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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06074601
Other study ID # MV-001
Secondary ID Pro00050765
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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