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Trials / Completed

CompletedNCT00660933

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Hospital Clinic of Barcelona · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGIron sucroseIron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
DRUGNaClNaCl 0,9% 200 ml /day iv in 60 minutes per 2 days

Timeline

Start date
2005-09-01
Primary completion
2007-09-01
Completion
2007-09-01
First posted
2008-04-17
Last updated
2016-03-08

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00660933. Inclusion in this directory is not an endorsement.