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A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric derisomaltose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric derisomaltose | Drug | Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who experienced a resolution of iron deficiency anemia | The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration | From enrollment to 6 weeks post partum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Research Unit Department of OB/Gyn | Contact | 503-494-3666 | whru@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science Univerity | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718030 | ferric derisomaltose |
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