Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in hemoglobin level
研究概览
简要总结
Postpartum anemia is a common condition associated with adverse maternal outcomes. This study aimed to compare the effectiveness of oral iron therapy versus intravenous iron therapy in women with postpartum anemia.
详细描述
This randomized, open-label, parallel-group study was conducted at Shahida Islam Medical College and Hospital, Lodhran, Pakistan. Women diagnosed with postpartum anemia who fulfilled the eligibility criteria were randomly allocated using a lottery method to receive either intravenous iron (ferric carboxymaltose) or oral iron therapy (ferrous sulfate). The primary outcome was the change in hemoglobin level from baseline to 6 weeks of follow-up.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women with postpartum anaemia as per operational definition i.e Haemoglobin <11 g/dl at 24 hours after delivery (either caesarean or SVD).
- •Age 20-40 years.
- •Pre-operative haemoglobin >10 g/dl.
- •Both primiparous and multiparous.
- •Both primigravida and multigravida.
排除标准
- •Iron Intolerance or previous history of allergy to iron
- •Parenteral Iron hypersensitivity
- •Patients with thalassemia
- •Indication of blood transfusion
- •Patients with bleeding/ clotting disorders
- •Patients with postpartum haemorrhage
- •Patients with chronic diseases.
研究组 & 干预措施
Group A: Intravenous Iron Therapy
Participants received intravenous iron therapy for the treatment of postpartum anemia
干预措施: Ferric Carboxy Maltose (Drug)
Group B: Oral Iron Therapy
Participants received oral iron therapy for the treatment of postpartum anemia.
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Change in hemoglobin level
时间窗: Baseline to 6 weeks postpartum
次要结局
未报告次要终点
研究者
Sidra Jalil Khan
PGR obstetrics and Gynaecology
Shahida Islam Medical Complex