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
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