CTRI/2024/10/075061尚未招募Phase 3 4
COMPARISON OF EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE AND IRON SUCROSE FOR TREATMENT OF IRON DEFICIENCY ANEMIA IN PREGNANCY
National Health Mission1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年11月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Rate of Increase in HB
研究概览
简要总结
To evaluate the efficacy and safety of intravenous Ferric Carboxy maltose and Iron sucrose for treatment of iron deficiency anemia in pregnancy.
FCM brings about greater and faster Hb increase in treatment of anemia.
FCM usually requires a shorter administration time approximately 15mins.
Maximum 2 doses (1500mg) is administrated as OP procedure.
Need of further Blood transfusion in future also gets reduced.
The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting.
研究设计
- 研究类型
- Interventional
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 AN mothers between 14-32weeks of gestation with moderate anemia.
排除标准
- •All AN mothers before 14weeks and after 32weeks of gestation with moderate anemia.
- •All AN mothers with severe anemia in all 3 trimesters.
- •AN mothers who received blood transfusion in this pregnancy.
- •AN mothers hypersensitive to any iron preparation.
- •AN mothers with liver disorder like Jaundice, cirrhosis.
- •AN mother’s with acute Cardiac failure or Renal failure.
- •AN mother’s with known case of hemolytic anemia.
结局指标
主要结局
Rate of Increase in HB
时间窗: AFTER 3WEEKS
次要结局
- EFFECACY AND SAFETY OF FERRIC CARBOXY MALTOSE AND IRON SUCROSE IN PREGNANCY(6MONTHS)
研究者
K P Mohanasundari
Government Medical College and Hospital Tiruppur
研究点 (1)
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