Metformin to Treat Corticosteroids-induced Hyperglycemia

NCT04332393 | Completed Phase 4

• 1 other identifier: 21-20POR
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• Mean maternal daily glucose values

  According to daily glucose charts

  Up to 4 days

• The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)

  Up to 7 days after delivery or discharge (which ever comes first)

Secondary Outcomes (13)

• Mean maternal daily pre-prandial glucose values

  Up to 4 days

• Mean maternal daily post-prandial glucose values

  Up to 4 days

• Percent of abnormal values in the daily glucose chart

  Up to 4 days

• Rate of cesarean sections and operative deliveries

  At delivery

• Rate of neonates who will be admitted to the neonatal intensive care unit

  Up to a week after delivery

Study Arms (2)

metformin group

EXPERIMENTAL

Drug: Metformin

No treatment group

NO INTERVENTION

Interventions

Metformin DRUG

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

metformin group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

Study Sites (4)

Baruch Padeh Medical center, Poriya

Tiberias, North, 15208, Israel

Location

Emek medical center

Afula, Israel

Location

Galilee medical center

Nahariya, Israel

Location

Ziv medical center

Safed, Israel

Location

Related Publications (1)

• Yefet E, Massalha M, Talmon G, Labay A, Matanis M, Sleman E, Nassra R, Frank Wolf M, Sgayer I, Lowenstein L, Nachum Z. Metformin, Maternal Glycemic Control, and Neonatal Hypoglycemia After Antenatal Steroids: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2552807. doi: 10.1001/jamanetworkopen.2025.52807.

  PMID: 41511771 DERIVED

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 2, 2020
• Study Start: July 5, 2020
• Primary Completion: July 7, 2024
• Study Completion: May 5, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IL (4)