Iron Deficiency Anemia study: Ferric derisomaltose vs Ferrous sulfate
Official title Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
ClinicalTrials.gov ID: NCT05462704
What this study is testing
What is Ferric derisomaltose?
This is an investigational intravenous iron medicine being studied to treat iron deficiency anemia in pregnant women. It is designed to deliver iron directly into the bloodstream to help the body make red blood cells.
Also referred to as Monoferric.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if getting iron through an IV is safe, effective, and cost-efficient for reducing severe anemia at delivery and improving baby development.
- Who it's for
- The study is looking for pregnant women in the U.S. who have low iron levels (anemia) between 13 and 30 weeks of pregnancy.
- What's involved
- Participants will be randomly assigned to receive either iron through an IV or a placebo (a treatment with no active ingredient) in a double-blind manner, meaning neither the patient nor the doctor knows which one is given.
- Time commitment
- The study involves participation from 13 to 30 weeks of pregnancy until delivery, with specific tests to check iron levels and health outcomes.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Pregnant women between the ages of 18-45
- Singleton gestation
- Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
- At 13-30 weeks gestation
- Plan to deliver at participating hospital
You likely can't join if
- Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.
- Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron
- Multiple gestation
- Inability or unwillingness to provide informed consent
- Inability to communicate with members of the study team, despite the presence of an interpreter
- Planned delivery at a non-study affiliated hospital
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Miami, Florida, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Portland, Oregon, United States
- Providence, Rhode Island, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Miami, Florida, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Portland, Oregon, United States; Providence, Rhode Island, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.