MIRACLE of LIFE Study

Active, not recruiting

• Conditions: Preterm Birth; Preterm Premature Rupture of Membrane; Gestational Hypertension; Preterm Labor; Gestational Diabetes Mellitus in Pregnancy; Intrauterine Growth Restriction; Preeclampsia; HELLP; Small for Gestational Age at Delivery; Preterm Birth Complication
• Interventions: Diagnostic Test: Mirvie Predictive Test for Adverse Pregnancy Outcomes

• Registration Number: NCT06074601
• Lead Sponsor: Mirvie

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. 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

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 Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Primary Completion: 2024-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant People	Mirvie Predictive Test for Adverse Pregnancy Outcomes	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (10)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Women's Care Florida; 🇺🇸 Orlando, Florida, United States

Ochsner Health System; 🇺🇸 New Orleans, Louisiana, United States

MultiCare; 🇺🇸 Tacoma, Washington, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States