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

Fetal Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399979
• Other study ID #: 1567908
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: May 5, 2022

Study information

• Verified date: June 2022
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Fetal Bradycardia

Intervention

Procedure:
• Labor Neuraxial Analgesia
Labor Neuraxial Analgesia

Locations

Country	Name	City	State
United States	Augusta University Medical Center	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal bradycardia	fetal heart rate under 120 lpm for more than 10 minutes	15 minutes