Recruiting
Phase 2

Progesterone

Sponsor:

University of Mississippi Medical Center

Code:

NCT02989025

Conditions

Pregnancy

Preeclampsia (PE)

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

17 OHPC

Study Details

Brief summary:

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

Preeclampsia (PE)

Study ID

NCT02989025

Start date

May 22, 2017

Status verified date

Apr, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes.

no intervention: Control

To determine how close the molecular markers are with 17 OHPC added to the management protocol.

Interventions

17 OHPC

The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.

Primary outcome measure

  • Improvement of maternal and perinatal outcomes [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Babbette LaMarca, PhD

(601)815-1430bblamarca@umc.edu

Lorena M Amaral, Ph.D.

lmamaral@umc.edu

Locations

Winfred L. Wiser Hospital

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Babbette LaMarca, PhD

(601)815-1430bblamarca@umc.edu

Sheila Belk, MSCI

(601)984-1690sbelk@umc.edu

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2026-05-01.