Gestational Diabetes Mellitus in Pregnancy
Conditions
Keywords
Metformin and Glyburide
Brief summary
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.
Detailed description
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
Interventions
Metformin (500 to 2000 mg orally)
DRUGGlyBURIDE 2.5 MG Oral Tablet
Glyburide (2.5 mg to 20 mg orally)
Sponsors
Middle-Eastern College of Obstetricians and Gynecologists
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | From 28 weeks till 41 weeks of pregnancy | Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of maternal hypoglycemia | From 28 weeks till 41 weeks of pregnancy | Incidence of blood glucose levels below 4 mmol/L during the period of treatment |
| Significant side effects | From 28 weeks till 41 weeks of pregnancy | Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects) |
| Fetal macrosomia (large for gestational age) | 32 weeks of gestation to onset of labour | Incidence of fetuses growing above the 90th percentile on third ultrasound scan using customised growth chart |
Contacts
Primary ContactSherif Shazly, MSc
Outcome results
None listed