NCT05763043

Monoferric for Prenatal Iron Deficiency

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-01-18
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2023-03-10
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study