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
Open accessAbstract
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.
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The RCT initially compared safety outcomes for those allocated to the vaping and NRT arms and then, in a secondary analysis, compared outcomes for those who were not smoking and who did or did not regularly use nicotine products (vaping or NRT, combined) during pregnancy.
“The RCT initially compared safety outcomes for those allocated to the vaping and NRT arms [16] and then, in a secondary analysis, compared outcomes for those who were not smoking and who did or did not regularly use nicotine products (i.e., vaping or NRT, combined) during pregnancy [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
When the RCT compared those abstinent from smoking and regularly vaping or using NRT with those not using these products, irrespective of trial arm, non-users had significantly more overall adverse outcomes and there were no significant differences for caesarean section rates.
“When the RCT compared those abstinent from smoking and regularly vaping or using NRT with those not using these products, irrespective of trial arm, non-users had significantly more overall adverse outcomes and there were no significant differences for caesarean section rates [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
The RCT reported that, irrespective of trial arm, exclusive-smokers had gestational age similar to those who dual-used smoking in combination with vaping or NRT.
“The RCT reported that, irrespective of trial arm, exclusive-smokers had rates of PTB and GA similar to those who dual-used smoking in combination with vaping or NRT [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
The RCT reported that, irrespective of trial arm, exclusive-smokers had rates of preterm birth similar to those who dual-used smoking in combination with vaping or NRT.
“The RCT reported that, irrespective of trial arm, exclusive-smokers had rates of PTB and GA similar to those who dual-used smoking in combination with vaping or NRT [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
The RCT found that, irrespective of trial arm, gestational age was similar between those who reported smoking cessation and the use of NRT or vaping and those reporting cessation and no use of these products.
“; GA was similar in these two groups.”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
The RCT found that, irrespective of trial arm, those who reported smoking cessation and the use of NRT or vaping in pregnancy had significantly fewer preterm births than did those reporting cessation and no use of these products.
“The RCT also found that, irrespective of trial arm, those who reported smoking cessation and the use of NRT or vaping in pregnancy had significantly fewer PTBs than did those reporting cessation and no use of these products [57]”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
Irrespective of trial arm, those who reported smoking cessation and the use of NRT or vaping during pregnancy had significantly greater birth weights than those reporting smoking.
“and significantly greater BWs than those reporting smoking [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
Irrespective of trial arm, those who reported smoking cessation and the use of NRT or vaping during pregnancy had similar birth weights and LBWs to those reporting cessation and no use of these products.
“Additionally, irrespective of trial arm, those who reported smoking cessation and the use of NRT or vaping during pregnancy had similar BWs and LBWs to those reporting cessation and no use of these products”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
When comparing dual-users and smokers, irrespective of trial arm, rates of congenital abnormalities were not significantly different.
“When comparing dual-users and smokers, irrespective of trial arm, rates of congenital abnormalities were not significantly different [57].”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
The secondary analysis reported no evidence of risk for exclusive-vaping, and comparable risk for dual-use (smoking and vaping or NRT) and exclusive-smoking for some outcomes.
“This secondary analysis reported no evidence of risk for exclusive-vaping, and comparable risk for dual-use (smoking and vaping or NRT) and exclusive-smoking for some outcomes.”
From Vaping during pregnancy: a systematic review of health outcomes. (2024) · cites this paper as [57]
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Additional file 1 of Vaping during pregnancy: a systematic review of health outcomes
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Self-citation
- Authors
- Pesola, F., Smith, K. M., Phillips‐Waller, A., Przulj, D., Griffiths, C., Walton, R., McRobbie, H., Coleman, T., Lewis, S., Whitemore, R., Clark, M., Ussher, M., Sinclair, L., Seager, E., Cooper, S., Bauld, L., Naughton, F., Sasieni, P., Manyonda, I., & Hajek, P.
- Affiliations
- Queen Mary University of London (GB)
- UNSW Sydney (AU)
- University of Nottingham (GB)
- Centre for Academic Primary Care University of Nottingham Nottingham UK
- University of Stirling (GB)
- University of Edinburgh (GB)
- University of East Anglia (GB)
- St George’s University Hospitals NHS Foundation Trust (GB)
- Wolfson Institute of Population Health Queen Mary University of London London UK
- Corresponding author
- Pesola, Francesca
- ORCID
- Venue
- Addiction
- Publisher
- Wiley
- Published
- 2024-01-17
- Volume
- 119
- Issue
- 5
- Pages
- 875-884
- ISSN
- 0965-2140 (ISSN-L)
- 1360-0443
- OpenAlex
- W4390951188
- Cited by
- 29
- References
- 28
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 8
- FWCI
- 8.20
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Addiction (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repository@Nottingham (University of Nottingham) (publishedVersion, other-oa)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (submittedVersion)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by)
- St George's Online Research Archive (St George's University of London) (submittedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by)
- Funders
- Health Technology Assessment Programme (15/57/85)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Prenatal Substance Exposure Effects
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- electronic cigarettes, nicotine patch, nicotine replacement therapy, smoking cessation during pregnancy, prenatal nicotine exposure, birth weight, salivary cotinine, cough, sputum, pregnancy outcomes, adverse events, maternal mental health, maternal anxiety
- MeSH terms
- Birth Weight, Cotinine, Female, Humans, Nicotine, Pregnancy, Recurrence, Smoking, Smoking Cessation, Electronic Nicotine Delivery Systems
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