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Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

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ClinicalTrials.gov Identifier: NCT00946088
Recruitment Status : Terminated (lower than expected enrollment)
First Posted : July 24, 2009
Results First Posted : February 8, 2017
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Deirdre Judith Lyell, 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: Progesterone
Drug: Polyethylene glycol&hydrogenated vegetable oil.
Enrollment 7
Recruitment Details Patients were enrolled from November 2010 through February 2011.
Pre-assignment Details  
Arm/Group Title Progesterone Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi
Hide Arm/Group Description Progesterone 400 mg per vagina qhs. Polyethylene glycol 400 distearate & hydrogenated vegetable oil
Period Title: Overall Study
Started 4 3
Completed 4 [1] 2 [1]
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
At least one dose administered and pre-term birth status known.
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil Total
Hide Arm/Group Description Progesterone 400 mg per vagina qhs. Polyethylene glycol 400 distearate & hydrogenated vegetable oil Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
28.5
(24 to 33)
27.0
(19 to 34)
27.9
(19 to 34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
4
 100.0%
3
 100.0%
7
 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 4 participants 3 participants 7 participants
Hispanic or Latino
4
 100.0%
3
 100.0%
7
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
1
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  75.0%
2
  66.7%
5
  71.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  25.0%
0
   0.0%
1
  14.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4
 100.0%
3
 100.0%
7
 100.0%
1.Primary Outcome
Title Reduction in Delivery Rate Prior to 37 Weeks Gestation
Hide Description Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
Time Frame Up to 37 weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol&Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Delivery at <37 weeks of gestation
2
  50.0%
0
   0.0%
Delivery at >=37 weeks of gestation
2
  50.0%
2
 100.0%
2.Secondary Outcome
Title Maternal Chorioamnionitis
Hide Description [Not Specified]
Time Frame Up to maternal hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Maternal Anticipated Adverse Medication Reaction
Hide Description [Not Specified]
Time Frame Up to the maternal discharge from delivery hospitalization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
4.Secondary Outcome
Title Birthweight
Hide Description Newborn birthweight in grams
Time Frame At the time of newborn birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Mean (Full Range)
Unit of Measure: grams
2740
(1390 to 3720)
3275
(3070 to 3380)
5.Secondary Outcome
Title Neonatal Intensive Care Unit (NICU) Admission
Hide Description [Not Specified]
Time Frame At time of neonatal discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
0
   0.0%
6.Secondary Outcome
Title Neonatal Morbidity
Hide Description [Not Specified]
Time Frame Up to 28 days after neonatal birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
7.Secondary Outcome
Title Neonatal Mortality
Hide Description [Not Specified]
Time Frame Up to 28 days after neonatal birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Neonatal Congenital Abnormalities
Hide Description [Not Specified]
Time Frame Up to the time of neonatal discharge from the delivery hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: Neonates
0 0
9.Secondary Outcome
Title Number of Days Delay of Delivery
Hide Description Number of days from intervention to delivery
Time Frame Up to the time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
exact delivery data unavailable for one term participant
Arm/Group Title Progesterone Polyethylene Glycol & Hydrogenated Vegetable Oil
Hide Arm/Group Description:
Progesterone 400 mg per vagina qhs.
Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
Overall Number of Participants Analyzed 4 2
Median (Full Range)
Unit of Measure: days
38.0
(6 to 62)
47.5
(43 to 52)
Time Frame Up to 28 days after the delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator: Progesterone Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab
Hide Arm/Group Description Progesterone 400mg per vagina qhs. Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
All-Cause Mortality
Active Comparator: Progesterone Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator: Progesterone Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Comparator: Progesterone Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Very limited enrollment, study terminated early.
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: Deirdre Lyell, MD
Organization: Stanford University School of Medicine
Phone: (650) 384-5107
Responsible Party: Deirdre Judith Lyell, Stanford University
ClinicalTrials.gov Identifier: NCT00946088     History of Changes
Other Study ID Numbers: SU-03312009-2078
11625 ( Other Identifier: Stanford University Med. Center IRB )
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: October 24, 2016
Results First Posted: February 8, 2017
Last Update Posted: March 16, 2017