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    Summary
    EudraCT Number:2021-001726-22
    Sponsor's Protocol Code Number:COLIGROW
    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:2021-12-17
    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 number2021-001726-22
    A.3Full title of the trial
    COok's ballon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Balón de Cook versus dinoprostona vaginal para la inducción del parto a término en la restricción del crecimiento intrauterino (estudio COLIGROW).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Inducción del parto a término en la restricción del crecimiento intrauterino (estudio COLIGROW).
    A.3.2Name or abbreviated title of the trial where available
    COLIGROW study
    Estudio COLIGROW
    A.4.1Sponsor's protocol code numberCOLIGROW
    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 SponsorDr. Ignacio Herraiz García
    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 supportISCIII
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Ignacio Herraiz García
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressAvda de Córdoba s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913908310
    B.5.6E-mailignacio.herraiz@salud.madrid.org
    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 Propess 10 mg sistema de liberación vaginal
    D.2.1.1.2Name of the Marketing Authorisation holderFerring S.A.U.
    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.3.1Product nameDinoprostona
    D.3.4Pharmaceutical form Vaginal delivery system
    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 INNDinoprostona
    D.3.9.3Other descriptive nameDINOPROSTONE
    D.3.9.4EV Substance CodeSUB07195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Induction of term pregnancies with fetal growth restriction.
    Inducción del parto a término en la restricción del crecimiento intrauterino.
    E.1.1.1Medical condition in easily understood language
    Induction of term pregnancies with fetal growth restriction.
    Inducción del parto a término en la restricción del crecimiento intrauterino.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070532
    E.1.2Term Fetal growth restriction
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether cervical ripening with a Cook's ballon for induction of labor from week 37 + 0 of gestation in late intrauterine growth restriction increases the probability of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.
    Evaluar si la maduración cervical con balón de Cook para la inducción del parto a partir de la semana 37+0 de gestación en la restricción del crecimiento intrauterino tardío consigue aumentar la probabilidad de parto vaginal respecto al uso de dinoprostona vaginal sin aumentar la morbilidad.
    E.2.2Secondary objectives of the trial
    - Compare the percentage of cesarean sections for suspected loss of fetal well-being.
    - Study the length of time between the beginning of cervical ripening and the moment of delivery.
    - Analyze neonatal outcomes: neonatal acidosis, MAIN score (morbidity assesment index for newborns) of neonatal morbidity and admissions to the Neonatal Intensive Care Unit.
    - Comparar el porcentaje de cesáreas por sospecha de pérdida de bienestar fetal.
    - Estudiar el tiempo de duración entre el inicio de la maduración cervical y el momento del parto.
    - Analizar los resultados neonatales: acidosis neonatal, score MAIN (morbidity asessment index for newborns) de morbilidad neonatal e ingresos en Unidad de Cuidados Intensivos Neonatales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following inclusion criteria:
    - Single gestation
    - Age ≥ 18 years
    - Gestational age dated by first trimester ultrasound ≥ 37 + 0 weeks
    - Cephalic presentation
    - Stage I intrauterine growth restriction: presence of at least one of these two criteria:
    1) Estimated fetal weight < percentile 3
    2) Estimated fetal weight < percentile 10 and at least one of the following:
    - IP umbilical artery > percentile 95
    - Cerebro-placental index < percentile 6
    - Bishop score <7
    - Entire amniotic sac
    - Non previous cesarean
    - No contraindication for vaginal delivery or induction of labor.
    Las pacientes deben cumplir los criterios de inclusión siguientes:
    - Gestación única
    - Edad ≥ 18 años
    - Edad gestacional datada por ecografía de primer trimestre ≥ 37+0 semanas
    - Presentación cefálica
    - Restricción del crecimiento intrauterino estadio I: presencia de al menos uno de estos dos criterios:
    1) Peso fetal estimado < percentil 3
    2) Peso fetal estimado < percentil 10 y al menos uno de los siguientes:
    - IP arteria umbilical > percentil 95 o
    - Índice cerebro-placentario < percentil 5
    - Puntuación de Bishop < 7
    - Bolsa amniótica íntegra
    - No cesárea anterior
    - No contraindicación para parto vaginal ni para la inducción del parto.
