ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12619000800123

Ethics application status

Approved

Date submitted

9/05/2019

Date registered

30/05/2019

Date last updated

3/04/2024

Date data sharing statement initially provided

30/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The MothersBabies Study - Examining the microbiome's role in preconception, pregnancy, and infancy.

Scientific title

The MothersBabies Study - Examining the microbiome's role in preconception, pregnancy, and infancy.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1233-2414

Trial acronym

Linked study record

ACTRN12618000471280 - Pilot Study, Microbiome Understanding in Maternity Study (MUMS)

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Pregnancy related hypertension

Pre-eclampsia

Gestational diabetes mellitus

Obesity

Pre-term labour

Antenatal Depression

Antenatal Anxiety

Postnatal Depression

Postnatal anxiety

Postnatal psychosis

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Mental Health

Other mental health disorders

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Map microbiome signatures for the various complications of pregnancy using 16s RNA and whole genome shotgun sequencing.

Complications being examined include:
• Hypertension in pregnancy
• Pre-eclampsia
• Gestational diabetes mellitus
• Obesity
• Pre-term labour
• Perinatal mood disorders (antenatal and postnatal depression, anxiety, psychosis)

Data on complications will collected by data linkage to medical records and hospital records, and through validated questionnaires such as the Edinburgh Depression Scale
Australian Eating Survey, and International Physical Activity Questionnaire.

Timepoint [1]

Data to be collected at following timepoints includes:

- Preconception: Microbiome samples including blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab, Australian Eating Survey, International Physical Activity Questionnaire & past obstetric records (if applicable).

- Trimesters 1, 2, & 3: Microbiome samples including blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab; Australian Eating Survey, International Physical Activity Questionnaire, Edinburgh Depression Scale, vital signs, body composition, COVID-19 exposure/infection/vaccination, and review maternal antenatal record information.

- Postpartum: 2months, 6months, 12months, 2 years portpartum
Microbiome samples including blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab,
Australian Eating Survey, International Physical Activity Questionnaire, Edinburgh Depression Scale, vital signs, body composition, COVID-19 exposure/infection/vaccination and data linkage to postpartum obstetric record.

Primary outcome [2]

To establish what constitutes normal microbiota from pre-pregnancy, pregnancy to postpartum in the gut, mouth and vagina in Australian women.

Timepoint [2]

Microbiome samples collected at:
- Preconception (blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab)
- Trimesters 1, 2, & 3 (blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab)
- Postpartum: 2months, 6months, 12months, 2 years (blood sample, urine sample, oral swab, skin swab, stool sample & vaginal swab)

Primary outcome [3]

Collect biospecimens from the babies to correlate with their future development and health, by establishing what constitutes normal gut and skin microbiota in the first 12 months of life in the infants of the participant women studied.

Timepoint [3]

The initial neonatal microbiome samples (oral swab, skin swab, stool sample, urine sample) will be collected 1 week post birth of the child. Data linkage to birth records and My Personal Health Record will also be collected.

Subsequent paediatric microbiome samples (oral swab, skin swab, stool sample, urine sample), Ages & Stages Questionnaire® 3rd Edition, Movement Behaviour Questionnaire – Child (MBQ-C), EPOCH Toddler Dietary Questionnaire (EPOCH-TDQ), COVID-19 infection/exposure/vaccination, length, weight, head circumference, sleep quality and data linkage to medical records, hospital records and My Personal Health Record will be collected at the following post-partum time points:
- 2 months
- 6 months
- 1/2/3/4/5 years of age
These outcomes will be compared with maternal data collected as described in Primary Outcome 1 & 2.

Secondary outcome [1]

Primary Outcome 4:
To examine how neonatal/infant microbiota in the first 12 months of life relates to mode of birth, maternal microbiota throughout the preconception, pregnancy and postpartum period, choice of milk (breastfeeding, formula), and the infant’s health in the first 12 months of life.

Data on complications will be collected by data linkage to medical records, hospital records, My Personal Health Record and validated questionnaire Ages and Stages Questionnaire® 3rd Edition.

