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Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation

NCT02791568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2025-08-22

No results posted yet for this study

Summary

The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate the blood and oxygen flow to the placenta using advanced U/S and MRI testing.

Conditions

Interventions

PROCEDURE

Ultrasound Scan

The research exam is expected to take 30 minutes for blood flow assessments

PROCEDURE

MRI Scan

MR imaging will take approximately 30 minutes.

DRUG

Ferumoxytol

A subset of subjects will complete MRI imaging with ferumoxytol as a contrast agent at the 24-28 week visit. A nurse will administer ferumoxytol in a hospital triage with pulse and blood pressure monitoring and fetal heart monitoring. The pharmacy will prepare the infusion and deliver to triage. Subjects will arrive at the obstetric triage unit for ferumoxytol injection three days prior to their scheduled ferumoxytol MRI study. In the triage, the nurse will obtain baseline vital signs and fetal heart rate. The IV Ferumoxytol infusion will be 30 minutes and atients will be monitored at 5 to 15-minute intervals. Three days after the ferumoxytol infusion, at 24-26 weeks gestation, subjects will have blood/urine collected, undergo a 30 minute ultrasound, a 30 minute MRI, an adverse event review, and medical record review. The MRI scanning procedure will be conducted at WIMR and will last approximately 30-60 minutes.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • 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

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02791568 on ClinicalTrials.gov