MIRACLE of LIFE Study (MoL)

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

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)?

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Birth; Preterm Labor; Preeclampsia; Intrauterine Growth Restriction; Gestational Diabetes Mellitus in Pregnancy; Small for Gestational Age at Delivery; Preterm Birth Complication; HELLP; Preterm Premature Rupture of Membrane; Gestational Hypertension
• Intervention / Treatment: Diagnostic test: Mirvie Predictive Test for Adverse Pregnancy Outcomes

Detailed Description

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 (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • University of California San Diego
  • Florida
    • Orlando, Florida, United States, 32803
      • Women's Care Florida
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll a diverse and representative population of pregnant people from across the United States who meet study inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant People; Enrolling any pregnant person over the age of 18 with a singleton pregnancy with their pregnancy having been effectively dated by first trimester ultrasound or last menstrual period	Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	December 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	December 2026

Collaborators and Investigators

• Sponsor: Mirvie

Publications and helpful links

General Publications

• Rasmussen M, Reddy M, Nolan R, Camunas-Soler J, Khodursky A, Scheller NM, Cantonwine DE, Engelbrechtsen L, Mi JD, Dutta A, Brundage T, Siddiqui F, Thao M, Gee EPS, La J, Baruch-Gravett C, Santillan MK, Deb S, Ame SM, Ali SM, Adkins M, DePristo MA, Lee M, Namsaraev E, Gybel-Brask DJ, Skibsted L, Litch JA, Santillan DA, Sazawal S, Tribe RM, Roberts JM, Jain M, Hogdall E, Holzman C, Quake SR, Elovitz MA, McElrath TF. RNA profiles reveal signatures of future health and disease in pregnancy. Nature. 2022 Jan;601(7893):422-427. doi: 10.1038/s41586-021-04249-w. Epub 2022 Jan 5.
• Camunas-Soler J, Gee EPS, Reddy M, Mi JD, Thao M, Brundage T, Siddiqui F, Hezelgrave NL, Shennan AH, Namsaraev E, Haverty C, Jain M, Elovitz MA, Rasmussen M, Tribe RM. Predictive RNA profiles for early and very early spontaneous preterm birth. Am J Obstet Gynecol. 2022 Jul;227(1):72.e1-72.e16. doi: 10.1016/j.ajog.2022.04.002. Epub 2022 Apr 6.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Wounds and Injuries; Endocrine System Diseases; Diabetes Mellitus; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Growth Disorders; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Rupture; Premature Birth; Pre-Eclampsia; Fetal Growth Retardation; Obstetric Labor, Premature; Diabetes, Gestational; Pregnancy in Diabetics; Hypertension, Pregnancy-Induced; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: MV-001; Pro00050765 (Other Identifier: Advarra IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No