Clinical trial

Monoferric for Prenatal Iron Deficiency

Name

OHSU IRB 25397

Description

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

Trial arms

Trial start

2023-11-01

Estimated PCD

2028-10-01

Trial end

2028-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Ferric derisomaltose

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

Arms:

Ferric derisomaltose

Other names:

Monoferric

Size

Primary endpoint

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

From enrollment to 6 weeks post partum

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-11-22

1 organization

1 product

1 indication

Organization

Oregon Health and Science University

Product

Ferric derisomaltose

Indication

Obstetric Labor Complications