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

Muhammad Aamir Latif

Status: Completed

Conditions: Anemia

Treatments: Drug: Intravenous Ferric Carboxymaltose; Drug: Intravenous Iron Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT07115121

Dr-Shamsa-BVH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ferric Carboxymaltose-Group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous Ferric Carboxymaltose

Iron Sucrose-Group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous Iron Sucrose