Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Phase 4

Completed

• Conditions: Anemia; Puerperal Disorders
• Interventions: Drug: Iron sucrose; Drug: NaCl

• Registration Number: NCT00660933
• Lead Sponsor: Hospital Clinic of Barcelona

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).

Study Timeline

• Status Verified: 2005-09
• Study Start: 2005-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-17
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Iron sucrose	Group A: Administration of intravenous iron sucrose.
Group B	NaCl	Group B: Administration of intravenous NaCl 0,9%.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clínic of Barcelona; 🇪🇸 Barcelona, Spain