Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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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).

Conditions

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Anemia Puerperal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Group A: Administration of intravenous iron sucrose.

Group Type ACTIVE_COMPARATOR

Iron sucrose

Intervention Type DRUG

Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.

Group B

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

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Interventions

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Iron sucrose

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

NaCl

NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Intervention Type DRUG

Other Intervention Names

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Venofer

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No