Comparative evaluation of efficacy, safety, cost effectiveness and acceptability of Ferric carboxymaltose versus Iron sucrose for treatment of Iron deficiency anemia in pregnancy
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparing the improvement in hemoglobin levels following administration of iron sucrose and FCM
研究概览
简要总结
Anemia during pregnancy in India contributes to 20% of maternal death directly and 50% of maternal mortality indirectly. Anemia in pregnancy causes susceptibility towards recurrent infections, intrauterine growth restriction, preterm delivery, increased perinatal morbidity and mortality. Anemic pregnant women have increased chances of postpartum hemorrhage requiring blood transfusion leading to a longer hospital stay, reduced lactation, and postpartum mood disorders . The reasons could be poor nutrition and oral intolerance. oral therapy is not sufficient for the treatment of moderate to severe anemia, especially in the late second and third trimester. Parenteral therapy promises a better response in these patients and can obviate the need for blood transfusions in the antenatal and postpartum period. The present study is undertaken to study the efficacy and safety profile of ferric carboxy maltose in comparison to iron sucrose for the treatment of anemia in pregnancy
AIM: To evaluate the efficacy, cost-effectiveness, and patient acceptability of ferric carboxymaltose (FCM) versus iron sucrose complex (ISC) for treatment of iron deficiency anemia (IDA) in pregnancy.
OBJECTIVES OF THIS STUDY:
· To find incidence of iron deficiency anemia in pregnant women during the study period.
· To find any adverse effects during drug administration.
· To check maternal and fetal outcomes.
· To compare the effectiveness and safety of intravenous ferric carboxy maltose (FCM) with intravenous iron sucrose (ISC) in pregnant women with Iron deficiency anemia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 42.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All pregnant women of 16-34 weeks of gestation who had been diagnosed with iron deficiency anaemia 2.All pregnant of 16-34 weeks of gestation who are noncompliant to oral iron therapy.
排除标准
- •1.Other causes anemia such as megaloblastic anemia ,sickle cell anemia, thalassemia.
- •2.Exclusions were chronic diseases including hepatitis and HIV, elevated serum creatinine levels, History of anaphylactic reaction to intravenous iron infusion, hemochromatosis, or other iron store sickness, significant cardiovascular disease.
结局指标
主要结局
Comparing the improvement in hemoglobin levels following administration of iron sucrose and FCM
时间窗: baseline hemoglobin will be measured. 4weeks and 8 weeks following drug administration will be checked
次要结局
- to determine cost effectiveness, safety & acceptability of FCM & iron sucrose(At the time of drug administration)
研究者
Dr Loshini s
Dr.M.G.R education and research institute university