Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000670875
Ethics application status
Approved
Date submitted
31/03/2021
Date registered
2/06/2021
Date last updated
13/04/2023
Date data sharing statement initially provided
2/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial using carbon monoxide (CO) monitoring to help women quit smoking in pregnancy
Scientific title
Investigating the Feasibility and Acceptability of Carbon Monoxide (CO) monitoring to Encourage Smoking Cessation in Pregnancy: A Non-randomised Pilot Trial
Secondary ID [1] 303710 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cigarettes in pregnancy 321133 0
Condition category
Condition code
Public Health 318939 318939 0 0
Health promotion/education
Public Health 319138 319138 0 0
Health service research
Reproductive Health and Childbirth 319488 319488 0 0
Antenatal care
Mental Health 319489 319489 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will explore the feasibility and acceptability of using CO monitoring during pregnancy to encourage smoking cessation.

CO monitoring
Women who smoke in pregnancy will be asked to breathe into a calibrated CO monitor (PiCO Baby Smokerlyzer). CO breath analysis involves the person taking a breath and holding it for 15 seconds, then blowing into a disposable mouthpiece attached to the CO monitor to empty their lungs. CO readings are then displayed on the monitor for both the mother and the fetus. The CO level will be explained to the participant with a poster (visual aid) provided by the manufacturer, which shows maternal and fetal CO content of blood. CO readings will be documented and researchers will then qualitatively discuss use of the monitor using a semi-structured interview schedule. The mode of delivery will be 30 mins face-to-face with a midwifery-trained researcher in the hospital setting where antenatal care is provided. The researcher will then discuss with participants and provide information on supports available to women. This will take two forms. The first refers to mental health services available to women at the hospital and in the community. The second refers to smoking cessation strategies and supports available to pregnant women. Both will be provided to all participants. Smoking cessation strategies for use in pregnancy include nicotine replacement therapy (NRT), smartphone applications, 'cold turkey' and counselling supports. Four weeks later researchers will meet with participants at a follow up appointment. This follow up will allow women time to reflect on the CO monitoring previously conducted and to ask whether they had changed their smoking behaviour. At this appointment participants will be asked to use the CO monitor for a second time and answer follow up qualitative questions, again using a semi-structured interview schedule. The mode of delivery will again be 30 minutes of face-to-face contact with a trained researcher in the hospital where antenatal care is provided, a community centre or the participants home. Thus, there are 2 points of intervention.
Intervention code [1] 320018 0
Treatment: Devices
Intervention code [2] 320019 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326866 0
Cessation of smoking in pregnancy as indicated by breathing in to the CO monitor (CO value of 4ppm or less).
Timepoint [1] 326866 0
Four weeks follow up after initial intervention meeting
Secondary outcome [1] 392912 0
Self-reported change in smoking behaviour determined by semi-structured qualitative interview.
Timepoint [1] 392912 0
Four weeks follow up after initial intervention meeting
Secondary outcome [2] 393301 0
Breath CO level measured using calibrated CO monitor.
Timepoint [2] 393301 0
Four weeks follow up after initial intervention meeting
Secondary outcome [3] 393476 0
Women's perspectives about feasibility and acceptability of CO monitoring for smoking cessation in pregnancy determined by semi-structured qualitative interview.
Timepoint [3] 393476 0
At initial intervention meeting and then at 4 week follow up from initial intervention meeting.

Eligibility
Key inclusion criteria
• Women who are currently pregnant (gestation<35 weeks) and smoke tobacco
• Aged 18 years or over
• Communicate in English without difficulty
• Receiving antenatal care from health professionals at the Northern Adelaide Local Health Network (NAHLN)
• Willing and able to give informed consent for participation in the study
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any pregnant woman who does not smoke tobacco or who quit smoking in pregnancy prior to meeting the researcher in the antenatal clinic

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analysis for this study is qualitative in nature. Interactions between participants and researchers will be audio recorded and transcribed. Transcriptions will be analysed using thematic analysis. This will allow the researchers to identify and interpret important themes and differences from this data, and to understand women’s experiences, meanings, and realities around the use of CO monitoring.

Characteristics of the study sample (e.g. age, parity) and the baseline and follow-up CO levels will be described quantitatively using means and standard deviations (for continuous normally distributed variables), medians and interquartile ranges (for non-normally distributed variables), and frequencies and percentages (for categorical data).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2022
Actual
6/06/2022
Date of last participant enrolment
Anticipated
17/05/2024
Actual
26/10/2022
Date of last data collection
Anticipated
14/06/2024
Actual
21/11/2022
Sample size
Target
15
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18934 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 18935 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 33440 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 33441 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 308123 0
Charities/Societies/Foundations
Name [1] 308123 0
Channel 7 Children's Research Foundation
Country [1] 308123 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
School of Public Health
L4 Rundle Mall Plaza
50 Rundle Mall
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 308883 0
None
Name [1] 308883 0
Address [1] 308883 0
Country [1] 308883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308109 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 308109 0
Ethics committee country [1] 308109 0
Australia
Date submitted for ethics approval [1] 308109 0
15/03/2021
Approval date [1] 308109 0
21/04/2021
Ethics approval number [1] 308109 0
2021/HRE00038

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109570 0
A/Prof Lisa Smithers
Address 109570 0
University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 109570 0
Australia
Phone 109570 0
+61 416357250
Fax 109570 0
Email 109570 0
[email protected]
Contact person for public queries
Name 109571 0
Cherise Fletcher
Address 109571 0
University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 109571 0
Australia
Phone 109571 0
+61 402055385
Fax 109571 0
Email 109571 0
[email protected]
Contact person for scientific queries
Name 109572 0
Lisa Smithers
Address 109572 0
University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 109572 0
Australia
Phone 109572 0
+61 8 83130546
Fax 109572 0
Email 109572 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
Ethical approval does not include sharing of IPD.


What supporting documents are/will be available?




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.