Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Study Overview
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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.

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).

Official Title
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Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Conditions
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Anemia, Puerperal Disorders

Intervention / Treatment
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* Drug: Iron sucrose
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A: Administration of intravenous iron sucrose. | Drug: Iron sucrose<br>* Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.<br>* Other names: Venofer;|
| Placebo Comparator: Group B<br>Group B: Administration of intravenous NaCl 0,9%. | Drug: NaCl<br>* NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum anemia, intravenous iron