Early Antenatal Support for Iron Deficiency Anemia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT04278651
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anemia of Pregnancy
  • Anemia, Iron Deficiency
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferumoxytol — DRUG
    510mg infusion x 2 doses 3-8 days apart
  • Ferrous Sulfate — DRUG
    325mg oral twice daily

Study Details

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.

Key Dates

Start date
Sep 29, 2021
Status verified
Nov 2025
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in Hemoglobin [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Rupsa C Boelig, MD
[email protected]

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By research site
Thomas Jefferson University Hospital· Philadelphia, PA

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