    E.4Principal exclusion criteria
    - Fetal malformation
    - Fetal genetic abnormality
    - Congenital fetal infection
    - Malformación fetal
    - Anomalía genética fetal
    - Infección congénita fetal
    E.5 End points
    E.5.1Primary end point(s)
    - Vaginal delivery; [yes/no]
    - Parto vaginal; [si/no]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Delivery
    Parto
    E.5.2Secondary end point(s)
    Secondary efficacy variables:
    -Vaginal delivery in less than 24 hours from the start of induction;
    - Urgent cesarean section for suspected loss of fetal well-being
    - Achievement of cervical ripening
    - Duration of labor
    - Latent phase duration
    - Hyperstimulation during the latent phase
    - Hyperstimulation during the active phase
    - Intrapartum fever
    - Instrumental delivery
    - Shoulder dystocia
    - Severe maternal morbidity
    - Level of satisfaction (Mackey childbirth satisfaction rating scale;
    - Neonatal acidosis
    - Score on the Apgar test
    - Neonatal morbidity score
    - Admission to the Neonatal Intensive Care Unit
    - Duration of admission to the Neonatal Intensive Care Unit

    Control variables:
    - Maternal age at the time of delivery
    - Maternal weight at the beginning of pregnancy
    - Maternal size
    - Tobacco use during pregnancy
    - Alcohol consumption during pregnancy
    - Consumption of drugs of abuse during pregnancy
    - Type of drugs of abuse consumed
    - Ethnicity / race
    - Level of studies achieved
    - Conception method [spontaneous, artificial insemination, in vitro fertilization, egg donation]
    - Number of previous pregnancies
    - Number of previous vaginal deliveries
    - Number of previous caesarean sections
    - Number of previous intrauterine deaths
    - Number of previous abortions
    - Small fetus or intrauterine growth restriction in previous pregnancy
    - Preeclampsia in previous pregnancy
    - Chronic hypertension
    - Chronic kidney disease
    - Pregestational diabetes mellitus
    - Thrombophilia
    - Systemic lupus erythematosus
    - Antiplatelet medication
    - Anticoagulant medication
    - Prenatal genetic tests performed
    - Hypertensive disorder of pregnancy at the start of induction
    - Administration of corticosteroids for fetal maturation
    - Gestational age of the administration of corticosteroids
    - Gestational age at diagnosis of intrauterine growth restriction
    - Previous mean arterial pressure
    - Ultrasound parameters obtained in the 7 days prior to the start of induction:
    - Gestational age at the time of the ultrasound
    - Mean pulsatility index of both uterine arteries normalized by gestational age
    - Estimated fetal weight (in the previous 14 days)
    - Estimated fetal weight percentile
    - Greater vertical bag of amniotic fluid
    - Pulsatility index of umbilical artery, middle cerebral artery, cerebro-placental ratio
    - Spontaneous premature rupture of membranes at the start of induction
    - SARS-CoV-2 infection during pregnancy / delivery
    - Bishop's test at the start of induction
    - Gestational age at randomization
    - Randomization group
    - Foley balloon catheter insertion failure
    - Use of oxytocin
    - Duration of oxytocin use
    - Use of neuroaxial anesthesia
    - Duration of use of neuraxial anesthesia
    - Use of intrapartum antibiotic therapy
    - Failed induction / non-progression of labor
    - Gestational age at birth
    - Neonatal weight
    - Sex of the newborn
    - Suspicion of neonatal infection
    - Respiratory distress
    - Transient tachypnea of ​​the newborn
    - Meconium aspiration
    - Hypoglycemia
    - suffocation
    - Postpartum maternal complications
    - Duration of maternal admission
    Variables secundarias de eficacia:
    -Parto vaginal en menos de 24 horas desde inicio de la inducción;
    - Cesárea urgente por sospecha de perdida de bienestar fetal
    - Consecución de la maduración cervical
