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| Name | Class |
|---|---|
| Department of Computer Science, University of Copenhagen, Denmark | UNKNOWN |
| Technical University of Denmark | OTHER |
| Sundhedsdonationer | UNKNOWN |
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This study prospectively evaluates whether the performance of an already-developed artificial intelligence (AI) model for predicting spontaneous preterm birth changes when cervical ultrasound images are obtained using different ultrasound image settings.
The primary research question is whether the AI model performs differently across images acquired with different imaging settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women attending routine second-trimester scan | Pregnant women aged ≥18 years attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol/workflow). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ultrasound image acquisition | Other | Acquisition of cervical ultrasound images with variation in image acquisition parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth <37+0 weeks | Birth <37+0 weeks after spontaneous onset of labor (with or without preterm prelabor rupture of membranes [PPROM]), regardless of mode of delivery, and excluding medically indicated (iatrogenic) preterm births without spontaneous onset. | At delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth <34+0 and <32+0 weeks | At delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Any preterm birth (including medically indicated) | At delivery. | |
| Time-to-delivery from scan | From second-trimester scan until delivery. |
Inclusion Criteria:
Exclusion Criteria:
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Pregnant women attending routine second-trimester scan at Rigshospitalet from March to September, 2026.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Pi F Sejer, MD | Contact | 0045 28890690 | emilie.pi.fogtmann.sejer.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Martin G Tolsgaard, MD, PhD, DMSc | Department of Obstetrics and Gynecology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Copenhagen Univeristy Hospital | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |