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

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657433
• Other study ID #: 1807765944
• Status: Completed
• Phase: Phase 3
• Start date: December 17, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 1, 2022
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy

Intervention

Dietary Supplement:
• Ferrous sulfate 325mg
Oral tablets supplied for home use

Drug:
• Ferumoxytol
Ferumoxytol will be administered in two infusions, one week apart

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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