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Trial registered on ANZCTR
Registration number
ACTRN12623000442606
Ethics application status
Approved
Date submitted
12/04/2023
Date registered
1/05/2023
Date last updated
1/05/2023
Date data sharing statement initially provided
1/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Measurement of Sleep Position in Pregnancy
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Scientific title
High resolution measurement of sleep position during pregnancy and the impact on infant birthweight.
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Secondary ID [1]
309285
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Nil
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Universal Trial Number (UTN)
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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:
pregnancy
329447
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sleep position
329448
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infant birthweight
329449
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Condition category
Condition code
Reproductive Health and Childbirth
326385
326385
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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
False
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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
Sleeping position during pregnancy will be objectively measured by the GENEActiv raw data accelerometer overnight for 7 consecutive nights in the participants home, between 32-36 weeks of gestation.
The GENEActiv will be worn around the top of the abdomen attached to a stretchy material belt. It will be worn by the participant from when they first get into bed at night until when they wake and start their day in the morning.
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Intervention code [1]
325721
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Early Detection / Screening
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Comparator / control treatment
observational study - no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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percentage of total sleep time in the supine position defined by traditional position sensors (-45 degrees through to 45 degrees) – as measured with the GENEActiv raw data accelerometer.
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Assessment method [1]
334243
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Timepoint [1]
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Average of 7 consecutive nights at 32-36 weeks gestation.
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Primary outcome [2]
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percentage of total sleep time in the fully supine position as measured by the GENEActiv raw data accelerator, defined as (-15 to 15 degrees with fully supine defined as 0 degrees).
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Assessment method [2]
334244
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Timepoint [2]
334244
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average of 7 consecutive nights at 32-36 weeks of gestation
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Secondary outcome [1]
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infant birthweight z scores corrected for infant sex and gestational age, obtained by review of medical records
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Assessment method [1]
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Timepoint [1]
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at birth
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Secondary outcome [2]
419962
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difference in percentage of supine sleep between those who do and do not use pregnancy pillows – pillow use data collected via sleep diary.
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Assessment method [2]
419962
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Timepoint [2]
419962
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average of 7 consecutive nights at 32-36 weeks gestation
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Secondary outcome [3]
419963
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Percentage of concordance between comparison of objective versus self-reported sleep onset position – based on the GENEActiv versus the sleep diary.
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Assessment method [3]
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Timepoint [3]
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Each of the 7 consecutive nights at 32-36 weeks gestation
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Secondary outcome [4]
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percentage of total sleep time in a "mild lateral tilt" as measured by the GENEActiv raw data accelerator, defined as (-30 to -15 or 15 to 30 degrees with fully supine defined as 0 degrees).
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Assessment method [4]
421261
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Timepoint [4]
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average of 7 consecutive nights at 32-36 weeks of gestation
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Secondary outcome [5]
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percentage of total sleep time in a "moderate lateral tilt" as measured by the GENEActiv raw data accelerator, defined as (-45 to -30 or 30 to 45 degrees with fully supine defined as 0 degrees).
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Assessment method [5]
421262
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Timepoint [5]
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average of 7 consecutive nights at 32-36 weeks of gestation
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Secondary outcome [6]
421263
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Percentage of concordance between comparison of objective versus self-reported "did you sleep on your back last night" – based on the GENEActiv versus the sleep diary.
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Assessment method [6]
421263
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Timepoint [6]
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Each of the 7 consecutive nights at 32-36 weeks gestation
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Eligibility
Key inclusion criteria
Persons with a singleton pregnancy in the third trimester (28 weeks of gestation onward), capable of giving informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
known fetal abnormalities or pregnancy complications including pre-eclampsia, gestational diabetes mellitus, fetal growth restriction, smokers, multiple pregnancy (twins, triplets), under 18 years of age, unable to give informed consent.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Statistical Power
As the primary aim of this study is to gather exploratory pilot data to quantify sleeping position more accurately and reliably, a power calculation cannot be performed for this analysis. Due to the paucity of data in this area it is difficult to calculate the required sample size for the second exploratory aim of this study. However, a previous study by the CIA Dr. Wilson (ACTRN12620000371998p) showed that women who spent more than a quarter of the night sleeping supinely had a significantly lower infant birthweight (2770 ± 1000g) than women who spent less than a quarter of the night in supine sleep (3279 ± 837g, p = .0003). Based on this, to identify a reduction in birthweight from 3279g to 2770g between nonsupine vs. supine sleepers would require a sample size of 85 for a power of 80% at an alpha level of 0.05.
