← Back to Search

Iron Supplement

Oral vs. IV Iron for Anemia in Pregnancy

Phase 3

Waitlist Available

Led By Deirdre Lyell

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Between 24-34 weeks' pregnancy

Pregnant women 18 years old and above

Must not have

Inflammatory Bowel Disease or history of gastric bypass surgery

Diagnosis of placenta previa

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to four weeks after the intervention

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will evaluate whether intravenous iron is more effective than oral iron in treating anemia in pregnant women.

Who is the study for?

This trial is for pregnant women aged 18 and above, between 24-34 weeks into their pregnancy, with iron deficiency anemia (hemoglobin <11 g/dL and low iron markers). They must be stable, carrying a single baby, able to consent, and planning to deliver at LPCH. Excluded are those with hemoglobin outside of 7-12 g/dL range, certain diseases like IBD or known allergies to IV iron.

What is being tested?

The study compares two treatments for anemia in late-stage pregnancy: oral ferrous sulfate versus intravenous Ferumoxytol injection. It aims to see if IV treatment more effectively increases hemoglobin levels than the standard oral supplement.

What are the potential side effects?

Possible side effects of Ferrous Sulfate include stomach upset and constipation. Ferumoxytol may cause allergic reactions or hypotension; however, it's generally well-tolerated with fewer gastrointestinal issues compared to oral iron.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 24 and 34 weeks pregnant.

Select...

I am pregnant and 18 years or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have Inflammatory Bowel Disease or have had gastric bypass surgery.

Select...

I have been diagnosed with placenta previa.

Select...

I have a known blood disorder like sickle cell or thalassemia.

Select...

I am unable to understand and give consent for treatment.

Select...

I have been diagnosed with cancer.

Select...

I am allergic to Tylenol.

Select...

I am on dialysis for chronic kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to four weeks after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to four weeks after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to four weeks after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Hemoglobin value before and after intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intravenous ironExperimental Treatment1 Intervention

Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes.

Group II: Oral ironActive Control1 Intervention

Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin \< 9.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferumoxytol Injection [Feraheme]

2021

Completed Phase 3

~80

0 / 9Eligibility criteria met