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

NCT00929409 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-02-17

No results posted yet for this study

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.

Conditions

  • Anemia, Iron-Deficiency
  • Puerperal Disorders
  • Depression, Postpartum

Interventions

DRUG

Ferric carboxymaltose

Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula

DRUG

Ferrous sulfate tablets

Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Sykehuset Innlandet HF

    collaborator OTHER

  • Sykehuset Buskerud HF

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Bjorn Backe, MD PhD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00929409 on ClinicalTrials.gov