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

• Sponsor: Augusta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05399979
• Collaborator: (none)
• Enrollment: 1,077
• Location: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 99.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Fetal Bradycardia	Procedure: Labor Neuraxial Analgesia

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1077 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
• Actual Study Start Date: Jun 9, 2021
• Actual Primary Completion Date: May 5, 2022
• Actual Study Completion Date: May 5, 2022

Outcome Measures

Primary Outcome Measures

1. fetal bradycardia [15 minutes]

   fetal heart rate under 120 lpm for more than 10 minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augusta University Medical Center	Augusta	Georgia	United States	30907

Sponsors and Collaborators

• Augusta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Efrain Riveros Perez, MD, Principal Investigator, Augusta University
• ClinicalTrials.gov Identifier: NCT05399979
• Other Study ID Numbers: 1567908
• First Posted: Jun 1, 2022
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bradycardia

Study Results

No Results Posted as of Jun 3, 2022