Impact of e-cigarettes during pregnancy on children's health
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes (ECHO) Study.
This study looks at how using e-cigarettes during pregnancy affects the health of children in their early years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 46 Years |
| Sex | Female |
| Sponsor | University College Dublin Academic / other |
| Locations | 3 sites (Dublin and 2 other locations) |
| Trial ID | NCT06297005 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of e-cigarette use during pregnancy on the health outcomes of children. It aims to gather data on pregnant women who smoke, vape, or are dual users, and follow their children for two years postnatally. The study will assess various health parameters, including respiratory diseases and developmental issues, to understand the long-term implications of e-cigarette exposure in utero. The research is motivated by the rising popularity of e-cigarettes and the need for more evidence regarding their safety compared to traditional tobacco smoking.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 to 46 who smoke, vape, or are dual users, as well as non-smokers willing to participate.
Not a fit: Patients who are pregnant with twins or higher order multiples, or those with major congenital abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of e-cigarettes during pregnancy and inform guidelines for expectant mothers.
How similar studies have performed: While there is limited data on the long-term effects of e-cigarettes during pregnancy, previous studies have shown significant health risks associated with traditional tobacco smoking, indicating a need for further investigation into e-cigarettes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 or greater and less than 46 years of age at booking * Pregnant with a singleton fetus * Smokers (exhaled CO reading of greater than or equal to 4) or * Self-reported vaper or * Dual user (smoker/vaper) * Non-smokers * Able to understand and read English. * Willing to agree to follow-up for the two-year duration of the study in the postnatal period (ie. unlikely to move out of the catchment area). Exclusion Criteria: * Women pregnant with twins or higher order multiples * Late bookers - defined as booking after 24+0 weeks' gestational age * Fetus or infant diagnosed with a major congenital abnormality (major structural abnormality, ie congenital diaphragmatic hernia (CDH), omphalocele, major cardiac defects ie. which require immediate admission to NICU +/- transfer to cardiology for surgery, chromosomal abnormalities, syndromes - Turner's/Noonan's) or a lethal fetal anomaly * Any inherited disorder of metabolism or Cystic Fibrosis on Guthrie Card/ neonatal blood spot screening * History of significant medical disorder in pregnancy e.g. cardiac, haematological, or endocrine disease (including gestational diabetes requiring insulin) * Significant maternal psychiatric disorder, e.g. delusional or psychotic disorders, severe depression requiring hospitalisation, use of \>1 psychotropic drugs for treatment * Serious co-morbid addiction issues e.g. opiate abuse, methadone maintenance program * Severe intellectual disability or lack of capacity
Where this trial is running
Dublin and 2 other locations
- Rotunda Hospital — Dublin, Ireland (Recruiting)
- National Maternity Hospital, Holles Street — Dublin, Ireland (Recruiting)
- Coombe Womens Hospital — Dublin, Ireland (Recruiting)
Study contacts
- Principal investigator: Des Cox, MB BCh BAO — University College Dublin
- Study coordinator: Des W Cox, MB BCh BAO
- Email: desmond.cox@ucd.ie
- Phone: +35314282638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.