- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628770
Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
August 1, 2016 updated by: Nazli Hossain, Dow University of Health Sciences
Iron Isomaltoside 1000 (Monofer)
The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
271
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Dow University of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: parenteral iron
dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
|
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 Names:
|
Active Comparator: oral iron
oral iron in form of ferrous sulphate 200 mg twice daily
|
200mg twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimate)
June 27, 2012
Study Record Updates
Last Update Posted (Estimate)
August 3, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7865
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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