Monoferric for Prenatal Iron Deficiency
ConditionObstetric Labor Complications
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorOregon Health and Science University
About this trial
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
Prior IV iron intolerance or hypersensitivity reaction
Trial design
Design model
Single group
Treatments tested in this trial
Ferric derisomaltose
DrugParticipants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Ferric derisomaltoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of participants who experienced a resolution of iron deficiency anemia
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
Time frame
From enrollment to 6 weeks post partumSponsors and contacts
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Source ClinicalTrials.gov