Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women

Assiut University

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Iron dextran; Drug: Ferrous Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT03212781

IDAO

Details and patient eligibility

About

Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).

Enrollment: 66 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemoglobin < 10 g/dL
• Gestational age between 14-28 weeks.
• Willingness to participate and signing the informed consent form.

Exclusion criteria

• Iron overload or disturbances in utilization of iron
• Decompensated liver cirrhosis and active hepatitis
• Active acute or chronic infections
• History of multiple allergies
• Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
• Erythropoietin treatment within 8 weeks prior to the screening visit
• Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
• Planned elective surgery during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

intravenous iron

Experimental group

Description:

patients will receive intravenous iron as total dose infusion

Treatment:

Drug: Iron dextran

oral iron

Active Comparator group

Description:

patients will receive oral iron

Treatment:

Drug: Ferrous Fumarate