| Outcome Measures: |
Primary: GDM Outcome Score (GOS) in Phase A, An aggregate score of eight clinically relevant endpoints, as previously defined: 1. pregnancy related hypertension, including (pre-) eclampsia, according validated guidelines, 2. large for gestational age baby (LGA) at delivery according validated guidelines, 3. premature delivery with a gestational age \< 37 weeks, 4. instrumental delivery, 5. caesarean delivery, 6. birth trauma, like fractures of clavicle and humerus, subdural / intracerebral haemorrhage, 7. neonatal hypoglycaemia, defined as blood glucose \< 2.6 mmol/l, 8. admission for neonatal intensive care., 30 months|T2D and obesity at the end of Phase B, Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child, 42 months|Development of T2D and obesity during Phase C, Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child, 282 months | Secondary: Secondary Outcome measures phase A mother, Maternal outcome score (MOS) 1. Caesarean delivery (yes=1, no=0) 2. (Pre-)eclampsia, HELPP and PIH (if at least one is diagnosed=yes=1,no=0) 3. Maternal mortality (yes=1, no=0) 4. Postpartum haemorrhage (blood loss \> 1000 ml)(yes=1, no=0) 5. Thrombosis (yes=1, no=0) For each individual component applies: if occured=1 point. If not occured =0 points. A total score per individual will be calculated (0-5 for MOS). Each component on its own is also a secondary outcome measure., 30 months|Secondary Outcome measures phase A child, Neonatal outcome score (NOS)\*\* 1. IRDS requiring oxygen therapy (CPAP, optiflow, mechanical ventilation or surfactant) (yes=1, no=0) 2. Stillbirth or neonatal death (yes=1, no=0) 3. Preterm birth \<37 weeks (yes=1, no=0) 4. Shoulder dystocia (yes=1, no=0) 5. Instrumental delivery (yes=1, no=0) 6. Caesarean delivery (yes=1, no=0) 7. Neonatal hypoglycaemia \< 2.6 mml/l (yes=1, no=0) 8. Neonatal jaundice needing phototherapy (yes=1, no=0) 9. NICU admission (yes=1, no=0) 10. Apgar score \< 7 at 5 minutes (yes=1, no=0) 11. Congenital anomaly (to a list, if one anomaly = yes = 1, no=0) For each individual component applies: if occured=1. If not occured=0. A total score per individual will be calculated (0-11 for NOS). Each component on its own is also a secondary outcome measure. Apgar score as a variable (1-10) at 1, 5, 10 min Foetal weight at delivery in grams, 30 months|Secondary outcome measures phase B, Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no), 42 months|Secondary outcome measures phase C, Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no), 282 months
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| Locations: |
Martini hospital Groningen, Groningen, Netherlands|University Medical Center Groningen, Groningen, Netherlands|Treant Zorggroep, Hoogenveen, Emmen, Stadskanaal, Netherlands|Medical Center Leeuwarden, Leeuwarden, Netherlands
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