Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Women's Studies |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2005 |
| End Date: | April 2011 |
Nicotine Replacement Therapy Methods for Pregnant Women
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.
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.
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.
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.
- 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.
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