Clinical Utility of a Predictive Model of Placental Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Number of participants with placental insufficiency composite
研究概览
简要总结
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
详细描述
Pregnant study participants will be recruited and monitored throughout pregnancy with ultrasound and blood draws, and delivery and neonatal data up to 28 days following birth. This data will be used to develop a model to predict placental insufficiency.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 15 or older
- •No known major fetal anatomic or genetic abnormalities
- •Singleton gestation
- •Planning to deliver at Oregon Health & Science University
- •Prior to 22 weeks' gestation
排除标准
- •Decisional impairment
- •Multiple gestation
- •Known fetal growth restriction or major congenital anomaly
- •Inability to consent
- •Inability to attend study visits
结局指标
主要结局
Number of participants with placental insufficiency composite
时间窗: At time of delivery to 28 days following delivery
The composite is made of the following: stillbirth and neonatal death, severe forms of hypertensive disease, placental abruption, birthweight below the 3rd percentile, umbilical cord arterial pH\<7, and/or placental primary indication for delivery (FGR, oligohydramnios, abnormal fetal testing)
次要结局
未报告次要终点
研究者
Karen Gibbins
Principal Investigator
Oregon Health and Science University