Actively Recruiting
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia - The PROGRESS Pilot Study
Led by University of Mississippi Medical Center · Updated on 2026-05-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers diagnosed with preeclampsia before 34 weeks of pregnancy improves outcomes for both mother and baby. This Phase 2 study focuses on severe or superimposed preeclampsia occurring preterm and aims to enhance the success of expectant management in these cases. Participants who join the study will receive 17 OHPC as an injection of 250mg into the muscle at admission and then weekly until delivery. Blood samples will be collected at baseline before the first injection, 24 hours later, every 72 hours thereafter until delivery, and once more 24 hours after delivery. Researchers will also collect placentas at birth and gather information about the mother and newborn during the hospital stay, including routine ultrasounds. During the study, participants will undergo regular blood tests and monitoring to assess maternal and perinatal health. Outcomes such as improvement in maternal and baby health will be measured, including changes within 24 hours after treatment. The study will continue to follow participants until hospital discharge, tracking clinical and molecular markers to evaluate the treatment's impact over time.
CONDITIONS
Brief Title
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- UMMC antepartum patients with preterm preeclampsia between 23 0/7 and 34 0/7 weeks gestation at initial evaluation
- Willing and able to understand study procedures and provide informed consent
You will not qualify if you...
- Gestational age less than 23 weeks or greater than 33 weeks
- Maternal medical emergencies requiring urgent delivery such as placental abruption, disseminated intravascular coagulation, or pulmonary edema
- Fetal emergencies requiring urgent delivery including fetal bradycardia, recurrent late fetal heart rate decelerations, or absent fetal heart rate variability
- Preterm premature rupture of membranes beyond 34 weeks gestation
- Low platelet count (less than 100,000/microliter) with HELLP syndrome
- Persistently abnormal liver enzyme levels (twice or more above normal)
- Severe fetal growth restriction (fetal weight below the fifth percentile)
- Severe low amniotic fluid (amniotic fluid index less than 5 cm)
- Reversal of end diastolic flow in umbilical artery Doppler
- Recurrent severe hypertension despite treatment
- Eclampsia
- Pulmonary edema
- Placental abruption
- Nonreassuring fetal status during daily testing (biophysical profile less than 4/10 or recurrent variable or late decelerations)
- Intrauterine fetal demise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From admission until delivery
Participants receive 17 OHPC injections at admission and every 7 days thereafter while being monitored for maternal and newborn health.
Weekly visits for injection and blood sampling
Trial Site Locations
Total: 1 location
1
Winfred L. Wiser Hospital
Jackson, Mississippi, United States, 39216
Actively Recruiting
Research Team
B
Babbette LaMarca, PhD
L
Lorena M Amaral, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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