Actively Recruiting

Phase 4
Age: 18Years - 65Years
FEMALE
NCT04278651

Early Antenatal Support for Iron Deficiency Anemia

Led by Thomas Jefferson University · Updated on 2025-12-02

80

Participants Needed

1

Research Sites

274 weeks

Total Duration

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Sponsors

T

Thomas Jefferson University

Lead Sponsor

A

Auerbach Hematology and Oncology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Early Antenatal Support for Iron Deficiency Anemia

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant with a single baby (singleton gestation)
  • Gestational age less than 24 weeks
  • Baseline hemoglobin between 9.0 and less than 11.0 with evidence of iron deficiency anemia
  • Iron deficiency anemia diagnosed by hemoglobin less than 11.0
  • Ferritin less than 30 and/or total iron saturation less than 20
Not Eligible

You will not qualify if you...

  • Sickle cell disease (sickle cell trait allowed)
  • Acute anemia needing transfusion or intravenous iron therapy
  • Major congenital or chromosomal anomalies
  • Previous intravenous iron use during this pregnancy
  • Severe heart, kidney, or liver disease
  • Autoimmune diseases such as systemic lupus erythematosus
  • Allergy or contraindication to either study drug
  • History of medication allergy, reaction to IV infusion, or reaction to ferumoxytol or other intravenous iron products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

R

Rupsa C Boelig, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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