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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia of Pregnancy
• Intervention / Treatment: Drug: Ferumoxytol; Dietary supplement: Ferrous sulfate 325mg

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ferumoxyltol; 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.	Drug: Ferumoxytol; Ferumoxytol will be administered in two infusions, one week apart
Active Comparator: Ferrous Sulfate; 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.	Dietary supplement: Ferrous sulfate 325mg; Oral tablets supplied for home use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin	We will assess the increase in maternal hemoglobin during the study timeframe	1 day - 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in other laboratory values	Including hematocrit, serum iron, transferrin saturation, ferritin	1 day - 22 weeks
Blood loss at delivery	Estimated or quantified blood loss at delivery	1 day - 22 weeks
Hemoglobin change after delivery	Measured change in hemoglobin after delivery	1 day - 22 weeks
Blood transfusion	Whether the mother requires a blood transfusion	1 day - 22 weeks
Iron infusion	Whether the mother requires additional iron infusions	1 day - 22 weeks
Concentration of substances in cord blood (iron studies)	Cord blood indices for iron, transferrin saturation and ferritin	1 day - 22 weeks
Preterm delivery	Whether the delivery occurs at less than 37 weeks of gestation	1 day - 22 weeks
Indication for delivery	Indication for delivery if not spontaneous	1 day - 22 weeks
Birth weight	Neonatal weight immediately after delivery	1 day - 22 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: AMAG Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Hematinics; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Ferrosoferric Oxide
• Other Study ID Numbers: 1807765944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No