Efficacy and Safety of Ferric Carboxymaltose Injection in Iron deficiency anemia in Pregnancy: AProspective Observational Study

Radhakrishna Multispecialty Hospital0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36
•2. Pregnant women with hemoglobin (Hb) level more than 6 and less
•than 10 g/dl.
•3. Pregnant women not responding to oral Iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical
•judgment of investigator
•4. Pregnant women ready to give informed consent for participation in study.

•1. Any other type of anemia other than Iron Deficiency anemia
•2. Evidence of iron overload conditions (e.g. hemochromatosis / hemosiderosis).
•3. Prior history of allergic reaction to IV iron
•4. Significant cardiovascular disease including myocardial infarction during the 6 months prior to study inclusion, congestive heart failure
•NYHA Class III or IV and poorly controlled hypertension)
•5. Uncontrolled endocrinological or metabolic disorders including uncontrolled hyperparathyroidism.
•6. Presence of any active infection
•7. Known case of malignancy
•8. Presence of active liver disease / HBV or HCV infection, HIV infection / AIDS, asthma, or rheumatoid arthritis
•9. Treatment with IV Iron preparations or any investigational drug within 4 weeks prior to study enrollment
•10. Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.

发起方

Radhakrishna Multispecialty Hospital