Using Monoferric to treat iron deficiency in pregnant women
Official title: Monoferric for Prenatal Iron Deficiency
Run by Oregon Health and Science University · NCT05763043 · Data updated 2026-11-12
This study is testing a single-dose treatment called Monoferric to see if it can safely help pregnant women with iron deficiency anemia who can't take regular iron pills.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | January 18, 2024 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT05763043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 and older, between 14 to 42 weeks gestation, who have iron deficiency anemia and are intolerant to oral iron.
✕Probably not a fit
Patients with known infectious, inflammatory, or malignant conditions that could affect iron repletion or those who have previously experienced hypersensitivity reactions to IV iron will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and efficacy of a single-dose intravenous therapy called Monoferric (ferric derisomaltose) for pregnant women suffering from iron deficiency anemia, particularly those who cannot tolerate oral iron or are in advanced stages of pregnancy. The study aims to enroll participants who are between 14 to 42 weeks gestation and have specific hemoglobin and ferritin levels indicative of iron deficiency. By administering Monoferric, the researchers hope to address both the time and cost barriers associated with iron repletion in this population.
Why it matters
Potential benefit: If successful, this treatment could provide a safe and effective option for managing iron deficiency anemia in pregnant women, improving maternal and fetal health outcomes.
How similar studies have gone: While the efficacy and safety of Monoferric in pregnant women have not been well studied, other studies on intravenous iron therapies have shown promising results in similar populations.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Oregon Health & Science Univerity
Portland, Oregon, United States Recruiting
Study contacts
- Study coordinator: Women's Health Research Unit Research Unit Department of OB/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.