Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Study Overview
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Brief Summary
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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
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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

Official Title
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Iron Isomaltoside 1000 (Monofer)

Conditions
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Postpartum Anemia

Intervention / Treatment
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* Drug: Iron isomaltoside 1000
* Drug: Ferrous sulphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parenteral iron<br>dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion | Drug: Iron isomaltoside 1000<br>* 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. It can be given in a dose of 20mg/kg body weight.<br>* Other names: Monofer;|
| Active Comparator: oral iron<br>oral iron in form of ferrous sulphate 200 mg twice daily | Drug: Ferrous sulphate<br>* 200mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see the rise in hemoglobin concentration of 2gm/dl or more. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary - time required for rise in hemoglobin concentration | time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, monofer, Pakistan