Metformin to Treat Corticosteroids-induced Hyperglycemia

Phase 4

Completed

• Conditions: Pregnancy Preterm; Glycemic Control; Corticosteroids Induced Hyperglycemia
• Interventions: Drug: Metformin

• Registration Number: NCT04332393
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-07-05
• Primary Completion: 2024-07-07
• Status Verified: 2025-05
• Study Completion: 2025-05-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin group	Metformin	-

Primary Outcome Measures

Name	Time	Method
The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)	Up to 7 days after delivery or discharge (which ever comes first)
Mean maternal daily glucose values	Up to 4 days	According to daily glucose charts

Secondary Outcome Measures

Name	Time	Method
Mean maternal daily post-prandial glucose values	Up to 4 days	According to daily glucose charts
Percent of abnormal values in the daily glucose chart	Up to 4 days	According to daily glucose charts
Rate of neonates who will be admitted to the neonatal intensive care unit	Up to a week after delivery	APGAR scale of 0-worst and 10-best
Apgar score at 1 and 5 minutes	At delivery
Rate of cesarean sections and operative deliveries	At delivery
Mean maternal daily pre-prandial glucose values	Up to 4 days	According to daily glucose charts
Mean and lowest neonatal blood glucose values in preterm neonates	Up to 7 days after delivery or discharge (which ever comes first)
Cord blood pH levels (when taken)	At delivery
The rate of neonates with hyperbilirubinemia	Up to 7 days after delivery or discharge (which ever comes first)
Neonatal mean birth weight	at delivery
Neonatal mean head circumference	Up to 7 days after delivery or discharge (which ever comes first)
The rate of fetal malformations and developmental disorders	Up to 7 days after delivery or discharge (which ever comes first)
The rate of maternal adverse effects	48 hours

Trial Locations

Locations (4)

Galilee medical center; 🇮🇱 Nahariya, Israel

Baruch Padeh Medical center, Poriya; 🇮🇱 Tiberias, North, Israel

Emek medical center; 🇮🇱 Afula, Israel

Ziv medical center; 🇮🇱 Safed, Israel