Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002061-29
    Sponsor's Protocol Code Number:08227
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002061-29
    A.3Full title of the trial
    Prospective randomized clinical trial comparing the effect of vaginal misoprostol synchronously with supracervical ball, versus only vaginal misoprostol for induction of labor.
    Ensayo clínico aleatorizado y prospectivo comparando el efecto de misoprostol vaginal de forma sincrónica con balón supracervical, versus misoprostol vaginal solamente para la inducción del parto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial comparing a pharmacological method for inducing labor with the combination of a pharmacological and a mechanical method.
    Ensayo clínico comparando un método farmacológico con la combinación de un método farmacológico y otro mecánico para la inducción del parto.
    A.4.1Sponsor's protocol code number08227
    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 SponsorConsorci Sanitari de Terrassa
    B.1.3.4CountrySpain
    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 supportConsorci Sanitari de Terrassa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Sanitari de Terrassa
    B.5.2Functional name of contact pointHospital de Terrassa
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Torrebonica s/n
    B.5.3.2Town/ cityTerrassa
    B.5.3.3Post code08227
    B.5.3.4CountrySpain
    B.5.4Telephone number00349373100077098
    B.5.5Fax number0034937003633
    B.5.6E-mailMAVives@cst.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Misofar 25 microgramos comprimidos vaginales
    D.2.1.1.2Name of the Marketing Authorisation holderBIAL Industrial Farmacéutica, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 tablet
    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 INNMISOPROSTOL
    D.3.9.1CAS number 59122-46-2
    D.3.9.2Current sponsor codeC22H38O5
    D.3.9.3Other descriptive nameMISOPROSTOL
    D.3.9.4EV Substance CodeSUB08998MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Pegnant women with a term singleton pregnancy, cephalic presentation, reassuring fetal heart rate pattern, intact membranes and an unfavorable cervix (Bishop score less than 6), admitted to our institution for labour induction.
    Gestantes a término con gestación única, presentación cefálica, registro cardiotocográfico normal al ingreso, membranas íntegras y condiciones cervicales desfavorables (Test de Bishop menor de 6) que ingresen en nuestro centro para la inducción del parto.
    E.1.1.1Medical condition in easily understood language
    Pregnant women with a term pregnancy and unfavorable cervix admitted to our institution for labour induction.
    Gestantes a término con condiciones cervicales desfavorables que ingresan en nuestro centro para la inducción del parto.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10055563
    E.1.2Term Labor induction
    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
    Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
    Demostrar que con el uso concomitante y sincrónico de balón supracervical y misoprostol vaginal para las inducciones de parto, se alcanza el parto vaginal en menos tiempo comparado con las inducciones con misoprostol vaginal solamente.
    E.2.2Secondary objectives of the trial
    1- To assess cervical ripening and labour progression.
    2- To assess the requirement and dosage of drugs for cervical ripening and labour induction.
    3- To assess the requirement of analgesia in labour.
    4- To assess adverse effects during labour and perinatal outcomes.
    5- To evaluate the route and type of delivery.
    1- Evaluar la capacidad de maduración cervical y progresión al trabajo de parto.
    2- Evaluar la necesidad y dosis de fármacos para la maduración y estimulación del parto.
    3- Evaluar la necesidad de analgesia para el parto.
    4- Evaluar los efectos adversos durante el trabajo de parto y resultados perinatales.
    5- Evaluar la vía y tipo de parto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pegnant women with a term singleton pregnancy, cephalic presentation, reassuring fetal heart rate pattern, intact membranes and an unfavorable cervix (Bishop score less than 6), admitted to our institution for labour induction.
    Gestantes a término con gestación única, presentación cefálica, registro cardiotocográfico normal al ingreso, membranas íntegras y condiciones cervicales desfavorables (Test de Bishop menor de 6) que ingresen en nuestro centro para la inducción del parto.
    E.4Principal exclusion criteria
    1- Exclusion criteria pre-randomization:
    - Patient refusal to participate in the trial
    - Misoprostol contraindication acording to the misoprostol leaflet:
    - Severe Preeclampsia
    - Prematurity (<37 weeks gestation dated by first trimester ultrasound)
    - Previous cesarean section or previous uterine surgery
    - Intrauterine growth restriction
    - Whenever placement of supracervical balloon might lead to an increase in the risk of infections and chorioamnionitis:
    - Premature rupture of membranes
    - Maternal colonization with Streptococcus agalactiae at any time during the pregnancy
    - Other infrequent situations that may act as a confounder factor:
    - Multifetal gestation
    - Breech presentation
    - Stillbirth

    2- Exclusion criteria postrandomization
    - Maternal leaving of the study during induction
    - Adverse effects secondary to the supracervical balloon, such as pain or maternal discomfort
    1- Criterios de exclusión prealeatorización
    - Negativa de la paciente a participar en el ensayo
    - Las indicaciones que no contempla el prospecto del misoprostol para la inducción del parto:
    - Preeclampsia grave
    - Prematuridad (< 37 semanas de gestación datada por ecografía durante el primer trimestre de embarazo)
    - Cesárea o cirugía uterina corporal previa.
