MIRACLE of LIFE Study

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)?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preterm Labor Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Gestational Diabetes Mellitus in Pregnancy Gestational Hypertension Growth Disorders HELLP Hypertension Hypertension, Pregnancy-Induced Intrauterine Growth Restriction Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Preeclampsia Pregnancy Complications Premature Birth Preterm Birth Preterm Birth Complication Preterm Premature Rupture of Membrane Preterm Premature Rupture of the Membranes Small for Gestational Age at Delivery Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Diego, San Diego, California, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is willing and able to provide written informed consent.
Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures.
Subject is a pregnant female before 22 weeks of gestation
Subject is at least 18 years of age

Exclusion criteria

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
Subject is pregnant with multifetal gestation (e.g., twins)
Subject is planning to deliver via home birth

Treatment and study plan

Mirvie Predictive Test for Adverse Pregnancy Outcomes

Diagnostic 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)

Primary outcomes

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

Time frame: 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)

Secondary outcomes

Discovery of multi-omic biomarkers of adverse pregnancy outcomes

Time frame: December 2026

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

Sponsors and collaborators

Lead sponsor

Mirvie

Industry

Registry information

Official study title

Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk

Acronym: MoL

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Oct 10, 2023
Registry last updated: Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed