ClinicalTrials.gov
ClinicalTrials.gov Menu

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

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: NCT01050647
Recruitment Status : Active, not recruiting
First Posted : January 15, 2010
Results First Posted : April 17, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pregnancy Complications
Interventions Drug: 17-Hydroxyprogesterone Caproate
Other: Caster Oil injections
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Period Title: Overall Study
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections Total
Hide Arm/Group Description

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
31.7  (1.9) 31.7  (2.0) 31.7  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
10
 100.0%
11
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Hispanic or Latino
7
  70.0%
8
  72.7%
15
  71.4%
Not Hispanic or Latino
3
  30.0%
2
  18.2%
5
  23.8%
Unknown or Not Reported
0
   0.0%
1
   9.1%
1
   4.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  10.0%
0
   0.0%
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
0
   0.0%
1
   4.8%
White
5
  50.0%
6
  54.5%
11
  52.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  30.0%
5
  45.5%
8
  38.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10
 100.0%
11
 100.0%
21
 100.0%
History of prior preterm birth  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
3
  30.0%
0
   0.0%
3
  14.3%
1.Primary Outcome
Title Number of Participants With Achievement of 34 Weeks Gestation
Hide Description Delayed delivery until 34 weeks gestation.
Time Frame From enrollment until delivery, an average of 34 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Neonatal Respiratory Distress Syndrome
Hide Description [Not Specified]
Time Frame From delivery until neonatal hospital discharge, assessed up to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
10
  90.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17-hydroxyprogesterone Caproate, Castor Oil Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage
Hide Description [Not Specified]
Time Frame From delivery until neonatal hospital discharge, assessed up to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
2
  18.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17-hydroxyprogesterone Caproate, Castor Oil Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Neonatal Necrotizing Enterocolitis
Hide Description [Not Specified]
Time Frame From delivery to neonatal discharge, assessed up to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
1
   9.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17-hydroxyprogesterone Caproate, Castor Oil Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days
Hide Description [Not Specified]
Time Frame From birth to discharge form delivery hospital, assessed up to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Mean (95% Confidence Interval)
Unit of Measure: days
39
(13 to 59)
50
(34 to 69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17-hydroxyprogesterone Caproate, Castor Oil Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Length of Latency Assessed as Number of Days
Hide Description [Not Specified]
Time Frame From rupture of membranes until delivery, assessed up to 34 weeks of gestation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description:

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Overall Number of Participants Analyzed 10 11
Median (95% Confidence Interval)
Unit of Measure: days
14.5
(8.9 to 29.1)
8
(5.3 to 13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 17-hydroxyprogesterone Caproate, Castor Oil Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame From enrollment up to discharge from the delivery hospital, assessed up to 2 months after delivery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 17-hydroxyprogesterone Caproate Castor Oil Injections
Hide Arm/Group Description

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.

Weekly injections of Caster Oil (placebo)

Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

All-Cause Mortality
17-hydroxyprogesterone Caproate Castor Oil Injections
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
17-hydroxyprogesterone Caproate Castor Oil Injections
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
17-hydroxyprogesterone Caproate Castor Oil Injections
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (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
Name/Title: Dr. Anna Girsen
Organization: Stanford University
Phone: 6507255720
Responsible Party: Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier: NCT01050647     History of Changes
Other Study ID Numbers: SU-01082010-4683
17976 ( Other Identifier: Stanford University Medical Center )
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: February 13, 2018
Results First Posted: April 17, 2018
Last Update Posted: May 16, 2018