Anemia, Puerperal Disorders
Conditions
Keywords
postpartum anemia, intravenous iron
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).
Interventions
DRUGIron sucrose
Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
DRUGNaCl
NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed