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临床试验/ACTRN12623001163695
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

发起方
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

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