Clinical Trial: Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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).
Sponsor: Hospital Clinic of Barcelona

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: April 14, 2008
Date Started: September 2005
Date Completion:
Last Updated: March 7, 2016
Last Verified: September 2005