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
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | NaCl | NaCl 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.