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

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:
- EligibilityCriteria: 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 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant woment - MinimumAge: 18 Years - MaximumAge: 46 Years - StdAgeList: Adult - StudyPopulation: 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. - SamplingMethod: Non-Probability Sample