Gestational Diabetes Mellitus in Pregnancy, Gestational Hypertension, HELLP, Intrauterine Growth Restriction, Preeclampsia, Preterm Birth, Preterm Birth Complication, Preterm Labor, Preterm Premature Rupture of Membrane, Small for Gestational Age at Delivery
Conditions
Brief 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)?
Detailed 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.
Interventions
DIAGNOSTIC_TESTMirvie 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
Mirvie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes | December 2024 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discovery of multi-omic biomarkers of adverse pregnancy outcomes | December 2026 | This study will enable the identification of other biomarkers (e.g., proteomic, metabolomic) of adverse pregnancy outcomes |
Countries
United States
Outcome results
None listed