NCT02989025

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 pregnancy

Timeline
9mo left

Started May 2017

Longer than P75 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
May 2017Jan 2027

First Submitted

Initial submission to the registry

November 28, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9.7 years

First QC Date

November 28, 2016

Last Update Submit

April 27, 2026

Conditions

PregnancyPreeclampsia (PE)

Outcome Measures

Primary Outcomes (1)

  • Improvement of maternal and perinatal outcomes

    Assessment of maternal BP trends

    Baseline

Secondary Outcomes (1)

  • Change is being assessed in Maternal Outcomes

    24 hours

Other Outcomes (15)

  • Change is being assessed in Maternal Outcomes

    48 hours

  • Change is being assessed in Maternal Outcomes

    Until delivery

  • Assessment of Placental Abruption

    Baseline until delivery

  • +12 more other outcomes

Study Arms (2)

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.

Drug: 17 OHPC

Control

NO INTERVENTION

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

Interventions

17 OHPCDRUG

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

Also known as: Study Drug
Experimental

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \>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);
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winfred L. Wiser Hospital

Jackson, Mississippi, 39216, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Babbette LaMarca, PhD

    University of Missisippi Medical Center

    PRINCIPAL INVESTIGATOR

  • Sheila S Belk

    UMMC Pharmacology and Toxicology

    STUDY DIRECTOR

Central Study Contacts

Babbette LaMarca, PhD

CONTACT

(601)815-1430bblamarca@umc.edu

Lorena M Amaral, Ph.D.

CONTACT

lmamaral@umc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Professor, Pharmacology and Toxicology

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 12, 2016

Study Start

May 22, 2017

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)