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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Anemia, Iron Deficiency; Anemia of Pregnancy
• Intervention / Treatment: Drug: Ferrous Sulfate; Drug: Ferumoxytol

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rupsa C Boelig, MD; Phone Number: 215-955-9196; Email: rupsa.boelig@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Rupsa C Boelig, MD; Email: rupsa.boelig@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Iron; 325mg oral iron (ferrous sulfate) twice daily	Drug: Ferrous Sulfate; 325mg oral twice daily
Experimental: Intravenous Iron; 510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.	Drug: Ferumoxytol; 510mg infusion x 2 doses 3-8 days apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin	Change in hemoglboin at day 90 following treatment initiation	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anemia resolution	Percent of participants in each group with Hb>=11.0 at day 90	90 days
Anemia at Delivery	Percent of participants in each group with Hb>=11.0 at delivery	9 months
Need for additional therapy	Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks	9 months
Quality of life scale	Linear Analogue Scale Assessment	30, 60, 90 days
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
Need for post partum transfusion	Incidence of transfusion after delivery/post partum	9 months
Neonatal outcomes: cord blood iron indices	Hb, ferritin, total iron saturation	9 months
Neonatal outcomes: birth weight	birth weight (grams)	9 months
Neonatal outcomes gestational age of delivery (weeks)	gestational age of delivery (weeks)	9 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Auerbach Hematology and Oncology

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Ferrous Compounds; Minerals; Ferrosoferric Oxide; ferrous sulfate
• Other Study ID Numbers: 19G.929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
• IPD Sharing Time Frame: 1 year after publication of study results
• IPD Sharing Access Criteria: After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes