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

Journal article

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 analysisA 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, Ethics and disseminationEthics 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 numberISRCTN84798566.

Authors: Campbell, KA; Clark, MM; Montgomery, AA; Partlett, C; Dickinson, A

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BMJ Publishing Group
• Journal: BMJ Open
• Volume: 15
• Issue: 11
• Pages: e109568
• Publication date: 2025-11-13
• DOI: 10.1136/bmjopen-2025-109568
• EISSN: 2044-6055
• ISSN: 2044-6055
• Pmid: 41238357
• Language: English
• Keywords: Nicotine Replacement Therapy; England; Randomized controlled trial; Female; Prenatal Care; Cost-Benefit Analysis; Multicenter Studies as Topic; Wales; Smoking; Humans; Pregnancy Complications; Smoking Reduction; Tobacco Use; Adult; Smoking Cessation; Counseling; Pregnancy; Randomized Controlled Trials as Topic; Tobacco Use Cessation Devices