Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT04281368
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050497', 'term': 'Stillbirth'}], 'ancestors': [{'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of preventable/non-preventable deaths and the level of delay', 'timeFrame': '2017', 'description': 'to analyze preventable/non-preventable deaths and the level of delay'}], 'secondaryOutcomes': [{'measure': 'The frequency of different causes of death', 'timeFrame': '2017', 'description': 'To analyze the different causes of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IUFD'], 'conditions': ['Intra-Uterine Death']}, 'referencesModule': {'references': [{'pmid': '33198695', 'type': 'DERIVED', 'citation': 'Sterpu I, Bolk J, Perers Oberg S, Hulthen Varli I, Wiberg Itzel E. Could a multidisciplinary regional audit identify avoidable factors and delays that contribute to stillbirths? A retrospective cohort study. BMC Pregnancy Childbirth. 2020 Nov 16;20(1):700. doi: 10.1186/s12884-020-03402-z.'}]}, 'descriptionModule': {'briefSummary': 'All stillbirths in Stockholm during 2017 were analysed according to the primary outcomes which were preventable/non-preventable deaths and the level of delay. The secondary outcomes were: causes of death, standard of care pre and post stillbirth and if a summary of the possible causes of death was made as well as the planning of supervision of the next pregnancy.', 'detailedDescription': 'This is a retrospective cohort study. A multidisciplinary team consisting of three obstetricians, one midwife and one neonatologist was assembled. The team represented the largest hospitals in the region-Karolinska University Hospital and Stockholm Soderl Hospital. Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy. Multiple meetings were organized for discussing the results of the individual assessment of each case. To enable an ethical discussion every member of the audit group signed a confidentiality form and all cases were assessed by comparison with local guidelines in praxis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All stillbirths in Stockholm 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All stillbirths in Stockholm 2017\n\nExclusion Criteria:\n\n* Missed abortion'}, 'identificationModule': {'nctId': 'NCT04281368', 'briefTitle': 'Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Analysis of All Stillbirths in Stockholm County 2017, a Multidisciplinary Audit', 'orgStudyIdInfo': {'id': 'IUFD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Analysis of IUFD', 'type': 'OTHER', 'description': 'Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18239', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Eva Wiberg-Itzel', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Eva Wiberg-Itzel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eva Wiberg-Itzel', 'investigatorAffiliation': 'Karolinska Institutet'}}}}