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To evaluate the efficacy, cost-effectiveness, and patient acceptability of ferric carboxymaltose (FCM) versus iron sucrose complex (ISC) for treatment of iron deficiency anaemia (IDA) in pregnancy

Comparative evaluation of efficacy, safety, cost effectiveness and acceptability of Ferric carboxymaltose versus Iron sucrose for treatment of Iron deficiency anemia in pregnancy - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084590
Enrollment
80
Registered
2025-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: O280- Abnormal hematological finding onantenatal screening of mother

Interventions

Intervention1: FERRIC CARBOXYMALTOSE: Dose: 1000mg Route: Intravenous Frequency: once or twice ( based on requirement) Duration of intervention:After 4 weeks of administration Intervention2: nil: nil

Sponsors

Dr Loshini S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All pregnant women of 16-34 weeks of gestation who had been diagnosed with iron deficiency anaemia 2.All pregnant of 16-34 weeks of gestation who are noncompliant to oral iron therapy

Exclusion criteria

Exclusion criteria: 1.Other causes anemia such as megaloblastic anemia ,sickle cell anemia, thalassemia. 2.Exclusions were chronic diseases including hepatitis and HIV, elevated serum creatinine levels, History of anaphylactic reaction to intravenous iron infusion, hemochromatosis, or other iron store sickness, significant cardiovascular disease

Design outcomes

Secondary

MeasureTime frame
to determine cost effectiveness, safety & acceptability of FCM & iron sucroseTimepoint: At the time of drug administration

Primary

MeasureTime frame
Comparing the improvement in hemoglobin levels following administration of iron sucrose and FCMTimepoint: baseline hemoglobin will be measured. 4weeks and 8 weeks following drug administration will be checked

Countries

India

Contacts

Public ContactDr Loshini s

Dr. M.G.R educational and research institute university

sekaran.viji@gmail.com9003166440

Outcome results

None listed

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