Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 5:13 PM
Study NCT ID:
NCT01152528
Status:
UNKNOWN
Last Update Posted:
2010-06-29
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D016585', 'term': 'Vaginosis, Bacterial'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal 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': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-28', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of preterm birth, gestational week at delivery.', 'timeFrame': '9 months', 'description': 'Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bacterial vaginosis', 'screening', 'abortion', 'preterm delivery'], 'conditions': ['Vaginal Infections', 'Bacterial Vaginosis', 'Late Miscarriage', 'Preterm Birth', 'Preterm Premature Rupture of Membranes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery.\n2. Subject is ready to sign an informed consent form.\n\nExclusion Criteria:\n\n1. Subject with ruptured membranes.\n2. Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.\n3. Subject with blood in her vaginal secretions.\n4. Subject is currently participating in another clinical study.\n5. Subject is unable or unwilling to cooperate with study procedures.'}, 'identificationModule': {'nctId': 'NCT01152528', 'briefTitle': 'Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Common Sense'}, 'officialTitle': 'VA-SENSE - BACTERIAL VAGINOSIS ONCE A WEEK SCREENING AND TREATMENT TO REDUCE INFECTIVE COMPLICATIONS, ABORTION AND PRETERM DELIVERY IN PREGNANT WOMEN WITH PREVIOUS PRETERM DELIVERY.', 'orgStudyIdInfo': {'id': 'F-7-27.3-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VA-SENSE', 'type': 'DEVICE', 'description': 'The VA-SENSE contains a strip of pH indicator (color indicator) that is sensitive to the acidity level. A change in the color of the strip due to changes in the acidity level of vaginal secretions absorbed in the panty liner clearly indicates high probability of bacterial or parasitic vaginal infection. Any color change that results from contact with urine will disappear 10 minutes of drying out, and then the color of the indicator strip will fade back to the original color (yellow).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Nahariya', 'state': 'Western Galilee', 'country': 'Israel', 'contacts': [{'name': 'hadar kessary, PhD', 'role': 'CONTACT', 'email': 'HADAR@CS-COMMONSENSE.COM', 'phone': '972-4-6277101', 'phoneExt': '1'}, {'name': 'Jacob Bonstein, Prof', 'role': 'CONTACT', 'email': 'mdjacob@techunix.technion.ac.il', 'phone': '972-4-9107517'}, {'name': 'Jacob Borenstein, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'Hadar Kessary, PhD', 'role': 'CONTACT', 'email': 'HADAR@CS-COMMONSENSE.COM', 'phone': '972-4-6277101', 'phoneExt': '126'}, {'name': 'Jacob Bornstein, Proffesor', 'role': 'CONTACT', 'email': 'mdjacob@techunix.technion.ac.il', 'phone': '972-4-9107517'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Common Sense', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hadar Kessary', 'oldOrganization': 'Common Sense'}}}}