MIRACLE of LIFE Study

Preterm Birth Clinical Trial

— MoL  

Official title:

Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06074601
• Other study ID #: MV-001
• Secondary ID: Pro00050765
• Status: Active, not recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Mirvie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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)?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Fetal Growth Retardation
• Fetal Membranes, Premature Rupture
• Gestational Diabetes Mellitus in Pregnancy
• Gestational Hypertension
• HELLP
• Hypertension, Pregnancy-Induced
• Intrauterine Growth Restriction
• Obstetric Labor, Premature
• Pre-Eclampsia
• Preeclampsia
• Pregnancy in Diabetics
• Premature Birth
• Preterm Birth
• Preterm Birth Complication
• Preterm Labor
• Preterm Premature Rupture of Membrane
• Rupture
• Small for Gestational Age at Delivery

Intervention

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)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Ochsner Health System	New Orleans	Louisiana
United States	Women's Care Florida	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Diego	San Diego	California
United States	MultiCare	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mirvie

Country where clinical trial is conducted

United States, 

References & Publications (2)

Camunas-Soler J, Gee EPS, Reddy M, Mi JD, Thao M, Brundage T, Siddiqui F, Hezelgrave NL, Shennan AH, Namsaraev E, Haverty C, Jain M, Elovitz MA, Rasmussen M, Tribe RM. Predictive RNA profiles for early and very early spontaneous preterm birth. Am J Obstet Gynecol. 2022 Jul;227(1):72.e1-72.e16. doi: 10.1016/j.ajog.2022.04.002. Epub 2022 Apr 6. — View Citation

Rasmussen M, Reddy M, Nolan R, Camunas-Soler J, Khodursky A, Scheller NM, Cantonwine DE, Engelbrechtsen L, Mi JD, Dutta A, Brundage T, Siddiqui F, Thao M, Gee EPS, La J, Baruch-Gravett C, Santillan MK, Deb S, Ame SM, Ali SM, Adkins M, DePristo MA, Lee M, Namsaraev E, Gybel-Brask DJ, Skibsted L, Litch JA, Santillan DA, Sazawal S, Tribe RM, Roberts JM, Jain M, Hogdall E, Holzman C, Quake SR, Elovitz MA, McElrath TF. RNA profiles reveal signatures of future health and disease in pregnancy. Nature. 2022 Jan;601(7893):422-427. doi: 10.1038/s41586-021-04249-w. Epub 2022 Jan 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes	This study will measure the test performance (e.g., ROC, sensitivity, specificity, negative and positive predictive value) of cell-free RNA-based biomarkers that are predictive of a variety of adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)	December 2024
Secondary	Discovery of multi-omic biomarkers of adverse pregnancy outcomes	This study will enable the identification of other biomarkers (e.g., proteomic, metabolomic) of adverse pregnancy outcomes	December 2026