MIRACLE of LIFE Study

N/AActive Not RecruitingNCT06074601

Mirvie10,000 enrolled

Overview

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)?

This is a multi-center, prospective, observational cohort study, that involves the collection of blood samples from pregnant people during their second trimester of pregnancy. Maternal plasma is isolated from blood samples and subjected to transcriptome and other multi-omic analyses. In conjunction with blood sample collection, extensive clinical data are collected about the pregnancy including any pregnancy complications (e.g., preterm birth, preeclampsia) that may have arisen during pregnancy. Biological markers and clinical data are combined to develop and validate Mirvie's investigational predictive test.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Preterm Labor Preterm Birth Preterm Birth Complication Preterm Premature Rupture of Membrane

Interventions

Mirvie Predictive Test for Adverse Pregnancy OutcomesDIAGNOSTIC_TEST

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)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is willing and able to provide written informed consent. 2. Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures. 3. Subject is a pregnant female before 22 weeks of gestation 4. Subject is at least 18 years of age Exclusion Criteria: 1. Estimated due date (EDD) via 1st or 2nd ultrasound, date of last menstrual period (LMP), or in-vitro fertilization (IVF) implantation date is not available 2. Subject is pregnant with multifetal gestation (e.g., twins) 3. Subject is planning to deliver via home birth

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

Outcomes

Primary Outcomes

Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes

This study will measure the test performance (e.g., ROC, sensitivity, specificity, negative and positive predictive value) of cell-free RNA-based biomarkers that are predictive of a variety of adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)

Time frame: December 2024

Secondary Outcomes

Discovery of multi-omic biomarkers of adverse pregnancy outcomes

This study will enable the identification of other biomarkers (e.g., proteomic, metabolomic) of adverse pregnancy outcomes

Time frame: December 2026