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A clinical trial to compare oral iron ferrous sulfate with newer intravenous iron (ferric carboxymaltose) injection in patients of iron deficiency anemia in post delivery period

Comparison of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anemia â?? a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005099
Enrollment
140
Registered
2014-10-14
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: null- Iron deficiency anemia

Interventions

Intervention1: Injection Ferric Carboxymaltose: As per calculated dose, not exceeding 1000 mg per infusion.usually 2 infusions per subject was required. Control Intervention1: Ferrous sulfate tablet:

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Postnatal women within 10 days of normal delivery. 2. Hb should be more than or equal to 7 gm% and less than or equal 10 gm%. 3. Peripheral smear showing microcytic hypochromic anemia or red cell indices suggestive of iron deficiency anemia (PCV <36%, MCV <80fl, MCH <27pg and MCHC <33gm/dl) with negative NESTROF test.

Exclusion criteria

Exclusion criteria: 1. Women with weight 2. Puerperal pyrexia. 3. Known drug allergy or intolerance to iron therapy. 4. History of chronic medical illness such as tuberculosis, asthma, liver diseases, kidney diseases, diabetes mellitus, hypertension, HIV infection. 5. Received other intervention for management of anemia such as blood transfusion, erythropoietin administration in last three months.

Design outcomes

Primary

MeasureTime frame
Percentage of patients achieving Hb rise 3 g/dl from baseline at 3 and 6 weeks.Timepoint: Percentage of patients achieving Hb rise 3 g/dl from baseline at 3 and 6 weeks.

Secondary

MeasureTime frame
- Percentage of patients achieving Hb 12 g/dl at 3 and 6 weeks. - Rise in Hb from baseline to 3 and 6 weeks. - Change in red cell indices and serum iron parameters from baseline to 6 weeks. - Recording the side effects in both the groups such as dysguesia, nausea, abdominal pain, urticaria, muscle cramps, headache, nasopharyngitis, fever, infusion site burning pain, serum transaminase elevation, etc.Timepoint: 6 weeks

Countries

India

Contacts

Public ContactDr Shikha

UCMS & GTB HOSPITAL

amita_suneja@yahoo.co.in9868399728

Outcome results

None listed

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