Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05579756
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychatric Impact of Miscarriage in Assiut University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevelance of post traumatic stress disorder , depression, and anxiety one month after miscarriage', 'timeFrame': '1 year maximum'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Miscarriage']}, 'descriptionModule': {'briefSummary': 'Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).', 'detailedDescription': "Miscarriage is basically defined as intrauterine fetal death before viability (1,2). Age of viability, in Egypt, sets at 26 weeks of gestation (3). Incidence of miscarriage is often referred to as an iceberg where the actual size of the problem cannot be determined. More than 50% of human conceptions are lost before the missed period either before or after implantation (4). In clinically recognized pregnancies, losses decrease as pregnancy progresses from 17% - 20 % after 6 weeks to only 3% at 10 weeks gestation (4). Beside the high incidence of miscarriage, it implies a high psychological morbidity to both partners with increased liability to anxiety, post stress disorder and depression(5,6). This psychological impact can be attributed not only to loss of desired child but also to the traumatic event of bleeding and pain encountered by those patients (7).\n\nWhile the clinical management of miscarriage and its physical complications have been extensively discussed; the psychological impact of this traumatic event of loss is usually overlooked especially in developing countries (8-11). Moreover, there are behind-the-scene factors that trigger or correlate to the development of psychiatric morbidities following miscarriage (12,13). Factors as sociodemographic, marital satisfaction, social support, individual's coping resources, history of infertility and previous miscarriage vary across different population samples, also vary in their influence on women's psychological resilience after traumatic events as miscarriage. No previous studies addressed this topic in Egyptian population."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- all pregnant women 18:45 years old presented by intrauterine pregnancy loss before \\<= 26 weeks gestation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pregnant women 18:45 years old presented by intrauterine pregnancy loss before \\<= 26 weeks gestation\n\nExclusion Criteria:\n\n* Ectopic pregnancy or vesicular mole\n* previous diagnosis of psychatric disorder\n* unwell to give consent'}, 'identificationModule': {'nctId': 'NCT05579756', 'briefTitle': 'Psychatric Impact of Miscarriage in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Psychatric Impact of Miscarriage and Its Associated Factors Among Women in Assiut University Women's Health Hospital", 'orgStudyIdInfo': {'id': 'miscarriag'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Esraa Mostafa', 'investigatorAffiliation': 'Assiut University'}}}}