ω-3 脂肪酸补充剂预防复发性早产：一项随机对照试验。
Omega-3 fatty acid supplementation to prevent recurrent preterm birth: a randomized controlled trial.
机构信息
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.
出版信息
Obstet Gynecol. 2010 Feb;115(2 Pt 1):234-242. doi: 10.1097/AOG.0b013e3181cbd60e.
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.
目的
评估在接受 17α-羟孕酮己酸酯治疗且至少有一次自发性早产史的女性中，添加ω-3 长链多不饱和脂肪酸补充剂是否会降低早产率。
方法
我们在 13 个中心进行了一项随机、双盲、安慰剂对照试验。有自发性早产史且目前为单胎妊娠的女性被分配至每日ω-3 补充剂（1200mg 二十碳五烯酸和 800mg 二十二碳六烯酸）或匹配的安慰剂组，从 16-22 周至 36 周。所有参与者每周接受肌内注射 17α-羟孕酮己酸酯（250mg）。主要研究结局是在 37 周前分娩。假设单侧 5%的Ⅰ类错误，需要 800 名样本量才能有 80%的效力检测到主要结局从 30%减少 30%。
结果
共纳入 852 名女性，无失访。在 ω-3 组中，37 周前分娩的发生率为 37.8%（164/434），安慰剂组为 41.6%（174/418）（相对风险 0.91，95%置信区间 0.77-1.07）。
结论
在接受 17α-羟孕酮己酸酯治疗且有早产史的女性中，ω-3 长链多不饱和脂肪酸补充剂并未降低早产率。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00135902。
证据水平
I。
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