for females ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
completion around



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)?

Official Title

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


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.


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, Premature Birth, Gestational Diabetes, Pre-Eclampsia, Premature Obstetric Labor, Premature Rupture Fetal Membranes, Fetal Growth Retardation, Pregnancy-Induced Hypertension, Pregnancy in Diabetics, Rupture, Mirvie Predictive Test for Adverse Pregnancy Outcomes, Pregnant People


You can join if…

Open to females ages 18 years and up

  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

You CAN'T join if...

  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


  • University of California San Diego
    San Diego California 92121 United States
  • MultiCare
    Tacoma Washington 98405 United States


in progress, not accepting new patients
Start Date
Completion Date
Study Type
Expecting 10000 study participants
Last Updated