Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT06742632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Psychiatric Problems Between First and Second Trimester Miscarriage
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': 155}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure psychiatric problems among the stuided groups', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'symptom checklist 90 "SCL 90\'\': It is a 90-item ques tionnaire used to assess psychological problems. Each item is scored on a scale from 0 to 4 based on how much an individual was bothered by each item. It has 9 subscales: (Somatization, Obsessive-compulsive, Inter personal sensibility, Depression, Anxiety, Anger-hostility, Phobic-anxi ety, Paranoid ideation, Psychoticism).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abortion'], 'conditions': ['Abortion']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Ayaulym N. Blushinova, Gulnara M. Shalgumbayeva, Duman Berikuly, Zaituna G. Khamidullina, Gaukhar A. Korganbayeva, Inabat N. Ordabayeva, Nazerke K. Sailauova ABB. Epidemiological aspects of pregnant losses. literature review. Sci Healthc J. 2023;25(2):236-43.'}, {'pmid': '34678403', 'type': 'RESULT', 'citation': 'Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'Description of the psychiatric impact of miscarriage on women.', 'detailedDescription': 'miscarriage, a significant reproductive health issue, often has profound psychological implications for women. The emotional and psychiatric effects of abortion can vary widely based on individual, cultural, and situational factors, as well as the timing of the procedure (1). First-trimester abortions are typically more common and are generally less complex medically, while second-trimester abortions often involve more intricate decision-making processes and greater societal and personal stigma (2).\n\nEmerging evidence suggests that women undergoing abortions in different trimesters may experience distinct psychiatric challenges, including anxiety, depression, and post-traumatic stress disorder. However, the comparative psychological burden between first- and second-trimester abortions remains underexplored (3-6). Understanding these differences is crucial for tailoring mental health interventions and providing comprehensive care to affected women.\n\nThis study aims to compare the prevalence and types of psychiatric problems in mothers undergoing abortion in the first versus the second trimester, thereby contributing to the body of knowledge on maternal mental health and informing evidence-based support strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all miscarrying women aged from 28 to 45 years less than or equal to 26 weeks gestation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all miscarrying women less than or equal to 26 weeks gestation\n\nExclusion Criteria:\n\n* ectopic pregnancy and vesicular mole'}, 'identificationModule': {'nctId': 'NCT06742632', 'briefTitle': 'Comparative Psychiatric Problems Between First and Second Trimester Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study in Psychiatric Problems Among Mothers With Miscarriage in First and Second Trimester', 'orgStudyIdInfo': {'id': 'psychiatry issues in Abortion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'first trimester abortion', 'interventionNames': ['Behavioral: Symptoms checklist-90']}, {'label': 'second trimester abortion', 'interventionNames': ['Behavioral: Symptoms checklist-90']}], 'interventions': [{'name': 'Symptoms checklist-90', 'type': 'BEHAVIORAL', 'description': 'The Symptom Checklist-90 (SCL90) is a 90-item questionnaire used to assess psychological problems. The Symptom Checklist-90-Revised (SCL90R) is the revised version of the questionnaire.', 'armGroupLabels': ['first trimester abortion', 'second trimester abortion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'gellan karamallah Ahmed, lecturer of neurology and psyc', 'role': 'CONTACT', 'email': 'gillankaram@aun.edu.eg', 'phone': 'gillankaram@aun.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of psychiatry,assiut university', 'investigatorFullName': 'Gellan Karamalllah Ramadan Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}