Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-07 @ 1:42 AM
Study NCT ID:
NCT01720394
Status:
UNKNOWN
Last Update Posted:
2018-09-11
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015232', 'term': 'Dinoprostone'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 253}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time interval from primary treatment to delivery', 'timeFrame': 'maximum of 72 hours', 'description': 'the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured'}], 'secondaryOutcomes': [{'measure': 'progress of labor', 'timeFrame': 'maximum of 72 hours', 'description': 'time from balloon-application to dilatation of the cervix (cervical opening \\> 3cm, or Bishop Score ≥ 9 ) in therapy arm 1 and from dinoprostone-vaginal-insert-application to dilatation of the cervix (cervical opening \\> 3cm, or Bishop Score ≥ 9 ) in therapy arm 2'}, {'measure': 'vaginal delivery', 'timeFrame': 'maximum of 72 hours', 'description': 'Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.'}, {'measure': 'failed induction of labor', 'timeFrame': 'maximum of 72 hours', 'description': 'Number of patients who received caesarean section after frustrating induction of labor. Frustrating induction is defined as application of the cervical-ripening-balloon + 2 times application of dinoprostone-vaginal-insert in therapy arm 1 and 3 times application of dinoprostone-vaginal-insert in therapy arm 2.'}, {'measure': "patient's satisfaction", 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5-7 days', 'description': "Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery"}, {'measure': 'maternal parameters', 'timeFrame': 'primary treatment - 48h postpartal, leading to a maximum time frame of 5 days', 'description': 'signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.'}, {'measure': 'fetal parameters', 'timeFrame': 'primary treatment - fetal hospital discharge, with an expected maximum of 3 months', 'description': 'umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Ripening', 'Induction of Labor']}, 'referencesModule': {'references': [{'pmid': '17051727', 'type': 'BACKGROUND', 'citation': 'Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S. Births: final data for 2004. Natl Vital Stat Rep. 2006 Sep 29;55(1):1-101.'}, {'pmid': '8888040', 'type': 'BACKGROUND', 'citation': 'Sherman DJ, Frenkel E, Tovbin J, Arieli S, Caspi E, Bukovsky I. Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review. Obstet Gynecol Surv. 1996 Oct;51(10):621-7. doi: 10.1097/00006254-199610000-00022.'}, {'pmid': '1876873', 'type': 'BACKGROUND', 'citation': 'Husslein P. Use of prostaglandins for induction of labor. Semin Perinatol. 1991 Apr;15(2):173-81. No abstract available.'}, {'pmid': '11687101', 'type': 'BACKGROUND', 'citation': 'Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.'}, {'pmid': '18715244', 'type': 'BACKGROUND', 'citation': 'Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.'}, {'pmid': '21962943', 'type': 'BACKGROUND', 'citation': 'Kehl S, Ehard A, Berlit S, Spaich S, Sutterlin M, Siemer J. Combination of misoprostol and mechanical dilation for induction of labour: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):315-9. doi: 10.1016/j.ejogrb.2011.09.010. Epub 2011 Oct 2.'}, {'pmid': '19656148', 'type': 'BACKGROUND', 'citation': "Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28."}, {'pmid': '21806490', 'type': 'BACKGROUND', 'citation': 'Mei-Dan E, Walfisch A, Suarez-Easton S, Hallak M. Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial. J Matern Fetal Neonatal Med. 2012 Jun;25(6):723-7. doi: 10.3109/14767058.2011.591459. Epub 2011 Aug 2.'}, {'pmid': '9366720', 'type': 'BACKGROUND', 'citation': 'Calder AA. Review of prostaglandin use in labour induction. Br J Obstet Gynaecol. 1997 Oct;104 Suppl 15:2-7; discussion 20-5. No abstract available.'}, {'pmid': '22704766', 'type': 'BACKGROUND', 'citation': 'Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.'}, {'pmid': '36996264', 'type': 'DERIVED', 'citation': 'de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.'