Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04413058
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Menstrual Cycle Characteristics of Healthcare Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-26', 'size': 77468, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-27T16:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-31', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of irregular menstrual cycle', 'timeFrame': '1 month after starting to work at pandemic clinic', 'description': 'Irregular menstrual cycle'}, {'measure': 'Length of cycle', 'timeFrame': '1 month after starting to work at pandemic clinic', 'description': 'Length of cycle (day)'}, {'measure': 'Rate of prolonged bleeding', 'timeFrame': '1 month after starting to work at pandemic clinic', 'description': 'Duration of bleeding (day)'}, {'measure': 'Amount of flow', 'timeFrame': '1 month after starting to work at pandemic clinic', 'description': 'Number of used tampons during bleeding'}, {'measure': 'Rate of dysmenorrhea', 'timeFrame': '1 month after starting to work at pandemic clinic', 'description': 'Dysmenorrhea status'}], 'secondaryOutcomes': [{'measure': 'The number of difference in menstrual cycle length', 'timeFrame': 'Up to 1 month after covid infection', 'description': 'Menstrual cycle difference between covid positive and negative healthcare workers (days)'}, {'measure': 'The number of difference in bleeding days', 'timeFrame': 'Up to 1 month after covid infection', 'description': 'Duration of bleeding difference between covid positive and negative healthcare workers (days)'}, {'measure': 'The number of difference in amount of flow', 'timeFrame': 'Up to 1 month after covid infection', 'description': 'Amount of flow difference between covid positive and negative healthcare workers (tampons)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['health care professionals', 'menstrual cycle', 'Covid 19', 'Pandemia'], 'conditions': ['Menstrual Irregularity', 'Covid 19']}, 'referencesModule': {'references': [{'pmid': '23618486', 'type': 'BACKGROUND', 'citation': 'Attarchi M, Darkhi H, Khodarahmian M, Dolati M, Kashanian M, Ghaffari M, Mirzamohammadi E, Mohammadi S. Characteristics of menstrual cycle in shift workers. Glob J Health Sci. 2013 Feb 28;5(3):163-72. doi: 10.5539/gjhs.v5n3p163.'}, {'pmid': '25914071', 'type': 'BACKGROUND', 'citation': 'Moen BE, Baste V, Morken T, Alsaker K, Pallesen S, Bjorvatn B. Menstrual characteristics and night work among nurses. Ind Health. 2015;53(4):354-60. doi: 10.2486/indhealth.2014-0214. Epub 2015 Apr 24.'}, {'pmid': '31547916', 'type': 'BACKGROUND', 'citation': 'Ok G, Ahn J, Lee W. Association between irregular menstrual cycles and occupational characteristics among female workers in Korea. Maturitas. 2019 Nov;129:62-67. doi: 10.1016/j.maturitas.2019.07.019. Epub 2019 Aug 2.'}, {'pmid': '22583945', 'type': 'BACKGROUND', 'citation': 'Wan GH, Chung FF. Working conditions associated with ovarian cycle in a medical center nurses: a Taiwan study. Jpn J Nurs Sci. 2012 Jun;9(1):112-8. doi: 10.1111/j.1742-7924.2011.00191.x. Epub 2011 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. The aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.', 'detailedDescription': "The Covid-19 pandemic has impacted healthcare workers physically and psychologically. Healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. Increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. All of these factors may negatively affect their menstrual cycle.\n\nThe aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. Second aim is to investigate whether there is an association between Covid 19 infection and menstrual cycle changes.\n\nThis cross-sectional study is conducted with healthy female participants who are working at Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic inpatient and outpatient clinics. The participants who are sure about their pertinent information are enrolled in the study. The exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation.\n\nAfter informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. The questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy female healthcare workers at Covid 19 pandemic hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Working at Covid 19 Pandemic Hospital\n* Being at between 18 and 47 years old\n* Having menstruation\n\nExclusion Criteria:\n\n* Oral contraceptive users\n* Pregnants\n* Having malignancy\n* Having primary amenorrhea\n* Being at menopause\n* Lactation'}, 'identificationModule': {'nctId': 'NCT04413058', 'briefTitle': 'Menstrual Cycle Characteristics of Healthcare Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'Menstrual Cycle Characteristics of Healthcare Professionals at Covid 19 Pandemic Hospital', 'orgStudyIdInfo': {'id': 'HNEAH KAEK 2020/KK/'}, 'secondaryIdInfos': [{'id': 'Ministry of Health', 'type': 'REGISTRY', 'domain': 'Sevcan Arzu ARINKAN-2020-05-03T22_54_16'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female healthcare workers', 'description': 'Healthy female healthcare workers at Covid 19 clinic in Istanbul, Turkey'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Turkey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Sevcan Arzu Arinkan', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}