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NCT04839185 · ClinicalTrials.gov registry record · Early Phase 1
Placental Lesions in Fetal Growth Restrictions
A Early Phase 1 study of Fetal Growth Retardation, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT04839185: Completed Early Phase 1 study of Fetal Growth Retardation, sponsored by University of Wisconsin, Madison.
NCT04839185 is a Early Phase 1 study of Fetal Growth Retardation that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 3 participants, below the 505-participant average among 3 other Fetal Growth Retardation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04839185, a Early Phase 1 study of Fetal Growth Retardation, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research because the use of IV iron, followed by a Magnetic resonance imaging (MRI), may help detect injury in the placenta. The IV iron, ferumoxytol, is an iron preparation used for treatment of iron deficiency anemia. It is given in hospital setting under close medical attention. Ferumoxytol(FE) is FDA approved for some uses, but in pregnant women, its use as a MRI contrast is investigational.
Primary Outcome
Intervillous Placental Blood will be detected by Magnetic resonance imaging (MRI). The patient will receive the first 60-minute MRI within 1-15 hours after completion of the ferumoxytol infusion.
Conditions Studied
Interventions
- PROCEDURE MRI scan
- DRUG Ferumoxytol infusion
Study Locations (1)
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2021-10-06 |
| Phase | Early Phase 1 |
What the finished NCT04839185 record still lists
NCT04839185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 505-participant average among 3 other Fetal Growth Retardation trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Fetal Growth Retardation appearing as the primary indexed condition, and to 2 interventions - of which MRI scan is the first listed.
NCT04839185 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04839185 about?
NCT04839185 is a clinical study titled "Placental Lesions in Fetal Growth Restrictions". The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research because the use of IV iron, followed by a Magnetic resonance imaging (MRI), may help detect injury in the ...
What is the current status of trial NCT04839185?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2021-04-15. Estimated completion is 2021-10-06.
What conditions does trial NCT04839185 study?
This clinical trial studies the following conditions: Fetal Growth Retardation.
What interventions are being tested in trial NCT04839185?
The interventions under investigation include: MRI scan (PROCEDURE), Ferumoxytol infusion (DRUG).
Who is sponsoring clinical trial NCT04839185?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04839185 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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