Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Hospital Clinic of Barcelona70 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anemia Puerperal Disorders

Interventions

Iron sucroseDRUG

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

NaClDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clínic of Barcelona

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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