Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth (PRO)
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|ClinicalTrials.gov Identifier: NCT03292731|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Drug: Hydroxyprogesterone 250 Mg Drug: hydroxyprogesterone 500mg||Phase 2 Phase 3|
The study will determine the association between plasma concentrations of 17-OHPC (hydroxyprogesterone caproate) and the rate of preterm birth and will evaluate the impact of several potential covariates on plasma concentrations of 17-OHPC and its efficacy. 17-OHPC (hydroxyprogesterone caproate) administration has proven effective in reducing preterm births in high risk groups but the current dose of 250mg administered IM is thought to be an inadequate for a substantial portion of women receiving the therapy. The potential benefit of identifying a therapeutic concentration range and of optimizing the dosage of 17-OHPC are substantial.
Pregnant subjects with a history of a prior spontaneous preterm birth with be randomized to either the 250mg or 500mg weekly intramuscular injections. All subjects will have trough blood samples collected immediately prior to their second injection of the 17-OHPC, at 26-30 weeks (but only after a minimum of 7 injections have been administered) , 6-9 weeks later and at the time of delivery. Another tube of maternal blood will be collected during one of the scheduled blood samples for genotyping. A cord blood specimen will also be collected and with consent, a cord blood specimen will be collected for genetic studies of the infant. We will also collect a small sample of the placenta after delivery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open labelled rct|
|Masking:||None (Open Label)|
|Official Title:||Relationship Between Plasma Concentration of (Hydroxyprogesterone Caproate) 17-OHPC and Preterm Birth|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: hydroxyprogesterone caproate 250 mg
Pregnant subject will receive 250mg of hydroxyprogesterone caproate Intramuscular injection weekly from 16 0/7-36 6/7 weeks or delivery which ever occurs first.
Drug: Hydroxyprogesterone 250 Mg
Pregnant subjects randomized to this study arm will receive a weekly Intramuscular injection of 250mg hydroxyprogesterone caproate injection weekly from 16 0/7 to 36 6/7 weeks or delivery which ever is first.
Experimental: hydroxyprogesterone caproate 500 mg
Pregnant subject will receive 500mg of hydroxyprogesterone caproate Intramuscular injection weekly from 16 0/7-36 6/7 weeks or delivery which ever occurs first.
Drug: hydroxyprogesterone 500mg
Pregnant subjects randomized to this study arm will receive a weekly Intramuscular injection of 500mg hydroxyprogesterone caproate injection weekly from 16 0/7 to 36 6/7 weeks or delivery which ever is first.
- relation of preterm birth to the plasma concentration of 17-OHPC (hydroxyprogesterone caproate) [ Time Frame: Plasma 17-OHPC concentration at 26-30 weeks ]Determine the plasma concentration of 17-OHPC at 26-30 weeks gestation and relate the concentrations of 17-OHPC to the incidence of preterm birth.
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): NCT03292731
|Contact: steve N Caritis, MDfirstname.lastname@example.org|
|Contact: Dawn E Fischer, BSNemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Katherine L Wisner, MD 312-695-8441 firstname.lastname@example.org|
|Contact: Minaz Kolia Cattan, MD 312-695-7190 Minaz.email@example.com|
|Principal Investigator: Katherine L Wisner, MD|
|United States, Pennsylvania|
|University of Pittsburgh-Magee Womens Hospital||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Steve N Caritis, MD 412-641-5403 firstname.lastname@example.org|
|Contact: Dawn E Fischer, BSN 412-641-5194 email@example.com|
|Principal Investigator: Steve N Caritis, MD|
|United States, Texas|
|University of Texas Medical Branch||Recruiting|
|Galveston, Texas, United States, 77555|
|Contact: Maged Costantine, MD 409-772-1571 firstname.lastname@example.org|
|Contact: Holly West, PA-C 409-747-8234 email@example.com|
|Principal Investigator: Maged Costantine, MD|
|Principal Investigator:||Steve N Caritis, MD||University of Pittsburgh|