried by an investigator at every prenatal visit regarding adverse events, and the electronic medical record was searched for any occurrences.
 
Arm/Group Title Progesterone Group Placebo
Hide Arm/Group Description 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
All-Cause Mortality
Progesterone Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Progesterone Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Progesterone Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/16 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: David McKenna
Organization: Fetal Medicine Foundation?USA
Phone: 937-208-4005
EMail: dsmckenna@mvh.org
Layout table for additonal information
Responsible Party: David S. McKenna, Fetal Medicine Foundation
ClinicalTrials.gov Identifier: NCT01180296    
Other Study ID Numbers: MVH-MP-Pilot-RCT
First Submitted: August 10, 2010
First Posted: August 12, 2010
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: February 18, 2019