Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT04067557
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'PCR diagnosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis', 'timeFrame': '4 month', 'description': 'Comparing the Gram stained vaginal smears using Hay/Ison (i.e. BV or normal) criteria with a molecular PCR method with 5 different bacterium and after an algoritm end up with the result (i.e. BV or normal). The number of women with the diagnosis of BV with each of the diagnostic test can be compared calculatitng a KAPPA index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection, Bacterial']}, 'descriptionModule': {'briefSummary': 'Among 300 women that are scheduled a therapeutic abortion screening diagnopsis of BV are done using Gram stained vaginal smear and with a molecular test using PCR for 5 different bacteria.', 'detailedDescription': 'The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden', 'eligibilityCriteria': 'Inclusion Criteria:\n\nwomen scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis\n\nExclusion Criteria:\n\n* women not pregnat'}, 'identificationModule': {'nctId': 'NCT04067557', 'briefTitle': 'Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Skaraborg Hospital'}, 'officialTitle': 'Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.', 'orgStudyIdInfo': {'id': 'BV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'molecuar test of BV', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnosis of BV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '541 85', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'Department of Ob/Gyn, Skaraborgshospital Skövde', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}], 'overallOfficials': [{'name': 'P-G Larsson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skaraborg Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Per-Goran Larsson', 'investigatorAffiliation': 'Skaraborg Hospital'}}}}