EASI-A: Early Antenatal Support for Iron Deficiency Anemia

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04278651
Collaborator
Auerbach Hematology and Oncology (Other)
80
1
2
27
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Hemoglobin [90 days]

    Change in hemoglboin at day 90 following treatment initiation

Secondary Outcome Measures

  1. Anemia resolution [90 days]

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

  2. Anemia at Delivery [9 months]

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

  3. Need for additional therapy [9 months]

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

  4. Quality of life scale [30, 60, 90 days]

    Linear Analogue Scale Assessment

  5. Adherence [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 [9 months]

    Incidence of transfusion after delivery/post partum

  7. Neonatal outcomes: cord blood iron indices [9 months]

    Hb, ferritin, total iron saturation

  8. Neonatal outcomes: birth weight [9 months]

    birth weight (grams)

  9. Neonatal outcomes gestational age of delivery (weeks) [9 months]

    gestational age of delivery (weeks)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University
  • Auerbach Hematology and Oncology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04278651
Other Study ID Numbers:
  • 19G.929
First Posted:
Feb 20, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022