Clinical trial

Use of Combination Metformin and Esomeprazole in Preterm Pre-eclampsia: a Randomized Controlled Trial

Name

41138

Description

The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia.

Trial arms

Trial start

2021-02-11

Estimated PCD

2025-06-01

Trial end

2025-06-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Metformin

Oral Metformin schedule: Day 1: 500 milligrams in morning Day 2: 500 milligrams two times a day Day 3: 1000 milligrams in morning, 500 milligrams in evening Day 4 onwards: 1000 milligrams two times a day based on individual tolerance Oral Esomeprazole schedule: 40 milligrams Oral Esomeprazole daily until delivery which can be tapered down to 20 milligrams daily based on individual tolerance.

Arms:

Metformin and Esomeprazole

Esomeprazole

40 milligrams Oral Esomeprazole daily until delivery which can be tapered down to 20 milligrams daily based on individual tolerance.

Arms:

Metformin and Esomeprazole

Size

Primary endpoint

Mean plasma difference in sFlt-1

Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months

Eligibility criteria

Inclusion Criteria: * Women 18 years or older * Women diagnosed with preeclampsia or preeclampsia with severe features or superimposed preeclampsia with 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 * Reflux disease or other conditions currently on esomeprazole * Contraindications to metformin, esomeprazole * Baseline creatinine \>124 μmol/L * Hypersensitivity to metformin or esomeprazole * Current use of metformin or esomeprazole * Metabolic acidosis * Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) * Multiple gestations

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two groups: experimental and control. The control group receives expectant management. The experimental group receives expectant management and medication treatment.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

Updated at

2024-04-11

1 organization

1 product

1 drug

4 indications

Organization

Christiana Care Health Services

Drug

Metformin

Indication

Preeclampsia Severe