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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 : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Babbette Lamarca, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE November 28, 2016
First Posted Date  ICMJE December 12, 2016
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE May 22, 2017
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
Improvement of maternal and perinatal outcomes [ Time Frame: Baseline ]
Assessment of maternal BP trends
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
Change is being assessed in Maternal Outcomes [ Time Frame: 24 hours ]
Assessment of maternal BP trends
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
Change is being assessed in Maternal Outcomes [ Time Frame: 12 hours ]
Assessment of maternal BP trends
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2017)
  • Change is being assessed in Maternal Outcomes [ Time Frame: 48 hours ]
    Assessment of maternal BP trends
  • Change is being assessed in Maternal Outcomes [ Time Frame: Until delivery ]
    Assessment of maternal BP trends
  • Assessment of Placental Abruption [ Time Frame: Baseline until delivery ]
    Assessment of Placental Abruption
  • Assessment of Pulmonary edema [ Time Frame: Change from Baseline until delivery ]
    Assessment of Pulmonary edema
  • Assessment of Acute Kidney Injury [ Time Frame: Change from Baseline until delivery ]
    Assessment of Acute Kidney Injury
  • Assessment of DIC [ Time Frame: Change from Baseline until delivery ]
    Assessment of DIC
  • Assessment of neurological events [ Time Frame: Change from Baseline until delivery ]
    Assessment of neurological events
  • Assessment of laboratory results [ Time Frame: Change from Baseline until delivery ]
    Assessment of laboratory results
  • Assessment of Biomarkers [ Time Frame: Change from Baseline until delivery ]
    Assessment of Biomarkers
  • Assessment of Infant Weight [ Time Frame: Delivery ]
    Assessment of Infant Weight
  • Assessment of APGAR score [ Time Frame: Delivery ]
    Assessment of APGAR score
  • Assessment of NICU stays [ Time Frame: Delivery ]
    Assessment of NICU stays
  • Assessment of Interventricular hemorrhage [ Time Frame: Delivery ]
    Assessment of Interventricular hemorrhage
  • Assessment of Respiratory Distress Syndrome [ Time Frame: Delivery ]
    Assessment of Respiratory Distress Syndrome
  • Assessment of Necrotizing enterocolitis (NEC) [ Time Frame: Delivery ]
    Assessment of Necrotizing enterocolitis (NEC)
Original Other Pre-specified Outcome Measures
 (submitted: December 9, 2016)
  • Change is being assessed in Maternal Outcomes [ Time Frame: 48 hours ]
    Assessment of maternal BP trends
  • Change is being assessed in Maternal Outcomes [ Time Frame: Until delivery ]
    Assessment of maternal BP trends
  • Assessment of Placental Abruption [ Time Frame: Baseline until delivery ]
  • Assessment of Pulmonary edema [ Time Frame: Change from Baseline until delivery ]
  • Assessment of Acute Kidney Injury [ Time Frame: Change from Baseline until delivery ]
  • Assessment of DIC [ Time Frame: Change from Baseline until delivery ]
  • Assessment of neurological events [ Time Frame: Change from Baseline until delivery ]
  • Assessment of laboratory results [ Time Frame: Change from Baseline until delivery ]
  • Assessment of Biomarkers [ Time Frame: Change from Baseline until delivery ]
  • Assessment of Infant Weight [ Time Frame: Delivery ]
  • Assessment of APGAR score [ Time Frame: Delivery ]
  • Assessment of NICU stays [ Time Frame: Delivery ]
  • Assessment of Interventricular hemorrhage [ Time Frame: Delivery ]
  • Assessment of Respiratory Distress Syndrome [ Time Frame: Delivery ]
  • Assessment of Necrotizing enterocolitis (NEC) [ Time Frame: Delivery ]
 
Descriptive Information
Brief Title  ICMJE Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
Official Title  ICMJE Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: 17 OHPC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2016)
30
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Babbette LaMarca, PhD (601)815-1430 bblamarca@umc.edu
Contact: Lorena M Amaral, Ph.D. lmamaral@umc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02989025
Other Study ID Numbers  ICMJE 2015-0029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Babbette Lamarca, University of Mississippi Medical Center
Study Sponsor  ICMJE Babbette Lamarca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Babbette LaMarca, PhD Professor
PRS Account University of Mississippi Medical Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP