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    Summary
    EudraCT Number:2013-002884-24
    Sponsor's Protocol Code Number:Quadruple-P-Study
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002884-24
    A.3Full title of the trial
    Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length
    Pessarium of progesteron ter preventie van vroeggeboorte in vrouwen met een korte cervixlengte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length
    Pessarium of progesteron ter reventie van vroeggeboorte in vrouwen met een korte cervixlengte
    A.3.2Name or abbreviated title of the trial where available
    Quadruple P Trial
    Quadruple P Studie
    A.4.1Sponsor's protocol code numberQuadruple-P-Study
    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 SponsorAMC
    B.1.3.4CountryNetherlands
    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 supportAMC Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMC
    B.5.2Functional name of contact pointE. Pajkrt
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205669111
    B.5.6E-mailquadruplep@amc.uva.nl
    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 Utrogestan
    D.2.1.1.2Name of the Marketing Authorisation holderBesins Health Care
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic micronized progesterone
    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
    vroeggeboorte
    E.1.1.1Medical condition in easily understood language
    preterm birth
    vroeggeboorte
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023555
    E.1.2Term Labour premature
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023545
    E.1.2Term Labor premature
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036594
    E.1.2Term Premature birth
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10036600
    E.1.2Term Premature labour
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036599
    E.1.2Term Premature labor
    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 effectiveness of vaginal progesterone and cervical pessary in the prevention of preterm birth in women with singleton and twin pregnancies and a short cervix.
    Vergelijken van de effectiviteit van vaginaal progesteron of pessarium ter preventie van vroeggeboorte in eenling en tweeling zwangerschappen van vrouwen met een korte cervix.
    E.2.2Secondary objectives of the trial
    not applicable
    niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less
    2. Twin pregnancy and cervical length at 16 to 22 weeks of 38 mm or less
    1. Eenling zwangerschap en cervixlengte van 35 millimeter of minder bij 18 tot 22 weken zwangerschap
    2. Tweeling zwangerschap en cervixlengte van 38 millimeter of minder bij 16 tot 22 weken zwangerschap
    E.4Principal exclusion criteria
    1. Cervical cerclage in this pregnancy
    2. Maternal age less than 18 years
    3. Identified major congenital abnormalities in this pregnancy
    4. Death of one or both of the foetuses in this pregnancy
    5. Spontaneous preterm birth before 34 weeks in previous pregnancy
    6. Participation Quadruple P study in previous pregnancy
    7. Cervical length less then 2mm
    8. Cervical dilatation of 3cm or more

    1. Cervicale cerclage in deze zwangerschap
    2. Leeftijd moeder onder de 18 jaar
    3. Geïdentificeerde congenitale afwijkingen in deze zwangerschap
    4. Spontane vroeggeboorte voor 34 weken in voorgaande zwangerschap
    5. Dood van een of beide foetussen
    6. Eerdere deelname aan Quadruple P studie in vorige zwangerschap
    7. Cervicale lengte van minder dan 2mm
    8. Cervicale dilatatie van 3cm of meer
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is composite adverse neonatal outcome. This composite outcome contains periventricular leukomalacia (PVL) > grade 1, severe respiratory distress syndrome (RDS) bronchopulmonary Dyplasia (BPD), Intraventricular Haemorrhage grade II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis, stillbirth and death before discharge from the nursery.
    Primaire uitkomstmaat is een samengestelde slechte neontale uitkomst. Deze uitkomst bestaat uit de volgende onderdelen: periventriculaire leukomalacie > graad 1. Ernstig respiratory , bronchopulmonaire dysplasie, intraventriculiare bloeding graad II of hoger, necrotiserende aenterocolitis, bewezen sepsis, intra-uterine vruchtdood en overlijden voor ontslag.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Information will be gathered when pregnancy has finished and the child is discharged.
    Informatie wordt verzameld na de geboorte van het kind en wanneer het kind is ontslagen uit het ziekenhuis.
    E.5.2Secondary end point(s)
    Secondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal and admission days for preterm labour and costs. Follow up of the children will be planned depending on the outcome of the trial.
    Secundaire uitkomstmaten: tijd tot bevalling na behandeling, vroeggeboorte ratio's voor 28, 32, 34 en 37 weken zwangerschap, opname dagen op de neonatale intensive care, maternale morbiditeit, maternale opname dagen en opname dagen voor dreigende vroeggeboorte en kosten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Information will be gathered when pregnancy has finished and the child is discharged.
    After the corrected age of 2 years information on long term follow-up will be collected.
    Informatie wordt verzameld na de geboorte van het kind en wanneer het kind is ontslagen uit het ziekenhuis.
    Tevens wordt bij een gecorrigeerde leeftijd van 2 jaar informatie verzameld of de lange termijn follow-up
    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 No
    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) 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 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
    Arabin pessarium
    Arabin pessary
    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 concerned33
    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 Yes
    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
    If 700 patients are randomized. Or if the data monitoring commission intervenes within the trial
    process.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 1020
    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 state960
    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)
    This trial runs only during pregnancy. Once pregnancy has finished further obstetric care is not indicated besides possible pediatric care.
    In case of preliminary dropout obstetric care will be given according to local protocol.
    De studie loopt gedurende de zwangerschap, wanneer de zwangerschap is afgelopen, waarmee ook het onderzoek, dan is verdere zorg niet nodig behalve kindergeneeskundige zorg.
    Bij een vroegtijdige dropout zal obstetrische zorg volgens locale protocollen en richtlijnen gegeven worden.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AMC Amsterdam
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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