Estudio de viabilidad técnica de imágenes musculares por ultrasonido en ecografía prenatal (FetUS)
Estudio de viabilidad técnica de imágenes musculares por ultrasonido en el cribado ecográfico prenatal de artrogriposis múltiple congénita
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lora PEJOT, Midwife
- Número de teléfono: 0476766561
- Correo electrónico: lpejot@chu-grenoble.fr
Ubicaciones de estudio
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Isère
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La Tronche, Isère, Francia, 38700
- Reclutamiento
- university hospital of Grenoble
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Contacto:
- Lora Pejot, midwife CRA
- Número de teléfono: +33 (0)4 76 76 65 61
- Correo electrónico: lpejot@chu-grenoble.fr
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Contacto:
- Caroline Tournegros, CRA
- Número de teléfono: +33 (0)4 76 76 72 30
- Correo electrónico: CTournegros@chu-grenoble.fr
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Investigador principal:
- Christine Ravier, Midwife
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Rhone
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Bron, Rhone, Francia, 69677
- Reclutamiento
- Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant
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Contacto:
- Mathilde Vermont, CRA
- Correo electrónico: mathilde.vermont@chu-lyon.fr
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Contacto:
- Jérôme Massardier, MD
- Correo electrónico: jerome.massardier@chu-lyon.fr
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Investigador principal:
- jérome Massardier, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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 |
|
Comparador activo: low risk of Arthrogryposis AMC
Patient coming for screening ultrasound |
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of achievement (success) of all four sections at the extremities
Periodo de tiempo: 72 hours +/- 24 hours
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of achievement (success) of each four sections
Periodo de tiempo: 72 hours +/- 24 hours
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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
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Collect the raisons for the failure of achievement of all sections
Periodo de tiempo: 72 hours +/- 24 hours
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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
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Duration of realization of the ultrasound sections
Periodo de tiempo: 72 hours +/- 24 hours
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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
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Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
Periodo de tiempo: 72 hours +/- 24 hours
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Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients |
72 hours +/- 24 hours
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Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively
Periodo de tiempo: 72 hours +/- 24 hours
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Klaus DIETERICH, MD,PhD, Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 38RC21.0423
Información sobre medicamentos y dispositivos, documentos del estudio
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