Document Detail


A randomized trial of nicotine-replacement therapy patches in pregnancy.
MedLine Citation:
PMID:  22375972     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Tim Coleman; Sue Cooper; James G Thornton; Matthew J Grainge; Kim Watts; John Britton; Sarah Lewis;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  366     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-01     Completed Date:  2012-03-08     Revised Date:  2012-09-04    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  808-18     Citation Subset:  AIM; IM    
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.
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN07249128
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Adult
Behavior Therapy
Cesarean Section / statistics & numerical data
Double-Blind Method
Female
Follow-Up Studies
Humans
Medication Adherence
Nicotine / administration & dosage,  adverse effects
Pregnancy
Pregnancy Complications / drug therapy*,  therapy
Smoking Cessation / methods*,  statistics & numerical data
Tobacco Use Cessation Products*
Chemical
Reg. No./Substance:
54-11-5/Nicotine
Investigator
Investigator/Affiliation:
Michael Coughtrie / ; Christine Godfrey / ; Clare Mannion / ; Neil Marlow / ; Janet Brown / ; Yvette Davis / ; Anne Dickinson / ; Caroline Dixon / ; Fiona Holloway / ; Joanne Lakin / ; Jayne Platts / ; Farzana Rashid / ; Amanda Redford / ; Cara Taylor / ; Jonathan Allsop / ; Simon Cunningham / ; Karen Glass / ; Vince Hall / ; Khaled Ismail / ; Margaret Ramsay / ; Sheena Appleby / ; Denise Bailey / ; Linda Gustard / ; Emma Haworth / ; Grace Hopps / ; Amanda Lindley / ; Chris Kettle / ; Colleen Pearce / ; Dymphna Sexton-Bradshaw / ; Julia Savage / ; Sandra Smith / ; Sheila Taylor / ; Alison Witham / ; Barbara Brady / ; Michelle Battlemuch / ; Wendy Dudley / ; Rochelle Edwards / ; Lorraine Frith / ; Indu Hari / ; Catriona Holden / ; Linda Hoskyns / ; Paul Jackson / ; Giri Rajaratnam / ; Deborah Richardson / ; Lucy Wade / ; Maureen Whittaker / ; Bernie Cook / ; Sheila Hodgson / ; Lisa Humphries / ; Bernie Sanders / ; Dan Simpkins / ; Sheila Sharp / ; Peter Brocklehurst / ; Carol Coupland / ; Peter Hajek / ; Sue Maguire / ; Michael Murphy / ; Christopher Butler / ; David Field / ; Janet Peacock /
Comments/Corrections
Comment In:
J Midwifery Womens Health. 2012 Jul-Aug;57(4):423-4
N Engl J Med. 2012 Mar 1;366(9):846-7   [PMID:  22375978 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis.
Next Document:  Placebo-controlled trial of amantadine for severe traumatic brain injury.