CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 187 enrolled
Drug / intervention
Metformindrug
Likely dose
Metformin 425 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04332393
NCT04332393Phase 4Completed

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

The Baruch Padeh Medical Center, Poriya·interventional·Posted Apr 2, 2020·Updated May 9, 2025

In Brief

A Phase 4 clinical trial evaluating Metformin for Pregnancy Preterm and 2 related conditions. Completed, enrolled 187 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedApr 2, 2020
Enrollment StartJul 5, 2020
Primary CompletionJul 7, 2024
Study CompletionMay 5, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.3 years ago

Interventions

Metformindrug

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