A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hemoglobin Level
研究概览
简要总结
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients.
Two randomly assigned groups will be compared during the postpartum period:
- Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID.
IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Delivery at our institution
- •Hemoglobin below 9 g/dl in postpartum day 1
- •Singleton gestation
排除标准
- •Diagnosis of malabsorptive disorder or history of gastric bypass procedure
- •Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
- •Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
- •Patient has received blood transfusion or there is a plan to transfuse
- •Lactose intolerance
研究组 & 干预措施
Oral Iron group
Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily.
Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.
干预措施: Ferrous sulfate (Drug)
IV Iron group
Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride.
Oral placebo will be given by mouth for a total of 6 weeks TID.
干预措施: Iron dextran (Drug)
结局指标
主要结局
Hemoglobin Level
时间窗: 6 weeks after delivery
hemoglobin in grams per deciliters
次要结局
- Number of Participants With Nausea or Vomiting(up to 6 weeks after delivery)
- Myalgia(up to 6 weeks after delivery)