Safety of e‐cigarettes and nicotine patches as stop‐smoking aids in pregnancy: Secondary analysis of the Pregnancy Trial of E-cigarettes and Patches (PREP) randomized controlled trial

Pesola, Francesca, Myers Smith, Katie, Phillips-Waller, Anna, Przulj, Dunja, Griffiths, Christopher, Walton, Robert, McRobbie, Hayden, Coleman, Tim, Lewis, Sarah, Whitemore, Rachel, Clark, Miranda, Ussher, Michael, Sinclair, Lesley, Seager, Emily, Cooper, Sue, Bauld, Linda, Naughton, Felix, Sasieni, Peter, Manyonda, Isaac and Hajek, Peter (2024) Safety of e‐cigarettes and nicotine patches as stop‐smoking aids in pregnancy: Secondary analysis of the Pregnancy Trial of E-cigarettes and Patches (PREP) randomized controlled trial. Addiction, 119 (5). pp. 875-884. ISSN 0965-2140

[thumbnail of Pesola_etal_ 2024_Addiction]
PDF (Pesola_etal_ 2024_Addiction) - Published Version
Available under License Creative Commons Attribution.

Download (245kB) | Preview


Aims: The aim of this study was to examine the safety of e-cigarettes (EC) and nicotine patches (NRT) when used to help pregnant smokers quit. Design: A recent trial of EC versus NRT reported safety outcomes in the randomized arms. We conducted a further analysis based on product use. Setting: Twenty-three hospitals in England and a stop-smoking service in Scotland took part. Participants: The participants comprised 1140 pregnant smokers. Interventions: We compared women using and not using EC and NRT regularly during pregnancy. Measurements: Measurements included nicotine intake compared with baseline, birth weight, other pregnancy outcomes, adverse events, maternal respiratory symptoms and relapse in early abstainers. Findings: Use of EC was more common than use of NRT (47.3% vs 21.6%, P < 0.001). Women who stopped smoking (abstainers) and used EC at the end-of-pregnancy (EOP) reduced their salivary cotinine by 45% [49.3 ng/ml, 95% confidence interval (CI) = −79.8 to −10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24 ng/ml, 95% CI = 3.5–68). In women reporting a reduction of at least 50% in cigarette consumption, cotinine levels increased by 10% in those using nicotine products and by 9% in those who did not. Birth weights in dual users and exclusive smokers were the same (3.1 kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3 kg, standard deviation (SD) = 0.7] versus 3.1 kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05–0.25) and not different from abstainers not using nicotine products (3.1 kg, SD = 0.8). Abstainers and smokers using nicotine products had no worse pregnancy outcomes or more adverse events than abstainers and smokers not using them. EC users reported more improvements than non-users in cough [adjusted relative risk (aRR) = 0.59, 95% CI = 0.37–0.93] and phlegm (aRR = 0.53, 95% CI = 0.31–0.92), controlling for smoking status. EC or NRT use had no association with relapse. Conclusions: Regular use of e-cigarettes or nicotine patches by pregnant smokers does not appear to be associated with any adverse outcomes.

Item Type: Article
Additional Information: Funding Information: The study was funded by the National Institute of Health and Care Research, Health Technology Assessment Programme, ref: 15/57/85. The funder had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the paper; or in the decision to submit the findings for publication.
Uncontrolled Keywords: birth weight,e-cigarettes,nicotine,pregnancy,safety,smoking,vaping,psychiatry and mental health,medicine (miscellaneous),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2738
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 04 Mar 2024 18:31
Last Modified: 12 Apr 2024 13:30
DOI: 10.1111/add.16422


Downloads per month over past year

Actions (login required)

View Item View Item