{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T20:24:18Z","timestamp":1787775858947,"version":"build-2784847793"},"reference-count":72,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2023,7,1]],"date-time":"2023-07-01T00:00:00Z","timestamp":1688169600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["15\/57\/85"],"award-info":[{"award-number":["15\/57\/85"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title>\n<jats:p>Some pregnant smokers try e-cigarettes, but effectiveness and safety of such use are unknown.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title>\n<jats:p>To compare effectiveness and safety of nicotine patches and e-cigarettes in pregnancy.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title>\n<jats:p>A pragmatic multi-centre randomised controlled trial.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title>\n<jats:p>Twenty-three hospitals across England, and a Stop Smoking Service in Scotland.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title>\n<jats:p>One thousand one hundred and forty pregnant daily smokers (12\u201324 weeks\u2019 gestation) motivated to stop smoking, with no strong preference for using nicotine patches or e-cigarettes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title>\n<jats:p>Participants in the e-cigarette arm were posted a refillable e-cigarette device with two 10\u2009ml bottles of tobacco-flavoured e-liquid (18\u2009mg nicotine). Participants in the nicotine patches arm were posted a 2-week supply of 15\u2009mg\/16-hour nicotine patches. Supplies were provided for up to 8 weeks. Participants sourced further supplies themselves as needed. Participants in both arms received support calls prior to their target quit date, on the quit date, and weekly for the next 4 weeks.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-7\"><jats:title>Outcome measures<\/jats:title>\n<jats:p>The primary outcome was validated prolonged abstinence at the end of pregnancy. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included self-reported abstinence at different time points, treatment adherence and safety outcomes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title>\n<jats:p>Only 55% of self-reported abstainers mailed back useable saliva samples. Due to this, validated sustained abstinence rates were low (6.8% vs. 4.4% in the e-cigarettes and nicotine patches arms, respectively, risk ratio\u2005=\u20051.55, 95% confidence interval 0.95 to 2.53; Bayes factor\u2005=\u20052.7). In a pre-specified sensitivity analysis that excluded abstainers using non-allocated products, the difference became significant (6.8% vs. 3.6%, risk ratio\u2005=\u20051.93, 95% confidence interval 1.14 to 3.26; Bayes factor\u2005=\u200510). Almost a third of the sample did not set a target quit date and the uptake of support calls was low, as was the initial product use. At end of pregnancy, 33.8% versus 5.6% of participants were using their allocated product in the e-cigarettes versus nicotine patches arm (risk ratio\u2005=\u20056.01, 95% confidence interval 4.21 to 8.58). Regular use of e-cigarettes in the nicotine patches arm was more common than use of nicotine replacement products in the e-cigarette arm (17.8% vs. 2.8%).<\/jats:p>\n<jats:p>Rates of adverse events and adverse birth outcomes were similar in the two study arms, apart from participants in the e-cigarette arm having fewer infants with low birthweight (&lt;2500\u2009g) (9.6% vs. 14.8%, risk ratio\u2005=\u20050.65, 95% confidence interval 0.47 to 0.90; Bayes factor\u2005=\u200510.3).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title>\n<jats:p>Low rates of validation reduced the study power. A substantial proportion of participants did not use the support on offer sufficiently to test its benefits. Sample size may have been too small to detect differences in less frequent adverse effects.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title>\n<jats:p>E-cigarettes were not significantly more effective than nicotine patches in the primary analysis, but when e-cigarettes use in the nicotine patches arm was accounted for, e-cigarettes were almost twice as effective as patches in all abstinence outcomes. In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in this study and may reduce the incidence of low birthweight.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title>\n<jats:p>Routine monitoring of smoking cessation and birth outcomes in pregnant women using nicotine patches and e-cigarettes and further studies are needed to confirm these results.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered as ISRCTN62025374 and Eudract 2017-001237-65.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title>\n<jats:p>This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in <jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 27, No. 13. See the NIHR Journals Library website for further project information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/agth6901","type":"journal-article","created":{"date-parts":[[2023,10,16]],"date-time":"2023-10-16T07:04:57Z","timestamp":1697439897000},"page":"1-53","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1133-8835","authenticated-orcid":true,"given":"Dunja","family":"Przulj","sequence":"first","affiliation":[{"name":"Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2054-7930","authenticated-orcid":true,"given":"Francesca","family":"Pesola","sequence":"additional","affiliation":[{"name":"Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1837-3924","authenticated-orcid":true,"given":"Katie","family":"Myers Smith","sequence":"additional","affiliation":[{"name":"Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7777-1845","authenticated-orcid":true,"given":"Hayden","family":"McRobbie","sequence":"additional","affiliation":[{"name":"National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7303-4805","authenticated-orcid":true,"given":"Tim","family":"Coleman","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5308-6619","authenticated-orcid":true,"given":"Sarah","family":"Lewis","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7935-8694","authenticated-orcid":true,"given":"Christopher","family":"Griffith","sequence":"additional","affiliation":[{"name":"Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7700-1907","authenticated-orcid":true,"given":"Robert","family":"Walton","sequence":"additional","affiliation":[{"name":"Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7599-8640","authenticated-orcid":true,"given":"Rachel","family":"Whitemore","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6179-046X","authenticated-orcid":true,"given":"Miranda","family":"Clark","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0995-7955","authenticated-orcid":true,"given":"Michael","family":"Ussher","sequence":"additional","affiliation":[{"name":"Population Health Research Institute, St George\u2019s University of London, London, UK; 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