drugset / Trial / NCT05462704
Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Phase 3
Recruiting
300 enrolled
Women and Infants Hospital of Rhode Island
GNP Research at Heme-on-Call · collabHasbro Children's Hospital · collabOregon Health and Science University · collabUniversity of Alabama at Birmingham · collabUniversity of Michigan · collabUniversity of Utah · collabWashington University School of Medicine · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2023-01-17
- Primary completion
- 2027-03-30
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Derisomaltose | Unknown | 1000 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 325 mg | Oral |