Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-26 @ 10:00 PM
Study NCT ID:
NCT06202768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2024-01-01', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Grobman score', 'timeFrame': 'per-partum, 9 months', 'description': 'calculate Grobman score according to different criteria. If the score is high, the probability of vaginal delivery is high. This a score which calculates probability of vaginal delivery thanks to 11 parameters (maternal âge, BMI, previous vaginal delivery before and after ceasection, recurring indication, gestational age, hypertensive disease of pregnancy, effacement, dilatation, foetal station, labor induction)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Delivery']}, 'descriptionModule': {'briefSummary': 'The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy.\n\nConsidering the outcome of a new birth following a cesarean section is not easy. There is no reliable score to predict the success rate of vaginal delivery with a history of scarred uterus. The aim of our study would be to validate the intrapartum Grobman nomogram within the population of the Nancy University Hospital and thus to target the population for whom vaginal delivery could be offered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population of women who gave birth at the Nancy maternity ward and met the inclusion criteria, from January 2014 to January 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vertex singleton pregnancy\n* Full-term delivery (beyond 37 weeks)\n* A history of cesarean section (segmental transverse scar)\n\nExclusion Criteria:\n\n* Fetal death in utero'}, 'identificationModule': {'nctId': 'NCT06202768', 'acronym': 'GPP', 'briefTitle': 'Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section', 'orgStudyIdInfo': {'id': '2023PI211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main population', 'description': 'History of cesarean section Vertex singleton gestation At term (at least 37 weeks of gestation)', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'data collection : age, gestational age, BMI, history of vaginal delivery after cesarean section, indication for cesarean section, preeclampsia for this pregnancy, the cervix dilatation, position in the pelvis, cervix consistency', 'armGroupLabels': ['Main population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'BELLOCHIO', 'role': 'CONTACT', 'email': 'melanie.bellochio@yahoo.fr'}, {'name': 'COTTEZ', 'role': 'CONTACT', 'email': 'c.cottez@chru-nancy.fr'}], 'facility': 'Maternity', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Charlotte COTTEZ', 'role': 'CONTACT', 'email': 'c.cottez@chru-nancy.fr', 'phone': '0689677319'}], 'overallOfficials': [{'name': 'Charlotte COTTEZ', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'post-resident', 'investigatorFullName': 'COTTEZ Charlotte', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}