None listed
Conditions
Brief summary
The human microbiome, the population of microbes occupying various body sites, is already known to have a major impact on human health with the changes in the gut microbiota during pregnancy known to be particularly fascinating. However, there is limited research on the microbiome and its relationship to maternal and newborn health and disease. Therefore, the aim of this study is to recruit a large perinatal and newborn cohort, of approximately 2000 participants, in order to comprehensively investigate the microbiome during this critical period of a mother and child’s life. Women will be recruited prior to conceiving a child, to fully examine the microbiota, and observe the changes from pre-conception, conception, and pregnancy through to birth and into the first year of thechild's life. There is a projected time commitment for participants of 22-33months, depending on time of conception.
Interventions
1. Multi-site microbiome sampling and analysis, including stool sample, urine sample, blood sample, oral, vaginal swab, and skin swab from mother. Stool sample and oral swab from male partner, stool sample, oral and vaginal swab from female partner. Stool sample, urine sample, oral and skin swab from newborn.
2. Previous pregnancy information (if applicable).
3. Type of conception (spontaneous vs assisted).
4. Medications.
5. Dietary, physical activity and mood assessment.
6. COVID-19 infections
1. Multi-site microbiome sampling and analysis, including stool sample, urine sample, blood sample, oral, vaginal swab, and skin swab from mother. Stool sample and oral swab from male partner, stool sample, oral and vaginal swab from female partner. Stool sample, urine sample, oral and skin swab from newborn. 2. Previous pregnancy information (if applicable). 3. Type of conception (spontaneous vs assisted). 4. Medications. 5. Dietary, physical activity and mood assessment. 6. COVID-19 infections, COVID-19 vaccinations, impact of lockdowns 7. Vital signs, height, weight, body composition. 8. Pregnancy complications (if any), type of birth. 9. Infant Developmental Questionnaire (ASQ) 10. EPOCH Toddler Dietary Questionnaire 11. Movement Behaviour Questionnaire 12. Sleep Health & Quality on both mother and child (once born) Data will be collected at: - 12 month baseline preconception period - Trimester 1, 2 & 3 - 1 week, 2months, 6months, 12months, 2 years postpartum (paired data on both mother and child) - 3rd, 4th and 5th birthday on child only All visits will last 30-60 minutes. Expected time commitment for each participant is 6-7 years, depending on date of conception and birth. Participants can participate face-to-face, or via Telehealth if they are not located close to a trial centre. Telehealth participants will be supplied with all resources to ship samples back to study sites.
Sponsors
University of New South Wales
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Female • Aged 18 years or older • Intending to fall pregnant within 12 months of enrollment • Intending to receive antenatal care within Australia • Be available for the duration of the study. • Agree to adhere to all protocol requirements. • Provide written informed consent for themselves and their newborn prior to undergoing any study related procedures.
Exclusion criteria
• Already pregnant at time of consent • Under the age of 18 years at time of consent • People highly dependent on medical care by virtue of major pre-existing mental and/or physical disabilities. • Women requiring interpreter services for either her usual care or to understand the study information will not be recruited.
Outcome results
None listed