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Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
RecruitingPhase 2
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
Who can join
Ages 18 to 45 · Women
Full 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
About the study
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.
What is being tested
- 17 OHPC (drug)
Sponsor: University of Mississippi Medical Center · Participants: 60 · Started: May 22, 2017
Contact the study team
- Babbette LaMarca, PhD · Phone: (601)815-1430
Official record on ClinicalTrials.gov — NCT02989025
Locations in the U.S.
| Mississippi | Winfred L. Wiser Hospital, Jackson |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.