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

University of Arizona

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia of Pregnancy

Treatments: Dietary Supplement: Ferrous sulfate 325mg; Drug: Ferumoxytol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03657433

1807765944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Ferumoxyltol

Experimental group

Description:

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.

Treatment:

Drug: Ferumoxytol

Ferrous Sulfate

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ferrous sulfate 325mg