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Taking people in United StatesPhase 4

Early Antenatal Support for Iron Deficiency Anemia

Key facts

Who runs it
Thomas Jefferson University
Where
Philadelphia, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
80 people, planned
Started
29 Sept 2021
Expected to end
30 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Ferumoxytol
  • Ferrous Sulfate
Record updated
2 December 2025

Who can take part

Age
18 years to 65 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Singleton gestation
  • Gestational age <24 weeks
  • Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia; Iron deficiency anemia diagnosed (at any point in patient history) by:
  • Hb<11.0
  • Ferritin<30 and/or total iron saturation <20

Who cannot take part

  • Evidence of acute anemia requiring transfusion or IV iron therapy
  • Previous use of IV iron in this pregnancy
  • Sickle cell Disease (NOT sickle cell trait)
  • Severe cardiac, renal, or liver disease
  • Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
  • Allergy or contraindication to either study drug
  • History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
  • Major congenital or chromosomal anomaly

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • Thomas Jefferson University HospitalPhiladelphia, United StatesContact: Rupsa C Boelig, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Oral IronExisting treatment, for comparison

    325mg oral iron (ferrous sulfate) twice daily

    Treatment: Ferrous Sulfate

  • Intravenous IronTreatment being tested

    510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

    Treatment: Ferumoxytol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
Fit questions
Built from NCT04278651, who can take part
Record updated
2 December 2025