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临床试验/CTRI/2021/12/038654
CTRI/2021/12/038654尚未招募不适用

DATA ACQUISITION STUDY FOR DEVELOPING AI (Artificial Intelligence) ALGORITHMS TO PREDICT PRETERM LABOR AND ADVERSE PERINATAL OUTCOME

Philips Research1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年12月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
试验地点
1
主要终点
Primary outcome that the study intends to predict is preterm labour, delivery and the related adverse perinatal outcome. Using the acquired data from relevant clinical details, lab and imaging data, as well as regularly performed NSTs – It is intended to develop a predictive AI model in order to predict the occurrence of preterm labour, delivery and the related adverse perinatal outcome. Study aims to develop as well as test the accuracy of such a predictive AI model in terms of sensitivity, specificity, positive and negative predictive value.

研究概览

简要总结

This study aims to acquire data from around 1500 unselected pregnant women attending antenetal OPD in a tertiary care referral center in South India (single center). Data acquired includes risk factors from history, examination, blood/urine reports, Ultrasound reports - all relevant to prediction of preterm labour. In addition, regularly performed Non-stress tests and uterine activity monitoring are digitally captured during their antenatal visits at or beyond 26 weeks of pregnancy. Once data is collected, study aims to develop and test Artificial Intelligence Algorithms to predict preterm labour in obstetric population.

Preterm labour/delivery (PTL/PTD) is a major health burden and contributes significantly to perinatal mortality/morbidity as well as long term health problems in the children. With a worldwide prevalence of 5-18%, it is an urgent need to predict and prevent preterm delivery. Multiple individual risk factors and risk scoring algorithms have been developed to predict PTL/PTD but none have reached a level of accuracy to be able to be employ in general obstetric practice. In addition, over half of PTD occur in women with no apparent risk factors. Complex interplay of risk factors is also a well-known phenomenon – which is difficult to be interpreted during routine obstetric practice. Hence this study aims to see if incorporating all these multiple risk factors in addition to periodic observation of fetal heart rate/uterine activity patterns – into an AI tool – to see if we can develop a prediction model for preterm delivery that has a better prediction value than the multiple existing risk factors/risk scoring systems. A large data set on fetal heart rate pattern along with uterine activity has not so far been studied by an AI algorithm in an attempt to predict preterm delivery. Also, incorporating multiple clinical, laboratory, imaging parameters to fetal heart+uterine activity patterns may help us develop a more robust tool to predict PTL/PTD - this information is not available in clinical literature. An accurate prediction may help employ preventive interventions in a suitable subset of vulnerable pregnant women in order to prevent PTL/PTD.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.Adult (>18 years) pregnant women (from 26th week of gestation), who have regular antenatal care at Department of OBG, KMC Manipal, willing and able to provide informed consent.

排除标准

  • 1.Pregnant women aged < 18 years.
  • 2.Women admitted to labour room/HDU/ICU due to obstetric/non-obstetric problem 3.Women in need of emergency management 4.Critical non-pregnancy related health issues (Road traffic accidents etc.) 5.Currently displaying COVID-19-related symptoms, namely fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days.

结局指标

主要结局

Primary outcome that the study intends to predict is preterm labour, delivery and the related adverse perinatal outcome. Using the acquired data from relevant clinical details, lab and imaging data, as well as regularly performed NSTs – It is intended to develop a predictive AI model in order to predict the occurrence of preterm labour, delivery and the related adverse perinatal outcome. Study aims to develop as well as test the accuracy of such a predictive AI model in terms of sensitivity, specificity, positive and negative predictive value.

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other [Corporate Research]

研究点 (1)

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