IV vs Oral Iron for Anemia during Pregnancy
(IVIDA2 Trial)
Trial Summary
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.
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.12345
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.12367
How does the drug Ferric derisomaltose differ from other treatments for anemia during pregnancy?
Research Team
Methodius Tuuli, MD, MPH, MBA
Principal Investigator
Women and Infants Hospital of Rhode Island
Eligibility Criteria
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
Trial Timeline
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
Treatment Details
Interventions
- Ferric derisomaltose (Iron Supplement)
- Ferrous sulfate (Iron Supplement)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women and Infants Hospital of Rhode Island
Lead Sponsor
Hasbro Children's Hospital
Collaborator
University of Michigan
Collaborator
Washington University School of Medicine
Collaborator