Electronic Cigarette Use During Pregnancy (NCT03480373) | Clinical Trial Compass
CompletedNot Applicable
Electronic Cigarette Use During Pregnancy
United States182 participantsStarted 2018-06-18
Plain-language 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. 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.
Who can participate
Age range
16 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared toxicant exposure between pregnant women who used e-cigarettes versus conventional cigarettes — based on what those findings showed, which option did researchers find was less harmful during pregnancy, or were the risks similar?
2Since this study specifically looked at pregnant women, how might the toxicant exposure data from this trial be relevant to my own situation or health history with smoking?
3This trial is now completed — has my doctor seen the published results, and what do those results suggest about whether switching from cigarettes to e-cigarettes during pregnancy actually reduces harmful chemical exposure?
4Given that this was an observational comparison study rather than a treatment trial, how should I weigh its findings when making decisions about smoking cessation options, and are there proven cessation programs my doctor would recommend instead?
5Are there any follow-up studies building on this research that my doctor thinks I should know about, particularly ones looking at longer-term health outcomes for mothers or babies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the overall toxicant exposure in pregnant women who use electronic cigarettes compared to women who smoke conventional cigarettes.