Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia
The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Group A
Group A: Administration of intravenous iron sucrose.
Drug: Iron sucrose
Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
Other Name: Venofer
Placebo Comparator: Group B
Group B: Administration of intravenous NaCl 0,9%.
NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
Other Name: NaCl
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).
|Hospital Clínic of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Montse Palacio, MD, PhD||Servei de Medicina Maternofetal. Institut de Ginecologia, Obstetrícia i Neonatología. Hospital Clínic. Universitat de Barcelona|