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    Summary
    EudraCT Number:2018-002965-20
    Sponsor's Protocol Code Number:MISFOL2018
    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:2018-11-05
    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 number2018-002965-20
    A.3Full title of the trial
    A randomized, open, 2 treatment arms clinical trial to evaluate the efficacy and safety of cervical ripening with Foley catheter vs cervical ripening with intravaginal synthetic analogue of prostaglandins E1 (MISOPROSTOL).
    Ensayo clínico aleatorizado, abierto, de 2 ramas de tratamiento para evaluar eficacia y seguridad de la maduración cervical con sonda Foley vs maduración cervical con análogo sintético de las prostaglandinas E1 (MISOPROSTOL) intravaginal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, open, 2 treatment arms clinical trial to evaluate the efficacy and safety of cervical ripening with Foley catheter vs cervical ripening with intravaginal synthetic analogue of prostaglandins E1 (MISOPROSTOL).
    Ensayo clínico aleatorizado, abierto, de 2 ramas de tratamiento para evaluar eficacia y seguridad de la maduración cervical con sonda Foley vs maduración cervical con análogo sintético de las prostaglandinas E1 (MISOPROSTOL) intravaginal
    A.4.1Sponsor's protocol code numberMISFOL2018
    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 SponsorSOLEDAD CARREGUI, NATIVIDAD BANEGAS, SARA CRUZ
    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 supportHOSPITAL UNIVERSITARI DE LA PLANA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARI DE LA PLANA
    B.5.2Functional name of contact pointSOLEDAD CARREGUI
    B.5.3 Address:
    B.5.3.1Street AddressCRTA. VILA-REAL - BURRIANA, KM0.5
    B.5.3.2Town/ cityVILA-REAL
    B.5.3.3Post code12540
    B.5.3.4CountrySpain
    B.5.4Telephone number+34657567373
    B.5.6E-mailsolecarregui@gmail.com
    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 Misofar 25mcg vaginal tablet
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios BIAL, 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.3.9.3Other 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
    Cervical ripening prior labor induction
    Maduración cervical previa a la inducción al parto
    E.1.1.1Medical condition in easily understood language
    Cervical ripening prior labor induction
    Maduración cervical previa a la inducción al 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10036585
    E.1.2Term Pregnancy, puerperium and perinatal conditions
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    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 efficacy and safety of the intracervical Foley catheter and vaginal misoprostol for cervical ripening in pregnant women with a medical indication for labor induction with an unfavorable cervical state
    comparar la eficacia y seguridad de la sonda Foley intracervical y el misoprostol vaginal para la maduración cervical en gestantes con indicación médica de induccion del trabajo de parto con un estado cervical desfavorable
    E.2.2Secondary objectives of the trial
    Determine the time difference in hours from the start of cervical ripening to the active period of labor between both groups.
    ● Determine the time difference in hours from the start of cervical ripening to delivery between both groups.
    ● Determine the type of delivery: eutocic, instrumented or cesarean section.
    ● Compare the Apgar test at the first minute and at the fifth minutes of life between both groups.
    ● Determine the presence of alterations in uterine dynamics during ripening in both groups.
    ● Determine the presence of FHR alterations during ripening in both groups.
    ● Compare the requeriments of analgesia during cervical ripening between both groups.
    ● To compare the requirements of induction with exogenous oxytocin after cervical ripening in both groups
    ● Determinar la diferencia del tiempo en horas desde el inicio de la maduración cervical hasta el periodo activo de parto entre ambos grupos.
    ● Determinar la diferencia del tiempo en horas desde el inicio de la maduración cervical hasta el parto entre ambos grupos.
    ● Determinar la diferencia en el tipo de finalización del parto: eutócico, instrumentado o cesárea.
    ● Comparar el test de Apgar al minuto y a los cinco minutos de vida entre ambos grupos.
    ● Determinar la presencia de alteraciones de la dinámica uterina durante la maduración en ambos grupos.
    ● Determinar la presencia de alteraciones de la FCF durante la maduración en ambos grupos.
    ● Comparar la necesidad de analgesia durante la maduración cervical entre ambos grupos.
