Document Detail


Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial.
MedLine Citation:
PMID:  20093894     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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). CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00135902. LEVEL OF EVIDENCE: I.
Authors:
Margaret Harper; Elizabeth Thom; Mark A Klebanoff; John Thorp; Yoram Sorokin; Michael W Varner; Ronald J Wapner; Steve N Caritis; Jay D Iams; Marshall W Carpenter; Alan M Peaceman; Brian M Mercer; Anthony Sciscione; Dwight J Rouse; Susan M Ramin; Garland D Anderson;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  115     ISSN:  1873-233X     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-01-22     Completed Date:  2010-02-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  234-42     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, North Carolina27157, USA. harper.margaret@gmail.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00135902
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MeSH Terms
Descriptor/Qualifier:
Dietary Supplements*
Double-Blind Method
Fatty Acids, Omega-3 / administration & dosage*
Female
Humans
Hydroxyprogesterones / administration & dosage
Infant, Newborn
Injections, Intramuscular
Pregnancy
Premature Birth / prevention & control*
Progesterone Congeners / administration & dosage
Recurrence
Grant Support
ID/Acronym/Agency:
HD19897/HD/NICHD NIH HHS; HD21410/HD/NICHD NIH HHS; HD27860/HD/NICHD NIH HHS; HD27869/HD/NICHD NIH HHS; HD27915/HD/NICHD NIH HHS; HD27917/HD/NICHD NIH HHS; HD34136/HD/NICHD NIH HHS; HD34208/HD/NICHD NIH HHS; HD36801/HD/NICHD NIH HHS; HD40485/HD/NICHD NIH HHS; HD40500/HD/NICHD NIH HHS; HD40512/HD/NICHD NIH HHS; HD40544/HD/NICHD NIH HHS; HD40545/HD/NICHD NIH HHS; HD40560/HD/NICHD NIH HHS; MO1-RR-000080/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Fatty Acids, Omega-3; 0/Hydroxyprogesterones; 0/Progesterone Congeners; 630-56-8/17-alpha-hydroxy-progesterone caproate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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