Randomized, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy

Background: Smoking in pregnancy is associated with increased perinatal risks, including intrauterine growth retardation, stillbirth, and the sudden infant death syndrome. Reducing maternal smoking using nicotine replacement therapy (NRT) is a possible way to decrease the risks to the fetus. Objective: The purpose of this study was to examine the efficacy of NRT in reducing smoking among pregnant women who were heavy smokers and who could not quit smoking during their first trimester. Methods: In this double-blind, placebo-controlled trial, pregnant women (12 to 24 weeks' gestation) who smoked ≥ 15 cigarettes per day were randomized to receive a daily, 18-hour patch of nicotine 15 mg for 8 weeks, 10 mg for an additional 2 weeks, and 5 mg for the last 2 weeks, or an identical placebo patch. At baseline and at 1, 4, and 8 weeks, women received counseling, and serum and salivary cotinine levels were measured. Results: Seventeen women received NRT and 13 received placebo. In the NRT group, 4 women (23.5%) successfully completed the program and quit smoking during their second trimester. None of the 13 women who received placebo and counseling completed the program or quit smoking. The difference in success rates was not statistically significant (P = 0.11). Conclusions: The effectiveness of NRT beyond the first trimester in pregnant women who smoke heavily is questionable, but NRT may be helpful in a minority of these women.