17-OHPC in Pregnancy: IM vs SC Routes

Stopped early

Conditions studied: Preterm Birth

In brief

This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).

Key facts

Study ID

NCT04183452

Run by

Steve N. Caritis, MD

People needed

24

Starts

2020-06-16

Expected to finish

2023-04-06

Last updated by the study team

2023-08-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant female with documented prior birth between 16 0/7- 36 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes
• Gestational age (GA) < 22 weeks, based on study determined GA (as treatment must start between 16 0/7 and 21 6/7 weeks)
• Singleton gestation
• Age between 18 - 45 years
• Able to give informed consent and undergo all study procedures including a single seven day pharmacokinetic study which requires daily venipunctures and willingness to answer questions about side effects and discomfort at each study visit.

You may not qualify if…

• Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery
• Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus)
• 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 disorders
• Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions
• Moderately severe depression (Patient Health Questionnaire-9 (PHQ-9) score ≥15, Edinburgh Postnatal Depression Scale (EPDS) score of >13, or suicidal ideation)

Where it is running

• Christiana Care — Newark, Delaware, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Pittsburgh-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.