| Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 20093894 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Obstetrics and gynecology Volume: 115 ISSN: 1873-233X ISO Abbreviation: Obstet Gynecol Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-01-22 Completed Date: 2010-02-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0401101 Medline TA: Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 234-42 Citation Subset: AIM; IM |
Affiliation:
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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.:
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ClinicalTrials.gov/NCT00135902 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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:
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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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