Anemia, Iron-Deficiency, Puerperal Disorders, Depression, Postpartum
Conditions
Keywords
Postpartum anemia, iron-deficiency
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.
Interventions
DRUGFerric carboxymaltose
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
Sponsors
St. Olavs Hospital
Sykehuset Innlandet HF
Sykehuset Buskerud HF
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin concentration | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed