E-cigarette use in reproductive-aged women and pregnancy: a rising health concern.
Shruti Agarwal, Mark P Trolice, Steven R Lindheim
https://pubmed.ncbi.nlm.nih.gov/32222252Actively Recruiting
Age: 18Years - 46Years
FEMALE
Healthy Volunteers
ID06297005
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study
Led by University College Dublin · Updated on 2024-04-12
1200
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University College Dublin
Lead Sponsor
R
Royal College of Surgeons, Ireland
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the long-term health effects on children born to mothers who used e-cigarettes during pregnancy. It focuses on important outcomes like birth weight, nutrition, brain development, and respiratory health. The study compares children of mothers who vape, smoke tobacco, or neither, aiming to fill gaps in knowledge about the safety and impact of e-cigarette exposure before birth. Pregnant women who use e-cigarettes, tobacco, or neither will be recruited and followed from pregnancy through their child's first two years. Detailed records of maternal e-cigarette and tobacco use will be collected and verified with monitoring tools. After birth, children's growth, neurocognitive development, and respiratory health will be assessed at 6 months, 1 year, and 2 years. Participants will undergo various assessments including growth measurements, neurocognitive tests, and respiratory questionnaires. Maternal health and smoking exposure will be monitored during pregnancy and after birth. The study will measure outcomes like preterm birth, low birth weight, and wheezing during the first two years. Follow-up visits will occur regularly to collect data on child development and health, lasting a total of two years post-delivery.
CONDITIONS
Brief Title
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study
Who Can Participate
Age: 18Years - 46Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women aged 18 or greater and less than 46 years of age at booking
- Pregnant with a singleton fetus
- Current smokers (exhaled CO reading of 4 or higher) or self-reported vapers or dual users (smoker and vaper)
- Non-smokers
- Able to understand and read English
- Willing to agree to follow-up for two years after birth without planning to move away
You will not qualify if you...
- Pregnant with twins or higher order multiples
- Booking pregnancy care after 24 weeks gestation
- Fetus or infant with major congenital abnormalities or lethal fetal anomalies
- Inherited metabolic disorders or cystic fibrosis detected by neonatal screening
- Significant medical disorders during pregnancy such as cardiac, haematological, or endocrine diseases
- Severe psychiatric disorders or use of multiple psychotropic drugs
- Serious addiction issues like opiate abuse or methadone maintenance
- Severe intellectual disability or lack of capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From recruitment during pregnancy up to 2 years after birth
Participants who are pregnant women classified as vapers, smokers, or non-smokers are observed throughout pregnancy and their children are followed for health outcomes.
Visits at recruitment, 20 weeks, 34 weeks gestation, at birth, and follow-ups at 6, 12, and 24 months after birth
Trial Site Locations
Total: 3 locations
1
Rotunda Hospital
Dublin, Ireland, D01 P5W9
Actively Recruiting
2
National Maternity Hospital, Holles Street
Dublin, Ireland, D02 YH21
Actively Recruiting
3
Coombe Womens Hospital
Dublin, Ireland, D08 XW7X
Actively Recruiting
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Research Team
D
Des W Cox, MB BCh BAO
C
Carmen Regan, FRCOG
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Exposure to Tobacco, Environmental Tobacco Smoke and Nicotine in Pregnancy: A Pragmatic Overview of Reviews of Maternal and Child Outcomes, Effectiveness of Interventions and Barriers and Facilitators to Quitting.
Gillian S Gould, Alys Havard, Ling Li Lim...
https://pubmed.ncbi.nlm.nih.gov/32204415Tobacco and pregnancy.
John M Rogers
https://pubmed.ncbi.nlm.nih.gov/19450949The effects of nicotine on human fetal development.
Bradley D Holbrook
https://pubmed.ncbi.nlm.nih.gov/27297020Evolution of Electronic Cigarette Brands From 2013-2014 to 2016-2017: Analysis of Brand Websites.
Greta Hsu, Jessica Y Sun, Shu-Hong Zhu
https://pubmed.ncbi.nlm.nih.gov/29530840e-Cigarettes More Effective Than Nicotine Replacement for Cessation of Tobacco Use in Adults.
Mark H Ebell
https://pubmed.ncbi.nlm.nih.gov/31573159A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.
Peter Hajek, Anna Phillips-Waller, Dunja Przulj...
https://pubmed.ncbi.nlm.nih.gov/30699054Efficacy of Electronic Cigarettes for Smoking Cessation: A Systematic Review and Meta-Analysis.
Shorouk Ibrahim, Mohamed Habiballah, Iman El Sayed
https://pubmed.ncbi.nlm.nih.gov/33327728E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis.
Richard J Wang, Sudhamayi Bhadriraju, Stanton A Glantz
https://pubmed.ncbi.nlm.nih.gov/33351653Electronic cigarettes for smoking cessation.
Jamie Hartmann-Boyce, Hayden McRobbie, Nicola Lindson...
https://pubmed.ncbi.nlm.nih.gov/33052602