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Monofer vs Oral Iron in Postpartum Anemia
NCT01628770Phase 4
Key facts
- Status
- Completed
- Start
- May 2012
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Dow University of Health Sciences
- Modality
- Inorganic Nanoparticles, Small Molecules
- Drugs
- ferric derisomaltose
- Conditions
- postpartum anemia
01
Overview
Phase 4, randomised, open-label trial of ferric derisomaltose in postpartum anemia (2 arms), sponsored by Dow University of Health Sciences. Primary endpoint: Rise in hemoglobin concentration of 2gm/dl or more at 3 months. Started May 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
IV Monofer
Single IV infusion of Iron Isomaltoside 1000
Oral Ferrous Sulphate
Oral ferrous sulphate 200mg twice daily
03
Who it enrols
Women within 24-48 hours of delivery with hemoglobin < 10gm/dl, excluding those with severe anemia (<7gm/dl), significant blood loss/PPH, cardiac failure, chronic liver disease, or recent blood transfusion.
04
Endpoints
Primary
Rise in hemoglobin concentration of 2gm/dl or more
Secondary
Time required for rise in hemoglobin concentration
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