Metformin to Treat Corticosteroids-induced Hyperglycemia

Glycemic Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332393
• Other study ID #: 21-20POR
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Enav Yefet, MD/PhD
• Phone: 972-46652306
• Email: enyefet[@]poria.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 323
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corticosteroids Induced Hyperglycemia
• Glycemic Control
• Hyperglycemia
• Pregnancy Preterm

Intervention

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

Locations

Country	Name	City	State
Israel	Emek medical center	Afula
Israel	Galilee medical center	Nahariya
Israel	Ziv medical center	Safed
Israel	Baruch Padeh Medical center, Poriya	Tiberias	North

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean maternal daily glucose values	According to daily glucose charts	Up to 4 days
Primary	The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)		Up to 7 days after delivery or discharge (which ever comes first)
Secondary	Mean maternal daily pre-prandial glucose values	According to daily glucose charts	Up to 4 days
Secondary	Mean maternal daily post-prandial glucose values	According to daily glucose charts	Up to 4 days
Secondary	Percent of abnormal values in the daily glucose chart	According to daily glucose charts	Up to 4 days
Secondary	Rate of cesarean sections and operative deliveries		At delivery
Secondary	Rate of neonates who will be admitted to the neonatal intensive care unit	APGAR scale of 0-worst and 10-best	Up to a week after delivery
Secondary	Apgar score at 1 and 5 minutes		At delivery
Secondary	Cord blood pH levels (when taken)		At delivery
Secondary	The rate of neonates with hyperbilirubinemia		Up to 7 days after delivery or discharge (which ever comes first)
Secondary	Neonatal mean head circumference		Up to 7 days after delivery or discharge (which ever comes first)
Secondary	Neonatal mean birth weight		at delivery
Secondary	The rate of fetal malformations and developmental disorders		Up to 7 days after delivery or discharge (which ever comes first)
Secondary	Mean and lowest neonatal blood glucose values in preterm neonates		Up to 7 days after delivery or discharge (which ever comes first)
Secondary	The rate of maternal adverse effects		48 hours