Comparison of efficacy and safety of intravenous Ferric carboxymaltose (FCM) with oral iron therapy in pregnant women with mild to moderate iron deficiency anemia (IDA) - An Open Labelled Randomised Controlled Trial - NI

RESEARCH AND ACADEMIC SECTION AIIMS NEW DELHI0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•Pregnant women aged =18, gestational week =14, =28 at baseline visit
•Iron deficiency anaemia (mild to moderate): defined as Hb concentration =7 g/dl and =11 g/dL at screening
•Willing to participate: Patients must provide written informed consent for their participation in the study

•Known hypersensitivity to FCM or other IV or oral iron preparations
•severe anaemia (Hb less than 7 g/dL)
•Blood transfusion, erythropoietin treatment, parenteral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study
•Aplastic , haemolytic or drug induced anaemia
•Haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases and enzyme defects
•Acute or chronic infection
•Multiple pregnancies
•Evidence on any significant abnormalities on anomaly ultrasound
•Haemochromatosis or other iron storage disorders
•Known case of chronic kidney disease (CKD), chronic liver disease (CLD), Severe cardiovascular diseases
•Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.
•Any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study
•Participation in any other interventional study since estimated conception and throughout study participation.

发起方

RESEARCH AND ACADEMIC SECTION AIIMS NEW DELHI