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    Summary
    EudraCT Number:2016-003143-11
    Sponsor's Protocol Code Number:CHUBX201620
    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:2016-08-12
    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 number2016-003143-11
    A.3Full title of the trial
    Effect of intra-venous ocytocine injection after fetal expulsion in management of third-stage of labor after second trimester medical pregnancy termination
    Analyse de la Délivrance Dirigée par Ocytocine dans les Interruptions Médicales de Grossesses au Deuxième trimestre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of intra-venous ocytocine injection after fetal expulsion in management of third-stage of labor after second trimester medical pregnancy termination
    Analyse de la Délivrance Dirigée par Ocytocine dans les Interruptions Médicales de Grossesses au Deuxième trimestre
    A.3.2Name or abbreviated title of the trial where available
    ANDDROID
    ANDDROID
    A.4.1Sponsor's protocol code numberCHUBX201620
    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 Bordeaux
    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 Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointREC
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTALENCE
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number+33557821067
    B.5.5Fax number+33556794926
    B.5.6E-mailjeremy.chateauraynaud@chu-bordeaux.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 SYNTOCINON 5 U.I/1 ml, solution injectable en ampoule
    D.2.1.1.2Name of the Marketing Authorisation holderSIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.p.A.
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    second trimester medical pregnancy termination
    Interruption médicale de grossesse au deuxième trimestre.
    E.1.1.1Medical condition in easily understood language
    second trimester medical pregnancy termination
    Interruption médicale de grossesse au deuxième trimestre.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10043285
    E.1.2Term Termination of pregnancy - medical
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary outcome: incidence of placental retention between the two groups defined by the absence of spontaneous expulsion of the placenta within 30 minutes.
    Diminution de l’incidence de la rétention placentaire complète et/ou de la nécessité d’une délivrance artificielle, par l’utilisation de 10 UI d’ocytocine IVL à l’expulsion au cours des IMG réalisées entre 14 et 28 SA.
    E.2.2Secondary objectives of the trial
    The study aims to evaluate:
    - A decrease in the incidence of partial placental retention
    - A decrease in the incidence of digital exploration
    - A decrease in the incidence of blunt curettage
    - An Improved uterine vacuity after delivery (spontaneous or manual)
    - A decrease in blood loss: comparison of blood loss in the 2 groups
    - A decrease in the incidence of postpartum hemorrhage (PPH) in the 2 groups
    Les objectifs secondaires sont de montrer
    - une diminution de l’incidence des rétentions placentaires partielles
    - une diminution intervention manuelle à type de révision utérine
    - une diminution de la nécessité d’un curetage évacuateur
    - une amélioration de la vacuité utérine à l’échographie après la délivrance (spontanée ou manuelle)
    - une diminution des pertes sanguines : comparaison des pertes sanguines dans les 2 groupes
    - une diminution de l’incidence de l’hémorragie du post-partum (HPP) dans les 2 groupes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women over 18
    • to use a medical termination of pregnancy between 14 and 28 weeks of amenorrhea
    • affiliated person or beneficiary of a social security scheme.
    • Free, informed and writing signed by the participant and the investigator (no later than the day of inclusion and foremost need examination by research).
    • femmes de plus de 18 ans
    • devant avoir recours à une Interruption médicale de grossesse entre 14 et 28 semaine d'Aménorrhée
    • Personne affiliée ou bénéficiaire d’un régime de sécurité sociale.
    • Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    • fetal death in utero
    • pre-existing cardiovascular disease
    • minor patients
    • Contraindications to the use of oxytocin according to the summary of product characteristics.
    • Denial of participation in the study
    • Mort fœtale in utéro
    • Maladie cardiovasculaire préexistante
    • patientes mineures
    • Contre-indications à l’utilisation d’ocytocine selon le résumé des caractéristiques du produit.
    • Refus de participation à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    complete placental retention rates after 30 minutes and / or necessity of artificial delivery.
    Taux de rétention placentaire complète à 30minutes et/ou de nécessité de délivrance artificielle.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The day of medical pregnancy termination
    Le jour l'interruption médicale de grossesse
    E.5.2Secondary end point(s)
    - The need for manual intervention type uterine revision
    - Need for instrumental intervention type curettage
    - Evaluation of uterine vacuity with ultrasound after delivery (spontaneous or manual)
    - Blood loss Rating: comparison of blood loss in the 2 groups
    - Evaluation and comparison of the incidence of postpartum hemorrhage (PPH) in the 2 groups
    - Comparison of pre and post hemoglobin delta IMG in the 2 groups
    - Comparison of fetal expulsion period - issuance in the 2 groups
    - Nécessité d’une intervention manuelle à type de révision utérine
    - Nécessité d’une intervention instrumentale à type de curetage
    - Evaluation de la vacuité utérine à l’échographie après la délivrance (spontanée ou manuelle)
    - Evaluation des pertes sanguines : comparaison des pertes sanguines dans les 2 groupes
    - Evaluation et comparaison de l’incidence de l’hémorragie du post partum (HPP) dans les 2 groupes
    - Comparaison du delta d’hémoglobine pré et post IMG dans les 2 groupes
    - Comparaison du délai expulsion fœtale – délivrance dans les 2 groupes
    E.5.2.1Timepoint(s) of evaluation of this end point
    The day of medical pregnancy termination
    Le jour l'interruption médicale de grossesse
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pas d'acte supplémentaire
    no additional medication
    E.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 114
    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 No
    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 state114
    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 Decision2016-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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