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Active Not RecruitingNCT06074601

MIRACLE of LIFE Study

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...

Lead sponsor: Mirvie•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Mirvie

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.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 27, 2024Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment10,000

Start dateAug 2021

Last updatedNov 27, 2024

Condition

Preterm Labor Preterm Birth Preterm Birth Complication Preterm Premature Rupture of Membrane Preeclampsia+5 more

Locations shown

University of California San Diego

San Diego, California

Women's Care Florida

Orlando, Florida

Ochsner Health System

New Orleans, Louisiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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