Skip to main content

Advertisement

SpringerLink
Log in

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

  • Published:
Maternal and Child Health Journal Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Simpson, W. J. (1957). A preliminary report on cigarette smoking and the incidence of prematurity. American Journal of Obstetrics and Gynecology, 73, 807–815.

    PubMed  CAS  Google Scholar 

  2. Mohsin, M., & Jalaludin, B. (2008). Influence of previous pregnancy outcomes and continued smoking on subsequent pregnancy outcomes: an exploratory study in Australia. BJOG: An International Journal of Obstetrics & Gynaecology, 115, 1428–1435.

    Article  CAS  Google Scholar 

  3. U.S. Department of Health and Human Services. (2010). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and health Promotion, Office on Smoking and Health. Retrieved from http://www.surgeongeneral.gov/library/tobaccosmoke/report/full_report.pdf.

  4. National Center for Health Statistics. (2010). Health, United States, 2009: With Special Feature on Medical Technology. Hyattsville, MD. Retreived from http://www.cdc.gov/nchs/data/hus/hus09.pdf.

  5. Fiore, M. C., Bailey, W. C., Cohen, S. J., Dorfman, S. F., Goldstein, M. G., & Gritz, E. R. (2000). Treating tobacco use and dependence: Clinical practice guideline. Rockville, MD: USDHHS, Public Health Service.

    Google Scholar 

  6. Fiore, M. C., & Jaén, C. R. (2008). A clinical blueprint to accelerate the elimination of tobacco use. Journal of the American Medical Association, 299(17), 2083–2085.

    Article  PubMed  CAS  Google Scholar 

  7. Windsor, R. (2010). Behavioral treatment methods for pregnant smokers: The evidence-base for prenatal care programs and professional practice. In A. Handler, J. Kennedy, & N. Peacock (Eds.), Reducing racial/ethnic disparities in reproductive and perinatal outcomes: The evidence from population-based interventions (pp. 239–264). New York: Springer.

    Google Scholar 

  8. Windsor, R., Boyd, N., & Orleans, C. (1998). A meta-evaluation of smoking cessation intervention research among pregnant women: Improving the science and art. Health Education Research, 13, 419–438.

    Article  PubMed  CAS  Google Scholar 

  9. Windsor, R., Oncken, C., Henningfield, J., Hartmann, K., & Edwards, N. (2005). Behavioral and pharmacological treatment methods for pregnant smokers: Issues for clinical practice. Journal of American Medical Women’s Association, 55, 304–310.

    Google Scholar 

  10. Benowitz, N. L. (1991). Nicotine replacement therapy during pregnancy. Journal of the American Medical Association, 266, 3174–3177.

    Article  PubMed  CAS  Google Scholar 

  11. Benowitz, N. L., & Dempsey, D. (2004). Pharmacotherapy for smoking cessation during pregnancy. Nicotine & Tobacco Research, 6(Suppl 2), S189–S202.

    Article  CAS  Google Scholar 

  12. American College of Obstetricians and Gynecologists. (2011). Smoking Cessation during Pregnancy. A Clinician’s Guide to Helping Pregnant Women Quit Smoking. 2011 Self-instructional Guide and Tool Kit. An Educational Program from the American College of Obstetricians and Gynecologists. Retrieved from http://www.acog.org/departments/healthIssues/scdp/files/scdp.pdf.

  13. Oncken, C., Campbell, W., Chan, G., Hatsukami, D., & Kranzler, H. R. (2009). Effects of nicotine patch or nasal spray on nicotine and cotinine concentrations in pregnant smokers. Journal of Maternal-Fetal and Neonatal Medicine, 22, 751–758.

    Article  PubMed  CAS  Google Scholar 

  14. Oncken, C., Dornelas, E., Greene, J., Sankey, H., Glasmann, A., Feinn, R., et al. (2008). Nicotine gum for pregnant smokers: A randomized controlled trial. Obstetrics & Gynecology, 112, 859–867.

    Article  CAS  Google Scholar 

  15. Pollak, K. I., Oncken, C. A., Lipkus, I. M., Lyna, P., Swamy, G. K., Pletsch, P. K., et al. (2007). Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. American Journal of Preventive Medicine, 33, 297–305.

    Article  PubMed  Google Scholar 

  16. Wisborg, K., Henriksen, T. B., Jespersen, L. B., & Secher, N. J. (2000). Nicotine patches for pregnant smokers: A randomized controlled study. Obstetrics & Gynecology, 96, 967–971.

