Omega-3 Fatty Acid Supplements for Preterm Labor Prevention in Smokers
(INFANTS Trial)
Trial Summary
What is the purpose of this trial?
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 low, particularly in underserved populations, and currently approved pharmacotherapies for smoking cessation either are considered unsafe in pregnancy or have uncertain effectiveness. Identifying safe and effective interventions, which might mitigate the adverse effects of smoking on maternal-fetal outcomes, is a major public health priority. We hypothesize that smoking-induced n-3 LCPUFA relative deficiencies may be an important mechanism contributing to tobacco-related adverse pregnancy outcomes and that n-3 LCPUFA supplementation specifically targeted to pregnant smokers may reduce these complications. Support for this hypothesis comes from a recent secondary analysis of the Omega-3 Fatty Acids Supplementation to Prevent Preterm Birth trial that found that only smokers taking n-3 LCPUFAs had a reduction in preterm labor risk as compared to non-smokers. While compelling, this study was a post hoc analysis that included only a small sample of smokers and did not collect data on smoking behaviors during follow up. Yet the ascertainment of longitudinal smoking behavior is critical, as some clinical studies have found that supplemental n-3 LCPUFAs might also reduce nicotine cravings, and lower daily cigarette use. Thus, smokers may doubly benefit from replenishing n-3 LCPUFAs via lower risk of preterm labor and/or increased smoking cessation. To address these knowledge gaps, we are proposing a multi-center, randomized, placebo-controlled, double-blinded study of n-3 LCPUFA supplementation in 400 pregnant smokers. We will collect detailed information on smoking behavior, validated biological markers of cigarette exposure (urinary cotinine, end-expiratory carbon monoxide) and biomarkers of n-3 LCPUFA status (red blood cell phospholipid membrane fatty acids). Our specific aims of this proposal are to 1) determine the effect of supplemental n-3 LCPUFAs on gestational age at delivery and preterm labor in pregnant smokers and 2) determine the effect of n-3 LCPUFA supplementation on tobacco use in pregnant smokers. We will recruit potential participants from eight obstetrics clinics across the Middle-Tennessee area. Our study could have a major translational impact on both adverse tobacco-related birth outcomes and smoking cessation efforts.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently using fish oil supplements, you cannot participate in the trial.
What data supports the idea that Omega-3 Fatty Acid Supplements for Preterm Labor Prevention in Smokers is an effective treatment?
The available research shows that omega-3 fatty acid supplements, like fish oil, may help delay preterm labor. Studies have found that populations with high fish consumption tend to have longer pregnancies. In experiments with sheep, omega-3 supplements delayed labor and even stopped contractions in some cases. This suggests that omega-3s could be useful in preventing early births in humans. However, while some studies show potential benefits, there is no widespread recommendation for their use in preventing preterm labor.12345
What safety data exists for omega-3 supplements in preventing preterm labor?
The safety of omega-3 fatty acid supplements, including EPA and DHA, has been evaluated in various studies. These supplements are generally considered safe and are available over the counter. Randomized controlled trials and systematic reviews have shown that omega-3 supplementation during pregnancy may delay the timing of birth and reduce the risk of early preterm delivery. No significant adverse effects on maternal or child health outcomes have been reported, making them a potentially safe option for preventing preterm labor.12467
Is Fish Oil a promising treatment for preventing preterm labor in smokers?
Yes, Fish Oil, which contains Omega-3 fatty acids, is a promising treatment for preventing preterm labor. Studies show that Omega-3s can help extend pregnancy duration, especially in populations with high fish consumption. This suggests that taking Omega-3 supplements like Fish Oil may help delay preterm birth.12489
Research Team
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Fish Oil (Containing Omega-3 Acids) (Omega-3 Fatty Acids)
Fish Oil (Containing Omega-3 Acids) is already approved in Canada for the following indications:
- Dietary supplement
- Hypertriglyceridemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Jeffrey R. Balser
Vanderbilt University Medical Center
Chief Executive Officer since 2009
MD and PhD from Vanderbilt University
Rick W. Wright
Vanderbilt University Medical Center
Chief Medical Officer since 2023
MD from University of Missouri-Columbia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Dr. Diana W. Bianchi
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chief Executive Officer since 2016
MD from Stanford University
Dr. Alison Cernich
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chief Medical Officer since 2020
PhD in Clinical Psychology from University of Maryland