Monoferric for Prenatal Iron Deficiency

Obstetric Labor Complications Clinical Trial

Official title:

Monoferric for Prenatal Iron Deficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763043
• Other study ID #: OHSU IRB 25397
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 2023
• Est. completion date: October 2028

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Women's Health Research Unit Research Unit Department of OB/Gyn
• Phone: 503-494-3666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science Univerity	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From enrollment to 6 weeks post partum