Using progesterone to improve outcomes for mothers and babies with preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: bblamarca@umc.edu
• Phone: (601)815-1430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.