    - Retraso de crecimiento intrauterino
    - Siempre que se considere que la colocación de un balón supracervical pueda condicionar un aumento en la tasa de infecciones y corioamnionitis:
    - Inducciones por rotura prematura de membranas
    - Colonización materna por Streptococcus agalactiae detectada por cultivo positivo en cualquier momento del embarazo o durante las 5 semanas previas a la inducción
    - Otras situaciones que por su pequeño volumen no representan resultados significativos y pueden actuar como factor de confusión:
    - Gestación múltiple
    - Presentación de nalgas
    - Óbito fetal

    2- Criterios de exclusión postaleatorización
    - Abandono del estudio durante la inducción
    - Aparición de reacciones adversas al balón supracervical, tales como dolor o disconfort.
    E.5 End points
    E.5.1Primary end point(s)
    Induction to delivery time with the concomitant use of misoprostol and supracervical balloon compared with misoprostol alone.
    Tiempo de inducción hasta el parto con el uso concomitante de misoprostol y balón supracervical comparado con el uso de misoprostol solamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once successful delivery.
    Una vez conseguido el parto.
    E.5.2Secondary end point(s)
    - Bishop score at 12 hours from the onset of induction
    - Bishop score at 24 hours from the onset of induction
    - Number of doses of misoprostol required
    - Percentage of pregnant women requiring oxytocin
    - Maximum dosage of oxytocin given (mU / min)
    - Percentage of pregnant women requiring epidural analgesia
    - Percentage of pregnant women with tachysystole and / or hypertone with absence of fetal heart rate decelerations
    - Percentage of pregnant women with tachysystole and / or hypertone with fetal heart rate decelerations
    - Percentage of pregnant women with intrapartum fever
    - Percentage of pregnant women with maternal side effects
    - Percetage of pregnant women with vaginal delivery within 12 hours from the onset of induction
    - Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
    - Total rate of cesarean section
    - Percentage of cesarean sections for failed induction
    - Percentage of cesarean sections for nonreassuring fetal status
    - Neonatal intesive care unit admission
    - Apgar score at 5 minutes
    - Umbilical artery pH
    - Test de Bishop a las 12 horas del inicio de la inducción
    - Test de Bishop a las 24 horas del inicio de la inducción
    - Número de dosis de misoprostol requeridas
    - Porentaje de gestantes que requieren oxitocina
    - Dosis máxima de oxitocina requerinda ( mU/min)
    - Porcentaje de gestantes que requieren analgesia peridural
    - Porcentaje de gestantes con taquisistolia y/o hipertono sin alteraciones del RCTG
    - Porcentaje de gestantes con taquisistolia y/o hipertono con alteraciones del RCTG
    - Porcentaje de gestantes con fiebre intraparto
    - Porcentaje de gestantes con efectos adversos maternos
    - Porcentaje de gestantes con parto vaginal antes de las 12 h desde el inicio de la inducción
    - Porcentaje de gestantes con parto vaginal antes de las 24 horas desde el inicio de la inducción
    - Tasa total de cesáreas
    - Porcentaje de cesáreas por fallo de inducción
    - Porcentaje de cesáreas por riesgo de perdida de bienestar fetal
    - Porcentaje de ingresos en unidad de cuidados intensivos neonatales
    - Apgar a los 5 minutos
    - pH de arteria umbilical
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once successful delivery.
    Una vez conseguido el parto.
    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) 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
    Asociación de un método farmacológico con uno mecánico para la inducción del parto
    Association of a pharmacological and a mecanical method for labour induction
    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
    When the 80 expected subjects have been recruited and the study endpoints have been evaluated.
    Cuando se hayan reclutado los 80 sujetos previstos y se hayan evaluado las variables del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 80
    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 state80
    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)
    No treatment is needed
    No es necesario ningún tratamiento posterior
    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 Decision2016-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 16:32:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA