Trials / Active Not Recruiting
Active Not RecruitingNCT06074601
MIRACLE of LIFE Study
Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (estimated)
- Sponsor
- Mirvie · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2024-06-30
- Completion
- 2025-12-31
- First posted
- 2023-10-10
- Last updated
- 2024-11-27
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06074601. Inclusion in this directory is not an endorsement.