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 range18 Years – 60 Years
SexFEMALE
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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
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