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Recruiting

NCT Number: NCT05763043

Monoferric for Prenatal Iron Deficiency

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Oregon Health & Science Univerity

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Women's Health Research Unit

CONTACT

[email protected]

503-494-3666

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferric derisomaltose

Drug

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

Other names: Monoferric

Primary outcomes

  1. The proportion of participants who experienced a resolution of iron deficiency anemia

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Research Unit Department of OB/Gyn

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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