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

Pregnancy Clinical Trial

— PROGRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989025
• Other study ID #: 2015-0029
• Status: Recruiting
• Phase: Phase 2
• Start date: May 22, 2017
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: University of Mississippi Medical Center
• Contact: Babbette LaMarca, PhD
• Phone: (601)815-1430
• Email: bblamarca[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Winfred L. Wiser Hospital	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Babbette Lamarca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	48 hours
Other	Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	Until delivery
Other	Assessment of Placental Abruption	Assessment of Placental Abruption	Baseline until delivery
Other	Assessment of Pulmonary edema	Assessment of Pulmonary edema	Change from Baseline until delivery
Other	Assessment of Acute Kidney Injury	Assessment of Acute Kidney Injury	Change from Baseline until delivery
Other	Assessment of DIC	Assessment of DIC	Change from Baseline until delivery
Other	Assessment of neurological events	Assessment of neurological events	Change from Baseline until delivery
Other	Assessment of laboratory results	Assessment of laboratory results	Change from Baseline until delivery
Other	Assessment of Biomarkers	Assessment of Biomarkers	Change from Baseline until delivery
Other	Assessment of Infant Weight	Assessment of Infant Weight	Delivery
Other	Assessment of APGAR score	Assessment of APGAR score	Delivery
Other	Assessment of NICU stays	Assessment of NICU stays	Delivery
Other	Assessment of Interventricular hemorrhage	Assessment of Interventricular hemorrhage	Delivery
Other	Assessment of Respiratory Distress Syndrome	Assessment of Respiratory Distress Syndrome	Delivery
Other	Assessment of Necrotizing enterocolitis (NEC)	Assessment of Necrotizing enterocolitis (NEC)	Delivery
Primary	Improvement of maternal and perinatal outcomes	Assessment of maternal BP trends	Baseline
Secondary	Change is being assessed in Maternal Outcomes	Assessment of maternal BP trends	24 hours