Maternal and Child Health Journal

, Volume 17, Issue 5, pp 897–906

A Randomized Clinical Trial of Trans-Dermal Nicotine Replacement in Pregnant African-American Smokers

  • Ayman A. E. El-Mohandes
  • Richard Windsor
  • Sylvia Tan
  • David C. Perry
  • Marie G. Gantz
  • Michele Kiely
Article

Abstract

We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.

Keywords

Pregnancy African-Americans Smoking Nicotine replacement therapy 

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Copyright information

© Springer Science+Business Media, LLC (outside the USA)  2012

Authors and Affiliations

  • Ayman A. E. El-Mohandes
    • 1
  • Richard Windsor
    • 2
  • Sylvia Tan
    • 3
  • David C. Perry
    • 4
  • Marie G. Gantz
    • 3
  • Michele Kiely
    • 5
  1. 1.College of Public HealthUniversity of Nebraska Medical CenterOmahaUSA
  2. 2.School of Public HealthGeorge Washington UniversityWashingtonUSA
  3. 3.RTI InternationalRockvilleUSA
  4. 4.Department of Pharmacology and PhysiologyGeorge Washington UniversityWashingtonUSA
  5. 5.Epidemiology Branch, Division of Epidemiology, Statistics and Prevention ResearchEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of HealthRockvilleUSA

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