Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

March 7, 2016 updated by: Hospital Clinic of Barcelona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (ESTIMATE)

April 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSTPARTFEEV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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