A Phase 2 interventional study of 17 OHPC in Pregnancy and Preeclampsia (PE), sponsored by University of Mississippi Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Mississippi Medical Center · Phase 2, Interventional, and Treatment
The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.
The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 60 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes.
Drug: 17 OHPC
To determine how close the molecular markers are with 17 OHPC added to the management protocol.
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
Also known as: Study Drug
Improvement of maternal and perinatal outcomes
Assessment of maternal BP trends
Time frame: Baseline
Change is being assessed in Maternal Outcomes
Assessment of maternal BP trends
Time frame: 24 hours
Change is being assessed in Maternal Outcomes
Assessment of maternal BP trends
Time frame: 48 hours
Change is being assessed in Maternal Outcomes
Assessment of maternal BP trends
Time frame: Until delivery
Assessment of Placental Abruption
Assessment of Placental Abruption
Time frame: Baseline until delivery
Assessment of Pulmonary edema
Assessment of Pulmonary edema
Time frame: Change from Baseline until delivery
Assessment of Acute Kidney Injury
Assessment of Acute Kidney Injury
Time frame: Change from Baseline until delivery
Assessment of DIC
Assessment of DIC
Time frame: Change from Baseline until delivery
Assessment of neurological events
Assessment of neurological events
Time frame: Change from Baseline until delivery
Assessment of laboratory results
Assessment of laboratory results
Time frame: Change from Baseline until delivery
Assessment of Biomarkers
Assessment of Biomarkers
Time frame: Change from Baseline until delivery
Assessment of Infant Weight
Assessment of Infant Weight
Time frame: Delivery
Assessment of APGAR score
Assessment of APGAR score
Time frame: Delivery
Assessment of NICU stays
Assessment of NICU stays
Time frame: Delivery
Assessment of Interventricular hemorrhage
Assessment of Interventricular hemorrhage
Time frame: Delivery
Assessment of Respiratory Distress Syndrome
Assessment of Respiratory Distress Syndrome
Time frame: Delivery
Assessment of Necrotizing enterocolitis (NEC)
Assessment of Necrotizing enterocolitis (NEC)
Time frame: Delivery
Plan to share: No
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Studies of the drug tested here: 17 alpha-Hydroxyprogesterone Caproate
University of Mississippi Medical Center →