Early Antenatal Support for Iron Deficiency Anemia (EASI-A)

Thomas Jefferson University

Status and phase: Enrolling; Phase 4

Conditions: Anemia of Pregnancy; Pregnancy Related; Anemia, Iron Deficiency

Treatments: Drug: Ferumoxytol; Drug: Ferrous Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04278651

19G.929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Oral Iron

Active Comparator group

Description:

325mg oral iron (ferrous sulfate) twice daily

Treatment:

Drug: Ferrous Sulfate

Intravenous Iron

Experimental group

Description:

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Treatment:

Drug: Ferumoxytol