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Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

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ClinicalTrials.gov Identifier: NCT01628770
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Postpartum Anemia Drug: Iron isomaltoside 1000 Drug: Ferrous sulphate

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Iron Isomaltoside 1000 (Monofer)
Study Start Date : May 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: parenteral iron
dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
Drug: 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.
Other Name: Monofer
Active Comparator: oral iron
oral iron in form of ferrous sulphate 200 mg twice daily
Drug: Ferrous sulphate
200mg twice daily


Outcome Measures

Primary Outcome Measures :
  1. To see the rise in hemoglobin concentration of 2gm/dl or more. [ Time Frame: 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 :
  1. secondary - time required for rise in hemoglobin concentration [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628770


Locations
Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 74200
Sponsors and Collaborators
Dow University of Health Sciences
More Information

Responsible Party: Nazli Hossain, Professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT01628770     History of Changes
Other Study ID Numbers: 7865
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Nazli Hossain, Dow University of Health Sciences:
iron
monofer
Pakistan

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics