Preeclampsia (PE)PregnancyDrugPhase 2
What this study is
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.
What's being tested
- 17 OHPC
Intervention · DRUG
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
Study details
- Official title
- Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
- Sponsor
- University of Mississippi Medical Center
- Conditions
- Pregnancy · Preeclampsia (PE)
- Enrolling
- 60 people
- Starts
- 2017-05-22
- Est. completion
- 2027-01-31
- Design
- Open-label, non-randomized, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- >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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openWinfred L. Wiser Hospital
Jackson, Mississippi, United States
- Babbette LaMarca, PhD · Contact(601)815-1430bblamarca@umc.edu
- Sheila Belk, MSCI · Contact(601)984-1690sbelk@umc.edu
Recruiting
Study team
Sponsor
University of Mississippi Medical Center
Study ID 2015-0029
Principal investigator
Babbette LaMarca, PhD
University of Missisippi Medical Center
Study director
Sheila S Belk
UMMC Pharmacology and Toxicology
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.