diabetes in pregnancy GDM gestational diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Singleton pregnancy - Aged >18 years - OGTT for all indications - OGTT conducted between gestational ages 16+0 and 30+ 0 weeks - Discordant result on a 3-point 75-gram OGTT i.e.: o Fasting glucose > 5.1 and =10.0 mmol/l OR o 2-hour glucose >7.8 and
Exclusion criteria
Exclusion criteria: - known preconception diabetes - major fetal congenital /chromosomal abnormality (eg trisomy 21, spina bifida), known at time of randomization - significant medical or psychiatric co-morbidities as judged by the investigator (e.g. high dose corticosteroid treatment) - inability to understand written informed consent without help as indicated by their usual care provider
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the incidence of birth weight >90th centile (LGA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include mode of delivery (caesarean sections), maternal outcomes, perinatal outcomes including perinatal mortality, gestational age at delivery, shoulder dystocia, birth trauma, neonatal hypoglycaemia, neonatal intensive care admission, need for phototherapy, quality of life and societal costs. | — |
Countries
Netherlands