NCT05462704 Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
| NCT ID | NCT05462704 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2023-01-17 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Methodius Tuuli, MD, MPH, MBA
PRINCIPAL INVESTIGATOR
Women and Infants Hospital of Rhode Island
Frequently Asked Questions
Who can join the NCT05462704 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Iron Deficiency Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05462704 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT05462704 currently recruiting?
Yes, NCT05462704 is actively recruiting participants. Contact the research team at cware@wihri.org for enrollment information.
Where is the NCT05462704 trial being conducted?
This trial is being conducted at Birmingham, United States, Miami, United States, Ann Arbor, United States, St Louis, United States and 4 additional locations.
Who is sponsoring the NCT05462704 clinical trial?
NCT05462704 is sponsored by Women and Infants Hospital of Rhode Island. The principal investigator is Methodius Tuuli, MD, MPH, MBA at Women and Infants Hospital of Rhode Island. The trial plans to enroll 300 participants.