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

Last updated: July 2, 2025
Sponsor: University of Mississippi Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Pregnancy

Treatment

17 OHPC

Clinical Study ID

NCT02989025
2015-0029
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeksgestation when initially evaluated

  • Willing and able to understand study procedures and to provide informed consent

Exclusion

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 latefetal heart rate decelerations, minimal to absent fetal heart rate variability).

  • Parameters according to current practice guidelines that exclude a patient fromexpectant management include the following:

  • Preterm premature rupture of membranes (PPROM) > 34 weeks gestation;

  • Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLPsyndrome;

  • Persistently abnormal hepatic enzyme concentrations (twice or more upper normalvalues);

  • Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifthpercentile);

  • Severe Oligohydramnios (AFI < 5cm)

  • Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;

  • Recurrent (> 2 readings > 30 minutes apart) severe hypertension despiteantihypertensive therapy;

  • Eclampsia;

  • Pulmonary edema;

  • Abruption placentae;

  • Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/orrecurrent variable or late decelerations);

  • IUFD

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: 17 OHPC
Phase: 2
Study Start date:
May 22, 2017
Estimated Completion Date:
January 31, 2027

Study Description

The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.

Connect with a study center

  • Winfred L. Wiser Hospital

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

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