Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT06207916
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
International Survey of Childbirth-Related Trauma - Swedish Part
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 619}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of childbirth-related PTSD', 'timeFrame': '2022'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childbirth-related PTSD', 'PTSD', 'Postnatal Depression', 'Fear of Childbirth', 'Post Traumatic Stress Disorder', 'Postpartum Sadness']}, 'descriptionModule': {'briefSummary': 'The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are:\n\n* What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample?\n* What are the risk factors for postnatal mental ill-health?\n\nAdditional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised.\n\nParticipants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women who had given birth at the participated clinics and whom answered to the inclusion and exclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria: having given birth 6-16 weeks previously -\n\nExclusion Criteria: having given birth to a child that did not survive\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06207916', 'acronym': 'SwIntersect', 'briefTitle': 'International Survey of Childbirth-Related Trauma - Swedish Part', 'organization': {'class': 'OTHER', 'fullName': 'Region Östergötland'}, 'officialTitle': 'International Survey of Childbirth-Related Trauma - Swedish Part', 'orgStudyIdInfo': {'id': 'SwIntersect'}}, 'contactsLocationsModule': {'locations': [{'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevisjukhuset', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Östergötland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hanna Grundström', 'investigatorAffiliation': 'Region Östergötland'}}}}