Progesterone for Preeclampsia Before 34 Weeks

This study is looking at whether giving 17-hydroxyprogesterone caproate (17 OHPC) can improve outcomes for mothers and babies when preeclampsia is diagnosed early in pregnancy (before 34 weeks). Preeclampsia is a serious pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. You may be able to join if you are a woman between 18 and 45 years old, are pregnant with preeclampsia between 23 and 34 weeks gestation, and are a patient at UMMC. The study aims to see if this treatment leads to better health for both mother and baby. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 women.
What's involved
If you join, you will receive 17 OHPC injections at admission and every 7 days. Blood samples will be taken at various times until after delivery, and your placenta will be collected after birth.
Compensation
Not stated in the trial record.
Follow-up
Information about the mother and newborn will be collected while in the hospital and until discharge.

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NCT02989025

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

Recruiting
PHASE2Ages 18–45InterventionalTreatment
University of Mississippi Medical Center
~60 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:17 OHPC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement of maternal and perinatal outcomes
Measured over Baseline
Pregnancy
Preeclampsia (PE)
1 sites across 1 states
Mississippi1
  • Babbette LaMarca, PhD · PRINCIPAL_INVESTIGATOR · University of Missisippi Medical Center
  • Sheila S Belk · STUDY_DIRECTOR · UMMC Pharmacology and Toxicology

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Eligibility criteria

Inclusion

UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
Willing and able to understand study procedures and to provide informed consent

Exclusion

\>33 weeks gestational age or \<23 weeks gestation
Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).
Parameters according to current practice guidelines that exclude a patient from expectant management include the following:
Preterm premature rupture of membranes (PPROM) \> 34 weeks gestation;
Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
Severe Oligohydramnios (AFI \< 5cm)
Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
Recurrent (\> 2 readings \> 30 minutes apart) severe hypertension despite antihypertensive therapy;
Eclampsia;
Pulmonary edema;
Abruption placentae;
Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
IUFD
  • Improvement of maternal and perinatal outcomesBaseline

    Assessment of maternal BP trends