Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-10 @ 1:42 AM
Study NCT ID:
NCT03820505
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observatory of Unintentional Births Hospital Extras
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of unexpected hospital deliveries (AIE)', 'timeFrame': 'DAY 0 TO DAY 7 TO DELIVRERY', 'description': 'Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity'}], 'secondaryOutcomes': [{'measure': 'Method of taking care of unannounced extra hospital deliveries', 'timeFrame': 'DAY 0 TO DAY 7 POST DELIVRERY', 'description': 'Method of taking care of unannounced extra hospital deliveries'}, {'measure': 'Difficulties during an unexpected delivery outside maternity', 'timeFrame': 'DAY 0 TO DAY 7 POST DELIVRERY', 'description': 'Identify the difficulties during an unexpected delivery outside maternity'}, {'measure': 'Risks during an unexpected delivery outside maternity', 'timeFrame': 'DAY 0 TO DAY 7 POST DELIVRERY', 'description': 'Identify the risks during an unexpected delivery outside maternity'}, {'measure': 'Possible immediate complications during an unexpected delivery outside maternity', 'timeFrame': 'DAY 0 TO DAY 7 POST DELIVRERY', 'description': 'Identify the possible immediate complications during an unexpected delivery outside maternity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstetrics', 'pre-hospital emergencies unannounced delivery outside maternity,', 'mortality-morbidity', 'reinforcement midwife in pre-hospital'], 'conditions': ['Unexpected Delivery Outside Maternity']}, 'descriptionModule': {'briefSummary': 'In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.\n\nFor this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.', 'detailedDescription': 'As a result, the investigators also found a very high variability in the number of deliveries per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per month (May 2014 example).\n\nFormalized expert recommendations were published in 2010 by SFAR, which then led to the establishment of a national observatory for IEA at the end of 2011, in which the investigators have been participating for 4 years.\n\nCurrently the national database lists 2000 unannounced deliveries including 230 in the Hérault.\n\nThis observational study allows us to evaluate the management of these patients and newborns, the risks and needs of pre-hospital teams, including the need for reinforcement and expertise of midwives.\n\nThe investigators can also assess mortality and morbidity, as well as the extension of hospital stays beyond J7'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Unexpected delivery outside maternity in the Hérault department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexpected delivery outside maternity, presence of a medical team during the care\n\nExclusion Criteria:\n\n* Absence of medicalization'}, 'identificationModule': {'nctId': 'NCT03820505', 'acronym': 'AIEH34', 'briefTitle': 'Observatory of Unintentional Births Hospital Extras', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Observatory of Unintentional Births Hospital Extras in Hérault', 'orgStudyIdInfo': {'id': 'RECHMPL18_0442'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle GRAF, wise woman', 'role': 'CONTACT', 'email': 'c-graf@chu-montpellier.fr', 'phone': '0677696194', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Christelle GRAF, wise woman', 'role': 'CONTACT', 'email': 'c-graf@chu-montpellier.fr', 'phone': '0677696194', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Christelle GRAF, wise woman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'SDIS34 - MONTPELLIER', 'class': 'UNKNOWN'}, {'name': 'SAMU CHU Montpellier', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}