Immune ResponseNCT02553577
Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes
An observational study of Immune Response and Birth Weight, run by Kristin Ashford at 1 site in United States.
Trial summary
There has been a dramatic escalation of electronic cigarette (e-cig) use among women of childbearing age, including pregnant women. The overall goal of this study is to determine the effects of e-cigs on prenatal biomarkers and birth outcomes. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Birth Weight, Gestational Age
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2016to 28 Feb 2021
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant and postpartum women, age 18-44 who use tobacco products (traditional cigarettes, ENDS, electronic cigarettes)
Who may be able to join
- current tobacco use (traditional cigarettes and/or electronic cigarettes ecig, ENDS)
- pregnant in the first or second trimester
- age 18-44
- can read and write in English.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Prenatal Clinics, Good Samaritian and Polk Dalton
Lexington, Kentucky, 40356
About this study
Official title: The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia
There has been a dramatic escalation of electronic cigarette (e-cig) use among women of childbearing age, including pregnant women. The overall goal of this study is to determine the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more data about these effects be available to better inform women of childbearing age.
Read the detailed description
The United States has the largest and fastest growing market for electronic cigarettes (e-cigs), and adult women of childbearing age are the most common users. However, no data exist regarding the health effects of e-cigs on pregnant women or their babies. It is well known that tobacco use during pregnancy is the most modifiable risk associated with adverse birth outcome, yet nearly one in four women in Kentucky continue to use tobacco products during pregnancy. E-cigs also contain varied (unregulated) concentrations of nicotine, despite nicotine being classified as a pregnancy class-D drug (exhibiting teratogenic effects on the fetus). The addictive nature of nicotine may explain continued use during this vulnerable time.
E-cigs have been the center of recent controversy regarding novel smoking cessation or harm reduction products. There is also concern that marketing strategies promoting harm reduction may increase the appeal and obfuscate the known adverse effects of nicotine on fetal development. In addition to the adverse effects of prenatal nicotine, maternal tobacco use alters immune response during pregnancy, placing women at increased risk for preterm birth.
The overall goal of this study is to determine the effects of e-cigs (and dual use) on perinatal biomarkers and birth outcomes. Three hundred and sixty pregnant women will be recruited. Participants will complete a survey to measure tobacco related behaviors, and provide perinatal biomarkers at four time points (each trimester and postpartum). Data analysis will include a series of repeated ANCOVAs to determine the association of perinatal cigarette smoking (conventional, e-cigarettes-only, and dual use) with perinatal biomarkers. A one-way ANCOVA will be used to determine the association with birth outcomes. Primary biomarker measures include: expired air carbon monoxide, urine and serum cotinine, serum immune markers and urinary NNAL. Gestational age at birth and birth weight are the primary birth outcomes.
Until more data about the effects of e-cigs and dual use on perinatal immune response and birth outcomes are available, promotion of e-cigs during pregnancy would be premature. There is an urgent need to investigate the impact of e-cigs and dual use on perinatal biomarkers and birth outcomes. The lack of research may unnecessarily place women-and their babies -at risk for lifelong adverse health outcomes.
- Conditions
- Immune Response, Birth Weight, Gestational Age
- Keywords
- prenatal, cytokines
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional cigarettes -only | Women who are pregnant and use conventional tobacco products -only | |
| Electronic Cigarette (ecig) (ENDS) -ONLY | Women who are pregnant and use electronic cigarettes (ecigs) -only | |
| Conventional + ecig use (DUAL) | Women who are pregnant and use conventional + ecigs (dual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Investigators will determine if there is a significant difference in gestational age at birth among three groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users
Measured: Up to nine months
Secondary outcomes (2)
Infant birth weight
Investigators will determine if there is a significant difference in birth weight among three groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users
Measured: Up to two hours
Change in Prenatal Cytokine level in each trimester and postpartum
Investigators will determine if there are significant changes in cytokine level between trimesters based on groups hree groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users
Measured: 14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start13 Jan 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Ashford
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor-investigator, Kristin Ashford, University of Kentucky
- Investigators
- Kristin B Ashford, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553577
- Sponsor's protocol ID
- 1R01DA040694-01
- Status last verified
- Jul 2021
- First submitted
- 4 Sep 2015
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes in Appalachia
- ClinicalTrials.gov ID
- NCT02553577
- Acronym / sponsor ID
- 1R01DA040694-01
- Conditions
- Immune Response, Birth Weight, Gestational Age
- Keywords
- prenatal, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Kristin AshfordUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
There has been a dramatic escalation of electronic cigarette (e-cig) use among women of childbearing age, including pregnant women. The overall goal of this study is to determine the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more data about these effects be available to better inform women of childbearing age.
