Monoferric for Prenatal Iron Deficiency
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of participants who experienced a resolution of iron deficiency anemia
研究概览
简要总结
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
详细描述
Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
- •Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
- •Experience intolerance to oral iron or are greater than 28 weeks gestation
- •Willing to participate in the study
排除标准
- •Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
- •Prior IV iron intolerance or hypersensitivity reaction
研究组 & 干预措施
Ferric derisomaltose
干预措施: Ferric derisomaltose (Drug)
结局指标
主要结局
The proportion of participants who experienced a resolution of iron deficiency anemia
时间窗: From enrollment to 6 weeks post partum
The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration
次要结局
未报告次要终点
研究者
Ashley Benson
Principal Investigator
Oregon Health and Science University