COMPARATIVE STUDY OF INTRAVENOUS FERRIC CARBOXY MALTOSE VERSUS INTRAVENOUS IRON SUCROSE FOR TREATMENT OF ANEMIA IN PREGNANCY
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.
研究概览
简要总结
Maternal Complete hemogram and Serum ferritin sampling were done under aseptic precautions, peripheral veni-puncture blood samples were collected from the pregnant subjects for the determination of Hb levels before and after administration of the drugs.
The pregnant women were randomized into 2 groups, one receiving 1g of Inj ferric carboxymaltose and the other group receiving Inj iron sucrose 200mg 5 doses. Inj B12(2500 mcg) with folic acid(0.7 mg) was received by both the groups to remove B12 and folic acid deficiency as a confounding factor.
It takes three weeks for the rise of hemoglobin after administration of IV iron preparations. Hence hemoglobin was repeated after 3-4 weeks of administration of respective drugs and results were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients diagnosed with mild to moderate anemia.
- •2.Antenatal patients with a period of gestation 16- 32 weeks of gestation.
- •3.Patients with Iron deficiency anemia.
排除标准
- •1.Pregnancy more than 32 weeks of gestation.
- •2.K/C/O thalassemia& sickle cell anemia.
- •3.H/O allergic reactions to iron preparations.
- •History of blood transfusion in last 3months.
结局指标
主要结局
To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.
时间窗: To Compare the efficacy of IV Ferric Carboxymaltose and IV Iron Sucrose after 4 weeks of last dose
次要结局
- To Compare the secondary response of IV Ferric Carboxymaltose & IV Iron Sucrose(To compare secondary response to IV Ferric Carboxymaltose & IV Iron Sucrose after 30 minutes of administration)
研究者
DR SANTOSH B NIRWANI
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI