Metformin to Treat Corticosteroids-induced Hyperglycemia

Baruch Padeh Medical Center

Status and phase: Completed; Phase 4

Conditions: Corticosteroids Induced Hyperglycemia; Glycemic Control; Pregnancy Preterm

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04332393

21-20POR

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

187 participants in 2 patient groups

metformin group

Experimental group

Treatment:

Drug: Metformin

No treatment group

No Intervention group