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Summary
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
Official title: Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10000
Start Date
2021-08-01
Completion Date
2025-12-31
Last Updated
2024-11-27
Healthy Volunteers
Not specified
Conditions
Interventions
Mirvie Predictive Test for Adverse Pregnancy Outcomes
This is a proprietary biomarker and clinical factor-based algorithm for predicting which pregnancies are at greatest risk of developing a variety of adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)
Locations (10)
University of California San Diego
San Diego, California, United States
Women's Care Florida
Orlando, Florida, United States
Ochsner Health System
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
MultiCare
Tacoma, Washington, United States