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Study of Pharmacology of 17-OHPC in Pregnancy

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ClinicalTrials.gov Identifier: NCT00409825
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : February 9, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Pregnancy
Interventions Drug: 17-OHPC
Procedure: Blood Draws
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AUC1 vs AUC2
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AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.

AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.

Period Title: Overall Study
Started 61
Completed 61
Not Completed 0
Arm/Group Title AUC1 vs AUC2
Hide Arm/Group Description

AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.

AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.

Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
28.01  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
61
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Hispanic or Latino
16
  26.2%
Not Hispanic or Latino
44
  72.1%
Unknown or Not Reported
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.6%
Native Hawaiian or Other Pacific Islander
1
   1.6%
Black or African American
18
  29.5%
White
40
  65.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants
61
1.Primary Outcome
Title Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.
Hide Description

Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.

We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days.

Time Frame Second and third trimesters of pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1
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Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: ng/ML/day
AUC -1 115  (44)
AUC - 2 136  (52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1
Hide Arm/Group Description Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
All-Cause Mortality
Part 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1
Affected / at Risk (%)
Total   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1
Affected / at Risk (%)
Total   0/61 (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: Steve N. Caritis, MD
Organization: University of Pittsburgh
Phone: 412-641-4874
Publications:
ACOG News Release: Progesterone recommended in certain high risk pregnancies to help prevent preterm birth. October 31, 2003
Kiesling H, Elmquist A: Acta Endocrinol 28:502, 1958
Langecker J, Harwart A, Junkmann K: Arch exptl Pathol. Pharacol 225:309, 1955.
Wierner M, Luiu C, Plotz E: Acta Endocrinol 36:511, 1961.
Endocrinology & human gestation. IN: Reproductive Endocrinology, p458. Edited by EY Adashi, Lippincott-Raven Publishers, Philadelphia, PA 1996.
Lye S: Personal communication
Reprotox Database. Hydroxyprogesterone 17-. Reprotox. org. March 1, 2003.
Florey K: Hydroxyprogesterone caproate. IN: Analytical profiles of drug substances. Vol 4. 208-224 Editors: Academic Press, NY, NY, 1975.
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00409825     History of Changes
Other Study ID Numbers: IRB #0603056
5U10HD047905-02 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2006
First Posted: December 11, 2006
Results First Submitted: January 13, 2015
Results First Posted: February 9, 2015
Last Update Posted: February 27, 2015