A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Medicines360
- 入组人数
- 5,500
研究概览
简要总结
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)] and risk of adverse outcomes.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Nulliparous (no previous births ≥20wk GA)
- •Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation
- •Ability to consent and comply with study procedures and follow-up
排除标准
- •Multiple gestation
- •Inability to provide blood
- •Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual
- •Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)
- •Current or recent (within two months) participation in an interventional clinical study.
研究组 & 干预措施
Blood Based Biomarkers, Derivation Cohort
To support the identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation, in blood-based biomarker products currently in development.
干预措施: None (this is an observational study with no intervention) (Other)
Blood Based Biomarkers, Validation Cohort
To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation, as defined above for identification of pregnancies at increased risk.
干预措施: None (this is an observational study with no intervention) (Other)
Retinal Imaging, Development of Algorithm
To develop a retinal imaging algorithm for risk prediction for preeclampsia.
干预措施: None (this is an observational study with no intervention) (Other)
Retinal Imaging, Validation of Algorithm
To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia.
干预措施: None (this is an observational study with no intervention) (Other)