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.

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. - Metformin to prevent gestational diabetes mellitus (GDM)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000446-30-NL

Enrollment

Unknown

Registered

2014-04-01

Start date

2014-07-23

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women with a high risk of gestational diabetes mellitus (GDM)

Interventions

Trade Name: Metformine HCl 500 PCH, filmomhulde tabletten 500 mg Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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 for this age range

Exclusion criteria

Exclusion criteria: No singleton pregnancy judged by ultrasonography, high fasting glucose at first trimester, cardiac insufficiency, renal insufficiency (MDRD < 60), liver disease, use of medication other than Paracetamol or vitamins and incompetent women.

Design outcomes

Primary

Measure	Time frame
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;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.;Primary end point(s): Incidence of gestational diabetes mellitus ;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)	—

Measure

Time frame

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;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.;Primary end point(s): Incidence of gestational diabetes mellitus ;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)

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Secondary

Measure	Time frame
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 ( 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	—

Measure

Time frame

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 ( 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

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Countries

Netherlands

Contacts

Public ContactDr. J van der Linden

Maasstad Ziekenhuis

0031102912382

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026