Monoferric for Prenatal Iron Deficiency

NCT ID: NCT05763043

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2028-10-31

Brief 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.

Conditions

Obstetric Labor Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric derisomaltose

Group Type: EXPERIMENTAL

Ferric derisomaltose

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Monoferric

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Ashley Benson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science Univerity

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

whru@ohsu.edu

503-494-3666

Facility Contacts

Women's Health Research Unit

Role: primary

whru@ohsu.edu

503-494-3666

Other Identifiers

OHSU IRB 25397

Identifier Type: -

Identifier Source: org_study_id