Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial

This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.

This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.

140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.

Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.

Inclusion Criteria:

• Maternal age >/= 18
• Singleton gestation
• >/=20 weeks gestation, <37 weeks gestation
• Hemoglobin <11g/dL and/or hematocrit <33%
• Able to read/speak English or Spanish

Exclusion Criteria:

• Maternal age <18
• Multiple gestation
• <20 weeks gestation, </= 37 weeks gestation
• Hemoglobin >/=11g/dL and/or hematocrit >/=33%
• Unable to read or speak English or Spanish
• Incarcerated patients