    - Duración del parto
    - Duración de fase latente
    - Hiperestimulación durante la fase latente
    - Hiperestimulación durante la fase activa
    - Fiebre intraparto
    - Parto instrumental
    - Distocia de hombros
    - Morbilidad materna severa
    - Nivel de satisfacción (Mackey childbirth satisfaction rating scale;
    - Acidosis neonatal
    - Puntuación en el test de Apgar
    - Score de morbilidad neonatal
    - Ingreso en Unidad de Cuidados Intensivos Neonatarles
    - Duración del ingreso en Unidad de Cuidados Intensivos Neonatales

    Variables de control:
    - Edad materna en el momento del parto
    - Peso materno al inicio de la gestación
    - Talla materna
    - Consumo de tabaco durante la gestación
    - Consumo de alcohol durante la gestación
    - Consumo de drogas de abuso durante la gestación
    - Tipo de drogas de abuso consumidas
    - Etnia/raza
    - Nivel de estudios alcanzado
    - Método de concepción [espontánea, inseminación artificial, fecundación in vitro, ovodonación]
    - Número de gestaciones previas
    - Número de partos vaginales previos
    - Número de cesáreas previas
    - Número de muertes intrauterinas previas
    - Número de abortos previos
    - Feto pequeño o restricción del crecimiento intrauterino en gestación previa
    - Preeclampsia en gestación previa
    - Hipertensión crónica
    - Enfermedad renal crónica
    - Diabetes mellitus pregestacional
    - Trombofilia
    - Lupus eritematoso sistémico
    - Medicación antiagregante
    - Medicación anticoagulante
    - Pruebas genéticas prenatales realizadas
    - Trastorno hipertensivo del embarazo al inicio de la inducción
    - Administración de corticoides para maduración fetal
    - Edad gestacional de la administración de corticoides
    - Edad gestacional al diagnóstico de restricción del crecimiento intrauterino
    - Tensión arterial media previa
    - Parámetros ecográficos obtenidos en los 7 días previos al inicio de la inducción:
    - Edad gestacional a la realización de la ecografía
    - Índice de pulsatilidad medio de ambas arterias uterinas normalizado por edad gestacional
    - Peso fetal estimado (en los 14 días previos)
    - Percentil de peso fetal estimado
    - Bolsa vertical mayor de líquido amniótico
    - Indice de pulsatilidad de arteria umbilical, de la arteria cerebral media, ratio cerebroplacentario
    - Rotura prematura de membranas espontánea al inicio de la inducción
    - Infección por SARS-CoV-2 durante el embarazo/parto
    - Test de Bishop al inicio de la inducción
    - Edad gestacional a la aleatorización
    - Grupo de aleatorización
    - Fallo de inserción de la sonda con balón de Foley
    - Uso de oxitocina
    - Duración del uso de oxitocina
    - Uso de anestesia neuroaxial
    - Duración del uso de la anestesia neuroaxial
    - Uso de antibioterapia intraparto
    - Fracaso de inducción / no progresión del parto
    - Edad Gestacional al nacimiento
    - Peso neonatal
    - Sexo del recién nacido
    - Sospecha de infección neonatal
    - Distrés respiratorio
    - Taquipnea transitoria del recién nacido
    - Aspiración meconial
    - Hipoglucemia
    - Asfixia
    - Complicaciones maternas del posparto
    - Duración del ingreso materno
    E.5.2.1Timepoint(s) of evaluation of this end point
    From hospital admission to delivery
    Desde el ingreso hospitalario hasta 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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Producto sanitario
    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 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 concerned3
    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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 172
    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 state172
    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 Decision2022-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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