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Monoferric for Prenatal Iron Deficiency

This study is looking at how safe and effective a single dose of an intravenous (IV) iron medication called Monoferric (ferric derisomaltose) is for pregnant women with iron deficiency anemia. You might be able to join if you are 18 years or older, between 14 and 42 weeks pregnant, and your doctor thinks IV iron is right for you because you have iron deficiency anemia (low red blood cell count due to lack of iron). The main goal is to see how many participants no longer have iron deficiency anemia by 6 weeks after giving birth. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 80 participants. It is an observational study of pregnant women.
What's involved
You would receive a single dose of IV Ferric derisomaltose during a routine prenatal visit. Your iron deficiency anemia will be measured from enrollment up to 6 weeks postpartum.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment to 6 weeks post partum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05763043

Monoferric for Prenatal Iron Deficiency

Recruiting
EARLY_PHASE1Ages 18–65InterventionalTreatment
Oregon Health and Science University
~80 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Ferric derisomaltose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of participants who experienced a resolution of iron deficiency anemia
Measured over From enrollment to 6 weeks post partum

Conditions

Obstetric Labor Complications

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Iron-Deficiency Anemia

NCT05763043

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Oregon Health & Science Univerity

    Portland, Oregonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Women's Health Research Unit Research Unit Department of OB/Gyn
[email protected]
503-494-3666
Email the study team

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Eligibility criteria

Inclusion

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

Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
Prior IV iron intolerance or hypersensitivity reaction

What this trial measures

  • The proportion of participants who experienced a resolution of iron deficiency anemiaFrom 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