Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

Preeclampsia Clinical Trial

Official title:

Esomeprazole Alone or With Sildenafil Citrate in Women With Early-onset Preeclampsia: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03724838
• Other study ID #: aswu 193/7/18
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2019
• Source: Aswan University Hospital
• Contact: hany f sallam
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Esomeprazole with Sildenafil Citrate
Patients will take esomeprazole single dose of 40 mg orally once a day
• Sildenafil Citrate
Patients will take Sildenafil Citrate 40mg every 8 hours
• 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
• Placebo to Sildenafil Citrate
Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolongation of gestation measured from the time of enrollment to the time of delivery.	Prolongation of gestation measured from the time of enrollment to the time of delivery	3 weeks
Secondary	Severe morbidity	Severe morbidity including eclampsia, liver or renal failure, hemolysis, elevated liver enzymes and low platelets syndrome (HELLP), disseminated intravascular coagulation (DIC), stroke, and pulmonary edema	4 weeks
Secondary	Side effects	any side effects or adverse events related to the intervention, intervention stopped due to side effects	4 weeks
Secondary	The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy	The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy	4 weeks