Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Dow University of Health Sciences

Status: Completed

Conditions: Postpartum Anemia

Treatments: Drug: Ferrous sulphate; Drug: Iron isomaltoside 1000

Study type: Interventional

Funder types: Other

Identifiers

NCT01628770

7865

Details and patient eligibility

About

The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

Full description

Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Enrollment: 271 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women within 24-48 hours of delivery with hemoglobin concentration < 10gm/dl

Exclusion criteria

• History of PPH, or significant blood loss in last 24 hours
• History of allergy to iron preparation
• Hemoglobin < 7gm/dl.
• Sign & symptoms of cardiac failure
• H/o blood transfusion in last 3 months
• H/O Chronic liver diseases.
• ↑ Creatinine > 2mg/dl.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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271 participants in 2 patient groups

parenteral iron

Experimental group

Description:

dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion

Treatment:

Drug: Iron isomaltoside 1000

oral iron

Active Comparator group

Description:

oral iron in form of ferrous sulphate 200 mg twice daily

Treatment:

Drug: Ferrous sulphate