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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Resource links provided by NLM:


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
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
Other Name: NaCl

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:

  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.
  Contacts and Locations
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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

No publications provided

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

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

Additional relevant MeSH terms:
Anemia
Puerperal Disorders
Hematologic Diseases
Pregnancy Complications
Ferric oxide, saccharated
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014