A Multicenter Randomized Trial of IV vs Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

静脉注射铁剂与口服铁剂治疗妊娠期缺铁性贫血的多中心随机试验

基本信息

项目摘要

ABSTRACT Iron-deficiency anemia is a common, under-treated problem in pregnancy. The prevalence of iron-deficiency anemia (anemia plus iron deficiency) is estimated at 16.2% overall in pregnancy and up to 30% at delivery, and it is associated with significant adverse maternal and fetal outcomes. While treatment with iron supplementation is recommended during pregnancy, important questions remain about the optimal route of delivery. Oral iron therapy, the current standard, is often suboptimal: up to 70% of patients experience significant gastrointestinal side effects that prevent adherence to treatment, resulting in persistent anemia. In addition, the timing and frequency of oral iron can influence absorption. Intravenous (IV) iron is an attractive alternative because it mitigates the adherence and absorption challenges of oral iron. However, it costs more, and there are historical concerns about adverse reactions. The American College of Obstetricians and Gynecologists recommends oral iron for the treatment of iron-deficiency anemia in pregnancy, with IV iron reserved for the “rare patient who cannot tolerate or will not take oral iron.” Our preliminary data show that this approach leads to 30% of patients with persistent IDA at delivery and an associated 3 to 6-fold increased risk of peripartum blood transfusion, a metric within the Centers for Disease Control and Prevention’s severe maternal morbidity composite. This preferential recommendation of oral iron is based on paucity of data on the benefits and safety of IV iron, compared with oral iron, in pregnancy. Our published systematic review and meta-analysis showed that IV iron is associated with greater increase in maternal hemoglobin (Hb), but most of the primary trials were conducted in developing countries, included small sample sizes (50 – 252), and did not assess meaningful maternal and neonatal outcomes. The current Cochrane review noted that despite the high incidence and disease burden associated with IDA in pregnancy, there is paucity of quality trials assessing clinical maternal and neonatal effects of iron administration in women with anemia. The authors called for “large, good quality trials assessing clinical outcomes.” The only large randomized trial of IV versus oral iron, conducted in India, showed no difference in a maternal composite outcome but is limited by use of iron sucrose with a wide range of iron doses (200 – 1600 mg) in up to 5 infusions. In addition, the primary composite outcome included components not directly related to anemia. In contrast, our pilot trial of a single infusion of 1000 mg of IV low molecular weight dextran in pregnant women in the U.S. with moderate-to-severe IDA significantly reduced the rate of maternal anemia at delivery and showed promise for reducing rates of blood transfusion. We propose the first definitive double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=746) to test the central hypothesis that IV iron in pregnant women with moderate-to-severe IDA (Hb<10 g/dL and ferritin<30 ng/mL) at 24 – 28 weeks will be effective, safe and cost-effective in reducing peripartum blood transfusion and improve offspring neurodevelopment. A multidisciplinary team of investigators in the U.S., will pursue the following specific aims: 1) Evaluate the effectiveness and safety of IV iron, compared with oral iron, in reducing the rate of peripartum blood transfusion in pregnant women with moderate-to-severe IDA. (Primary Aim); 2) Estimate the cost- effectiveness of IV iron, compared with oral iron, in pregnant women with moderate-to-severe IDA as measured by incremental cost per Quality Adjusted Life-year (QALY). (Secondary Aim 1); and 3) Assess the effect of IV iron, compared with oral iron, on offspring brain myelin content and neurodevelopment. (Secondary Aim 2).
摘要 缺铁性贫血是一种常见的,治疗不足的问题在怀孕。缺铁症的患病率 贫血(贫血加缺铁)在怀孕期间估计为16.2%,分娩时高达30%, 它与孕产妇和胎儿的严重不良结局有关。而补铁治疗 虽然建议在怀孕期间使用,但关于最佳分娩途径的重要问题仍然存在。口服铁 目前的标准疗法通常是次优的:高达70%的患者会出现严重的胃肠道疾病。 阻止坚持治疗的副作用,导致持续性贫血。此外,时间和 口服铁的频率会影响吸收。静脉(IV)铁是一种有吸引力的替代品,因为它 减轻口服铁的粘附和吸收挑战。然而,它的成本更高,而且有历史 关注不良反应。美国妇产科学院建议口服 铁用于治疗妊娠期缺铁性贫血,IV铁保留给“罕见的患者, 不能忍受或不会口服铁。我们的初步数据显示,这种方法导致30%的患者 分娩时持续性缺铁性贫血,围产期输血的风险增加3 - 6倍, 疾病控制和预防中心的严重孕产妇发病率综合指标。这 口服铁剂的优先推荐是基于缺乏关于IV铁剂的益处和安全性的数据, 与口服铁相比,在怀孕期间。我们发表的系统综述和荟萃分析表明,静脉铁剂 与母体血红蛋白(Hb)的更大增加相关,但大多数初步试验都是在 在发展中国家,包括小样本量(50 - 252),没有评估有意义的孕产妇和 新生儿结局目前的科克伦综述指出,尽管高发病率和疾病负担, 与妊娠期缺铁性贫血相关,缺乏评估临床母体和新生儿影响的高质量试验 铁的管理与贫血的妇女。作者呼吁“大规模、高质量的临床试验, 结果”。唯一一项在印度进行的IV与口服铁剂的大型随机试验显示, 但由于使用范围广泛的铁剂量(200 - 1600 mg),最多5次输注。此外,主要复合结局包括与以下内容不直接相关的组成部分: 贫血相比之下,我们的试点试验,一个单一的输液1000毫克的静脉低分子量右旋糖酐在怀孕 在美国,患有中度至重度IDA的妇女在分娩时显著降低了母亲贫血的发生率 并显示出降低输血率的希望。我们提出了第一个明确的双盲,安慰剂 一项在美国孕妇中进行的对照、多中心随机试验(N=746),以检验中心假设 在24 - 28岁患有中度至重度IDA(Hb<10 g/dL和铁蛋白<30 ng/mL)的孕妇中, 周将是有效的,安全的和具有成本效益的减少围产期输血和改善后代 神经发育美国的一个多学科调查小组,将努力实现以下具体目标: 1)评价静脉铁剂与口服铁剂相比在降低围产期贫血发生率方面的有效性和安全性 中重度IDA孕妇输血。(二)成本估算: 与口服铁剂相比,静脉注射铁剂对中重度IDA孕妇的有效性 质量调整生命年(QALY)的增量成本。(次要目的1);和3)评估IV的效果 与口服铁相比,铁对后代脑髓鞘含量和神经发育的影响。(第二目标)。

