ACTRN12623000787684尚未招募4 期
Kinetics of hypophosphatemia in Malawian pregnant women receiving intravenous iron administered during the second trimester in the management of anaemia
Training and Research Unit of Excellence (TRUE), Malawi0 个研究点目标入组 55 人开始时间: 2023年7月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
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
- o limit 至 o limit(—)
- 性别
- Female
入选标准
- •Participants meeting the following criteria will be included in the trial:
- •1. Confirmed singleton pregnancy in the second trimester (13-26) weeks of gestation, dated by ultrasound
- •2. Moderate to severe anaemia as measured by capillary haemoglobin on HemoCue instrument, not requiring an immediate blood transfusion (Hb <10g/dl)
- •3. Negative malaria parasitaemia measured by rapid diagnostic test
- •4. Currently afebrile with no evidence of septicaemia
- •5. Written informed consent (including assent if <18 years old)
排除标准
- •1. Previous enrolment in REVAMP trial, REVAMP-TT trial or REVAMP-OBS trial
- •2. Actively participating in another interventional trial
- •3. Known hypersensitivity to the study drugs
- •4. Clinical symptoms of malaria or other infection
- •5. Any condition requiring hospitalisation in the next seven days of serious concomitant illness
- •6. Known history of sickle cell or sickle-haemoglobin C anaemia
- •7. Clinically low haemoglobin level requiring a blood transfusion (usually Hb<5g/dl)
- •8. Preeclampsia
- •9. HIV positive
研究者
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