Monoferric for Prenatal Iron Deficiency

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called Monoferric for pregnant women who have iron deficiency anemia and cannot tolerate oral iron supplements. Iron deficiency anemia means that a person's blood doesn't have enough healthy red blood cells due to low iron levels, which can be common during pregnancy. The trial is looking for women aged 18 and older who are between 14 to 42 weeks pregnant and have been advised by their healthcare provider to receive iron through an IV (a method of delivering medication directly into the bloodstream).

To participate, women should have low hemoglobin levels (a key component of blood) and low ferritin, which indicates low iron stores. They should also either have trouble taking oral iron or be more than 28 weeks pregnant. Participants will undergo regular monitoring and treatment with Monoferric, contributing to our understanding of how well this option works for managing iron deficiency during pregnancy. It's important to note that women with certain health conditions or previous reactions to IV iron may not be eligible for this study.

Gender

FEMALE

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