Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341432
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Effectiveness of Nicotine Replacement Therapy in Reducing the Risk of Nicotine Exposure in Pregnant Minority Smokers
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nicotine Replacement Therapy Methods for Pregnant Women
Status:
COMPLETED
Status Verified Date:
2011-04-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 womens permission their medical records health and treatments during pregnancy are reviewed At the end of the pregnancy the infants weight and health are also reviewed
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 womens permission their medical records health and treatments during pregnancy are reviewed At the end of the pregnancy the infants weight and health are also reviewed
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-N227 | None | None | None |