The MothersBabies Study, an Australian Prospective Cohort Study Analyzing the Microbiome in the Preconception and Perinatal Period to Determine Risk of Adverse Pregnancy, Postpartum, and Child-Related Health Outcomes: Study Protocol

Author:

Strout Naomi1ORCID,Pasic Lana1ORCID,Hicks Chloe1ORCID,Chua Xin-Yi1ORCID,Tashvighi Niki1,Butler Phoebe1,Liu Zhixin23,El-Assaad Fatima1ORCID,Holmes Elaine4ORCID,Susic Daniella156ORCID,Samaras Katherine789ORCID,Craig Maria E.6ORCID,Davis Gregory K.56ORCID,Henry Amanda56ORCID,Ledger William L.6ORCID,El-Omar Emad M.1ORCID

Affiliation:

1. UNSW Microbiome Research Centre, St George and Sutherland Clinical Campuses, UNSW Sydney, Sydney, NSW 2052, Australia

2. UNSW Stats Central, Biological Sciences South Building (E26), Level 2 Kensington, UNSW Sydney, Sydney, NSW 2052, Australia

3. Healthdirect Australia, Level 4, 477 Pitt Street, Sydney, NSW 2000, Australia

4. The Australian National Phenome Centre, Harry Perkins Institute, Murdoch University, Perth, WA 6150, Australia

5. Department of Women’s and Children’s Health, St George Hospital, Kogarah, NSW 2217, Australia

6. Discipline of Women’s Health, School of Clinical Medicine, UNSW Sydney, Sydney, NSW 2052, Australia

7. Complex Diseases Program, Garvan Institute of Medical Research, Darlinghurst, NSW 2010, Australia

8. Department of Endocrinology, St Vincent’s Hospital, Darlinghurst, NSW 2010, Australia

9. St Vincent’s Clinical Campus, UNSW Sydney, Sydney, NSW 2052, Australia

Abstract

The microbiome has emerged as a key determinant of human health and reproduction, with recent evidence suggesting a dysbiotic microbiome is implicated in adverse perinatal health outcomes. The existing research has been limited by the sample collection and timing, cohort design, sample design, and lack of data on the preconception microbiome. This prospective, longitudinal cohort study will recruit 2000 Australian women, in order to fully explore the role of the microbiome in the development of adverse perinatal outcomes. Participants are enrolled for a maximum of 7 years, from 1 year preconception, through to 5 years postpartum. Assessment occurs every three months until pregnancy occurs, then during Trimester 1 (5 + 0–12 + 6 weeks gestation), Trimester 2 (20 + 0–24 + 6 weeks gestation), Trimester 3 (32 + 0–36 + 6 weeks gestation), and postpartum at 1 week, 2 months, 6 months, and then annually from 1 to 5 years. At each assessment, maternal participants self-collect oral, skin, vaginal, urine, and stool samples. Oral, skin, urine, and stool samples will be collected from children. Blood samples will be obtained from maternal participants who can access a study collection center. The measurements taken will include anthropometric, blood pressure, heart rate, and serum hormonal and metabolic parameters. Validated self-report questionnaires will be administered to assess diet, physical activity, mental health, and child developmental milestones. Medications, medical, surgical, obstetric history, the impact of COVID-19, living environments, and pregnancy and child health outcomes will be recorded. Multiomic bioinformatic and statistical analyses will assess the association between participants who developed high-risk and low-risk pregnancies, adverse postnatal conditions, and/or childhood disease, and their microbiome for the different sample types.

Funder

Australian Government Medical Research Future Fund Accelerated Research Scheme

St George and Sutherland Medical Research Foundation

Publisher

MDPI AG

Subject

Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health

Reference66 articles.

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