Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: protocol of the ECLIPSES randomized clinical trial.
Adapting iron dose supplementation in pregnancy for greater effectiveness on mother and child health: protocol of the ECLIPSES randomized clinical trial.
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DOI：
10.1186/1471-2393-14-33
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发表时间：
2014-01-18
影响因子：
3.1
通讯作者：
Aranda N
中科院分区：
文献类型：
--
作者：
Arija V;Fargas F;March G;Abajo S;Basora J;Canals J;Ribot B;Aparicio E;Serrat N;Hernández-Martínez C;Aranda N
目前，对于妊娠期间最有益于母体和后代健康的补铁剂量没有达成共识。推荐的补铁剂量不能预防约20%的孕妇贫血，也不能预防15%的孕妇血液浓缩的风险。这种铁的缺乏或过量会损害母婴健康。因此，本研究的目的是确定适合孕早期血红蛋白（Hb）水平的铁补充剂的最高有效性水平，这对母婴健康是最佳的。设计图：随机临床试验（RCT）三盲设置：来自卡塔卢尼亚（西班牙）的10个初级保健中心研究对象：878名妊娠早期的非贫血孕妇及其随后的新生儿方法：该研究被构造为具有2层的RCT，取决于妊娠12周前的Hb水平。分层#1：如果Hb为110 - 130 g/L，则在第12周随机分配接受40或80 mg/d的铁补充剂。分层#2：如果Hb >130 g/L，在第12周随机分配接受40或20 mg/d的铁补充剂。测量值：在母亲：社会经济数据、临床病史、食物项目频率、生活方式和情绪状态以及对铁补充剂处方的依从性。生化指标包括：Hb、血清铁蛋白、C反应蛋白、皮质醇和HFE基因（C282 Y、H63 D）的改变。在儿童：超声胎儿生物测量，人体测量和气质发展。使用Windows SPSS程序进行的统计分析将包括针对与研究关系相关的变量进行调整的双变量和多变量分析。如果得出结论性结果，该研究将指出促进孕产妇和婴儿健康所需的最佳补铁剂量。这些结果将有助于制定良好的临床实践指南。本临床试验在http://www.clinicaltrialsregister.eu上注册为EudraCT编号2012-005480-28
Currently, there is no consensus regarding iron supplementation dose that is most beneficial for maternal and offspring health during gestation. Recommended iron supplementation dose does not preempt anemia in around 20% of the pregnancies, nor the risk of hemoconcentration in 15%. This deficit, or excess, of iron prejudices the mother-child wellbeing. Therefore the aims of the study are to determine the highest level of effectiveness of iron supplementation adapted to hemoglobin (Hb) levels in early pregnancy, which would be optimum for mother-child health. Design: Randomized Clinical Trial (RCT) triple-blinded Setting: 10 Primary Care Centers from Catalunya (Spain) Study subjects: 878 non-anemic pregnant women at early gestation stage, and their subsequent newborns Methods: The study is structured as a RCT with 2 strata, depending on the Hb levels before week 12 of gestation. Stratum #1: If Hb from 110 to 130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 80 mg/d. Stratum #2: If Hb >130 g/L, randomly assigned at week 12 to receive iron supplement of 40 or 20 mg/d. Measurements: In the mother: socio-economic data, clinical history, food item frequency, lifestyle and emotional state, and adherence to iron supplement prescription. Biochemical measurements include: Hb, serum ferritin, C reactive protein, cortisol, and alterations in the HFE gene (C282Y, H63D). In children: ultrasound fetal biometry, anthropometric measurements, and temperament development. Statistical analyses, using the SPSS program for Windows, will include bivariate and multivariate analyses adjusted for variables associated with the relationship under study. Should conclusive outcomes be reached, the study would indicate the optimal iron supplementation dose required to promote maternal and infant health. These results would contribute towards developing guidelines for good clinical practice. This clinical trial is registered at http://www.clinicaltrialsregister.eu as EudraCT number 2012-005480-28
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