PROMOTE Cohort Study: maternal & PeRinatal Outcomes aMongst wOmen with and without obEsity – a personalised and acceptable approach of risk assessment and stratification using social, clinical, nutritional and physical activity data

Study design: Prospective cohort study. Study setting/population: Pregnant women booking/attending for antenatal care (<16 weeks gestation) at Westmead Hospital will be recruited. (i) Exposures of interest collected from routine clinical data (electronic maternity records) will include: sociodemographic, clinical history (including past medical history, medical co-morbidities – particularly pre-existing diabetes / hypertension, medical complications in pregnancy, weight gain between pregnancy), obstetric history (e.g. parity, previous obstetric complications), weight, height and BMI, mental health screening, and breastfeeding history using the BLISS score, all currently measured as part of routine care. (ii) Participants will complete surveys at booking that will take the participants approximately 15-30 minutes to complete. All participants will be requested to: • Record self-reported physical activity levels using the Australia Active Survey (5-15 minutes) • Complete a dietary assessment using a validated short screening tool, based on state nutrition monitoring assessment questions from the Centre for Epidemiology and Evidence, NSW Ministry of Health (5-15 minutes) • Complete the Depression, Anxiety and Stress Scale (DASS) (5-15 minutes) • Provide socioeconomic information, including household structure, educational attainment, employment status and income (5-15 minutes) Furthermore, a subgroup cohort will be requested to sign a separate PICF and complete the following additional 3 surveys: • The Pregnancy Physical Activity Questionnaire (5-15 minutes) • A 50-item Food Frequency Questionnaire (10-15 minutes) • Vulnerable Personality Style Questionnaire (5-15 minutes) Study recruitment acceptance rate and questionnaire completion rate will be collected. (iii) An optional request for participants to consent for the collection of a maternal blood sample, to perform a limited range of blood tests on this sample when funding becomes available, and consent for biobanking. Samples will be collected via the hospital’s pathology service, or by study recruitment staff where appropriately qualified. Blood tests we wish to perform are related to cardiometobolic risk and include: glucose level, HbA1c, glycated albumin, lipid profile (total cholesterol, triglycerides, low density lipoprotein, high density lipoprotein), liver function tests and inflammatory markers (C-reactive protein and erythrocyte sedimentation rate). Where tests are part of routine care, results will be obtained from routine data. Where tests are not part of routine care (e.g. lipid profile and inflammatory markers) we seek permission for the collection of samples. We also seek permission for biobanking. The aims of biospecimen collection and biobanking are to better understand the biochemical indicators of metabolic and placental related adverse outcomes in pregnancy in this population. Ethics approval and further funding will be sought for any additional future analysis on biobanked samples, beyond the scope of what has been described above. During pregnancy (subgroup) – The subgroup of women consenting to longitudinal data collection will be asked to undergo their routine 20 week morphology scan at Westmead Hospital. Such scans form part of routine care, but are often performed externally by private radiology services. The participants in the substudy will be invited to have their routine scans at Westmead Hospital itself. They will be asked to perform the following at their routine antenatal care visits at two additional timepoints during pregnancy at 24-28 weeks’ and 34-39 weeks’ gestation. (i) Participants will be asked to repeat the four surveys completed in early pregnancy: (ii) Collection of maternal blood samples for biobanking and to later perform a limited range of tests related to cardiometabolic risk as detailed above. These will be collected by the hospital’s pathology service or by appropriately qualified study recruitment staff. They will be performed at the same time as routine pathology collection wherever possible (for example, at the same time as routine oral glucose tolerance test). (iii) Fetal ultrasounds for routine biometry and investigational measures potentially related to fetal growth and perinatal outcomes. These will be performed by a qualified member of the study team at Westmead Hospital. Any concerns raised at any ultrasound visit will be escalated to the clinical teams as per routine clinical pathways. At delivery – (iv) We will also request participant consent for the collection of a blood sample from the umbilical cord and biobanking this blood sample. Samples will be collected by appropriately trained recruitment midwife or study staff. Ethics approval and further funding will be sought for any future study on biobanked samples. The intended goal of the biobank maternal and fetal cord blood would be to better understand biomarkers of cardiometabolic risk, both well known variables and also newer potential markers of cardiometabolic health. These will include glucose level, glycated albumin, glycated haemoglobin F by modified methods, c-peptide, insulin, lipid profile and inflammatory markers. After delivery (subgroup only) – (i) The subgroup of women consenting to longitudinal data collection will be asked to consent to measurement of neonatal anthropometry. This will be performed by study staff within three days of delivery and while the infant remains admitted at Westmead Hospital. Measurements will not be performed if the infant is clinically unsuitable as deemed by study, medical or nursing staff or the participant (for example, infant in neonatal intensive care). There will be no follow-up requirements following hospital discharge after delivery. Pregnancy and birth outcomes –routine data on the maternity information systems: (i) Progress in pregnancy: e.g longitudinal BP and weight gain in pregnancy, fetal growth; (ii) Complications: e.g glycaemic problems and gestational diabetes, pregnancy induced hypertension (PIH), pre-eclampsia (PET), fetal growth anomalies, and their associated morbidity; (iii) Birth onset: e.g preterm induction of labour, and outcomes: e.g live birth, mode of delivery, neonatal condition at birth;