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NCT04332393

Metformin to Treat Corticosteroids-induced Hyperglycemia

Completed Phase 4 Last updated 9 May 2025
What this trial tests

Phase 4 trial testing Metformin in Pregnancy Preterm in 187 participants. Completed in 5 May 2025.

Timeline
5 July 2020
Primary endpoint
7 July 2024
5 May 2025

Quick facts

Lead sponsorThe Baruch Padeh Medical Center, Poriya
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment187
Start date5 July 2020
Primary completion7 July 2024
Estimated completion5 May 2025
Sites4 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

The Baruch Padeh Medical Center, Poriya

Who can join

18 and older, female only, with Pregnancy Preterm or Glycemic Control. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Metformin, Maternal Glycemic Control, and Neonatal Hypoglycemia After Antenatal Steroids: A Randomized Clinical Trial.
    Yefet E, Massalha M, Talmon G, Labay A, et al · · 2026 · PMID 41511771 · DOI 10.1001/jamanetworkopen.2025.52807

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Pregnancy Preterm

Currently open trials in the same condition.

Other The Baruch Padeh Medical Center, Poriya trials

Trials by the same sponsor.

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