Detailed description
The United States has the largest and fastest growing market for electronic cigarettes (e-cigs), and adult women of childbearing age are the most common users. However, no data exist regarding the health effects of e-cigs on pregnant women or their babies. It is well known that tobacco use during pregnancy is the most modifiable risk associated with adverse birth outcome, yet nearly one in four women in Kentucky continue to use tobacco products during pregnancy. E-cigs also contain varied (unregulated) concentrations of nicotine, despite nicotine being classified as a pregnancy class-D drug (exhibiting teratogenic effects on the fetus). The addictive nature of nicotine may explain continued use during this vulnerable time.
E-cigs have been the center of recent controversy regarding novel smoking cessation or harm reduction products. There is also concern that marketing strategies promoting harm reduction may increase the appeal and obfuscate the known adverse effects of nicotine on fetal development. In addition to the adverse effects of prenatal nicotine, maternal tobacco use alters immune response during pregnancy, placing women at increased risk for preterm birth.
The overall goal of this study is to determine the effects of e-cigs (and dual use) on perinatal biomarkers and birth outcomes. Three hundred and sixty pregnant women will be recruited. Participants will complete a survey to measure tobacco related behaviors, and provide perinatal biomarkers at four time points (each trimester and postpartum). Data analysis will include a series of repeated ANCOVAs to determine the association of perinatal cigarette smoking (conventional, e-cigarettes-only, and dual use) with perinatal biomarkers. A one-way ANCOVA will be used to determine the association with birth outcomes. Primary biomarker measures include: expired air carbon monoxide, urine and serum cotinine, serum immune markers and urinary NNAL. Gestational age at birth and birth weight are the primary birth outcomes.
Until more data about the effects of e-cigs and dual use on perinatal immune response and birth outcomes are available, promotion of e-cigs during pregnancy would be premature. There is an urgent need to investigate the impact of e-cigs and dual use on perinatal biomarkers and birth outcomes. The lack of research may unnecessarily place women-and their babies -at risk for lifelong adverse health outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional cigarettes -only | – | –Women who are pregnant and use conventional tobacco products -only |
| Electronic Cigarette (ecig) (ENDS) -ONLY | – | –Women who are pregnant and use electronic cigarettes (ecigs) -only |
| Conventional + ecig use (DUAL) | – | –Women who are pregnant and use conventional + ecigs (dual) |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant and postpartum women, age 18-44 who use tobacco products (traditional cigarettes, ENDS, electronic cigarettes)
Key inclusion criteria (4 listed)
- current tobacco use (traditional cigarettes and/or electronic cigarettes ecig, ENDS)
- pregnant in the first or second trimester
- age 18-44
- can read and write in English.
Key exclusion criteria (1 listed)
- -
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
Gestational age at birth
Time frame: Up to nine months
Investigators will determine if there is a significant difference in gestational age at birth among three groups: pregnant women who use conventional tobacco-only; pregnant women who use e-cig only; and dual users
2 secondary outcomes
Infant birth weight
Time frame: Up to two hours
Change in Prenatal Cytokine level in each trimester and postpartum
Time frame: 14 weeks; 24 weeks; 34 weeks; 48 weeks and up to 64 weeks
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 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Kristin B Ashford, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Response and Birth Weight, run by Kristin Ashford at 1 site 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 4 inclusion and 1 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Gestational age at birth (time frame: Up to nine 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 7 Jul 2021.