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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Drug: 17 OHPC

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Babbette LaMarca, PhD; Phone Number: (601)815-1430; Email: bblamarca@umc.edu
• Study Contact Backup: Name: Lorena M Amaral, Ph.D.; Email: lmamaral@umc.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Winfred L. Wiser Hospital
      • Contact: Babbette LaMarca, PhD; Phone Number: 601-815-1430; Email: bblamarca@umc.edu
      • Contact: Sheila Belk, MSCI; Phone Number: (601)984-1690; Email: sbelk@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.; Other Names: Makena, AMAG Pharmaceuticals
No Intervention: Control; To determine how close the molecular markers are with 17 OHPC added to the management protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of maternal and perinatal outcomes	Assessment of maternal BP trends	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	48 hours
Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	Until delivery
Assessment of Placental Abruption	Assessment of Placental Abruption	Baseline until delivery
Assessment of Pulmonary edema	Assessment of Pulmonary edema	Change from Baseline until delivery
Assessment of Acute Kidney Injury	Assessment of Acute Kidney Injury	Change from Baseline until delivery
Assessment of DIC	Assessment of DIC	Change from Baseline until delivery
Assessment of neurological events	Assessment of neurological events	Change from Baseline until delivery
Assessment of laboratory results	Assessment of laboratory results	Change from Baseline until delivery
Assessment of Biomarkers	Assessment of Biomarkers	Change from Baseline until delivery
Assessment of Infant Weight	Assessment of Infant Weight	Delivery
Assessment of APGAR score	Assessment of APGAR score	Delivery
Assessment of NICU stays	Assessment of NICU stays	Delivery
Assessment of Interventricular hemorrhage	Assessment of Interventricular hemorrhage	Delivery
Assessment of Respiratory Distress Syndrome	Assessment of Respiratory Distress Syndrome	Delivery
Assessment of Necrotizing enterocolitis (NEC)	Assessment of Necrotizing enterocolitis (NEC)	Delivery

Collaborators and Investigators

• Sponsor: Babbette Lamarca
• Investigators: Principal Investigator: Babbette LaMarca, PhD, University of Missisippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 2015-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No