Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

This study is looking at the best way to treat iron-deficiency anemia (low iron in your blood) during pregnancy. It compares an intravenous (IV) iron treatment called ferric derisomaltose (Monoferric) to oral iron tablets called ferrous sulfate. Researchers want to see if IV iron is more effective, safer, and more affordable at reducing anemia in mothers at the time of delivery, and if it improves the baby's brain development. You might be able to join if you are pregnant, between 18 and 45 years old, have a single baby, and have iron-deficiency anemia (your ferritin level is below 30ng/mL and your hemoglobin is below 11 g/dL) between 13 and 30 weeks of pregnancy. The study is currently unclear about its recruitment status.

Study design
This is a randomized study where participants are assigned to one of two groups by chance. It is a double-blind study, meaning neither you nor your doctors will know which treatment you are receiving. About 300 pregnant women in the U.S. will participate.
What's involved
Participants in the IV iron group will receive one IV infusion of 1000 mg ferric derisomaltose over 20 minutes. Participants in the oral iron group will take 1 to 3 ferrous sulfate tablets by mouth each day.
Compensation
Not stated in the trial record.
Follow-up
The main goal is to measure the rate of maternal anemia (hemoglobin below 11mg/dL) at delivery, which is measured within 24 hours of admission to the hospital for delivery.

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NCT05462704

Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Recruiting
PHASE3Ages 18–45InterventionalTreatment
Women and Infants Hospital of Rhode Island
~300 participants
Updated 2025-06-10 on ClinicalTrials.gov
What's tested:Ferric derisomaltoseFerrous sulfate

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of maternal anemia (hgb<11mg/dL) at delivery
Measured over Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Iron Deficiency Anemia
Pregnancy
8 sites across 7 states
Rhode Island2
Alabama1
Florida1
Michigan1
Missouri1
Oregon1
Utah1
  • Methodius Tuuli, MD, MPH, MBA · PRINCIPAL_INVESTIGATOR · Women and Infants Hospital of Rhode Island

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Eligibility criteria

Inclusion

Pregnant women between the ages of 18-45
Singleton gestation
Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
At 13-30 weeks gestation
Plan to deliver at participating hospital

Exclusion

Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
Multiple gestation
Inability or unwillingness to provide informed consent
Inability to communicate with members of the study team, despite the presence of an interpreter
Planned delivery at a non-study affiliated hospital
  • Rate of maternal anemia (hgb<11mg/dL) at deliveryWithin 24 hours of admission to inpatient obstetrics unit for delivery of infant

    Hemoglobin \<11mg/dL on admission to inpatient obstetrics unit for labor and delivery