Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT04297956
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2020-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey on Patients After Childbearth Following Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview (SCID)', 'timeFrame': 'date of recruitement (> 6 months after childbirth)', 'description': 'questionnaires for depression:\n\n* Beck Depression Inventory (BDI-II)\n* Patient Health Questionnaire-9 (PHQ-9)\n* Edinburgh Postnatal Depression Scale (EPDS)\n\nquestionnaire for anxiety:\n\n* Generalized Anxiety Disorder-7 (GAD-7)\n\nPrevalence of symptoms can be defined by scores higher than defined cut-offs in questionnaires or scores that lead to diagnosis of psychiatric disorder in structured clinical interview'}, {'measure': 'Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview', 'timeFrame': 'retrospective: time frame 0-4 weeks after birth', 'description': 'questionnaires for depression:\n\n* Patient Health Questionnaire-9 (PHQ-9)\n\nquestionnaire for anxiety:\n\n* Generalized Anxiety Disorder-7 (GAD-7)\n\nPrevalence of symptoms can be defined by scores higher than defined cut-offs in questionnaires or scores that lead to diagnosis of psychiatric disorder in structured clinical interview'}, {'measure': 'Number of patients with prevalence of symptoms of depression assessed by structured clinical interview', 'timeFrame': 'retrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 years', 'description': 'Prevalence of symptoms can be defined by scores that lead to diagnosis of psychiatric disorder in structured clinical interview'}], 'secondaryOutcomes': [{'measure': 'Mean change of body weight from baseline', 'timeFrame': 'from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years', 'description': 'Body weight is measured on scales and participants are asked additionally via questionnaire. Baseline measurement starts at date of bariatric surgery.'}, {'measure': 'Status of nutritional deficiencies and therapy adherence', 'timeFrame': 'from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years', 'description': 'Participants are asked to answer Medication Adherence Report Scale (MARS-D) and blood levels concerning nutrients that are examined routinely in bariatric surgery follow-up care are analysed.'}, {'measure': 'Adverse events in pregnancy and child development', 'timeFrame': 'from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years', 'description': "Record of prenatal care and record of child's examinations are screened for complications."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Status in Childbirth', 'Puerperal Depression']}, 'descriptionModule': {'briefSummary': 'Women with a history of bariatric surgery may face various difficulties during pregnancy and puerperal time. Therefore it is assumed the prevalence of mental health disorders might be higher than in average women during and after pregnancy. This could possibly lead to an unsatisfying weight progress and therapeutic non-adherence. These factors shall be observed in the study in order to characterize this special cohort of participants.', 'detailedDescription': "Women following bariatric surgery are included at least 6 months after childbirth to evaluate retrospectively pregnancy and puerperal time. For mental health issues questionnaires, a structured clinical interview (SCID) and a psychological interview give an insight to past and present status. In order to evaluate weight progress and nutrient deficiencies routine follow-up care data of bariatric surgery is screened. In order to assess the course of pregnancy and child development data is extracted from pregnancy and child's examinations reports. Furthermore medication adherence, quality of life and sleep are registered by questionnaires."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* status following bariatric / metabolic surgery due to indication criteria\n* childbirth after bariatric / metabolic surgery, at least 6 months ago\n* written informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04297956', 'acronym': 'SPOtMom', 'briefTitle': 'Survey on Patients After Childbearth Following Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Survey on Patients After Childbearth Following Bariatric Surgery - Data Collection on Mental Health Complications, Weight Change, Nutrition Deficiencies and Postpartal Progress', 'orgStudyIdInfo': {'id': 'spot_mom'}}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '63069', 'city': 'Offenbach', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Sana Adipositaszentrum Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '42853', 'city': 'Remscheid', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Sana Adipositaszentrum NRW', 'geoPoint': {'lat': 51.17983, 'lon': 7.1925}}, {'zip': '25746', 'city': 'Heide', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Adipositaszentrum Westküstenklinium Heide', 'geoPoint': {'lat': 54.19562, 'lon': 9.09742}}], 'overallOfficials': [{'name': 'Ann-Cathrin Koschker, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Würzburg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of outpatient clinic for diabetes and lipids', 'investigatorFullName': 'Ann-Cathrin Koschker', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}