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| Name | Class |
|---|---|
| Auerbach Hematology and Oncology | UNKNOWN |
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This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Iron | Active Comparator | 325mg oral iron (ferrous sulfate) twice daily |
|
| Intravenous Iron | Experimental | 510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | 510mg infusion x 2 doses 3-8 days apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin | Change in hemoglboin at day 90 following treatment initiation | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia resolution | Percent of participants in each group with Hb>=11.0 at day 90 | 90 days |
| Anemia at Delivery | Percent of participants in each group with Hb>=11.0 at delivery |
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Inclusion Criteria:
Iron deficiency anemia diagnosed (at any point in patient history) by:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupsa C Boelig, MD | Contact | 215-955-9196 | rupsa.boelig@jefferson.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
1 year after publication of study results
After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| C020748 | ferrous sulfate |
| 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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| Ferrous Sulfate |
| Drug |
325mg oral twice daily |
|
| 9 months |
| Need for additional therapy | Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks | 9 months |
| Quality of life scale | Linear Analogue Scale Assessment | 30, 60, 90 days |
| Adherence | adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts | 90 days |
| Need for post partum transfusion | Incidence of transfusion after delivery/post partum | 9 months |
| Neonatal outcomes: cord blood iron indices | Hb, ferritin, total iron saturation | 9 months |
| Neonatal outcomes: birth weight | birth weight (grams) | 9 months |
| Neonatal outcomes gestational age of delivery (weeks) | gestational age of delivery (weeks) | 9 months |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008903 |
| Minerals |