Influence of Imaging Angle in Measurement of Cisterna Magna
赞助:
Hospital Universitario Dr. Jose E. Gonzalez
合作者:
信息的提供 (责任方):
Flavio Hernández Castro，Hospital Universitario Dr. Jose E. Gonzalez
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 15, 2018 | ||
| 预计主要完成日期 | October 15, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Cisterna Magna length[ Time Frame: 24 hours ] The length measurement on the CM with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements of the anteroposterior diameter Will be obtained along straight lines between the posterior border of the cerebellar vermis and the internal face of the occipital bone. |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Influence of Imaging Angle in Measurement of Cisterna Magna | ||
| 正式标题 ICMJE | Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester | ||
| 简要概况 | The aim of this study is to determine the effect of imaging angle on the measurement of fetal cisterna magna (CM) in the second trimester. Fetal CM will be prospectively measured in women at 18-24.6 weeks' gestation. Measurements will be made on different angles between the transducer and fetal cerebellar axial plane with internal landmarks. Design: Observative, cross sectional |
||
| 详细说明 | Patients and methods: 94 women with low risk single pregnancy will be studied. Fetuses with multiple pregnancies, maternal chronic disease and severe congenital anomalies except mega cisterna magna (MCM) will be excluded from the study. Measurements will be performed on the axial cerebellar plane.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone. The primary outcome variables will be cisterna magna length measured on different angles between the transducer and the axial cerebellar plane of the fetal head. Cisterna magna length measurement related to fetal presentation and gender will be secondary outcomes. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
94 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 15, 2019 | ||
| 预计主要完成日期 | October 15, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Pregnant women between the 18th and 24th weeks. - Confirmed gestational age by regular menstrual cycle or determined from crown- rump length at first trimester ultrasonography for those with unknown menstruation date . Exclusion Criteria: - Uncertain gestational age - Twin or multiple pregnancy. - Increased risk for aneuploidy determined by first trimester screening. - Absence of intracranial translucency in first trimester ultrasound examination. - Fetal malformations identified EXCEPT megacisterna magna. - Karyotype anomaly. - Chronic maternal diseases such as arterial hypertension, diabetes mellitus, hypothyroidism and hyperthyroidism. - Failure to obtain accurate measurement for technical reasons. | ||
| 性别 |
|
||
| 年龄 | 最小年龄：N/A ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Mexico | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | Flavio Hernández Castro，Hospital Universitario Dr. Jose E. Gonzalez | ||
| 研究赞助商 ICMJE | Hospital Universitario Dr. Jose E. Gonzalez | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | Hospital Universitario Dr. Jose E. Gonzalez | ||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号