Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-06 @ 4:52 PM
Study NCT ID:
NCT00545194
Status:
WITHDRAWN
Last Update Posted:
2025-09-04
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2002-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2007-10-16', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of vaginal deliveries within the 48 hours after cervical ripening', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Proportion of total vaginal deliveries', 'timeFrame': '48 hours'}, {'measure': 'Vaginal deliveries at 12 hours, 24 hours and 36 hours', 'timeFrame': '48 hours'}, {'measure': 'Number of hyperkinesia with or without fetal heart rate monitoring abnormalities', 'timeFrame': '48 hours'}, {'measure': 'Number of hypertonia with or without fetal heart rate monitoring abnormalities', 'timeFrame': '48 hours'}, {'measure': 'Apgar score at 5 min less or equal 7', 'timeFrame': '48 hours'}, {'measure': 'Apgar score at 10 min less or equal 7', 'timeFrame': '48 hours'}, {'measure': 'Arterial pH less or equal 7.20', 'timeFrame': '48 hours'}, {'measure': 'Arterial base excess more than 12', 'timeFrame': '48 hours'}, {'measure': 'Number of maternal post-partum haemorrhage', 'timeFrame': '48 hours'}, {'measure': 'Time to reach 3cm cervical dilatation', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostaglandin E2', 'Intravaginal gel', 'Bishop score', 'Induction of labor', 'randomized trial', 'Vaginal insert'], 'conditions': ['Cervical Ripening', 'Labor, Induced']}, 'referencesModule': {'references': [{'pmid': '11236117', 'type': 'BACKGROUND', 'citation': 'Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x.'}, {'pmid': '16553177', 'type': 'BACKGROUND', 'citation': 'Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685.'}, {'pmid': '17071427', 'type': 'BACKGROUND', 'citation': 'El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two different preparation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy\n* cephalic presentation\n* gestation of more than 37 Weeks confirmed by ultrasound\n* Bishop score less than 7\n* Informed consent\n\nExclusion Criteria:\n\n* previous cesarean section (scarred uterus)\n* polyhydramnios\n* multiple pregnancy\n* fetal malformation'}, 'identificationModule': {'nctId': 'NCT00545194', 'briefTitle': 'Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy', 'orgStudyIdInfo': {'id': 'PROPESS Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'sustained release preparation of prostaglandin E2', 'interventionNames': ['Drug: Prostaglandin E2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'short-acting (instant-released) preparation of prostaglandin E2', 'interventionNames': ['Drug: Prostaglandin E2']}], 'interventions': [{'name': 'Prostaglandin E2', 'type': 'DRUG', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Olympe de Gouges Women Health Centre, Bretonneau University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Franck Perrotin, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tours Universiity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}