Secondary outcomes
Maternal - Pre-eclampsia, severe pre-eclampsia; mode of delivery: caesarean section (elective, emergency, pre-labour, in labour), vaginal delivery, operative vaginal delivery; induction of labour; blood loss at delivery (>1000 ml; >2000 ml); inpatient nights (antenatal, postnatal); GWG, trimester specific GWG; fasting plasma glucose, fasting plasma insulin, insulin resistance calculated by homeostatic model assessment 2 (HOMA2-IR) [
46] at 28 weeks’ gestation; diagnosis of GDM by local criteria; referral to GDM antenatal service following OGTT; requirement for insulin or metformin during pregnancy; fetal growth at 28 weeks. Health related quality of life as assessed by EQ-5D. At 27
+0- 28
+6 and 34
+0- 36
+0 weeks’ gestation and 6 months postpartum; mid-arm, neck, hip, thigh and wrist circumference and skinfold thickness (subscapular, triceps, biceps, supra-iliac); plasma fructosamine, triglycerides, LDL, VLDL and HDL cholesterol, plasma insulin, C-reactive protein, other relevant epigenetic and metabolomic biomarkers, and urinary biomarkers; dietary measures including glycemic load, saturated fat and total sugar intake; dietary feeding patterns; physical activity scores; measures of depression; maternal smoking. At 6 months postpartum, postnatal weight retention, existing maternal morbidity (diabetic status, hypertension, thromboembolism, low mood [
47]).
Neonatal; Gestational age at delivery, delivery at <37 weeks’, delivery at <34 weeks’; birth weight, birth weight >4,000 g, <2,500 g; birth weight >95th <10th and <5th customised birth weight centile, distribution of birth weight, neonatal death, days in special care baby unit, total inpatient days, need for mechanical ventilation and duration, discharge home on O2, suspected and confirmed infection, evidence of intraventricular haemorrhage and other complications, (pulmonary haemorrhage, necrotizing enterocolitis), retinopathy of prematurity, hypoglycaemia. Occipitofrontal head circumference, abdominal circumference, mid-arm circumference, chest circumference, crown-rump length and crown-heel length (neonatometer), triceps and subscapular skin fold thicknesses and estimated fat mass.
Key epigenetic and metabolomic biomarkers will be investigated using cord blood or whole blood (maternal and fetal) and their relation to specific outcomes.
Infant at 6 months; duration of breast feeding, choice of formula milk, weaning history (introduction of foods and frequency/timing of foods), a general measure of appetite, and four specific scales: enjoyment of food, food responsiveness, slowness in eating, and satiety responsiveness, anthropometric measurements (occipitofrontal circumference, abdominal circumference, mid-arm circumference, chest circumference, crown-rump length and crown-heel length by infantometer, subscapular and triceps skin fold thicknesses and estimated fat mass; activity (total number of 14 standard milestones reached) and sleeping patterns (time spent sleeping; morning, afternoon and night; health care resource use (hospital admissions and medications); frequency of use of kindergarten/mother’s help.