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NCT Number: NCT04278651

Early Antenatal Support for Iron Deficiency Anemia

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.

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Key information

Conditions

Pregnancy Related Anemia Anemia of Pregnancy Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Rupsa C Boelig, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferumoxytol

Drug

510mg infusion x 2 doses 3-8 days apart

Ferrous Sulfate

Drug

325mg oral twice daily

Primary outcomes

  1. Change in Hemoglobin

    Time frame: 90 days

    Change in hemoglboin at day 90 following treatment initiation

Secondary outcomes

  1. Anemia resolution

    Time frame: 90 days

    Percent of participants in each group with Hb>=11.0 at day 90

  2. Anemia at Delivery

    Time frame: 9 months

    Percent of participants in each group with Hb>=11.0 at delivery

  3. Need for additional therapy

    Time frame: 9 months

    Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks

  4. Quality of life scale

    Time frame: 30, 60, 90 days

    Linear Analogue Scale Assessment

  5. Adherence

    Time frame: 90 days

    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

  6. Need for post partum transfusion

    Time frame: 9 months

    Incidence of transfusion after delivery/post partum

  7. Neonatal outcomes: cord blood iron indices

    Time frame: 9 months

    Hb, ferritin, total iron saturation

  8. Neonatal outcomes: birth weight

    Time frame: 9 months

    birth weight (grams)

  9. Neonatal outcomes gestational age of delivery (weeks)

    Time frame: 9 months

    gestational age of delivery (weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Rupsa C Boelig, MD

CONTACT

[email protected]

215-955-9196

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Auerbach Hematology and Oncology

Registry information

Official study 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

Acronym: EASI-A

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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