Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

June 4, 2026 updated by: Deirdre Lyell, Stanford University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine/Lucile Packard Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intravenous iron
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.
Drug: Ferumoxytol Injection [Feraheme]
510mg intravenous ferumoxytol
Active Comparator: Oral iron
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.
Drug: Ferrous Sulfate
325mg oral ferrous sulfate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Discontinued Treatment
Time Frame: From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)
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)
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)
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)
Score range: 0 to 100 (lower scores indicate more severe symptoms, higher scores correspond to fewer symptoms)
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)
Score range: 0 to 100 (lower scores indicate less physical function, higher scores correspond to more physical function).
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)
Score range: 0 to 100 (lower scores indicate more limitations, higher scores correspond to fewer limitations).
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)
Score range: 0 to 100 (lower scores indicate more fatigue, higher scores correspond to more energy).
From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Change in Hemoglobin Value Before and After Intervention by Sex
Time Frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention
From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
Median Change in Hemoglobin Value Before and After Intervention by Race / Ethnicity
Time Frame: From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)
NIH-required analysis. Hemoglobin is measured as g/dL at enrollment and after the study intervention
From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deirdre Lyell, Stanford University
  • Principal Investigator: Irogue Igbinosa, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 54788
  • K12HD103084 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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