Intravenous Treatment of Anemia in Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: iron sucrose (200 mg VENOFER®); Drug: recombinant human erythropoietin (10,000 U EPREX®)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: iron therapy with good response; 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.	Drug: iron 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.; Other Names: Venofer
Other: iron therapy with poor response; 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).	Drug: iron 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.; Other Names: Venofer; Drug: recombinant human erythropoietin (10,000 U EPREX®); According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.; Other Names: Eprex
Other: iron therapy and erythropoietin; Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.	Drug: iron 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.; Other Names: Venofer; Drug: recombinant human erythropoietin (10,000 U EPREX®); According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.; Other Names: Eprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Treatment: hemoglobin increase after therapy	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Director: Roland Zimmermann, Prof., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2002
• Primary Completion (Actual): July 31, 2006
• Study Completion (Actual): July 31, 2006

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa; Ferric Oxide, Saccharated
• Other Study ID Numbers: 34130203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No