Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Increase in hemoglobin
研究概览
简要总结
Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV iron sources in anemic antenatal patients in our local population.
详细描述
It was hypothesized that there was a difference in mean change in hemoglobin with ferric carboxymaltose as compared to IV iron sources in anemic antenatal patients. The findings of the study would be a valuable addition to the existing stats, and if the hypothesis stands correct, a large number of women of reproductive age would benefit from effective iron replacement therapy, with a comparatively low incidence of side effects.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •Aged 18 to 40 years
- •Presented with anemia
- •Any parity
- •Gestational age < 12 weeks on LMP
排除标准
- •Females with a history of hypertension
- •Type II diabetes mellitus
- •Gestational diabetes mellitus
- •Ischemic heart disease
- •Endocrine disorder
- •Hematological disorders (hemophilia, leukemia, lymphoma, or myeloma)
- •History of taking iron-lowering drugs
研究组 & 干预措施
Ferric Carboxymaltose-Group
Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes.
干预措施: Intravenous Ferric Carboxymaltose (Drug)
Iron Sucrose-Group
Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses.
干预措施: Intravenous Iron Sucrose (Drug)
结局指标
主要结局
Increase in hemoglobin
时间窗: 12 weeks
Baseline hemoglobin was subtracted from post-treatment hemoglobin to assess increase in the hemoglobin
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research