Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001523897
Ethics application status
Approved
Date submitted
25/08/2021
Date registered
9/11/2021
Date last updated
9/11/2021
Date data sharing statement initially provided
9/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnoea (OSA) and Outcomes in Pregnancy
Scientific title
Feasibility and acceptability of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnoea and Maternal and Fetal Outcomes in Pregnancy (COOP): A Pilot trial
Secondary ID [1] 305103 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1268-8856
Trial acronym
COOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 323323 0
Obesity during Pregnancy 323324 0
Condition category
Condition code
Reproductive Health and Childbirth 320885 320885 0 0
Antenatal care
Respiratory 320886 320886 0 0
Sleep apnoea
Diet and Nutrition 321177 321177 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will be recruited and if eligible will undertake a sleep study. Women less than 24 weeks gestation will be eligible for recruitment.
Women with an Apnea Hypopnea Index (AHI) greater than or equal to 15 will then be randomised to the intervention or standard care arm. Women with an AHI less than 15 will follow a standard care pathway (as per Queensland Health guidelines). If the participant is in the intervention arm, the following will be additional requirements:
• If the sleep study indicates moderate to severe sleep apnoea (AHI greater than or equal to 15), the participant will be asked to use a CPAP device for the remainder of the pregnancy. This includes comprehensive fitting and advice regarding the use of the device. This session will be undertaken by a CPAP technician and will take approximately 2 hours, a week prior to the commencement of CPAP. Recommendations for duration of CPAP will be from the time of mask fitting for the duration of the pregnancy, for at least 4 hours per night for at least 5 nights per week.
• Data will be collected regarding duration of use in pregnancy (depending on gestational age at commencement of treatment and birth), and also from the device itself regarding adherence overnight.
Intervention code [1] 321495 0
Treatment: Devices
Comparator / control treatment
Women with an AHI less than 15 AND women with AHI greater than or equal to 15 who are randomised to standard care will follow a standard care pathway (as per Queensland Health guidelines). Standard care pathway involved routine antenatal review with a midwife, GP or obstetrician, and associated care. These appointments routinely fall at 28, 31, 34, 36 and 38 weeks, and sometimes at 40 and 41 weeks also, but may be variable if required for other pregnancy related conditions, which may be pre-existing, or arise during the course of the pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 328683 0
Recruitment rate assessed by audit of study database.
Timepoint [1] 328683 0
Recruitability of the trial will be assessed at 2 years post-enrolment commencement, or after 80 patients are recruited, whichever occurs first.
Secondary outcome [1] 399950 0
Acceptability of the CPAP intervention will be assessed using a composite outcome. This will include using a tick box questionnaire for side effects experienced from CPAP which is a study specific questionairre, as well as validated surveys SF-36 and PROMIS Scales. These are validated surveys using a combination of 3-10 point Likert scales.
Timepoint [1] 399950 0
Completed at 36 weeks
Secondary outcome [2] 399951 0
Compliance - Compliance data collected from the machines will be analysed to assess treatment compliance (adherence to protocol). Treatment time of >5hours per night is considered compliant.
Timepoint [2] 399951 0
Compliance data will be monitored continuously from intervention commencement to completion of pregnancy.
Secondary outcome [3] 399952 0
Number of pregnancy related hospital admissions - this will be assessed using hospital records
Timepoint [3] 399952 0
After delivery
Secondary outcome [4] 399953 0
Placental Histopathology findings - this is an exploratory outcome.
Timepoint [4] 399953 0
Placental histopathology will be collected at the time of delivery.
Secondary outcome [5] 400971 0
post-partum length of stay - this will be assessed using hospital records
Timepoint [5] 400971 0
Following discharge after delivery
Secondary outcome [6] 400972 0
hypertension - this will routinely be assessed using sphygmomanometer, and recorded in the hospital records which will be reviewed
Timepoint [6] 400972 0
following discharge after delivery
Secondary outcome [7] 400973 0
gestational or pre-existing diabetes - this will be assessed using blood sample, and recorded in the hospital records which will be reviewed
Timepoint [7] 400973 0
following delivery
Secondary outcome [8] 400974 0
gestational weight gain - this will be assessed using digital scales, and recorded in the hospital records which will be reviewed.
Timepoint [8] 400974 0
following delivery
Secondary outcome [9] 400975 0
onset of labour - this will be assessed in the hospital records
Timepoint [9] 400975 0
following delivery
Secondary outcome [10] 400976 0
mode of birth - this will be assessed in the hospital records
Timepoint [10] 400976 0
following delivery
Secondary outcome [11] 400977 0
estimated blood loss - this will be assessed in the hospital records
Timepoint [11] 400977 0
following delivery
Secondary outcome [12] 400978 0
blood transfusion - this will be assessed in the hospital records
Timepoint [12] 400978 0
following discharge after delivery
Secondary outcome [13] 400979 0
ICU admission - this will be assessed in the hospital records
Timepoint [13] 400979 0
following discharge after delivery
Secondary outcome [14] 400980 0
maternal death
Timepoint [14] 400980 0
following delviery
Secondary outcome [15] 400981 0
gestation at birth - this will be assessed in the hospital records
Timepoint [15] 400981 0
after delivery
Secondary outcome [16] 400982 0
birth weight - this will be assessed in the hospital records
Timepoint [16] 400982 0
after delivery
Secondary outcome [17] 400983 0
admission of neonate to special care nursery - this will be assessed in the hospital records
Timepoint [17] 400983 0
following discharge after delivery
Secondary outcome [18] 400984 0
neonatal length of stay - this will be assessed in the hospital records
Timepoint [18] 400984 0
following discharge after delivery
Secondary outcome [19] 400985 0
neonatal respiratory support - this will be assessed in the hospital records
Timepoint [19] 400985 0
following discharge after delivery
Secondary outcome [20] 400986 0
neonatal death - this will be assessed in the hospital records
Timepoint [20] 400986 0
assessed 28 days after delivery

