Back to resultsMonoferric for Prenatal Iron Deficiency
Primary Purpose
Obstetric Labor Complications
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ferric derisomaltose
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labor Complications
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
Sites / Locations
- Oregon Health & Science Univerity
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ferric derisomaltose
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05763043
First Posted
February 28, 2023
Last Updated
April 6, 2023
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT05763043
Brief Title
Monoferric for Prenatal Iron Deficiency
Official Title
Monoferric for Prenatal Iron Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ferric derisomaltose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferric derisomaltose
Other Intervention Name(s)
Monoferric
Intervention Description
Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Primary Outcome Measure Information:
Title
The proportion of participants who experienced a resolution of iron deficiency anemia
Description
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
Time Frame
From enrollment to 6 weeks post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Research Unit Department of OB/Gyn
Phone
503-494-3666
Email
whru@ohsu.edu
Facility Information:
Facility Name
Oregon Health & Science Univerity
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
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Monoferric for Prenatal Iron Deficiency
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