Status:
NOT_YET_RECRUITING
Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes
Lead Sponsor:
Assiut University
Collaborating Sponsors:
Middle-Eastern College of Obstetricians and Gynecologists
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 an...
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 Ou...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06589141
Start Date
January 1 2025
End Date
June 30 2026
Last Update
September 19 2024
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