Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

N/ANot Yet RecruitingNCT06589141

Assiut University180 enrolled

Overview

This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes. The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.

Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects. Secondary Outcomes: Maternal: * Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment * Incidence of maternal hypoglycemia * Reported maternal side effects * Maternal weight gain * Preterm delivery * Development of pregnancy-induced hypertension * Labor dystocia. * Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion) * Mode of delivery * Incidence of third and fourth perineal tear Fetal and neonatal: * Fetal large for gestational age * Intrauterine fetal death * Newborn weight * Gestational age at delivery * Neonatal birth injuries * Stillbirth and neonatal death * Apgar score at 1 minute

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Gestational Diabetes Mellitus in Pregnancy

Interventions

MetFORMIN 500 Mg Oral TabletDRUG

Metformin (500 to 2000 mg orally)

GlyBURIDE 2.5 MG Oral TabletDRUG

Glyburide (2.5 mg to 20 mg orally)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women over 18 years old. * Gestational age between 24 - 28 weeks. * New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test. * Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM). Exclusion Criteria: Patients with pre-gestational diabetes. * First trimester fasting blood glucose ≥105 mg/dl or HbA1c \> 6.4%. * Major fetal anomalies. * Intrauterine growth restriction (IUGR) before 24 weeks. * Abnormal renal or liver function. * Contraindications to metformin or glyburide. * Medical treatment declined by the patient. * Direct indication to commence insulin (initial fasting blood glucose \>= 7 mmol/l or 126 mg/dl or \>= 6 mmol/l or 108 mg/dl with macrosomia or polyhydramnios). * Significant medical co-morbidities requiring continuous medical treatment in pregnancy. * Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)

Outcomes

Primary Outcomes

Treatment failure

Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects

Time frame: From 28 weeks till 41 weeks of pregnancy

Secondary Outcomes

Incidence of maternal hypoglycemia

Incidence of blood glucose levels below 4 mmol/L during the period of treatment

Time frame: From 28 weeks till 41 weeks of pregnancy

Significant side effects

Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects)

Time frame: From 28 weeks till 41 weeks of pregnancy

Fetal macrosomia (large for gestational age)

Incidence of fetuses growing above the 90th percentile on third ultrasound scan using customised growth chart

Time frame: 32 weeks of gestation to onset of labour

Central Contacts

Sherif Shazly, MSc

CONTACT

+447554480388 shazly.sherif2020@gmail.com

Data from ClinicalTrials.gov

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