title: Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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%.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00135902.
  
  
  METHODS
  I.
authors.affiliation: From the Departments of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, North Carolina; the University of North Carolina, Chapel Hill, North Carolina; Wayne State University, Detroit, Michigan; the University of Utah Health Sciences Center, Salt Lake City, Utah; Columbia University, New York, New York; the University of Pittsburgh, Pittsburgh, Pennsylvania; The Ohio State University, Columbus, Ohio; Women and Infants Hospital, Brown University, Providence, Rhode Island; Northwestern University, Chicago, Illinois; Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio; Drexel University College of Medicine, Philadelphia, Pennsylvania; the University of Alabama at Birmingham, Birmingham, Alabama; the University of Texas at Houston, Houston, Texas; the University of Texas Medical Branch, Galveston, Texas; and the George Washington University Biostatistics Center, Washington DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
authors.forename: Margaret
authors.initials: M
authors.lastname: Harper
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Thom
authors.forename: Mark A
authors.initials: MA
authors.lastname: Klebanoff
authors.forename: John
authors.initials: J
authors.lastname: Thorp
authors.forename: Yoram
authors.initials: Y
authors.lastname: Sorokin
authors.forename: Michael W
authors.initials: MW
authors.lastname: Varner
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Wapner
authors.forename: Steve N
authors.initials: SN
authors.lastname: Caritis
authors.forename: Jay D
authors.initials: JD
authors.lastname: Iams
authors.forename: Marshall W
authors.initials: MW
authors.lastname: Carpenter
authors.forename: Alan M
authors.initials: AM
authors.lastname: Peaceman
authors.forename: Brian M
authors.initials: BM
authors.lastname: Mercer
authors.forename: Anthony
authors.initials: A
authors.lastname: Sciscione
authors.forename: Dwight J
authors.initials: DJ
authors.lastname: Rouse
authors.forename: Susan M
authors.initials: SM
authors.lastname: Ramin
authors.forename: Garland D
authors.initials: GD
authors.lastname: Anderson
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006908:Hydroxyprogesterones / Q000008:administration & dosage; D007231:Infant, Newborn; D007273:Injections, Intramuscular; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D045167:Progesterone Congeners / Q000008:administration & dosage; D012008:Recurrence
chemical_list: D015525:Fatty Acids, Omega-3; D006908:Hydroxyprogesterones; D045167:Progesterone Congeners; D000077713:17 alpha-Hydroxyprogesterone Caproate