NCT06074601Active, not recruiting
MIRACLE of LIFE Study
Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
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)?
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 1 Aug 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Mirvie
- Diseases
- High blood pressure
- NCT number
- NCT06074601
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 1 Aug 2021 to the primary completion date, 30 Jun 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
- Subject is pregnant with multifetal gestation (e.g., twins)
- Subject is planning to deliver via home birth
Who the study is looking for
- Subject is willing and able to provide written informed consent.
- Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures.
- Subject is a pregnant female before 22 weeks of gestation
- Subject is at least 18 years of age
Age in the registry: 18 years to - · Sex: Female
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Medical Branch Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
| Ochsner Health System Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Women's Care Florida Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| MultiCare Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.