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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00050765 | Other Identifier | Advarra IRB |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant People | Enrolling any pregnant person over the age of 18 with a singleton pregnancy with their pregnancy having been effectively dated by first trimester ultrasound or last menstrual period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirvie Predictive Test for Adverse Pregnancy Outcomes | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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This study is open to biological females who are pregnant and identify as female, male, or non-binary
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This study will enroll a diverse and representative population of pregnant people from across the United States who meet study inclusion and exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92121 | United States | ||
| Women's Care Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34987224 | Background | 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. | |
| 35398029 |
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IPD will not be made available to other researchers
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Maternal plasma
|
| Orlando |
| Florida |
| 32803 |
| United States |
| Ochsner Health System | New Orleans | Louisiana | 70115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| MultiCare | Tacoma | Washington | 98405 | United States |
| Background |
| 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. |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D047928 | Premature Birth |
| C563032 | Preterm Premature Rupture of the Membranes |
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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