May 2013 partnership project. outpatients clinic hirf ccd research mother’s and babies infection and immunity brain and mental health cancer.

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