Intravenous Treatment of Anemia in Pregnancy

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: iron sucrose (200 mg VENOFER®); Drug: recombinant human erythropoietin (10,000 U EPREX®)

Study type: Interventional

Funder types: Other

Identifiers

NCT03317210

34130203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

iron therapy with good response

Other group

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.

Treatment:

Drug: iron sucrose (200 mg VENOFER®)

iron therapy with poor response

Other group

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).

Treatment:

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

Drug: iron sucrose (200 mg VENOFER®)

iron therapy and erythropoietin

Other group

Description:

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

Treatment:

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

Drug: iron sucrose (200 mg VENOFER®)