Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
Recruiting · NCT02989025 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Mississippi Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
17 OHPC
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Winfred L. Wiser Hospital - Jackson, Mississippi, United States