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Iron Replacement Therapy

Intravenous Iron Therapy for Iron Deficiency in Pregnancy

Phase 3

Recruiting

Led By Ryan Lett, MD, FRCPC

Research Sponsored by Saskatchewan Health Authority - Regina Area

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and over

Pregnancy with Gestational age ≥13 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at 6 weeks postpartum

Awards & highlights

Study Summary

This trial is testing a new intravenous iron replacement drug to see if it is as effective as other formulations of IV iron, with the goal of reducing maternal and neonatal risks.

Who is the study for?

This trial is for pregnant women over 18 with moderate to severe iron deficiency anemia, defined by specific blood test results. They must be at least 13 weeks into their pregnancy and willing to attend all treatment and follow-up appointments. Women with kidney or heart disease, certain infections, iron utilization disorders, recent IV iron or transfusions, multiple pregnancies, serious allergies or other significant health issues are excluded.Check my eligibility

What is being tested?

The study compares two intravenous (IV) iron treatments: ferric derisomaltose (iron isomaltoside) versus the standard treatment of iron sucrose in pregnant women with iron deficiency anemia. The aim is to correct IDA effectively with fewer healthcare visits and improve maternal and neonatal health outcomes.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the IV components, which could range from mild skin reactions to more severe responses. Other common side effects of IV iron treatments can include headache, nausea, high blood pressure episodes during infusion, muscle cramps or joint pains.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am pregnant and in my second trimester or later.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at delivery admission survey

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at delivery admission survey

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at delivery admission survey for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correction of anemia

Secondary outcome measures

Changes in Participant's Mental Health and Physical Well-Being

Comparison of participant's pregnancy related symptoms- subjective measure

Convenience/barriers of IV iron appointment(s)- subjective measure

+2 more

Trial Design

2Treatment groups

Active Control

Group I: Iron SucroseActive Control1 Intervention

Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table

Group II: Iron Isomaltoside/ferric derisomaltoseActive Control1 Intervention

route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaLead Sponsor

27 Previous Clinical Trials

5,238 Total Patients Enrolled

Saskatchewan Centre for Patient-Oriented ResearchOTHER

11 Previous Clinical Trials

1,646 Total Patients Enrolled

Ryan Lett, MD, FRCPCPrincipal InvestigatorSaskatchewan Health Authority - Regina Area

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly people qualify for this research program?

"The age limit for this clinical trial is 50 years old. As long as you are over 18 years old, you may be eligible to participate."

Answered by AI

Who meets the eligibility requirements for participating in this research?

"Anemia and iron-deficiency are the primary inclusion criteria for this clinical trial. Additionally, all participants must be between 18 and 50 years old. In total, the trial is looking for 280 individuals to enroll."

Answered by AI