Actively Recruiting
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
Led by Thomas Jefferson University · Updated on 2025-12-02
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
A
Auerbach Hematology and Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pregnant women with iron deficiency anemia to compare two types of iron treatments started in the second trimester. The trial aims to find out if intravenous iron therapy is better than oral iron therapy at improving blood counts, quality of life, and reducing side effects. This is a randomized, controlled study conducted at multiple sites and sponsored by Thomas Jefferson University. Participants with a single pregnancy between 14 and 24 weeks will be randomly assigned to receive either oral iron tablets (325 mg ferrous sulfate twice daily) or intravenous iron (ferumoxytol, 510 mg given in two doses 3 to 8 days apart). The study evaluates early initiation of these treatments to address iron deficiency anemia during pregnancy. During the study, researchers will monitor changes in hemoglobin levels over 90 days as the main outcome. They will also assess anemia resolution, anemia status at delivery, the need for additional therapy or blood transfusion, quality of life at various time points, adherence to treatment, and newborn outcomes like birth weight and gestational age. Participants will be followed for up to nine months to gather these important health measures.
CONDITIONS
Brief Title
Early Antenatal Support for Iron Deficiency Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a single baby (singleton gestation)
- Pregnancy less than 24 weeks gestation
- Baseline hemoglobin between 9.0 and less than 11.0 with evidence of iron deficiency anemia
- Iron deficiency anemia diagnosed by hemoglobin less than 11.0 and ferritin less than 30 and/or total iron saturation less than 20
You will not qualify if you...
- Sickle cell disease (not sickle cell trait)
- Acute anemia needing transfusion or intravenous iron therapy
- Major congenital or chromosomal anomalies
- Previous use of intravenous iron during this pregnancy
- Severe heart, kidney, or liver disease
- Autoimmune diseases such as systemic lupus erythematosus (SLE)
- Allergy or contraindication to study drugs
- History of allergic reaction to medications, intravenous iron infusions, Feraheme, or other intravenous iron products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 10 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants receive either two intravenous doses of ferumoxytol or oral ferrous sulfate twice daily to treat iron deficiency anemia during pregnancy.
1 to 2 visits for intravenous infusion or routine oral medication intake
Duration - Up to 9 months
Participants are monitored for anemia resolution, quality of life, and neonatal outcomes up to delivery and postpartum.
Visits at 30, 60, 90 days and delivery assessment
Trial Site Locations
Total: 1 location
1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
R
Rupsa C Boelig, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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