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Metformin to Treat Corticosteroids-induced Hyperglycemia

NCT04332393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2025-05-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04332393 on ClinicalTrials.gov