ACTRN12615000950561已完成4 期
A study to assess whether two different doses of antenatal intravenous iron administration (500 mg and 1000mg ferric carboxymaltose) are equivalent in replenishing and sustaining iron stores successfully in pregnant iron deficient women
yell McEwin Hospital0 个研究点目标入组 306 人开始时间: 2015年9月10日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Female
入选标准
- •Pregnant women (2nd and 3rd trimester) with iron deficiency (serum ferritin <15mcg/mL) ; if elevated CRP then serum ferritin <50mcg/mL and TSAT <20%).
排除标准
- •1.Patients with B12 pmol/L or folate nmol/L deficiency that cannot be corrected before trial entry will be excluded.
- •2.Known hypersensitivity to ferric carboxymaltose or not eligible for dosing per approved Product Insert
- •3.Haemoglobin (Hb) >130g/dL
- •4.Hemochromatosis or other iron storage disorders
- •5.Serious medical condition, uncontrolled systemic disease or any other medical condition (including an inability to fully comprehend and/or perform study procedures) that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study
研究者
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