RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-05-22
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02989025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
  2. * Willing and able to understand study procedures and to provide informed consent
  1. * \>33 weeks gestational age or \<23 weeks gestation
  2. * Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
  3. * Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).
  4. * Parameters according to current practice guidelines that exclude a patient from expectant management include the following:
  5. * Preterm premature rupture of membranes (PPROM) \> 34 weeks gestation;
  6. * Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
  7. * Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
  8. * Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
  9. * Severe Oligohydramnios (AFI \< 5cm)
  10. * Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
  11. * Recurrent (\> 2 readings \> 30 minutes apart) severe hypertension despite antihypertensive therapy;
  12. * Eclampsia;
  13. * Pulmonary edema;
  14. * Abruption placentae;
  15. * Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
  16. * IUFD

Contacts and Locations

Study Contact

Babbette LaMarca, PhD
CONTACT
(601)815-1430
bblamarca@umc.edu
Lorena M Amaral, Ph.D.
CONTACT
lmamaral@umc.edu

Principal Investigator

Babbette LaMarca, PhD
PRINCIPAL_INVESTIGATOR
University of Missisippi Medical Center
Sheila S Belk
STUDY_DIRECTOR
UMMC Pharmacology and Toxicology

Study Locations (Sites)

Winfred L. Wiser Hospital
Jackson, Mississippi, 39216
United States

Collaborators and Investigators

Sponsor: Babbette Lamarca

  • Babbette LaMarca, PhD, PRINCIPAL_INVESTIGATOR, University of Missisippi Medical Center
  • Sheila S Belk, STUDY_DIRECTOR, UMMC Pharmacology and Toxicology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-22
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2017-05-22
Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy