Metformin and Esomeprazole For Preterm Pre-eclampsia

Status unconfirmed · Phase 1

Conditions studied: Preeclampsia Severe, Preeclampsia Second Trimester, Preterm Birth Complication

In brief

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.

Key facts

Study ID

NCT05232994

Run by

Christiana Care Health Services

People needed

38

Starts

2023-03-01

Expected to finish

2025-12-31

Last updated by the study team

2023-02-10

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Christiana Care Health Systems — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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