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NCT05047211 · ClinicalTrials.gov registry record · Phase 4
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT05047211 is a Phase 4 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 40 participants.
The verdict
NCT05047211, a Phase 4 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. 2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
Interventions
- DRUG Ferrous sulfate
- DRUG Iron dextran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2023-04-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05047211
The ClinicalTrials.gov registry entry for NCT05047211 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ferrous sulfate is the first listed.
NCT05047211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05047211 about?
NCT05047211 is a clinical study titled "Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia". This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: 1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by...
What is the current status of trial NCT05047211?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2021-10-07. Estimated completion is 2023-04-15.
What interventions are being tested in trial NCT05047211?
The interventions under investigation include: Ferrous sulfate (DRUG), Iron dextran (DRUG).
Who is sponsoring clinical trial NCT05047211?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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