Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519766
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2007-08-21
Brief Title:
Examining a New Biomarker of Nicotine Use Among Pregnant Women Who Participated in the New England SCRIPT
Sponsor:
Memorial Hospital of Rhode Island
Organization:
Memorial Hospital of Rhode Island
Study Overview
Official Title:
Assessment of Nicotine Metabolism Among Underserved Pregnant Women From NE SCRIPT
Status:
COMPLETED
Status Verified Date:
2014-05
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:
SCRIPT
Brief Summary:
Smoking during pregnancy is the single most preventable cause of illness and death among mothers and infants Because of the stigma associated with tobacco use during pregnancy pregnant women are less likely to disclose their smoking status to doctors or study researchers This study will evaluate the use of a new biomarker of nicotine metabolism to estimate tobacco use in a group of pregnant women who participated in the New England Smoking Cessation and Reduction in Pregnancy Trial SCRIPT
Detailed Description:
According to one source of 2004 data approximately 13 of pregnant women reported smoking during the last 3 months of pregnancy This is a major public health concern because smoking during pregnancy can lead to pregnancy complications and serious health problems in newborns including a 50 increase in risk of low birth weight The effect of tobacco exposure on infant birth weight may have long-term consequences as fetal growth appears to be a predictor of coronary heart disease later in life Pregnant women participating in clinical trials are less likely to disclose that they are smoking because of a desire to please study researchers Therefore a way to test for nicotine exposure is needed to accurately determine the number of pregnant women who smoke and the number of women who quit smoking during pregnancy
A new biomarker of nicotine metabolism the ratio of trans-3-hydroxycotinine to cotinine 3-HCC may be an accurate estimate of nicotine exposure from tobacco Trans-3-hydroxycotinine and cotinine are both byproducts of nicotine that are excreted in the urine The purpose of this study is to evaluate the effectiveness of the 3-HCC ratio as a measure of prenatal tobacco smoke exposure between the first and third trimesters of pregnancy and to examine the use of the 3-HCC ratio in relation to infant birth weight In addition changes in the 3-HCC metabolism during pregnancy will be analyzed according to different racial and ethnic groups
This study will enroll pregnant women who participated in the New England SCRIPT study which drew from a predominately low-income multi-ethnic population There will be no study visits specifically for this study Study researchers will analyze participants SCRIPT study data from four surveys collected at baseline during the third trimester and 6 weeks and 6 months following childbirth Researchers will analyze the following study data smoking behavior attitudes toward smoking self-reported smoking status number of cigarettes smoked per day use of the assigned smoking cessation materials and infant birth weight Demographic information including the participants age race and ethnicity years of education age of the fetus at study entry and smoking practices of other household members will also be examined Urine samples collected from participants during the SCRIPT study will be analyzed for the 3-HCC biomarker This current study will use a new technique liquid chromatographyatmospheric pressure ionization tandem spectrometry to measure both cotinine and hydroxycotinine levels in the urine samples
A new biomarker of nicotine metabolism the ratio of trans-3-hydroxycotinine to cotinine 3-HCC may be an accurate estimate of nicotine exposure from tobacco Trans-3-hydroxycotinine and cotinine are both byproducts of nicotine that are excreted in the urine The purpose of this study is to evaluate the effectiveness of the 3-HCC ratio as a measure of prenatal tobacco smoke exposure between the first and third trimesters of pregnancy and to examine the use of the 3-HCC ratio in relation to infant birth weight In addition changes in the 3-HCC metabolism during pregnancy will be analyzed according to different racial and ethnic groups
This study will enroll pregnant women who participated in the New England SCRIPT study which drew from a predominately low-income multi-ethnic population There will be no study visits specifically for this study Study researchers will analyze participants SCRIPT study data from four surveys collected at baseline during the third trimester and 6 weeks and 6 months following childbirth Researchers will analyze the following study data smoking behavior attitudes toward smoking self-reported smoking status number of cigarettes smoked per day use of the assigned smoking cessation materials and infant birth weight Demographic information including the participants age race and ethnicity years of education age of the fetus at study entry and smoking practices of other household members will also be examined Urine samples collected from participants during the SCRIPT study will be analyzed for the 3-HCC biomarker This current study will use a new technique liquid chromatographyatmospheric pressure ionization tandem spectrometry to measure both cotinine and hydroxycotinine levels in the urine samples
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