title: A randomized trial of nicotine-replacement therapy patches in pregnancy.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.).
authors.affiliation: Division of Primary Care, U.K. Centre for Tobacco Control Studies and National Institute for Health Research School for Primary Care Research, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Coleman
authors.forename: Sue
authors.initials: S
authors.lastname: Cooper
authors.forename: James G
authors.initials: JG
authors.lastname: Thornton
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Grainge
authors.forename: Kim
authors.initials: K
authors.lastname: Watts
authors.forename: John
authors.initials: J
authors.lastname: Britton
authors.forename: Sarah
authors.initials: S
authors.lastname: Lewis
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001521:Behavior Therapy; D002585:Cesarean Section / Q000706:statistics & numerical data; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055118:Medication Adherence; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000628:therapy; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D061485:Tobacco Use Cessation Devices
chemical_list: D009538:Nicotine