Placental Lesions in Fetal Growth Restrictions
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      Research Procedure Descriptions

      Blood/urine collection for research Blood and urine samples are collected at the consenting
      visit and at the time of delivery. A total of 10 mL, of blood is collected via venipuncture
      along with an aliquot of a urine sample. For research visits that coincide with clinical
      visits, research blood samples are collected in conjunction with clinical samples, saving
      subjects an additional needle stick. All subjects are asked if they wish to have left over
      research samples banked for future unspecified research. Blood and urine samples will be
      analyzed to monitor relevant maternal growth factors, multiplex assays for Cytokine panel and
      Matrix metalloproteinases (MMPs). Urine will be tested for Shed VE-Cadherin (VE Cad).

      60 minute MRI: This MRI scan will take approximately 60 minutes. Prior to entering the MR
      suite, subjects are screened again for MRI safety and compatibility. The MR imaging exam is
      expected to take approximately 60 minutes with some additional time to get subjects
      comfortably placed in the scanner. Subjects are made as comfortable as possible in the bore
      and are provided with an alarm, which allows them to get the attention of the MR technologist
      conducting the scan. There is a break between scans to ensure the comfort of the subjects.

      Ferumoxytol administration:

      The MRI imaging with ferumoxytol as a contrast agent will be conducted at the scheduled
      visits based on timing of FGR diagnosis. Ferumoxytol will be administered in a hospital
      triage setting with maternal pulse and blood pressure monitoring and fetal heart rate
      monitoring. The pharmacy will be notified in advance of the arrival of the participant, so
      that they can prepare the infusion in a timely fashion and deliver it to triage upon
      participant's arrival. Participants will arrive at UnityPoint-Health Meriter Hospital
      obstetric triage unit as prescheduled for ferumoxytol infusion. Later that same day, the
      participants will present to the University of Wisconsin (UW) Hospital, Wisconsin Institutes
      for Medical Research (WIMR) or 1 S. Park location for their pre-scheduled MRI. In the triage
      unit, the nurse will obtain baseline vital signs, including maternal pulse, blood pressure,
      and fetal heart rate. Following this, the nurse will initiate an infusion dose of
      ferumoxytol. Ferumoxytol will be administered intravenously, by infusion, over 30 minutes.
      The participants will be monitored at 5 to 15-minute intervals, for pulse, blood pressure,
      respiration, and fetal heart rate. The MRI scanning procedure will be conducted at the UW
      Hospital, WIMR or 1 S. Park location for approximately 60 minutes.

      The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3
      to 8 days later. Investigators plan to dilute half of the recommended initial dose, i.e. 255
      mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Feraheme
      will be given only once, in one infusion of 255 mg to each participant who has consented for
      this study.
    

Intervention name(s): Ferumoxytol infusion; MRI scan
Intervention type(s): Drug; Procedure
Intervention description(s): 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.; The MRI scanning procedure will last for approximately 60 minutes.
Other intervention name(s): Feraheme
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic