Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial.

INTERVENTION: Trade Name: Metformine HCl 500 PCH, filmomhulde tabletten 500 mg Pharmaceutical Form: Tablet CONDITION: Pregnant women with a high risk of gestational diabetes mellitus (GDM) Therapeutic area: Body processes [G] ‐ Metabolic Phenomena [G03] PRIMARY OUTCOME: Main Objective: To compare the incidence of gestational diabetes (GDM) in pregnant; women with a high risk of GDM treated with Metformin from second; trimester till delivery versus control group Primary end point(s): Incidence of gestational diabetes mellitus Secondary Objective: To compare pregnancy outcome in pregnant women treated with; Metformin versus control group. To compare neonatal outcome in; pregnant women treated with Metformin versus control group. To; compare the number of neonatal complications in pregnant women; treated with Metformin versus control group. Timepoint(s) of evaluation of this end point: At 16 weeks of pregnancy in women with gestational diabetes mellitus in; history (4‐8 weeks after inclusion, 4 weeks after start medication); At 24 weeks of pregnancy in other subjects (16‐12 weeks after inclusion,; 10 weeks after start medication) SECONDARY OUTCOME: Secondary end point(s): Maternal: pregnancy induced hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg), weight gain during; pregnancy, abnormal glucose daily curve (measurement of blood glucose concentration seven times daily).; ; Neonatal: head circumference, birth weight and height, pH of umbilicalcord; ; Neonatal complications: severe birth defects, stillbirth, neonatal; hypoglycaemia that requires therapy, birth trauma, need for; phototherapy, (respiratory distress), premature birth (< 37 weeks of gestation), small for gestational age (birth weight < 2 SD units), low 5‐minutes Apgar score (< 7), birth weight > 90th percentile, birth weight < 10th percentile, admission to neonatal intensive care unit Timepoint(s) of evaluation of this end point: Maternal endpoints:; Evaluated during pregnancy on the regular visits with the obstretican.; Abnormal glucose daily curve: dvaluated 4 weeks after pregnancy; ; Neonatal outcomes: evaluated after delivery by the gynaecologist or obstretican INCLUSION CRITERIA: 'High risk' is defined if one or more of the risk factors below is present, according to the Dutch national criteria for screening ‐ Gestational diabetes in history ‐ Body mass index > 30 (kg/m2) at the first prenatal screening ‐ Birth weight previous child > P95 or > 4500 gram ‐ First degree relative with diabetes mellitus ‐ Certain ethnic groups with a high prevalence of diabetes mellitus (South Asians, like Hindustani, Afro‐Caribbean people, women from the Middle East, Morocco and Egypt) ‐ History of unexplained intra‐uterine foetal death/stillbirth ‐ Polycystic ovary syndrome (PCOS) And aged between 18 and 40 years, gestational age between 8 and 12 weeks, able to communicate and read in Dutch 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 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects f