Early Antenatal Support for Iron Deficiency Anemia

Pregnancy Related Clinical Trial

— EASI-A  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278651
• Other study ID #: 19G.929
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: Rupsa C Boelig, MD
• Phone: 215-955-9196
• Email: rupsa.boelig[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of Pregnancy
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Pregnancy Related

Intervention

Drug:
• Ferumoxytol
510mg infusion x 2 doses 3-8 days apart
• Ferrous Sulfate
325mg oral twice daily

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Auerbach Hematology and Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin	Change in hemoglboin at day 90 following treatment initiation	90 days
Secondary	Anemia resolution	Percent of participants in each group with Hb>=11.0 at day 90	90 days
Secondary	Anemia at Delivery	Percent of participants in each group with Hb>=11.0 at delivery	9 months
Secondary	Need for additional therapy	Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks	9 months
Secondary	Quality of life scale	Linear Analogue Scale Assessment	30, 60, 90 days
Secondary	Adherence	adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts	90 days
Secondary	Need for post partum transfusion	Incidence of transfusion after delivery/post partum	9 months
Secondary	Neonatal outcomes: cord blood iron indices	Hb, ferritin, total iron saturation	9 months
Secondary	Neonatal outcomes: birth weight	birth weight (grams)	9 months
Secondary	Neonatal outcomes gestational age of delivery (weeks)	gestational age of delivery (weeks)	9 months