Study Stopped
Stopped prematurely because too few patients were recruited.
Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
4 other identifiers
interventional
30
1 country
3
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 supplementation is superior to standard peroral iron.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 17, 2012
February 1, 2012
1.1 years
June 26, 2009
February 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemoglobin concentration
6 weeks
Secondary Outcomes (4)
Ferritin
6 weeks
Fatigue
6 weeks
Quality of life
6 weeks
Post partum depression
6 weeks
Study Arms (2)
Peroral iron - ferrous sulfate tablets
ACTIVE COMPARATORPeroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Ferric carboxymaltose
ACTIVE COMPARATORIntravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given.
Interventions
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- Sykehuset Innlandet HFcollaborator
- Sykehuset Buskerud HFcollaborator
Study Sites (3)
Department of Obstetrics, Vestre Viken Hospital Trust
Drammen, 3004, Norway
Sykehuset Innlandet HF
Lillehammer, N 2609, Norway
St Olavs Hospital
Trondheim, N 7006, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bjorn Backe, MD PhD
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 17, 2012
Record last verified: 2012-02