Metformin and Esomeprazole For Preterm Pre-eclampsia

NCT ID: NCT05232994

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.

Detailed Description

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Conditions

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Preeclampsia Severe Preeclampsia Second Trimester Preterm Birth Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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combination metformin and esomeprazole

Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.

Group Type EXPERIMENTAL

Esomeprazole 20mg

Intervention Type DRUG

Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.

expectant management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Esomeprazole 20mg

Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.

Intervention Type DRUG

Other Intervention Names

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Metformin

Eligibility Criteria

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Inclusion Criteria

Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies

* Women 18 years or older
* Women diagnosed with preeclampsia
* Women with pre-eclampsia superimposed on chronic hypertension
* Candidates for expectant management and had no clinical indication for immediate delivery

Exclusion Criteria

* Delivery within 48hr is highly likely
* Maternal or fetal compromise that necessitated immediate delivery
* Diabetes or gestational diabetes currently on metformin therapy
* Contraindications to metformin, esomeprazole
* Baseline creatinine \>124 μmol/L
* Hypersensitivity to metformin or esomeprazole
* Metabolic acidosis
* Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Hoffman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

ChristianaCare

Locations

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Christiana Care Health Systems

Newark, Delaware, United States

Site Status

Countries

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United States

Central Contacts

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Marwan Ma'ayeh, MD

Role: CONTACT

302-319-5680

Kendall M Bielak, MD

Role: CONTACT

302-320-4414

Facility Contacts

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Marwan Ma'ayeh, MD

Role: primary

302-320-5680

Matthew Hoffman, MD, MPH

Role: backup

Other Identifiers

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DDD# 605095

Identifier Type: -

Identifier Source: org_study_id

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