Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

NCT03717701 | Unknown

• 1 other identifier: aswu/273/9l18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

preeclampsia; esomeprazole; metformin

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.

  4 weeks

Secondary Outcomes (3)

• Severe morbidity

  4 weeks

• The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy

  4 weeks

• Side effects

  4 weeks

Study Arms (2)

metformin and esomeprazole

EXPERIMENTAL

Patients will take esomeprazole single dose of 40 mg orally once a day plus single dose of metformin 1000mg orally single dose once a day

Drug: metformin; Drug: esomeprazole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

metformin DRUG

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

Also known as: Experimental

metformin and esomeprazole

esomeprazole DRUG

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

Also known as: Experimental

metformin and esomeprazole

Placebo DRUG

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

Placebo

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 metformin
• Contraindications to the use of esomeprazole or metformin
• The patient is unable or unwilling to give consent
• An established fetal compromise that necessitates delivery
• The presence of any of the following at presentation:
• Eclampsia.
• Severe hypertension.
• A cerebrovascular event as an ischemic or hemorrhagic stroke.
• Renal impairment.
• Signs of left ventricular failure which include pulmonary edema.
• Disseminated intravascular coagulation (DIC)
• Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Metformin; Esomeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• hany f sallam

  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: This is a randomized double-blinded placebo-controlled intervention trial

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: January 1, 2021
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)