Pregnancy RelatedPhase 3NCT04253626
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
A Phase 3 study testing Ferumoxytol Injection [Feraheme] and Ferrous Sulfate in people with Pregnancy Related and Anemia, Iron Deficiency, run by Stanford University at 1 site in United States.
Trial summary
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Anemia, Iron Deficiency
- What is being tested?
- Ferumoxytol Injection [Feraheme] and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 1 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women 18 years old and above
- Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20%
- Between 24-34 weeks' pregnancy
- Singleton pregnancy
- Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
- Hemodynamically stable
Who cannot join
- Patients unable to give informed consent
- Known allergy/hypersensitivity to IV iron
- Inflammatory Bowel Disease or history of gastric bypass surgery
- Dialysis-dependent Chronic Kidney Disease/ ESRD
- Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
- Folate/Vitamin B12 deficiency
Show all 11Show fewer
- Known malignancy
- Medication allergy to Tylenol (acetaminophen)
- Hemoglobin above 12 or less than 7 g/dL
- Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc.
- Diagnosis of placenta previa
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine/Lucile Packard Childrens Hospital
Stanford, California, 94305
About this study
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.
- Conditions
- Pregnancy Related, Anemia, Iron Deficiency
- Being tested
- Ferumoxytol Injection [Feraheme], Ferrous Sulfate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol Injection [Feraheme]Drug
510mg intravenous ferumoxytol
Ferrous SulfateDrug
325mg oral ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Experimental | 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. Receives: Drug: Ferumoxytol Injection [Feraheme] |
| Oral iron | Active comparator | 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. Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Change in Hemoglobin Value Before and After Intervention
Hemoglobin is measured as g/dL at enrollment and after the study intervention
Measured: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Secondary outcomes (7)
Number of Participants Who Discontinued Treatment
Measured: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants With Serious Adverse Events Associated With Treatment
Measured: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants Who Need Blood Transfusion Postpartum
Measured: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Change in Short Form (SF-)36 General Health Symptom Score
Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)
Measured: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Physical Functioning Score
Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).
Measured: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score
Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).
Measured: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Energy/Fatigue Score
Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy).
Measured: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Jan 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Deirdre Lyell, Stanford University
- Investigators
- Deirdre Lyell, Principal investigator, Stanford UniversityIrogue Igbinosa, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253626
- Sponsor's protocol ID
- 54788
- Other IDs
- K12HD103084
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2020
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Igbinosa II, Leonard SA, Iwekaogwu I, Sherwin EB, Berube C, Lyell DJ. Intravenous Ferumoxytol Compared With Oral Ferrous Sulfate for Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2026 May 1;147(5):745-753. doi: 10.1097/AOG.0000000000006245. Epub 2026 Mar 19.
PubMed 41860281
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT04253626
- Acronym / sponsor ID
- 54788
- Conditions
- Pregnancy Related, Anemia, Iron Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Experimental | Drug: Ferumoxytol Injection [Feraheme]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. |
| Oral iron | Active comparator | Drug: Ferrous SulfateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women 18 years old and above
- Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20%
- Between 24-34 weeks' pregnancy
- Singleton pregnancy
- Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
Key exclusion criteria (11 listed)
- Patients unable to give informed consent
- Known allergy/hypersensitivity to IV iron
- Inflammatory Bowel Disease or history of gastric bypass surgery
- Dialysis-dependent Chronic Kidney Disease/ ESRD
- Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferumoxytol Injection [Feraheme]510mg intravenous ferumoxytol | Drug | Intravenous iron |
| Ferrous Sulfate325mg oral ferrous sulfate | Drug | Oral iron |
Primary outcome
Median Change in Hemoglobin Value Before and After Intervention
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Hemoglobin is measured as g/dL at enrollment and after the study intervention
7 secondary outcomes
Number of Participants Who Discontinued Treatment
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants With Serious Adverse Events Associated With Treatment
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Number of Participants Who Need Blood Transfusion Postpartum
Time frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
Change in Short Form (SF-)36 General Health Symptom Score
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Physical Functioning Score
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Role Limitations Due to Physical Health Score
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Change in Short Form (SF-)36 Energy/Fatigue Score
Time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41860281Igbinosa II, Leonard SA, Iwekaogwu I, Sherwin EB, Berube C, Lyell DJ. Intravenous Ferumoxytol Compared With Oral Ferrous Sulfate for Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2026 May 1;147(5):745-753. doi: 10.1097/AOG.0000000000006245. Epub 2026 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deirdre Lyell principal investigator
Stanford University
Irogue Igbinosa, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferumoxytol Injection [Feraheme] and Ferrous Sulfate in people with Pregnancy Related and Anemia, Iron Deficiency, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Change in Hemoglobin Value Before and After Intervention (time frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.