Postpartum Anemia
Conditions
Keywords
iron, monofer, Pakistan
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
Interventions
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.
DRUGFerrous sulphate
200mg twice daily
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To see the rise in hemoglobin concentration of 2gm/dl or more. | 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
| Measure | Time frame | Description |
|---|---|---|
| secondary - time required for rise in hemoglobin concentration | 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. |
Countries
Pakistan
Outcome results
None listed