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

NCT ID: NCT07115121

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-02
• Study Completion Date: 2025-07-31

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.

Detailed Description

It was hypothesized that there was a difference in mean change in hemoglobin with ferric carboxymaltose as compared to IV iron sources in anemic antenatal patients. The findings of the study would be a valuable addition to the existing stats, and if the hypothesis stands correct, a large number of women of reproductive age would benefit from effective iron replacement therapy, with a comparatively low incidence of side effects.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric Carboxymaltose-Group

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.

Group Type: EXPERIMENTAL

Intravenous Ferric Carboxymaltose

Intervention Type: 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.

Iron Sucrose-Group

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.

Group Type: EXPERIMENTAL

Intravenous Iron Sucrose

Intervention Type: 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.

Interventions

Intravenous Ferric Carboxymaltose

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.

Intervention Type: DRUG

Intravenous Iron Sucrose

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Dr-Shamsa-BVH

Identifier Type: -

Identifier Source: org_study_id