ClinicalTrials.gg
RecruitingNCT06130592FetUSUpdated Oct 6, 2026

Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound

An interventional study of ultrasound muscle imaging technique in Arthrogryposis Multiplex Congenita (AMC), sponsored by University Hospital, Grenoble. Recruiting at 2 sites in France. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Updated Oct 6, 2026Now RecruitingFirst site in France+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Arthrogryposis Multiplex Congenita (AMC)

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03

In context

Arthrogryposis

16 studies on the registry are indexed under Arthrogryposis; 5 are open to participants now.

Browse Arthrogryposis studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Multiple pregnancies, and / or non-progressive .
  • Obese women ( > 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • 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

  • Active comparator
    low risk of Arthrogryposis AMC

    Patient coming for screening ultrasound

    Diagnostic Test: ultrasound muscle imaging technique

Interventions

  • Diagnostic testultrasound muscle imaging technique

    ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis

06

What researchers measure

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 hours

Secondary 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 hours

  2. 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 hours

  3. 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 hours

  4. 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 hours

  5. 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.

    Time frame: 72 hours +/- 24 hours

07

Study locations

2 of 2 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: start Jan 2024 → May 2024, primary completion Jan 2025 → Nov 2026 and completion Feb 2025 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2023
First posted
Nov 14, 2023
StartActual
May 12, 2024was Jan 2024
Primary completionEst.
Nov 30, 2026was Jan 2025
CompletionEst.
Dec 31, 2026was Feb 2025
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
2 sites added — first site in France
Show 2 added (2 France)
  • university hospital of Grenoble · La Tronche, France
  • Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant · Bron, France
Oct 6, 2026
Start date
Jan 1, 2024→May 12, 2024 (actual)
Oct 6, 2026
Primary completion
Jan 1, 2025→Nov 30, 2026
Oct 6, 2026
Study completion
Feb 1, 2025→Dec 31, 2026
Oct 6, 2026
Eligibility
Minimum age 16 Years→18 Years
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    2 sites added — first site in France
    Show 2 added (2 France)
    • university hospital of Grenoble · La Tronche, France
    • Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant · Bron, France
    Start date Jan 1, 2024→May 12, 2024 (now actual)
    Primary completion Jan 1, 2025→Nov 30, 2026
    Study completion Feb 1, 2025→Dec 31, 2026
    Eligibility Minimum age 16 Years→18 Years
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06130592
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
May 12, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 6, 2026

Study contacts

Lora PEJOT, Midwife
Contact
lpejot@chu-grenoble.fr
0476766561
Klaus DIETERICH, MD,PhD
principal investigator · Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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