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

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Babbette Lamarca
• Treatments: Progesterone

Criteria

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