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Trial record 6 of 16 for:    labor or delivery or childbirth | Recruiting, Not yet recruiting, Available Studies | NICHD

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 : September 4, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Steve N. Caritis, MD, University of Pittsburgh

Brief Summary:
The study plans to determine the relationship between plasma concentrations of 17-OHPC (hydroxyprogesterone caproate) and the rate of preterm birth. The study is a randomized, open label study of pregnant women with one or more prior spontaneous preterm births. Subjects are randomized to a weekly single injection of either 250 or 500mg 17-OHPC (hydroxyprogesterone caproate).

Condition or disease Intervention/treatment Phase
Preterm Birth Drug: Hydroxyprogesterone 250 Mg Drug: hydroxyprogesterone 500mg Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open labelled rct
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study of pregnant participants
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant with a prior preterm birth 16 0/7-35 6/7 weeks from spontaneous labor or PPROM,
  • current gestational age <22 weeks,
  • pregnant with one baby
  • age between 18-45 years
  • able to give consent and undergo study procedures

Exclusion Criteria:

  • plans for cerclage at enrollment, plan for progesterone treatment other than study medications at enrollment
  • known fetal anomaly or chromosomal anomaly that could affect gestational age at delivery
  • malformation of the uterus or known cervical length <2.5cm
  • participation in another trial that may affect gestational age at delivery
  • planned delivery where outcome data cannot be collected
  • medical or obstetrical complication that may affect gestational age at delivery, such as active ulcerative colitis, liver tumors, liver disease/failure, renal disease/failure, undiagnosed vaginal bleeding unrelated to pregnancy, or hypertension requiring 2 or more agents
  • Current or history of thrombosis or thromboembolic disorders
  • known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions
  • moderately severe depression (PHQ-9 score ≥ 15, EPDS score of >13, or suicidal ideation)

Information from the National Library of Medicine

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


Contacts
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Contact: steve N Caritis, MD 412-641-5403 scaritis@mail.magee.edu
Contact: Dawn E Fischer, BSN 412-641-5194 dfischer@mail.magee.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Katherine L Wisner, MD    312-695-8441    katherine.wisner@northwestern.edu   
Contact: Elizabeth Torres, MD    312-695-6076    elizabeth.torres@northwestern.edu   
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    scaritis@mail.magee.edu   
Contact: Dawn E Fischer, BSN    412-641-5194    dfischer@mail.magee.edu   
Principal Investigator: Steve N Caritis, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Shannon Clark, MD    409-772-5313    shclark@UTMB.edu   
Contact: Holly West, PA-C    409-747-8234    hawest@utmb.edu   
Principal Investigator: Shannon Clark, MD         
University of Texas Not yet recruiting
Houston, Texas, United States, 77030
Contact: Suneet Chauhan, MD    713-500-6474    Suneet.P.Chauhan@uth.tmc.edu   
Contact: Sunbola Ashimi, PhD    713-500-6410    sunbola.s.ashimi@uth.tmc.edu   
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Torri D Metz, MD    802-581-8425    torri.metz@hsc.utah.edu   
Contact: Kelly Vorwaller, RN    801-585-6996    kelly.vorwaller@hsc.utah.edu   
Sponsors and Collaborators
Steve N. Caritis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Steve N Caritis, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Steve N. Caritis, MD, University of Pittsburgh:
Study Protocol  [PDF] July 31, 2019


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Responsible Party: Steve N. Caritis, MD, Professor, Department of OB/Gyn/RS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03292731     History of Changes
Other Study ID Numbers: PRO16110007
U54HD047905-11 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones