CTRI/2021/10/037065Other4 期
Ferric Carboxymaltose Injection in Iron deficiency anemia in Pregnancy: A Multicentric, Prospective, Observational Study in India
Global Rainbow Healthcare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Pregnant women ready to give informed consent for participation in study.
- •2. Pregnant women more than 18 years of age visiting to department of Obstetrics and Gynecology of gestational age between 16-36 weeks.
- •3. Pregnant women with hemoglobin (Hb) level more than 6 and less than 10 g/dl.
- •4. Pregnant women with serum ferritin level less than 50 Ã?µg/L
- •5. Pregnant women with poor compliance to oral iron or oral iron therapy not tolerable or oral iron therapy is inappropriate based on clinical judgment of investigator.
排除标准
- •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 patientââ?¬•s inclusion in the study.
研究者
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