Maternal metabolic health And Mother and Baby health Outcomes (MAMBO): An observational cohort study

Women will be recruited to the MAMBO study when they attend maternity care visits at The Women’s or Frances Perry House prior to 20±4 completed weeks gestation. The initial contact will be made by the maternity care provider. Subsequent contact will be made by a dedicated trial nurse at the time of the standard maternity care visit. Written consent will be obtained. To facilitate long-term follow-up of the MAMBO cohort, we are collaborating with Generation Victoria (GenV: https://genv.org.au). GenV is aiming to recruit parallel cohorts of newborns and their parents (estimated 160,000) in the state of Victoria (population 6.5 million), Australia, over two full years from October 2021. Its goal is to generate translatable evidence (prediction, prevention, treatments, services and policy) to improve the future wellbeing of all children and adults and to reduce future disease burden. Importantly, the GenV cohort only recruits parents and offspring after birth and will follow the child and parent/s indefinitely until the study closes (no end date set at this point) or withdrawal. GenV conducts retrospective and prospective linkage to clinical and administrative datasets and banking of retrospective and prospective clinical and GenV specific biosamples for the GenV cohorts. Women will be informed about the Gen V study when they are recruited to the MAMBO study. They can make the decision whether or not they wish to participate in Gen V after the birth of their baby. For the MAMBO study, the first clinical trial visit can occur the same day as the consent or within 4 weeks of recruitment, provided that the initial visit occurs before 24 completed weeks gestation. All MAMBO participants will be given information about GenV and asked whether 1) they consent to MAMBO sharing their contact details with GenV, ie so that MAMBO and GenV are aware of who is participating in both studies and GenV can contact MAMBO participants for recruitment to GenV and 2) they consent to MAMBO and GenV sharing information between the two studies. This optional data sharing consent will only apply to participants who are enrolled in both studies. Study Visits: First study visit: The study visit will occur at 20 weeks on the day of recruitment or within 4 weeks of recruitment. To minimize the burden on women, this could occur on the same day as the consent. The GenV study will be discussed with participants but recruitment to GenV will only occur after delivery. Study activities include: • Documentation of maternal and (if available) paternal demographic details • Collect medical history and medication history from the electronic medical record • Maternal anthropometry: Height, weight, waist circumference, bioimpedance, blood pressure • Collection of blood (non-fasting): Glucose, lipids, leptin, CRP, c-peptide, insulin. Second study visit: The second study visit will occur at 36 weeks gestation ±4 weeks gestation. At this visit, subjects will be provided with a kit to collect maternal and baby mouth swabs within a few days of delivery. Study activities include: • Collect medical history and medication history from the electronic medical record (including GTT, and maternity ultrasound results) • Ultrasound data: Estimated fetal weight and abdominal circumference on all available obstetric ultrasounds that have been formally reported and appear in the electronic medical record. • Maternal anthropometry: Height, waist circumference, bioimpedance, blood pressure • Collection of blood (non-fasting): Glucose, lipids, leptin, CRP, c-peptide, insulin. Data Collection Visit (peripartum): • Cheek swab (for epigenetic analysis) will be taken from mother and baby according to the protocol. These samples will be self-collected before discharge from hospital using a kit supplied at 36 weeks gestation. Samples will be given to nursing staff and will be sent to pathology for long-term storage until all samples are collected. • Collection of history discharge summary which includes the birth record. Third study visit: The third study visit will occur at 12-18 months post-delivery. Study activities include: • Collect medical history and medication history from the electronic medical record and/or patient • Maternal anthropometry: Height, weight, waist circumference, bioimpedance, blood pressure • Collection of blood (non-fasting): Glucose, lipids, leptin, CRP, c-peptide, insulin. • Weight and height of children as recorded in the childhood development book (‘Baby book’) • Neonatal anthropometry: Weight, length, abdominal circumference, body composition (using mid-arm circumference and triceps skinfold)(18) In order to encourage attendance at this visit, parking and meal vouchers will be provided. Women will be provided with a comprehensive summary of their metabolic health and a plan for appropriate long-term follow-up. The Gen V team will have regular contact with participants between 0 and 12-18 months and will encourage women to attend the 12-18 month visit. If a face-to-face visit is not possible, a phone visit will be deemed acceptable.