1. may 2013 partnership project

2. outpatients clinic hirf ccd research mother’s and babies infection and immunity brain and mental health cancer

3. Primary Care Primary Care

4. early detection of disease, intervention, prevention and treatment

5. Preconception and Early Pregnancy Care

6. early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy R − CH 3 methyl R − CH 2 - methylene R − CH = methenyl R − CHO formyl one carbon metabolism

7. early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy one carbon metabolism transfer of one carbon units folate and methionine cycles DNA synthesis aa and protein synthesis epigenetic regulation redox status

8. early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy one carbon metabolism

10. lack evidence-based framework for the use of micronutrient supplements during the preconception / early pregnancy for improving pregnancy outcomes clinical gap

11. MIA IVD for assessing OCM status and personalised nutrient supplementation to reduce the incidence of adverse pregnancy outcomes outcome (label use)

12. RCT 5% decrease in the incidence of complications of pregnancy in the intervention vs control arm outcome measure

13. 1.Surveillance of maternal one carbon metabolism during early pregnancy will identify women at high risk of developing pregnancy complications; and 2. Personalised nutraceutical intervention, in high- risk women, will decrease the incidence of adverse pregnancy outcomes. hypotheses

14. To establish the clinical utility of red cell and serum folate, vitamin B12 and homocysteine determinations to identify women at risk of adverse pregnancy outcomes. To determine whether or not early identification of high-risk pregnancies and personalised nutraceutical treatment throughout pregnancy reduces the prevalence of these adverse pregnancy outcomes in Australian women. aims (i.e. preterm birth, fetal growth restriction, low birth weight, congenital abnormalities, preeclampsia, miscarriage and stillbirth)

15. experimental design iso17025 (R&D) iso 13485 (medical devices) NATA accredited 21 CFR part 11 compliance sample tracking FreezerPro data and document handling IrisNote trained personnel

16. 7 clinics qld 1clinic sa 1clinic santiago

17. Dr Leith Moxon-Lester

18. Randomisation Consent and Questionnaire Randomisation Consent and Questionnaire CONTROL ARM 1000 CONTROL ARM 1000 INTERVENTION ARM 1000 INTERVENTION ARM 1000 Pregnancy Risk Assessment SA & NHMRC Guidelines Pregnancy Risk Assessment SA & NHMRC Guidelines Pregnancy Risk Assessment SA & NHMRC Guideline + OCM Screening Pregnancy Risk Assessment SA & NHMRC Guideline + OCM Screening Normal 0.5 mg folate/day 1 st trimester Normal 0.5 mg folate/day 1 st trimester HIGH Risk 5mg folate/day throughout pregnancy HIGH Risk 5mg folate/day throughout pregnancy Normal 0.5 mg folate/day 1 st trimester Normal 0.5 mg folate/day 1 st trimester HIGH Risk Personalised Micronutrient treatment HIGH Risk Personalised Micronutrient treatment Recruitment Sites Qld =1100 SA = 500 Santiago = 400 Recruitment Sites Qld =1100 SA = 500 Santiago = 400 Blood and Urine tests at 26 -28 weeks Incidence of Adverse Pregnancy Outcomes Blood and Urine tests at 36 weeks Incidence of Adverse Pregnancy Outcomes experimental design

19. assigning risk

22. may 2013 nhmrc partnership