Clinical trial NCT00929409: Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Anemia, Iron-Deficiency
Puerperal Disorders
Depression, Postpartum
Keywords: Postpartum anemia, iron-deficiency
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Sykehuset Innlandet HF
name: Sykehuset Buskerud HF
First posted: 2009-06-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Haemoglobin concentration
timeFrame: 6 weeks
Secondary outcomes:
measure: Ferritin
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
measure: Post partum depression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Department of Obstetrics, Vestre Viken Hospital Trust
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet HF
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bjorn Backe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: