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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
At a glance
Conditions
Where it's being run
8 sites across 7 statesStudy leadership
- Methodius Tuuli, MD, MPH, MBA · PRINCIPAL_INVESTIGATOR · Women and Infants Hospital of Rhode Island
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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