Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia
研究概览
简要总结
The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.
详细描述
Postpartum anemia is commonly defined as hemoglobin levels less than 8.5 g/dl and it is usually treated with oral iron supplements. Blood transfusion is reserved to women with hemoglobin levels < 6 g/dl and/or clinical symptoms of anemia. Without treatment, the restoration of blood parameters in postpartum anemia can take approximately one month (hemoglobin levels increase to 2.8 g/dl in 30 days). Several reports have demonstrated the efficacy of intravenous iron in severe anemia in non-obstetric pathologies. However, the clinical effect of intravenous iron in patients with postpartum hemoglobin levels ranging from 6.0 to 8.0 g/dl has been not reported. There has not been evaluated its capacity to restore hemoglobin levels and to minimize clinical side-effects of anemia (sickness, weariness, depression, anxiety).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •Diagnosis of postpartum anemia within the first 48 h postpartum with an haemoglobin level equal or higher than 6 g/dL and lower than 8.0 g/dL,
- •Ability to read and understand the relevant purpose of the trial and consent obtained in accordance with specifications of the local research ethics committee.
排除标准
- •Clinical symptoms or suspicion of acute or chronic infection.
- •Allergic history or iron intolerance.
- •Indication of blood transfusion.
- •Non iron deficit anemia.
- •Hepatopathy.
- •Parenteral iron hypersensitivity.
研究组 & 干预措施
Group A
Group A: Administration of intravenous iron sucrose.
干预措施: Iron sucrose (Drug)
Group B
Group B: Administration of intravenous NaCl 0,9%.
干预措施: NaCl (Drug)
结局指标
主要结局
To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia
时间窗: 6 weeks
次要结局
- To compare if the administration of intravenous iron supplementation is better than the oral dosage to reestablish clinical symptoms of severe anemia minimizing its side-effects (weariness, depression, anxiety) or to avoid the need for blood transfusion(6 weeks)