Actively Recruiting
Monoferric for Prenatal Iron Deficiency
Led by Oregon Health and Science University · Updated on 2024-09-19
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study pregnant women who have iron deficiency anemia and either cannot tolerate oral iron or are in advanced stages of pregnancy. The study focuses on evaluating the safety and effectiveness of a single dose of intravenous Monoferric (ferric derisomaltose), which is designed for rapid infusion and may reduce treatment time and costs. This treatment's effects in pregnant women have not been well studied before. Participants who are pregnant between 14 and 42 weeks and diagnosed with iron deficiency anemia will receive a single intravenous dose of 1,000 mg Monoferric at a routine prenatal visit. This treatment is provided as part of standard care for those who either experience oral iron intolerance or are beyond 28 weeks of gestation. During the study, participants will be monitored from enrollment until six weeks after giving birth to measure how many experience a resolution of their iron deficiency anemia. Researchers will evaluate safety and treatment outcomes through medical assessments and laboratory tests as part of regular prenatal care. The total participation period spans from treatment through postpartum follow-up.
CONDITIONS
Brief Title
Monoferric for Prenatal Iron Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 hemoglobin less than or equal to 10.5 g/dL or less than or equal to 11 g/dL, respectively, and ferritin less than 50 bcg/L
- Experience intolerance to oral iron or are greater than 28 weeks gestation
- Willing to participate in the study
You will not qualify if you...
- Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
- Prior IV iron intolerance or hypersensitivity reaction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One-time treatment during pregnancy between 14 to 42 weeks gestation
Participants receive a single dose of intravenous Ferric derisomaltose during a routine prenatal visit to treat iron deficiency.
1 visit (in-person)
Duration - From enrollment to 6 weeks post partum
Participants are monitored for safety and efficacy outcomes up to 6 weeks after delivery.
Follow-up visits as part of routine prenatal and postnatal care
Trial Site Locations
Total: 1 location
1
Oregon Health & Science Univerity
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Research Unit Department of OB/Gyn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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