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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
30/05/2019
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] 298196 0
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 312778 0
Pregnancy related hypertension 312780 0
Pre-eclampsia 312781 0
Gestational diabetes mellitus 312782 0
Obesity 312783 0
Pre-term labour 312784 0
Antenatal Depression 312795 0
Antenatal Anxiety 312796 0
Postnatal Depression 312797 0
Postnatal anxiety 312798 0
Postnatal psychosis 312799 0
Condition category
Condition code
Reproductive Health and Childbirth 311279 311279 0 0
Normal pregnancy
Reproductive Health and Childbirth 311280 311280 0 0
Fetal medicine and complications of pregnancy
Mental Health 311296 311296 0 0
Other mental health disorders
Diet and Nutrition 311297 311297 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
1. Multi-site microbiome sampling and analysis, including stool, oral, vaginal swab, and skin swab from mother. Stool and oral swab from partner, vaginal swab also if partner is female. Stool, 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. Vital signs, height, weight, body composition.
7. Pregnancy complications (if any), type of birth.
8. Infant Developmental Questionnaire.

Data will be collected at:
- 12 month baseline preconception period
- Trimester 1, 2 & 3
- 1 week, 6 weeks, 4months, 6months, 12months postpartum
All visits will last 30-60 minutes.
Expected time commitment for each participant is 22-33months, depending on date of conception and birth.
Intervention code [1] 314429 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320023 0
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] 320023 0
Data to be collected at following timepoints includes:

- Preconception:
Microbiome samples including blood, 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, oral swab, skin swab, stool sample & vaginal swab; Australian Eating Survey, International Physical Activity Questionnaire, Edinburgh Depression Scale and review maternal antenatal record information.

- Postpartum: 1 week, 6 weeks, 4months, 6months, 12months
Microbiome samples including oral swab, skin swab, stool sample & vaginal swab, Australian Eating Survey, International Physical Activity Questionnaire, Edinburgh Depression Scale and data linkage to postpartum obstetric record.

Primary outcome [2] 320068 0
To establish what constitutes normal microbiota from pre-pregnancy, pregnancy to postpartum in the gut, mouth and vagina in New South Wales women.
Timepoint [2] 320068 0
Microbiome samples collected at:
- Preconception (blood, oral swab, skin swab, stool sample & vaginal swab)
- Trimesters 1, 2, & 3 (blood, oral swab, skin swab, stool sample & vaginal swab)
- Postpartum: 1 week, 6 weeks, 4months, 6months, 12months (oral swab, skin swab, stool sample & vaginal swab)
Primary outcome [3] 320069 0
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] 320069 0
The initial neonatal microbiome samples (oral swab, skin swab, stool 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 neonatal microbiome samples (oral swab, skin swab, stool sample), Ages & Stages Questionnaire® 3rd Edition and data linkage to medical records, hospital records and My Personal Health Record will be collected at the following post-partum time points:
- 6 weeks
- 4 months
- 6 months
- 12 months

These outcomes will be compared with maternal data collected as described in Primary Outcome 1 & 2.
Secondary outcome [1] 370274 0
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] 370274 0
The initial neonatal microbiome samples (oral swab, skin swab, stool sample) will be collected 1 week post birth of the child.

Subsequent neonatal microbiome samples (oral swab, skin swab, stool sample), Ages & Stages Questionnaire® 3rd Edition and data linkage to medical records, hospital records and My Personal Health Record will be collected at the following post-partum time points:
- 6 weeks
- 4 months
- 6 months
- 12 months

These outcomes will be compared with maternal data collected as described in Primary Outcome 1 & 2.

Eligibility
Key inclusion criteria
• Female
• Aged 18 years or older
• Be actively trying to fall pregnant
• Intending to receive antenatal care within NSW
• 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
Gender
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13725 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 26468 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 302738 0
Government body
Name [1] 302738 0
Australian Government, Department of Health Medical Research Future Fund - Accelerated Research Project
Address [1] 302738 0
Australian Government, Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 302738 0
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] 302672 0
None
Name [1] 302672 0
Address [1] 302672 0
Country [1] 302672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303340 0
South Eastern Sydney Local health District
Ethics committee address [1] 303340 0
Research Support Office
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031
Ethics committee country [1] 303340 0
Australia
Date submitted for ethics approval [1] 303340 0
15/02/2019
Approval date [1] 303340 0
08/05/2019
Ethics approval number [1] 303340 0
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93334 0
Prof Emad El-Omar
Address 93334 0
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 93334 0
Australia
Phone 93334 0
+61 2 9113 2036
Fax 93334 0
Email 93334 0
e.el-omar@unsw.edu.au
Contact person for public queries
Name 93335 0
Mrs Naomi Strout
Address 93335 0
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 93335 0
Australia
Phone 93335 0
+61 2 9113 1832
Fax 93335 0
Email 93335 0
n.strout@unsw.edu.au
Contact person for scientific queries
Name 93336 0
Mrs Naomi Strout
Address 93336 0
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 93336 0
Australia
Phone 93336 0
+61 2 9113 1832
Fax 93336 0
Email 93336 0
n.strout@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 other documents available
Summary results
No Results