Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia

NCT07648628 | Completed Phase 2 DMC

• 1 other identifier: ESIPGIMSR-IEC/2024031
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb \>7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index \>13. Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb \>11 g/dl at 4 and 6 weeks. Percentage of patients achieving Hb rise \>3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron. Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done. Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks. All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.

Conditions

Anemia; Anemia, Postpartum; Iron Deficiency Anemia of Pregnancy; Iron Deficiency Anemia Treatment; FCM

Keywords

Post partum iron deficiency anemia; Ferric carboxymaltose; Oral iron treatment; Post partum anaemia

Outcome Measures

Primary Outcomes (1)

• Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II

  The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.

  Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment

Secondary Outcomes (5)

• Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II

  Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment

• Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II

  Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment

• Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II

  Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment

• Change in red cell indices and peripheral smear from baseline to 6 weeks

  Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment

• Side effects profile for participants of Group I and II

  Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..

Study Arms (2)

Group I: Ferric carboxymaltose (FCM)

EXPERIMENTAL

FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes During infusion, subject was kept under strict observation. FCM was repeated weekly up to calculated dose or maximum of 2500mg. Total dose of IV FCM was calculated by Ganzoni formula: - Total dose of iron = body weight (in kg) x (14-actual Hb) x 2.4 + 500 where, 14 is target Hb (g/dl), 2.4 unitless conversion constant, 500 is target iron store in mg

Drug: Ferric Carboxymaltose (FCM)

Group II : Oral Iron

ACTIVE COMPARATOR

Second group of subjects were instructed to take oral iron (ferrous fumarate tablet containing 112 mg elemental iron) 2 times daily 1 hour before meals for 6 weeks.

Drug: Ferric Carboxymaltose (FCM)

Interventions

Ferric Carboxymaltose (FCM) DRUG

FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes. FCM was repeated weekly up to calculated dose or maximum of 2500mg.

Group I: Ferric carboxymaltose (FCM); Group II : Oral Iron

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postnatal women within 10 days of delivery.
• Hb should be \>7 gm/dl and ≤10 gm.
• Peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index \>13.

You may not qualify if:

• \. Puerperal pyrexia. 2. Known drug allergy or intolerance to iron therapy. 3. History of chronic medical illness. 4. Known cases of Thalassemia 5. Received other intervention for management of anaemia such as blood transfusion in last three months.

Sponsors & Collaborators

• ESI-PGIMSR, Basaidarapur: lead

Study Sites (1)

ESI-PGIMSR, Basaidarapur

Delhi, 110015, India

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Shreya Mahajan, MBBS

  Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Doctor, Department of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start: March 1, 2024
• Primary Completion: July 5, 2025
• Study Completion: August 16, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)