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Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

This study is currently recruiting participants.
Verified June 2012 by Dow University of Health Sciences
Sponsor:
Information provided by (Responsible Party):
Nazli Hossain, Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01628770
First received: June 21, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Postpartum Anemia
 Drug: Iron isomaltoside 1000
Drug: Ferrous sulphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Iron Isomaltoside 1000 (Monofer)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dow University of Health Sciences:

Primary Outcome Measures:
  • To see the rise in hemoglobin concentration of 2gm/dl or more. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • secondary - time required for rise in hemoglobin concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.


Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628770

Locations
Pakistan
Dow University of Health Sciences Recruiting
Karachi, Sindh, Pakistan, 74200
Contact: Nazeer Khan, Phd     92 21 32745827     n.khan@duhs.edu.pk    
Principal Investigator: Nazli Hossain, FCPS            
Sponsors and Collaborators
Dow University of Health Sciences
  More Information

No publications provided

Responsible Party: Nazli Hossain, Professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT01628770     History of Changes
Other Study ID Numbers: 7865
Study First Received: June 21, 2012
Last Updated: June 26, 2012
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by 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
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013