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A clinical trial to study efficacy of a injectable iron preparation (FCM) as compared to oral iron in the treatment of iron deficiency anemia in 3rd trimester of pregnancy.

To study efficacy of injection Ferric Carboxymaltose as compared to oral iron in the treatment of iron deficiency anemia in 3rd trimester of pregnancy. - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008884
Enrollment
173
Registered
2017-06-20
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- Antenatal cases between 28 weeks to 36 weeks POG reporting to OPD and admitted to ANC ward

Interventions

Intervention1: Injection Ferric Carboxy Maltose: 1000 mg Intravenously in 200 ml Normal Saline over 15-20 minutes. Once in third trimester Control Intervention1: Tablet Ferrous Sulphate: 200 mg twice

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal cases detected to have Haemoglobin >7.5 gm% and <11 gm% between 28 to 36 weeks POG reporting to ANC clinic and admitted in ANC ward

Exclusion criteria

Exclusion criteria: Anemia due to other than iron deficiency History of blood transfusion Treatment with any bone marrow suppressive therapy Erythropoietin within 3 months prior to screening

Design outcomes

Primary

MeasureTime frame
Increase in Haemoglobin level to more than 11 gm%.Timepoint: Hb level gm % every 2 weeks till 37 weeks POG Final outcome to be assessed at 37 weeks POG

Secondary

MeasureTime frame
Safety and tolerability, quality of life and newborn statusTimepoint: Safety and tolerability, quality of life to be assessed every 2 weeks. New born status in postnatal period.

Countries

India

Contacts

Public ContactSurg Capt Dr Sushil Chawla

Armed Forces Medical College

chawla_sushil@rediffmail.com7030499665

Outcome results

None listed

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