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临床试验/CTRI/2026/02/104618
CTRI/2026/02/104618尚未招募Phase 3 4

Intravenous Iron Sucrose Versus Blood Transfusion In The Management Of Moderate Post Partum Iron Deficiency Anemia.

Dr Sakshi Bhojwani1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2026年3月15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
155
试验地点
1

研究概览

简要总结

Postpartum anaemia remains a significant global health concern with prevalence rates varying between 10-40 percent of women globally. A prospective non-randomized quasi-experimental study conducted by Dhaka Medical College Hospital found that intravenous iron sucrose (600 mg administered over three days) was as effective as blood transfusion in improving haemoglobin levels and iron stores in women with moderate postpartum anaemia (Hb 7-8 g/dl). Their results showed mean Hb level increased by 4.2 g/dl in the IV iron group and 4.5 g/dl in the blood transfusion group at six weeks post-intervention, with no significant differences between groups.A study from Saudi Arabia reported postpartum anaemia prevalence of 52.percent with 55.4 percent classified as moderate anaemia. Risk factors identified include anaemia during pregnancy, primiparity, and childbirth complications.  Another comparative study found intravenous iron sucrose to be safe, efficacious, and cost-effective for treating postpartum anaemia, with minimal adverse reactions compared to blood transfusion. Research on iron sucrose therapy has demonstrated significant improvements in haemoglobin levels, serum ferritin, reticulocyte count, and other haematological parameters with negligible side effects. The average dose requirement reported in studies ranges from 300-600 mg with administration protocols typically involving divided doses given on alternate days. Multiple studies have confirmed that iron sucrose is well-tolerated, with minor side effects including nausea, vomiting, mild fever, and rare instances of thrombophlebitis. This study will provide evidence based guidance on the optimal management strategy for moderate postpartum anaemia, potentially improving maternal care protocols. Intravenous iron sucrose therapy may prove to be an effective alternative to blood transfusion, reducing transfusion-associated risks such as transfusion reactions, infections, and alloimmunization. The findings may contribute to the development of standardized protocols for managing postpartum anaemia, optimizing resource utilization in healthcare 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
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Consenting and willing for follow up postpartum women within the age group of 18 to 40 years.Women who delivered a single intrauterine live foetus.Women with hemodynamically stable status postpartum with haemoglobin concentration of 7 to 9.9 gm percent after 48 hours of delivery.

排除标准

  • Women with haemoglobin concentration of less than 7 gm percent (severe anaemia) or more than equal to 10 gm percent (mild anaemia).
  • Women with excessive bleeding or with hemodynamic instability.
  • Women delivering more than or equal to twin foetuses.
  • Women with known hemoglobinopathies like sickle cell anaemia, thalassemia, G6PD deficiency or bone marrow disorders.
  • Women with acute or chronic infections or having pre existing significant renal or hepatic dysfunction.
  • Women unwilling to receive blood products or iron therapy.

研究者

发起方
Dr Sakshi Bhojwani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sakshi Bhojwani

Datta Meghe Institute Of Higher Education and Research

研究点 (1)

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