Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 1:41 AM
Study NCT ID:
NCT04482504
Status:
UNKNOWN
Last Update Posted:
2020-07-24
First Post:
2020-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Disorders Related to Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-18', 'studyFirstSubmitQcDate': '2020-07-18', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine differences of postural stability between pregnant and non-pregnant women.', 'timeFrame': '1 hour', 'description': 'To determine differences of postural stability between pregnant and non-pregnant women.'}], 'secondaryOutcomes': [{'measure': 'find out predisposing factors of falling during pregnancy', 'timeFrame': '1 hour', 'description': 'Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['static posturography', 'Fall', 'pregnancy'], 'conditions': ['Balance, Postural', 'Fall', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Primary aim of this study is to evaluate postural equilibrium and risk of falls during pregnancy by comparing static postural stability between pregnant and non-pregnant control women. Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability. The investigators also determine level of vitamin D in the blood.', 'detailedDescription': 'Several hormonal, anatomical and physiological changes occur in the female body during pregnancy. These changes caused by pregnancy include significant weight gain, increased ligamentous laxity and spinal lordosis, decreased neuromuscular control and abdominal muscle strength, altered biomechanics and an anterior shift in the location of the centre of mass. These alteration of pregnant woman body can lead to balance problems.\n\nFalls during pregnancy are very common. Pregnant women especially in advanced stage of pregnancy are at higher risk of falling compared to non-pregnant women. Falls during pregnancy may cause maternal injuries such as bone fractures, joint sprains, muscle strains, head injury, rupture of internal organs, abruptio placentae, rupture of the uterus and membranes and occasionally maternal death or intrauterine fetal demise. Pregnant women are hospitalized due to a fall 2,3 times more than non-pregnant reproductive-aged women.\n\nThere is few evidence in a literature about postural stability but not about risk factors, that caused stability disorders. By determination of risk factors, the investigators can reduce number of falls in pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant and non-pregnant women', 'genderDescription': 'pregrancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The investigators involve every pregnant woman in 36.-38. week of pregnancy that attending an outpatient clinic at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic.\n\nExclusion Criteria:\n\n* Unwilling to participate\n* Minors (under 18 years old)\n* Musculoskeletal and neurological abnormalities\n* Unfamiliar with slovak language\n* Multiple pregnancy'}, 'identificationModule': {'nctId': 'NCT04482504', 'acronym': 'PRST', 'briefTitle': 'Balance Disorders Related to Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'Balance Disorders Related to Pregnancy', 'orgStudyIdInfo': {'id': 'EC/099/2019/UNBRuzinov'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy pregnant women', 'description': '200 healthy pregnant women in 36.-38. Week of pregnancy. The investigators involve every healthy pregnant woman in 36.-38. week of pregnancy.\n\nExclusion criteria:\n\n1. Unwilling to participate\n2. Minors (under 18 years old)\n\ne) Unfamiliar with slovak language f) Multiple pregnancy g) Musculoskeletal and neurological abnormalities', 'interventionNames': ['Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D']}, {'label': 'non-pregnant women', 'description': '30 non-pregnant healthy control women The investigators involve every healthy non-pregnant woman.\n\nExclusion criteria:\n\n1. Unwilling to participate\n2. Minors (under 18 years old)\n\ne) Unfamiliar with slovak language f) Pregnancy g) Musculoskeletal and neurological abnormalities', 'interventionNames': ['Diagnostic Test: 3 tests: Posturography, Questionnaire, vitamin D']}], 'interventions': [{'name': '3 tests: Posturography, Questionnaire, vitamin D', 'type': 'DIAGNOSTIC_TEST', 'description': 'Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.', 'armGroupLabels': ['healthy pregnant women', 'non-pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83232', 'city': 'Bratislava', 'state': 'Slovensko', 'country': 'Slovakia', 'facility': '2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not yet setup.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}