Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound Screening of Congenital Multiple Arthrogryposis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 主要终点
- Rate of achievement (success) of all four sections at the extremities
研究概览
简要总结
The objective of the study is to evaluate the performance of muscle ultrasound sections on antenatal ultrasound between 21-24 amenorrhea weeks for the screening of muscle atrophy, in a sample of low-risk and high-risk pregnancies of congenital multiple arthrogryposis
详细描述
Frequent rare diseases (100-200 births in France / year), congenital multiple arthrogryposis include a set of pathologies characterized by the limitation of joint movements at least two joint levels.Their functional prognosis and muscle atrophy are often severe after birth.
Routine ultrasound call signs are either non-specific or insensitive and difficult to detect due to time constraints. Antenatal ultrasound screening is not very effective for these pathologies, which are often particularly serious.
The main criterion will be the success rate of realization of all four ultrasound sections at the extremities (deltoide, biceps, quadriceps, triceps) and measurements of the distances "skin - muscle fascia" and "muscular fascia - periosteum" between 21-24 amenorrhea weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any pregnant woman consulting in one of the two obstetric gynecology departments in connection with the CPDPN (Multidisciplinary Prenatal Diagnostic Centers) of the University hospitals of Lyon or Grenoble.
- •Mono-embryonic pregnancy.
- •Gestational ages retained on the first dating ultrasound or the 1st trimester ultrasound between 21-24 amenorrhea weeks.
- •For women at "high risk": diagnosis during ultrasound of the 1st, 2nd, or 3rd trimesters, of an abnormality of position / deformation of one or more joints, and / or an abnormality of fetal movements on screening ultrasound or interrogation (population group at "high risk of AMC").
- •Regulatory criteria: adults, affiliated to a social security scheme, having signed a consent
排除标准
- •Multiple pregnancies, and / or non-progressive .
- •Obese women (BMI > 30 in early pregnancy)
- •Subject in a period of exclusion from another study
- •Subject under administrative or judicial supervision
- •Subject who cannot be contacted in case of emergency
结局指标
主要结局
Rate of achievement (success) of all four sections at the extremities
时间窗: 72 hours +/- 24 hours
Rate of achievement (success) of all four sections at the extremities for measurements (in mm) of the distances "skin - muscular aponeurosis" and "muscular aponeurosis- periosteum" between 21-24 amenorrhea weeks
次要结局
- Rate of achievement (success) of each four sections(72 hours +/- 24 hours)
- Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients(72 hours +/- 24 hours)
- Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively(72 hours +/- 24 hours)
- Collect the raisons for the failure of achievement of all sections(72 hours +/- 24 hours)
- Duration of realization of the ultrasound sections(72 hours +/- 24 hours)