Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
Completed · Phase 3 · Has a placebo group
Conditions studied: Preterm Birth
In brief
A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."
Key facts
- Study ID
- NCT00135902
- Run by
- The George Washington University Biostatistics Center
- People needed
- 800
- Starts
- 2005-02-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2019-07-12
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
You may not qualify if…
- Major fetal anomaly or demise
- Regular intake of fish oil supplements
- Daily use of nonsteroidal anti-inflammatory agents
- Allergy to fish or fish products
- Gluten intolerant
- Heparin use or known thrombophilia
- Hemophilia
- Planned termination
- Current hypertension or current use of antihypertensive medications
- Type D, F or R diabetes
- Maternal medical complications
- Current or planned cerclage
- Illicit drug or alcohol abuse during current pregnancy
- Delivery at a non-Network hospital
- Participation in another pregnancy intervention study
- Participation in this trial in a previous pregnancy
Where it is running
- University of Alabama - Birmingham — Birmingham, Alabama, United States
- Northwestern University — Chicago, Illinois, United States
- Wayne State University — Detroit, Michigan, United States
- Columbia University — New York, New York, United States
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
- Case Western University — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Drexel University — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Brown University — Providence, Rhode Island, United States
- University of Utah Medical Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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