Details

Autor(en) / Beteiligte

• HARPER, Margaret
• THOM, Elizabeth
• PEACEMAN, Alan M
• MERCER, Brian M
• SCISCIONE, Anthony
• ROUSE, Dwight J
• RAMIN, Susan M
• ANDERSON, Garland D
• KLEBANOFF, Mark A
• THORP, John
• SOROKIN, Yoram
• VARNER, Michael W
• WAPNER, Ronald J
• CARITIS, Steve N
• IAMS, Jay D
• CARPENTER, Marshall W

Titel

Omega-3 Fatty Acid Supplementation to Prevent Recurrent Preterm Birth: A Randomized Controlled Trial

Ist Teil von

• Obstetrics and gynecology (New York. 1953), 2010-02, Vol.115 (2), p.234-242

Ort / Verlag

Hagerstown, MD: Lippincott Williams & Wilkins

Erscheinungsjahr

2010

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• To assess whether the addition of an omega-3 long-chain polyunsaturated fatty acid supplement would reduce preterm birth in women with at least one prior spontaneous preterm birth receiving 17alpha-hydroxyprogesterone caproate. We conducted a randomized, double-masked, placebo-controlled trial in 13 centers. Women with a history of prior spontaneous singleton preterm birth and a current singleton gestation were assigned to either a daily omega-3 supplement (1,200 mg eicosapentaenoic acid and 800 mg docosahexaenoic acid) or matching placebo from 16-22 through 36 weeks of gestation. All participants received weekly intramuscular 17alpha-hydroxyprogesterone caproate (250 mg). The primary study outcome was delivery before 37 weeks of gestation. A sample size of 800 was necessary to have 80% power to detect a 30% reduction in the primary outcome from 30%, assuming a type I error two-sided of 5%. A total of 852 women were included, and none was lost to follow up. Delivery before 37 weeks of gestation occurred in 37.8% (164/434) of women in the omega-3 group and 41.6% (174/418) in the placebo group (relative risk 0.91, 95% confidence interval 0.77-1.07). Omega-3 long-chain polyunsaturated fatty acid supplementation offered no benefit in reducing preterm birth among women receiving 17alpha-hydroxyprogesterone caproate who have a history of preterm delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00135902. I.