    ● Comparar la necesidad de inducción con oxitocina exógena tras la maduración cervical en ambos grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● At term pregnancy with indication of cervical ripening of low and medium risk according to the Basic Control of Pregnancy card of the Valencian Community (Annex II)
    ● At term pregnancy with indication of cervical ripening with well-controlled thyroid endocrinopathy during pregnancy.
    ● Single fetus in longitudinal situation and cephalic presentation
    ● Previous CTG without pathological findings
    ● Acceptance of the IC by the pregnant woman to participate in the study
    Gestante a término con indicación de maduración cervical de bajo y medio riesgo según la cartilla de Control Básico del Embarazo de la Comunidad Valenciana (Anexo II)
    ● Gestante a término con indicación de maduración cervical con endocrinopatía tiroidea bien controlada durante la gestación.
    ● Feto único en situación longitudinal y presentación cefálica
    ● RCTG previo sin hallazgos patológicos
    ● Aceptación del CI por parte de la gestante para participar en el estudio
    E.4Principal exclusion criteria
    ● Hypersensitivity to latex
    ● Pregnant women with low insertion placenta in 3rd trimester ultrasound
    ● Pregnant women classified as high and very high risk according to the Basic Control of Pregnancy card of the Valencian Community.
    ● Premature rupture of membranes.
    ● Contraindication of administration of prostaglandins (misoprostol)
    ● Language barrier
    ● Antecedentes de hipersensibilidad al látex
    ● Gestantes con placenta de inserción baja en ecografía del 3er trimestre
    ● Gestantes clasificadas de alto y muy alto riesgo según la cartilla de Control Básico del Embarazo de la Comunidad Valenciana.
    ● Rotura prematura de membranas.
    ● Contraindicación de administración de prostaglandinas (misoprostol)
    ● Barrera idiomática
    E.5 End points
    E.5.1Primary end point(s)
    ● Bishop test pre-maturation (0-5 points)
    ● Bishop test pre-induction (0-15 points)
    ● Uterine dynamics during ripening.
    ● Alterations of the FHR during ripening: YES / NO
    ● Test de Bishop pre-maduración (0-5 puntos)
    ● Test de Bishop pre-inducción (0-15 puntos)
    ● Dinámica uterina durante la maduración.
    ● Alteraciones de la FCF durante la maduración: SI/ NO
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bishop test: 24 hours.
    The uterine dynamics and the alterations of the FHR during ripening: every 4 hours.
    El test de Bishop: 24 horas.
    La dinámica uterina y las alteraciones de la FCF durante la maduración: cada 4 horas.
    E.5.2Secondary end point(s)
    ● Time in hours from the start of cervical ripening to the active period of labor
    ● Time in hours from the start of cervical ripening to delivery
    ● Termination of delivery: eutocic, instrumented, cesarean.
    ● Cesarean reason: induction failure, risk of loss of fetal well-being, parity, disproportion, anomalous presentation and others.
    ● Maternal age
    ● Parity: nulliparous / multiparous
    ● Weeks of gestation
    ● Apgar at minute and five minutes of life.
    ● Need for analgesia during maturation: YES / NO
    ● Induction with exogenous oxytocin after maturation: SI / NO
    ● Membrane rupture: Spontaneous / Artificial
    ● Epidural analgesia: YES / NO
    ● Tiempo en horas desde el inicio de la maduración cervical hasta el periodo activo de parto
    ● Tiempo en horas desde el inicio de la maduración cervical hasta el parto
    ● Terminación del parto: eutócico, instrumentado, cesárea.
    ● Motivo de la cesárea: fallo inducción, riesgo de pérdida de bienestar fetal, parto estacionado, desproporción, presentación anómala y otros.
    ● Edad materna
    ● Paridad: nulípara/ multípara
    ● Semanas de gestación
    ● Apgar al minuto y a los cinco minutos de vida:
    ● Necesidad de analgesia durante la maduración: SI/NO
    ● Inducción con oxitocina exógena tras maduración: SI/NO
    ● Rotura de membranas: Espontánea/ Artificial
    ● Analgesia epidural: SI / NO
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of labor
    A la finalización del 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
    Sonda Foley (producto sanitario)
    Foley Catheter (medical device)
    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
    LVLS. 24 hours.
    LVLS. 24 horas.
    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 months5
    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: 30
    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 state30
    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
    Ninguno
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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