MoL: MIRACLE of LIFE Study

Sponsor

Mirvie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06074601

Collaborator

(none)

10,000

Enrollment

Locations

Anticipated Duration (Months)

1000

Patients Per Site

18.9

Patients Per Site Per Month

Study Details

Study Description

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:

Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)?
What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

Discovery of multi-omic biomarkers of adverse pregnancy outcomes [December 2026]
This study will enable the identification of other biomarkers (e.g., proteomic, metabolomic) of adverse pregnancy outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	San Diego	California	United States	92121
2	Women's Care Florida	Orlando	Florida	United States	32803
3	Ochsner Health System	New Orleans	Louisiana	United States	70115
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Washington University School of Medicine	Saint Louis	Missouri	United States	63108
6	The Ohio State University	Columbus	Ohio	United States	43210
7	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
8	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
9	University of Texas Medical Branch	Galveston	Texas	United States	77555
10	MultiCare	Tacoma	Washington	United States	98405