Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-02-01

Brief Summary

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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

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Detailed Description

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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

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Arthrogryposis Multiplex Congenita (AMC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

study prospective,randomized ,two groups (low risk of AMC vs hight risk of AMC), multicentre

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ultrasound muscle imaging technique

Intervention Type DIAGNOSTIC_TEST

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

low risk of Arthrogryposis AMC

Patient coming for screening ultrasound

Group Type ACTIVE_COMPARATOR

ultrasound muscle imaging technique

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ultrasound muscle imaging technique

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes