Iron Isomaltoside 1000 (Monofer)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- To see the rise in hemoglobin concentration of 2gm/dl or more.
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
parenteral iron
dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion
Intervention: Iron isomaltoside 1000 (Drug)
oral iron
oral iron in form of ferrous sulphate 200 mg twice daily
Intervention: Ferrous sulphate (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- secondary - time required for rise in hemoglobin concentration(3 months)
Investigators
Nazli Hossain
Professor
Dow University of Health Sciences