Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester
Clinical Validation of an Artificial Intelligence System for Determining Fetal Lie and Position in 3rd Trimester
연구 개요
상세 설명
Accurate assessment of fetal lie and presentation during the third trimester is essential for obstetric management and delivery planning. Ultrasound is the gold standard for determining fetal orientation; however, the examination is highly operator-dependent and requires considerable experience to correctly identify fetal anatomy and orientation. Artificial intelligence (AI)-based navigational support systems have the potential to assist clinicians by providing real-time guidance during ultrasound examinations and improving the consistency of fetal orientation assessment.
The purpose of this study is to prospectively validate an AI-based navigational support system for determining fetal lie and presentation during routine third-trimester ultrasound examinations. The system analyzes blind ultrasound sweeps acquired along the maternal midline and automatically predicts fetal lie and presentation. AI-generated predictions will be compared with expert clinician assessment, which serves as the reference standard.
Eligible pregnant women attending third-trimester ultrasound examinations at the Fetal Medicine Department, Rigshospitalet, Slagelse - or Hillerød hospital, will be invited to participate. Following written informed consent, an expert clinician will first determine fetal lie and presentation as part of the routine ultrasound examination. The same clinician will subsequently acquire three blind ultrasound sweeps along the maternal midline. The AI navigational support system will analyze each sweep and generate predictions of fetal lie and presentation. All examinations will be completed within 5-10 minutes to minimize changes in fetal orientation between the clinical assessment and AI evaluation.
The primary objective is to evaluate the diagnostic performance of the AI system by comparing AI-generated predictions with expert clinician assessment. Primary outcome measures include overall diagnostic accuracy and agreement,
These findings will provide additional insight into the feasibility of implementing AI-assisted navigational support in routine obstetric ultrasound practice.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mary Le Ngo, MD, MD
- 전화번호: +45 20773779
- 이메일: mary.van.anh.le.ngo.01@regionh.dk
연구 장소
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Slagelse, 덴마크, 3450
- 아직 모집하지 않음
- Slagelse Hospital, Department of Obstetrics and Gynecology
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연락하다:
- Kathinka Nyborg, MD
- 전화번호: 20773779
- 이메일: kany@regionsjaelland.dk
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Capital Region
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Hillerød, Capital Region, 덴마크, 3400
- 아직 모집하지 않음
- Nordsjællands Hospital, Department of Obstetrics and Gynecology
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연락하다:
- Gitte Hedermann, Associate Professor
- 전화번호: +2520773779
- 이메일: gitte.hedermann.christensen@regionh.dk
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København Ø
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Copenhagen, København Ø, 덴마크, 2100
- 모병
- Rigshospitalet - Department of Obstetrics and Gynecology
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연락하다:
- Martin Tolsgaard, professor,, Medical doctor, Ph.D
- 전화번호: +4520773779
- 이메일: martin.groennebaek.tolsgaard@regionh.dk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pregnant women aged ≥18 years.
- Singleton pregnancy.
- Gestational age ≥28+0 weeks.
- Fetus in longitudinal lie (cephalic or breech presentation) as determined by the routine clinical ultrasound examination.
- Able to understand Danish or English.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Multiple pregnancy.
- Fetus in transverse lie.
- Inability to provide written informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Prospective Clinical Validation Cohort
Pregnant women with singleton pregnancies in the third trimester (≥28+0 weeks' gestation) undergoing obstetric ultrasound examination.
Participants undergo three blind ultrasound sweeps, and AI-generated predictions of fetal lie and presentation are compared with expert clinician assessment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Diagnostic accuracy of the AI navigational support system for determining fetal lie and presentation.
기간: During the study ultrasound examination (approximately 5 minutes).
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Overall proportion of correct AI predictions of fetal lie and presentation compared with expert clinician assessment (reference standard).
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During the study ultrasound examination (approximately 5 minutes).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Agreement between AI predictions and expert clinician assessment.
기간: During the study ultrasound examination.
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Agreement will be evaluated using Cohen's kappa coefficient.
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During the study ultrasound examination.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- P-2019-3101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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