MIRACLE of LIFE Study

NCT06074601 · tracked via the Priya Life Science USA tracker

Sponsor

Mirvie

Phase

Observational

Started

2021-08-01

Last updated

2024-11-27

Condition(s) studied

Preterm LaborPreterm BirthPreterm Birth ComplicationPreterm Premature Rupture of MembranePreeclampsiaHELLPGestational HypertensionGestational Diabetes Mellitus in PregnancySmall for Gestational Age at DeliveryIntrauterine Growth Restriction

Investigational drug(s) / intervention(s)

Mirvie Predictive Test for Adverse Pregnancy Outcomes

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)

Study 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)?

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes — December 2024
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)

Trial sites (10)

Facility	City	Region
University of California San Diego	San Diego	California
Women's Care Florida	Orlando	Florida
Ochsner Health System	New Orleans	Louisiana
Beth Israel Deaconess Medical Center	Boston	Massachusetts
Washington University School of Medicine	St Louis	Missouri
The Ohio State University	Columbus	Ohio
Thomas Jefferson University	Philadelphia	Pennsylvania
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
University of Texas Medical Branch	Galveston	Texas
MultiCare	Tacoma	Washington

Other trials for the same condition

Reducing Pregnancy Risks: The Mastery Lifestyle Intervention Recruiting

Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates Starting soon

Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders Recruiting

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06074601 on ClinicalTrials.gov ↗ ← All trials in the USA