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

NCT03657433 | Completed Phase 3 FDA Drug

• 1 other identifier: 1807765944
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

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

  1 day - 22 weeks

Secondary Outcomes (9)

• Change in other laboratory values

  1 day - 22 weeks

• Blood loss at delivery

  1 day - 22 weeks

• Hemoglobin change after delivery

  1 day - 22 weeks

• Blood transfusion

  1 day - 22 weeks

• Iron infusion

  1 day - 22 weeks

Study Arms (2)

Ferumoxyltol

EXPERIMENTAL

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

Ferrous Sulfate

ACTIVE COMPARATOR

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

Interventions

Ferrous sulfate 325mg DIETARY_SUPPLEMENT

Oral tablets supplied for home use

Ferrous Sulfate

Ferumoxytol DRUG

Ferumoxytol will be administered in two infusions, one week apart

Ferumoxyltol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

• Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Neonatal outcomes from a randomized controlled trial of maternal treatment of iron deficiency anemia with intravenous ferumoxytol vs oral ferrous sulfate. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101063. doi: 10.1016/j.ajogmf.2023.101063. Epub 2023 Jun 20.

  PMID: 37348817 DERIVED

• Awomolo AM, McWhirter A, Sadler LC, Coppola LM, Hill MG. Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101064. doi: 10.1016/j.ajogmf.2023.101064. Epub 2023 Jun 20.

  PMID: 37348816 DERIVED

MeSH Terms

Interventions

ferrous sulfate; Ferrosoferric Oxide

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 5, 2018
• Study Start: December 17, 2018
• Primary Completion: August 27, 2021
• Study Completion: April 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)