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    Summary
    EudraCT Number:2020-005202-26
    Sponsor's Protocol Code Number:OPTIM-PTL
    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:2026-01-22
    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 number2020-005202-26
    A.3Full title of the trial
    OPTIM-PTL study: Optimization of the treatment of pregnant women with preterm labor and intact membranes applying multivariate prediction models
    Estudio OPTIM-PTL: Optimización del tratamiento de gestantes con trabajo de parto prematuro y membranas íntegras aplicando modelos de predicción multivariable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To individualise management of women in preterm labor
    Individualizar el manejo de mujeres con amenaza de parto pretérmino
    A.3.2Name or abbreviated title of the trial where available
    OPTIM-PTL
    OPTIM-PTL
    A.4.1Sponsor's protocol code numberOPTIM-PTL
    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 SponsorFundació de Recerca Clínic Barcelona_ Institut d'Investigacions Biomèdiques Augustí Pi i Sunyer Barcelona
    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 supportBeca del Instituto de Salud Carlos III PI21/00972.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació de Recerca Clínic Barcelona_ Institut d'Investigacions Biomèdiques Augustí Pi i Sunyer Barcelona
    B.5.2Functional name of contact pointmpalacio
    B.5.3 Address:
    B.5.3.1Street AddressSabino Arana
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.6E-mailmpalacio@clinic.cat
    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 Celestone cronodose
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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 nameCelestone cronodose
    D.3.2Product code 40.628
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETAMETHASONE
    D.3.9.1CAS number 378-44-9
    D.3.9.3Other descriptive nameBETAMETHASONE
    D.3.9.4EV Substance CodeSUB05797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.4
    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
    Preterm birth
    Parto pretérmino
    E.1.1.1Medical condition in easily understood language
    prematurity
    prematuridad
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:
    1. Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
    Evaluar si la implementación de un modelo de predicción de riesgo de parto pretérmino espontáneo o de infección intra-amniótica:
    1. optimiza el manejo antenatal (respecto corticoides, tocolisis, antibióticos, estancia hospitalaria) sin empeorar los resultados perinatales.
    E.2.2Secondary objectives of the trial
    To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:
    2. It is a cost-effective strategy.
    3. It improves neonatal outcome (in premature newborns < 30 weeks), and reduces infectious maternal morbidity.
    4. It improves neurodevelopmental outcome at 1, 2 and 5 years.
    Evaluar si la implementación de un modelo de predicción de riesgo (de parto pretérmino espontáneo o de infección intra-amniótica):
    2. es una estrategia costo-efectiva.
    3. mejora el pronóstico neonatal (en prematuros < 30 semanas), y reduce la morbilidad materna de tipo infeccioso.
    4. mejora el neurodesarrollo al 1, 2 y 5 años de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
    Mujeres gestantes con gestaciones únicas ingresadas con el diagnóstico de amenaza de parto pretérmino entre las 23.0 y 34.6 semanas que no estén en fase activa del parto en el momento de la randomización y que no cumplan criterios de exclusión.
    E.4Principal exclusion criteria
    1- women who do not accept to be part of the study;
    2- maternal age < 18 years,
    3- multiple gestations,
    4- clinical chorioamnionitis at randomization (defined by the presence of fever ≥ 38ºC, fetal tachycardia (> 160 heart beat per minute > 10 minutes), maternal White blood cells > 15000/mm3 (not justified by the administration of antenatal steroids)
    5- cervical dilatation > 3 cm;
    6- major structural malformations of fetal complications that are related to neurodevelopmental impairment,
    7- technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).
    1- Mujeres que no acepten participar en el estudio;
    2- edad < 18 años;
    3- gestaciones múltiples;
    4- signos clínicos de corioamnionitis definidos por la presencia de fiebre materna ≥ 38ºC, taquicardia fetal (> 160 latidos por minuto durante > 10 minutos sin otra causa que lo justifique) y leucocitosis materna > 15000/mm3 (no explicada por el efecto de los corticoides);
    5- dilatación cervical > 3 cm;
    6- malformaciones estructurales mayores, cromosómicas o complicaciones fetales previas a la inclusión en el estudio que condicionen un defecto en el neurodesarrollo;
    7- imposibilidad técnica de realizar una amniocentesis (ya que los modelos de predicción incluyen información obtenida en el líquido amniótico, como la concentración de glucosa y IL-6).
