MIRACLE of LIFE Study

Study Overview
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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: 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)?

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.

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

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

Intervention / Treatment
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* Diagnostic Test: Mirvie Predictive Test for Adverse Pregnancy Outcomes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant People<br>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<br>* 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)<br>|

What is the study measuring?
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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 |