Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers

Pregnancy Clinical Trial

Official title:

Nicotine Replacement Therapy Methods for Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00341432
• Other study ID #: 999905227
• Secondary ID: 05-CH-N227
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2006
• Last updated: June 30, 2017
• Start date: August 16, 2005
• Est. completion date: April 20, 2011

Study information

• Verified date: April 20, 2011
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness of counseling plus use of a nicotine patch with counseling alone for helping pregnant women quit smoking. Smoking during pregnancy is the most preventable cause of fetal and newborn health problems such as low birth weight, fetal growth retardation, sudden infant death syndrome, spontaneous abortion, decreased lung function and premature delivery.

African-American and Hispanic women 18 years of age or older, smoke cigarettes, and live in the District of Columbia metropolitan area may be eligible for this study. Candidates are recruited from the George Washington University and Providence Hospital prenatal health clinics. They are screened with a review of their medical records and a survey that includes questions about their age, residency, race and ethnicity, educational level and employment status, number of weeks pregnant, and exposure to cigarette smoke and other types of tobacco.

Participants answer questions about their smoking behavior, then receive a 10-minute counseling session and watch a videotape about quitting smoking. Women who are not able to quit smoking in 1 week are then randomly assigned to one of two treatment groups. One group continues to receive counseling sessions during the remainder of their pregnancy; the second group receives nicotine patches as well as the counseling sessions. In addition, all participants watch a video about smoking and receive a guide to help them quit. Women who receive the patches must stop smoking completely. If they cannot stop immediately, their participation in the study ends. The behavioral counseling sessions for all the women are a series of conversations between the women and a trained counselor to help the woman through the process of quitting.

Participants are followed during the study with six clinic visits and three telephone calls. During the first visit, the women answer a series of questions about their smoking habits and health concerns. A portion of the urine sample they provide during their routine prenatal visit is used by this study to assess their cotinine (a breakdown product of nicotine) levels. Saliva and breath samples to test for cotinine and carbon monoxide levels are collected at each visit. Saliva is collected by brushing the inside of the cheek with a cotton swab, and breath samples are collected by having the woman blow into a tube connected to a machine. Participants are evaluated four times during the study with questions about their smoking behavior.

With the women's permission, their medical records, health, and treatments during pregnancy are reviewed. At the end of the pregnancy, the infant's weight and health are also reviewed.

Description:

The overall focus of the proposed concept submitted by the George Washington University Medical Center investigators is "The Efficacy of NRT to Reduce the Risk of Nicotine Exposure in Pregnant Minority Smokers." Prenatal smoke exposure to the fetus and environmental tobacco smoke exposure of infants and children causes significant harm in both the short- and long-term. Smoking during pregnancy is the foremost preventable cause of perinatal morbidity and mortality. There is strong evidence that these exposures are associated with low birth weight (LBW) and infant mortality, respiratory illness, ear infections, tonsillectomy and adenoidectomy, asthma, and sudden infant death syndrome (SIDS), developmental delay, and increased health care utilization and hospitalizations.

George Washington University Medical Center investigators are submitting two concept papers that aim to test the efficacy of innovative intervention methods tailored to reduce fetal and infant exposure to nicotine secondary to maternal smoking and environmental tobacco exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 20, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

• INCLUSION CRITERIA

At least 18 years of age

Resident of the District of Columbia or Greater Metropolitan Area

Minority Woman (Either African American or Hispanic)

No more than 30 weeks estimated gestational age

Able to read and speak English

Current cigarette smoker

Baseline saliva continine level equal to or exceeding 30 ng/ml

Expresses desire to quit smoking in this pregnancy

EXCLUSION CRITERIA

Currently participating in any other smoking cessation treatment program

Has the following conditions: heart disease, irregular heart beat, high blood pressure, diabetes, liver condition, kidney condition, stomach ulcer, asthma, chronic pulmonary disease, or skin condition

Currently being treated for psychiatric illness, alcoholism, or other drug addiction.

Related Conditions & MeSH terms

• Pregnancy
• Smoking

Intervention

Behavioral:
• Nicotine Replacement Therapy

Locations

Country	Name	City	State
United States	GW University Medical Center	Washington, D.C.	District of Columbia
United States	Providence Hospital	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Castles A, Adams EK, Melvin CL, Kelsch C, Boulton ML. Effects of smoking during pregnancy. Five meta-analyses. Am J Prev Med. 1999 Apr;16(3):208-15. — View Citation

Kleinman JC, Pierre MB Jr, Madans JH, Land GH, Schramm WF. The effects of maternal smoking on fetal and infant mortality. Am J Epidemiol. 1988 Feb;127(2):274-82. — View Citation

Mathews TJ, Menacker F, MacDorman MF. Infant mortality statistics from the 2000 period linked birth/infant death data set. Natl Vital Stat Rep. 2002 Aug 28;50(12):1-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cotinine validated quit rates.
Secondary	Contine validated significant reduction.