ACTRN12621001239853已完成3 期
Effectiveness of intravenous iron administered during the third trimester in Malawian women in the management of anaemia: a 4-year, multicentre, parallel-group, two-arm, open-label randomised controlled superiority trial
Training and Research Unit of Excellence (TRUE), Malawi0 个研究点目标入组 590 人开始时间: 2021年9月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 590
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
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •Confirmed singleton pregnancy in the third trimester (27-35 weeks of gestation, dated by Last Menstrual Period)
- •Moderate to severe anaemia not requiring an immediate blood transfusion (Hb <10 g/dl)
- •Negative malaria parasitaemia by mRDT
- •Currently afebrile with no evidence of septicaemia
- •Resident in the study catchment area of Zomba district (Malawi)
- •Able to deliver at health facilities within Zomba district (Malawi)
- •Written informed consent (including assent if <18 years old)
排除标准
- •Previous enrolment in REVAMP trial – ACTRN12618001268235.
- •Actively participating in another intervention trial.
- •Known hypersensitivity to any of the study drugs.
- •Clinical symptoms of malaria or other infection (no fever, no focal symptoms of internal infection i.e. LRTI/ diarrhoea).
- •Any condition requiring hospitalisation in the next seven days or serious concomitant illness.
- •Known history of sickle cell or sickle-haemoglobin C anaemia.
- •Clinically low haemoglobin level requiring a blood transfusion (usually Hb <5g/dl).
- •Preeclampsia
研究者
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