维生素 C 和 E 补充剂预防自发性早产：一项随机对照试验。
Vitamin C and E supplementation to prevent spontaneous preterm birth: a randomized controlled trial.
机构信息
From the Departments of Obstetrics and Gynecology at the University of Alabama at Birmingham, Birmingham, Alabama; University of Pittsburgh, Pittsburgh, Pennsylvania; University of Cincinnati, Cincinnati, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; University of Utah, Salt Lake City, Utah; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Case Western Reserve University, Cleveland, Ohio; Northwestern University, Chicago, Illinois; University of Texas Health Science Center at Houston, Houston, Texas; Drexel University, Philadelphia, Pennsylvania; Wake Forest University Health Sciences, Winston-Salem, North Carolina; Oregon Health and Science University, Portland, Oregon; University of Texas Medical Branch, Galveston, Texas; Wayne State University, Detroit, Michigan; University of Texas Medical Center, Galveston, Texas; The George Washington University Biostatistics Center, Washington, DC; National Heart, Lung, and Blood Institute, Bethesda, Maryland; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
出版信息
Obstet Gynecol. 2010 Sep;116(3):653-658. doi: 10.1097/AOG.0b013e3181ed721d.
OBJECTIVE
To estimate whether maternally administered vitamins C and E lower the risk of spontaneous preterm birth.
METHODS
This is a secondary analysis of a randomized, double-masked, placebo-controlled trial in nulliparous women at low-risk administered 1,000 mg vitamin C and 400 international units vitamin E or placebo daily from 9 to 16 weeks of gestation until delivery. Outcomes include preterm birth attributable to premature rupture of membranes (PROM) and total spontaneous preterm births (spontaneous preterm birth attributable to PROM or spontaneous labor).
RESULTS
Of the 10,154 women randomized, outcome data were available for 9,968 (4,992 vitamin group and 4,976 placebo group). A total of 1,038 women (10.4%) delivered preterm, of whom 698 (7.0%) had spontaneous preterm birth. A spontaneous preterm birth occurred in 356 women (7.1%) assigned to daily vitamin C and E supplementation and in 342 (6.9%) assigned to placebo. There were 253 women (2.5%) who delivered after preterm PROM and 445 (4.5%) after a spontaneous preterm labor. In women supplemented with vitamins C and E, births attributed to preterm PROM were similar at less than 37 and 35 weeks of gestation, but births were less frequent before 32 weeks of gestation (0.3% compared with 0.6%, adjusted odds ratio 0.3-0.9). However, total spontaneous preterm births across gestation in women supplemented with vitamins C and E or a placebo were similar.
CONCLUSION
Maternal supplementation with vitamins C and E beginning at 9 to 16 weeks of gestation in nulliparous women at low risk did not reduce spontaneous preterm births.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00135707.
LEVEL OF EVIDENCE
I.
目的
评估母体补充维生素 C 和维生素 E 是否降低自发性早产风险。
方法
这是一项对低危初产妇进行的随机、双盲、安慰剂对照试验的二次分析，试验中，孕妇从妊娠 9 至 16 周开始每天接受 1000 毫克维生素 C 和 400 国际单位维生素 E 或安慰剂治疗，直至分娩。结局包括因胎膜早破（PROM）导致的早产和总自发性早产（因 PROM 或自发性临产导致的自发性早产）。
结果
在 10154 名随机分配的孕妇中，有 9968 名（4992 名维生素组和 4976 名安慰剂组）提供了结局数据。共有 1038 名（10.4%）孕妇早产，其中 698 名（7.0%）发生自发性早产。在接受每日维生素 C 和 E 补充的孕妇中，有 356 名（7.1%）发生自发性早产，在接受安慰剂的孕妇中，有 342 名（6.9%）发生自发性早产。有 253 名（2.5%）孕妇在发生早产 PROM 前分娩，有 445 名（4.5%）在自发性早产临产前分娩。在接受维生素 C 和 E 补充的孕妇中，早产 PROM 发生在不足 37 周和不足 35 周的情况相似，但在 32 周之前的分娩次数较少（0.3%比 0.6%，调整后的优势比 0.3-0.9）。然而，在接受维生素 C 和 E 补充或安慰剂的孕妇中，整个妊娠期的自发性早产发生率相似。
结论
低危初产妇从妊娠 9 至 16 周开始补充维生素 C 和维生素 E 并不能降低自发性早产的发生。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00135707。
证据水平
I。
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