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

NCT04253626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-08-26

Study results available
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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 increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Conditions

  • Pregnancy Related
  • Anemia, Iron Deficiency

Interventions

DRUG

Ferumoxytol Injection [Feraheme]

510mg intravenous ferumoxytol

DRUG

Ferrous Sulfate

325mg oral ferrous sulfate

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Deirdre Lyell · Stanford University

  • Irogue Igbinosa, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-07-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253626 on ClinicalTrials.gov