Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| T002825N | Other Grant/Funding Number | FWO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek) | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate the added value of three-dimensional transvaginal ultrasound (3D TVUS) and gel infusion sonography (3D GIS) for diagnosing a partition in the uterus (uterine septum) in comparison to magnetic resonance imaging (MRI). The main question it aims to answer is:
How well do 3D TVUS and 3D GIS detect a uterine septum compared to MRI?
Participants will receive 3D TVUS/ 3D GIS and MRI, and will complete questionnaires.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound | Experimental | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | MRI of the pelvis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI | Within 12 weeks after inclusion |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura D'hoore, MD | Contact | 0032 9 332 07 58 | septum@uzgent.be |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Recruiting | Ghent | 9000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Central readers of US and MRI images
Not provided
| Three-dimensional transvaginal ultrasound | Diagnostic Test | Three-dimensional transvaginal ultrasound |
|
| Three-dimensional transvaginal Gel Infusion Sonography | Diagnostic Test | Three-dimensional transvaginal Gel Infusion Sonography |
|
| Questionnaires | Other | Questionnaires |
|
| ID | Term |
|---|---|
| D000093665 | Septate Uterus |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000093662 | Uterine Duplication Anomalies |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided