Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in hemoglobin
研究概览
简要总结
This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.
The main question it aimed to answer was:
Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.
Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.
- Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
- Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.
详细描述
The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A & B.
Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •28-34 weeks of gestation
- •Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is <10 gm% and serum Ferritin < 30 ng/ml.
排除标准
- •Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
- •serum creatinine level of more than 2.0 mg/dL
- •history of allergic reaction to intravenous iron infusion
研究组 & 干预措施
Carboxymaltose
Intravenous infusion
干预措施: Iron Carboxymaltose (Drug)
Sucrose
Intravenous infusion
干预措施: Iron Sucrose Injection (Drug)
结局指标
主要结局
Change in hemoglobin
时间窗: After three weeks of completing parenteral iron therapy
Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin
次要结局
- Ferritin levels(Three weeks after completion of parenteral iron therapy)
研究者
Kiran Saleem
Principal Investigator
CMH Multan Institute of Medical Sciences