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Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor (PAL)

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ClinicalTrials.gov Identifier: NCT01840228
Recruitment Status : Terminated (Low enrollment rate)
First Posted : April 25, 2013
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Premature Birth
Obstetric Labor, Premature
Intervention Drug: Micronized progesterone suppository
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Period Title: Overall Study
Started 19 19
Completed 18 18
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository Total
Hide Arm/Group Description

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
1
   5.3%
0
   0.0%
1
   2.6%
Between 18 and 65 years
18
  94.7%
19
 100.0%
37
  97.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
25.8  (5.5) 26.3  (4.6) 26.0  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
19
 100.0%
19
 100.0%
38
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  10.5%
1
   5.3%
3
   7.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  57.9%
10
  52.6%
21
  55.3%
White
6
  31.6%
7
  36.8%
13
  34.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.3%
1
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Parity  
Median (Inter-Quartile Range)
Unit of measure:  Births
Number Analyzed 19 participants 19 participants 38 participants
1
(1 to 2)
1
(1 to 2)
1
(1 to 2)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 19 participants 19 participants 38 participants
25.3  (7.9) 25.4  (8.3) 25.3  (8.0)
Prior preterm birth  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
6
  31.6%
8
  42.1%
14
  36.8%
Twin gestation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
4
  21.1%
4
  21.1%
8
  21.1%
Marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Single
13
  68.4%
11
  57.9%
24
  63.2%
Married
6
  31.6%
6
  31.6%
12
  31.6%
Divorced
0
   0.0%
1
   5.3%
1
   2.6%
Unknown
0
   0.0%
1
   5.3%
1
   2.6%
Insurance use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Public insurance
14
  73.7%
11
  57.9%
25
  65.8%
Private insurance
3
  15.8%
7
  36.8%
10
  26.3%
Other
2
  10.5%
1
   5.3%
3
   7.9%
Gestational age at enrollment  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 19 participants 19 participants 38 participants
30.6
(29.9 to 32.9)
30.4
(28.1 to 32.6)
30.5
(29.3 to 32.6)
Cervical dilation at admission  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 19 participants 19 participants 38 participants
1.5
(1 to 3)
1
(1 to 2)
1.25
(1 to 3)
Cervical dilation at enrollment  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 19 participants 19 participants 38 participants
3
(1.5 to 4)
2.5
(1 to 3)
2.75
(1.5 to 3)
Tobacco use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
3
  15.8%
4
  21.1%
7
  18.4%
Prior use of progesterone (17OHP-C)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
0
   0.0%
3
  15.8%
3
   7.9%
1.Primary Outcome
Title Number of Participants Who Delivered Before 37 Weeks'
Hide Description [Not Specified]
Time Frame Duration of current pregnancy, anticipated maximum 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  61.1%
10
  55.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micronized Progesterone Suppository, Placebo Suppository
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.63 to 1.91
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Delivered Before 34 Weeks'
Hide Description Evaluated in women enrolled prior to 32 weeks gestation
Time Frame Duration of current pregnancy, anticipated maximum 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Overall Number of Participants Analyzed 14 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
  21.4%
6
  50.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micronized Progesterone Suppository, Placebo Suppository
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.14 to 1.36
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Delivery Within 2 Weeks of Randomization
Hide Description [Not Specified]
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  33.3%
4
  22.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micronized Progesterone Suppository, Placebo Suppository
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.51 to 4.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Weeks Pregnancy Prolongation
Hide Description [Not Specified]
Time Frame Duration of current pregnancy, anticipated maximum 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: weeks
5.3
(1.3 to 6.7)
5.0
(2.0 to 8.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micronized Progesterone Suppository, Placebo Suppository
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Infant Birth Weight
Hide Description [Not Specified]
Time Frame Day of delivery in current pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository - SINGLETON Placebo Suppository - SINGLETON Micronized Progesterone Suppository - TWINS Placebo Suppository - TWINS
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in singleton subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in singleton subgroup

Micronized progesterone suppository

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup

Micronized progesterone suppository

Overall Number of Participants Analyzed 14 14 8 8
Mean (Standard Deviation)
Unit of Measure: grams
2454.9  (659.4) 2523.1  (748.5) 2164.4  (215.9) 1974.1  (252.8)
6.Secondary Outcome
Title Neonatal Intensive Care Unit Admission
Hide Description [Not Specified]
Time Frame Followed for duration of neonatal hospital stay, estimated maximum 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository - SINGLETON Placebo Suppository - SINGLETON Micronized Progesterone Suppository - TWINS Placebo Suppository - TWINS
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in singleton subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in singleton subgroup

Micronized progesterone suppository

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup

Micronized progesterone suppository

Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
2
  14.3%
0
   0.0%
1
  12.5%
7.Secondary Outcome
Title Number of Participants With Chorioamnionitis
Hide Description [Not Specified]
Time Frame Duration of current pregnancy, anticipated maximum 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Composite Neonatal Outcome
Hide Description A composite neonatal outcome comprising neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, severe (grade III/IV) interventricular hemorrhage, necrotizing enterocolitis, and sepsis.
Time Frame Followed for duration of neonatal hospital stay, estimated maximum 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micronized Progesterone Suppository - SINGLETON Placebo Suppository - SINGLETON Micronized Progesterone Suppository - TWINS Placebo Suppository - TWINS
Hide Arm/Group Description:

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in singleton subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in singleton subgroup

Micronized progesterone suppository

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup

Micronized progesterone suppository

Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
5
  35.7%
5
  35.7%
3
  37.5%
7
  87.5%
Time Frame Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micronized Progesterone Suppository Placebo Suppository
Hide Arm/Group Description

Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

One placebo suppository vaginally daily until 36 6/7 weeks' gestation.

Micronized progesterone suppository

All-Cause Mortality
Micronized Progesterone Suppository Placebo Suppository
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Micronized Progesterone Suppository Placebo Suppository
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Micronized Progesterone Suppository Placebo Suppository
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      5/18 (27.78%)    
General disorders     
Other  [1]  0/18 (0.00%)  0 3/18 (16.67%)  3
Reproductive system and breast disorders     
Vaginal discharge   3/18 (16.67%)  3 5/18 (27.78%)  5
Vaginal irritation   3/18 (16.67%)  3 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Includes swelling of extremities, dizziness and fatigue
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: Dr. Heather Frey
Organization: Ohio State University
Phone: 614-688-6798
EMail: Heather.Frey@osumc.edu
Publications:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01840228     History of Changes
Other Study ID Numbers: 201301148
First Submitted: April 17, 2013
First Posted: April 25, 2013
Results First Submitted: May 7, 2019
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019