Status:
ACTIVE_NOT_RECRUITING
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Labor
Tobacco Use Disorder
Eligibility:
FEMALE
16-40 years
Phase:
PHASE2
Brief Summary
Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during pregnancy are...
Detailed Description
Tobacco use is the most important modifiable risk factor associated with adverse pregnancy outcomes and increases the risk of preterm birth, intrauterine growth restriction and sudden infant death syn...
Eligibility Criteria
Inclusion
- ≥ 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
- 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)
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04417595
Start Date
November 10 2020
End Date
January 8 2026
Last Update
December 15 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232