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    Summary
    EudraCT Number:2016-000889-35
    Sponsor's Protocol Code Number:CHUB-PIB
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-25
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000889-35
    A.3Full title of the trial
    Comparison of two methods of administration of the epidural, by programmed intermittent bolus or continuous perfusion, on the incidence of instrumented deliveries and cesareans in primiparous women.
    Comparaison de deux modes d'administration de la péridurale, par bolus intermittents programmés ou perfusion continue, sur l’incidence d’accouchement instrumenté et de césarienne chez les primipares.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two methods of administration of the epidural, by bolus or continuous perfusion, on the incidence of cesareans and the need for instrumentation during deliveries in women having their first child.
    A.4.1Sponsor's protocol code numberCHUB-PIB
    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 SponsorCentre Hospitalier Universitaire Brugmann
    B.1.3.4CountryBelgium
    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 Brugmann
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Brugmann
    B.5.2Functional name of contact pointAnesthesiology Service
    B.5.3 Address:
    B.5.3.1Street Address4 Place A Van Gehuchten
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1020
    B.5.3.4CountryBelgium
    B.5.4Telephone number3224772330
    B.5.5Fax number3224773345
    B.5.6E-mailPhilippe.VANDERLINDEN@chu-brugmann.be
    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 Sufentanil Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan bvba/sprl
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    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.IMP: 2
    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 CHIROCAINE
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    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
    Fist child delivery with epidural
    Accouchement sous péridurale du premier enfant.
    E.1.1.1Medical condition in easily understood language
    Fist child delivery with epidural
    Accouchement sous péridurale du premier enfant.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the incidence of instrumentated deliveries and caesarean sections according to the mode of administration of the local anesthetic in the epidural.
    Déterminer l'incidence d'accouchement instrumenté et de césarienne selon le mode d'administration de l'anesthésique local dans la péridurale.
    E.2.2Secondary objectives of the trial
    - To determine the quality of the analgesia according to the administration mode of the epidural
    - To assess the satisfaction of the mother
    - To evaluate the presence of a motor block at the beginning of the second stage of the labor
    - Évaluer la qualité de l'analgésie selon le mode d'administration, en se basant sur le nombre d'interventions nécessaires de la part de l'anesthésiste
    - Évaluer la satisfaction maternelle
    - Évaluer la présence de bloc moteur au début du deuxième stade du travail
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women over 18 years of age
    - Primiparous
    - Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
    - Written informed consent
    - Cervical dilatation between 3 and 6 cm at recruitment
    - Single pregnancy
    - Foetus in cephalic position
    - Femmes de 18 ans et plus
    - Primipare
    - Grossesse > 36 semaines d'âge gestationnel et < 42 semaines
    - Consentement écrit recueilli
    - Dilatation du col au moment du recrutement comprise entre 3 et 6 cm
    - Grossesse unique
    - Foetus en position céphalique
    E.4Principal exclusion criteria
    - Participation refusal or epidural contra-indication
    - Multiparous
    - Allergy to the products used
    - Twin pregnancy
    - Height <1m55 and/or narrow pelvis, as shown by imagery
    - Langage barrier
    - Patients with a BMI superior or equal to 35 (computed with the weight at the beginning of the pregnancy)
    - Cervical dilatation at recruitment <3 or >6 cm
    - ASA 3 or 4
    - Foetus in transverse or seat position
    - Refus ou contre-indication à la péridurale
    - Multipare
    - Allergie aux produits utilisés
    - Grossesse gémellaire
    - Taille < 1m55 et/ou bassin étroit démontré à l'imagerie
    - Barrière linguistique
    - Patientes avec IMC ≥ 35 (calculé avec le poids en début de grossesse)
    - Dilatation du col au moment du recrutement < 3 ou > 6 cm
    - ASA 3 ou 4
    - Foetus en position transverse ou de siège
    E.5 End points
    E.5.1Primary end point(s)
    Delivery mode: vaginal, instrumentated (suction cups, forceps) or caesarian section.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At delivery
    E.5.2Secondary end point(s)
    - Number of anesthesist interventions, either by patient request (pain), either by side effects monitoring
    - Maternal satisfaction: visual questionnaire on a scale from 0 to 100, regarding perceived analgesia and anesthesist management
    - Presence of a motor block: assessed by the Bromage modified score
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Number of anesthesist interventions: from the beginning of epidural administration by the anesthesist (T0) till delivery
    - Maternal satisfaction: the day after the delivery
    - Motor Block: at the begining of the second stage of labor, as defined as the complete cervical dilatation
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different modes of administration of the same solution (continuous infusion vs bolus)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    Last patient last visit
    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 months
    E.8.9.1In the Member State concerned days
    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: 784
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state784
    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)
    Expected normal treatment of women after delivery (standard of care)
    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 Decision2016-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-06
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