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

Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

Sponsors

Lead sponsor: Aswan University Hospital

Source Aswan University Hospital
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.

Overall Status Recruiting
Start Date December 1, 2018
Completion Date January 1, 2022
Primary Completion Date November 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prolongation of gestation measured from the time of enrollment to the time of delivery. 3 weeks
Secondary Outcome
Measure Time Frame
Severe morbidity 4 weeks
Side effects 4 weeks
The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy 4 weeks
Enrollment 180
Condition
Intervention

Intervention type: Drug

Intervention name: Esomeprazole with Sildenafil Citrate

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

Other name: Active Comparator

Intervention type: Drug

Intervention name: Sildenafil Citrate

Description: Patients will take Sildenafil Citrate 40mg every 8 hours

Arm group label: Esomeprazole with Sildenafil Citrate

Other name: active comparator

Intervention type: Drug

Intervention name: Placebo to Esomeprazole

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

Arm group label: placebo to Esomeprazole plus placebo to Sildenafil Citrate

Intervention type: Drug

Intervention name: Placebo to Sildenafil Citrate

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

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

Gender: Female

Gender based: Yes

Gender description: pregnant women with early-onset preeclampsia

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
hany f sallam, md Principal Investigator Aswan University Hospital
Overall Contact

Last name: hany f sallam

Phone: 01022336052

Phone ext: 002

Email: [email protected]

Location
facility status contact contact_backup Aswan University hany f sallam, md 01092440504 002 [email protected]
Location Countries

Egypt

Verification Date

January 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Aswan University Hospital

Investigator full name: hany farouk

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Esomeprazole with Sildenafil Citrate

Arm group type: Active Comparator

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

Arm group label: Esomeprazole alone plus placebo to Sildenafil Citrate

Arm group type: Active Comparator

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

Arm group label: placebo to Esomeprazole plus placebo to Sildenafil Citrate

Arm group type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: We 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.

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: both participants and researchers will be blinded to the intervention given

Source: ClinicalTrials.gov