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OpenTrials
Completed

NCT Number: NCT05399979

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Augusta University Medical Center

Augusta, Georgia, 30907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Labor Neuraxial Analgesia

Procedure

Labor Neuraxial Analgesia

Primary outcomes

  1. fetal bradycardia

    Time frame: 15 minutes

    fetal heart rate under 120 lpm for more than 10 minutes

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2022
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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