Metformin and Esomeprazole For Preterm Pre-eclampsia

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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 sFlt-1 and soluble endoglin, and reduce endothelial dysfunction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christiana Care Health Services
• Treatments: Esomeprazole; Metformin

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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