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Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

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ClinicalTrials.gov Identifier: NCT00660933
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : March 8, 2016
Information provided by:
Hospital Clinic of Barcelona

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

Condition or disease Intervention/treatment Phase
Anemia Puerperal Disorders Drug: Iron sucrose Drug: NaCl Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial
Study Start Date : September 2005
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group A
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.
Other Name: Venofer
Placebo Comparator: Group B
Group B: Administration of intravenous NaCl 0,9%.
Drug: NaCl
NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660933

Hospital Clínic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Montse Palacio, MD, PhD Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona

Responsible Party: Montse Palacio, Hospital Clínic of Barcelona
ClinicalTrials.gov Identifier: NCT00660933     History of Changes
Other Study ID Numbers: POSTPARTFEEV
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: September 2005

Keywords provided by Hospital Clinic of Barcelona:
postpartum anemia
intravenous iron

Additional relevant MeSH terms:
Puerperal Disorders
Hematologic Diseases
Pregnancy Complications
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs