Metformin and Esomeprazole in Preterm Pre-eclampsia (NCT06359015) | Clinical Trial Compass
TerminatedPhase 4
Metformin and Esomeprazole in Preterm Pre-eclampsia
Stopped: Lost funding
United States4 participantsStarted 2021-02-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean plasma difference in sFlt-1
Timeframe: Over the first 14 days after randomization and during the remainder of pregnancy, an average of 3-4 months