Trial reportBMJ (Clinical research ed.)2014
Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy.
Trial report in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00507975 (Assessment of the Effectiveness of Nicotine Replacement Therapies), which is not on this map. Cited by 37 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
Who cites it
37 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- The efficacy and acceptability of pharmacological monotherapies and e-cigarette on smoking cessation: a systemic review and network meta-analysis.Frontiers in public health · 2024Pooled it
- Cessation classification likelihood increases with higher expired-air carbon monoxide cutoffs: a meta-analysis.Drug and alcohol dependence · 2021Pooled it
- Pooled it
- Factors influencing the uptake and use of nicotine replacement therapy and e-cigarettes in pregnant women who smoke: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2020Pooled it
- Pharmacological interventions for promoting smoking cessation during pregnancy.The Cochrane database of systematic reviews · 2020Pooled it
- Comparison of nicotine exposure during pregnancy when smoking and abstinent with nicotine replacement therapy: systematic review and meta-analysis.Addiction (Abingdon, England) · 2019Pooled it
- Nicotine replacement therapy versus control for smoking cessation.The Cochrane database of systematic reviews · 2018Pooled it
- A systematic review of possible serious adverse health effects of nicotine replacement therapy.Archives of toxicology · 2017Pooled it
- Consideration of sex in clinical trials of transdermal nicotine patch: a systematic review.Experimental and clinical psychopharmacology · 2014Pooled it
- Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy.Health technology assessment (Winchester, England) · 2023Trial
- Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial.Nature medicine · 2022Trial
- Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study.BMJ open · 2016Trial
- A Comparison of the Fagerström Test for Cigarette Dependence and Cigarette Dependence Scale in a Treatment-Seeking Sample of Pregnant Smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016Trial
- Randomized, controlled pilot trial of bupropion for pregnant smokers: challenges and future directions.American journal of perinatology · 2015Trial
- Article
- Breaking the Habit: A Systematic Review and Meta-Analysis of Pregnancy-Related Smoking Cessation Randomized Controlled Trials.Healthcare (Basel, Switzerland) · 2025Review
- Nicotine replacement therapy and oral health: a network meta-analysis of adverse effects in randomized trials.Evidence-based dentistry · 2025Article
- Safety of Nicotine Replacement Therapy during Pregnancy: A Narrative Review.International journal of environmental research and public health · 2022Review
- Can electronic cigarettes help pregnant smokers quit, and are they as safe to use in pregnancy as nicotine replacement treatments?Clinical and translational medicine · 2022Article
- Maternal nicotine exposure induces congenital heart defects in the offspring of mice.Journal of cellular and molecular medicine · 2022Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).
designRandomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013.
setting23 maternity wards in France.
participants476 pregnant smokers aged more than 18 years and between 12 and 20 weeks' gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group.
interventionsNicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support.
main outcome measuresThe primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤ 8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis.
resultsComplete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.
conclusionThe nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.
trial registrationClinicalTrials.gov NCT00507975.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.