Fetal BradycardiaNCT05399979
Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
An observational study of Fetal Bradycardia, run by Augusta University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Bradycardia
- What is being tested?
- Labor Neuraxial Analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,077 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 5 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: -Pregnant patients admitted to the labor and delivery unit of an academic center
Who may be able to join
- Older than 18 years
- Pregnancy requiring labor analgesia
- Active labor
- Request of neuraxial analgesia per patient and/or obstetrician
- Received combined spinal-epidural technique
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University Medical Center
Augusta, Georgia, 30907
About this study
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
Read the 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.
- Conditions
- Fetal Bradycardia
- Being tested
- Labor Neuraxial Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor Neuraxial AnalgesiaProcedure or surgery
Labor Neuraxial Analgesia
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal bradycardia
fetal heart rate under 120 lpm for more than 10 minutes
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start9 Jun 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399979
- Sponsor's protocol ID
- 1567908
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
- ClinicalTrials.gov ID
- NCT05399979
- Acronym / sponsor ID
- 1567908
- Conditions
- Fetal Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- -Pregnant patients admitted to the labor and delivery unit of an academic center
Key inclusion criteria (5 listed)
- Older than 18 years
- Pregnancy requiring labor analgesia
- Active labor
- Request of neuraxial analgesia per patient and/or obstetrician
- Received combined spinal-epidural technique
Key exclusion criteria (7 listed)
- Uterine tachysystole before neuraxial analgesia.
- Baseline blood pressure <90/60 mmHg.
- Third trimester hemorrhage
- Eclampsia
- Allergies to local anesthetics or fentanyl.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor Neuraxial AnalgesiaLabor Neuraxial Analgesia | Procedure or surgery | – |
Primary outcome
fetal bradycardia
Time frame: 15 minutes
fetal heart rate under 120 lpm for more than 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Fetal Bradycardia
Not yet recruiting
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
Pruritis, Hypotension Drug-Induced
Recruiting
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)
Labor Pain
RecruitingPhase 4
Oxytocin and Fetal Heart Rate Changes
Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Bradycardia, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal bradycardia (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.