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)

Oregon Health & Science Univerity

Portland, Oregon, United States

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NCT05763043


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