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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women between 24-42 weeks of gestation | No interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic biases | The secondary objective is to investigate whether the deep learning models show any demographic biases when estimating fetal growth in clinical practice. This is assessed by comparing the accuracy of the Hadlock formula and the deep learning models against the fetal weight at the time of the scan, which is estimated from the birth weight using the Marsal growth curve. | From enrollment to the birth of the child |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women between 24-42 weeks of gestation.
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Department of Prenatal Examinations at Rigshospitalet, Copenhagen, Denmark.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169958 | Background | 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. |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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