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临床试验/CTRI/2021/03/031828
CTRI/2021/03/031828已完成不适用

Efficacy of Ferric Carboxymaltose and Iron sucrose complex in treatment of Iron deficiency anemia among pregnant women.

Gadag Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2021年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
1
主要终点
To evaluate the efficacy of Ferric Carboxymaltose and Iron sucrose complex in correcting Iron deficiency anemia in pregnant women.

研究概览

简要总结

Iron deficiency anemia (IDA) is the most common cause of anemia in Antenatal patients. Oral supplementation of iron in pregnant women prevents development of iron deficiency anemia. Sometimes, the pregnant women cannot tolerate oral iron, and develop gastric irritation, metallic taste and nausea. FCM and Iron sucrose complex and FCM are used in treatment of Iron deficiency.  FCM has decreased incidence of anaphylactic reactions compared to Iron sucrose complex. This  is a prospective non randomised interventional study  designed  to assess the efficacy  of  Ferric Carboxymaltose and Iron sucrose complex in antenatal women with iron deficiency anemia.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • •All pregnant women with moderate to severe iron deficiency anemia between the gestation period of 20-32 weeks.

排除标准

  • •History of Allergic reaction for Intravascular Iron in the past.
  • •Hemoglobin less than 4 gm/dl.
  • •(as they require Blood transfusion) 3)History of Blood transfusion in the past 3 months.
  • •Anemias other than Iron defieciency Anemia.

结局指标

主要结局

To evaluate the efficacy of Ferric Carboxymaltose and Iron sucrose complex in correcting Iron deficiency anemia in pregnant women.

时间窗: Assessed after 4 months of giving Iron supplementation.

次要结局

  • 4.To assess the side-effects of both Ferric Carboxymaltose and Iron sucrose complex for treatment of Iron defieciency anemia in pregnant women.(within 1 day of starting the Iron supplementation)

研究者

发起方
Gadag Institute of Medical Sciences
申办方类型
Government medical college

研究点 (1)

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