Recruiting

Early Antenatal Support

Sponsor:

Thomas Jefferson University

Code:

NCT04278651

Conditions

Pregnancy Related

Anemia, Iron Deficiency

Anemia of Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ferumoxytol

Ferrous Sulfate

Study Details

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.

Conditions

Pregnancy Related

Anemia, Iron Deficiency

Anemia of Pregnancy

Study ID

NCT04278651

Start date

Sep 29, 2021

Status verified date

Nov, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oral Iron

325mg oral iron (ferrous sulfate) twice daily

experimental: Intravenous Iron

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Interventions

Ferumoxytol

510mg infusion x 2 doses 3-8 days apart

Ferrous Sulfate

325mg oral twice daily

Primary outcome measure

  • Change in Hemoglobin [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Rupsa C Boelig, MD

215-955-9196rupsa.boelig@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Rupsa C Boelig, MD

rupsa.boelig@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-12-02.