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IV iron may beat pills for anemia in late pregnancy

NCT ID NCT04253626

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether a single intravenous dose of ferumoxytol raises hemoglobin more effectively than daily oral ferrous sulfate in pregnant women with iron deficiency anemia. Participants are between 24 and 34 weeks pregnant with a single baby. The trial measures hemoglobin changes, side effects, and whether fewer women need blood transfusions after delivery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ferumoxytol (intravenous) and ferrous sulfate (oral)
What this could lead to
If IV iron works better, it could offer a faster, more effective treatment for anemia in late pregnancy, reducing the need for blood transfusions.
What could go wrong
This is a single-center trial with 83 participants, so results may not apply broadly. IV iron carries a small risk of allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

83 people

The number who actually took part.

Started

Jan 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pregnant women 18 years old and above 2. Hemoglobin \< 11 g/dL, serum ferritin \< 30 ug/dL and or transferrin saturation (TSAT) \< 20% 3. Between 24-34 weeks' pregnancy 4. Singleton pregnancy 5. Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH 6. Hemodynamically stable Exclusion Criteria: 1. Patients unable to give informed consent 2. Known allergy/hypersensitivity to IV iron 3. Inflammatory Bowel Disease or history of gastric bypass surgery 4. Dialysis-dependent Chronic Kidney Disease/ ESRD 5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia 6. Folate/Vitamin B12 deficiency 7. Known malignancy 8. Medication allergy to Tylenol (acetaminophen) 9. Hemoglobin above 12 or less than 7 g/dL 10. Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc. 11. Diagnosis of placenta previa

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Conditions

The condition(s) this trial relates to.

iron deficiency anemia pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia, iron-deficiency Pregnancy related

Contacts and locations

Locations

  • Stanford University School of Medicine/Lucile Packard Childrens Hospital

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.