Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Interventions
- Dietary Supplement: Ferrous sulfate 325mg
- Registration Number
- NCT03657433
- Lead Sponsor
- University of Arizona
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ferrous Sulfate Ferrous sulfate 325mg Patients will be provided with oral ferrous sulphate, 325mg, to take 2x daily at home. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies. Ferumoxyltol Ferumoxytol Patients will receive two infusions of Ferumoxyltol, 510mg, intravenously, one week apart. Iron studies will be completed at study inclusion and again at presentation for delivery. Cord blood will also be assessed for iron studies.
- Primary Outcome Measures
Name Time Method Change in hemoglobin 1 day - 22 weeks We will assess the increase in maternal hemoglobin during the study timeframe
- Secondary Outcome Measures
Name Time Method Concentration of substances in cord blood (iron studies) 1 day - 22 weeks Cord blood indices for iron, transferrin saturation and ferritin
Preterm delivery 1 day - 22 weeks Whether the delivery occurs at less than 37 weeks of gestation
Blood loss at delivery 1 day - 22 weeks Estimated or quantified blood loss at delivery
Iron infusion 1 day - 22 weeks Whether the mother requires additional iron infusions
Change in other laboratory values 1 day - 22 weeks Including hematocrit, serum iron, transferrin saturation, ferritin
Indication for delivery 1 day - 22 weeks Indication for delivery if not spontaneous
Birth weight 1 day - 22 weeks Neonatal weight immediately after delivery
Blood transfusion 1 day - 22 weeks Whether the mother requires a blood transfusion
Hemoglobin change after delivery 1 day - 22 weeks Measured change in hemoglobin after delivery
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States