Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial
Harper M, Thom E, Klebanoff MA, Thorp J, Sorokin Y, Varner MW, Wapner RJ, Caritis SN, Iams JD, Carpenter MW, Peaceman AM, Mercer BM, Sciscione A, Rouse DJ, Ramin SM, Anderson GD, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
Obstetrics and gynecology · 80 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Center for Research Resources
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Gobierno
- NICHD NIH HHS
- Gobierno
- NCRR NIH HHS
- Gobierno
- NCATS NIH HHS
- Subvenciones
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD40512); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD040560); National Center for Research Resources (M01RR000080); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD040544); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD27917); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD040485); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD040544); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD-27915); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD027869); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD040512); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD40545); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD34136); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD040500); Eunice Kennedy Shriver National Institute of Child Health and Human Development ((HD40500); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD027915); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD034208); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD027917); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD040560); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1HD040545); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD 40544); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD-27860); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD40560); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1HD040500); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD021410); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD040485); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD 34208); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD036801); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD 36801); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD027869); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD040545); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1HD027915); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD27869); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD034208); Eunice Kennedy Shriver National Institute of Child Health and Human Development ([HD21410); National Center for Research Resources (MO1-RR-000080); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01HD019897); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01 HD036801); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD034136); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD027860); National Center for Advancing Translational Sciences (UL1 TR000005); Eunice Kennedy Shriver National Institute of Child Health and Human Development (U24HD036801); Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1HD040512); Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD 40485)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2010-01-19 · Obstet Gynecol · vol. 115 · número 2 · págs. 234–242
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 113 citas · más que el 98% de estudios similares · 8.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 43 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Fatty Acid Research and Health · Preterm Birth and Chorioamnionitis · Infant Development and Preterm Care
- Palabras clave
- omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid, long-chain polyunsaturated fatty acids, recurrent preterm birth, 17-hydroxyprogesterone caproate, preterm birth prevention, pregnancy
- MeSH
- humans, premature birth, recurrence, hydroxyprogesterones, progesterone congeners, fatty acids, omega-3, injections, intramuscular, double-blind method, pregnancy, dietary supplements, infant, newborn, female, 17 alpha-hydroxyprogesterone caproate
16 autores
- Margaret Harper🇺🇸University of North Carolina at Chapel Hill; University of Pittsburgh; Wayne State University; University of Utah; Brown University; University of Alabama at Birmingham; Wake Forest University Health Sciences; Wake Forest University; The Ohio State University; Columbia University
- Elizabeth A Thom🇺🇸University of North Carolina at Chapel Hill
- Mark A. Klebanoff🇺🇸Wayne State University
- John M. Thorp🇺🇸University of Utah
- Yoram Sorokin🇺🇸Columbia University
- Michael Walter Varner🇺🇸University of Pittsburgh
- Ronald J. Wapner🇺🇸The Ohio State University
- Steve N. Caritis🇺🇸Brown University; Women & Infants Hospital of Rhode Island
- Jay D. Iams🇺🇸Northwestern University
- Marshall W. Carpenter🇺🇸MetroHealth Medical Center; Case Western Reserve University
- Alan M. Peaceman🇺🇸Drexel University
- Brian M. Mercer🇺🇸University of Alabama at Birmingham
- ANTHONY C. SCISCIONE
- Dwight J. Rouse🇺🇸The University of Texas Medical Branch at Galveston
- Susan M. Ramin🇺🇸George Washington University
- Garland D. Anderson🇺🇸National Institutes of Health; Eunice Kennedy Shriver National Institute of Child Health and Human Development
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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