Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04839185
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2021-04-07
Brief Title:
Placental Lesions in Fetal Growth Restrictions
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Detection of Placental Lesions in Fetal Growth Restriction
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 FerumoxytolFE is FDA approved for some uses but in pregnant women its use as a MRI contrast is investigational
Detailed Description:
Research Procedure Descriptions
Bloodurine 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 participants 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 ie 255 mg in 50 mL of 09 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
Bloodurine 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 participants 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 ie 255 mg in 50 mL of 09 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A532860 | OTHER | None | None |
| SMPHOBSTET GYNECOL | OTHER | None | None |
| 1U01HD087216-01 | NIH | None | None |
| Protocol ver 04-06-2020 | OTHER | HS-IRB UW Madison | httpsreporternihgovquickSearch1U01HD087216-01 |