超声肌肉成像在产前超声检查中的技术可行性研究 (FetUS)
超声肌肉成像产前超声筛查先天性多发性关节弯曲的技术可行性研究
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
研究概览
详细说明
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
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lora PEJOT, Midwife
- 电话号码：0476766561
- 邮箱：lpejot@chu-grenoble.fr
学习地点
-
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Isère
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La Tronche、Isère、法国、38700
- 招聘中
- university hospital of Grenoble
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接触：
- Lora Pejot, midwife CRA
- 电话号码：+33 (0)4 76 76 65 61
- 邮箱：lpejot@chu-grenoble.fr
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接触：
- Caroline Tournegros, CRA
- 电话号码：+33 (0)4 76 76 72 30
- 邮箱：CTournegros@chu-grenoble.fr
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首席研究员：
- Christine Ravier, Midwife
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Rhone
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Bron、Rhone、法国、69677
- 招聘中
- Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant
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接触：
- Mathilde Vermont, CRA
- 邮箱：mathilde.vermont@chu-lyon.fr
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接触：
- Jérôme Massardier, MD
- 邮箱：jerome.massardier@chu-lyon.fr
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首席研究员：
- jérome Massardier, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：high risk of Arthrogryposis AMC
Patient with a diagnosis during the 1st, 2nd, or 3rd trimester ultrasound, of an abnormality of position / deformation of one or more joints, and / or an abnormality of fetal movements at screening ultrasound or interrogation |
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis |
|
有源比较器：low risk of Arthrogryposis AMC
Patient coming for screening ultrasound |
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of achievement (success) of all four sections at the extremities
大体时间：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 |
72 hours +/- 24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of achievement (success) of each four sections
大体时间：72 hours +/- 24 hours
|
Rate of achievement (success) of measurements (in mm) of the distances "skin - muscular aponeurosis" and "muscular aponeurosis- periosteum" between 21-24 amenorrhea weeks for biceps, deltoide, quadriceps and sural triceps |
72 hours +/- 24 hours
|
|
Collect the raisons for the failure of achievement of all sections
大体时间：72 hours +/- 24 hours
|
Collect the raisons for the failure of achievement of all sections (Inadequate foetal position,Insufficient echogenicity, Reasons related to the position of the limbs (full extension or flexion of the elbows or knees, abduction of the shoulder, other), other raison (to be specified) |
72 hours +/- 24 hours
|
|
Duration of realization of the ultrasound sections
大体时间：72 hours +/- 24 hours
|
Duration of realization of the ultrasound sections (investigators make an hypotheses of a duration of 3 minutes necessary for the realization of the sections |
72 hours +/- 24 hours
|
|
Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
大体时间：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
大体时间：72 hours +/- 24 hours
|
Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively by dividing by half the high-risk pregnancies, to whom it will be proposed a 2nd ultrasound of the 2nd trimester, within 3 days (±24) hours by the same / another referent sonographer in the same center. A group of 30 low-risk pregnancies will be evaluated in the same way, with the study of intra-observer reproducibility in 15. The sample of 30 pregnancies in which two measurements are made makes it possible to obtain a lower bound of the 95% confidence interval of the intra-class correlation coefficient greater than 0.7, if this coefficient is 0.85 or more. This threshold is usually considered to reflect a satisfactory concordance. |
72 hours +/- 24 hours
|
合作者和调查者
调查人员
- 首席研究员：Klaus DIETERICH, MD,PhD、Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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