Nicotine gum for pregnant smokers: a randomized controlled trial. Nicotine patches for pregnant smokers: a randomized controlled study. A randomized trial of nicotine-replacement therapy patches in pregnancy. A randomised-controlled pilot study using nicotine patches with pregnant women. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.
To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.
                Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study.
                Participants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014).
                Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing. To assess the effect of nicotine patches on continine-validated smoking cessation in pregnant women and the effect of nicotine on birth weight and preterm delivery.
                Pregnant women who smoked ten or more cigarettes after the first trimester (N = 250) were randomly assigned to receive nicotine patches (n = 124) or placebo patches (n = 126). Women randomized to nicotine were treated with 15-mg patches (16 hours/day) for 8 weeks, and 10-mg patches (16 hours/day) for 3 weeks.
                Overall, 26% stopped smoking and 14% were nonsmokers 1 year after delivery. There was no difference between nicotine and placebo groups. At the end of the intervention, the mean value of cotinine in saliva in women assigned to nicotine was 120 ng/mL and placebo 153 ng/mL (mean difference -33; 95% CI -72, 6 ng/mL). Mean birth weight difference was 186 g (95% CI 35, 336 g) higher in the nicotine than placebo group, and there was an insignificantly lower rate of low birth weight (under 2500 g) in the former group. There was no difference in the rate of preterm delivery between the two groups.
                Nicotine patches had no influence on smoking cessation during pregnancy, although they might increase birth weight in comparison with placebo. Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy.
                We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral 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 1050 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 (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 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 behavioral 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. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.). Stopping smoking in pregnancy is a public health priority and a clinical imperative. However, many women who have not been able to 'quit' in early pregnancy find it very difficult to do so. This randomised-controlled pilot study examined feasibility issues in offering free nicotine patches with counselling to a group of 20 mid-trimester pregnant women at the Women's and Children's Hospital, Adelaide. A further 20 were offered counselling only. Smoking status at each visit was measured by self-report, carbon monoxide monitoring, and salivary cotinine. The most common pattern (eleven of the twenty women) was intermittent patch use. Only five women used patches continuously up to the 12 week maximum available. Three women in the patch group were abstinent at delivery compared with none in the control group. Notable features of the study were the low interest in participation and the high withdrawal rate. Nicotine patches may not be highly useful for pregnant women. Continuing tobacco control measures and customized support for women and their partners, often smokers, may prove more fruitful. This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.
                An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum.
                Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth.
                The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.
Nicotine replacement therapy is the only pharmacotherapy for smoking cessation that has been tested in RCTs conducted in pregnancy.  There is insufficient evidence to determine whether or not NRT is effective or safe when used to promote smoking cessation in pregnancy or to determine whether or not using NRT has positive or negative impacts on birth outcomes. Further research evidence of efficacy and safety is needed, ideally from placebo-controlled RCTs that investigate higher doses of NRT than were tested in the included studies.