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临床试验/NCT05785338
NCT05785338已完成不适用

Diagnosis of Fetal Isolated Cleft Palate Using Assessment of the Posterior Hard Palate Angle

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Rate of cleft palate without cleft lip

研究概览

简要总结

The aim of this retrospective longitudinal study was to describe a key factor in the prenatal diagnosis of isolated cleft palate on the axial transverse view, in order to provide better understanding, detection and diagnosis of this anomaly.

详细描述

Objective

The study aims to evaluate the role of the posterior hard palate angle in the prenatal diagnosis of cleft palate.

Methods: Stored images of the axial transverse view of the fetal secondary palate, obtained at three-level ultrasounds, were used to evaluate the posterior border of the hard palate. The investigators studied the visualization of the posterior nasal spine and the presence of a gap within the hard palate. The investigators also assessed the posterior angle of the hard palate, formed by the posterior borders of the palatine bones next to the most posterior middle point of the palatine bone. The study population comprised 65 consecutive pregnancies of unaffected cases and 17 pregnancies with 24 assessments at different time points, suspected for a cleft palate without cleft lip, including 7 cases of cleft palate, 4 cases of high arched palate and 6 false positive cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • all patients suspected for a cleft palate without cleft lip referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January
  • Exclusion Criteria for the control group:
  • major congenital anomalies or chromosomal aberration,
  • premature rupture of the membranes,
  • fetal demise,
  • patients aged under 18 years.
  • If the available images did not allow the evaluation of the hard palate, the case was excluded from further consideration.

排除标准

  • 未提供

结局指标

主要结局

Rate of cleft palate without cleft lip

时间窗: derivery

Presence of cleft palate without cleft lip in postnatal exam

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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