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MIRACLE of LIFE Study — MoL  

Preterm Birth Clinical Trial

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

Clinical Trial 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)?

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06074601
Study type Observational
Source Mirvie
Contact
Status Active, not recruiting
Phase
Start date August 1, 2021
Completion date December 31, 2025
View Details
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