Using Monoferric to treat iron deficiency in pregnant women
Monoferric for Prenatal Iron Deficiency
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05763043 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Portland, Oregon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.