Prevention of smoking relapse in women following the birth of a child Not Applicable
Conditions
Interventions
The three groups are:
1. No incentives – postpartum care will proceed as usual.
2. Incentives will be offered up to three months postpartum. There will be three incentive payments of a £20 voucher. E
Sponsors
University of Stirling
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/11/2020: 1. Confirms having not smoked a single puff of a cigarette for at least four weeks 2. Is between 34 weeks gestation and two weeks postpartum 3. Expired carbon monoxide (CO) reading 4. Aged at least 16 years 5. Intends remaining abstinent from smoking after the birth 6. Able to speak and read English 7. If participant needs to use a single-person, self-administered carbon monoxide (iCO) monitor, she needs to have a device (e.g., phone) that is compatible with the monitor app 8. Willing and able to give written informed consent for participation in the study _____ Previous inclusion criteria as of 15/10/2020: 1. At a time between 34 weeks gestation and 2 weeks postpartum, reports having not smoked a single puff of a cigarette since their last quit attempt in pregnancy 2. Reports having not smoked a single puff of a cigarette for at least four weeks 3. If the woman needs to use a Bedfont single-person, self-administered iCO monitor (e.g., during COVID-19 restrictions on face-to-face contact), has a device (e.g. phone) that is compatible with using the iCO monitor app 4. Expired carbon monoxide (CO) reading < 4 parts per million (ppm) 5. Aged at least 16 years 6. Intends remaining abstinent from smoking after the birth 7. Able to speak and read English 8. Willing and able to give informed consent for participation in the study _____ Previous inclusion criteria: 1. At 36 weeks gestation reports having not smoked a single puff of a cigarette since beginning a quit attempt during pregnancy 2. Expired carbon monoxide (CO) reading < 4 parts per million (ppm) 3. Aged at least 16 years 4. Intends remaining abstinent from smoking after the birth 5. Able to speak and read English 6. Willing and able to give informed consent for participation in the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/11/2020: 1. Reports having smoked even a single puff of a cigarette within the last four weeks 2. Is less than 34 weeks gestation or more than two weeks postpartum 3. Expired CO reading >3ppm 4. Does not intend to remain abstinent from smoking after giving birth 5. Insufficient understanding of spoken and written English 6. Needs to use single-person, self-administered iCO monitor and does not have a device (e.g., phone) that is compatible with using the iCO monitor app 7. Unwilling and or unable to give written informed consent for participation in the study _____ Previous exclusion criteria as of 15/10/2020: 1. At a time between 34 weeks gestation and 2 weeks postpartum woman reports having smoked even a single puff of a cigarette since her last quit attempt in pregnancy 2. Reports smoking even a single puff of a cigarette in the last four weeks 3. Does not have a device (e.g. phone) that is compatible with using the iCO monitor app 4. Expired CO reading > 3 ppm 5. Does not intend to remain abstinent from smoking after giving birth 6. 3 ppm 3. Does not intend to remain abstinent from smoking after giving birth 4. <16 years old 5. Insufficient understanding of spoken and written English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/10/2020: Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the woman’s last quit date in pregnancy will be confirmed by an expired CO reading of <8 ppm, and also by saliva cotinine (only among those reporting not currently using e-cigarettes or NRT) at 12 months postpartum. _____ Previous primary outcome measure: Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed by an expired CO reading of <8 ppm, and also by saliva cotinine (only among those reporting not currently using e-cigarettes or NRT) at 12 months postpartum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 27/02/2024: Self-report of smoking status at 3 months post-partum. Report of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed at this time by an expired CO reading of <8 ppm. Where a CO reading is not available, (e.g., due to COVID-19 restrictions), self-report alone will be assessed. Self-reported and CO-validated smoking abstinence two plus years postpartum. _____ Previous secondary outcome measure as of 15/10/2020 to 27/02/2024: Self-report of smoking status at 3 months post-partum. Report of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed at this time by an expired CO reading of <8 ppm. Where a CO reading is not available, (e.g., due to COVID-19 restrictions), self-report alone will be assessed. _____ Previous secondary outcome measure: Self-report of smoking status at 3 months post-partum. Report of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed at this time by an expired CO reading of <8 ppm. | — |
Countries
England, United Kingdom
Outcome results
None listed