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Comparison of intravenous ferric carboxymaltose and iron sucrose complex for the treatment of iron deficiency anaemia in pregnancy

Comparison of efficacy and safety of intravenous ferric carboxymaltose and iron sucrose complex for the treatment of iron deficiency anaemia in pregnancy: A randomised controlled study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063025
Enrollment
100
Registered
2024-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: O99- Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Iron sucrose, ferric carboxymaltose: Iron preparation given as intravenous infusion to correct anaemia, given as an infusion with normal saline over 30 minutes and helpful in correctin

Sponsors

Lol nayak Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Pregnant women from 20 weeks to 36 weeks period of gestation 2-Haemoglobin more than 7 g% and less than 11g% 3-Having pure iron deficiency anaemia: baseline serum ferritin

Exclusion criteria

Exclusion criteria: 1-History of allergy to IV iron preparation 2-Chronic infections like HIV/ TB/hepatitis 3-Known case of chronic heart/ lung disease

Design outcomes

Primary

MeasureTime frame
Rise in haemoglobin and hematocrit from baseline in 4 weeks expressed as Mean ± Standard Deviation and percentage rise from baseline.Timepoint: Rise in haemoglobin and hematocrit from baseline in 4 weeks expressed as Mean ± Standard Deviation and percentage rise from baseline.

Secondary

MeasureTime frame
1. Rise in ferritin levels as Mean ± Standard Deviation in both groups. 2. The rate of adverse effects in both groups (local site reaction, allergic reaction and anaphylaxis) 3. Change in FACIT Fatigue score baseline and at 4 weeks in two groups.Timepoint: 0 and 4 weeks

Countries

India

Contacts

Public ContactDr Krishna Agarwal

Lok nayak hospital

drkrishna.agarwal@gmail.com9968604350

Outcome results

None listed

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