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Completed

NCT Number: NCT03657433

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

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.

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Key information

Conditions

Iron Deficiency Anemia of Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous sulfate 325mg

Dietary Supplement

Oral tablets supplied for home use

ferumoxytol

Drug

Ferumoxytol will be administered in two infusions, one week apart

Primary outcomes

  1. Change in hemoglobin

    Time frame: 1 day - 22 weeks

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

Secondary outcomes

  1. Change in other laboratory values

    Time frame: 1 day - 22 weeks

    Including hematocrit, serum iron, transferrin saturation, ferritin

  2. Blood loss at delivery

    Time frame: 1 day - 22 weeks

    Estimated or quantified blood loss at delivery

  3. Hemoglobin change after delivery

    Time frame: 1 day - 22 weeks

    Measured change in hemoglobin after delivery

  4. Blood transfusion

    Time frame: 1 day - 22 weeks

    Whether the mother requires a blood transfusion

  5. Iron infusion

    Time frame: 1 day - 22 weeks

    Whether the mother requires additional iron infusions

  6. Concentration of substances in cord blood (iron studies)

    Time frame: 1 day - 22 weeks

    Cord blood indices for iron, transferrin saturation and ferritin

  7. Preterm delivery

    Time frame: 1 day - 22 weeks

    Whether the delivery occurs at less than 37 weeks of gestation

  8. Indication for delivery

    Time frame: 1 day - 22 weeks

    Indication for delivery if not spontaneous

  9. Birth weight

    Time frame: 1 day - 22 weeks

    Neonatal weight immediately after delivery

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • AMAG Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 5, 2018
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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