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    Summary
    EudraCT Number:2012-004880-36
    Sponsor's Protocol Code Number:CRB
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004880-36
    A.3Full title of the trial
    Efficacy of induction of labor on term using a double balloon catheter compared to Dinoprostone vaginal-insert – a multicenter randomized controlled trial.
    Erfolgsrate bei Geburtseinleitung am Termin mittels Doppelballon-Einleitungskatheter verglichen mit Dinoproston Vaginal-Insert – eine prospektive multizentrisch-randomisierte Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Success rate of initiation of birth process at term by inserting a balloon into the cervix compared by inserting a vaginal delivery system (dinoprostone).
    Erfolgsrate bei Einleitung des Geburtsvorganges am Termin durch Einlegen eines Ballons in den Muttermund im Vergleich durch Einlegen eines vaginalen Freisetzungssystem (Dinoproston).
    A.4.1Sponsor's protocol code numberCRB
    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 SponsorMedizinische Universität Graz, Klinische Abteilung für Geburtshilfe, Univ. Klinik für Frauenheilkunde und Geburtshilfe
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz,Devision of Gynecology
    B.5.2Functional name of contact pointObstetrics & Gynecology Department
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 14
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number4331638512150
    B.5.5Fax number4331638514197
    B.5.6E-mailobgyn@medunigraz.at
    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
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 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 INNDinoproston
    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.3.11 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
    Gestational age between the 37th and 42th gestation week
    Gestationsalter zwischen der 37. und 42. Schwangerschaftswoche
    E.1.1.1Medical condition in easily understood language
    Pregnant Women between the 37th and 42th gestation week
    Schwangere Frauen in der 37. und 42. Schwangerschaftswoche
    E.1.1.2Therapeutic area Not possible to specify
    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
    Time between first intervention (Balloon Application or Propess administration) and birth in treatment arm 1 and 2.
    Zeitraum zwischen Erstintervention (Ballon-Applikation oder Propess-Erstgabe) und Geburt in Therapiearm 1 und 2.
    E.2.2Secondary objectives of the trial
    1.Time interval from first treatment (balloon application/first Propess application) to cervical dilating progress of labor;2.Time interval from first treatment (balloon application/first Propess application) to continous labor (>6contractions/hour);3.Percentage of patients in arm 1 and 2,who achieve vaginal or vaginal-operative delivery;4.Percentage of patients in arm 1 and 2,who underwent caesarean section after failed induction of labor.Failed induction of labor is defined as not-achieving vaginal delivery after balloon application+2xPropess application in arm 1 and 3xPropess application in arm 2;5.Patient satisfaction with treatment in arm 1 and 2;6.Neonatal Parameters:Fetal and/or neonatal morbidity and/or mortality (pH-levels,Base Exsess,APGAR,fetal birth weight,admission to ICU,days at ICU);7.Maternal Parameters:Signs of infection or inflammation (temp>38,5°, WBC>25%+CRP-elevation >25%compared to hospital admission), cervical tear,vaginal tear, episoiotomy), epidural anaesthesia
    1.Zeitraum bis zum Erreichen eines muttermundswirksamen Geburtsfortschritts nach Zervixreifung in Therapiearm 1 im Vergleich zu Arm 2. 2.Zeitraum bis zum Einsetzen regelmäßiger Wehentätigkeit 3.Anzahl der Patientinnen in Therapiearm 1 und 2,die eine vaginale oder vaginal-operative Entbindung erreichen.4.Anzahl der Patientinnen in Therapiearm 1 und 2,die nach frustraner Einleitung eine primäre Sectio erhalten.Eine frustrane Einleitung wird als Nichterreichen einer Spontangeburt nach Ballon-Applikation + 2x Propessapplikation (Arm 1) bzw.3x Propessapplikation (Arm 2) definiert.5.Patientinnenzufriedenheit 6.Kindliche Parameter:Fetale, neonatale Morbidität oder Mortalität (pH-Werte, Base Exsess, APGAR, Geburtsgewicht, Aufnahme bzw. Aufenhaltsdauer Intensivstation/Frühgeburtenstation)7.Mütterliche Parameter:Infektionszeichen (Temperatur >38,5°, Leukoanstieg >25 % zum Ausgangswert, CRP-Anstieg > 25 % zum Ausgangswert), Häufigkeit von Zervixrissen, Scheidenrissen+Episoiotomien), PDA ja/nein
