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Clinical Trials/NCT05738954
NCT05738954RecruitingNot Applicable

Pattern Recognition and Anomaly Detection in Fetal Morphology Using Deep Learning and Statistical Learning

University of Craiova1 site in 1 country4,000 target enrollmentStarted: May 4, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
4,000
Locations
1
Primary Endpoint
Signal congenital anomalies

Study Overview

Brief Summary

Congenital anomalies (CA) are the most encountered cause of fetal death, infant mortality and morbidity.7.9 million infants are born with CA yearly. Early detection of CA facilitates life-saving treatments and stops the progression of disabilities. CA can be diagnosed prenatally through Morphology Scan (MS). Discrepancies between pre and postnatal diagnosis of CA reach 29%. A correct interpretation of MS allows a detailed discussion regarding the prognosis with parents. The central feature of PARADISE is the development of a specialized intelligent system that embeds a committee of Deep Learning and Statistical Learning methods, which work together in a competitive/collaborative way to increase the performance of MS examinations by signaling CA. Using preclinical testing and clinical validation, the main goal will be the direct implementation into clinical practice. This multi-disciplinary project offers a unique integration of approaches, competences, breakthroughs in key applications in human, psychological, technological, and economical interest such as the 'smarter' healthcare system, opening new fields of research. PARADISE creates an environment that contributes significantly to the healthcare system, medical and pharma industries, scientific community, economy and ultimately to each individual. Its outcome will increase impact on the management of CA by enabling the establishment of detailed plans before birth, which will decrease morbidity and mortality in infants.

Detailed Description

Probe guidance: The IS guides the sonographer's probe for better acquisition of the fetal biometric plane - Basic scanning to be performed by non-expert(> 90% accuracy (AC)) Fetal biometric plane finder: The fetal planes are automatically detected, measured and stored - Insurance that all anatomical parts are checked (100% AC) Anomaly detection: unusual findings are signaled - Assistance in decision making (>90% AC)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Second trimester pregnant women

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Signal congenital anomalies

Time Frame: 32 months

Number of congetinal anomalies found in a fetus at the second trimester morphology scan

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Craiova
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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