ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

U1111-1209-2492

Trial acronym

MUMS

Linked study record

Health condition

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

Pregnancy

Pre-eclampsia

Gestational Diabetes

Pre term labour

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Oral and Gastrointestinal

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

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Microbiome composition and diversity will be assessed by performing DNA extraction and 16S genomic sequencing.

Timepoint [1]

Time of birth and a year post partum

Secondary outcome [1]

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]

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?

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]

St George Hospital - Kogarah

Recruitment hospital [2]

The Sutherland Hospital - Caringbah

Recruitment hospital [3]

Royal Hospital for Women - Randwick

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2229 - Caringbah

Recruitment postcode(s) [3]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

St George Sutherland Medical Research Foundation

Address [1]

St George Hospital
Grey Street, Kogarah, NSW 2217

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Human Research Ethics Committee

Ethics committee address [1]

Edmund Blackett Building
Prince of Wales Hospital,
High Street Randwick, NSW, 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2017

Approval date [1]

09/01/2018

Ethics approval number [1]

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

Dr Amanda Henry

Address

Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217

Country

Australia

Phone

+61 2 91132315

Fax

[email protected]

Contact person for public queries

Name

Daniella Susic

Address

Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217

Country

Australia

Phone

+61 2 91132315

Fax

[email protected]

Contact person for scientific queries

Name

Daniella Susic

Address

Department of Women's and Children's Health
Level 2 Prichard Wing
St George Hospital
Grey St, Kogarah, NSW 2217

Country

Australia

Phone

+61 2 91132315

Fax

[email protected]

Data sharing statement

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

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

Source	Title	Year of Publication	DOI
Embase	Microbiome Understanding in Maternity Study (MUMS), an Australian prospective longitudinal cohort study of maternal and infant microbiota: study protocol.	2020	https://dx.doi.org/10.1136/bmjopen-2020-040189

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically