NCT04278651 · Thomas Jefferson University
Early Antenatal Support for Iron Deficiency Anemia
(EASI-A)
What this study is about
This is a randomly assigned, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of given through a vein (IV) (IV) iron therapy is better than taken by mouth iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
Where
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 2, 2025 · Source of record for eligibility and locations