A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Haemoglobin concentration
研究概览
简要总结
200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).
The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.
详细描述
The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.
The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.
The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).
Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.
Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman within 48 h post partum
- •Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
- •Able to read and understand the Norwegian language
- •Signed informed consent
排除标准
- •Anemia not attributable to iron deficiency
- •Contraindications for any of the study drugs
- •Treatment with drugs, dietary supplements or natural remedies containing iron
- •Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
- •Assessed as requiring blood transfusion(s)
研究组 & 干预措施
Peroral iron - ferrous sulfate tablets
Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
干预措施: Ferrous sulfate tablets (Drug)
Ferric carboxymaltose
Intravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given.
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Haemoglobin concentration
时间窗: 6 weeks
次要结局
- Ferritin(6 weeks)
- Fatigue(6 weeks)
- Quality of life(6 weeks)
- Post partum depression(6 weeks)