    E.5 End points
    E.5.1Primary end point(s)
    1- Number of antenatal steroid dosed administered.
    2- Maternal hospital length stay (days).
    1- Número de dosis de corticoides antenatales administrados.
    2- Días de ingreso hospitalario materno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    We planned duration of the study around 2 years for objectives 1-3 and 7 years for objective 4.
    Se estima una duración del estudio de 2 años para los objetivos 1-3 y de 7 años para el objetivo 4.
    E.5.2Secondary end point(s)
    3- Gestational age at delivery.
    4- Spontaneous delivery within 7 days from admission (yes/no), defined as the latency from admission to delivery less or equal to 7 days.
    5- Intra-amniotic infection (yes/no), defined as the presence of microorganisms in the amniotic fluid identified using aerobic/anaerobic/genital mycoplasma cultures or 16S rRNA gene sequencing.
    6- Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need of transfusion, maternal death.
    7- Neonatal stay length duration (days).
    8- Neonatal anthropometric data: birthweight, height, cephalic, thoracic and abdominal perimeters, arm circumference
    9- Major neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal dead, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotising enterocolitis, retinopathy that needs laser.
    10- Neurodevelopmental impairment (yes/no) and definition of the domains involved: communication, fine motor, gross motor, problem solving and personal-social.
    11- Cost analysis: costs were calculated as the product of resource use and unit costs. Resource use during the study period was documented. The following resource items were collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, medication, maternal laboratory tests, neonatal monitoring. Maternal admissions were differentiated into three levels of care (intensive, medium, ward). Neonatal admissions were divided into four levels of care (intensive, high, medium ward). Ward admissions of newborns were not calculated; these costs were already incorporated in costs of maternal ward admissions. Use of the labor room was calculated as hours between admission to labor room and birth plus 1 h extra for extended recovery care.
    3- Edad gestacional al parto.
    4- Parto espontáneo en 7 días desde el ingreso (SI/NO), definido como la latencia desde ingreso por amenaza de parto pretérmino al parto menor a 7 días.
    5- Infección intra-amniótica (SI/NO), definida por la presencia de microorganismos en líquido amniótico identificados mediante cultivo aerobios/anaerobios/o micoplasma genital.
    6- Morbilidad materna (SI/NO) que incluye fiebre intraparto, endometritis, infección herida quirúrgica, sepsis, necesidad de legrado, ingreso en UCI, histerectomía, necesidad de transfusión, muerte materna
    7- Días de ingreso neonatal.
    8- Datos antropométricos neonatales como talla, peso, perímetro cefálico, torácico, abdominal y circunferencia media del brazo.
    9- Morbilidad neonatal grave (SI/NO) definida por la presencia de muerte fetal, muerte neonatal, sepsis precoz, displasia broncopulmonar moderada/severa, hemorragia intraventricular severa, leucomalacia periventricular, enterocolitis necrotizante quirúrgica y retinopatía del prematuro tratado con láser.
    10- Alteración Neurodesarrollo (SI/NO) y de qué dominio (cognitivo, visuales, habilidades motoras finas y gruesas, memoria, lenguaje receptivo y expresivo y velocidad de procesamiento) valorados mediante cuestionarios ASQ-3 y test de Bayley III.
    11- Análisis de costes: Costes derivados del ingreso materno en función de los 3 niveles de riesgo (intensivo (UCOI), medio (sala hospitalización), sala de partos). Costes visitas ambulatorias hasta el parto, costes medicación y costes pruebas complementarias realizadas durante ingreso. Costes ingreso neonatal en función de los 4 niveles de riesgo (UCIN, intermedios, sala hospitalización, no ingreso).
    E.5.2.1Timepoint(s) of evaluation of this end point
    We planned duration of the study around 2 years for objectives 1-3 and 7 years for objective 4.
    Se estima una duración del estudio de 2 años para los objetivos 1-3 y de 7 años para el objetivo 4.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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
    Práctica clínica habitual
    Usual clinical management
    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 concerned4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 370
    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 state370
    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 Decision2021-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-05
    P. End of Trial
    P.End of Trial StatusOngoing
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