A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
研究概览
简要总结
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
详细描述
Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women above 18 years old after giving birth
- •Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the exclusion criteria
排除标准
- •Women who suffer from known allergy for iron supplements
- •Women who suffer from anemia not due to iron deficiency
- •Women who suffer from acute infection
- •Women who suffer from liver failure or viral hepatitis
- •Women who suffer from thalassemia or hemoglobinopathies
- •Women who suffer from renal failure
- •Women who suffer from unbalanced thyroid disorder
结局指标
主要结局
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
时间窗: After 6 weeks post partum
次要结局
- Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum(Up to 6 weeks post partum)
- The rate of patients who discontinued treatment(Up to 6 weeks post partum)
- Type and rate of adverse events(Up to 6 weeks post partum)
- The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum(From randomization to 6 weeks post partum)
- The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment(Six weeks post partum)
- The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire(six weeks post partum)
研究者
Zohar Nachum
MD
HaEmek Medical Center, Israel