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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-008489-11
    Sponsor's Protocol Code Number:PHRI08-FP/PLACENTA ACCRETA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2008-008489-11
    A.3Full title of the trial
    Placenta accreta : analyse en échographie de contraste en population à haut risque
    A.3.2Name or abbreviated title of the trial where available
    Placenta Accreta
    A.4.1Sponsor's protocol code numberPHRI08-FP/PLACENTA ACCRETA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHRU de TOURS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SONOVUE
    D.2.1.1.2Name of the Marketing Authorisation holderBRACCO International BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSONOVUE
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    grossesse pathologique
    placenta praevia et utérus cicatriciel / placenta praevia et plus de 35 ans
    placenta accreta
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10035119
    E.1.2Term Placenta praevia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062936
    E.1.2Term Placenta accreta
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer les paramètres morphologiques et hémodynamiques de contraste valides pour le diagnostic de placenta accreta.
    E.2.2Secondary objectives of the trial
    - Evaluer la performance de l’échographie de contraste dans la précision de la profondeur de l’infiltration du myomètre : accreta (atteinte d'une partie de l'épaisseur du myomètre), increta (atteinte de la totalité de l'épaisseur du muscle utérin) ou percreta (atteinte et dépassement de la séreuse utérine).
    Pour répondre à cet objectif secondaire, le gold standard retenu sera l’histologie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Patiente enceinte présentant l’une des deux conditions suivantes :
    o utérus cicatriciel (césarienne antérieure) avec placenta praevia inséré en partie ou en totalité sur la cicatrice utérine
    o placenta praevia et patiente âgée de plus de 35 ans

     Terme ≥ 34 semaines d’aménorrhée
     Patiente âgée de 18 ans au moins
     Patiente ayant donné son consentement éclairé écrit
     Patiente affiliée à un régime de sécurité sociale
    E.4Principal exclusion criteria
     Patiente dans l’incapacité de comprendre l’intérêt de l’étude
     Contre-indications à l’injection du SonoVue® :
    Hypersensibilité à l’hexafluore de soufre ou à l’un des autres composants de SonoVue®
    Maladie coronarienne connue
    Infarctus du myocarde récent
    Angor instable
    Insuffisance cardiaque aiguë ou insuffisance cardiaque stade III et IV
    Troubles du rythme sévères
    Shunt droit-gauche
    Endocardite aiguë
    Prothèse valvulaire
    Hypertension artérielle pulmonaire sévère (pression artérielle pulmonaire > 90 mm Hg)
    Hypertension systémique non contrôlée
    Syndrome de détresse respiratoire
    Décompensation récente d’une pathologie cardiaque (< 1 mois avant l’inclusion)
    E.5 End points
    E.5.1Primary end point(s)
    Gold standard :
    Le placenta sera considéré comme accreta si :
     Critère clinique :
    La délivrance spontanée ne s’effectue pas en per opératoire, et si les tentatives habituelles de délivrance artificielle ou manuelle simples sont inefficaces (critère reconnu dans la littérature). En pratique une tentative de traction douce sur le cordon ombilical sera réalisée (opérateur entrainé). Si cette tentative ne permet pas le décollement placentaire, la manœuvre sera considérée comme négative et le placenta laissé en place.
    ou
     Critère histologique :
    Histologiquement sur le placenta ou sur pièce d’hystérectomie si cette dernière a été réalisée. Le critère histologique sur pièce d’hystérectomie est indiscutable. Sur le placenta c’est la constatation de fibres musculaires lisses dissociées par les villosités placentaires les plus profondes au niveau de la plaque basale du placenta qui permet d’être affirmatif.

    Paramètres diagnostiques
    Paramètres mesurés à l’échographie de contraste :
     Temps d’arrivée de l’agent de contraste dans le placenta
     Temps jusqu’au pic de rehaussement
     Pente de rehaussement
     Pente de demi washout
     Temps de transit moyen des microbulles dans le placenta (mTT)
     Index de perfusion : rapport entre mTT et aire sous la courbe
     Rapport de rehaussement entre le placenta et le myomètre voisin au pic
     Rapport des pentes de rehaussement du placenta et du myomètre
     Mesure de l’espace entre la zone de vascularisation placentaire et la zone myométriale voisine.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Dernière visite de la dernière patiente incluse, plus environ 12 semaines de suivi , soit jusqu'à l'accouchement.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-11
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