Arthrogryposis Multiplex Congenita (AMC)FetUSNCT06130592
Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound
A study testing ultrasound muscle imaging technique in people with Arthrogryposis Multiplex Congenita (AMC), run by University Hospital, Grenoble at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthrogryposis Multiplex Congenita (AMC)
- What is being tested?
- ultrasound muscle imaging technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesFrance
- Study dates
- 12 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant
Bron, Rhone, 69677
Mathilde Vermont, CRA, mathilde.vermont@chu-lyon.fr
Jérôme Massardier, MD, jerome.massardier@chu-lyon.fr
- Recruiting
university hospital of Grenoble
La Tronche, Isère, 38700
Lora Pejot, midwife CRA, +33 (0)4 76 76 65 61, lpejot@chu-grenoble.fr
Caroline Tournegros, CRA, +33 (0)4 76 76 72 30, CTournegros@chu-grenoble.fr
About this study
Official title: 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
Read the 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
- Conditions
- Arthrogryposis Multiplex Congenita (AMC)
- Being tested
- ultrasound muscle imaging technique
- Medical subject headings
- Arthrogryposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound muscle imaging techniqueDiagnostic test
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis
| Study group | Role | What they receive |
|---|---|---|
| high risk of Arthrogryposis AMC | Active comparator | 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 Receives: Diagnostic Test: ultrasound muscle imaging technique |
| low risk of Arthrogryposis AMC | Active comparator | Patient coming for screening ultrasound Receives: Diagnostic Test: ultrasound muscle imaging technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours +/- 24 hours
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 72 hours +/- 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start12 May 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthrogryposis Multiplex Congenita (AMC)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study prospective,randomized ,two groups (low risk of AMC vs hight risk of AMC), multicentre
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus DIETERICH, MD,PhD, Principal investigator, Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130592
- Sponsor's protocol ID
- 38RC21.0423
- Acronym
- FetUS
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound Screening of Congenital Multiple Arthrogryposis
- ClinicalTrials.gov ID
- NCT06130592
- Acronym / sponsor ID
- FetUS / 38RC21.0423
- Conditions
- Arthrogryposis Multiplex Congenita (AMC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study prospective,randomized ,two groups (low risk of AMC vs hight risk of AMC), multicentre
| Arm | Type | Receives |
|---|---|---|
| high risk of Arthrogryposis AMC | Active comparator | Diagnostic Test: ultrasound muscle imaging techniquePatient 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 |
| low risk of Arthrogryposis AMC | Active comparator | Diagnostic Test: ultrasound muscle imaging techniquePatient coming for screening ultrasound |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound muscle imaging techniqueultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis | Diagnostic test | high risk of Arthrogryposis AMC, low risk of Arthrogryposis AMC |
Primary outcome
Rate of achievement (success) of all four sections at the extremities
Time frame: 72 hours +/- 24 hours
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
5 secondary outcomes
Rate of achievement (success) of each four sections
Time frame: 72 hours +/- 24 hours
Collect the raisons for the failure of achievement of all sections
Time frame: 72 hours +/- 24 hours
Duration of realization of the ultrasound sections
Time frame: 72 hours +/- 24 hours
Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
Time frame: 72 hours +/- 24 hours
Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively
Time frame: 72 hours +/- 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klaus DIETERICH, MD,PhD principal investigator
Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound muscle imaging technique in people with Arthrogryposis Multiplex Congenita (AMC), run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lora PEJOT, Midwife (0476766561, lpejot@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of achievement (success) of all four sections at the extremities (time frame: 72 hours +/- 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.