Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation

CompletedOBSERVATIONAL
Enrollment

121

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
PregnancyObesityPreeclampsia
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.

Trial Locations (2)

53715

UnityPoint Health-Meriter Hospital, Madison

University of Wisconsin-Hospitals and Clinics, Madison

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

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

NIH

lead

University of Wisconsin, Madison

OTHER

NCT02791568 - Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation | Biotech Hunter | Biotech Hunter