Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-27 @ 5:42 AM
Study NCT ID:
NCT04948892
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presence of the Father During Hyperacute Cesarean Section in General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 235016, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-05T06:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Obstetric complications', 'timeFrame': 'Up to 1 week after the cesarean section', 'description': 'Perforation of bladder or bowel, bleeding \\> 1000 ml, infection, need for transfusion'}, {'measure': 'Anesthetic complications', 'timeFrame': 'During cesarean section', 'description': 'Esophageal intubation, difficult airway management'}, {'measure': 'Neonatal complications', 'timeFrame': 'During cesarean section', 'description': 'Low APGAR-score, need for resuscitation, need for intubation, need for transfusion'}], 'primaryOutcomes': [{'measure': 'Father/partners experience', 'timeFrame': '1-2 days after the cesarean section combined with assessment of change from baseline in father/partners experience at 3 months after the cesarean sectio', 'description': 'Father/partners experience of being present or not in the OR during the hyperacute cesarean section category 1, described by questionnaire, semi-structured interview and PTSD-screening'}], 'secondaryOutcomes': [{'measure': 'Mothers experience', 'timeFrame': '1-2 days after the cesarean section', 'description': 'Mothers experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'Surgeons (obstetricians) experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'Surgeons experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'Anesthesiologists experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'Anesthesiologists experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'Midwifes experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'Midwifes experience of the father/partner being present or not in the OR during the acute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'OR nurses experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'OR nurses experience of the father being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'Anesthetic nurses experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'Anesthetic nurses experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}, {'measure': 'Pediatricians experience', 'timeFrame': 'Up to 2 weeks after the cesarean section', 'description': 'Pediatricians experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'hyperacute cesarean section', 'family presence', 'experience of family presence', 'general anesthesia'], 'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This study concerns cesarean sections, category 1, meaning those cases where the life of mother and/or fetus is in immedeate danger and the child must be delivered within 15 minutes from activating the cesarean section team. In most hospitals in Denmark, these cesarean sections are most often performed in general anesthesia and the mother is endotracheally intubated.\n\nPreviously in these situations, as the mother was rushed from the Labour Ward to the operation room (OR), her spouse/partner, would be placed outside the operating room (OR), and would stay there until the child had been delivered.\n\nIn Lillebaelt Hospital, Kolding, Denmark, the newborn-resuscitation table is placed inside the OR. The father would most often be allowed to enter the OR when the child was delivered and placed on the resuscitation table (no matter the status of the child).\n\nHowever, during spring 2021, Lillebaelt Hospital Kolding updated the policy regarding the handling of the father/partner during cesarean section category 1. Now the father/partner is present in the OR during the whole procedure, including induction of general aesthesia, endotracheal intubation, performance of the cesarean section (drapings are positioned so that the father cannot see the operation field) and potential resuscitation efforts of the newborn.\n\nIn another hospital in the same region (Region of Southern Denmark), Aabenraa Hospital, the father is not present in the OR during the cesarean section. He waits in the labour ward.\n\nThe investigators therefore wish to investigate how the cesarean section category 1 is experienced by: the father/partner; the mother; the obstetrician; the anestesiologist; the midwife; the OR nurse; the anesthetic nurse, both in Kolding where the father/partner is present in the OR, and in Aabenraa, where the father/partner is not present in the OR during the cesarean sectio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All mothers and father/partners who experiences a cesarean section category 1 in Kolding Hospital, Denmark.\n\nAll mothers and father/partners who experiences a cesarean section category 1 in Aabenraa Hospital, Denmark\n\nHospital staff (obstetricians, anesthesiologists, pediatricians, midwifes, OR-nurses, anesthetic nurses) in Kolding and Aabenraa hospital, who participate in cesarean sectio category 1.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cesarean section category 1\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04948892', 'briefTitle': 'Presence of the Father During Hyperacute Cesarean Section in General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Sygehus Lillebaelt'}, 'officialTitle': 'Presence of the Father in the Operating Room During Hyperacute Cesarean Section in General Anesthesia', 'orgStudyIdInfo': {'id': 'SC210815'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Father/partner present, Kolding hospital', 'description': 'All father/partners, mothers and hospital staff involved in hyperacute cesarean section category 1 in general anesthesia (obstetrician, anesthesiologist, OR-nurse, midwife, anesthetic nurse, pediatrician) in Kolding Hospital, where the father is present in the OR during the cesarean section category 1', 'interventionNames': ['Other: Prescence of the father during cesarean section in general anesthesia']}, {'label': 'Father/partner not present, Aabenraa hospital', 'description': 'All father/partners and mothers involved in hyperacute cesarean section category 1 in general anesthesia in Aabenraa hospital, where the father is not present in the OR during the cesarean sectio category 1.\n\nAll relevant hospital staff, who sometimes participates in cesarean sectio category 1 (obstetrician, anesthesiologist, OR-nurse, midwife, anesthetic nurse, pediatrician) will be asked to fill in a questionnaire on their thoughts and opinions on having the father/partner present during hyperacute cesarean sectio category 1.'}], 'interventions': [{'name': 'Prescence of the father during cesarean section in general anesthesia', 'type': 'OTHER', 'description': 'The father is now present in the OR during cesarean section category 1, instead of waiting outside', 'armGroupLabels': ['Father/partner present, Kolding hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200', 'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Aabenraa Hospital', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Helene K. Nedergaard', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'overallOfficials': [{'name': 'Hanne I Jensen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Southern Denmark, Kolding'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Helene Korvenius Nedergaard', 'investigatorAffiliation': 'Sygehus Lillebaelt'}}}}