RecruitingPhase 2NCT02989025
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
Sponsor
University of Mississippi Medical Center
Enrollment
60 participants
Start Date
May 22, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria2
- 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 Criteria16
- \>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
Interventions
DRUG17 OHPC
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02989025
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