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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; Smith, Katie Myers; 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; Hajek, Peter

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 Thumbnail


Authors

Francesca Pesola

Katie Myers Smith

Anna Phillips‐Waller

Dunja Przulj

Christopher Griffiths

Robert Walton

Hayden McRobbie

TIM COLEMAN tim.coleman@nottingham.ac.uk
Professor of Primary Care

Rachel Whitemore

Michael Ussher

Lesley Sinclair

Emily Seager

Sue Cooper

Linda Bauld

Felix Naughton

Peter Sasieni

Isaac Manyonda

Peter Hajek



Abstract

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% [49.3ng/ml, 95% confidence interval (CI) = −79.8 to −10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24ng/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 (3.1kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3kg, standard deviation (SD) = 0.7] versus 3.1kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05–0.25) and not different from abstainers not using nicotine products (3.1kg, 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.

Citation

Pesola, F., Smith, K. M., Phillips‐Waller, A., Przulj, D., Griffiths, C., Walton, R., …Hajek, P. (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), 875-884. https://doi.org/10.1111/add.16422

Journal Article Type Article
Acceptance Date Nov 16, 2023
Online Publication Date Jan 17, 2024
Publication Date 2024-05
Deposit Date Jan 23, 2024
Publicly Available Date Jan 23, 2024
Journal Addiction
Print ISSN 0965-2140
Electronic ISSN 1360-0443
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 119
Issue 5
Pages 875-884
DOI https://doi.org/10.1111/add.16422
Keywords Birth weight, e-cigarettes, nicotine, pregnancy, safety, smoking, vaping
Public URL https://nottingham-repository.worktribe.com/output/29841645
Publisher URL https://onlinelibrary.wiley.com/doi/10.1111/add.16422
Additional Information Received: 2023-07-07; Accepted: 2023-11-16; Published: 2024-01-17

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