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

Phase 2

Terminated

• Conditions: Anemia, Iron-Deficiency; Puerperal Disorders; Depression, Postpartum
• Interventions: Drug: Ferrous sulfate tablets; Drug: Ferric carboxymaltose

• Registration Number: NCT00929409
• Lead Sponsor: Norwegian University of Science and Technology

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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peroral iron - ferrous sulfate tablets	Ferrous sulfate tablets	Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily
Ferric carboxymaltose	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.

Primary Outcome Measures

Name	Time	Method
Haemoglobin concentration	6 weeks

Secondary Outcome Measures

Name	Time	Method
Ferritin	6 weeks
Fatigue	6 weeks	Fatigue scale
Quality of life	6 weeks	SF-36
Post partum depression	6 weeks	Edinburgh Post Partum Depression Scale

Trial Locations

Locations (3)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Sykehuset Innlandet HF; 🇳🇴 Lillehammer, Norway

Department of Obstetrics, Vestre Viken Hospital Trust; 🇳🇴 Drammen, Norway