Early Antenatal Support for Iron Deficiency Anemia

NCT04278651 — Phase 4, Recruiting, 80 participants, Thomas Jefferson University

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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

Registry	NCT04278651, acronym EASI-A
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Thomas Jefferson University (Other); collaborators: Auerbach Hematology and Oncology
Conditions	Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy
Interventions	Ferumoxytol, Ferrous Sulfate (Drug)
Dates	start 2021-09-29, primary completion 2026-08-30 (estimated), completion 2026-12-30 (estimated), first posted 2020-02-20, last updated 2025-12-02
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Oral Iron	Active comparator	Drug: Ferrous Sulfate	325mg oral iron (ferrous sulfate) twice daily
Intravenous Iron	Experimental	Drug: Ferumoxytol	510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

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

+Outcome measures

Primary outcomes

Change in Hemoglobin [90 days]: Change in hemoglboin at day 90 following treatment initiation

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Thomas Jefferson University Hospital	Philadelphia, Pennsylvania	United States	Recruiting