Monoferric for Prenatal Iron Deficiency

Early Phase 1

Not yet recruiting

• Conditions: Obstetric Labor Complications
• Interventions: Drug: Ferric derisomaltose

• Registration Number: NCT05763043
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Status Verified: 2023-11
• Study Start: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferric derisomaltose	Ferric derisomaltose	-

Primary Outcome Measures

Name	Time	Method
The proportion of participants who experienced a resolution of iron deficiency anemia	From enrollment to 6 weeks post partum	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

Trial Locations

Locations (1)

Oregon Health & Science Univerity; 🇺🇸 Portland, Oregon, United States