NCT04332393

Metformin to Treat Corticosteroids-induced Hyperglycemia

The Effect of Metformin in Pregnant Women Who Received Antenatal Corticosteroids on Glycemic Control and the Rate of Neonatal Hypoglycemia - Multicenter Prospective Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Preterm
• Glycemic Control
• Corticosteroids Induced Hyperglycemia

Interventions

Type	Name	Description
DRUG	Metformin	Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control

Timeline

• Start date: 2020-07-05
• Primary completion: 2024-07-07
• Completion: 2025-05-05
• First posted: 2020-04-02
• Last updated: 2025-05-09

Locations

4 sites across 1 country: Israel