iron sucrose (200 mg VENOFER®)
DrugAccording 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.
Other names: Venofer
NCT Number: NCT03317210
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.
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Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Venofer
According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
Other names: Eprex
Time frame: 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.
University of Zurich
Other
Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy
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