SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Central readers of US and MRI images
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 45 years
- •With suspicion of a uterine septum on routine 2D TVUS
- •Who are willing to give informed consent
排除标准
- •Women aged below 18 years and over 45 years
- •Prior definitive diagnosis of a uterine septum or other congenital uterine anomaly
- •Prior surgery in relation to a uterine septum
- •Cervical (unilateral) aplasia
- •Vaginal aplasia
- •Untreated obstructive vaginal septum
- •Any co-morbidity that is found to interfere with the uterine measurements required in the study
- •Contraindications for MRI
- •Not willing or not possible to undergo transvaginal ultrasound
- •Pregnancy at the time of inclusion
- •Wish to conceive between inclusion and last diagnostic intervention
- •Visual or pathological evidence of cervical, uterine or ovarian malignancy
- •Patients with an intrauterine device (by mistake), who are not willing to remove this device before the start of the diagnostic interventions
研究组 & 干预措施
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
干预措施: Three-dimensional transvaginal ultrasound (Diagnostic Test)
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
干预措施: Three-dimensional transvaginal Gel Infusion Sonography (Diagnostic Test)
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
干预措施: Questionnaires (Other)
结局指标
主要结局
Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI
时间窗: Within 12 weeks after inclusion
次要结局
未报告次要终点