Status:
TERMINATED
Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth
Lead Sponsor:
Steve N. Caritis, MD
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth. The study is an open label study of pregnan...
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 covaria...
Eligibility Criteria
Inclusion
- Randomized Clinical Trial Eligibility Criteria:
- pregnant with a prior preterm birth 16 0/7-35 6/7 weeks from spontaneous labor or preterm premature rupture of membranes(PPROM),
- current gestational age \<22 weeks,
- pregnant with one baby
- age between 18-45 years
- able to give consent and undergo study procedures
Exclusion
- 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)
- Ancillary Cohort Eligibility Criteria:
- Inclusion Criteria:
- Pregnant female with documented prior birth between 16 0/7- 35 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes
- Receiving 250 mg 17-OHPC weekly- must be compliant with that treatment based on interview and reviewing the medical record
- Gestational age (GA) \<26 weeks, based on study determined GA
- Singleton gestation
- Age between 18 - 45 years
- Able to give informed consent and undergo study procedures
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2021
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03292731
Start Date
February 12 2018
End Date
September 2 2021
Last Update
October 23 2023
Active Locations (5)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
3
University of Texas Medical Branch
Galveston, Texas, United States, 77555
4
University of Texas
Houston, Texas, United States, 77030