MIRACLE of LIFE Study

NCT06074601 | Active Not Recruiting

• 2 other identifiers: MV-001Pro00050765
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 10

Brief 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. 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. 2.What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

Conditions

Preterm Labor; Preterm Birth; Preterm Birth Complication; Preterm Premature Rupture of Membrane; Preeclampsia; HELLP; Gestational Hypertension; Gestational Diabetes Mellitus in Pregnancy; Small for Gestational Age at Delivery; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Discovery of multi-omic biomarkers of adverse pregnancy outcomes

  December 2026

Study Arms (1)

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

Interventions

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)

Pregnant People

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to biological females who are pregnant and identify as female, male, or non-binary
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mirvie: lead

Study Sites (10)

University of California San Diego

San Diego, California, 92121, United States

Location

Women's Care Florida

Orlando, Florida, 32803, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MultiCare

Tacoma, Washington, 98405, United States

Location

Related Publications (2)

• 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.

  PMID: 34987224 BACKGROUND

• 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.

  PMID: 35398029 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Maternal plasma

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth; Preterm Premature Rupture of the Membranes; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: August 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)