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

Phase 3

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

• Registration Number: CTRI/2024/02/063025
• Lead Sponsor: ol nayak Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <30 ng/ml

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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