Progesterone in Expectantly Managed Early-onset Preeclampsia

Preeclampsia Clinical Trial

Official title:

Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077853
• Other study ID #: PPET
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2019
• Est. completion date: January 15, 2022

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 15, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• 17 Hydroxyprogesterone Capronate
Intramuscular injection 250 mg

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference between blood pressure measurements in both groups	blood pressure measured by mercury sphygmomanometer	one month