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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to four weeks after the intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 24 and 34 weeks pregnant.
Select...
I am pregnant and 18 years or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Change in Hemoglobin value before and after intervention
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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,928 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,661 Total Patients Enrolled
Deirdre LyellPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to intravenous (IV) iron.You have a complicated medical history with multiple medication allergies or connective tissue disorder.Your hemoglobin level is less than 11 grams per deciliter, your serum ferritin level is less than 30 micrograms per deciliter, or your transferrin saturation is less than 20%.I have been diagnosed with placenta previa.I have a known blood disorder like sickle cell or thalassemia.I have Inflammatory Bowel Disease or have had gastric bypass surgery.I have been diagnosed with cancer.You have low levels of folate or vitamin B12 in your body.I am between 24 and 34 weeks pregnant.I am allergic to Tylenol.I am pregnant and 18 years or older.You are pregnant with only one baby.I am unable to understand and give consent for treatment.Your hemoglobin level is higher than 12 or lower than 7 grams per deciliter.My heart and blood circulation are stable.I am on dialysis for chronic kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous iron
- Group 2: Oral iron
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA green-lit Ferumoxytol Injection [Feraheme] for public use?
"There is both efficacy and safety data supporting Ferumoxytol Injection [Feraheme], which is why it received a score of 3."
Answered by AI
Is this trial looking for more participants?
"Although this particular study is no longer recruiting patients, according to the information found on clinicaltrials.gov, it is still possible to participate in one of the 436 other active clinical trials."
Answered by AI
Are there other scientific papers which document the use of Ferumoxytol Injection [Feraheme]?
"There are 40 different active clinical trials researching Ferumoxytol Injection [Feraheme]. 8 of those studies are currently in Phase 3. The majority of trials for Ferumoxytol Injection [Feraheme] are based in Nigeria, more specifically Kano and Lagos. However, there are a total of 160 locations worldwide conducting these trials."
Answered by AI
How does Ferumoxytol Injection [Feraheme] help patients?
"Ferumoxytol Injection [Feraheme] is commonly used to address breast feeding, but can also be given as a folic acid deficiency treatment, for iron supplementation, or as a general dietary supplement."
Answered by AI
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