Using Precision Medicine for the Prediction and Prevention of Early Pre-eclampsia: A Feasibility Study at Sunnybrook Health Sciences Centre.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Feasibility of Screening Tool
研究概览
简要总结
This study aims to evaluate the feasibility of implementing a clinical model for precision screening of early pre-eclampsia into the current prenatal screening service at Sunnybrook Health Sciences Center (SHSC).
详细描述
Pre-eclampsia (PE) represents a pregnancy-specific systemic disorder that affects 3-8% of all pregnancies. In developed countries PE is considered a major public health problem responsible for severe maternal complications such as coagulopathy, renal and liver failure, stroke, and maternal death (>76,000 maternal death annually).
The traditional approach to screening for preeclampsia endorsed by national guidelines is based on a combination of maternal characteristics along with medical, obstetric and family history.
However, although these methods are simple and easy to perform, maternal factors can only identify less than 35% of all preeclampsia and approximately 40% of preterm-preeclampsia at a false- positive rate of 10%.
More recently, multivariate analysis has been used to develop predictive models for preeclampsia that can be applied as early as 11-13+6 weeks gestation. One such algorithm, developed by the Fetal Medicine Foundation UK(MFM UK), incorporates maternal risk factors, uterine artery doppler, mean arterial pressure, and serum markers of placental function and placental growth factor. The FMFUK algorithm has been shown to predict approximately 75-90% of those women destined to develop preeclampsia prior to 37 and 34 weeks respectively, at a false positive rate of 10%. This algorithm has been validated prospectively in several studies, including the prediction of other placental mediated complications of pregnancy, such as fetal growth restriction and perinatal death.
The new clinical model will include the following additions to the existing first trimester screening for aneuploidy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a singleton pregnancy > 18 years old
- •Not on low dose aspirin
- •Carrying a live fetus with crown rump length (CRL) between 41 and 84mm
- •Able to provide informed consent
- •Having a nuchal translucency ultrasound
排除标准
- •Women with a singleton pregnancy < 18 years old
- •Women currently taking low dose aspirin
- •Women declining a nuchal translucency ultrasound
- •Women unable to provide informed consent
- •Women with a multiple pregnancy
- •Women with a demised fetus or a CRL <41mm and >84mm
结局指标
主要结局
Feasibility of Screening Tool
时间窗: 11.3-13.6 weeks gestation
Implementation of the screening: To assess the feasibility, the investigators will judge success if the full screening process without deviation is completed for at least 90% of consented participants.
次要结局
- Acceptability of Screening Tool to Participants(11.3-13.6 weeks gestation)
- Accuracy of Screening(11.3-13.6 weeks gestation)
- Compliance with low dose ASA for screen positive participants.(16-36 weeks gestation)