Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000471280
Ethics application status
Approved
Date submitted
17/03/2018
Date registered
3/04/2018
Date last updated
2/03/2020
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Microbiome Understanding in Maternity Study. A comprehensive assessment of its composition and relationship to health and disease throughout pregnancy and infancy.
Scientific title
Microbiome Understanding in Maternity Study - MUMS. A comprehensive assessment of its composition and relationship to health and disease throughout pregnancy and infancy.
Secondary ID [1] 293978 0
None
Universal Trial Number (UTN)
U1111-1209-2492
Trial acronym
MUMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy
 306549 0
Pre-eclampsia
 306550 0
Gestational Diabetes 307222 0
Pre term labour 307223 0
Condition category
Condition code
Reproductive Health and Childbirth 305647 305647 0 0
Normal pregnancy
Oral and Gastrointestinal 306279 306279 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
1. Collection of Saliva, vaginal swab and stool sample from mother and baby. These samples will be processed, stored and analysed to determine the microbiome composition and diversity. An online dietary intake survey will also be completed every 6 months.
2. Assessments will be performed three times (in each trimester) during pregnancy, at birth, 6 weeks, 6 months and 12 months post partum
3. Total duration will be the length of pregnancy and for 12 months post-partum
Intervention code [1] 300679 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305232 0
Microbiome composition and diversity will be assessed by performing DNA extraction and 16S genomic sequencing.
Timepoint [1] 305232 0
Time of birth and a year post partum
Secondary outcome [1] 344545 0
As a composite secondary outcome we will document the development of maternal pregnancy related conditions will be assessed by following the clinical course of the woman's antenatal care. Taking blood pressure measurements, documenting the clinical course and development of conditions such as gestational hypertension, pre-eclampsia, gestation diabetes and pre term birth as diagnosed by the woman's primary care team.
Timepoint [1] 344545 0
Time of birth

Eligibility
Key inclusion criteria
- Less than 12 weeks gestation
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Under the age of 18 years.
- People highly dependent on medical care by virtue of major preexisting mental and/or
physical disabilities
- Woman requiring interpreter services for either her usual care or to understand the study
information will not be recruited
- Planning to have a home birth.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/05/2018
Actual
20/04/2018
Date of last participant enrolment
Anticipated
30/03/2019
Actual
20/12/2018
Date of last data collection
Anticipated
22/07/2020
Actual
Sample size
Target
100
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10409 0
St George Hospital - Kogarah
Recruitment hospital [2] 10410 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 10411 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 22095 0
2217 - Kogarah
Recruitment postcode(s) [2] 22096 0
2229 - Caringbah
Recruitment postcode(s) [3] 22097 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 298611 0
Charities/Societies/Foundations
Name [1] 298611 0
St George Sutherland Medical Research Foundation
Country [1] 298611 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Microbiome Research Centre,
Research and Education Centre, St George Hospital
4-10 South Street, Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 297769 0
None
Name [1] 297769 0
Address [1] 297769 0
Country [1] 297769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299570 0
South Eastern Sydney Human Research Ethics Committee
Ethics committee address [1] 299570 0
Edmund Blackett Building
Prince of Wales Hospital,
High Street Randwick, NSW, 2031
Ethics committee country [1] 299570 0
Australia
Date submitted for ethics approval [1] 299570 0
30/10/2017
Approval date [1] 299570 0
09/01/2018
Ethics approval number [1] 299570 0
17/293

Summary
Brief summary
The human microbiome is known to have a major impact on human health. Pregnancy is a unique state where enormous hormonal, metabolic, immune and cardiovascular changes occur. We will assess the changes occurring in the microbiome in association to dietary changes at stages throughout this critical period of a mother and child’s life in response to these changes. Samples of the microbiome during pregnancy (faecal, oral, and vaginal) and after birth (placental, breastmilk, meconium) will be assessed to determine a link between pregnancy outcome and disease. We will study each participant during her pregnancy and for 1 year post partum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80874 0
Dr Amanda Henry
Address 80874 0
Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217
Country 80874 0
Australia
Phone 80874 0
+61 2 91132315
Fax 80874 0
Email 80874 0
[email protected]
Contact person for public queries
Name 80875 0
Dr Daniella Susic
Address 80875 0
Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217
Country 80875 0
Australia
Phone 80875 0
+61 2 91132315
Fax 80875 0
Email 80875 0
[email protected]
Contact person for scientific queries
Name 80876 0
Dr Daniella Susic
Address 80876 0
Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217
Country 80876 0
Australia
Phone 80876 0
+61 2 91132315
Fax 80876 0
Email 80876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no individual participant data will be shared as this is not within the scope of the study


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
SourceTitleYear of PublicationDOI
EmbaseMicrobiome Understanding in Maternity Study (MUMS), an Australian prospective longitudinal cohort study of maternal and infant microbiota: study protocol.2020https://dx.doi.org/10.1136/bmjopen-2020-040189
N.B. These documents automatically identified may not have been verified by the study sponsor.