Placental Volume, Flow, and Vascularity Study

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 Overview

• Status: Completed
• Conditions: Pre-Eclampsia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants are pregnant adults in the first trimester of gestation who are receiving an ultrasound at one of the qualifying study sites.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Observed Group; Participants will be enrolled in the study at the time of their first-trimester screen (10w3d-13w6d weeks of gestation) to the time of their delivery. Collection of first-trimester 3D-volume ultrasound imaging to measure the placental volume, blood flow, and vascularity and maternal serum markers will occur over a 6-12 months period. Collection of descriptive and pregnancy outcome information will be obtained from the electronic medical records will continue through their pregnancy episode (typical 9 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Stephen Contag, MD, University of Minnesota Medical School Department of Obstetrics, Gynecology, & Women's Health

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: STUDY00009133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No