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Early Antenatal Support for Iron Deficiency Anemia

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

Who can join

Ages 18 to 65 · Women

Inclusion Criteria:

* 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

Exclusion Criteria:

* Sickle cell Disease (NOT sickle cell trait)
* Evidence of acute anemia requiring transfusion or IV iron therapy
* Major congenital or chromosomal anomaly
* Previous use of IV iron in this pregnancy
* 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

About the study

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.

What is being tested

• Ferumoxytol (drug)
• Ferrous Sulfate (drug)

Sponsor: Thomas Jefferson University · Participants: 80 · Started: Sep 29, 2021

Contact the study team

• Rupsa C Boelig, MD · Phone: 215-955-9196

Official record on ClinicalTrials.gov — NCT04278651

Locations in the U.S.

Conditions

• Iron-Deficiency Anemia

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.