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

Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound Screening of Congenital Multiple Arthrogryposis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arthrogryposis Multiplex Congenita (AMC)
• Intervention / Treatment: Diagnostic test: ultrasound muscle imaging technique

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

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lora PEJOT, Midwife; Phone Number: 0476766561; Email: lpejot@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Diagnostic test: ultrasound muscle imaging technique; ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis
Active Comparator: low risk of Arthrogryposis AMC; Patient coming for screening ultrasound	Diagnostic test: ultrasound muscle imaging technique; ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours +/- 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours +/- 24 hours
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)	72 hours +/- 24 hours
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	72 hours +/- 24 hours
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	72 hours +/- 24 hours
Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Klaus DIETERICH, MD,PhD, Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Arthrogryposis
• Other Study ID Numbers: 38RC21.0423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No