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临床试验/NCT03671863
NCT03671863已完成不适用

Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2014年1月1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
219
试验地点
1
主要终点
Antenatal detection rate of clubfeet

研究概览

简要总结

Clubfoot is one of the most common birth defects, with a prevalence in Europe estimated between 1 and 4.5 for 1000 live birth.

It is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). For the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality.

In those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself.

In case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with CGH array is a consensual attitude.

What the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. Thus, the management of these patients may vary from one CPDP to another.

This study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.

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
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Antenatal detection rate of clubfeet

时间窗: At birth

Antenatal detection rate of clubfeet in percentage

次要结局

  • Rate of consultation with geneticist(At birth)
  • Rate of consultation with a orthopedic surgeon(At birth)
  • Rate of isolated clubfoot among children followed for clubfoot(At birth)
  • Rate of refered for second-degree examination(At birth)
  • Rate of invasive samples taken and their results(At birth)
  • Rate of files submitted to our reference center committee(At birth)
  • Research rates of musculoskeletal genetic disease(At birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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