RecruitingEarly Phase 1NCT05763043

Monoferric for Prenatal Iron Deficiency


Sponsor

Oregon Health and Science University

Enrollment

80 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of Monoferric (ferric derisomaltose), a type of intravenous (IV) iron infusion, for treating iron deficiency anemia during pregnancy. Iron deficiency is the most common nutritional deficiency in pregnancy and can cause serious problems for both mother and baby, including fatigue, preterm birth, and low birth weight. Many pregnant women cannot tolerate iron tablets or absorb enough iron through the gut, making IV iron a critical alternative. Women who are 18 years or older and between 14 and 42 weeks pregnant are eligible if their doctor has recommended IV iron as part of their standard care and they meet specific hemoglobin and ferritin thresholds indicating significant iron deficiency. Women who cannot take oral iron or are past 28 weeks of pregnancy are also eligible. Women with certain infections, inflammatory conditions, cancer, or a previous bad reaction to IV iron are excluded. This research matters because IV iron can restore iron stores much faster than oral supplements, but there are several IV iron products and limited data comparing them in pregnancy. Understanding how well Monoferric works and how safe it is during pregnancy will help doctors make more informed treatment decisions and improve health outcomes for mothers and their newborns.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric derisomaltose

Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.


Locations(1)

Oregon Health & Science Univerity

Portland, Oregon, United States

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NCT05763043


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