Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound
- Conditions
- Arthrogryposis Multiplex Congenita (AMC)
- Interventions
- Diagnostic Test: ultrasound muscle imaging technique
- Registration Number
- NCT06130592
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 230
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high risk of Arthrogryposis AMC ultrasound muscle imaging technique 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 low risk of Arthrogryposis AMC ultrasound muscle imaging technique Patient coming for screening ultrasound
- Primary Outcome Measures
Name Time Method Rate of achievement (success) of all four sections at the extremities 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
- Secondary Outcome Measures
Name Time Method Rate of achievement (success) of each four sections 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
Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients 72 hours +/- 24 hours Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively 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.
Collect the raisons for the failure of achievement of all sections 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)
Duration of realization of the ultrasound sections 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