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Trial registered on ANZCTR


Registration number
ACTRN12620000371998p
Ethics application status
Submitted, not yet approved
Date submitted
30/01/2020
Date registered
17/03/2020
Date last updated
17/03/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a new pillow to prevent sleeping on the back during pregnancy
Scientific title
A trial of a position modification device for the prevention of supine sleep during pregnancy
Secondary ID [1] 300392 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep position in pregnancy 316016 0
fetal heart rate decelerations on fetal heart rate monitoring 316017 0
Condition category
Condition code
Reproductive Health and Childbirth 314292 314292 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will be a randomized cross-over repeated measures study of an intervention to prevent supine sleep in pregnancy. A total of 40 participants will be randomized to receive either the intervention (Back-Off Pillow) or no intervention (control) for the first week and will be crossed over to the alternate regimen on the second week. During the intervention week, the participant will be asked to use the pillow at home each night for the whole sleep period. During each week, the participant will wear the Night Shift Sleep Positioner during sleep, which will record their body position overnight. At the end of each week the participant will undergo a night of polysomnography (PSG – “sleep study”) in their own homes, and participants will wear the Monica AN24 during the sleep period which will continuously monitor the fetal heart rate (CTG – cardiotocography).
The Back-Off Pillow is a U-shaped pillow designed to prevent rolling onto the back during sleep. One arm of the pillow is firm and supports the back, whilst the other arm is softer for resting the arms/body. Participants will complete a sleep diary for each night of the study, which will include details of adherence to the pillow.
Intervention code [1] 316677 0
Behaviour
Comparator / control treatment
Women in the control arm will sleep with their usual bedding and pillows.
Control group
Active

Outcomes
Primary outcome [1] 322682 0
1. Percentage of total sleep time spent in the supine position, confirmed on sleep study position sensor and Night Shift position sensor
Timepoint [1] 322682 0
Intervention and Control week - third trimester of pregnancy
Secondary outcome [1] 379280 0
Sleep quality as measured on PSG, including total sleep time, percentage of REM and slow wave sleep, number of cortical arousals. This is a composite outcome.
Timepoint [1] 379280 0
last night of intervention and control week - third trimester of pregnancy
Secondary outcome [2] 379281 0
subjective sleep quality as measured on a study specific questionnaire - sleep duration, rating of sleep quality from 1-10. This is a composite outcome.
Timepoint [2] 379281 0
each night of intervention and control week - third trimester of pregnancy
Secondary outcome [3] 379282 0
sleep-disordered breathing indices as measured on polysomnography, including apnea/hypopnoea index and oxygen desaturation index
Timepoint [3] 379282 0
Last night of intervention and control week - third trimester of pregnancy
Secondary outcome [4] 379283 0
fetal heart rate decelerations as measured on cardiotocography with the Monica AN24 (Monica Healthcare)
Timepoint [4] 379283 0
Last night of intervention and control week - third trimester of pregnancy
Secondary outcome [5] 380583 0
Acceptability of the intervention pillow, as measured with a study specific questionnaire
Timepoint [5] 380583 0
Each night of the intervention week - third trimester of pregnancy.

Eligibility
Key inclusion criteria
Participants enrolled into the study will be low risk women with a singleton pregnancy in the third trimester (>28 weeks gestation) without known fetal abnormalities, who are aged 18 years or older, and capable of giving informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known fetal abnormalities, aged 18 years or less, unable to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Our previous study showed that healthy pregnant women spent a median of 17.7% (IQR 0.7 – 39.7) of their sleep time in the supine position. Similarly, a recent study showed that the percentage of supine sleep time on the sham treatment night was 16.4% compared to 3.5% on the treatment intervention night. Based on this, to identify a reduction of supine sleep time from 16.4% to 3.5% of the night would require a sample size of 26 for a power of 80% at an alpha level of 0.05. Increasing power to 90% would require a sample size of 34, and if we account for potential data loss of 15% of participants similar to that described previously, this study will aim for a sample size of 40 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15716 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 29137 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304814 0
Charities/Societies/Foundations
Name [1] 304814 0
Norman Beischer Medical Research Foundation
Address [1] 304814 0
Level 1, 459 Toorak Road, Toorak, Victoria, 3142
Country [1] 304814 0
Australia
Funding source category [2] 304819 0
Charities/Societies/Foundations
Name [2] 304819 0
Austin Medical Research Foundation
Address [2] 304819 0
Austin Hospital
145 - 163 Studley Road
Heidelberg Vic 3084
Australia
Country [2] 304819 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute for Breathing and Sleep
Address
Level 5 Harold Stokes Building,
Austin Hospital
145 - 163 Studley Road
Heidelberg Vic 3084
Australia
Country
Australia
Secondary sponsor category [1] 305140 0
Hospital
Name [1] 305140 0
Mercy Hospital for Women
Address [1] 305140 0
163 Studley Road
Heidelberg VIC 3084
Country [1] 305140 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305229 0
Mercy Human Research Ethics Committee
Ethics committee address [1] 305229 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 305229 0
Australia
Date submitted for ethics approval [1] 305229 0
03/02/2020
Approval date [1] 305229 0
Ethics approval number [1] 305229 0

Summary
Brief summary
The aim of this study is to test the effectiveness of a new pillow designed to decrease the amount of time pregnant women spend sleeping on their back. This study will involve two conditions for each woman: one week using the new pillow and one week without the pillow, each ending with a night of overnight sleep monitoring. The sleep monitoring will (i) measure body position throughout the night to establish whether the new pillow is preventing back sleeping, and (ii) to determine if the pillow is comfortable and encourages better sleep. Importantly, we will (iii) perform fetal heart rate monitoring during the night to compare whether there are measurable differences in the baby's heart rate between these two settings. This study will help us to determine the impact of sleeping on your back during pregnancy, and whether we can encourage a safer sleeping position.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99686 0
Dr Danielle Wilson
Address 99686 0
Institute for Breathing and Sleep
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 99686 0
Australia
Phone 99686 0
+61 3 9496 3517
Fax 99686 0
Email 99686 0
danielle.wilson@austin.org.au
Contact person for public queries
Name 99687 0
Dr Danielle Wilson
Address 99687 0
Institute for Breathing and Sleep
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 99687 0
Australia
Phone 99687 0
+61 3 9496 3517
Fax 99687 0
Email 99687 0
danielle.wilson@austin.org.au
Contact person for scientific queries
Name 99688 0
Dr Danielle Wilson
Address 99688 0
Institute for Breathing and Sleep
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 99688 0
Australia
Phone 99688 0
+61 3 9496 3517
Fax 99688 0
Email 99688 0
danielle.wilson@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results