Clinical Trials Directory

Trials / Completed

CompletedNCT04077853

Progesterone in Expectantly Managed Early-onset Preeclampsia

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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

Detailed 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

Conditions

Interventions

TypeNameDescription
DRUG17 Hydroxyprogesterone CapronateIntramuscular injection 250 mg

Timeline

Start date
2019-12-15
Primary completion
2021-10-30
Completion
2022-01-15
First posted
2019-09-04
Last updated
2022-05-09

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04077853. Inclusion in this directory is not an endorsement.