NCT05763043EARLY_PHASE1RecruitingAccepts Healthy Volunteers
Monoferric for Prenatal Iron Deficiency
Oregon Health and Science University
Start Date
1/18/2024
Completion Date
10/1/2028
Summary
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 65 years
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
Interventions
DRUG
Ferric derisomaltose
Conditions
Obstetric Labor Complications
Locations
Oregon Health & Science Univerity
Portland, Oregon 97239
United States