RecruitingEarly Phase 1NCT05763043
Monoferric for Prenatal Iron Deficiency
Sponsor
Oregon Health and Science University
Enrollment
80 participants
Start Date
Jan 18, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
- Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
- Experience intolerance to oral iron or are greater than 28 weeks gestation
- Willing to participate in the study
Exclusion Criteria2
- Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
- Prior IV iron intolerance or hypersensitivity reaction
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Interventions
DRUGFerric derisomaltose
Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05763043
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