Examining a New Biomarker of Nicotine Use Among Pregnant Women Who Participated in the New England Smoking Cessation and Reduction in Pregnancy Trial (SCRIPT)
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Purpose
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).
| Condition |
|---|
|
Smoking Tobacco Use Disorder |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Assessment of Nicotine Metabolism Among Underserved Pregnant Women From NE SCRIPT |
- biochemically confirmed smoking quit rates
| Estimated Enrollment: | 252 |
| Study Start Date: | September 1997 |
| Study Completion Date: | November 2002 |
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-HC:C), 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-HC:C 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-HC:C ratio in relation to infant birth weight. In addition, changes in the 3-HC:C 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 participant's 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-HC:C biomarker. This current study will use a new technique, liquid chromatography/atmospheric pressure ionization tandem spectrometry, to measure both cotinine and hydroxycotinine levels in the urine samples.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participated in the New England SCRIPT study
Contacts and Locations| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Principal Investigator: | Donna R. Parker, ScD | Memorial Hospital of Rhode Island |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00519766 History of Changes |
| Other Study ID Numbers: | 1392, R21 HL087879-01 |
| Study First Received: | August 21, 2007 |
| Last Updated: | December 17, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Ratio of 3-Hydroxycotinine to Cotinine Nicotine Metabolism Pregnancy |
Additional relevant MeSH terms:
|
Smoking Tobacco Use Disorder Habits Substance-Related Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013