Eligibility
Key inclusion criteria
Eligibility:
- Women with a Body Mass Index (BIM) equal to or greater than 35
- > 18 years of age
- Singleton gestation
- <24 weeks at booking visit/recruitment
- low risk first trimester screen and a normal morphology ultrasound (if done prior to recruitment)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- known sleep disordered breathing with mechanical therapy
- patient declines randomisation
- multiple gestation
- fetal anomalies or high risk first trimester screen
- women with coronary artery disease or congestive heart failure or cardiomyopathy
- inability to read or understand the consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All women recruited will undergo a sleep study. Women with an AHI<15 will be assigned tp standard antenatal care. Women with an AHI >/= 15 will be randomised to standard care, or use of CPAP for the remainder of their pregnancy.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
If 80 women can be recruited over 24 months, this represents a recruitment rate of 20%. Inability to recruit to this level would make a larger scale RCT project unfeasible given that many interventional studies will recruit at approximately 30 – 50%.

Data will be analysed using an intention to treat analysis. Relevance and proportions of variables surveyed will be reported. Group comparisons comparing equivalency of control and interventions will be conducted with chi-squared test for categorical measures and analysis of variance or Kruskal-Wallis test for continuous measures as appropriate assessing for normality and equality of variances.

Questionnaire results will be entered into a purpose-built Microsoft Excel database for data cleaning and preparation for statistical analysis. Statistician support will be accessed to assist with data analysis.

Clinical outcome data will be used to determine prevalence estimates. The pilot will help to define the prevalence of sleep apnoea in the eligible population at SCHHS and the prevalence of the primary composite outcome of placental disease. The prevalence of the composite outcome will be used to inform the sample size for the larger study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/09/2020
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
80
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20305 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 20306 0
Gympie Hospital - Gympie
Recruitment postcode(s) [1] 35047 0
4575 - Birtinya
Recruitment postcode(s) [2] 35048 0
4570 - Gympie

Funding & Sponsors
Funding source category [1] 309497 0
Hospital
Name [1] 309497 0
The Sunshine Coast Hospital and Health Service
Country [1] 309497 0
Australia
Primary sponsor type
Hospital
Name
The Sunshine Coast University Hospital and Health Service
Address
6 Doherty St
Birtinya, QLD, 4575
Country
Australia
Secondary sponsor category [1] 310472 0
University
Name [1] 310472 0
James Cook Universtiy
Address [1] 310472 0
College of Medicine and Dentistry
1 James Cook Drive
Douglas, Townsville
Queensland 4811
Country [1] 310472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309283 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 309283 0
The Prince Charles Hospital
Building 14
Rode Rd
Chermside, QLD, 4012
Ethics committee country [1] 309283 0
Australia
Date submitted for ethics approval [1] 309283 0
08/02/2019
Approval date [1] 309283 0
10/06/2019
Ethics approval number [1] 309283 0
HREC/2019/QPCH/50233

Summary
Brief summary
Our study's primary aim is to inform the feasibility and recruitability of a larger scale RCT to investigate maternal and foetal outcomes after diagnosis and treatment of moderate-severe OSA in pregnancy. We aim to test women with body mass index greater than or equal to 35 for sleep apnoea, and determine if treating moderate to severe disease will in pregnancy will impact maternal or neonatal outcomes. Additionally we will investigate if the intervention is acceptable to women, and if it has any impact on their quality of life, or any impact on placental histology after the birth of their baby. Additionally we will assess the predictive utility of questionnaires, BMI, neck circumference in OSA in pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113618 0
Dr Rebekah Shakhovskoy
Address 113618 0
c/- The Sunshine Coast University Hospital
6 Doherty St
Birtinya QLD 4575
Country 113618 0
Australia
Phone 113618 0
+617 52022933
Fax 113618 0
Email 113618 0
[email protected]
Contact person for public queries
Name 113619 0
Dr Rachael Nugent
Address 113619 0
c/- The Sunshine Coast University Hospital
6 Doherty St
Birtinya QLD 4575
Country 113619 0
Australia
Phone 113619 0
+617 52022933
Fax 113619 0
Email 113619 0
[email protected]
Contact person for scientific queries
Name 113620 0
Dr Rachael Nugent
Address 113620 0
c/- The Sunshine Coast University Hospital
6 Doherty St
Birtinya QLD 4575
Country 113620 0
Australia
Phone 113620 0
+617 52022933
Fax 113620 0
Email 113620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The PICF does not include any discussion of IPD, therefore we cannot share data from this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12951Ethical approval    382640-(Uploaded-17-09-2021-10-33-58)-Study-related document.pdf
12991Study protocol    382640-(Uploaded-25-08-2021-11-30-37)-Study-related document.docx



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.