Gestational Diabetes Mellitus Clinical Trial
— Medico-GDMOfficial title:
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
Status | Recruiting |
Enrollment | 400 |
Est. completion date | September 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: a subject must meet all of the following criteria: - high risk (according to ductch national criteria) for gestational diabetes - aged between 18 and 40 years - gestational age between 8 and 12 weeks - and able to communicate and read in Dutch. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - no singleton pregnancy judged by ultrasonography - diagnosis of diabetes mellitus before the current pregnancy- - high fasting glucose at first trimester (> 5.3 mmol/l) - cardiac insufficiency-\ - renal insufficiency (MDRD < 60) - liver disease - use of medication other than Paracetamol or vitamins and incompetent women. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Maasstad Ziekenhuis | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Maasstad Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of gestational diabetes mellitus in both groups | from 14 weeks pregnancy untill delivery | No | |
Secondary | Maternal outcomes | Maternal: pregnancy induced hypertension (yes vs no: systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg), weight gain during pregnancy (kg), abnormal glucose daily curve after pregnancy (yes vs no: measurement of blood glucose concentration seven times daily).), insulin therapy required. | from 14 weeks pregnancy untill delivery | No |
Secondary | Neonatal outcomes | head circumference (cm), birth weight (g) and height (cm), pH of umbilical-cord. Neonatal complications: serious neonatal complications (including: severe birth defects, stillbirth, birth trauma, respiratory distress, admission to neonatal intensive care unit, low 5-minutes Apgar score (< 7) and premature birth (< 37 weeks of gestation)), neonatal hypoglycaemia that requires therapy, need for phototherapy, small for gestational age (birth weight < 2 SD units), birth weight > 90th percentile, birth weight < 10th percentile. |
from 14 weeks pregnancy untill delivery | No |
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