Exploratory Study of the Efficacy, Practicability and Safety of Intravenous Iron Supplementation Therapy in Moderate to Severe Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
研究概览
简要总结
In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population. During pregnancy iron tablets are the only available safe medication but their efficacy is rather poor. It is the aim of this study to examine the efficacy, practicability and safety of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia.
20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy.
- Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ferric carboxymaltose
Hb> 11 g/dl and Ferritin < 35 (controlled by CRP): 500mg to correct iron deficiency Hb ≥ 10 and < 11g/dl; Ferritin < 35 (controlled by CRP): 700 mg Hb ≥9 and < 10 g/dl; Ferritin < 35 (controlled by CRP): 800 mg Hb < 9g/dl; Ferritin < 35 (controlled by CRP): 900 mg
干预措施: ferric carboxymaltose (Drug)
结局指标
主要结局
Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
时间窗: 3 days, 7 days, 14 days, 28 days, and 60 days after iron infusion
次要结局
- Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry(screening, 7 days, 14 days after iron infusion)
- Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)(screening, 7 days after iron infusion, 14 days post partum)
- Improvement of sleepiness using Epworth Sleepiness Scale (ESS)(screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum)
- Improvement of fatigue using Fatigue Severity Scale (FSS)(screening, 7 days, 14 days, 28 days after iron infusion, 14 days post partum)
- Safety of ferric carboxymaltose during pregnancy in the 3rd trimester(Day 1, Day 3, Day 7, Day 14, Day 28, 14 days pre partum, 14 days post partum)
- Parameters of the newborn baby (apgar, umbilical artery pH, weight, mode of delivery)(8 weeeks)