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

Primary Purpose

Iron Deficiency Anemia of Pregnancy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferrous sulfate 325mg
Ferumoxytol
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferumoxyltol

Ferrous Sulfate

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in hemoglobin
We will assess the increase in maternal hemoglobin during the study timeframe

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2018
Last Updated
September 5, 2022
Sponsor
University of Arizona
Collaborators
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03657433
Brief Title
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
Official Title
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
AMAG Pharmaceuticals, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxyltol
Arm Type
Experimental
Arm 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.
Arm Title
Ferrous Sulfate
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulfate 325mg
Intervention Description
Oral tablets supplied for home use
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Intervention Description
Ferumoxytol will be administered in two infusions, one week apart
Primary Outcome Measure Information:
Title
Change in hemoglobin
Description
We will assess the increase in maternal hemoglobin during the study timeframe
Time Frame
1 day - 22 weeks
Secondary Outcome Measure Information:
Title
Change in other laboratory values
Description
Including hematocrit, serum iron, transferrin saturation, ferritin
Time Frame
1 day - 22 weeks
Title
Blood loss at delivery
Description
Estimated or quantified blood loss at delivery
Time Frame
1 day - 22 weeks
Title
Hemoglobin change after delivery
Description
Measured change in hemoglobin after delivery
Time Frame
1 day - 22 weeks
Title
Blood transfusion
Description
Whether the mother requires a blood transfusion
Time Frame
1 day - 22 weeks
Title
Iron infusion
Description
Whether the mother requires additional iron infusions
Time Frame
1 day - 22 weeks
Title
Concentration of substances in cord blood (iron studies)
Description
Cord blood indices for iron, transferrin saturation and ferritin
Time Frame
1 day - 22 weeks
Title
Preterm delivery
Description
Whether the delivery occurs at less than 37 weeks of gestation
Time Frame
1 day - 22 weeks
Title
Indication for delivery
Description
Indication for delivery if not spontaneous
Time Frame
1 day - 22 weeks
Title
Birth weight
Description
Neonatal weight immediately after delivery
Time Frame
1 day - 22 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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