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Artificial Intelligence (AI) in Cardiotocography (CTG) Interpretation

Conditions
To Introduce Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use
Registration Number
NCT04584281
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
15000
Inclusion Criteria
  • CTG-registrations of patients with singleton pregnancies during labour from 01.01.2006 to 31.12.2019
  • Gestational age ≥ 24+0 weeks
  • Age ≥ 18 years
  • Written informed consent
Exclusion Criteria
  • Documented refusal
  • Multiple pregnancies
  • CTG-registrations of planned caesarean sections

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Superior prediction of fetal morbidity through the self-learning CDS system than if performed by obstetricians alone, especially in regards to specificity.3 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Frauenklinik Inselspital Bern

🇨🇭

Bern, Switzerland

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