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Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Terminated
CT.gov ID
NCT00929409
Collaborator
St. Olavs Hospital (Other), Sykehuset Innlandet HF (Other), Sykehuset Buskerud HF (Other)
30
Enrollment
3
Locations
2
Arms
13
Duration (Months)
10
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ferric carboxymaltose
  • Drug: Ferrous sulfate tablets
 Phase 2/Phase 3

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 formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.

The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).

Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.

Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Peroral iron - ferrous sulfate tablets

Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily

Drug: Ferrous sulfate tablets
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Other Names:
  • Duroferon

    		•
    Active Comparator: Ferric carboxymaltose

    Intravenous 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.

    Drug: Ferric carboxymaltose
    Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
    Other Names:
  • Ferinject

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Haemoglobin concentration [6 weeks]

    Secondary Outcome Measures

    1. Ferritin [6 weeks]

    2. Fatigue [6 weeks]

      Fatigue scale

    3. Quality of life [6 weeks]

      SF-36

    4. Post partum depression [6 weeks]

      Edinburgh Post Partum Depression Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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 Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital
    • Sykehuset Innlandet HF
    • Sykehuset Buskerud HF

    Investigators

    • Principal Investigator: Bjorn Backe, MD PhD, Norwegian University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT00929409
    Other Study ID Numbers:
    • 4.2009.373
    • 21830
    • 09/03045-4
    • 2008-008526-79
    First Posted:
    Jun 29, 2009
    Last Update Posted:
    Feb 17, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Norwegian University of Science and Technology
    Postpartum anemia, iron-deficiency
    Additional relevant MeSH terms:
    Depression, Postpartum
    Puerperal Disorders
    Anemia
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of Feb 17, 2012