Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

NCT00660933 | Completed Phase 4

• 1 other identifier: POSTPARTFEEV
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.

Conditions

Anemia; Puerperal Disorders

Keywords

postpartum anemia; intravenous iron

Outcome Measures

Primary Outcomes (1)

• To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia

  6 weeks

Secondary Outcomes (1)

• To compare if the administration of intravenous iron supplementation is better than the oral dosage to reestablish clinical symptoms of severe anemia minimizing its side-effects (weariness, depression, anxiety) or to avoid the need for blood transfusion

  6 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A: Administration of intravenous iron sucrose.

Drug: Iron sucrose

Group B

PLACEBO COMPARATOR

Group B: Administration of intravenous NaCl 0,9%.

Drug: NaCl

Interventions

Iron sucrose DRUG

Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.

Also known as: Venofer

Group A

NaCl DRUG

NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Group B

Eligibility Criteria

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

You may qualify if:

• years and older,
• Diagnosis of postpartum anemia within the first 48 h postpartum with an haemoglobin level equal or higher than 6 g/dL and lower than 8.0 g/dL,
• Ability to read and understand the relevant purpose of the trial and consent obtained in accordance with specifications of the local research ethics committee.

You may not qualify if:

• Clinical symptoms or suspicion of acute or chronic infection.
• Allergic history or iron intolerance.
• Indication of blood transfusion.
• Non iron deficit anemia.
• Hepatopathy.
• Parenteral iron hypersensitivity.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• Perello MF, Coloma JL, Masoller N, Esteve J, Palacio M. Intravenous ferrous sucrose versus placebo in addition to oral iron therapy for the treatment of severe postpartum anaemia: a randomised controlled trial. BJOG. 2014 May;121(6):706-13. doi: 10.1111/1471-0528.12480. Epub 2014 Jan 15.

  PMID: 24423186 BACKGROUND

MeSH Terms

Conditions

Anemia; Puerperal Disorders

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Montse Palacio, MD, PhD

  Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 17, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 8, 2016

Record last verified: 2005-09

Locations

ES (1)