Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 4:41 PM
Study NCT ID:
NCT06721403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychatric Effect of Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}], '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of ectopic pregnancy', 'timeFrame': 'Within one week', 'description': 'Prevalence of anxiety,depressive symptoms and post-traumatic stress disorder after ectopic pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ectopic Pregnancy']}, 'referencesModule': {'references': [{'pmid': '27807081', 'type': 'BACKGROUND', 'citation': 'Farren J, Jalmbrant M, Ameye L, Joash K, Mitchell-Jones N, Tapp S, Timmerman D, Bourne T. Post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy: a prospective cohort study. BMJ Open. 2016 Nov 2;6(11):e011864. doi: 10.1136/bmjopen-2016-011864.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy Determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy', 'detailedDescription': 'Ectopic pregnancy is any pregnancy in which the fertilized ovum implants outside the intrauterine cavity. More than 95 percent of ectopic pregnancies occur in the fallopian tubes.\n\nAnother 2.5 percent occur in the cornua of the uterus, and the remainder are found in the ovary, cervix or abdominal cavity.\n\nEctopic pregnancy causes major maternal morbidity and mortality, with pregnancy loss, and its incidence is increasing worldwide.\n\nPrevious ectopic pregnancy becomes a more significant risk factor with each successive occurrence. With one previous ectopic pregnancy treated by linear salpingostomy, the recurrence rate ranges from 15 to 20 percent, depending on the integrity of the contralateral tube.\n\nThe unanticipated and sudden loss of a pregnancy can be a devastating and traumatic experience resulting in high levels of psychological morbidity for some women.\n\nEPLs can significantly contribute to the overall burden of psychopathology within a population. Recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. Further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial"'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women 18:45 years old presented with ectopic pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant woman 18:45 years old presented with ectopic pregnancy.\n\nExclusion Criteria:\n\n* intrauterine pregnancy\n* previous diagnosis of psychiatric disorders\n* Unwell to give consent'}, 'identificationModule': {'nctId': 'NCT06721403', 'briefTitle': 'Psychatric Effect of Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Anxiety,Depressive Symptoms &PTSD in Cases of Post Ectopic Pregnancy', 'orgStudyIdInfo': {'id': 'Anxiety post ectopic pregnancy'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marina R Youssef, Bachelor', 'role': 'CONTACT', 'email': 'marinareda642@gmail.com', 'phone': '+20 01288575747'}], 'overallOfficials': [{'name': 'Ahmed Abbas, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecture', 'investigatorFullName': 'Marina Reda Youssef', 'investigatorAffiliation': 'Assiut University'}}}}