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Maternal age > 18 years Alter
    Signed Informed Consent
    Singleton Pregnancy
    Cephalic presentation
    no preterm rupture of membranes
    gestational age: 37+0 – 42+0 weeks
    unfavourable cervix (Bishop-Score ≤ 6)
    absence of contra-indications for pharmaceutical induction of labor
    no clinical signs of infection or inflammation (temperature < 37,5, WBC < 20.000, C-reactive protein < 20)
    Alter über 18 Jahre
    Unterschriebene Einverständniserklärung
    Einlingsschwangerschaft
    Fetale Schädellage
    Intakte Fruchtblase
    Gestationsalter 37+0 – 42+0 SSW
    unreifer Zervixbefund (Bishop-Score ≤ 6)
    keine Kontraindikationen für eine medikamentöse Einleitung
    kein klinischer Hinweis auf Vorliegen einer Infektion (Temperatur < 37,5, Leukozyten
    < 20.000, CRP < 20)
    E.4Principal exclusion criteria
    Fetal malformation
    Presence of contra-indications for pharmaceutical induction of labor
    Placentation disorders
    History of uterine surgery with opening of the uterine cavum incl. ceasaren section.
    preterm rupture of membranes
    multiple gestations
    gestational age < 37+0 weeks
    History of surgery for cervical tear
    Fetale Fehlbildungen
    Vorliegen von Kontraindikation für medikamentöse Einleitung
    bekannte Plazentationsstörung
    Zustand nach Cavum-eröffnenden Uterusoperationen inkl. Sectio
    Vorzeitiger Blasensprung
    Mehrlingsschwangerschaften
    Gestationsalter < 37+0 SSW
    Zustand nach Zervixriss
    E.5 End points
    E.5.1Primary end point(s)
    1. Due to the use of a cook balloon catheter an effective birth cervix progress (defined as Bishop score ≥ 9 and / or cervical dilatation ≥ 3 cm) patients with unripe cervix (Bishop score ≤ 6) can be performed.
    2. The time intervall between the first intervention and the birth is shorter for inducing labor with balloon application than first propess application.
    3. The proportion of patients who receive after failed induction of labor a caesarean is lower than balloon induction
    1. Durch den Einsatz eines Cook Ballonkatheters kann eine muttermundswirksamer Geburtsfortschritt (definiert als Bishop Score ≥ 9 und/oder Muttermundsweite ≥ 3 cm) bei Patientinnen mit unreifer Cervix (Bishop-Score ≤ 6) durchgeführt werden.
    2. Der Zeitraum zwischen Erstintervention und Geburt ist kürzer bei Geburtseinleitung mittels Ballon-Applikation als bei Propess-Erstgabe.
    3. Der Anteil der Patientinnen die nach "frustraner Einleitung" einen Kaiserschnitt erhalten ist bei Ballon-Einleitung geringer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, Day 1, Day 2, Day 3, postpartal: within 48 hours
    Tag 0, Tag 1, Tag 2, Tag 3, postpartal: binnen 48 Stunden
    E.5.2Secondary end point(s)
    The patients are more satisfied with the implementation of a balloon than propess-induction.
    Die Patientinnen sind mit der Durchführung einer Ballon-Einleitung zufriedener als bei Propess-Einleitung
    E.5.2.1Timepoint(s) of evaluation of this end point
    postpartal: within 48 hours
    postpartal: binnen 48 Stunden
    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 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) 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
    Cervical Ripening Ballon (Preinduction cervical dilation)
    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 concerned8
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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: 253
    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 No
    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 state253
    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
    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 Decision2013-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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