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

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ClinicalTrials.gov Identifier: NCT02989025
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Babbette Lamarca, University of Mississippi Medical Center

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
Pregnancy Drug: 17 OHPC Phase 3

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  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


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 Name: Makena, AMAG Pharmaceuticals




Primary Outcome Measures :
  1. Improvement of maternal and perinatal outcomes [ Time Frame: Baseline ]
    Assessment of maternal BP trends


Secondary Outcome Measures :
  1. Change is being assessed in Maternal Outcomes [ Time Frame: 24 hours ]
    Assessment of maternal BP trends


Other Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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;
  • New onset renal dysfunction or increasing renal dysfunction (serum creatinine > 1.1 mg/dL;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989025


Contacts
Contact: Babbette LaMarca, PhD (601)815-1430 bblamarca@umc.edu

Locations
United States, Mississippi
Winfred L. Wiser Hospital Recruiting
Jackson, Mississippi, United States, 39216
Contact: Babbette LaMarca, PhD    601-815-1430    bblamarca@umc.edu   
Contact: Venessia Johnson, RN    (601)984-5328    vkjohnson@umc.edu   
Sponsors and Collaborators
Babbette Lamarca
Investigators
Principal Investigator: Babbette LaMarca, PhD Professor

Responsible Party: Babbette Lamarca, Professor, Obstretrics and Gynecology, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT02989025     History of Changes
Other Study ID Numbers: 2015-0029
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs