Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
June 1, 2022 updated by: Efrain Riveros Perez, MD, Augusta University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1077
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30907
- Augusta University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
-Pregnant patients admitted to the labor and delivery unit of an academic center
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fetal bradycardia
Time Frame: 15 minutes
|
fetal heart rate under 120 lpm for more than 10 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Actual)
May 5, 2022
Study Completion (Actual)
May 5, 2022
Study Registration Dates
First Submitted
May 27, 2022
First Submitted That Met QC Criteria
May 27, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1567908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.