Examining a New Biomarker of Nicotine Use Among Pregnant Women Who Participated in the New England SCRIPT

Smoking Clinical Trial

— SCRIPT  

Official title:

Assessment of Nicotine Metabolism Among Underserved Pregnant Women From NE SCRIPT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519766
• Other study ID #: 1392
• Status: Completed
• Phase: N/A
• First received: August 21, 2007
• Last updated: May 22, 2014
• Start date: September 1997
• Est. completion date: November 2002

Study information

• Verified date: May 2014
• Source: Memorial Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: November 2002
• Est. primary completion date: March 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participated in the New England SCRIPT study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

Parker DR, Windsor RA, Roberts MB, Hecht J, Hardy NV, Strolla LO, Lasater TM. Feasibility, cost, and cost-effectiveness of a telephone-based motivational intervention for underserved pregnant smokers. Nicotine Tob Res. 2007 Oct;9(10):1043-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemically confirmed smoking quit rates