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Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Primary Purpose

Anemia, Puerperal Disorders

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Iron sucrose
NaCl
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring postpartum anemia, intravenous iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Group A: Administration of intravenous iron sucrose.

Group B: Administration of intravenous NaCl 0,9%.

Outcomes

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

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

Full Information

First Posted
April 14, 2008
Last Updated
March 7, 2016
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00660933
Brief Title
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia
Official Title
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Puerperal Disorders
Keywords
postpartum anemia, intravenous iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: Administration of intravenous iron sucrose.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Group B: Administration of intravenous NaCl 0,9%.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
Venofer
Intervention Description
Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
Intervention Type
Drug
Intervention Name(s)
NaCl
Intervention Description
NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montse Palacio, MD, PhD
Organizational Affiliation
Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24423186
Citation
Perello MF, Coloma JL, Masoller N, Esteve J, Palacio M. Intravenous ferrous sucrose versus placebo in addition to oral iron therapy for the treatment of severe postpartum anaemia: a randomised controlled trial. BJOG. 2014 May;121(6):706-13. doi: 10.1111/1471-0528.12480. Epub 2014 Jan 15.
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Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

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