NCT02989025 · University of Mississippi Medical Center
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
(PROGRESS)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
17 OHPC
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
Primary outcome measures
Improvement of maternal and perinatal outcomes
Time frame: Baseline
Assessment of maternal BP trends
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- \>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;
- Pulmonary edema;
- Abruption placentae;
- Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
Where
- Jackson, Mississippi
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations