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may 2013

partnership project. may 2013. research. mother ’ s and babies infection and immunity brain and mental health cancer. c cd. h i rf. outpatients clinic. Primary Care. early detection of disease, intervention, prevention and treatment.

kamran
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may 2013

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  1. partnership project may 2013

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

  3. 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 onecarbon metabolism R − CH3 methyl R − CH2- methylene R − CH= methenyl R − CHO formyl

  7. early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy onecarbon 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 onecarbon metabolism

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

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

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

  12. hypotheses • 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.

  13. aims 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. (i.e. preterm birth, fetal growth restriction, low birth weight, congenital abnormalities, preeclampsia, miscarriage and stillbirth)

  14. experimental design • iso17025 (R&D) • iso13485 (medical devices) • NATA accredited • 21 CFR part 11 compliance • sample tracking FreezerPro • data and document handling IrisNote • trained personnel

  15. 1clinic santiago 1clinic sa 7 clinics qld

  16. Dr Leith Moxon-Lester

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

  18. assigning risk

  19. nhmrc partnership may 2013

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