Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia - Full Text View

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00660933

Purpose

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

Condition	Intervention	Phase
Anemia Puerperal Disorders	Drug: Iron sucrose Drug: NaCl	Phase IV

MedlinePlus related topics: Anemia

Drug Information available for: Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	September 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator Group A: Administration of intravenous iron sucrose.	Drug: Iron sucrose Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
Group B: Placebo Comparator Group B: Administration of intravenous NaCl 0,9%.	Drug: NaCl NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Detailed Description:

Postpartum anemia is commonly defined as hemoglobin levels less than 8.5 g/dl and it is usually treated with oral iron supplements. Blood transfusion is reserved to women with hemoglobin levels < 6 g/dl and/or clinical symptoms of anemia. Without treatment, the restoration of blood parameters in postpartum anemia can take approximately one month (hemoglobin levels increase to 2.8 g/dl in 30 days). Several reports have demonstrated the efficacy of intravenous iron in severe anemia in non-obstetric pathologies. However, the clinical effect of intravenous iron in patients with postpartum hemoglobin levels ranging from 6.0 to 8.0 g/dl has been not reported. There has not been evaluated its capacity to restore hemoglobin levels and to minimize clinical side-effects of anemia (sickness, weariness, depression, anxiety).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660933

Locations

Spain
Hospital Clínic of Barcelona
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:

Montse Palacio, MD, PhD

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

More Information

Responsible Party:	Hospital Clínic of Barcelona ( Montse Palacio )
Study ID Numbers:	POSTPARTFEEV
Study First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00660933
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

postpartum anemia
intravenous iron

Study placed in the following topic categories:

Ferric oxide, saccharated
Pregnancy Complications
Puerperal Disorders

Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009