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:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT04417595
Eligibility Criteria:
Inclusion Criteria:
* ≥ 16 or ≤ 40 years of age
* Currently reporting daily cigarette use (≥ 1 CPD; reporting 10 or more CPD prior to pregnancy)
* Between 12 and 24 weeks gestation
* An exhaled carbon monoxide reading of at least 8 ppm
* A cell phone or land line that can be reached directly
Exclusion Criteria:
* Allergy to fish; currently using fish oil supplements
* Active substance abuse (not including supervised buprenorphine use)
* Unable to give consent or obtain assent for minors
* Known fetal abnormality
* Chronic hypertension
* Seizure disorder
* Clotting disorder
* White's classification D or higher diabetes
* Planned cerclage
* Plan move from the Middle-Tennessee area within the next 9-months
* Insufficient time to perform the complete enrollment process
* Barrier to communication (e.g., low English proficiency or hearing/speech impairment)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT04417595
Study Brief:
Protocol Section:
NCT04417595