Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Secondary ID [1] 281237 0
NIl
Universal Trial Number (UTN)
U1111-1134-7797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gene expression in placentas collected from healthy fetuses 287427 0
Condition category
Condition code
Reproductive Health and Childbirth 287761 287761 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 285702 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287992 0
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.
Timepoint [1] 287992 0
At the time of delivery
Secondary outcome [1] 299215 0
No Secondary outcome
Timepoint [1] 299215 0
NA

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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe complication of pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5773 0
5112
Recruitment postcode(s) [2] 5774 0
5006

Funding & Sponsors
Funding source category [1] 286015 0
Government body
Name [1] 286015 0
Australian Research Council
Country [1] 286015 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
South Australia
Country
Australia
Secondary sponsor category [1] 284832 0
None
Name [1] 284832 0
Address [1] 284832 0
Country [1] 284832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288064 0
SA Health HREC (TQEH/LMH/MH)
Ethics committee address [1] 288064 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 288064 0
Australia
Date submitted for ethics approval [1] 288064 0
26/04/2012
Approval date [1] 288064 0
24/07/2012
Ethics approval number [1] 288064 0
HREC/12/TQEHLMH/16

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34714 0
Address 34714 0
Country 34714 0
Phone 34714 0
Fax 34714 0
Email 34714 0
Contact person for public queries
Name 17961 0
Professor Claire Roberts
Address 17961 0
School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
Country 17961 0
Australia
Phone 17961 0
+61 8 8313 3118
Fax 17961 0
Email 17961 0
[email protected]
Contact person for scientific queries
Name 8889 0
Professor Claire Roberts
Address 8889 0
School of Paediatrics & Reproductive Health
Level 3
Medical School South Building
Frome Road
The University of Adelaide
SA 5005
AUSTRALIA
Country 8889 0
Australia
Phone 8889 0
+61 8 8313 3118
Fax 8889 0
Email 8889 0
[email protected]

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.