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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. - PowerPoint PPT Presentation
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may 2013partnership project
outpatients clinic
hirf
ccd
research• mother’s and babies• infection and immunity• brain and mental health • cancer
Primary Care
early detection of disease,
intervention,
prevention and
treatment
Preconception and Early Pregnancy Care
early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy
R − CH3
methyl
R − CH2 -
methylene
R − CH=
methenyl
R − CHO
formyl
one carbon metabolism
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
early identification of high-risk pregnancies and personalised nutraceutical intervention to reduce the incidence of adverse pregnancy
one carbon metabolism
lack evidence-based framework for the use of micronutrient supplements during the preconception / early pregnancy for
improving pregnancy outcomes
clinical gap
MIA IVD for assessing OCM status and personalised nutrient supplementation to
reduce the incidence of adverse pregnancy outcomes
outcome (label use)
RCT5% decrease in the incidence of
complications of pregnancy in the intervention vs control arm
outcome measure
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
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)
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
7 clinics qld
1clinic sa
1clinic santiago
Dr Leith Moxon-Lester
RandomisationConsent and Questionnaire
CONTROL ARM1000
INTERVENTION ARM1000
Pregnancy Risk AssessmentSA & NHMRC Guidelines
Pregnancy Risk AssessmentSA & NHMRC Guideline +
OCM Screening
Normal0.5 mg folate/day
1st trimester
HIGH Risk5mg folate/day
throughout pregnancy
Normal0.5 mg folate/day
1st trimester
HIGH RiskPersonalised
Micronutrient treatment
Recruitment SitesQld =1100 SA = 500 Santiago = 400
Blood and Urine tests at 26 -28 weeks Blood and Urine tests at 26 -28 weeks
Incidence of Adverse Pregnancy Outcomes
Blood and Urine tests at 36 weeks Blood and Urine tests at 36 weeks
Incidence of Adverse Pregnancy Outcomes
experimental design
assigning risk
may 2013nhmrc partnership
