EUCTR2017-000994-35-ES进行中（未招募）1 期
Study of tolerability of iron liposome compared to ferrous sulphate in pregnant women with iron deficiency anemia.
Hospital General Universitario de Alicante0 个研究点目标入组 130 人开始时间: 2017年12月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Pregnant women diagnosed with iron deficiency anemia in second trimester analysis (week 24-28), understood as hemoglobin <11 g / dL, serum ferritin <12 and hematocrit <33%.
- •-Pregnant women aged 18 or over.
- •- Single pregnancy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· Anemia from other causes.
- •· Blood transfusion, treatment with oral or intravenous iron one month prior to analytical analysis of the second quarter.
- •· Chronic maternal medical pathology prior to gestation (clinical and/or analitic evidence of hepatic, renal, pulmonary, haematological or cardiovascular abnormalities, history of peptic ulcer
- •Women with dietary restrictions (allergies or food intolerances). Women with specific dietary patterns (vegetarian or vegan).
- •Hypersensitivity to iron supplements.
- •Lactose intolerance.
- •Severe anemia: hemoglobin <9 g/dl
- •· Fetal pathology: chromosomal abnormalities or fetal malformations on ultrasound.
研究者
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