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Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

NCT03717701 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-10

No results posted yet for this study

Summary

Preeclampsia is globally responsible for tens of thousands of maternal and neonatal deaths each year. Currently, there are no medical therapies to halt disease progression and expectant management and delivery remain the mainstay of treatment. An important step in the pathogenesis of preeclampsia is a poor placental invasion and the subsequent release of the anti-angiogenic factors soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng)into the maternal circulation. Given metformin and esomeprazole successfully mitigate key pathogenic features of preeclampsia, the investigator will study whether combining low-doses of metformin and esomeprazole may be additive or synergistic (or neither) in reducing sFlt-1 and sEng secretion, and mitigating endothelial dysfunction, compared to placebo.

Conditions

  • Pre-Eclampsia

Interventions

DRUG

metformin

Patients will take metformin single dose of 1000 mg orally once a day

DRUG

esomeprazole

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

DRUG

Placebo

Patients will take inert tablets similar in appearance, color, and consistency

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-11-30
Completion
2021-01-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03717701 on ClinicalTrials.gov