Intravenous iron therapy for anemia in pregnant women
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
Run by Thomas Jefferson University · NCT04278651 · Data updated 2026-11-12
This study tests whether getting iron through an IV works better than taking iron pills for treating anemia in pregnant women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | September 29, 2021 |
| Main results expected | August 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT04278651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women with singleton gestations diagnosed with iron deficiency anemia between 14-24 weeks of gestation.
✕Probably not a fit
Patients with sickle cell disease, severe cardiac or renal disease, or those who have previously received IV iron during the current pregnancy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of intravenous iron therapy compared to oral iron therapy for treating iron deficiency anemia in pregnant women. Pregnant individuals diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks of gestation and randomly assigned to receive either ferumoxytol or oral iron. The study aims to evaluate improvements in blood count, quality of life, and reduction of side effects associated with each treatment. By focusing on the second trimester, the trial seeks to determine the optimal timing and method for iron supplementation during pregnancy.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for pregnant women suffering from iron deficiency anemia, leading to better health outcomes for both mothers and their babies.
How similar studies have gone: Other studies have shown promising results with intravenous iron therapy in similar populations, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Rupsa C Boelig, MD
- Email: rupsa.boelig@jefferson.edu
- Phone: 215-955-9196
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.