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

Primary Purpose

Pregnancy

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

17 OHPC

About this trial

This is an interventional treatment trial for Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Winfred L. Wiser HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Improvement of maternal and perinatal outcomes

Assessment of maternal BP trends

Secondary Outcome Measures

Change is being assessed in Maternal Outcomes

Assessment of maternal BP trends

Full Information

NCT ID

NCT02989025

First Posted

November 28, 2016

Last Updated

May 4, 2023

Sponsor

Babbette Lamarca

1. Study Identification

Unique Protocol Identification Number

NCT02989025

Brief Title

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

Acronym

PROGRESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2017 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Babbette Lamarca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

17 OHPC

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of maternal and perinatal outcomes

Description

Assessment of maternal BP trends

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Change is being assessed in Maternal Outcomes

Description

Assessment of maternal BP trends

Time Frame

24 hours

Other Pre-specified Outcome Measures:

Title

Change is being assessed in Maternal Outcomes

Description

Assessment of maternal BP trends

Time Frame

48 hours

Title

Change is being assessed in Maternal Outcomes

Description

Assessment of maternal BP trends

Time Frame

Until delivery

Title

Assessment of Placental Abruption

Description

Assessment of Placental Abruption

Time Frame

Baseline until delivery

Title

Assessment of Pulmonary edema

Description

Assessment of Pulmonary edema

Time Frame