Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
研究概览
简要总结
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
详细描述
Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters).
In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.
This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.
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 aged ≥18 years
- •Pregnancy at GA 14+0 - 19+0
- •Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
- •Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form
排除标准
- •History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- •Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
- •Known hypersensitivity to any excipients in the investigational drug products
- •History of active asthma within the last 5 years
- •History of multiple allergies
- •Known decompensated liver cirrhosis or active hepatitis
- •Active acute or chronic infections (assessed by clinical judgement)
- •Rheumatoid arthritis with symptoms or signs of active inflammation
- •Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
- •Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
- •Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
- •Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
- •Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
- •Multiple pregnancies
- •Inability to read and understand the Danish language
研究组 & 干预措施
IV administration
Iron isomaltoside (Monofer) Administered iv
干预措施: Iron Isomaltoside 1000 (Drug)
Oral administration
Ferrous fumarate with ascorbic acid Administered oral
干预措施: ferrous fumarate with ascorbic acid (Drug)
结局指标
主要结局
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
时间窗: from baseline to 18 weeks after treatment
次要结局
- Change in iron biomarkers(From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks)
- Achievement of an hemoglobin equal to or above 11 g/dL(T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks)