Using progesterone to improve outcomes for mothers and babies with preeclampsia

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study

This study is testing if a hormone treatment can help improve health outcomes for mothers and their babies who have preeclampsia before 34 weeks of pregnancy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Mississippi Medical Center (Academic / other)
• Locations: 1 site (Jackson, Mississippi)
• Trial ID: NCT02989025 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of 17-hydroxyprogesterone caproate (17 OHPC) in improving outcomes for mothers and their babies diagnosed with preeclampsia before 34 weeks of gestation. Participants will receive 250mg of 17 OHPC via intramuscular injection upon admission and every 7 days thereafter. Blood samples will be collected at various intervals to monitor maternal and fetal health, and placentas will be analyzed post-delivery. The study will also track maternal and newborn health until discharge from the hospital.

Who should consider this trial

Good fit: Ideal candidates are pregnant women between 23 and 34 weeks gestation diagnosed with preterm severe or superimposed preeclampsia.

Not a fit: Patients who are beyond 34 weeks gestation or have conditions requiring immediate delivery will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the health outcomes for mothers and their babies affected by preeclampsia.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in improving outcomes for preeclampsia, but this specific intervention is still under investigation.

Eligibility criteria

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;
* Eclampsia;
* Pulmonary edema;
* Abruption placentae;
* Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
* IUFD

Where this trial is running

Jackson, Mississippi

• Winfred L. Wiser Hospital — Jackson, Mississippi, United States (Recruiting)

Study contacts

• Principal investigator: Babbette LaMarca, PhD — University of Missisippi Medical Center
• Study coordinator: Babbette LaMarca, PhD

Conditions Pregnancy; Preeclampsia