Early Antenatal Support for Iron Deficiency Anemia

Recruiting now · Phase 4

Conditions studied: Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy

In brief

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 facts

Study ID

NCT04278651

Run by

Thomas Jefferson University

People needed

80

Starts

2021-09-29

Expected to finish

2026-12-30

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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