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Trial registered on ANZCTR
Registration number
ACTRN12612000999831
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
18/09/2012
Date last updated
18/09/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Does sexual inequality start in utero with sex differences in the placental transcriptome
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Scientific title
Transcriptome-wide gene expression analysis of placentas collected at birth from male and female fetuses to evaluate the sex specific differences in human placental development.
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Secondary ID [1]
281237
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NIl
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Universal Trial Number (UTN)
U1111-1134-7797
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gene expression in placentas collected from healthy fetuses
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Condition category
Condition code
Reproductive Health and Childbirth
287761
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0
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Normal pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
We will be extracting RNA from placenta samples to observe gene expression using RNA-seq and microarray platforms. This is a single time-point "snapshot" observation to generate a gene expression profile.
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Intervention code [1]
285702
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Identification and expression level of all genes in male and female placentas. We will sequence RNA molecules using the Illumina Hi-Seq and Microarray platforms to generate the data and test the differences between the sexes using established and custom designed bioinformatics pipleines.
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Assessment method [1]
287992
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Timepoint [1]
287992
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At the time of delivery
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Secondary outcome [1]
299215
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No Secondary outcome
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Assessment method [1]
299215
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Timepoint [1]
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NA
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Eligibility
Key inclusion criteria
Caucasian women pregnant with a singleton or twins who will deliver by elective cesarean. Non-smokers BMI 20-40
Fathers of the pregnancy (where possible) will asked to supply a saliva sample for genome-wide SNP genotyping.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Severe complication of pregnancy
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
5773
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5112
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Recruitment postcode(s) [2]
5774
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5006
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Funding & Sponsors
Funding source category [1]
286015
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Government body
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Name [1]
286015
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Australian Research Council
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Address [1]
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GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
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Country [1]
286015
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
South Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
284832
0
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Country [1]
284832
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288064
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SA Health HREC (TQEH/LMH/MH)
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Ethics committee address [1]
288064
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Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
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Ethics committee country [1]
288064
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Australia
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Date submitted for ethics approval [1]
288064
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26/04/2012
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Approval date [1]
288064
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24/07/2012
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Ethics approval number [1]
288064
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HREC/12/TQEHLMH/16
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Summary
Brief summary
We will collect placenta samples from male and female fetuses delivered by cesarean section. RNA will be extracted from these samples and will be used for whole transcriptome gene expression profiling. This will provide insight into the sex-specific differences in human placental development.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
34714
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Contact person for public queries
Name
17961
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Professor Claire Roberts
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Address
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School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
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Country
17961
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Australia
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Phone
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+61 8 8313 3118
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Claire Roberts
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Address
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School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
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Country
8889
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Australia
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Phone
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+61 8 8313 3118
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Fax
8889
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Email
8889
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[email protected]
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No information has been provided regarding IPD availability
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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