NCT04584281|UnknownDMC
Artificial Intelligence (AI) in Cardiotocography (CTG) Interpretation
Introduction of Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use
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Introduction of Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use
Sponsor study identifier
observational
15,000
1 country
1
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The project leaders plan to create a clinical decision support (CDS) system by programming a self-learning software to analyze the cardiotocography (CTG) traces in the - already existing - database from the maternity department of the Inselspital Berne. The project leaders will process and analyze all clinical outcomes of the estimated 10000-15000 eligible patient records. CSEM will design, develop, and validate several AI architectures with the intend to create the CDS system. The AI would learn to assist on this task by training machine learning (ML) algorithms. The main purpose of the AI-CDS will be to determine the best fetal extraction moment during labor, based on a self-learning approach, as a "superhuman" support tool for obstetricians in decision making during labor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2020
Actual (reported)October 12, 2020
Actual (reported)June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Superior prediction of fetal morbidity through the self-learning CDS system than if performed by obstetricians alone, especially in regards to specificity.
3 months
Patients with singleton pregnancies and CTG-registrations during labour from 01.01.2006 to 31.12.2019
Frauenklinik Inselspital Bern
Bern, 3010, Switzerland
First Submitted
October 5, 2020
First Posted
October 12, 2020
Study Start
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2021
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 12, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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