Skip to main content
OpenTrials
Completed

NCT Number: NCT07648628

Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for 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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ESI-PGIMSR, Basaidarapur

Delhi, 110015, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

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

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

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

Secondary outcomes

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

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

    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.

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

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

    Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of >3gm/dl at 4 and 6 weeks post intervention.

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

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

    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.

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

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

    To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.

  5. Side effects profile for participants of Group I and II

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

    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.

Sponsors and collaborators

Lead sponsor

ESI-PGIMSR, Basaidarapur

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.