Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-09 @ 5:20 PM
Study NCT ID:
NCT05840367
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mothers' Experience of Category 1 Cesarean Section
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': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mothers' experience of the category 1 cesarean section", 'timeFrame': 'Three months after the cesarean section', 'description': "Qualitative analysis of data regarding mothers' experience of a category 1 cesarean section in a hospital where the partner is present in the operation room.\n\nSemi-structured interviews will be held, recorded digitally and transscribed. Content will be analysed qualitatively using manifest content analysis, and major themes as well as sub-themes will be identified, describing mothers' experience with the category 1 cesarean section."}], 'secondaryOutcomes': [{'measure': 'PTSD', 'timeFrame': 'Three months after the cesarean section', 'description': 'Occurence of posttraumatic stress as evaluated using the PTSD-8 tool (in Danish)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this qualitative prospective study is to investigate how mothers experience a category 1 cesarean section in a hospital where the partner is present in the operation room during the entire process (induction of general anestesia, cesarean section, possible resuscitation of newborn).\n\nMothers will be included in the study, if they wish to participate, on day 1 or 2 following the cesarean section and a brief, structured interview will be held concerning her experience of the cesarean section.\n\nClinical baseline data regarding the mother, the cesarean section and the infant will be collected from patients files.\n\nMothers will be contacted again three months after the cesarean section, and a semi-structured interview will be held via telephone. At the end of the interview a screening for posttraumatic stress will be performed, using the PTSD-8 tool. The interviews will be recorded and transscribed verbatim.\n\nContent of interviews will be analysed using manifest content analysis. NVivo software will be used for coding interviews.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study aims to include all mothers who undergoes a category 1 cesarean section in Kolding Hospital, Denmark, during a 1-year period. Mothers will be approached for inclusion in the study regardless of the outcome of the infant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers who had a category 1 cesarean section in Kolding Hospital, Denmark during a 1-year period\n\nExclusion Criteria:\n\n* Not speaking/understanding Danish'}, 'identificationModule': {'nctId': 'NCT05840367', 'briefTitle': "Mothers' Experience of Category 1 Cesarean Section", 'organization': {'class': 'OTHER', 'fullName': 'Sygehus Lillebaelt'}, 'officialTitle': "Mothers' Experience of Category 1 Cesarean Section - in a Hospital Where the Partner is Present in the Operating Room. A Qualitative Study.", 'orgStudyIdInfo': {'id': '972294863'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Partner present in the operation room', 'type': 'BEHAVIORAL', 'description': 'The partner (father, co-mother or other close relative present for the birth) is present in the operation room during the entire category 1 cesarean section. This is standard clinical practice in this particular hospital since June 2021.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Kolding', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Helene K Nedergaard, MD, PhD', 'role': 'CONTACT', 'email': 'helene.korvenius.nedergaard@rsyd.dk', 'phone': '53272244', 'phoneExt': '+45'}, {'name': 'Eva E Weitling, MD', 'role': 'CONTACT', 'email': 'eva.weitling@rsyd.dk'}], 'facility': 'Lillebaelt Hospital, Kolding', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'centralContacts': [{'name': 'Helene K Nedergaard, MD, PhD', 'role': 'CONTACT', 'email': 'helene.korvenius.nedergaard@rsyd.dk', 'phone': '+45 53272244'}, {'name': 'Eva Weitling, MD', 'role': 'CONTACT', 'email': 'eva.weitling@rsyd.dk'}], 'overallOfficials': [{'name': 'Anne C Brøchner, MD, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Lillebaelt Hospital Kolding, Department of Anesthesiology and Intensive Care, and University of Southern Denmark, Department of Regional Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark, Department of Regional Health Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Helene Korvenius Nedergaard', 'investigatorAffiliation': 'Sygehus Lillebaelt'}}}}