Clinical trial NCT06130592: Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound
Official title: Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound Screening of Congenital Multiple Arthrogryposis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthrogryposis Multiplex Congenita (AMC)
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 230
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study prospective,randomized ,two groups (low risk of AMC vs hight risk of AMC), multicentre
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of achievement (success) of all four sections at the extremities
timeFrame: 72 hours +/- 24 hours
Secondary outcomes:
measure: Rate of achievement (success) of each four sections
timeFrame: 72 hours +/- 24 hours
measure: Collect the raisons for the failure of achievement of all sections
timeFrame: 72 hours +/- 24 hours
measure: Duration of realization of the ultrasound sections
timeFrame: 72 hours +/- 24 hours
measure: Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
timeFrame: 72 hours +/- 24 hours
measure: Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively
timeFrame: 72 hours +/- 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
name: Klaus DIETERICH, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: