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

21-20POR

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.

2020-05-15

2024-04-01

2024-12-01

Recruiting

Early phase I

323

Inclusion Criteria: * Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks * Before or within 24 hours following the first dose of betamethasone * ≥18 years old Exclusion Criteria: * Women with pre-gestational and gestational diabetes mellitus (GDM) * Known allergic sensitivity to metformin * Known chronic heart failure * Known chronic renal failure * Refuse to participate * Refuse to perform glucose challenge test/glucose tolerance test later on

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 323, 'type': 'ESTIMATED'}}

2023-11-21