Progesterone in Expectantly Managed Early-onset Preeclampsia

NCT ID: NCT04077853

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2022-01-15

Brief 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

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

women will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE

Group Type: EXPERIMENTAL

17 Hydroxyprogesterone Capronate

Intervention Type: DRUG

Intramuscular injection 250 mg

control group

No intervention will be given apart from the usual conservative measures of early-onset PE

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

17 Hydroxyprogesterone Capronate

Intramuscular injection 250 mg

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

PPET

Identifier Type: -

Identifier Source: org_study_id