Intravenous Iron Sucrose Versus Oral Ferrous Bis-glycinate for Treatment of Postpartum Iron Deficiency Anemia: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the percentage of patients achieving Hb rise 3 gm or more
研究概览
简要总结
Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations.
Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin level 7-11.5 gm/dl. No chronic diseases. Breastfeeding. Delivered at gestational age >38 weeks. Within 24-72 hours postpartum. Women who accept to participate in the study
排除标准
- •Severe anemia < 7 gm/dl.
- •Women received iron therapy during pregnancy.
- •Intolerance to iron preparations
- •Anemia due to other causes
- •Peripartum blood transfusion.
研究组 & 干预措施
Intravenous iron
Women will receive iron sucrose (sacrofer ampules 100 mg/5ml) A patient's total body iron deficit will be calculated using the Ganzoni formula (total iron dose = [body weight (kilogram)× (15-actual Hemoglobin)] × 2.4 + 500 mg) then the total dose will be divided on 3 settings
干预措施: Iron Sucrose Injection (Drug)
Oral ferrous bis-glycinate
Women will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets
干预措施: Ferrous Bisglycinate (Drug)
结局指标
主要结局
the percentage of patients achieving Hb rise 3 gm or more
时间窗: 6 weeks
次要结局
- Mean rise of Hb from baseline to 6 weeks.(6 weeks)