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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Iron Deficiency Anemia of Pregnancy; Iron Deficiency Anemia Treatment; Anemia, Postpartum; FCM
• Intervention / Treatment: Drug: Ferric Carboxymaltose (FCM)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110015
    • ESI-PGIMSR, Basaidarapur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: Ferric carboxymaltose (FCM); 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); 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.
Active Comparator: Group II : Oral Iron; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II	Percentage of women in the parenteral group as compared to oral group who achieved correction of anaemia i.e. Hb >11gm/dl at 4 and 6 weeks post intervention.	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	Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of >3gm/dl at 4 and 6 weeks post intervention.	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	Women in the parenteral group as compared to oral group who achieved haemoglobin (Hb) rise>2gm from baseline at 4 week and 6 week post intervention.	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	To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.	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	To record the side effect profile in participants of parenteral and oral group in order to determine safety of the intervention upto 6 weeks post intervention.	Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..

Collaborators and Investigators

• Sponsor: ESI-PGIMSR, Basaidarapur
• Investigators: Principal Investigator: Shreya Mahajan, MBBS, Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): July 5, 2025
• Study Completion (Actual): August 16, 2025

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ferric carboxymaltose; Post partum iron deficiency anemia; Oral iron treatment; Post partum anaemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; ferric carboxymaltose
• Other Study ID Numbers: ESIPGIMSR-IEC/2024031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No