Status:
RECRUITING
Early Antenatal Support for Iron Deficiency Anemia
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Auerbach Hematology and Oncology
Conditions:
Pregnancy Related
Anemia, Iron Deficiency
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief 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 or...
Detailed Description
Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04278651
Start Date
September 29 2021
End Date
December 30 2026
Last Update
December 2 2025
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107