The medical condition to be investigated in this trial is gestational diabetes with insufficient glycemic control by means of dietary adjustments and thus an indication for addiotional pharmacological treatment. MedDRA version: 20.0 Level: PT Classification code 10018209 Term: Gestational diabetes System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Metformin
Product Name: Metformin
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: range
Concentratio
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 810 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to conventional insulin (INS) treatment.;Secondary Objective: To study the effect of OHA treatment compared with INS treatment, on maternal and perinatal outcome, including maternal hypoglycemia, pregnancy related hypertensive disorders, premature delivery, birth injury, caesarean section, neonatal hypoglycemia and neonatal Medium Care / NICU admission. To evaluate the effect of OHA compared with INS treatment on cost-effectiveness, both from a societal perspective, and patient perspective (i.e. treatment satisfaction and health-related quality of life). ;Primary end point(s): The primary outcome of the RCT will be the rate of large for gestational age (neonatal birth weight >90th percentile, LGA).;Timepoint(s) of evaluation of this end point: After delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Maternal hypoglycemia (biochemical hypoglycemia <3.9 mmol/l, symptomatic hypoglycemia and severe hypoglycemia prompting the need for help by another person, hospital admission for hypoglycaemia) 2) Primary / secondary caesarean section 3) Pregnancy related hypertensive disorders: pregnancy induced hypertension, preeclampsia 4) Preterm delivery (<37 weeks of gestation) 5) Neonatal hypoglycemia: moderate (serum glucose <2.6 mmol/l), severe (serum glucose <2.0 mmol/l) 6) Neonatal hyperbilirubinemia requiring phototherapy 7) Neonatal Medium care / NICU admission;Timepoint(s) of evaluation of this end point: 1) during pregnancy and delivery 2) during and after delivery 3) during pregnancy and delivery 4) during pregnancy and delivery 5) postpartum until discharge or 6 weeks postpartum 6) postpartum until discharge or 6 weeks postpartum 7) postpartum until discharge or 6 weeks postpartum | — |
Countries
Netherlands
Contacts
Public ContactDr R.C. Painter
Academic Medical Center
Outcome results
None listed