Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy

Intravenous Treatment of Anemia in Pregnancy

Sponsors

Lead sponsor: University of Zurich

Source University of Zurich
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.

Overall Status Completed
Start Date September 1, 2002
Completion Date July 31, 2006
Primary Completion Date July 31, 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy of Treatment: hemoglobin increase after therapy 4 weeks
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: iron sucrose (200 mg VENOFER®)

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.

Other name: Venofer

Intervention type: Drug

Intervention name: recombinant human erythropoietin (10,000 U EPREX®)

Description: According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.

Other name: Eprex

Eligibility

Criteria:

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

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Roland Zimmermann, Prof. Study Director University of Zurich
Verification Date

October 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: iron therapy with good response

Arm group type: Other

Description: Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. 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.

Arm group label: iron therapy with poor response

Arm group type: Other

Description: Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase <0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).

Arm group label: iron therapy and erythropoietin

Arm group type: Other

Description: Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

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.

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov