Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
1 other identifier
observational
1,077
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedJune 3, 2022
June 1, 2022
11 months
May 27, 2022
June 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
fetal bradycardia
fetal heart rate under 120 lpm for more than 10 minutes
15 minutes
Interventions
Labor Neuraxial Analgesia
Eligibility Criteria
-Pregnant patients admitted to the labor and delivery unit of an academic center
You may qualify if:
- Older than 18 years
- Pregnancy requiring labor analgesia
- Active labor
- Request of neuraxial analgesia per patient and/or obstetrician
- Received combined spinal-epidural technique
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Augusta University Medical Center
Augusta, Georgia, 30907, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
June 9, 2021
Primary Completion
May 5, 2022
Study Completion
May 5, 2022
Last Updated
June 3, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share