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Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00660933
First received: April 14, 2008
Last updated: NA
Last verified: September 2005
History: No changes posted

April 14, 2008
April 14, 2008
September 2005
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

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

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Anemia
  • Puerperal Disorders
  • 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.
    Other Name: Venofer
  • Drug: NaCl
    NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
    Other Name: NaCl
  • Active Comparator: Group A
    Group A: Administration of intravenous iron sucrose.
    Intervention: Drug: Iron sucrose
  • Placebo Comparator: Group B
    Group B: Administration of intravenous NaCl 0,9%.
    Intervention: Drug: NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years and older,
  2. 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,
  3. 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:

  1. Clinical symptoms or suspicion of acute or chronic infection.
  2. Allergic history or iron intolerance.
  3. Indication of blood transfusion.
  4. Non iron deficit anemia.
  5. Hepatopathy.
  6. Parenteral iron hypersensitivity.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00660933
POSTPARTFEEV
No
Montse Palacio, Hospital Clínic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Montse Palacio, MD, PhD Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona
Hospital Clinic of Barcelona
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP