Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients

NCT07115121 | Completed

• 1 other identifier: Dr-Shamsa-BVH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV iron sources in anemic antenatal patients in our local population.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Increase in hemoglobin

  Baseline hemoglobin was subtracted from post-treatment hemoglobin to assess increase in the hemoglobin

  12 weeks

Study Arms (2)

Ferric Carboxymaltose-Group

EXPERIMENTAL

Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes.

Drug: Intravenous Ferric Carboxymaltose

Iron Sucrose-Group

EXPERIMENTAL

Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses.

Drug: Intravenous Iron Sucrose

Interventions

Intravenous Ferric Carboxymaltose DRUG

Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes.

Ferric Carboxymaltose-Group

Intravenous Iron Sucrose DRUG

Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses.

Iron Sucrose-Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• Aged 18 to 40 years
• Presented with anemia
• Any parity
• Gestational age \< 12 weeks on LMP

You may not qualify if:

• Females with a history of hypertension
• Type II diabetes mellitus
• Gestational diabetes mellitus
• Ischemic heart disease
• Endocrine disorder
• Hematological disorders (hemophilia, leukemia, lymphoma, or myeloma)
• History of taking iron-lowering drugs

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: February 2, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)