Metformin to Treat Corticosteroids-induced Hyperglycemia

NCT ID: NCT04332393

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-05

Study Completion Date

2025-05-05

Brief Summary

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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

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Conditions

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Pregnancy Preterm Glycemic Control Corticosteroids Induced Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin group

Group Type EXPERIMENTAL

Metformin

Intervention Type 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

No treatment group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baruch Padeh Medical center, Poriya

Tiberias, North, Israel

Site Status

Emek medical center

Afula, , Israel

Site Status

Galilee medical center

Nahariya, , Israel

Site Status

Ziv medical center

Safed, , Israel

Site Status

Countries

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Israel

Other Identifiers

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21-20POR

Identifier Type: -

Identifier Source: org_study_id

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