Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

NCT ID: NCT03724838

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-01-01

Brief Summary

Previous studies have shown that expectant management of preeclampsia in the context of extreme prematurity may improve perinatal outcomes. Indeed, it has been estimated that for each additional day of pregnancy prolongation between 24 and 32 weeks of gestation, there is a nonlinear corresponding gain of 1% in fetal survival. In this study, we evaluate the use of Esomeprazole alone or with Sildenafil Citrate for the treatment of singleton pregnancies complicated by preeclampsia. We hypothesized that the potential increase in uteroplacental and fetoplacental blood flow with the use of Esomeprazole alone or with Sildenafil Citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes.

Detailed Description

The etiology and pathophysiology of preeclampsia have not been clearly established; impaired immunologic adaptation and genetic incompatibility seem to be involved in deficient trophoblastic implantation. Placental hypoxia and endothelial dysfunction may lead to preeclampsia through an exacerbated systemic inflammatory reaction. Increased placental expression and secretion of soluble fms-like tyrosine kinase 1 appear to play a central role in the pathogenesis of preeclampsia. The soluble fms-like tyrosine kinase 1 antagonizes the proangiogenic biologic activity of circulating vascular endothelial growth factor and placental growth factor, leading to a failure of nitric oxide signaling to smooth muscle The investigators will conduct a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Esomeprazole alone or with Sildenafil Citrate in preterm pregnancies complicated by preeclampsia.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Esomeprazole with Sildenafil Citrate

Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of Sildenafil Citrate 40mg orally every 8 hours

Group Type: ACTIVE_COMPARATOR

Esomeprazole with Sildenafil Citrate

Intervention Type: DRUG

Patients will take esomeprazole single dose of 40 mg orally once a day

Sildenafil Citrate

Intervention Type: DRUG

Patients will take Sildenafil Citrate 40mg every 8 hours

Esomeprazole alone plus placebo to Sildenafil Citrate

Patients will take esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours

Group Type: ACTIVE_COMPARATOR

Esomeprazole with Sildenafil Citrate

Intervention Type: DRUG

Patients will take esomeprazole single dose of 40 mg orally once a day

Placebo to Sildenafil Citrate

Intervention Type: DRUG

Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

placebo to Esomeprazole plus placebo to Sildenafil Citrate

Patients will take placebo identical in shape and consistency with esomeprazole single dose of 40 mg orally once a day plus three doses of placebo identical in shape and consistency withSildenafil Citrate 40mg orally every 8 hours

Group Type: PLACEBO_COMPARATOR

Placebo to Esomeprazole

Intervention Type: DRUG

Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day

Placebo to Sildenafil Citrate

Intervention Type: DRUG

Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

Interventions

Esomeprazole with Sildenafil Citrate

Patients will take esomeprazole single dose of 40 mg orally once a day

Intervention Type: DRUG

Sildenafil Citrate

Patients will take Sildenafil Citrate 40mg every 8 hours

Intervention Type: DRUG

Placebo to Esomeprazole

Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day

Intervention Type: DRUG

Placebo to Sildenafil Citrate

Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

Intervention Type: DRUG

Other Intervention Names

Active Comparator; active comparator

Eligibility Criteria

Inclusion Criteria

• Pregnant women presenting at a Gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia
• The patient will be managed with an expectant management
• Give written informed consent

Exclusion Criteria

• Multiple pregnancies.
• Previous hypersensitivity reaction esomeprazole or sildenafil citrate
• Contraindications to the use of esomeprazole or sildenafil citrate
• The patient is unable or unwilling to give consent
• An established fetal compromise that necessitates delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f sallam

Role: CONTACT

hany.farouk@aswu.edu.eg

01022336052 ext. 002

Facility Contacts

hany f sallam, md

Role: primary

nahla.elsayed@aswu.ed.eg

01092440504 ext. 002

Nahla w Shady, m

Role: backup

nahla.elsayed@aswu.edu.eg

1019240504 ext. 002

Other Identifiers

aswu 193/7/18

Identifier Type: -

Identifier Source: org_study_id