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.

NCT06314178 | Completed

• 1 other identifier: p-2024-15469
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Comparing the accuracy of the Hadlock formula and the AI model

  The primary objective is to compare the accuracy of fetal weight estimation between the Hadlock formula and two deep learning models in clinical practice

  From enrollment to the birth of the child

Secondary Outcomes (1)

• Demographic biases

  From enrollment to the birth of the child

Study Arms (1)

Pregnant women between 24-42 weeks of gestation

No interventions

Eligibility Criteria

• Gender Eligibility Details: Pregnant women between 24-42 weeks of gestation.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Prenatal Examinations at Rigshospitalet, Copenhagen, Denmark.

You may qualify if:

• Women with gestational age between 24-42 weeks undergoing a third-trimester growth scan.

You may not qualify if:

• Women with multiple pregnancies.

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Salomon LJ, Alfirevic Z, Da Silva Costa F, Deter RL, Figueras F, Ghi T, Glanc P, Khalil A, Lee W, Napolitano R, Papageorghiou A, Sotiriadis A, Stirnemann J, Toi A, Yeo G. ISUOG Practice Guidelines: ultrasound assessment of fetal biometry and growth. Ultrasound Obstet Gynecol. 2019 Jun;53(6):715-723. doi: 10.1002/uog.20272.

  PMID: 31169958 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: July 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

DK (1)