Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

NCT06911034 | Completed Phase 4

• 1 other identifier: U1111-1319-2291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women. The main question it aimed to answer was: Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women. Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.

• Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
• Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.

Conditions

Iron Deficiency Anemia (IDA); Pregnancy

Keywords

Iron deficiency anemia; Pregnancy; Ferric carboxymaltose; Iron sucrose

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

  Rise in hemoglobin (g/dl) will be calculated by subtracting post treatment hemoglobin from pre-treatment hemoglobin

  After three weeks of completing parenteral iron therapy

Secondary Outcomes (1)

• Ferritin levels

  Three weeks after completion of parenteral iron therapy

Study Arms (2)

Carboxymaltose

EXPERIMENTAL

Intravenous infusion

Drug: Iron Carboxymaltose

Sucrose

ACTIVE COMPARATOR

Intravenous infusion

Drug: Iron Sucrose Injection

Interventions

Iron Carboxymaltose DRUG

In ferrous carboxymaltose treatment maximum dose per sitting was 1000 mg, diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.

Also known as: Ferrous Carboxymaltose

Carboxymaltose

Iron Sucrose Injection DRUG

Iron sucrose infusion was administered as 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.

Also known as: sucroferric oxyhydroxide, Iron saccharate

Sucrose

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• weeks of gestation
• Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is \<10 gm% and serum Ferritin \< 30 ng/ml.

You may not qualify if:

• Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
• serum creatinine level of more than 2.0 mg/dL
• history of allergic reaction to intravenous iron infusion

Sponsors & Collaborators

• CMH Multan Institute of Medical Sciences: lead

Study Sites (1)

Cmh Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (3)

• Bharadwaj MK, Patrikar S, Singh Y. Comparative analysis of injection ferric carboxymaltose vs iron sucrose for treatment of iron-deficiency anemia in pregnancy: systematic review and meta-analysis. J South Asian Fed Obstet Gynaecol. 2023;15(5):629-36.

  BACKGROUND

• Comparison of ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia in pregnancy at tertiary care centre, Western India. Int J Reprod Contracept Obstet Gynecol. 2023;12(6):1844-8.

  BACKGROUND

• Jose A, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M, Kriplani A. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.

  PMID: 30717690 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated; sucroferric oxyhydroxide

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Nidda Ya Consultant, FCPS

  CMH Multan Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: February 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)