Observational Study of Pregnant People to Validate Biomarkers of Pregnancy Complication Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10,000
- 试验地点
- 10
- 主要终点
- Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes
研究概览
简要总结
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:
- Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)?
- What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical validation of cell-free RNA-based biomarkers of adverse pregnancy outcomes
时间窗: 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)
次要结局
- Discovery of multi-omic biomarkers of adverse pregnancy outcomes(December 2026)