The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-46
SponsorUniversity College Dublin

About this trial

Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.

The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The population under scrutiny in this prospective observational cohort are adult (18 to 46 years of age) women pregnant with a singleton, non-anomalous fetus, who can understand English and can give consent to partake in the study for its duration. Participants who smoke cigarettes, use vapes and controls will be invited to partake when they attend for the booking appointment at any of the Dublin maternity hospitals. They will be given written information about the study in their first visit booking back either in electronic or hardcopy format.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 3 trial groups
Group A: Vapers
Group B: Smokers
Group C: Controls

Trial outcomes

Primary outcomes

1

Incidence of preterm birth

Obstetric

Time frame
Up to the time of birth
2

Incidence of low birth weight

Neonatal: Defined as less than the 10th centile

Time frame
Up to the time of birth
3

Incidence of wheeze during the first two years of life

Paediatric

Time frame
6, 12 and 24 months

Secondary outcomes

1

Incidence of smoking and vaping

Obstetric and paediatric

Time frame
Through study completion, up to 24 months
2

Estimated foetal weight

Obstetric

Time frame
20 and 34 weeks gestation
3

Trends in carbon monoxide levels

Obstetric

Time frame
Antenatal: At time of recruitment, 20 weeks, 34 weeks; postnatally: birth, 12 and 24 months
4

Blood pressure measurements (both diastolic and systolic)

Obstetric

Time frame
At time of recruitment, 20 weeks, 34 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College Dublin

Lead sponsor

Royal College of Surgeons, Ireland

Collaborator