Timepoint [1]

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Random sample

Timing

Prospective

Statistical methods / analysis

Microbiota operational taxonomic units (OTUs) will be classified and described for each sampling site and timepoint, as will community richness (a diversity) and evolutionary distance between microbiota (ß diversity). Major comparisons will then include:
• Independent two sample t test will be used to compare the outcome measurement (a diversity, ß diversity) between disease and control groups, Mann-Whitney U test will be used if the normality assumption cannot hold.
• Logistic regression model would also be used to examine the association between the maternal microbiome and the binary health outcome of mother or baby (having health condition or not).

Statistical analysis will be conducted at 2-sided significance level of 0.05.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/07/2019

Actual

3/12/2019

Date of last participant enrolment

Anticipated

31/12/2023

Actual

1/03/2024

Date of last data collection

Anticipated

8/05/2029

Actual

Sample size

Target

2000

Accrual to date

Final

591

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment hospital [2]

Royal Hospital for Women - Randwick

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government, Department of Health Medical Research Future Fund - Accelerated Research Project

Address [1]

Australian Government, Department of Health
GPO Box 9848
Canberra ACT 2601
Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

Microbiome Research Centre
St George and Sutherland Clinical School, UNSW Sydney
Level 2, Clinical Sciences Building (WR Pitney), Short Street, St George Hospital, KOGARAH NSW 2217

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local health District

Ethics committee address [1]

Research Support Office
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/02/2019

Approval date [1]

08/05/2019

Ethics approval number [1]

2019/ETH00192

Summary

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.

Trial website

www.unsw.to/mothersbabies

Trial related presentations / publications

Public notes

MothersBabies is ensuring continual education, dissemination, and translation of outcomes through the presentation of preliminary cohort data and the study protocol at many local and state-based conferences, as well as social and mainstream media including:
o NSW Ministry of Health First 2000 Days Summit in November 2022 https://www.nsw.gov.au/family-and-relationships/brighter-beginnings/brighter-beginnings-summit-video
o Celebration 100 Years of CWA
o Microbiome in Pregnancy and Birth, Canterbury Maternity Meet, Eat & Learn
o Q&A on Gut Bacteria, probiotics and the microbiome, University of Newcastle - Masters of Nurse Practitioner Program
o Australian Breastfeeding Association Volunteers Online Conference ‘Learn, Care, Share’ 2021
o ShireLive Festival 2020
o ACM 2020 NSW State Conference
o SGH Maternity & Breastfeeding Conference 2019

Media coverage includes:
• InSPHERE: The Microbiome in Pregnancy https://issuu.com/in-sphere/docs/february_2023 
• Podcast: Wellness Women Radio (in-press, to be published this quarter)
• Podcast: Qiara & PureMedic (in-press, to be published this quarter)
• Channel 7: https://fb.watch/jsRnHQmzGk/ 
• NSW Health Office of Health & Medical Research https://www.medicalresearch.nsw.gov.au/how-expectant-mums-microbiome-influences-pregnancy-and-baby-health/ 
• The Leader: https://www.theleader.com.au/story/6784993/study-examines-how-a-mothers-health-affects-baby/ 
• Just don’t douche – what your vaginal biome can tell you about your health and pregnancy, The Conversation
• Balancing Act, Women’s Health Magazine (pages 30 – 32), December 2021 Edition
• PlayGroups NSW: https://www.playgroupnsw.org.au/ParentResources/EarlyChildhoodDevelopment/Womenhavethepotentialtochangethehealthoftheworlditsallinyou

Contacts

Principal investigator

Name

Prof Emad El-Omar

Address

UNSW Microbiome Research Centre
School of Clinical Medicine, UNSW Medicine & Health
St George & Sutherland Clinical Campuses
Level 2, Clinical Sciences Building (WR Pitney)
Short Street, St George Hospital
KOGARAH NSW 2217

Country

Australia

Phone

+61 2 9113 2036

Fax

e.el-omar@unsw.edu.au

Contact person for public queries

Name

Naomi Strout

Address

Country

Australia

Phone

+61 2 9113 1832

Fax

mothersbabies@unsw.edu.au

Contact person for scientific queries

Name

Naomi Strout

Address

Country

Australia

Phone

+61 2 9113 1832

Fax

mothersbabies@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Deidentified individual participant data that underlie any reported results, when they arise.

When will data be available (start and end dates)?

IPD will be available at completion of study, once results have been released and published. No end date is set currently.

Available to whom?

Researchers, upon request.

Available for what types of analyses?

Can be discussed at time of request.

How or where can data be obtained?

Requests for data will need to be made to the Executive Officer, Mrs Naomi Strout.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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