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临床试验/NCT04794855
NCT04794855Enrolling By Invitation不适用

Study of the Risk Prediction Model of Preeclampsia

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,000
试验地点
1
主要终点
preeclampsia

研究概览

简要总结

Preeclampsia is the main cause of increased maternal and perinatal mortality during pregnancy. Preeclampsia is mainly manifested as hypertension, urine protein, or damage symptoms of other target organs after 20 weeks of pregnancy. In preeclampsia high-risk group, early intervention and prevention of aspirin treatment can reduce preeclampsia or reduce its complications. Some serological biomarkers, such as placental protein 13 and placental growth factor, are closely related to preeclampsia. The clinical manifestations of preeclampsia are diverse, and the biomarkers distribution of early and late preeclampsia is also different. Multivariate models will be the trend for the prediction of risk of preeclampsia. The deep learning model can train the algorithm layer by layer by unsupervised learning method, and then use the supervised back propagation algorithm for tuning. It has strong capability and flexibility, and has been successfully applied in medical fields, such as the diagnosis of skin cancer.

In this study, maternal clinical data, routine laboratory indicators and biological markers in early pregnancy will be combined, and a deep learning method based on multiple models will be adopted to establish a risk prediction model for early preeclampsia, so as to improve the clinical ability for early diagnosis of preeclampsia. The deep learning method reduces the number of parameters by using spatial relative relation, which can improve the prediction ability of the model. Multi-model method is a less commonly used modeling method, and the models established by this method generally have better stability.

This project combines the above two methods to establish a risk prediction model for preeclampsia, and the research is of great significance.

详细描述

Research objects:

This is a prospective study. About 2000 pregnant women who will take regular prenatal examination in the Department of Obstetrics, Peking University Third Hospital. During 6-8 weeks of gestation, routine laboratory tests, such as liver function, were required before the establishment of obstetric records. The remain serum from routine laboratory tests will be collected and frozen at -80℃ for detection of biological markers after delivery.

Some routine laboratory tests will be carried out with the prenatal examination at 16-18 GWs、26-28 GWs、30-34GWs. The remain serum of the participants will be collected if the routine tests were done.

We will not draw extra blood samples from the participants.

Quality assurance plan:

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
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 20-50 years old, primiparas or postparturas,
  • and undergoing prenatal examination in Peking University Third Hospital ;
  • and deliver live fetuses or stillborn fetuses with normal appearance after 24 weeks.

排除标准

  • The pregant woman has tumor ,
  • or has severe fetal abnormality,
  • or terminates the pregnancy before 24 weeks,
  • or the fetus dies.

结局指标

主要结局

preeclampsia

时间窗: pregnancy after 20 getational weeks

Pre-eclampsia is defined as new hypertension (blood pressure of 140/90 mmHg) with proteinuria (300 mg/24 h) at or after 20 gestational weeks of pregnancy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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