NCT04278651PHASE4Recruiting
Early Antenatal Support for Iron Deficiency Anemia
Thomas Jefferson University
Start Date
9/29/2021
Completion Date
12/30/2026
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 oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
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 iron (325mg) twice daily.
Eligibility Criteria
Age Range: 18 years to 65 years
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
Interventions
DRUG
Ferumoxytol
DRUG
Ferrous Sulfate
Conditions
Pregnancy RelatedAnemia, Iron DeficiencyAnemia of Pregnancy
Locations
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States