An Open Label, Multicentre, Single Arm Clinical Trial to Determine the Efficacy and Safety of Hemoday Manufactured By G. C. Chemie PharmieLtd in Iron Deficiency Anemia in Pregnant Women.

GC Chemie Pharmie Ltd0 个研究点目标入组 4 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Age Ã¢â?°Â¥ 18 years at recruitment.
•Pregnant women between 16 and 28 weeks of gestation diagnosed with Iron deficiency Anemia
•Haemoglobin between 7 to 9gm%
•Treatment New Patients
•Singleton Pregnancy
•Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.

•Within two months of starting iron therapy.
•Multiple pregnancy
•History of previous or repeated blood transfusion.
•History of haematological disease.
•Hemodynamic instability or clinically perceived or anticipated need of blood transfusion
•Risk of preterm labour.
•Pregnant women with any other comorbidities such as renal or hepatic impairment, cardiovascular diseases, preeclampsia, GDM, thyroid disorders, acid peptic disease, esophagitis and malabsorption syndrome.
•Treatment with any other investigational drug in the last 1 month before study entry
•Current usage of iron supplement
•High risk pregnancy.
•Women who are unable to give informed consent. Women who have intolerant to iron derivatives,
•Patients suffering from any bleeding disorder like bleeding piles or active peptic ulcer.
•Women with antepartum haemorrhage and those who delivered

发起方

GC Chemie Pharmie Ltd