项目成果

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Methodius Gamuo Tuuli其他文献

Methodius Gamuo Tuuli的其他文献

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{{ truncateString('Methodius Gamuo Tuuli', 18)}}的其他基金

Novel Vacuum-Induced Postpartum Hemorrhage Control: a Multicenter Randomized Trial.
新型真空诱导产后出血控制:多中心随机试验。
  • 批准号:
    10418896
  • 财政年份:
    2022
  • 资助金额:
    $ 67.45万
  • 项目类别:
Novel Vacuum-Induced Postpartum Hemorrhage Control: a Multicenter Randomized Trial.
新型真空诱导产后出血控制:多中心随机试验。
  • 批准号:
    10673043
  • 财政年份:
    2022
  • 资助金额:
    $ 67.45万
  • 项目类别:
A Multicenter Randomized Trial of IV vs Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
静脉注射铁剂与口服铁剂治疗妊娠期缺铁性贫血的多中心随机试验
  • 批准号:
    10610888
  • 财政年份:
    2022
  • 资助金额:
    $ 67.45万
  • 项目类别:
Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: Multicenter Randomized Trial
肥胖女性剖腹产时的预防性负压伤口治疗:多中心随机试验
  • 批准号:
    9175529
  • 财政年份:
    2016
  • 资助金额:
    $ 67.45万
  • 项目类别:
Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Multicenter Randomized Trial
肥胖女性剖腹产多中心随机试验的预防性负压伤口治疗
  • 批准号:
    9443985
  • 财政年份:
    2016
  • 资助金额:
    $ 67.45万
  • 项目类别:

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