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Placental Lesions in Fetal Growth Restrictions

NCT04839185 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Fetal Growth Retardation

Interventions

DRUG

Ferumoxytol infusion

Ferumoxytol will be administered intravenously, by infusion, over 30 minutes. It will be used a contrast agent for MRI imaging to detect placental lesions in fetal growth restriction. Dose will be 255 mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Ferumoxytol/Feraheme will be administered only once, in one infusion of 255 mg to each subject.

PROCEDURE

MRI scan

The MRI scanning procedure will last for approximately 60 minutes.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Dinesh Shah, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839185 on ClinicalTrials.gov