Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900207
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2021-04-26
Brief Title:
Placental Volume Flow and Vascularity Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Placental Volume Flow and Vascularity Study
Status:
COMPLETED
Status Verified Date:
2022-08
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 preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume blood flow and vascularity This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume This information will then be used to further investigate whether placental volume blood flow and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound
Detailed Description:
Preeclampsia is defined as a multi-system disorder typically characterized by hypertension proteinuria andor end organ damage Preeclampsia can develop rapidly at any time after 20 weeks gestation and into the postpartum period and can at times lead to systemic complications and even death Preeclampsia continues to be a leading cause of maternal morbidity and mortality secondary to the development of hypertensive disorders systemic inflammatory changes affecting the endothelium and hemorrhagic complications It also contributes indirectly to neonatal morbidity and mortality by leading to premature delivery Our current ability to screen patients for the risk of developing preeclampsia relies on clinical factors as recommended by ACOG and the USPHS At this time if a patient is deemed high risk our only intervention for prevention of preeclampsia is to prescribe low-dose aspirin Being able to identify the population at higher risk for preeclampsia would allow for implementation of new management options among these persons The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume blood flow and vascularity This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume This information will then be used to further investigate whether placental volume blood flow and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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