Placental Volume, Flow, and Vascularity Study

Pre-Eclampsia Clinical Trial

Official title:

Placental Volume, Flow, and Vascularity Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900207
• Other study ID #: STUDY00009133
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Preeclampsia is defined as a multi-system disorder typically characterized by hypertension, proteinuria, and/or 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 30, 2022
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton gestation

• Qualify for a first-trimester screen at the time of enrollment. Criteria for the screen include pregnancy with gestational age between 10 weeks 3 days and 13 weeks 6 days of gestation as well as a crown-rump length between 40 and 84 mm.

• Complete a first-trimester ultrasound at the qualifying M Health Fairview Maternal Fetal Medicine Clinics, which include University Riverside, Ridges, South Dale, and Health East sites

• Provide a blood sample for either completion of the first-trimester screen and/or for the completion of the research study

Exclusion Criteria:

• Multi-fetal gestation or pregnancy with major fetal congenital anomalies and/or known fetal aneuploidy

• Unwilling to complete a first-trimester ultrasound and/or unwilling to provide a serum sample

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive Value of Model for the Development of Preeclampsia	The primary measure for this study will be the positive predictive value of the model for the development of preeclampsia. Outcome is reported as the percent of correct predictions made by the model.	up to 12 months