Monoferric for Prenatal Iron Deficiency

• Status: Not yet recruiting
• Trial end date: 2025-03-15
• Target enrollment: 0
• Participant gender: Female

Summary

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University

Criteria

Inclusion Criteria:

• 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 Criteria:

• Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis

• Prior IV iron intolerance or hypersensitivity reaction