Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 6:02 PM
Study NCT ID:
NCT06771661
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parents' Experience of Child Loss During Pregnancy or Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'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': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parent's experience", 'timeFrame': 'During pregnancy and up to 7 days after birth', 'description': "The investigators are interested in parents' in-depth and lived experience before and during their intrauterine or perinatal child loss."}], 'secondaryOutcomes': [{'measure': "Parents' subjective needs", 'timeFrame': 'During pregnancy and up to 7 days after birth', 'description': 'In qualitative interviews, the subjective needs that parents developed before and during their intrauterine or perinatal child loss will be investigated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy loss', 'Child loss', 'Qualitative research', 'Mixed-methods', 'Experience', 'Need', 'Parents', 'Perinatal loss', 'Fetal death', 'Miscarriage', 'Stillbirth'], 'conditions': ['Stillbirth and Fetal Death', 'Miscarriages', 'Experience']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.th-deg.de/sterneneltern', 'label': 'Landing Page of the Study'}]}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.', 'detailedDescription': 'The entire study is following a participatory approach and including parents after stillbirth in the research team. Along a co-creative design, the investigators planned a multistep-explorative mixed-methods study.\n\nIn detail, three key steps will be conducted. First, workshops and focus groups will be carried out to identify central needs of affected parents. Afterwards, one investigator will interview the parents narratively to gain an in-depth understanding of their experiencs. Finally, these findings will be summarized and translated into treatment recommendations for healthcare professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Parents (mothers, fathers) will be recruited that lost their child during pregnancy or birth in hospitals, at home or birth houses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* German speaking\n* Living in Austria, Germany or Switzerland\n* Child loss during pregnancy or birth\n* Child loss within last 12 months\n* Legal capacity\n* Voluntary participation\n\nExclusion Criteria:\n\n* Loss of child after birth\n* Not speaking and understanding German\n* Not in a good mental condition to participate'}, 'identificationModule': {'nctId': 'NCT06771661', 'briefTitle': "Parents' Experience of Child Loss During Pregnancy or Birth", 'organization': {'class': 'OTHER', 'fullName': 'Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences'}, 'officialTitle': "Parents' Experience of Child Loss During Pregnancy or Birth - an Explorative, Sequential Mixed-methods Study", 'orgStudyIdInfo': {'id': 'GEHBa-202409-V-237-R2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents after intrauterine or perinatal child loss', 'interventionNames': ['Other: Workshops', 'Other: Focus group interviews', 'Other: Narrative interviews', 'Other: Delphi approach']}], 'interventions': [{'name': 'Workshops', 'type': 'OTHER', 'description': 'The investigators will conduct workshops with parents to get closer to the main topic.', 'armGroupLabels': ['Parents after intrauterine or perinatal child loss']}, {'name': 'Focus group interviews', 'type': 'OTHER', 'description': 'The investigators will conduct focus group interviews with parents on their needs before and during child loss.', 'armGroupLabels': ['Parents after intrauterine or perinatal child loss']}, {'name': 'Narrative interviews', 'type': 'OTHER', 'description': 'The investigators will conduct narrative interviews with parents to gain an in-depth understanding of their lived experience before and during the intrauterine or perinatal child loss.', 'armGroupLabels': ['Parents after intrauterine or perinatal child loss']}, {'name': 'Delphi approach', 'type': 'OTHER', 'description': 'The investigators will carry out a Delphi approach with parents to translate and confirm or revise the findings into treatment recommendations for healthcare professionals.', 'armGroupLabels': ['Parents after intrauterine or perinatal child loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94469', 'city': 'Deggendorf', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fritz Sterr, M.Sc.', 'role': 'CONTACT', 'email': 'fritz.sterr@th-deg.de', 'phone': '+49-991-3615-8344'}, {'name': 'Julian Siepmann, M.Sc.', 'role': 'CONTACT', 'email': 'julian.siepmann@th-deg.de', 'phone': '+49-991-3615-8368'}, {'name': 'Fritz Sterr, M.Sc.', 'role': 'CONTACT'}, {'name': 'Julian Siepmann, M.Sc.', 'role': 'CONTACT'}, {'name': 'Lydia Bauernfeind, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences', 'geoPoint': {'lat': 48.84085, 'lon': 12.96068}}], 'centralContacts': [{'name': 'Fritz Sterr, M.Sc.', 'role': 'CONTACT', 'email': 'fritz.sterr@th-deg.de', 'phone': '+49-991-3615-8344'}, {'name': 'Julian Siepmann, M.Sc.', 'role': 'CONTACT', 'email': 'julian.siepmann@th-deg.de', 'phone': '+49-991-3615-8368'}], 'overallOfficials': [{'name': 'Christian Rester, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Deggendorf Institute of Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data to be collected is particularly sensitive and is stored securely and deleted after the study. Individual pseudonymised excerpts are made public in the publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fritz Sterr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research associate', 'investigatorFullName': 'Fritz Sterr', 'investigatorAffiliation': 'Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences'}}}}