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Completed
NCT06314178
Comparing Artificial Intelligence and Standard Ultrasound Methods for Estimating Fetal Weight in Pregnancy. Patients Eligible for Inclusion Are Women With a Gestational Age Between 24-42 Weeks Undergoing a Growth Scan. The Image Data From the Scan Are Used to Calculate Fetal Weight.
Conditions: Pregnancy Complications
Sex: Female
Healthy volunteers: Yes
Enrollment: 283
Sponsor: Copenhagen Academy for Medical Education and Simulation
Location: Copenhagen University Hospital, Rigshospitalet Copenhagen
Summary
The primary aim of this observational study is to compare the accuracy of two artificial intelligence (AI) models with the traditional Hadlock formula for estimating fetal weight from ultrasound scans performed in pregnant women between 24 and 42 weeks of gestation. The secondary aim is to investigate potential demographic bias in the AI models. The demographic factors examined include body mass index (BMI), parity, gestational age, maternal age, fetal sex, and the presence of preeclampsia.
Participants' ultrasound scans will be pseudonymized and securely stored on password-protected removable drives to ensure the protection of their identity and privacy. The ultrasound data will subsequently be transferred to the Technical University of Denmark (DTU), where the AI models will analyze the images to estimate fetal weight.
Eligibility Criteria
Inclusion Criteria:
* Women with gestational age between 24-42 weeks undergoing a third-trimester growth scan.
Exclusion Criteria:
* Women with multiple pregnancies.
Source: ClinicalTrials.gov (NCT06314178). StuddyBuddy aggregates publicly available trial information.