Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04566705
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014597', 'term': 'Uterine Rupture'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the risks factors of uterine rupture', 'timeFrame': '1 day', 'description': 'Assess the risks factors of uterine rupture\n\nAssess the risks factors of uterine rupture using obstetric measures'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Assess the maternal and perinatal complications and outcomes', 'timeFrame': '1 day', 'description': 'Number of Participants withAssess the maternal and perinatal complications and outcomes : looking for maternal complications (chorioamnionitis , transfusion, post-partum hemorrhage, surgery for blad-der wound, maternal death,…) and neonatal comply-cations (apgar\\<7 at 5minutes, pH \\<7,15, neonatal intein-sive care unit and perinatal death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risks factors', 'Uterine rupture after a previous cesarean delivery', 'Vaginal birth after cesarean', 'Prior cesarean', 'Perinatal outcome'], 'conditions': ['Uterine Rupture', 'Mode of Delivery']}, 'descriptionModule': {'briefSummary': 'Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.\n\nIdentifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.\n\nThe aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with uterine rupture after previous cesarean delivery versus women without uterine rupture after previous cesarean delivery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Singleton pregnancy \\> 24 weeks of gestation\n* Second or multiparous with a previous cesarean section without vaginal delivery since\n* Cephalic presentation or completed breech\n* Uterine rupture during labor\n\nExclusion criteria:\n\n* Incomplete uterine rupture\n* Multiple gestation\n* Transverse presentation or complete breech\n* Vaginal delivery after cesarean\n* Non-low transverse cesarean section\n* Placenta praevia\n* Antepartum intrauterine fetal death\n* History of uterine surgery (myomectomy)'}, 'identificationModule': {'nctId': 'NCT04566705', 'briefTitle': 'Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes', 'orgStudyIdInfo': {'id': 'RECHMPL20_0142'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with uterine rupture', 'description': 'Women with uterine rupture'}, {'label': 'Women without uterine rupture', 'description': 'Women without uterine rupture', 'interventionNames': ['Other: Risks factors, maternal and neonatal outcomes/complications']}], 'interventions': [{'name': 'Risks factors, maternal and neonatal outcomes/complications', 'type': 'OTHER', 'description': 'Risks factors, maternal and neonatal outcomes/complications', 'armGroupLabels': ['Women without uterine rupture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florent FUCHS, PUPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}