Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound (FetUS)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Arthrogryposis Multiplex Congenita (AMC)

Treatments: Diagnostic Test: ultrasound muscle imaging technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06130592

38RC21.0423

Details and patient eligibility

About

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

Full 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

Enrollment: 230 estimated patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

high risk of Arthrogryposis AMC

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: ultrasound muscle imaging technique

low risk of Arthrogryposis AMC

Active Comparator group

Description:

Patient coming for screening ultrasound

Treatment:

Diagnostic Test: ultrasound muscle imaging technique