Study Results
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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NOT_YET_RECRUITING
PHASE1
38 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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.
Esomeprazole 20mg
Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.
expectant management
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
FEMALE
No
Sponsors
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Christiana Care Health Services
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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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