Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001462279
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
30/08/2018
Date last updated
30/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep in Pregnancy Pilot Trial
Scientific title
SliPP: A multi centre randomised trial assessing time spent in supine position during sleep in the third trimester of pregnancy with or without a position aid.
Secondary ID [1] 295445 0
None
Universal Trial Number (UTN)
Trial acronym
SliPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal sleep position in the third trimester of pregnancy. 308789 0
Condition category
Condition code
Reproductive Health and Childbirth 307721 307721 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All women attending for their routine antenatal appointment will be approached and informed about the study by a midwife or a member of the research team. Women will be given a brochure already being used as part of an Australian public health campaign about sleep position in pregnancy. The brochure is freely available in paper form and on the internet.
All women participating in the study will be given a NightShift device to wear for 7 consecutive nights between 28-30 weeks and 36-38 weeks. They will be asked to return the device to the research team between the two time points for data collection.
Women in the intervention group will also be given a U shaped pillow slip, which were designed and made in NZ by a midwife. The pillow slip can be purchased online and is marketed for pregnant women to assist more comfortable sleeping in pregnancy.
Intervention code [1] 312155 0
Behaviour
Comparator / control treatment
Women in the control group will be given identical verbal and written advice about the importance of side sleeping.
Control group
Active

Outcomes
Primary outcome [1] 307113 0
All women will have the proportion of the night spent in supine sleep measured objectively using the non-invasive night shift device. It will then be determined whether advice alone or advice and a position aid is more effective in reducing time spent sleeping in supine.
Timepoint [1] 307113 0
7 consecutive nights between at two time points in the third trimester, between 28-30 weeks and again between 36-38 weeks.
Secondary outcome [1] 350727 0
Composite secondary outcome: Sleep data- Sleep duration, sleep quality, snoring via the nightshift monitoring report.
Timepoint [1] 350727 0
7 consecutive nights between at two time points in the third trimester, between 28-30 weeks and again between 36-38 weeks.
Secondary outcome [2] 350728 0
Acceptability: Study specific questionnaires on acceptability, comfort, partner acceptability.
Timepoint [2] 350728 0
7 consecutive nights between at two time points in the third trimester, between 28-30 weeks and again between 36-38 weeks.
Secondary outcome [3] 350729 0
Feasibility: Recruitment rates, loss to follow up, non-adherence (self reported and NightShift data)..
Timepoint [3] 350729 0
After the birth of the baby.
Secondary outcome [4] 350730 0
Anxiety: Validated scaled of depression, anxiety and social support (DASS-21)
Timepoint [4] 350730 0
Measured at 30 and 38 weeks gestation.
Secondary outcome [5] 350731 0
Composite secondary outcome: Clinical outcomes- routinely collected perinatal outcome data including birthweight, gestation, mode of delivery will be collected from hospital medical records for all participants.
Timepoint [5] 350731 0
After the birth of the baby,

Eligibility
Key inclusion criteria
Women with a singleton pregnancy, >28 weeks gestation.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple pregnancy, inability to side sleep (e.g. existing conditions), known major congenital abnormality of the fetus, women <18yrs.

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 generated sequence..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table of variable blocks created by computer software (i.e computerised computer randomisation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Delivery of the intervention is not blinded however outcomes assessment will be blinded to allocation of intervention or control program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based on a median proportion of supine sleep in late pregnancy of 26.5% . We estimate a 50% reduction in proportion of night spent supine in women who use the pillow from 26.5% to 13.3% which would require 138 women per arm. To account for any operational issues with the night shift device (which is measuring primary outcome) or women who deliver before 38 weeks this number will be inflated by 17% to 166 women per arm. This sample size of 332 will provide 80% power to detect a 50% reduction in proportion of the night spent supine from 26.5% to 13.3%.
Primary and secondary outcomes will be analysed using an intention-to-treat approach, which includes all losses-to follow-up, non-compliances or withdrawals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/09/2018
Actual
Date of last participant enrolment
Anticipated
28/08/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
332
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11675 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 23722 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 20780 0
New Zealand
State/province [1] 20780 0
Auckland

Funding & Sponsors
Funding source category [1] 300035 0
Charities/Societies/Foundations
Name [1] 300035 0
Red Nose and Cure Kids
Country [1] 300035 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hosital
Address
Missenden Road, Camperdown
Sydney, NSW, 2050
Country
Australia
Secondary sponsor category [1] 299423 0
Hospital
Name [1] 299423 0
Auckland City Hospital
Address [1] 299423 0
2 Park Rd, Grafton,
Auckland, 1023,
Country [1] 299423 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300885 0
Ethics Review Committee (RPA Zone), Sydney Local Health District
Ethics committee address [1] 300885 0
Research development Office,
Level 3, Building 92,
Royal Prince Alfred, Missenden Rd,
CAMPERDOWN nsw 2050
Ethics committee country [1] 300885 0
Australia
Date submitted for ethics approval [1] 300885 0
Approval date [1] 300885 0
15/08/2018
Ethics approval number [1] 300885 0
X18-0080

Summary
Brief summary
This trial will test whether advice alone compared to advice and a pillow device best supports non-supine sleep using the Night Shift as an objective measure of both sleep duration and position. This design could also be employed in the future for a roll out of sleep position interventions, but crucially the optimum intervention would need to be properly validated, which is what this trial aims to do.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85154 0
Dr Adrienne Gordon
Address 85154 0
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW AUSTRALIA 2050
Country 85154 0
Australia
Phone 85154 0
+61 2 95158248
Fax 85154 0
Email 85154 0
[email protected]
Contact person for public queries
Name 85155 0
Ms Lucy McCudden
Address 85155 0
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW AUSTRALIA 2050
Country 85155 0
Australia
Phone 85155 0
+61 2 95158248
Fax 85155 0
Email 85155 0
[email protected]
Contact person for scientific queries
Name 85156 0
Ms Lucy McCudden
Address 85156 0
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW AUSTRALIA 2050
Country 85156 0
Australia
Phone 85156 0
+61 2 95158248
Fax 85156 0
Email 85156 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.