ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Smoking cigarettes in pregnancy

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Health service research

Reproductive Health and Childbirth

Antenatal care

Mental Health

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]

Treatment: Devices

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Cessation of smoking in pregnancy as indicated by breathing in to the CO monitor (CO value of 4ppm or less).

Timepoint [1]

Four weeks follow up after initial intervention meeting

Secondary outcome [1]

Self-reported change in smoking behaviour determined by semi-structured qualitative interview.

Timepoint [1]

Four weeks follow up after initial intervention meeting

Secondary outcome [2]

Breath CO level measured using calibrated CO monitor.

Timepoint [2]

Four weeks follow up after initial intervention meeting

Secondary outcome [3]

Women's perspectives about feasibility and acceptability of CO monitoring for smoking cessation in pregnancy determined by semi-structured qualitative interview.

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [2]

Modbury Hospital - Modbury

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Recruitment postcode(s) [2]

5092 - Modbury

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Channel 7 Children's Research Foundation

Address [1]

c/- Novita Children’s Services
341 Port Road
Hindmarsh SA 5007

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)

Ethics committee address [1]

Level 3, Roma Mitchell House
136 North Terrace
Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2021

Approval date [1]

21/04/2021

Ethics approval number [1]

2021/HRE00038

Summary

Brief summary

Smoking throughout pregnancy causes irreversible harm to both the mother and fetus. Although smoking rates have declined considerably, rates of smoking during pregnancy remain steady among socioeconomically disadvantaged populations. The Northern Area Local Health Network (NALHN) serves a substantially disadvantaged population with approximately 1 in 4 women smoking during pregnancy. Standard practice at NALHN is to refer women to the Quitline, yet it is widely acknowledged by women and health professionals that women rarely engage with the service (Fletcher et al. 2021, unpublished).  Studies exploring the use of carbon monoxide (CO) monitoring in antenatal care to encourage smoking cessation have shown promising results. This project will explore the feasibility and acceptability of using CO monitoring in antenatal care at the NALHN antenatal services.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lisa Smithers

Address

University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005

Country

Australia

Phone

+61 416357250

Fax

lisa.smithers@adelaide.edu.au

Contact person for public queries

Name

Cherise Fletcher

Address

University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005

Country

Australia

Phone

+61 402055385

Fax

cherise.fletcher@adelaide.edu.au

Contact person for scientific queries

Name

Lisa Smithers

Address

University of Adelaide, School of Public Health, L4 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005

Country

Australia

Phone

+61 8 83130546

Fax

lisa.smithers@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Ethical approval does not include sharing of IPD.

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
11028	Study protocol	cherise.fletcher@adelaide.edu.au		381628-(Uploaded-31-03-2021-15-21-41)-Study-related document.pdf
11029	Informed consent form	cherise.fletcher@adelaide.edu.au		381628-(Uploaded-31-03-2021-15-22-27)-Study-related document.pdf
11031	Other		Smoking Cessation & Support Resource	381628-(Uploaded-16-03-2021-15-21-02)-Study-related document.pdf
11163	Ethical approval	cherise.fletcher@adelaide.edu.au		381628-(Uploaded-04-05-2021-12-46-13)-Study-related document.pdf

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.

Trial Review

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