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
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Anemia||Drug: Iron isomaltoside 1000 Drug: Ferrous sulphate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||271 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iron Isomaltoside 1000 (Monofer)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- 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 - 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.
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
|Dow University of Health Sciences|
|Karachi, Sindh, Pakistan, 74200|