NCT05763043 · Oregon Health and Science University
Monoferric for Prenatal Iron Deficiency
What this study is about
A forward-looking observational study of pregnant women with iron deficiency anemia and taken by mouth iron intolerance or advanced gestational age.
View original scientific description
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations