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临床试验/NCT04228627
NCT04228627已完成4 期

Intravenous Iron for Non-anaemic Iron Deficiency in Pregnancy:a Multicenter,Two-arm,Randomised Controlled Trial

Services Institute of Medical Sciences, Pakistan3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年1月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
600
试验地点
3
主要终点
Maternal anaemia

研究概览

简要总结

Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.

详细描述

Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Allocation concealment

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-anaemic iron deficiency

排除标准

  • Anaemia or normal iron stores

研究组 & 干预措施

Treatment

Active Comparator

Intravenous Iron to correct Iron deficiency without anaemia

干预措施: Parentral Iron (Drug)

Prophylaxis

No Intervention

Usual antenatal care

结局指标

主要结局

Maternal anaemia

时间窗: 36 weeks' gestation

Haemoglobin concentration (g/dl)

次要结局

  • Fetal growth restriction(At birth)

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tayyiba Wasim

Professor

Services Institute of Medical Sciences, Pakistan

研究点 (3)

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