IV vs Oral Iron for Anemia during Pregnancy
(IVIDA2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if giving iron through an IV drip can help pregnant women with severe anemia who can't tolerate oral iron. It aims to see if this method reduces the need for blood transfusions and improves baby development.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is it safe to use IV or oral iron for anemia during pregnancy?
Research shows that both intravenous (IV) iron treatments like ferric derisomaltose and ferric carboxymaltose, as well as oral iron treatments like ferrous sulfate, have been studied for safety in pregnant women with iron deficiency anemia. These studies generally indicate that both forms of iron are safe for use during pregnancy, although specific side effects and tolerability can vary between individuals.12345
How does the drug Ferric derisomaltose differ from other treatments for anemia during pregnancy?
What data supports the effectiveness of the drug Ferric derisomaltose for treating anemia during pregnancy?
Research shows that intravenous iron treatments like ferric derisomaltose can be more effective than oral iron supplements, such as ferrous sulfate, in treating anemia in pregnant women. Studies comparing similar treatments have found that IV iron often works better and faster in increasing iron levels in the body.124910
Who Is on the Research Team?
Methodius Tuuli, MD, MPH, MBA
Principal Investigator
Women and Infants Hospital of Rhode Island
Are You a Good Fit for This Trial?
Pregnant women aged 18-45 with moderate-to-severe iron-deficiency anemia, at 24-28 weeks gestation, planning to deliver at a participating hospital. Excluded are those unable to consent or communicate with the team, carrying multiple babies, having certain digestive conditions or sensitivities to iron treatments, and non-iron-related anemias.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a single IV infusion of 1000 mg ferric derisomaltose or oral iron tablets until delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including maternal and neonatal outcomes
Postpartum Monitoring
Monitoring of maternal and neonatal health outcomes, including neurodevelopment assessments
What Are the Treatments Tested in This Trial?
Interventions
- Ferric derisomaltose
- Ferrous sulfate
Ferric derisomaltose is already approved in United States, European Union for the following indications:
- Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron
- Iron deficiency anemia in adult patients with chronic kidney disease when oral iron preparations are ineffective, cannot be used or for whom there is a clinical need for rapid increase in iron stores
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women and Infants Hospital of Rhode Island
Lead Sponsor
University of Utah
Collaborator
University of Alabama at Birmingham
Collaborator
Oregon Health and Science University
Collaborator
GNP Research at Heme-on-Call
Collaborator
Hasbro Children's Hospital
Collaborator
University of Michigan
Collaborator
Washington University School of Medicine
Collaborator