Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001179820
Ethics application status
Approved
Date submitted
6/11/2012
Date registered
6/11/2012
Date last updated
6/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The complete placental transcriptome in health and disease in pregnant Caucasian women
Scientific title
An observational study examining gene expression in term placentas collected from women whose pregnancies were complicated by preeclampsia or intrauterine growth restriction compared to those from healthy pregnancies.
Secondary ID [1] 281497 0
NIL
Universal Trial Number (UTN)
U1111-1136-7231
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gene expression in placentas collected from fetuses from pregnancies complicated by preeclampsia or intrauterine growth restriction compared to those from healthy pregnancies. 287750 0
Condition category
Condition code
Reproductive Health and Childbirth 288091 288091 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will extract RNA from placenta samples to quantify gene expression using deep sequencing by RNA-seq and microarray platforms. This is a single time-point "snapshot" observation to generate the complete placental transcriptome in health and disease. A saliva sample from both mothers and fathers will also be collected in the antenatal clinic for genome-wide SNP genotyping to determine parent of origin allele expression in placentas
Intervention code [1] 286012 0
Not applicable
Comparator / control treatment
Placentas from normal healthy pregnancies
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288316 0
Identification and expression level of all coding and non-coding RNA in placentas from normal pregnancies and those complicated by preeclampsia (PE) and intrauterine growth restriction (IUGR). We will sequence RNA using the Illumina Hi-Seq platform to generate the data and test the differences between normal and complicated pregnancies using established and custom designed bioinformatics pipelines.
Timepoint [1] 288316 0
At the time of delivery.
Secondary outcome [1] 299836 0
No secondary outcome.
Timepoint [1] 299836 0
NA

Eligibility
Key inclusion criteria
Caucasian women pregnant with singleton, non-smokers, BMI 20-35. Both pregnant mothers and fathers of the pregnancy (where possible) will be 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
non caucasian ethnicity, smokers, BMI over 35 or under 20, non english speaking

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
29/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286278 0
Government body
Name [1] 286278 0
Australian Research Council
Country [1] 286278 0
Australia
Primary sponsor type
University
Name
The 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] 285071 0
None
Name [1] 285071 0
Address [1] 285071 0
Country [1] 285071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288339 0
SA Health (TQEH/LMH/MH)
Ethics committee address [1] 288339 0
Basil Hetzel Institute
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 288339 0
Australia
Date submitted for ethics approval [1] 288339 0
Approval date [1] 288339 0
Ethics approval number [1] 288339 0
Ethics committee name [2] 288348 0
Women's and Children's Health Network Human Research Ethics Committee EC00197
Ethics committee address [2] 288348 0
Women's & Children's Health Network Human Research Ethics Committee Research Secretariat 2nd Floor, Samuel Way Bldg 2 72 King William Road NORTH ADELAIDE SA 5006
Ethics committee country [2] 288348 0
Australia
Date submitted for ethics approval [2] 288348 0
31/10/2012
Approval date [2] 288348 0
Ethics approval number [2] 288348 0
AU/1/51CF012

Summary
Brief summary
We will collect placenta samples from both normal pregnancies and those complicated by preeclampsia (PE) or intrauterine growth restriction (IUGR). RNA will be extracted from these samples and will be used for whole transcriptome gene expression profiling including both coding and non-coding RNA. This will provide insight into differences between normal and PE and IUGR pregnancies in which the placenta is key to maternal and neonatal outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34909 0
Address 34909 0
Country 34909 0
Phone 34909 0
Fax 34909 0
Email 34909 0
Contact person for public queries
Name 18156 0
Claire Roberts
Address 18156 0
School of Paediatrics and Reproductive Health
The University of Adelaide
Level 3
Medical School South
Frome Road
SA 5005
Australia
Country 18156 0
Australia
Phone 18156 0
61 08 8313 3118
Fax 18156 0
61 08 8313 4099
Email 18156 0
[email protected]
Contact person for scientific queries
Name 9084 0
Claire Roberts
Address 9084 0
School of Paediatrics and Reproductive Health
The University of Adelaide
Level 3
Medical School South
Frome Road
SA 5005
Australia
Country 9084 0
Australia
Phone 9084 0
61883133118
Fax 9084 0
61883134099
Email 9084 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
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Documents added automatically
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