    Article  CAS  Google Scholar 

  17. Swamy, G. K., Roelands, J. J., Peterson, B. L., Fish, L. J., Oncken, C.A., Pletsch, P.K., et al. (2009). Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial. American Journal of Obstetrics and Gynecology, 201(4), 354e1–354e7.

    Google Scholar 

  18. Physicians’ desk reference (2003) Oradell, NJ: Medical Economics Co.

  19. Thornberry, J., Bhaskar, B., Krulewitch, C. J., Wesley, B., Hubbard, M. L., Das, A., et al. (2002). Audio computerized self-report interview use in prenatal clinics: Audio computer-assisted self interview with touch screen to detect alcohol consumption in pregnant women: Application of a new technology to an old problem. Computers, Informatics, Nursing, 20, 46–52.

    Article  PubMed  Google Scholar 

  20. Windsor, R. A., Woodby, L. L., Miller, T. M., Hardin, J. M., Crawford, M. A., & DiClemente, C. C. (2000). Effectiveness of Agency for Health Care Policy and Research clinical practice guideline and patient education methods for pregnant smokers in Medicaid maternity care. American Journal of Obstetrics and Gynecology, 182(1 Pt 1), 68–75.

    Article  PubMed  CAS  Google Scholar 

  21. Beck, A. T., Steer, R. A., & Brown, G. K. (2000). BDI-II fast screen for medical patients’ manual. London: The Psychological Corporation.

    Google Scholar 

  22. Windsor, R. (2000). A Pregnant woman’s guide to quit smoking. The Society for Public Health Education; SOPHE, 10 G St. Suite 605, Washington DC, 20002.

  23. Windsor, R., Whiteside Jr., H. P., Solomon, L. J., Prows, S. L., Donatelle, R. J., Cinciripini, P. M., et al. (2000). A process evaluation model for patient education programs for pregnant smokers. Tobacco Control, 9(S. 3), III29–35.

  24. Windsor, R., Woodby, L., Miller, T., & Hardin, M. (2011). Effectiveness of the smoking cessation and reduction in pregnancy treatment (SCRIPT) program for a medicaid system of care: SCRIPT trial III. Health Education & Behavior, 38, 653–663.

    Article  Google Scholar 

  25. Wang, X., Zuckerman, B., Pearson, C., Kaufman, G., Chen, C., Wang, G., et al. (2001). Maternal cigarette smoking, metabolic gene polymorphism, and infant birth weight. Journal of the American Medical Association, 287, 195–202.

    Article  Google Scholar 

  26. Gaither, K. H., Brunner Huber, L. R., Thompson, M. E., & Huet-Hudson, Y. M. (2009). Does the use of nicotine replacement therapy during pregnancy affect pregnancy outcomes? Maternal and Child Health Journal, 13, 497–504.

    Article  PubMed  Google Scholar 

  27. Lassen, T. H., Madsen, M., Skovgaard, L. T., Strandberg-Larsen, K., Olsen, J., & Andersen, A.-M. N. (2010). Naterbak use of nicotine replacement therapy during pregnancy and offspring birthweight: a study within the Danish National Birth Cohort. Paediatric and Perinatal Epidemiology, 24, 272–281.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD036104 and U18 HD031206-07). This research was supported, in part, by the intramural program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Conflict of interest

None of the authors have any competing interests to declare.

Author information

Authors and Affiliations

  1. College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA

    Ayman A. E. El-Mohandes

  2. School of Public Health, George Washington University, Washington, DC, USA

    Richard Windsor

  3. RTI International, Rockville, MD, USA

    Sylvia Tan & Marie G. Gantz

  4. Department of Pharmacology and Physiology, George Washington University, Washington, DC, USA

    David C. Perry

  5. Epidemiology Branch, Division of Epidemiology, Statistics and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Blvd, Rm. 7B-05, Rockville, MD, 20852-7510, USA

    Michele Kiely

Authors
  1. Ayman A. E. El-Mohandes
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Richard Windsor
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sylvia Tan
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. David C. Perry
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Marie G. Gantz
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Michele Kiely
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Michele Kiely.

Additional information

Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00341432.

Rights and permissions

Reprints and permissions

About this article

Cite this article

El-Mohandes, A.A.E., Windsor, R., Tan, S. et al. A Randomized Clinical Trial of Trans-Dermal Nicotine Replacement in Pregnant African-American Smokers. Matern Child Health J 17, 897–906 (2013). https://doi.org/10.1007/s10995-012-1069-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10995-012-1069-9

Keywords

Search

Navigation