Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

April 3, 2025 updated by: Kiran Saleem, CMH Multan Institute of Medical Sciences

Comparison of Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anemia in Pregnant Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A & B.

Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 60000
        • CMH Multan Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 28-34 weeks of gestation
  • Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is <10 gm% and serum Ferritin < 30 ng/ml.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carboxymaltose
Intravenous infusion
Drug: Iron Carboxymaltose
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.
Other Names:
  • Ferrous Carboxymaltose
Active Comparator: Sucrose
Intravenous infusion
Drug: Iron Sucrose Injection
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.
Other Names:
  • sucroferric oxyhydroxide
  • Iron saccharate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemoglobin
Time Frame: After three weeks of completing parenteral iron therapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ferritin levels
Time Frame: Three weeks after completion of parenteral iron therapy
Post treatment ferritin levels will be done
Three weeks after completion of parenteral iron therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMH Multan Institute of Medical Sciences

Investigators

  • Study Chair: Nidda Ya Consultant, FCPS, CMH Multan Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1319-2291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing IPD can compromise patient privacy, even if identifying details are removed. Sensitive medical information could potentially be re-identified, violating ethical guidelines.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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