Intravenous Iron for Non-anaemic Iron Deficiency in Pregnancy:a Multicenter,Two-arm,Randomised Controlled Trial
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
- 否
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
Intravenous Iron to correct Iron deficiency without anaemia
干预措施: Parentral Iron (Drug)
Prophylaxis
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
Tayyiba Wasim
Professor
Services Institute of Medical Sciences, Pakistan
