NCT05462704 · Women and Infants Hospital of Rhode Island
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
(IVIDA2)
What this study is about
Double blind, placebo controlled, conducted at multiple hospitals randomly assigned trial in pregnant women in the U.S.
View original scientific description
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Interventions
DRUG
Ferric derisomaltose
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes.
DRUG
Ferrous sulfate
325mg ferrous sulfate tablets (65 mg of elemental iron), 1 to 3 orally per day.
Primary outcome measures
Rate of maternal anemia (hgb<11mg/dL) at delivery
Time frame: Within 24 hours of admission to inpatient obstetrics unit for delivery of infant
Hemoglobin \<11mg/dL on admission to inpatient obstetrics unit for labor and delivery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Birmingham, Alabama
- Miami, Florida
- Ann Arbor, Michigan
- St Louis, Missouri
- Portland, Oregon
- Providence, Rhode Island
- Salt Lake City, Utah
Collaborators
Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2025 · Source of record for eligibility and locations