drugset / Trial / NCT04332393

Metformin to Treat Corticosteroids-induced Hyperglycemia

NCT04332393 ↗

Phase 4 Completed 187 enrolled The Baruch Padeh Medical Center, Poriya
RandomizedParallel-groupOpen-labelTreatment

Summary

Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes. Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates. In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.

Timeline

Start
2020-07-05
Primary completion
2024-07-07
Completion
2025-05-05

Outcome

Met primary endpoint

paper Mean (SD) maternal total and postprandial glucose values were significantly lower in the metformin group (121 [15] vs 127 [17] mg/dL; P = .01 PMID 41511771 ↗

paper Neonatal hypoglycemia rate was lower in the metformin group (10 [21%] vs 23 [40%]; P = .04; relative risk, 0.53; 95% CI, 0.28-0.99). PMID 41511771 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 425 mg —
Subject Metformin Small molecule 1700 mg —

Indications