Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

• Status: Completed
• Trial end date: 2021-09-02
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Steve N. Caritis, MD
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

Criteria

1. Randomized Clinical Trial Eligibility 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)

2. 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

• Medical or obstetrical complication that might 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 disorder.

• 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)- based on criteria in the RCT