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

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.

Conditions

Pregnancy

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Pregnancy
Intervention / Treatment

-

Contacts and Locations

Jackson

Winfred L. Wiser Hospital, Jackson, Mississippi, United States, 39216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * \>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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Babbette Lamarca,

Babbette LaMarca, PhD, PRINCIPAL_INVESTIGATOR, University of Missisippi Medical Center

Sheila S Belk, STUDY_DIRECTOR, UMMC Pharmacology and Toxicology

Study Record Dates

2026-01-31