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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Drug: 17-OHPC Procedure: Blood Draws||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy|
|Study Start Date :||March 2006|
|Primary Completion Date :||April 2008|
|Study Completion Date :||February 2014|
Experimental: Part 1
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 3, 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 4: 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.
Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.
Other Name: 17-alpha-hydroxyprogesterone caproateProcedure: Blood Draws
10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.
- Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy. [ Time Frame: Second and third trimesters of pregnancy ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409825
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20010|
|United States, Pennsylvania|
|Magee-Womens Hospital of University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University of Texas|
|Galveston, Texas, United States, 77555|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Steve N. Caritis, MD||University of Pittsburgh|