A Phase 4 interventional study of Iron sucrose and NaCl in Anemia and Puerperal Disorders, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Hospital Clinic of Barcelona · Phase 4, Interventional, and Treatment
The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.
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).
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 70 is below the median of 96 across 1,318 interventional studies indexed under Anemia.
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Exclusion Criteria:
Group A: Administration of intravenous iron sucrose.
Drug: Iron sucrose
Group B: Administration of intravenous NaCl 0,9%.
Drug: NaCl
Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days.
Also known as: Venofer
NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days
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
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
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron sucrose
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