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    Summary
    EudraCT Number:2020-002640-23
    Sponsor's Protocol Code Number:APHP200003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-16
    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 number2020-002640-23
    A.3Full title of the trial
    Effect of increased oxytocin doses on the mode of delivery in obese primiparous women with spontaneous labour. A double-blind, randomised, controlled trial
    Effet de l'augmentation des doses d'ocytocine sur le mode d'accouchement chez les femmes primipares obèses en travail spontané. Un essai randomisé contrôlé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens
    Comparer les taux de césarienne chez les patients obèses avec travail spontané entre deux posologiques d'ocytocine
    A.3.2Name or abbreviated title of the trial where available
    PROXYMA
    A.4.1Sponsor's protocol code numberAPHP200003
    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 SponsorASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    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 supportAP-HP/Direction de la Recherche Clinique et de l’Innovation (DRCI)
    B.4.2CountryFrance
    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 OXYTOCINE MEDISOL 5 UI/mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderMEDISOL
    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/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYTOCIN
    D.3.9.1CAS number 50-56-6
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens
    E.1.1.1Medical condition in easily understood language
    To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on the rate of caesarean sections in obese patients with spontaneous onset of labour
    Comparer les taux de césarienne chez les patients obèses avec travail spontané entre deux posologiques d'ocytocine
    E.2.2Secondary objectives of the trial
    a. To compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on:
    •Maternal and labour complications: - Length of labour - Arrest of labour-Interruption of
    oxytocin perfusion and reason- Uterine hyper-stimulation- Mode of vaginal delivery
    - Reason for caesarean section- Post-partum haemorrhage- Maternal blood transfusion
    - Volume of oxytocin infusion- Oxytocin side effects•Foetal complications •Neonatal complications
    b. To create a biobank of maternal and cord blood.This bank will be used for an ancillary study part of the SENEC project which has been recently created as a FHU. The SENEC project aims at developing a multidisciplinary approach common to chronic diseases (red blood-cell, neurodegenerative, lung, cardiovascular & metabolic including obesity)
    Comparez les deux posologies d'ocytocine concernant:
    - Circonstances de travail et d'accouchement
    - Complications maternelles
    - Complications foetales
    - Complications néonatales
    - Effets secondaires de l'ocytocine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A 22.5 mL blood sample will be taken during the work for the biological collection of the auxiliary project SENEC in order to conserve maternal plasma, serum and DNA.
    The SENEC project aims to develop a common multidisciplinary approach to chronic diseases (such as neurodegenerative, pulmonary, cardiovascular and metabolic diseases, including obesity).
    Un prélèvement sanguin de 22.5 mL sera effectué pendant le travail pour la collection biologique du projet auxiliaireSENEC afin de conserver du plasma maternel, du sérum et de l'ADN.
    Le projet SENEC vise à développer une approche multidisciplinaire commune aux maladies chroniques (telles que les maladies neurodégénératives, pulmonaires, cardiovasculaires et métaboliques, y compris l'obésité).
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Nulliparous
    - Singleton pregnancy
    - Obesity defined as BMI ≥ 30 kg/m2 (during first trimester of pregnancy)
    - Spontaneous onset of labour
    - Cephalic presentation
    - Term ≥ 37 weeks of gestation and < 42 weeks of gestation
    - Medical indication and absence of medical contraindication for oxytocin during labour: inadequate and/or ineffective uterine contraction and/or delayed cervical dilation
    - Written consent
    - Affiliation to a french social security system
    Âge ≥ 18 ans
    - Nullipare
    - Grossesse singleton
    - Obésité définie par un IMC ≥ 30 kg / m2 (au cours du premier trimestre de la grossesse)
    - Début spontané du travail
    - Présentation céphalique
    - Terme ≥ 37 semaines de gestation et <42 semaines de gestation
    - Indication médicale et absence de contre-indication médicale à l'ocytocine pendant le travail: contraction utérine insuffisante et / ou inefficace et / ou dilatation cervicale retardée
    - Consentement écrit
    - Affiliation à un système de sécurité sociale français
    E.4Principal exclusion criteria
    - Hypersensitivity to the active substance (oxytocin) or to any of its excipients
    - Medical contraindication for oxytocin
    - Coagulation disorders
    - Foetal growth restriction (inferior to 5th percentile)
    - Foetal malformation
    - Foetal heart rate anomalies before use of oxytocin
    - History of uterine surgery
    - Patient with a disease requiring induction of labour or caesarean section prior to labour
    - Curatorship or guardianship
    - Participation in another interventional trial
    Hypersensibilité à la substance active (ocytocine) ou à l'un de ses excipients
    - Contre-indication médicale à l'ocytocine
    - Troubles de la coagulation
    - Restriction de croissance fœtale (inférieure au 5e percentile)
    - Malformation fœtale
    - Anomalies de la fréquence cardiaque fœtale avant l'utilisation de l'ocytocine
    - Histoire de la chirurgie utérine
    - Patient avec une maladie nécessitant le déclenchement du travail ou une césarienne avant le travail
    - Curatelle ou tutelle
    - Participation à une autre recherche interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens
    Comparer les taux de césarienne chez les patients obèses avec travail spontané entre deux posologiques d'ocytocine
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of follow-up for the last patient
    fin de suivi de la dérniere patiente
    E.5.2Secondary end point(s)
    Compare the two oxytocin dosage regimens for:
    - Labour and delivery circumstances
    - Maternal complications
    - Foetal complications
    - Neonatal complications
    - Oxytocin side effects
    Comparez les deux posologies d'ocytocine concernant:
    - Circonstances de travail et d'accouchement
    - Complications maternelles
    - Complications foetales
    - Complications néonatales
    - Effets secondaires de l'ocytocine
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of follow-up for the last patient
    At the end of follow-up for the last patient
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3.1Comparator description
    Compare the two oxytocin dosage
    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 concerned14
    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
    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 months25
    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: 882
    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 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 state882
    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
    aucun
    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 Decision2020-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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