Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia
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|ClinicalTrials.gov Identifier: NCT00660933|
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia Puerperal Disorders||Drug: Iron sucrose Drug: NaCl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia Randomized Trial|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660933
|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|