Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

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.

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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

Conditions

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Postpartum Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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parenteral iron

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

Group Type EXPERIMENTAL

Iron isomaltoside 1000

Intervention Type DRUG

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.

oral iron

oral iron in form of ferrous sulphate 200 mg twice daily

Group Type ACTIVE_COMPARATOR

Ferrous sulphate

Intervention Type DRUG

200mg twice daily

Interventions

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Iron isomaltoside 1000

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.

Intervention Type DRUG

Ferrous sulphate

200mg twice daily

Intervention Type DRUG

Other Intervention Names

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Monofer

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No