Comparative study between intravenous iron sucrose and ferric carboxymaltose for treatment of anemia in pregnant women in rural tertiary care centre : Single blind randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Outcomes will be measured on basis of changes in hemoglobin and iron indices like Serum Iron Serum Ferritin TIBC Transferrin saturation and safety and acceptability of intravenous iron sucrose vs ferric carboxymaltose will be determined
研究概览
简要总结
Anemia in pregnancy is a major public health problem in India and is associated with adverse maternal and fetal outcomes. Intravenous iron therapy is recommended in moderate to severe anemia or when oral iron is poorly tolerated or ineffective. Among the available intravenous iron preparations, iron sucrose and ferric carboxymaltose are commonly used; however, comparative data regarding their efficacy and safety in pregnant women in rural tertiary care settings are limited.
This study is a single-centre, single-blind, randomized, active-controlled, parallel-group trial designed to compare the efficacy and safety of intravenous iron sucrose and ferric carboxymaltose in the treatment of anemia in pregnant women. Eligible pregnant women diagnosed with anemia will be randomly allocated into two groups. One group will recieve intravenous iron sucrose, and the other group will recieve intravenous ferric carboxymaltose, administered as per standard treatment protocols based on calculated iron requirement.
The primary outcome will be the change in hemoglobin levels from baseline to follow-up and improvement in iron stores, need for additional iron therapy, and occurrence of adverse events. Participants will be assessed at baseline and during follow-up visits at predefined time points.
The results of this study will help in determining the comparative effectiveness and safety of intravenous iron sucrose and ferric carboxymaltose, thereby guiding optimal management of anemia in pregnant women in rural tertiary care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Antenatal women of second and third trimester of pregnancy with moderate anemia with hemoglobin 7-9.9gm/dl and who are willing to participate in study.
排除标准
- •Non iron deficiency anemia Bleeding disorders or coagulopathy History of blood transfusion during antenatal period Hypersensitivity reaction to any iron preparation Previous surgery of intestinal resection Co morbid conditions like cardiovascular disease chronic liver or renal disease Medical disorders like tuberculosis, hepatitis B/C or HIV infection.
结局指标
主要结局
Outcomes will be measured on basis of changes in hemoglobin and iron indices like Serum Iron Serum Ferritin TIBC Transferrin saturation and safety and acceptability of intravenous iron sucrose vs ferric carboxymaltose will be determined
时间窗: Baseline on Day 0 and then on day 30
次要结局
未报告次要终点
研究者
DR SONAM CHOUDHARY
University of medical sciences Saifai
