Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT03310333
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2017-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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', 'maskingDescription': 'open'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time between the beginning of the induction of labor and the delivery', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'Time limits between the PROM and the beginning of induction', 'timeFrame': 'at day 1'}, {'measure': 'Rate of delivery in the first 24 hours', 'timeFrame': 'at day 1'}, {'measure': 'Application time of Cook® balloon', 'timeFrame': 'at day 1'}, {'measure': 'Application time of Propess®', 'timeFrame': 'at day 1'}, {'measure': 'Time between labour induction and vaginal delivery', 'timeFrame': 'at day 1'}, {'measure': 'Rate of vaginal delivery with and without extraction', 'timeFrame': 'at day 1'}, {'measure': 'Rate of cesarean', 'timeFrame': 'at day 1'}, {'measure': 'Rate of delivery hemorrhage', 'timeFrame': 'at day 1'}, {'measure': 'Bischop score when Cook balloon is fallen or retry', 'timeFrame': 'at day 1'}, {'measure': 'Rate of balloon present after 12 hours', 'timeFrame': 'at day 1'}, {'measure': 'Rate of anomaly of fetal heart rate leading stop of dinoprostone', 'timeFrame': 'at day 1'}, {'measure': 'Rate of epidural analgesia', 'timeFrame': 'at day 1'}, {'measure': 'Time to obtain active labour', 'timeFrame': 'at day 1'}, {'measure': 'Time to obtain complete cervix dilatation', 'timeFrame': 'at day 1'}, {'measure': 'Rate of fever during the labour', 'timeFrame': 'at day 1'}, {'measure': 'Rate of uterine hyperkinesias', 'timeFrame': 'at day 1'}, {'measure': 'Rate of clinic chorio-amnionitis defined by Newton criteria', 'timeFrame': 'at day 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PROM', 'Dinoprostone', 'cervical ripening device', 'oxytocin'], 'conditions': ['PROM (Premature Rupture Of Foetal Membrane)']}, 'referencesModule': {'references': [{'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.'}, {'pmid': '31227530', 'type': 'DERIVED', 'citation': 'Devillard E, Delabaere A, Rouzaire M, Pereira B, Accoceberry M, Houlle C, Dejou-Bouillet L, Bouchet P, Gallot D. Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments. BMJ Open. 2019 Jun 20;9(6):e026090. doi: 10.1136/bmjopen-2018-026090.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.', 'detailedDescription': "The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.\n\nIf the cervix is unfavourable (cervical Bishop's score \\<6), the information of the study is given to the patient and the consent collected.\n\nAn antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.\n\nAfter randomization, the patient is included in one of the two groups: Cook ® balloon or Propess ®.\n\n* In the Cook cervical ripening balloon group: the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin\n* In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.\n\nAfter 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.\n\n* The fetal heart rate is monitoring 30 minutes before and after the insertion of the device. After, the patient has a monitoring each 6 hours.\n* Since the oxytocin is started, the monitoring is registered in continue until the delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women\n\n * 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clinic or biologic (ActimProm® test).\n\nUnfavourable cervix (Bishop's score \\< 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system\n\nExclusion Criteria:\n\n* Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic Contraindication of vaginal delivery (placenta praevia, …) Temperature \\> 38,2°C Suspicion of chorio-amnionitis among Newton requirements Intra-uterine growth restriction \\< 3rd percentile with Doppler abnormalities History of cesarean and uterine scare Suspected genital herpes infection Known VIH seropositivity (confirmed by blood serology) Fetus with suspected severe congenital abnormalities Pathological fetal heart rate (see appendix 1) Contra-indications to Propess®, Cook® Cervical Ripening Balloon, Oxytocin Women under guardianship or trusteeship"}, 'identificationModule': {'nctId': 'NCT03310333', 'acronym': 'RUBAPRO', 'briefTitle': 'Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Comparison Between Two Strategies of Induction in Case of Unfavourable Cervix After 12 Hours of Premature Rupture of Membranes (PROM) at Term: Cook Cervical Ripening + Oxytocine From 6 Hours Versus Dinoprostone Vaginal Insert', 'orgStudyIdInfo': {'id': 'CHU-352'}, 'secondaryIdInfos': [{'id': '2017-A00811-52', 'type': 'OTHER', 'domain': '2017-A00811-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cook cervical ripening', 'description': 'the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin', 'interventionNames': ['Device: cook cervical pipening balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dinoprostone vaginal group', 'description': 'the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.\n\nAfter 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.', 'interventionNames': ['Drug: Propess® (dinoprostone)']}], 'interventions': [{'name': 'Propess® (dinoprostone)', 'type': 'DRUG', 'description': "The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.\n\nIf the cervix is unfavourable (cervical Bishop's score \\<6), the information of the study is given to the patient and the consent collected.\n\nAn antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.", 'armGroupLabels': ['Dinoprostone vaginal group']}, {'name': 'cook cervical pipening balloon', 'type': 'DEVICE', 'description': '• In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.', 'armGroupLabels': ['Cook cervical ripening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Denis GALLOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Denis GALLOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}