Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Anemia; Puerperal Disorders

Treatments: Drug: Iron sucrose; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00660933

POSTPARTFEEV

Details and patient eligibility

About

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

Full 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).

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Group A: Administration of intravenous iron sucrose.

Treatment:

Drug: Iron sucrose

Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl