Monoferric for Prenatal Iron Deficiency

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Early Phase 1

Conditions: Obstetric Labor Complications

Treatments: Drug: Ferric derisomaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT05763043

OHSU IRB 25397

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Ferric derisomaltose

Experimental group

Treatment:

Drug: Ferric derisomaltose