Incentives to Quit tobacco in Pregnancy

• Register: ANZCTR
• Last refreshed on: 9 August 2022
• Main ID: ACTRN12618000576224
• Date of registration: 16/04/2018
• Prospective Registration: Yes
• Primary sponsor: Hunter New England Health Drug and Alcohol Clinical Services
• Public title: Incentives to Quit tobacco in Pregnancy
• Scientific title: Targeted antenatal smoking cessation intervention in high-risk substance dependent pregnancy: a feasibility study
• Date of first enrolment: 08/08/2018
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000576224.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Adrian Dunlop

• Name: Prof Adrian Dunlop

Key inclusion & exclusion criteria

Inclusion criteria: Participants will be:
1) Pregnant women attending substance use in pregnancy services up to and including 32 weeks gestation
2) Aged >=16 years of age and willing and able to provide written informed consent
3) Current verified daily tobacco smokers interested in reducing smoking during pregnancy with a positive breath carbon monoxide (CO) level greater than 3 p.p.m.
4) Willing and able to comply with requirements of the study

Exclusion criteria: Clients will be unable to participate if they will not be available for follow-up


Age minimum: 16 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Mental Health - Addiction

Nicotine dependence;
Nicotine dependence

Reproductive Health and Childbirth - Antenatal care

Intervention(s)

This study will assess the impact of the addition of a smoking treatment to the routine antenatal care offered to pregnant women who smoke tobacco and attend high risk antenatal clinics targeting substance use in pregnancy, at two NSW principle referral hospitals.
The treatment will offer a combination of evidence-based methods to cease smoking during pregnancy, consisting of:
1. Financial incentives (in the form of retail e-vouchers) to be earnt for every instance of biochemically verified abstinence. The first negative sample will earn $3:00 and increase by $0.10 for each negative sample thereafter. Participants will be required to self-monitor breath carbon monoxide (CO) levels according to a set monitoring schedule, starting at twice per day and gradually reducing to every other day. Video evidence of the test and result will be required for verification purposes.
2. Tobacco-related psychosocial counselling delivered by qualified drug and alcohol counsellors. Four x 30 minute antenatal sessions and two postpartum sessions will be offered. Timing of sessions is flexible and will depend on length of time on study, Additional sessions will be available if required.
3. Nicotine replacement therapy, both short- and long-acting, delivered as required as per RACGP guidelines for pregnant women
All three components of the intervention will be available for consenting women aged 16 years and over from study enrolment (any time prior to 33 weeks gestation) until birth. Following delivery, women will be offered counselling and nicotine replacement therapy until 12-weeks postpartum.
The intervention will be offered to all clients and delivered by staff of a NSW health-based drug and alcohol clinical research team. Participation in weekly research da

Primary Outcome(s)

Acceptability of the intervention will be assessed using qualitative and quantitative measures.
• In-depth interviews with participants and SUPPS clinic staff will address (a) perceived effectiveness of each component (b) attitudes towards addressing tobacco smoking and (c) barriers and facilitators to implementation of the intervention as routine antenatal care
• Treatment Acceptability Questionnaire
[At study completion
]

Intervention feasibility as assessed by:
• Recruitment rate (no. of women recruited divided by no. of women screened)
• Retention rates to birth
• Completion rates at 12-weeks postpartum
• No. of counselling sessions completed
• No. of women taking nicotine replacement therapy (NRT)
• Adherence to NRT (proportion of dispensed NRT that is consumed)
• Partners/household members receiving NRT
[At study completion]

Secondary Outcome(s)

Rates of miscarriage as assessed by medical chart review[At delivery]

Rates of Stillbirth as assessed by medical chart review[At delivery]

Rates of sudden infant death syndrome as assessed by medical chart review[At 12-weeks postpartum]

Economic evaluation - a cost-consequence analysis (CCA) will be used to provide an evaluation of the intervention, incorporating all costs incurred with the implementation and delivery of the intervention, incorporating all costs incurred with the implementation and delivery of the intervention and evaluating them against reductions in the health costs of smoking. Outcomes will be: abstinence at delivery and reductions in CO at delivery
[At study completion

]

Neonatal malformations as assessed by medical chart review[At delivery]

Rates of breastfeeding as assessed by medical chart review[At 12-weeks postpartum]

Neonatal birth weight as assessed by medical chart review[At delivery]

Rates of intra-uterine growth restriction as assessed by medical chart review[At delivery]

Rates of placental abruption as assessed by medical chart review[At delivery]

Change in tobacco smoking outcomes measured by self-reported 7-day point prevalence verified by CO

[At birth or 38 ± 2 weeks gestational age
]

Change in tobacco smoking outcomes measured by self-reported reduction in number of cigarettes smoked/day in past 7-days[At birth or 38 ± 2 weeks gestational age

]

Neonatal gestational age as assessed by medical chart review[At delivery]

Neonatal head circumference as assessed by medical chart review[At delivery]

Rates of premature rupture of the membranes as assessed by medical chart review[At delivery]

Rates of placenta praevia as assessed by medical chart review[At delivery]

Rates of preterm birth as assessed by medical chart review[At delivery]

Secondary ID(s)

None

Source(s) of Monetary Support

NSW Health Translational Research Grant Scheme

Ethics review

Status: Approved
Approval date: 29/08/2017
Contact:

Hunter New England Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 11/07/2022
• Date Completed: 12/03/2021