Smoking in pregnancy Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 21/11/2023:
The study design is randomised control trial (RCT) recruiting from antenatal settings and via online recruitment. There will be two trial arms. The control arm
2. Reported and validated 7-day smoking abstinence at 36 weeks gestation
3. Reported = 50% reduction in daily cigarettes at 36 weeks gestation
4. Exhaled CO concentration at delivery
5. Whether or not
Sponsors
University of Nottingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/03/2022: Women of any age who: 1. Are <25 weeks’ gestation and have been referred for or have received or attended an intment as part of standard antenatal care 2. Smoke = 5 daily cigarettes 3. Willing to set a quit date and accept referral to SSS 4. Willing to use NRT patch to try to stop smoking 5. Able to understand written and spoken English 6. Able to give consent _____ Previous inclusion criteria: Women of any age who: 1. Are =25 weeks’ gestation with dating ultrasound-confirmed pregnancies 2. Smoke =5 daily cigarettes 3. Willing to set a quit date and accept referral to SSS 4. Are willing to use an NRT patch to try to stop smoking 5. Able to give consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/11/2023: 1. Already in a cessation study 2. Contraindications to NRT including: known severe reaction/hypersensitivity to NRT, recent cardiovascular/cerebrovascular event or changes and taking theophylline/clozapine 3. Currently uses e-cigarette every day or more frequently Previous exclusion criteria: 1. Already in a cessation study 2. Currently uses e-cigarettes daily or more frequently 3. Contraindications to NRT including: severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or transient ischaemic attack (TIA), chronic, generalized skin disorders or sensitivity to nicotine patches, chemical dependence/alcohol addiction or major fetal anomalies 4. Not able to read or understand text written in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically validated, prolonged abstinence from smoking self-reported between 6 weeks after randomisation and 36 weeks gestation or childbirth, whichever is earlier. Biochemical validation: cotinine/anabasine levels in saliva sample and/or CO levels tested using CO monitor. Timepoint: 36 weeks gestation or at childbirth, whichever is the soonest. Added 06/10/2025: Smoking lapses are permitted during this period, provided no more than 5 cigarettes in total are smoked and a 7-day period of total abstinence is reported immediately before primary outcome follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/11/2023: Smoking-related: 1. Reported and validated 7-day smoking abstinence at 36 weeks gestation (measured by self-reported follow-up questionnaire, saliva sample analysed for cotinine and/or anabasine, exhaled breath sample for carbon monoxide levels) 2. Self-reported =50% reduction in daily cigarettes at 36 weeks gestation 3. Exhaled CO concentration at delivery (measured by exhaled breath sample for carbon monoxide levels) 4. Whether or not brief smoking lapse experienced, reported at 6 weeks post randomisation (self report) Pregnancy and safety-related (collected from medical records at birth or up to 10 weeks postpartum): 1. Miscarriage (patient notes) 2. Stillbirth (patient notes) 3. Low birth weight for gestational age (patient notes) 4. Unadjusted birthweight and birthweight z score (patient notes) 5. Premature birth (patient notes) 6. Gestation at birth (patient notes) 7. Congenital abnormality (patient notes) 8. Mode of delivery (patient notes) 9. Admission to special care (patient notes) 10. Neonatal death (patient notes) Exploratory outcomes: 1. Cigarettes per day when using NRT for ‘preloading’ or to cut down smoking (self report) 2. Exhaled CO when using NRT for ‘preloading’ or to cut down smoking (measured by exhaled breath sample for carbon monoxide levels) at around day 7 3. Saliva cotinine concentration when using NRT for ‘preloading’ or to cut down smoking (saliva sample analysed for cotinine and/or anabasine) at around day 7 4. Use of stop smoking support (self report) measured using self-report – follow up 1 questionnaire at 6 weeks after randomisation Previous secondary outcome measures: Smoking-related: 1. Reported 7-day smoking abstinence at 6 weeks after randomisation 2. Reported and validated 7-day smoking abstinence at 36 weeks gestation (cotinine/anabasine levels in saliva sample and/or CO levels tested using CO monitor) 3. Reported and validated =50% reduction in daily cigarettes at 36 w | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed