NCT05763043 Monoferric for Prenatal Iron Deficiency
| NCT ID | NCT05763043 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Oregon Health and Science University |
| Condition | Obstetric Labor Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-01-18 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05763043 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Obstetric Labor Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05763043 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05763043 currently recruiting?
Yes, NCT05763043 is actively recruiting participants. Contact the research team at whru@ohsu.edu for enrollment information.
Where is the NCT05763043 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05763043 clinical trial?
NCT05763043 is sponsored by Oregon Health and Science University. The trial plans to enroll 80 participants.