To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery
研究概览
简要总结
This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.
详细描述
Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.
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)
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
- •Singleton pregnancy
- •Iron deficiency anemia
- •Intolerance or low compliance for oral iron
排除标准
- •Known allergy for iron supplements
- •Anemia not due to iron deficiency
- •Acute infection
- •Liver failure or viral hepatitis
- •Thalassemia or hemoglobinopathies
- •Multiple pregnancy
研究组 & 干预措施
Iron sucrose 200 mg
first arm will be treated with iron sucrose 200 mg 2-3 times a week
干预措施: Iron sucrose 200 mg (Dietary Supplement)
Iron sucrose 500 mg
Second arm will be treated with iron sucrose 500 mg once a week
干预措施: Iron sucrose 500 mg (Dietary Supplement)
结局指标
主要结局
The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery
时间窗: from randomization to delivery
Hemoglobin levels will be obtained at the beginning of the study and around delivery
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)
时间窗: The day after delivery
次要结局
- The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization(Up to 4 weeks)
- Type and rate of adverse events(Up to 30 weeks)
- The rate of patients who discontinued treatment(Up to 30 weeks)
- The change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from the last dose of iron sucrose to delivery in 3 weeks intervals(Up to 30 weeks)
- The need for blood transfusion post partum(up to 4 days post partum)
- The need for iron sucrose administration post partum(up to 4 days post partum)
- The rate of anemia associated symptoms(From randomization and up to 30 weeks)
- The levels of neonatal hemoglobin, ferritin and bilirubin(up to 4 days post partum)
- The rate of neonatal polycythemia and need for phototherapy(up to 4 days post partum)
研究者
enav yefet
MD/PhD
HaEmek Medical Center, Israel