diabetes in pregnancy Gestational diabetes
Conditions
Interventions
Randomization to either treatment with the oral antidiabetic agents (metformin
and if necessary supplemental glibenclamide) or standard treatment with
insulin.
Sponsors
Academisch Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: - Aged 18 years or over - Singleton pregnancy - Diagnosis of GDM as per national guidelines - Indication for pharmacological treatment of GDM - Gestational age between 16 and 34 weeks - Ability to understand Dutch or English - Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: - Known pre-existent type 1 or type 2 diabetes mellitus - Severe medical or psychiatric comorbidities - Serious liver disease or kidney failure, or any other condition with contraindications for the use of either metformin or glibenclamide* - Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities * * e.g. hypersensitivity to glibenclamide / metformin or to any of the excipients, hypersensitivity to other sulphonylureas, history of ketoacidosis, impaired adrenal function, severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure will be large-for-gestational-age (birthweight > 90th percentile) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures: • Maternal hypoglycemia (biochemical hypoglycemia | — |
Countries
Netherlands
Outcome results
None listed