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临床试验/NCT05399979
NCT05399979已完成不适用

Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

Augusta University1 个研究点 分布在 1 个国家目标入组 1,077 人开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,077
试验地点
1
主要终点
fetal bradycardia

研究概览

简要总结

This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods

详细描述

Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Older than 18 years
  • Pregnancy requiring labor analgesia
  • Active labor
  • Request of neuraxial analgesia per patient and/or obstetrician
  • Received combined spinal-epidural technique

排除标准

  • Uterine tachysystole before neuraxial analgesia.
  • Baseline blood pressure <90/60 mmHg.
  • Third trimester hemorrhage
  • Eclampsia
  • Allergies to local anesthetics or fentanyl.
  • Maternal fever.
  • Pruritus before performance of neuraxial analgesia

结局指标

主要结局

fetal bradycardia

时间窗: 15 minutes

fetal heart rate under 120 lpm for more than 10 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Efrain Riveros Perez, MD

Principal Investigator

Augusta University

研究点 (1)

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