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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A: Administration of intravenous iron sucrose. |
|
| Group B | Placebo Comparator | Group B: Administration of intravenous NaCl 0,9%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose | Drug | Iron sucrose 200 mg/day iv, (20 mg/ml) + 200 cc de NaCl 0,9%/day in 60 minutes per 2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate if intravenous iron administration is better than oral treatment to improve hemoglobin and hematocrit parameters in women with severe postpartum anemia | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Montse Palacio, MD, PhD | Servei de Medicina Maternofetal. Institut de Ginecologia, ObstetrÃcia i NeonatologÃa. Hospital ClÃnic. Universitat de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic of Barcelona | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24423186 | Background | Perello MF, Coloma JL, Masoller N, Esteve J, Palacio M. Intravenous ferrous sucrose versus placebo in addition to oral iron therapy for the treatment of severe postpartum anaemia: a randomised controlled trial. BJOG. 2014 May;121(6):706-13. doi: 10.1111/1471-0528.12480. Epub 2014 Jan 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 19, 2016 | |
| Reset | Oct 11, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 19, 2016 | Oct 11, 2016 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D011644 | Puerperal Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| NaCl | Drug | NaCl 0,9% 200 ml /day iv in 60 minutes per 2 days |
|
| D000091642 | Urogenital Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |