Cigarette Smoking-Related CarcinomaNCT03480373
Electronic Cigarette Use During Pregnancy
An observational study of Cigarette Smoking-Related Carcinoma, run by UConn Health at 6 sites in United States.
Trial 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 cigarettes. Aim 2. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- How many people
- 182 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Jun 2018to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Child, Adult
Study population: * Age: at least 16 years of age * Ethnicity: Hispanic and non-Hispanic. All race and ethnic groups will be eligible * Gender: Female * Other characteristics - (e.g. primary language etc.): English or Spanish speaking
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado
Denver, Colorado, 80045
Denver Health Medical Center
Denver, Colorado, 80204
UCONN Health
Farmington, Connecticut, 06032
Women's Ambulatory Health Services at Hartford Hospital
Hartford, Connecticut, 06106
East Tennessee State University
Johnson City, Tennessee, 37614
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
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 cigarettes.
Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes.
Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.
Read the 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 toxicant exposure to cigarettes and e-cigs in a sample of pregnant smokers who are using these products. Although studies have reported on toxic exposures with e-cigs, this is the first study to apply toxic exposure tests to pregnant women.
Second this is the first study to examine the impact of electronic cigarette use on birth outcomes in pregnant smokers. Although e-cigarettes are similar to tobacco cigarettes in that they deliver nicotine, they are distinguished from tobacco cigarettes in that they do not contain many toxic substances such as carbon monoxide and volatile organic compounds. Consequently, similar to nicotine replacement therapies they have the potential to improve birth outcomes. However, it possible that there may be unanticipated negative effects on birth outcomes, and this study could provide a signal for potential other adverse effects (i.e., miscarriages etc.). Third, this study is the first to examine whether e-cigs alter carcinogen exposure to the fetus, which has been implicated in causing low birth weight and in long-term cancer risk for infants born to smokers. Finally, this is the first study to explore formaldehyde in urine as a measurement of conventional smoking and electronic cigarette use.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Keywords
- Nicotine, Nicotine addiction, Tobacco Use Disorder, Pregnancy, Electronic cigarettes, Cigarettes, Vaping, Carcinoma, Pregnant, Birth Outcomes, E-liquid
- Medical subject headings
- Tobacco Use Disorder, Vaping, Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.
The overall toxicant exposure will be measured at each trimester and adjusted for potential confounding covariates. A multivariate analysis of variance (MANOVA) with repeated measures will be used to evaluate the pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes at each trimester.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start18 Jun 2018
- Primary completion31 May 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Hartford Hospital, Roswell Park Cancer Institute, Denver Health Medical Center, Baystate Medical Center, East Tennessee State University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erin Mead-Morse, UConn Health
- Investigators
- Erin Mead-Morse, MD, MPH, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480373
- Sponsor's protocol ID
- 17-180-6
- Other IDs
- 5R01CA207491-04
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarette Use During Pregnancy
- ClinicalTrials.gov ID
- NCT03480373
- Acronym / sponsor ID
- 17-180-6
- Conditions
- Cigarette Smoking-Related Carcinoma
- Keywords
- Nicotine, Nicotine addiction, Tobacco Use Disorder, Pregnancy, Electronic cigarettes, Cigarettes, Vaping, Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Hartford Hospital, Roswell Park Cancer Institute, Denver Health Medical Center, Baystate Medical Center, East Tennessee State University, National Cancer Institute (NCI)
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cigarettes.
Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes.
Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.
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 toxicant exposure to cigarettes and e-cigs in a sample of pregnant smokers who are using these products. Although studies have reported on toxic exposures with e-cigs, this is the first study to apply toxic exposure tests to pregnant women.
Second this is the first study to examine the impact of electronic cigarette use on birth outcomes in pregnant smokers. Although e-cigarettes are similar to tobacco cigarettes in that they deliver nicotine, they are distinguished from tobacco cigarettes in that they do not contain many toxic substances such as carbon monoxide and volatile organic compounds. Consequently, similar to nicotine replacement therapies they have the potential to improve birth outcomes. However, it possible that there may be unanticipated negative effects on birth outcomes, and this study could provide a signal for potential other adverse effects (i.e., miscarriages etc.). Third, this study is the first to examine whether e-cigs alter carcinogen exposure to the fetus, which has been implicated in causing low birth weight and in long-term cancer risk for infants born to smokers. Finally, this is the first study to explore formaldehyde in urine as a measurement of conventional smoking and electronic cigarette use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- * Age: at least 16 years of age * Ethnicity: Hispanic and non-Hispanic. All race and ethnic groups will be eligible * Gender: Female * Other characteristics - (e.g. primary language etc.): English or Spanish speaking
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.
Time frame: 9 months
The overall toxicant exposure will be measured at each trimester and adjusted for potential confounding covariates. A multivariate analysis of variance (MANOVA) with repeated measures will be used to evaluate the pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes at each trimester.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Mead-Morse, MD, MPH principal investigator
UConn Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking-Related Carcinoma, run by UConn Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.