Pre and postnatal support for women who have stopped smoking in pregnancy Not Applicable
Conditions
Interventions
Screening:
RAs at each site will engage with service gatekeepers regarding the trial and they will disseminate trial information to relevant staff (e.g. midwives, health visitors, sonographers, stop s
Sponsors
University of East Anglia
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women who have stopped smoking completely in the 12 months prior to pregnancy, or at any time during pregnancy 2. At 26 weeks gestation or any time up until birth, woman confirms having not smoked a single puff of a cigarette for at least 4 weeks. 3. Able to read and understand English 4. Willing and able to give informed consent for participation in the study 5. Smoking abstinence confirmed by expired carbon monoxide (CO) reading less than 4 ppm
Exclusion criteria
Exclusion criteria: 1. Under the age of 16 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported continuous postpartum smoking abstinence, biochemically validated by CO monitoring at 12-months postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postpartum self-reported abstinence measured using self-report questionnaire at 6 months postpartum 2. Self-reported time to relapse measured using time from randomisation to self-reported date first smoked at 6 and 12 months postpartum 3. Self-reported partner smoking status measured using self-report questionnaire at 6 and 12 months postpartum 4. Relapse predictors measured using self-reported past smoking behaviour at 6 and 12 months postpartum 5. Self-efficacy related to long-term smoking abstinence measured using self-reported self-efficacy to remain smoke free at 6 and 12 months postpartum 6. Postpartum depression measured using the Edinburgh postnatal depression scale at 6 and 12 months postpartum 7. Behavioural support use measured using self-report questionnaire at 6 and 12 months postpartum 8. Nicotine product use measured using self-report questionnaire at 6 and 12 months postpartum 9. Perceived stress measured using Cohen perceived stress scale at 6 and 12 months postpartum 10. Alcohol use measured using AUDIT-C at 6 and 12 months postpartum 11. Quality of life measured using EQ-5D-5L at 6 and 12 months postpartum 12. Participant resource use measured using data collection from patient notes and GP records at 12 months postpartum 13. Infant health outcomes measured using data collection from patient notes and GP records at 12 months postpartum | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed