Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06297005
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT06297005
Study Brief:
Protocol Section:
NCT06297005