The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 350
- 主要终点
- Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
研究概览
简要总结
Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?
详细描述
Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women at approximately 20 weeks
- •ages 18-50
- •singleton pregnancy
- •plans to deliver at North Shore University Hosp
- •completed step-wise sequential screening
排除标准
- •multifetal gestation
- •patients who have undergone diagnostic genetic testing
- •incarcerated patients
- •intention to deliver at a hospital other than North Shore University hosp
结局指标
主要结局
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
时间窗: completion of pregnancy
In patients who have undergone step-wise sequential screening, how often will the evaluation of 10 midtrimester sonographic soft markers of aneuploidy such that the recommendation regarding invasive diagnostic testing be changed?
次要结局
未报告次要终点
研究者
Burt Rochelson
Investigator, MD
Northwell Health