Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Not Applicable

Completed

• Conditions: Postpartum Anemia
• Interventions: Drug: Iron isomaltoside 1000; Drug: Ferrous sulphate

• Registration Number: NCT01628770
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 271

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parenteral iron	Iron isomaltoside 1000	dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
oral iron	Ferrous sulphate	oral iron in form of ferrous sulphate 200 mg twice daily

Primary Outcome Measures

Name	Time	Method
To see the rise in hemoglobin concentration of 2gm/dl or more.	3 months	To see the rise in hemoglobin concentration of 2gm/dl or more.This rise in hemoglobin concentration will be measured at day 14 and at 3 months, in both groups.

Secondary Outcome Measures

Name	Time	Method
secondary - time required for rise in hemoglobin concentration	3 months	time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan