Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound Screening of Congenital Multiple Arthrogryposis

Conditions
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Arthrogryposis Multiplex Congenita (AMC)

Intervention / Treatment
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* Diagnostic Test: ultrasound muscle imaging technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: study prospective,randomized ,two groups (low risk of AMC vs hight risk of AMC), multicentre
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high risk of Arthrogryposis AMC<br>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 | Diagnostic Test: ultrasound muscle imaging technique<br>* ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis<br>|
| Active Comparator: low risk of Arthrogryposis AMC<br>Patient coming for screening ultrasound | Diagnostic Test: ultrasound muscle imaging technique<br>* ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of achievement (success) of all four sections at the extremities | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of achievement (success) of each four sections | 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 | 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 | 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 | 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 | 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 |