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A Randomized Control Study: Comparison of Two Iron preparations for Anemia in Pregnant Women: Ferric Carboxymaltose vs. Iron Sucrose

COMPARATIVE STUDY OF INTRAVENOUS FERRIC CARBOXY MALTOSE VERSUS INTRAVENOUS IRON SUCROSE FOR TREATMENT OF ANEMIA IN PREGNANCY - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074985
Enrollment
100
Registered
2024-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Administration of 1gm of Ferric Carboxy maltose: Single dose Intravenous administration of 1gm of Ferric Carboxy maltose in 250ml Normal saline over 20 minutes Control Intervention1

Sponsors

Dr Santosh B Nirwani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with mild to moderate anemia. 2.Antenatal patients with a period of gestation 16- 32 weeks of gestation. 3.Patients with Iron deficiency anemia.

Exclusion criteria

Exclusion criteria: 1.Pregnancy more than 32 weeks of gestation. 2.K/C/O thalassemia& sickle cell anemia. 3.H/O allergic reactions to iron preparations. 4. History of blood transfusion in last 3months.

Design outcomes

Primary

MeasureTime frame
To study and compare the difference in rise in hemoglobin on administration of IV ferric carboxymaltose and IV iron sucrose.Timepoint: To Compare the efficacy of IV Ferric Carboxymaltose and IV Iron Sucrose after 4 weeks of last dose

Secondary

MeasureTime frame
To Compare the secondary response of IV Ferric Carboxymaltose & IV Iron SucroseTimepoint: To compare secondary response to IV Ferric Carboxymaltose & IV Iron Sucrose after 30 minutes of administration

Countries

India

Contacts

Public ContactDR SANTOSH B NIRWANI

KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE HUBBALLI

svn1974@gmail.com9343882242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026