跳至主要内容
临床试验/CTRI/2021/05/033674
CTRI/2021/05/033674尚未招募不适用

Validation of Artificial Intelligence based Software in prediction of fetal distress

Janitri Innovations Pvt Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
The prediction will help us in categorizing a patient with fetal distress,

研究概览

简要总结

Background: Fetal distress is also known as an emergency pregnancy, labor, and delivery complication where a baby experiences oxygen deprivation. Decreased fetal movement in the womb and an abnormal fetal heart rate, abnormal amniotic fluid levels, abnormal results of biophysical profile, insufficient or excessive maternal weight gain are few signs of fetal distress. Fetal distress increases the concern of the obstetrician about the fetal condition and can help in an immediate intervention like cesarean section or instrumental vaginal delivery in order to prevent fetal death.

Objectives: The Main aim of this study is to validate the Artificial Intelligence based Software for prediction of fetal distress.

Methods:  This is a Prospective observational study. Pregnant women will be admitted for delivery in the labor unit of Bharati Vidyapeeth Deemed University Medical College, Pune, who are willing to participate in the study. Singleton pregnancy with an estimated gestational age of more than 28 weeks will be included. Informed consent will be obtained from the patients willing to participate in the study and those satisfying the inclusion criteria.  The accuracy of prediction of fetal distress cases will be done by using a fetal monitoring device that provides a digitized data for FHR and UC directly or indirectly to the  “DAKSH†application/ dashboard from which the application will categorize the cases into 3 classes.

Expected Outcomes:

  1. The prediction will help us in categorizing a patient with potential fetal distress, hereby helping the doctor in taking a faster-informed decision.
  2. The outcome will also be able to help in improving the accuracy of the predictive model

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Singleton​ pregnancy with an estimated gestational age of more than 32 weeks.

排除标准

  • Multiple pregnancies and Gestational age less than 32 weeks.​.

结局指标

主要结局

The prediction will help us in categorizing a patient with fetal distress,

时间窗: 1 years

hereby helping the doctor in taking a faster-informed decision.

时间窗: 1 years

次要结局

  • The outcome will also be able to help in improving the accuracy of the predictive model .(If the prediction is accurate, then FHR monitoring at remote places with)

研究者

发起方
Janitri Innovations Pvt Ltd
申办方类型
Other [Private Limited Company]

研究点 (1)

Loading locations...

相似试验