Early Antenatal Support for Iron Deficiency Anemia

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Auerbach Hematology and Oncology
• Treatments: Ferrosoferric Oxide; Iron

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