Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

Aswan University Hospital

Status: Unknown

Conditions: Preeclampsia

Treatments: Drug: Esomeprazole with Sildenafil Citrate; Drug: Placebo to Sildenafil Citrate; Drug: Sildenafil Citrate; Drug: Placebo to Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03724838

aswu 193/7/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Esomeprazole with Sildenafil Citrate

Active Comparator group

Description:

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

Treatment:

Drug: Sildenafil Citrate

Drug: Esomeprazole with Sildenafil Citrate

Esomeprazole alone plus placebo to Sildenafil Citrate

Active Comparator group

Description:

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

Treatment:

Drug: Placebo to Sildenafil Citrate

Drug: Esomeprazole with Sildenafil Citrate

placebo to Esomeprazole plus placebo to Sildenafil Citrate

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to Sildenafil Citrate

Drug: Placebo to Esomeprazole