Status:
TERMINATED
Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Sykehuset Innlandet HF
Conditions:
Anemia, Iron-Deficiency
Puerperal Disorders
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group). The hypothesis is that intravenous iron supplementatio...
Detailed Description
The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway. The amount of iron given to the intervention group is calculated according to the modified Ganzoni fo...
Eligibility Criteria
Inclusion
- Woman within 48 h post partum
- Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
- Able to read and understand the Norwegian language
- Signed informed consent
Exclusion
- Anemia not attributable to iron deficiency
- Contraindications for any of the study drugs
- Treatment with drugs, dietary supplements or natural remedies containing iron
- Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
- Assessed as requiring blood transfusion(s)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00929409
Start Date
June 1 2009
End Date
July 1 2010
Last Update
February 17 2012
Active Locations (3)
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1
Department of Obstetrics, Vestre Viken Hospital Trust
Drammen, Norway, 3004
2
Sykehuset Innlandet HF
Lillehammer, Norway, N 2609
3
St Olavs Hospital
Trondheim, Norway, N 7006