Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

Abstract

Objective To 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).Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France.Participants 476 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.Interventions Nicotine 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.Results Complete 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 registration ClinicalTrials.gov NCT00507975.

Nicotine Replacement Therapy in Pregnancy and Major Congenital Anomalies in Offspring

“…A similar reduction in the risk of CAs among women prescribed NRT was found in a more recent trial including 476 pregnant smokers from 23 maternity wards in France. 14 We found that the odds of MCAs in the NRT group were 7% higher compared with smokers, although this finding was not statistically significant. Similarly, the absolute risks of system-specific anomalies were also generally higher than in the overall population and in smokers, although these differences were small.…”

“…10 Evidence of safety specifically in relation to CA risks is limited to 1 observational study of linked clinical data from Denmark, which did not find an increased risk with major CAs, and 2 randomized controlled trials of pregnant women in England and France, both of which found a reduced risk but were not adequately powered to assess this outcome. [12][13][14] Using a large population-based pregnancy cohort, the present study investigated whether exposure to NRT increases the risk of major congenital anomalies (MCAs) compared with pregnant women who neither smoked nor were prescribed NRT antenatally and who smoked during pregnancy.…”

Getting over the shock: taking action on Indigenous maternal smoking

“…Owing to the risk of compensatory smoking, health gains are only realised if cutting down is accompanied with NRT. Preliminary studies involving pregnant smokers suggest that using NRT while cutting down is safe (Berlin et al 2014), although pre-cessation use has not been addressed in formal guidelines (Zwar et al 2014).…”

Identification of Behavioral Risk Factors During Pregnancy

“…The proportion of deaths attributable to smoking was approximately 24 % for men and 6 % for women. From the total premature deaths, nearly one in four (for those aged between 30-44 years) also one in three (for those aged between 45-59 years) were attributed to tobacco use [2,3].…”

“…Thus, to reduce the number of diseases caused by smoking also implicitly the costs entailed by these diseases, requires a reduction in smoking prevalence. Increasing the rate smoking cessation is considered the only high-impact strategy that can lead to short-term improvement [3,4].…”