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    Summary
    EudraCT Number:2016-000147-13
    Sponsor's Protocol Code Number:I15014
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-22
    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 number2016-000147-13
    A.3Full title of the trial
    Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?
    Y a-t-il un interet à répéter l’administration de dinoprostone vaginal (Propess®), pour favoriser la maturation cervicale des patientes à terme ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?
    Y a-t-il un interet à répéter l’administration de dinoprostone vaginal (Propess®), pour favoriser la maturation cervicale des patientes à terme ?
    A.3.2Name or abbreviated title of the trial where available
    RE-DINO
    A.4.1Sponsor's protocol code numberI15014
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de LIMOGES
    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 supportCHU de LIMOGES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de LIMOGES
    B.5.2Functional name of contact pointDirection Research and Innovation
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Martin Luther King
    B.5.3.2Town/ cityLIMOGES
    B.5.3.3Post code87042
    B.5.3.4CountryFrance
    B.5.4Telephone number+33555056349
    B.5.5Fax number+33555056696
    B.5.6E-maildrc@chu-limoges.fr
    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 Propess
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDINOPROSTONE
    D.3.9.3Other descriptive nameDINOPROSTONE
    D.3.9.4EV Substance CodeSUB07195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    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
    cervix ripening

    maturation cervicale
    E.1.1.1Medical condition in easily understood language
    cervix ripening
    maturation cervicale
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10073175
    E.1.2Term Induction of cervix ripening
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate, if cervical ripening failure by a first Propess®, the laying of a second Propess® (followed if necessary by oxytocin (Syntocinon®)) increases the rate of births vaginally by compared to the direct injection of oxytocin (Syntocinon®).
    L’objectif principal de ce travail est de démontrer, en cas d’échec de maturation cervicale par un premier Propess®, que la pose d’un deuxième Propess® (suivi si nécessaire d’ocytocine (Syntocinon®)) permet d’augmenter le taux d’accouchements par voie basse par rapport à l’injection directe d’Ocytocine (Syntocinon®).
    E.2.2Secondary objectives of the trial
    1. Comparison of the proportion trigger failure
    2. Assessment and comparison of maternal morbidity and mortality
    3. Assessment and comparison of fetal morbidity and mortality
    1.La comparaison de la proportion d’échec de déclenchement
    2. L’évaluation et comparaison de la morbimortalité maternelle
    3. L’évaluation et comparaison de la morbimortalité fœtale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years.
    - Term pregnancy> 37 weeks
    - Current Trigger medically indicated
    - Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
    - Cephalic presentation
    - Unfavorable cervical conditions (Bishop score <6), one hour before inclusion
    - Intact membranes
    - Affiliated with the French social security system
    - Having signed the consent form.
    - Patiente âgée d’au moins 18 ans.
    - Grossesse à terme > 37 SA
    - Déclenchement en cours, sur indication médicale
    - Patientes ayant déjà eu la mise en place d’un premier Propess®, dans un délai de 24 à 36 heures (avant la signature du consentement)
    - Présentation céphalique
    - Conditions cervicales défavorables (score de Bishop<6), 1 heure avant l’inclusion
    - Membranes intactes
    - Affiliée à un régime de sécurité sociale française
    - Ayant signé le formulaire de consentement.
    E.4Principal exclusion criteria
    - Multiple pregnancy
    - Uterus scar
    - Contraindications to epidural anesthesia
    - Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins
    - Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
    - Contraindications to vaginal delivery
    - Premature Rupture of Membranes (PROM)
    - Intra Uterine Growth retardation (IUGR) < 3rd percentile
    - Macrosomia > 97th percentile
    - Impaired fetal heart rate
    - Fetal Death In Utéro (IUFD)
    - Patient under guardianship, curatorship or safeguard justice
    - Grossesse multiple
    - Utérus cicatriciel
    - Contre-indications à l’anesthésie péridurale
    - Contre-indications au Propess® : antécédent récent de pathologie inflammatoire pelvienne; hypersensibilité aux prostaglandines
    - Contre-indications au Syntocinon® : Hypersensibilité à l’ocytocine, troubles cardiovasculaires et toxémie gravidique sévère.
    - Contre-indications à l’accouchement voie basse
    - Rupture Prématurée des Membranes (RPM)
    - Retard de Croissance Intra Utérin (RCIU) < 3ème percentile
    - Macrosomie > 97ème percentile
    - Altération du rythme cardiaque fœtal
    - Mort Fœtale In Utéro (MFIU)
    - Patiente sous tutelle, curatelle ou sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    The rate of vaginal deliveries.
    Le taux d’accouchements par voie basse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the delivery
    A l'accouchement
    E.5.2Secondary end point(s)
    1. The triggering of failure
    The failure of the trigger is the lack of work setting: remaining cervical dilation <3cm despite 8am Syntocinon (or 1 syringe) and lack of regular uterine contractions and amniotomy. The success of the trigger is defined by regular uterine contractions and cervical dilatation ≥ 3 cm.

    2. Criteria of maternal morbidity and mortality:
    - Duration of work: time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilatation of ≥3 cm and childbirth.
    - Caesarean indications
    - Proportion of instrumental delivery
    - Proportion of complications of delivery and the various supported.
    - Proportion of uterine rupture
    - The transfer to intensive care
    - Duration of hospital stay of the mother
    - maternal death

    3. Criteria fetal morbidity and mortality:
    - Apgar score at 3, 5 and 10 min
    - Assessment of fetal acidosis umbilical arterial pH and lactate
    - The presence of amniotic fluid meconium
    - The share transfer in neonatology or neonatal resuscitation
    - Fetal / neonatal death
    1. L’échec du déclenchement
    L’échec du déclenchement correspond à l’absence de mise en travail : dilatation cervicale restant < 3cm malgré 8h de Syntocinon® (ou 1 seringue) et absence de contractions utérines régulières et d’amniotomie.
    Le succès du déclenchement est défini par des contractions utérines régulières et une dilatation cervicale ≥ 3 cm.
    .
    2. Critères de morbi-mortalité maternelle :
    - Durée du travail : durée en minutes, entre le début du travail défini par la survenue de contractions utérines régulières et d’une dilatation cervicale ≥3 cm et l’accouchement.
    - les indications de césarienne
    - la proportion d’extraction instrumentale
    - la proportion de complications de la délivrance et les différentes prises en charge.
    - la proportion de rupture utérine
    - le transfert en réanimation
    - la durée d’hospitalisation de la maman
    - le décès maternel

    3. Critères de morbi-mortalité fœtale :
    - score d’Apgar à 3, 5 et 10 min
    - évaluation de l’acidose fœtale : pH artériel ombilical ou lactates
    - présence de liquide amniotique méconial
    - la proportion de transfert en néonatalogie ou réanimation néonatale
    - décès fœtal / néonatal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 24h

    2. At the end of hospitalisation

    3. After delivery
    1. 24h

    2. A la fin de l'hospitalisation

    3. Après l'accouchement
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 360
    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 state360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    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 Decision2016-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-23
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