Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth
Stopped early · Phase 1/Phase 2
Conditions studied: Preterm Birth
In brief
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 pregnant women with one or more prior spontaneous preterm births who are receiving either 250mg of 500 mg of 17-OHPC as a weekly single injection. The safety of the 500 mg dose will also be assessed.
Key facts
- Study ID
- NCT03292731
- Run by
- Steve N. Caritis, MD
- People needed
- 159
- Starts
- 2018-02-12
- Expected to finish
- 2021-09-02
- Last updated by the study team
- 2023-10-23
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Exclusion Criteria:
- Inclusion in the RCT of 250 vs 500 mg OPRC study
- Cerclage in place
- Plan for progesterone treatment other than study medication
- Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery
- Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus) or known cervical length <2.5 cm
- Participation in another trial that may affect gestational age at delivery
- Planned delivery at other institution where pregnancy outcome data cannot be obtained
Where it is running
- Northwestern University — Chicago, Illinois, United States
- University of Pittsburgh-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- University of Texas — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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