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Omega-3 Fatty Acids

Omega-3 Fatty Acid Supplements for Preterm Labor Prevention in Smokers (INFANTS Trial)

Phase 2

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 16 or ≤ 40 years of age

Between 12 and 24 weeks gestation

Must not have

Clotting disorder

Planned cerclage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Summary

This trial will test whether or not supplementing with n-3 LCPUFAs (a type of Omega-3 fatty acid) can help pregnant smokers quit smoking and/or reduce the risk of preterm labor.

Who is the study for?

This trial is for pregnant smokers aged 16-40, who are between 12 and 24 weeks gestation, smoke at least one cigarette per day (previously ten before pregnancy), and have a carbon monoxide reading of at least 8 ppm. They must not be using fish oil supplements or have allergies to fish, substance abuse issues, certain medical conditions like chronic hypertension or clotting disorders, nor plans to move from Middle-Tennessee within nine months.

What is being tested?

The study tests if Omega-3 acids in fish oil can help prevent premature labor in pregnant women who smoke by potentially reducing nicotine cravings and cigarette use. It's a double-blinded study with two groups: one taking fish oil and the other olive oil as a placebo. The effects on both preterm labor risk and smoking behavior will be monitored.

What are the potential side effects?

While the side effects aren't detailed here, typical ones associated with Omega-3 supplements may include an upset stomach, nausea, or a fishy aftertaste. Olive oil is generally well-tolerated but could cause similar digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 16 and 40 years old.

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I am between 3 and 6 months pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder.

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I am scheduled for a procedure to prevent premature birth.

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I have a seizure disorder.

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I am unable to give consent for myself or my child.

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I am allergic to fish and/or currently taking fish oil supplements.

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I have long-term high blood pressure.

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My diabetes is classified as severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cigarettes per day

Gestational age at delivery

Secondary study objectives

Apgar score

Individualized birth weight Z-score (adjusted for gestational age and maternal weight)

Percent of neonates with a congenital abnormality

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fish OilExperimental Treatment1 Intervention

Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).

Group II: Olive OilPlacebo Group1 Intervention

Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules

0 / 9Eligibility criteria met