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Iron Supplement

Monoferric for Iron Deficiency in Pregnancy

Phase < 1
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 6 weeks post partum
Awards & highlights
No Placebo-Only Group

Summary

This trial studied pregnant women with anemia, difficulty taking iron pills, or nearing the end of their pregnancy.

Who is the study for?
This trial is for pregnant women over 18 with iron deficiency anemia who can't take oral iron or are past 28 weeks of pregnancy. They should have low hemoglobin and ferritin levels indicating anemia, and be willing to participate.
What is being tested?
The study is observing the effects of Ferric derisomaltose, a type of IV iron treatment, on pregnant women with iron deficiency who either can't tolerate oral iron supplements or are in their late stages of pregnancy.
What are the potential side effects?
While not explicitly listed here, common side effects from IV iron treatments like Ferric derisomaltose may include nausea, dizziness, high blood pressure, flushing, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant, in my second or third trimester, and have low iron levels and hemoglobin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 6 weeks post partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 6 weeks post partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants who experienced a resolution of iron deficiency anemia

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ferric derisomaltoseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,892 Total Patients Enrolled

Media Library

Ferric Derisomaltose (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05763043 — Phase < 1
Complications of Labor Research Study Groups: Ferric derisomaltose
Complications of Labor Clinical Trial 2023: Ferric Derisomaltose Highlights & Side Effects. Trial Name: NCT05763043 — Phase < 1
Ferric Derisomaltose (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763043 — Phase < 1
~53 spots leftby Oct 2028
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