Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-29 @ 8:55 PM
Study NCT ID:
NCT04898192
Status:
UNKNOWN
Last Update Posted:
2021-05-26
First Post:
2021-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2021-05-21', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence and risk factors', 'timeFrame': '9 months', 'description': 'prevalence and risk factors of depression, anxiety and obsessive-compulsive disorder in the population of pregnant women in association with COVID-19 pandemic situation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental state', 'pregnancy', 'COVID'], 'conditions': ['Pregnant Woman']}, 'descriptionModule': {'briefSummary': 'This study is aimed to detect severe fear of delivery and its association with the incidence of obsessive-compulsive disorder and symptoms of depression and anxiety in the population of pregnant women in the third trimester during the serious COVID-19 pandemic situation in Slovakia. Data will be acquired from three departments of gynaecology and obstetrics of University Hospital Bratislava. The majority of pregnancies from the region are managed in this hospital; the total number of deliveries in 2020 achieved 7,835', 'detailedDescription': "The pregnancy is a risk factor for the first manifestation of several mental disorders. Current serious pandemic situation and a constant risk of COVID-19 infection negatively affects the mental state of the population, risk groups of pregnant women in particular. The aim of this project is to discover the incidence of symptoms of depression, anxiety and obsessive-compulsive disorder in association with the fear of delivery in current COVID-19 pandemic conditions in Slovakia. We also decided to add a short tool for detection of domestic violence among other scales to detect the incidence among Slovak pregnant population. All pregnant women in their third trimester who visit the prenatal clinic for their routine weekly check-up will be asked to participate in the study. The questionnaire which comprises of validated mental scales will be handed out to the patients waiting for their examination. After collection of filled questionnaires, those will be later paired with patients' medical documentation and statistically evaluated. The questionnaires will be collected during the period of 1.4.2021-31.3.2022 and statistical analysis will be conducted in the period of 1.4.2022-1.8.2022. It is expected that approximately 1,500 women will be included into the study. All three departments of gynaecology and obstetrics of the University Hospital Bratislava will participate at the study. In total, approximately 7,800 deliveries a year are managed in the University Hospital Bratislava.\n\nFollowing questionnaires are planned to be used in the study:\n\n* Wijma Delivery Expectancy/Experience Questionnaire - aimed at fear of delivery\n* PASS (Perinatal Anxiety Screening Scale) - aimed at anxiety in women before and after delivery\n* PHQ-9-SK (Patient Health Questionnaire) - aimed at depressive disorder\n* HITS Domestic Violence Screening Tool - aimed at domestic violence\n* DOK (The Obsessive-Compulsive Inventory) - aimed at obsessive and compulsive symptoms\n* GAD-7 (General Anxiety Disorder-7) - aimed at general anxiety disorder\n* EPDS (Edinburgh Postnatal Depression Scale) - aimed at symptoms of postpartal depression"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women in her third trimester who attend regular prenatal check-ups', 'genderDescription': 'pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy after 34th week\n* Vital fetus\n\nExclusion Criteria:\n\n* Unwilling to participate\n* Age less than 18 years\n* Foetus mortus or perinatal death of the newborn\n* Low knowledge of Slovak language\n* Serious pathology in the pregnancy (e.g. placenta praevia, known congenital disorders)'}, 'identificationModule': {'nctId': 'NCT04898192', 'acronym': 'COTEPS', 'briefTitle': 'Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'COTEPS: Monitoring of Incidence of Mental Discomfort in the Population of Pregnant Women in the Third Trimester During the Serious COVID-19 Pandemic Conditions', 'orgStudyIdInfo': {'id': 'EC/045/2021/UNBRuzinov'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'questionnaire - the complex of 6 questionnaires aimed to recognize the fear of delivery, perinatal anxiety, depressive disorder, obsessive-compulsive disorder, general anxiety disorder, postpartal depression and domestic violence.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83232', 'city': 'Bratislava', 'state': 'Slovensko', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Petra Psenkova, MD', 'role': 'CONTACT', 'email': 'petrapsenkova@gmail.com', 'phone': '+421907629336'}, {'name': 'Jozef Zahumensky, prof. MD', 'role': 'CONTACT', 'email': 'jozef.zahumensky@gmail.com'}], 'facility': '2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'centralContacts': [{'name': 'Peter Musil, PhD.', 'role': 'CONTACT', 'email': 'peter.musil@fmed.uniba.sk', 'phone': '+421903836788'}], 'overallOfficials': [{'name': 'Jozef Zahumensky, prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Comenius University in Bratislava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of project centre Faculty of Medicine', 'investigatorFullName': 'Peter Musil', 'investigatorAffiliation': 'Comenius University'}}}}