ISRCTN62025374.

Study name	Helping pregnant smokers quit: a multi‐centre RCT of electronic cigarette and nicotine patches
Methods	Design: multicentre RCT
Participants	Propose to randomize 1140  pregnant smokers Participants: Pregnant smokers (12 to 24 weeks gestation) who smoke daily and are interested in stopping smoking. Setting: Maternity services across the UK
Interventions	Intervention representative of usual care (behavioural support provided by proactive phone calls and accompanied by nicotine patches) or to the same support accompanied instead by EC  Usual care: Standard care across the Stop Smoking Services (SSS) ranges from advice by midwives through telephone support to standard SSS clinics to home visits by specialist advisors. Across these, interventions usually include behavioural support and provision of 16‐hour nicotine patches for up to 8 weeks. We propose to provide a representative intervention comprising initial face‐to‐face advice by midwives followed by telephone counselling by SSS advisors with 6 weekly calls, accompanied by 16‐hour nicotine patches Experimental intervention: This will be the same as the control intervention, but instead of patches, participants will receive EC to use.  Procedures and visits: Participants will attend a baseline visit with a research midwife, and would be randomized to either EC or patch. A stop‐smoking advisor would then post the relevant study product to the participant and call them to set a quit date. Weekly behavioural support phone calls will be conducted on the quit date, and for 4 weeks after. Patches or EC would be dispensed for up to 8 weeks. All participants would be followed up at the end of pregnancy and for 3 months post‐partum
Outcomes	Primary outcome: Prolonged smoking cessation, reported throughout pregnancy and validated by salivary cotinine and anabasine at end of pregnancy (36 weeks gestation to 4 weeks post‐partum) Secondary outcomes: Changes in smoke intake and in nicotine intake indexed by salivary anabasine and cotinine levels, assessed for quitters currently using NRT/EC products and, and smokers currently using NRT/EC products; self‐reported quit rates at 4 weeks and at end of pregnancy; 7‐day PPA (end of pregnancy); use of NRT and EC throughout pregnancy. Safety outcomes: Adverse effects throughout pregnancy and birth and maternal safety outcomes at end of pregnancy and 3 months post‐partum The primary outcome will use the Russell Standard (RS) criterion of abstinence with participants lost to follow‐up classified as smokers.
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