MIRACLE of LIFE Study (MoL)

Mirvie

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Mirvie Predictive Test for Adverse Pregnancy Outcomes

Study type: Observational

Funder types: Industry

Identifiers

NCT06074601

Pro00050765 (Other Identifier)

MV-001

Details and patient eligibility

About

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)?

Full 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.

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 1 patient group

Pregnant People

Description:

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

Treatment:

Diagnostic Test: Mirvie Predictive Test for Adverse Pregnancy Outcomes