A study to assess if using IV Ferric Carboxy Maltose (FCM) in Management of Iron Deficiency Anemia (IDA) among pregnant women is better than IV Iron Sucrose in terms of duration of treatment, side effects and cost-effectiveness at sub district health system in Maharashtra

Not Applicable

• Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecifiedHealth Condition 2: D509- Iron deficiency anemia, unspecified

• Registration Number: CTRI/2021/08/036037
• Lead Sponsor: Department of health research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Diagnosed with iron deficiency anemia with hemoglobin levels between 5- 9.9gm/dl between 22-32 weeks of gestational age with following criteria

Severe anemia with hemoglobin <7 gms anytime between 22-32 weeks

Moderate anemia with hemoglobin between 7-9.9 gms during 22-28 weeks not responding to oral iron given for 6 weeks

Moderate anemia in last trimester irrespective of previous iron intake.

Willing to sign an informed consent, deliver at the same site and willing for follow up

Exclusion Criteria

�Pregnant women with hemoglobin levels below 5gm/dl and above 9.9 gm/dl in the first or second trimester of pregnancy.

�Pregnant women diagnosed with anemia other than iron deficiency anemia based on peripheral smear examination and red cell indices, picture suggestive of pancytopenia,

�Any known cases of hemoglobinopathies or with Pregnancy Induced Hypertension

� History of iron overload disorder (Thalassemia, hemochromatosis, hemosiderosis]

�Pregnant women with known cardiac, renal, hepatic disease

�Pregnant women having associated medical disorders like hypertension, asthma, tuberculosis, heart disease rheumatic or congenital heart disease), heart failure or cardiac decompensation,

�history of intravenous iron therapy in the past 6 months or history of repeated blood transfusions

�Pregnant women with known OR history of hypersensitivity to ferric carboxy-maltose or iron sucrose

�Pregnant women in labor

�Blood loss due to hemodynamic instability

�History of malignancy, GI bleed, surgery

�suspected acute infections (such as upper respiratory tract infections, urinary tract infections, or fever at the time of visit), h/o of rashes and fever during pregnancy to rule rubella)

Study & Design

• Study Type: Interventional
• Study Design: Not specified