Status:
COMPLETED
Electronic Cigarette Use During Pregnancy
Lead Sponsor:
UConn Health
Collaborating Sponsors:
University of Colorado, Denver
Hartford Hospital
Conditions:
Cigarette Smoking-Related Carcinoma
Eligibility:
FEMALE
16-45 years
Brief Summary
Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigare...
Detailed Description
In addition to examining characteristics of pregnant e-cig users as well as patterns of their product use, this study is innovative in several ways. First, it is the first known study to examine toxic...
Eligibility Criteria
Inclusion
- cigarette smokers who exclusively smoke conventional cigarettes daily, or who use e-cigs daily, or who use either product daily and the other product at least weekly.
- Participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users.
- at least 16 years of age
- able to speak English or Spanish;
- able to read and sign consent form
- intent to carry pregnancy to term.
Exclusion
- current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance)
- participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
- Regular use of tobacco products other than conventional or e-cigs
Key Trial Info
Start Date :
June 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT03480373
Start Date
June 18 2018
End Date
August 30 2023
Last Update
September 21 2023
Active Locations (6)
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1
University of Colorado
Denver, Colorado, United States, 80045
2
Denver Health Medical Center
Denver, Colorado, United States, 80204
3
UCONN Health
Farmington, Connecticut, United States, 06032
4
Women's Ambulatory Health Services at Hartford Hospital
Hartford, Connecticut, United States, 06106