A randomised trial of nicotine-replacement therapy patches in pregnancy

Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. The study investigated the efficacy and safety of nicotine patches during pregnancy.

In this study, the authors recruited participants from seven hospitals in England who were 16 - 50 years of age with pregnancies of 12 - 24 weeks’ gestation and who smoked 5 or more cigarettes per day. Participants received behavioural cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes.

Of 1 050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups, although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% v. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups.

Adding a nicotine patch (15 mg per 16 hours) to behavioural cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety.

Coleman T, et al. N Engl J Med 2012;366:808-818.