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Fish oil may protect babies of moms who smoke

NCT ID NCT04417595

Prevention Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether omega-3 supplements (fish oil) could help pregnant women who smoke have healthier pregnancies and possibly smoke less. About 237 pregnant smokers took either omega-3 pills or a placebo. The goal was to see if the supplements could reduce preterm labor and help women cut back on cigarettes. The results could lead to a safe way to improve outcomes for both mom and baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

237 people

The number who actually took part.

Started

Nov 2020

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

nicotine dependence Obstetric Labor, Premature

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preterm labor Tobacco use disorder

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.