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NCT Number: NCT02989025

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

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17 OHPC

Drug

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

Other names: Study Drug

Primary outcomes

  1. Improvement of maternal and perinatal outcomes

    Time frame: Baseline

    Assessment of maternal BP trends

Secondary outcomes

  1. Change is being assessed in Maternal Outcomes

    Time frame: 24 hours

    Assessment of maternal BP trends

Other outcomes

  1. Change is being assessed in Maternal Outcomes

    Time frame: 48 hours

    Assessment of maternal BP trends

  2. Change is being assessed in Maternal Outcomes

    Time frame: Until delivery

    Assessment of maternal BP trends

  3. Assessment of Placental Abruption

    Time frame: Baseline until delivery

    Assessment of Placental Abruption

  4. Assessment of Pulmonary edema

    Time frame: Change from Baseline until delivery

    Assessment of Pulmonary edema

  5. Assessment of Acute Kidney Injury

    Time frame: Change from Baseline until delivery

    Assessment of Acute Kidney Injury

  6. Assessment of DIC

    Time frame: Change from Baseline until delivery

    Assessment of DIC

  7. Assessment of neurological events

    Time frame: Change from Baseline until delivery

    Assessment of neurological events

  8. Assessment of laboratory results

    Time frame: Change from Baseline until delivery

    Assessment of laboratory results

  9. Assessment of Biomarkers

    Time frame: Change from Baseline until delivery

    Assessment of Biomarkers

  10. Assessment of Infant Weight

    Time frame: Delivery

    Assessment of Infant Weight

  11. Assessment of APGAR score

    Time frame: Delivery

    Assessment of APGAR score

  12. Assessment of NICU stays

    Time frame: Delivery

    Assessment of NICU stays

  13. Assessment of Interventricular hemorrhage

    Time frame: Delivery

    Assessment of Interventricular hemorrhage

  14. Assessment of Respiratory Distress Syndrome

    Time frame: Delivery

    Assessment of Respiratory Distress Syndrome

  15. Assessment of Necrotizing enterocolitis (NEC)

    Time frame: Delivery

    Assessment of Necrotizing enterocolitis (NEC)

Study contacts

Contact information is provided by the study sponsor or research team.

Babbette LaMarca, PhD

CONTACT

[email protected]

(601)815-1430

Lorena M Amaral, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

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

Acronym: PROGRESS

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2016
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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