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| Name | Class |
|---|---|
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
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This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.
140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.
Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxyltol | Experimental | Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. |
|
| Ferrous Sulfate | Active Comparator | Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate 325mg | Dietary Supplement | Oral tablets supplied for home use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin | We will assess the increase in maternal hemoglobin during the study timeframe | 1 day - 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other laboratory values | Including hematocrit, serum iron, transferrin saturation, ferritin | 1 day - 22 weeks |
| Blood loss at delivery | Estimated or quantified blood loss at delivery |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348817 | Derived | Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20. | |
| 37348816 | Derived |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 14, 2023 | Mar 13, 2023 | 6 |
| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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Randomized Controlled Trial
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| Ferumoxytol |
| Drug |
Ferumoxytol will be administered in two infusions, one week apart |
|
| 1 day - 22 weeks |
| Hemoglobin change after delivery | Measured change in hemoglobin after delivery | 1 day - 22 weeks |
| Blood transfusion | Whether the mother requires a blood transfusion | 1 day - 22 weeks |
| Iron infusion | Whether the mother requires additional iron infusions | 1 day - 22 weeks |
| Concentration of substances in cord blood (iron studies) | Cord blood indices for iron, transferrin saturation and ferritin | 1 day - 22 weeks |
| Preterm delivery | Whether the delivery occurs at less than 37 weeks of gestation | 1 day - 22 weeks |
| Indication for delivery | Indication for delivery if not spontaneous | 1 day - 22 weeks |
| Birth weight | Neonatal weight immediately after delivery | 1 day - 22 weeks |
| Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20. |
| D008903 |
| Minerals |