drugset / Trial / NCT05232994

Metformin and Esomeprazole For Preterm Pre-eclampsia

NCT05232994

Phase 1 Unknown 38 enrolled Christiana Care Health Services
RandomizedParallel-groupOpen-labelPrevention

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 soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.

Timeline

Start
2023-03-01
Primary completion
2024-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 20 mg
Subject Metformin Small molecule 2 g Oral

Indications