Progesterone in Expectantly Managed Early-onset Preeclampsia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate

Criteria

Inclusion Criteria:

• Gestational age between 20+0 and 33+6 weeks.

• Singleton pregnancy.

• Willing to participate in the study and sign the informed consent.

Exclusion Criteria:

• Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).

• Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).

• 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;

• Eclampsia;

• Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations);

• Intrauterine fetal death.

• Patient is unable or unwilling to give consent.

• Patients currently using progesterone for other indications.