Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-07 @ 3:05 PM
Study NCT ID:
NCT07188259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Impact on Quality of Life, Academic Performance, and Blood Indices of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of heavy menstrual bleeding (HMB)', 'timeFrame': 'through study completion, an average of 6 months to 1 year.', 'description': 'to estimate the prevalence of heavy menstrual bleeding (HMB) among Assiut university female students.'}], 'secondaryOutcomes': [{'measure': "impact of heavy menstrual bleeding (HMB) on participants' quality of life and academic performance.", 'timeFrame': 'through study completion, an average of 6 months to 1 year', 'description': "To evaluate the impact of heavy menstrual bleeding (HMB) on participants' quality of life and academic performance."}, {'measure': 'Hematologic (CBC indices, serum ferritin and coagulation profile) between participants', 'timeFrame': 'within 2 months after questionnaire', 'description': 'Compare hematologic (CBC indices, serum ferritin and coagulation profile) between participants with HMB and partcipants without HMB.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menorrhagia']}, 'referencesModule': {'references': [{'pmid': '34213477', 'type': 'BACKGROUND', 'citation': 'Nwagha TU, Okoye HC, Ugwu AO, Ugwu EO. Clinical screening for menorrhagia and other bleeding symptoms in Nigerian women. Ann Afr Med. 2021 Apr-Jun;20(2):111-115. doi: 10.4103/aam.aam_26_20.'}, {'pmid': '37802092', 'type': 'BACKGROUND', 'citation': 'Sinharoy SS, Chery L, Patrick M, Conrad A, Ramaswamy A, Stephen A, Chipungu J, Reddy YM, Doma R, Pasricha SR, Ahmed T, Chiwala CB, Chakraborti N, Caruso BA. Prevalence of heavy menstrual bleeding and associations with physical health and wellbeing in low-income and middle-income countries: a multinational cross-sectional study. Lancet Glob Health. 2023 Nov;11(11):e1775-e1784. doi: 10.1016/S2214-109X(23)00416-3. Epub 2023 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The cause of menstrual disorders is unknown because many female students, embarrassed or unsure of what is "normal," never seek care. In young females, abnormal uterine bleeding is usually functional-reflecting immaturity or dysregulation of the hypothalamic-pituitary-ovarian axis, anovulatory cycles, or inherited bleeding disorders-while serious structural pathology is rare. Nevertheless, early bleeding can be the first sign of conditions such as polycystic-ovary syndrome, endometriosis, or von Willebrand disease. It is the primary source of iron-deficiency anemia in females before marriage, leading to chronic fatigue, diminished academic performance, and lower exam results.\n\nA sectional study will be performed using a semi-structured questionnaire to assess the presence of HMB using the SAMANTA scale after its Arabic validation, and also evaluate the effect of HMB on quality of life using the validated heavy menstrual bleeding scale and assess impact on academic performance finally both females with positive HMB or not will asked to do Complete blood count (CBC), serum ferritin and coagulation profile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female Students in Assiut University, Egypt who accepted to share in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- Female students of Assiut University.\n\nExclusion Criteria:\n\n1. Females known to have chronic anemia or hemolytic anemia by history\n2. Females on anticoagulation treatment.\n3. Females known to have coagulopathy.\n4. Females with any chronic condition (diabetes mellitus, liver diseases, etc.) in the previous 12 months were excluded from participation in this study.\n5. Females with a history of prior pregnancy (gravidity ≥1), regardless of outcome (live birth, miscarriage, abortion, or ectopic).'}, 'identificationModule': {'nctId': 'NCT07188259', 'acronym': 'menorrhagia', 'briefTitle': 'Prevalence and Impact on Quality of Life, Academic Performance, and Blood Indices of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence and Impact of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt', 'orgStudyIdInfo': {'id': 'PIHMBFSAUE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heavy menstrual bleeding positive group', 'description': 'After using the SAMANTA scale, if we find a score of 3 or more, this will be:\n\nHeavy menstrual bleeding positive group'}, {'label': 'Heavy menstrual bleeding negative group', 'description': 'After using the SAMANTA scale, if we find a score less than 3, this will be:\n\nHeavy menstrual bleeding negative group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Mahmoud Fahmy Fathalla, prof', 'role': 'CONTACT', 'email': 'mfathalla@aun.edu.eg', 'phone': '01154320395'}], 'facility': 'Assiut University,', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Yasmin I.Mohamed', 'role': 'CONTACT', 'email': 'Yasmin.20134496@med.aun.edu.eg', 'phone': '01150883767'}, {'name': 'Amany Heshmat Abdelmoneam', 'role': 'CONTACT', 'email': 'Dramany9@med.aun.edu.eg', 'phone': '01008725338'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yasmin Ismail Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}