ACTRN12623001163695尚未招募3 期
Implementation and evaluation of an intravenous iron intervention for pregnant women with moderate and severe anaemia in the primary healthcare system of Bangladesh: a demonstration project
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)0 个研究点目标入组 2,000 人开始时间: 2023年11月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 o limit(—)
- 性别
- Female
入选标准
- •Pregnant women in the second or third trimester (13-32 weeks of gestation, dated by last menstrual period).
- •Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10g/dL).
- •Not known to have a diagnosis of thalassemia or other inherited red cell condition.
- •Not known to have a prior allergy to intravenous iron.
- •Clinically afebrile with no evidence of systemic infection.
- •Resident in the study catchment area.
排除标准
- •Previous enrolment in EDIVA efficacy trial.
- •Actively participating in another intervention trial.
- •Known hypersensitivity to any of the study drugs.
- •Any condition requiring hospitalisation in the next seven days or serious concomitant illness.
- •Known history of thalassemia or other inherited red cell condition.
- •Clinically low haemoglobin level requiring a blood transfusion (Hb <5g/dL).
研究者
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