Monoferric for Prenatal Iron Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric derisomaltose.
- Who it may be relevant to
- Registry conditions: Obstetric Labor Complications. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Detailed description
Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.
Interventions
- Drug Ferric derisomaltose
Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Primary outcome measures
- The proportion of participants who experienced a resolution of iron deficiency anemia [Time frame: From enrollment to 6 weeks post partum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health & Science Univerity — Portland
Identifiers
NCT: NCT05763043 · OHSU IRB 25397