}], 'seeAlsoLinks': [{'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000363246&QV1=DINOPROSTONE', 'label': 'Drug Information on Dinoprostone'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medical indication for induction of labor\n* 18 years of age\n* signed informed consent\n* cephalic presentation\n* no PROM\n* 37+0 - 42+0 weeks of gestation\n* Bishop-Score ≤ 6\n* no contra-indication for medical induction of labor\n* no clinical signs of infection\n\nExclusion Criteria:\n\n* fetal anomalies\n* contra-indications for medical induction of labor\n* placental pathologies\n* St.p. surgery with opening the uterine cavity (incl. caesarean section)\n* PROM\n* multiple gestations\n* \\< 37-0 weeks of gestation\n* St.p. cervical tear'}, 'identificationModule': {'nctId': 'NCT01720394', 'briefTitle': 'Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MUG-CRB-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical ripening balloon', 'description': 'primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.', 'interventionNames': ['Device: Cervical Ripening Balloon, Cook Medical Inc.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propess', 'description': 'Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)', 'interventionNames': ['Drug: Dinoprostone']}], 'interventions': [{'name': 'Cervical Ripening Balloon, Cook Medical Inc.', 'type': 'DEVICE', 'otherNames': ['Cook cervical ripening balloon, Cook OB/GYN, Spencer, IN, 47460 USA - CE 0088, 400470E', 'Propess-vaginal-insert (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria'], 'description': 'Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.', 'armGroupLabels': ['Cervical ripening balloon']}, {'name': 'Dinoprostone', 'type': 'DRUG', 'otherNames': ['Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria'], 'description': 'Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2.', 'armGroupLabels': ['Propess']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-5280', 'city': 'Braunau am Inn', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christiane Freudl, MD', 'role': 'CONTACT', 'email': 'Christiane.Freudl@khbr.at', 'phone': '0043-7722-804-5858'}, {'name': 'Gottfried Hasenöhrl, MD', 'role': 'CONTACT', 'email': 'gottfried.haseoehrl@khbr.at', 'phone': '0043- 7722-804-5800'}, {'name': 'Christiane Freudl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gottfried Hasenöhrl', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau', 'geoPoint': {'lat': 48.25628, 'lon': 13.04343}}, {'zip': 'A-8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Philipp Reif, MD', 'role': 'CONTACT', 'email': 'philipp.reif@medunigraz.at', 'phone': '004331638580053'}, {'name': 'Philipp Klaritsch, MD', 'role': 'CONTACT', 'email': 'philipp.klaritsch@medunigraz.at', 'phone': '004331638581641'}, {'name': 'Philipp Reif, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philipp Klaritsch, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-8230', 'city': 'Hartberg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stefan Schosteritsch, MD', 'role': 'CONTACT', 'email': 'Stefan.Schosteritsch@lkh-hartberg.at'}, {'name': 'Saskia de Bruin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg', 'geoPoint': {'lat': 47.28333, 'lon': 15.96667}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Johanna Tiechl, MD', 'role': 'CONTACT', 'email': 'Johanna.Tiechl@i-med.ac.at'}, {'name': 'Angela Ramoni, MD', 'role': 'CONTACT', 'email': 'Angela.RAMONI@uki.at', 'phone': '004351250481444'}, {'name': 'Johanna Tiechl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-9020', 'city': 'Klagenfurt', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christoph Herbst, MD', 'role': 'CONTACT', 'email': 'christoph.herbst@kabeg.at', 'phone': '0043 463 438 26417'}, {'name': 'Daniela Wolin, MD', 'role': 'CONTACT', 'email': 'daniela.wolin@kabeg.at', 'phone': '0043 463 438 0'}, {'name': 'Manfred Mörtl, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christoph Herbst, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': 'A-5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Claudius Fazelnia, MD', 'role': 'CONTACT', 'email': 'c.fazelnia@salk.at'}, {'name': 'Claudius Fazelnia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Hanns Helmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Philipp Reif, MD', 'role': 'CONTACT', 'email': 'philipp.reif@medunigraz.at', 'phone': '004331638580053'}, {'name': 'Philipp Klaritsch, MD', 'role': 'CONTACT', 'email': 'philipp.klaritsch@medunigraz.at', 'phone': '004331638581641'}], 'overallOfficials': [{'name': 'Philipp Klaritsch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Graz'}, {'name': 'Philipp Reif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'Klinikum Klagenfurt am Wörthersee', 'class': 'OTHER'}, {'name': 'University of Salzburg', 'class': 'OTHER'}, {'name': 'Hospital Hartberg, Austria', 'class': 'UNKNOWN'}, {'name': 'Hospital Braunau, Austria', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}