Monoferric for Prenatal Iron Deficiency

Early Phase 1RecruitingNCT05763043

Oregon Health and Science University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstetric Labor Complications

Interventions

Ferric derisomaltoseDRUG

Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science Univerity

Portland, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

The proportion of participants who experienced a resolution of iron deficiency anemia

The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration

Time frame: From enrollment to 6 weeks post partum

Central Contacts

Women's Health Research Unit Research Unit Department of OB/Gyn

CONTACT

503-494-3666 whru@ohsu.edu

Data from ClinicalTrials.gov

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