Intravenous Treatment of Anemia in Pregnancy

NCT03317210 | Completed Phase 4 DMC

• 1 other identifier: 34130203
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

iron therapy with good response

OTHER

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®)

iron therapy with poor response

OTHER

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

iron therapy and erythropoietin

OTHER

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

Interventions

iron sucrose (200 mg VENOFER®) DRUG

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.

Also known as: Venofer

iron therapy and erythropoietin; iron therapy with good response; iron therapy with poor response

recombinant human erythropoietin (10,000 U EPREX®) DRUG

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

Also known as: Eprex

iron therapy and erythropoietin; iron therapy with poor response

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l

You may not qualify if:

• vitamin B12 deficiency anemia
• folic acid deficiency anemia
• hemoglobinopathy
• multiples
• liver disease
• kidney disease

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated; Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Roland Zimmermann, Prof.

  University of Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: October 23, 2017
• Study Start: September 1, 2002
• Primary Completion: July 31, 2006
• Study Completion: July 31, 2006
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share