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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Oral tablets supplied for home use
Ferumoxytol will be administered in two infusions, one week apart
University of Arizona
Tucson, Arizona, United States
Change in hemoglobin
We will assess the increase in maternal hemoglobin during the study timeframe
Time frame: 1 day - 22 weeks
Change in other laboratory values
Including hematocrit, serum iron, transferrin saturation, ferritin
Time frame: 1 day - 22 weeks
Blood loss at delivery
Estimated or quantified blood loss at delivery
Time frame: 1 day - 22 weeks
Hemoglobin change after delivery
Measured change in hemoglobin after delivery
Time frame: 1 day - 22 weeks
Blood transfusion
Whether the mother requires a blood transfusion
Time frame: 1 day - 22 weeks
Iron infusion
Whether the mother requires additional iron infusions
Time frame: 1 day - 22 weeks
Concentration of substances in cord blood (iron studies)
Cord blood indices for iron, transferrin saturation and ferritin
Time frame: 1 day - 22 weeks
Preterm delivery
Whether the delivery occurs at less than 37 weeks of gestation
Time frame: 1 day - 22 weeks
Indication for delivery
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Indication for delivery if not spontaneous
Time frame: 1 day - 22 weeks
Birth weight
Neonatal weight immediately after delivery
Time frame: 1 day - 22 weeks