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

Sponsor
Babbette Lamarca (Other)
Overall Status
Recruiting
CT.gov ID
NCT02989025
Collaborator
(none)
60
1
1
80.3
0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.

Condition or Disease Intervention/Treatment Phase
  • Drug: 17 OHPC
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
Actual Study Start Date :
May 22, 2017
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Improvement of maternal and perinatal outcomes [Baseline]

      Assessment of maternal BP trends

    Secondary Outcome Measures

    1. Change is being assessed in Maternal Outcomes [24 hours]

      Assessment of maternal BP trends

    Other Outcome Measures

    1. Change is being assessed in Maternal Outcomes [48 hours]

      Assessment of maternal BP trends

    2. Change is being assessed in Maternal Outcomes [Until delivery]

      Assessment of maternal BP trends

    3. Assessment of Placental Abruption [Baseline until delivery]

      Assessment of Placental Abruption

    4. Assessment of Pulmonary edema [Change from Baseline until delivery]

      Assessment of Pulmonary edema

    5. Assessment of Acute Kidney Injury [Change from Baseline until delivery]

      Assessment of Acute Kidney Injury

    6. Assessment of DIC [Change from Baseline until delivery]

      Assessment of DIC

    7. Assessment of neurological events [Change from Baseline until delivery]

      Assessment of neurological events

    8. Assessment of laboratory results [Change from Baseline until delivery]

      Assessment of laboratory results

    9. Assessment of Biomarkers [Change from Baseline until delivery]

      Assessment of Biomarkers

    10. Assessment of Infant Weight [Delivery]

      Assessment of Infant Weight

    11. Assessment of APGAR score [Delivery]

      Assessment of APGAR score

    12. Assessment of NICU stays [Delivery]

      Assessment of NICU stays

    13. Assessment of Interventricular hemorrhage [Delivery]

      Assessment of Interventricular hemorrhage

    14. Assessment of Respiratory Distress Syndrome [Delivery]

      Assessment of Respiratory Distress Syndrome

    15. Assessment of Necrotizing enterocolitis (NEC) [Delivery]

      Assessment of Necrotizing enterocolitis (NEC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Winfred L. Wiser Hospital Jackson Mississippi United States 39216

    Sponsors and Collaborators

    • Babbette Lamarca

    Investigators

    • Principal Investigator: Babbette LaMarca, PhD, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Babbette Lamarca, Professor, Obstretrics and Gynecology, University of Mississippi Medical Center
    ClinicalTrials.gov Identifier:
    NCT02989025
    Other Study ID Numbers:
    • 2015-0029
    First Posted:
    Dec 12, 2016
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2022