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

Norwegian University of Science and Technology

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Puerperal Disorders; Depression, Postpartum; Anemia, Iron-Deficiency

Treatments: Drug: Ferrous sulfate tablets; Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT00929409

4.2009.373

09/03045-4 (Other Identifier)

21830 (Other Identifier)

2008-008526-79 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Peroral iron - ferrous sulfate tablets

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous sulfate tablets

Ferric carboxymaltose

Active Comparator group

Description:

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.

Treatment:

Drug: Ferric carboxymaltose