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MIRACLE of LIFE Study

NCT06074601 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-11-27

No results posted yet for this study

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)?

Conditions

  • 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

Interventions

DIAGNOSTIC_TEST

Mirvie Predictive Test for Adverse Pregnancy Outcomes

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)

Sponsors & Collaborators

  • Mirvie

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-06-30
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074601 on ClinicalTrials.gov