Behavioral support for smoking cessation has been shown to help pregnant women to stop smoking, but it is unclear whether medications shown to improve cessation rates among nonpregnant women are also effective in pregnant women. It is generally believed that that nicotine replacement therapy is less harmful in pregnancy than smoking. Thus, several guidelines for smoking cessation have recommended nicotine replacement use for smoking cessation in pregnancy. Individual trials of nicotine-replacement therapy in pregnant women have been too small to assess efficacy or safety, and the results of pooled data from these studies in a meta-analysis were inconclusive.This randomized trial assessed the efficacy and safety of nicotine patches during pregnancy as a supplement to behavioral support for smoking cessation. The study was conducted at 7 hospitals in England between 2007 and 2010. The study population included 1050 pregnant women 16 to 50 years, who were at 12 to 24 weeks of gestation and currently smoked 5 or more cigarettes daily. All participants received behavioral cessation support and were randomized to 8 weeks of treatment with nicotine-replacement patches (15 mg per 16 hours, n = 521) or matched placebo patches (n = 529). The primary outcome, self-reported abstinence from the smoking cessation date until delivery, was validated by determining the concentration of exhaled carbon monoxide or salivary cotinine levels. Multiple linear regression analysis was used to adjust for covariables. Adverse pregnancy and birth outcomes were monitored to assess safety.Data showed no significant difference between groups in the rate of prolonged abstinence from the quit date until delivery (nicotine replacement 9.4% vs placebo 7.6%); the unadjusted odds ratio was 1.26, with a 95% confidence interval of 0.82 to 1.96. The rate was higher, however, at 1 month with nicotine-replacement therapy (21.3% vs 11.7%). Outcomes were similar in adjusted analyses. Compliance was low in both groups: only 7.2% of women who received nicotine-replacement therapy and 2.8% of those receiving placebo reported using patches for more than 1 month. There were no significant differences between the 2 groups in rates of adverse pregnancy and birth outcomes.These findings provide no evidence that adding nicotine replacement therapy to behavioral support for smoking cessation has either a beneficial or a harmful effect on birth outcomes. Compliance rates are low as in similar studies and limit the assessment of safety.
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