Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000587202
Ethics application status
Approved
Date submitted
13/07/2009
Date registered
15/07/2009
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Date results information initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal Sleep Health and Foetal Outcomes
Scientific title
The relationship between maternal sleep health and foetal growth restriction and cardiotocography (CTG) in pregnant women at risk of sleep-disordered breathing versus healthy pregnant women.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 237238 0
Maternal sleep health 237251 0
Condition category
Condition code
Respiratory 239559 239559 0 0
Sleep apnoea
Reproductive Health and Childbirth 239570 239570 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
Foetal growth will be observed via ultrasound at 32 and 36 weeks gestation, and at birth.
Sleep and foetal heart rate will be monitored with polysomnography and cardiotocography at 38 weeks gestation, for one 8 hour overnight session.
Intervention code [1] 236931 0
Not applicable
Comparator / control treatment
No treatment given
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238356 0
Infant birth weight - A >1/3 fall in birth weight percentile from expected will be considered as slowed late foetal growth.
Timepoint [1] 238356 0
32 weeks gestation, 36 weeks gestation, delivery.
Primary outcome [2] 238358 0
abnormal cardiotocography
Timepoint [2] 238358 0
38 weeks gestation
Secondary outcome [1] 244790 0
blood sample and cord blood for detection of elevated levels of cytokines and markers of oxidative stress.
Timepoint [1] 244790 0
28 weeks gestation, delivery.

Eligibility
Key inclusion criteria
between 20-24 weeks gestation
Risk factors for sleep disordered breathing, including pre-pregnant obesity (Body Mass Index (BMI) greater than 30kg/m2) and snoring (cases); healthy controls with no history of snoring.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiple pregnancy, current pregnancy complicated by pre-eclampsia, previously diagnosed and treated Obstructive Sleep Apnoea (OSA) or other sleep disorder, e.g. narcolepsy, periodic leg movements in sleep (PLMS).

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
15/10/2009
Date of last participant enrolment
Anticipated
Actual
21/07/2011
Date of last data collection
Anticipated
Actual
29/07/2011
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1892 0
3084

Funding & Sponsors
Funding source category [1] 237322 0
Charities/Societies/Foundations
Name [1] 237322 0
Institute for Breathing and Sleep
Country [1] 237322 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
Bowen Centre
Austin Health
Studley Road
Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 236807 0
Hospital
Name [1] 236807 0
Mercy Hospital for Women
Address [1] 236807 0
Studley Road
Heidelberg, VIC, 3084
Country [1] 236807 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239421 0
Austin Health
Ethics committee address [1] 239421 0
Studley Road
Heidelberg, VIC, 3084
Ethics committee country [1] 239421 0
Australia
Date submitted for ethics approval [1] 239421 0
Approval date [1] 239421 0
07/05/2009
Ethics approval number [1] 239421 0
03514
Ethics committee name [2] 239422 0
Mercy Hospital for Women
Ethics committee address [2] 239422 0
Studley Road
Heidelberg, VIC, 3084
Ethics committee country [2] 239422 0
Australia
Date submitted for ethics approval [2] 239422 0
Approval date [2] 239422 0
17/05/2009
Ethics approval number [2] 239422 0
R09/12

Summary
Brief summary
The study will investigate the association between sleep-disordered breathing during pregnancy and foetal growth and well-being. It is hypothesised that Obstructive Sleep Apnoea is detrimental to foetal health (acute foetal compromise as evidenced by abnormal cardiotocography (foetal heart rate monitoring) during sleep and impaired foetal growth in late pregnancy).
Trial website
Trial related presentations / publications
Fung AM, Wilson DL, Lappas M, Howard M, Barnes M, O’Donoghue F, Tong S, Esdale H, Fleming G, Walker SP. Effects of maternal obstructive sleep apnoea on fetal growth: a prospective cohort study. PLoS ONE. 2013; 8(7):e68057.
Public notes

Contacts
Principal investigator
Name 29891 0
Address 29891 0
Country 29891 0
Phone 29891 0
Fax 29891 0
Email 29891 0
Contact person for public queries
Name 13138 0
Danielle Wilson
Address 13138 0
Institute for Breathing and Sleep
Bowen Centre, Austin Health
Studley Road
Heidelberg, VIC, 3084
Country 13138 0
Australia
Phone 13138 0
+61 3 9496 3688
Fax 13138 0
Email 13138 0
[email protected]
Contact person for scientific queries
Name 4066 0
Dr. Maree Barnes
Address 4066 0
Institute for Breathing and Sleep
Bowen Centre, Austin Health
Studley Road
Heidelberg, VIC, 3084
Country 4066 0
Australia
Phone 4066 0
+61 3 9496 3688
Fax 4066 0
Email 4066 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.