Anemia
Conditions
Brief summary
The investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.
Detailed description
Fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the Anemia clinic at the Department of Obstetrics, University Hospital Zurich. All patients had singleton pregnancies. All pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (Hb) between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l. In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted. According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly. Patients with an Hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (VENOFER®, Vifor Int., St. Gallen, Switzerland) intravenously twice weekly (group A). If response to therapy was poor (i.e. Hb increase \<0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhEPO (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland) (group B). This cut-off for adequate primary response the investigators choose on the basis of previous experience. Patients with an Hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (Venofer) and rhEPO (Eprex) twice weekly from the start of therapy (group C). Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase \>1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb \> 10.5 g/dL was achieved.
Interventions
DRUGiron sucrose (200 mg VENOFER®)
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
DRUGrecombinant human erythropoietin (10,000 U EPREX®)
According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l
Exclusion criteria
* vitamin B12 deficiency anemia * folic acid deficiency anemia * hemoglobinopathy * multiples * liver disease * kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Treatment: hemoglobin increase after therapy | 4 weeks | In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted.The hematological parameters were checked twice a week in the anemia clinic and iron status once a week. |
Outcome results
None listed