Microbiome Understanding in Maternity Study. A comprehensive assessment of its composition and relationship to health and disease throughout pregnancy and infancy.

Not Applicable

Active, not recruiting

• Conditions: Gestational Diabetes; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Pregnancy; Pre-eclampsia; Pre term labour; Reproductive Health and Childbirth - Normal pregnancy

• Registration Number: ACTRN12618000471280
• Lead Sponsor: St George Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-03
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

Less than 12 weeks gestation

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome composition and diversity will be assessed by performing DNA extraction and 16S genomic sequencing.[Time of birth and a year post partum]

Secondary Outcome Measures

Name	Time	Method
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.[Time of birth]