Esomeprazole With Sildenafil Citrate in Women With Early-onset Preeclampsia

NCT03724838 | Unknown DMC

• 1 other identifier: aswu 193/7/18
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Esomeprazole; Sildenafil Citrate; preterm preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Esomeprazole with Sildenafil Citrate

ACTIVE COMPARATOR

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

Drug: Esomeprazole with Sildenafil Citrate; Drug: Sildenafil Citrate

Esomeprazole alone plus placebo to Sildenafil Citrate

ACTIVE COMPARATOR

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

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

placebo to Esomeprazole plus placebo to Sildenafil Citrate

PLACEBO COMPARATOR

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

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

Interventions

Esomeprazole with Sildenafil Citrate DRUG

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

Also known as: Active Comparator

Esomeprazole alone plus placebo to Sildenafil Citrate; Esomeprazole with Sildenafil Citrate

Sildenafil Citrate DRUG

Patients will take Sildenafil Citrate 40mg every 8 hours

Also known as: active comparator

Esomeprazole with Sildenafil Citrate

Placebo to Esomeprazole 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 Esomeprazole plus placebo to Sildenafil Citrate

Placebo to Sildenafil Citrate DRUG

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

Esomeprazole alone plus placebo to Sildenafil Citrate; placebo to Esomeprazole plus placebo to Sildenafil Citrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women with early-onset preeclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Esomeprazole; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Sulfones; Piperazines; Purines

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam

CONTACT

01022336052; hany.farouk@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: both participants and researchers will be blinded to the intervention given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: January 1, 2022
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)