Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-29 @ 4:43 AM
Study NCT ID:
NCT03576950
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Rupture International Data Acquisition
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine rupture', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'Women with uterine rupture occurred during pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Gestational age at uterine rupture', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'Gestational age, calculated as weeks and days, in which uterine rupture occurred.'}, {'measure': 'Parity', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The number of previous delivery.'}, {'measure': 'Body Mass Index', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The Body Mass Index of each patient in which uterine rupture occurred.'}, {'measure': 'Presence of myomas', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The occurrence of myomas in each patient in which uterine rupture occurred.'}, {'measure': 'Hysterectomy', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The number of cases in which it was necessary to perform hysterectomy after uterine rupture.'}, {'measure': 'Hospital stay', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The hospital stay from the admission to the discharge, expressed in days.'}, {'measure': 'Neonatal complications', 'timeFrame': 'A retrospective analysis of 10 years.', 'description': 'The occurrence of neonatal complications, included neonatal deaths.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine rupture', 'Cesarean section', 'Labour', 'Myomectomy', 'Delivery'], 'conditions': ['Uterine Rupture Gravid']}, 'descriptionModule': {'briefSummary': 'Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.\n\nUterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.\n\nPregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.\n\nDespite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with uterine rupture occurred during pregnancy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with uterine rupture occurred during pregnancy.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03576950', 'acronym': 'URIDA', 'briefTitle': 'Uterine Rupture International Data Acquisition', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study', 'orgStudyIdInfo': {'id': 'URIDA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uterine rupture', 'description': 'Women with uterine rupture occurred during pregnancy.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea Tinelli, M.D.', 'role': 'CONTACT', 'email': 'andreatinelli@gmail.com', 'phone': '+393392074078'}], 'overallOfficials': [{'name': 'Andrea Tinelli, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Antonio Simone Laganà', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}