MIRACLE of LIFE Study

Running, not enrolling

Conditions studied: 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

In brief

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)?

Key facts

Study ID

NCT06074601

Run by

Mirvie

People needed

10000

Starts

2021-08-01

Expected to finish

2025-12-31

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is willing and able to provide written informed consent.
• Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures.
• Subject is a pregnant female before 22 weeks of gestation
• Subject is at least 18 years of age

You may not qualify if…

• 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
• Subject is pregnant with multifetal gestation (e.g., twins)
• Subject is planning to deliver via home birth

Where it is running

• 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
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• MultiCare — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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