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

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.

Study Overview

• Status: Terminated
• Conditions: Anemia, Iron-Deficiency; Depression, Postpartum; Puerperal Disorders
• Intervention / Treatment: Drug: Ferrous sulfate tablets; Drug: Ferric carboxymaltose

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Norway
  • Drammen, Norway, 3004
    • Department of Obstetrics, Vestre Viken Hospital Trust
  • Lillehammer, Norway, N 2609
    • Sykehuset Innlandet HF
  • Trondheim, Norway, N 7006
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Haemoglobin concentration	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferritin		6 weeks
Fatigue	Fatigue scale	6 weeks
Quality of life	SF-36	6 weeks
Post partum depression	Edinburgh Post Partum Depression Scale	6 weeks

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Sykehuset Innlandet HF; Sykehuset Buskerud HF
• Investigators: Principal Investigator: Bjorn Backe, MD PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: June 26, 2009
• First Posted (Estimate): June 29, 2009

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Postpartum anemia, iron-deficiency
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Mood Disorders; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Pregnancy Complications; Depressive Disorder; Anemia, Iron-Deficiency; Depression, Postpartum; Anemia; Puerperal Disorders
• Other Study ID Numbers: 4.2009.373; 21830 (Other Identifier: NSD, Norway); 09/03045-4 (Other Identifier: SLV, Norway); 2008-008526-79 (EudraCT Number)