Iron Isomaltoside 1000 (Monofer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- To see the rise in hemoglobin concentration of 2gm/dl or more.
研究概览
简要总结
The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.
详细描述
Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women within 24-48 hours of delivery with hemoglobin concentration < 10gm/dl
排除标准
- •History of PPH, or significant blood loss in last 24 hours
- •History of allergy to iron preparation
- •Hemoglobin < 7gm/dl.
- •Sign & symptoms of cardiac failure
- •H/o blood transfusion in last 3 months
- •H/O Chronic liver diseases.
- •↑ Creatinine > 2mg/dl.
研究组 & 干预措施
parenteral iron
dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
干预措施: Iron isomaltoside 1000 (Drug)
oral iron
oral iron in form of ferrous sulphate 200 mg twice daily
干预措施: Ferrous sulphate (Drug)
结局指标
主要结局
To see the rise in hemoglobin concentration of 2gm/dl or more.
时间窗: 3 months
To see the rise in hemoglobin concentration of 2gm/dl or more.This rise in hemoglobin concentration will be measured at day 14 and at 3 months, in both groups.
次要结局
- secondary - time required for rise in hemoglobin concentration(3 months)
研究者
Nazli Hossain
Professor
Dow University of Health Sciences