Statistical methods
Aim 1 – In order to characterise sleep position during pregnancy, the percentage of time spent in the supine position each night will be calculated by different definitions of supine sleep and compared –
- Traditional position sensor definition of supine sleep; i) 0 (fully supine) to 45 degrees lateral in both directions.
- Degree of “roll” as an interval variable; ii) 0 (fully supine) to 15 degrees, iii) 15 – 30 degrees and iii) 30 - 45 degrees.
- Degree of “roll” as a continuous variable, from which circular histograms and cumulative frequency-based statistics can be produced.
- Data will be analysed to determine the variability in sleep position across the week, as to whether pregnant women can be classified as primarily supine sleepers, primary lateral sleepers, or a mixture of both.
Secondary analysis will be performed to determine –
o whether women using commercially available pregnancy pillows behind the back reduces the amount of supine sleep overnight (supine position data will likely be skewed – Mann-Whitney test).
o the accuracy of self-reported back sleeping compared to position measured with the GENEActiv.
Aim 2 – to determine whether supine sleep during pregnancy is related to infant birthweight, multivariate regression analysis adjusting for BMI and late pregnancy complications will be conducted using generalised linear models to examine if percentage of total sleep time in the supine position is related to infant birthweight. This analysis will also allow determination of whether fully supine sleep (0 – 15 degree tilt) is a stronger predictor of infant birthweight than supine sleep as a categorical variable (0 – 45 degree tilt).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/05/2023
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Actual
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Date of last participant enrolment
Anticipated
15/05/2024
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Actual
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Date of last data collection
Anticipated
15/06/2024
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Actual
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Sample size
Target
85
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
24499
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Redcliffe Hospital - Redcliffe
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Recruitment postcode(s) [1]
40088
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4020 - Redcliffe
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Metro North Collaborative Research Grant
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Address [1]
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Metro North Research
Level 7, Block 7, Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Road
Herston QLD 4029
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Country [1]
313480
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Australia
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Primary sponsor type
Hospital
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Name
Metro North
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Address
Metro North Research
Level 7, Block 7, Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Road
Herston QLD 4029
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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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NA
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Address [1]
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NA
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Country [1]
315253
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Other collaborator category [1]
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University
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Name [1]
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The University of Queensland
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Address [1]
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St Lucia QLD 4067
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Country [1]
282624
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312671
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Metro North HREC
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Ethics committee address [1]
312671
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Metro North Office of Research
Level 7, Block 7,
Royal Brisbane and Women's Hospital
Cnr Butterfield St and Bowen Bridge Road
Herston QLD 4029
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Ethics committee country [1]
312671
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Australia
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Date submitted for ethics approval [1]
312671
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15/09/2022
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Approval date [1]
312671
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30/11/2022
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Ethics approval number [1]
312671
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HREC/2022/MNHA/88879
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Summary
Brief summary
Following on from the meta-analysis findings that pregnant women who subjectively report going to sleep on their back are at higher risk of stillbirth, the purpose of this project is to objectively characterise overnight sleep position during pregnancy by using more precise measurement techniques over a longer period of time. This assessment of supine sleep during pregnancy will also help to collect data on the relationship between sleeping on the back during pregnancy and lower fetal birthweight as a risk factor for stillbirth, to inform future study designs and power calculations.
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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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Dr Danielle Wilson
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Address
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Sleep Disorders Centre
Level 1 Main Building
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
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Country
125506
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Australia
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Phone
125506
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+61402075862
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Fax
125506
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Email
125506
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[email protected]
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Contact person for public queries
Name
125507
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Dr Danielle Wilson
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Address
125507
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Sleep Disorders Centre
Level 1 Main Building
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
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Country
125507
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Australia
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Phone
125507
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+61402075862
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Fax
125507
0
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Email
125507
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[email protected]
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Contact person for scientific queries
Name
125508
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Dr Danielle Wilson
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Address
125508
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Sleep Disorders Centre
Level 1 Main Building
The Prince Charles Hospital
Rode Rd Chermside QLD 4032
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Country
125508
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Australia
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Phone
125508
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+61402075862
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Fax
125508
0
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Email
125508
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
individual de-identified participant data underlying published results only
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When will data be available (start and end dates)?
After publication - anticipated in early 2025 no end date
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
via data sharing online repository such as Figshare.
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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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