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Intravenous single dose iron infusion

"To study safety and efficacy of intravenous iron ferric-carboxymaltose in iron deficiency anaemia of pregnancy"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033579
Enrollment
50
Registered
2021-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Intravenous iron ferric carboxymaltose will be given to 50 pregnant women with iron deficiency anaemia.: All 50 women will be given infusion of ferric carboxymaltose 750 mg in 250 ml of

Sponsors

DST Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Hemoglobin levels of >= 6 gm/dl - 9 gm/dl 2. Diagnosed case of Iron deficiency anemia. 3. Period of gestation between 20 to 36 weeks. 4. Singleton live pregnancy

Exclusion criteria

Exclusion criteria: 1.Anemia other than iron deficiency anemia. 2.Known serious hypersensitivity to other parenteral iron products. 3.Patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy. 4.Patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis). 5.Chronic medical disorder 7.Antepartum hemorrhage 8.Anemia with heart failure 9. H/O Blood transfusion during current pregnancy. 11.COVID positive patient

Design outcomes

Primary

MeasureTime frame
1. Increase in hemoglobin at 2 weeks, 6 weeks and at the time of delivery from the baseline hemoglobin. 2. Increase in serum ferritin levels at 2 and 6 weeks from baseline value. 3. Rise in reticulocyte count at 2 weeks. 4.Side effects of intravenous iron Carboxymaltose Timepoint: At 2 weeks,6 weeks and on the day of delivery.

Secondary

MeasureTime frame
Blood transfusion any time after complete dose of Intravenous ferric carboxymaltose injectionTimepoint: After complete dose of ferric carboxymaltose till delivery.

Countries

India

Contacts

Public ContactDr Sunita Dubey

GMCH-Sector-32,Chandigarh

sunitas504@gmail.com9646323268

Outcome results

None listed

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