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MIRACLE of LIFE Study

NCT ID: NCT06074601

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-12-31

Brief Summary

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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)?

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Mirvie Predictive Test for Adverse Pregnancy Outcomes

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mirvie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California San Diego

San Diego, California, United States

Site Status

Women's Care Florida

Orlando, Florida, United States

Site Status

Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

MultiCare

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34987224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35398029 (View on PubMed)

Other Identifiers

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Pro00050765

Identifier Type: OTHER

Identifier Source: secondary_id

MV-001

Identifier Type: -

Identifier Source: org_study_id