Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy.

introductionNicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting ('preloading'), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead. METHODS AND ANALYSIS: A two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care, <25 weeks' gestation, smoke ≥5 daily cigarettes; accept referral for NHS stop smoking support and agree to set quit dates, try NRT and vape less than daily. Participants are randomised to: (1) usual care (UC) or (2) UC plus an intervention combining (1) NRT for preloading, (2) counselling to continue NRT during brief smoking lapses, and for those who cannot stop, (3) NRT to reduce smoking. The primary outcome is biochemically validated, smoking abstinence from 6 weeks after randomisation to 36 weeks gestation. Secondary outcomes include birth outcomes and cost per quality-adjusted life year. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 15.9% in the control and intervention groups (OR=1.7). By recruiting 1430 participants, smoking, nicotine and pregnancy 3 should have 90% power (alpha=5%) to detect this effect. We will use the Economics of Smoking in Pregnancy model to estimate cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by the West Midlands-Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers. TRIAL REGISTRATION NUMBER: ISRCTN84798566.