Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity Hospital, Grenoble
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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").
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ultrasound muscle imaging technique
Diagnostic testultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: high risk of Arthrogryposis AMCActive comparator 1 intervention
Group B: low risk of Arthrogryposis AMCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
72 hours +/- 24 hoursSecondary outcomes
1
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
Time frame
72 hours +/- 24 hours2
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)
Time frame
72 hours +/- 24 hours3
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
Time frame
72 hours +/- 24 hours4
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
Time frame
72 hours +/- 24 hoursSponsors and contacts
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Source ClinicalTrials.gov