Gestational diabetes mellitus
Conditions
Sponsors
Bethesda Diabetes research Center (BDRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women with GDM defined as a FPG = 5,3 mmol/l and/or an OGTT with a PG = 7,8 mmol/l, two hours after the oral intake of 75 gram glucose 2. Written informed consent 3. Age 18-45 years 4. Gestational age at inclusion 16-34 weeks 5. HbA1c at inclusion = 48 mmol/mol (6.5% Hb) 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 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus before pregnancy, except previous GDM 2. Proteinuria (UACR > 35 mg/mmol) at screening (UTI excluded) 3. Malignancy during the last 5 years before inclusion, except non- melanoma skin cancer 4. Psychiatric and/or mood disorder potentially affecting compliance of treatment 5. Chronic liver disease and/or ASAT and/or ALAT > 3x ULN 6. Chronic renal failure with a GFR 160 mm Hg despite medical treatment 9. Chronic treatment with oral corticosteroids 10. Intolerance for metformin and/or earlier use of metformin in this pregnancy 11. Membership of the POEM study group 12. Severe foetal anomaly at inclusion – like major neural tube and/or cardiac malformation 13. Ruptured membranes 14. Multiple pregnancy 15. Inability to understand or read the Dutch or English language 16. Bariatric surgery in medical history 17. Hyperemesis gravidarum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: to investigate the effects of an early start of metformin (in GDM) on top of standard of care (versus standard of care alone) on clinically relevant endpoints in mother and child, during pregnancy and delivery. Please, see protocol for details. ;Secondary Objective: Secondary objectives: to investigate the effects of an early start of metformin (in GDM) on top of standard of care (versus standard of care alone) on long term outcomes of mother and child. Please, see protocol for details. ;Primary end point(s): Phase A: GDM Outcome Score (= GOS), an ordinal variable (range 0-8) per pregnancy: (1) pregnancy related hypertension, including pre-eclampsia and eclampsia, (2) large for gestational age (LGA) at delivery (neonatal weight > 90th percentile), (3) premature delivery (< 37.0 weeks of gestation), (4) instrumental delivery, (5) caesarean delivery, (6) birth trauma, (7) neonatal hypoglycaemia (< 2.6 mmol/l), and (8) admission to the NICU.;Timepoint(s) of evaluation of this end point: After Phase A and B | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase A: each of these eight endpoints apart is a secondary endpoint. MOS (maternal outcome score): including Caesarean delivery, Pre-eclampsia/eclampsia/HELLP syndrome/gestational hypertension, Maternal mortality, Postpartum haemorrhage, Thrombosis (in pregnancy and/or childbed). NOS (neonatal outcome score): including Infant Respiratory Distress Syndrome (IRDS) needing nasal CPAP, optiflow, mechanical ventilation and/or surfactant replacement, stillbirth and neonatal death, preterm birth = birth before 37.0 weeks, dystocia of the shoulder during delivery, instrumental delivery, caesarean delivery, neonatal hypoglycaemia < 2.6 mmol/l, neonatal jaundice needing phototherapy, admission to NICU, Apgar score as a variable, Apgar score < 7 at 5 minutes, congenital anomaly Maternal weight, weight gain and change in body compostition (impedance) Maternal glycaemic control: FPG and glucose tolerance Maternale proteinuria Maternal insulin rescue and daily dose of insulin after failure of study drug Acceptability of treatment Maternal urinary tract infection Maternal metabolic varibales from venous sampling (please see protocol) Child: intra-uterine measurements by ultra-sonography Child: foetal weight at delivery Neonatal metabolic variables from umbilical cord Phase B/C: Diabetes & Prediabetes development, Weight development, Hypertension development, thrombotic and CVD incidents, development of any chronic disease Phase B/C: Growth and weight development, gonadal and gender development, puberty and maturation, eductional and intellectual development;Timepoint(s) of evaluation of this end point: after Phase A, B and C | — |
Countries
Netherlands
Contacts
Public ContactBDRC
Bethesda Diabetes research Center
Outcome results
None listed