Obstetric Labor Complications
Conditions
Brief summary
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
Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants who experienced a resolution of iron deficiency anemia | From enrollment to 6 weeks post partum | The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Research Unit Department of OB/Gyn
Outcome results
None listed