Technische Machbarkeitsstudie zur Ultraschall-Muskelbildgebung im vorgeburtlichen Ultraschall (FetUS)
Technische Machbarkeitsstudie zur Ultraschall-Muskelbildgebung beim vorgeburtlichen Ultraschall-Screening der angeborenen multiplen 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lora PEJOT, Midwife
- Telefonnummer: 0476766561
- E-Mail: lpejot@chu-grenoble.fr
Studienorte
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Isère
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La Tronche, Isère, Frankreich, 38700
- Rekrutierung
- university hospital of Grenoble
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Kontakt:
- Lora Pejot, midwife CRA
- Telefonnummer: +33 (0)4 76 76 65 61
- E-Mail: lpejot@chu-grenoble.fr
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Kontakt:
- Caroline Tournegros, CRA
- Telefonnummer: +33 (0)4 76 76 72 30
- E-Mail: CTournegros@chu-grenoble.fr
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Hauptermittler:
- Christine Ravier, Midwife
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Rhone
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Bron, Rhone, Frankreich, 69677
- Rekrutierung
- Hopitaux Civils de Lyon - Hôpital Femme Mère Enfant
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Kontakt:
- Mathilde Vermont, CRA
- E-Mail: mathilde.vermont@chu-lyon.fr
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Kontakt:
- Jérôme Massardier, MD
- E-Mail: jerome.massardier@chu-lyon.fr
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Hauptermittler:
- jérome Massardier, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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 |
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis |
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Aktiver Komparator: low risk of Arthrogryposis AMC
Patient coming for screening ultrasound |
ultrasound muscle imaging technique in antenatal ultrasound screening of congenital multiple arthrogryposis |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Rate of achievement (success) of all four sections at the extremities
Zeitfenster: 72 hours +/- 24 hours
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Rate of achievement (success) of each four sections
Zeitfenster: 72 hours +/- 24 hours
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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
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Collect the raisons for the failure of achievement of all sections
Zeitfenster: 72 hours +/- 24 hours
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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
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Duration of realization of the ultrasound sections
Zeitfenster: 72 hours +/- 24 hours
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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
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Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients
Zeitfenster: 72 hours +/- 24 hours
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Comparison of the completion rates of all cuts during ultrasounds between high- and low-risk patients |
72 hours +/- 24 hours
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Concordance of measures (CCI coefficient) will be evaluated in intra-observer and inter-observer respectively
Zeitfenster: 72 hours +/- 24 hours
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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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Klaus DIETERICH, MD,PhD, Univ. Grenoble Alpes Inserm U1209 IAB CHU Grenoble Alpes
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 38RC21.0423
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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