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Early Antenatal Support for Iron Deficiency Anemia

NCT04278651 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-02

No results posted yet for this study

Summary

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Conditions

  • Pregnancy Related
  • Anemia, Iron Deficiency
  • Anemia of Pregnancy

Interventions

DRUG

Ferumoxytol

510mg infusion x 2 doses 3-8 days apart

DRUG

Ferrous Sulfate

325mg oral twice daily

Sponsors & Collaborators

  • Auerbach Hematology and Oncology

    collaborator UNKNOWN

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2026-08-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04278651 on ClinicalTrials.gov