Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in hemoglobin
研究概览
简要总结
This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
详细描述
This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age >/= 18
- •Singleton gestation
- •>/=20 weeks gestation, <37 weeks gestation
- •Hemoglobin <11g/dL and/or hematocrit <33%
- •Able to read/speak English or Spanish
排除标准
- •Maternal age <18
- •Multiple gestation
- •<20 weeks gestation, </= 37 weeks gestation
- •Hemoglobin >/=11g/dL and/or hematocrit >/=33%
- •Unable to read or speak English or Spanish
- •Incarcerated patients
研究组 & 干预措施
Ferrous Sulfate
Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home.
Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies.
干预措施: Ferrous sulfate 325mg (Dietary Supplement)
Ferumoxyltol
Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart.
Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies.
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Change in hemoglobin
时间窗: 1 day - 22 weeks
We will assess the increase in maternal hemoglobin during the study timeframe
次要结局
- Blood loss at delivery(1 day - 22 weeks)
- Change in other laboratory values(1 day - 22 weeks)
- Indication for delivery(1 day - 22 weeks)
- Birth weight(1 day - 22 weeks)
- Blood transfusion(1 day - 22 weeks)
- Hemoglobin change after delivery(1 day - 22 weeks)
- Iron infusion(1 day - 22 weeks)
- Concentration of substances in cord blood (iron studies)(1 day - 22 weeks)
- Preterm delivery(1 day - 22 weeks)
研究者
Meghan Hill
Assistant Professor
University of Arizona