Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-01-27 @ 6:06 AM
Study NCT ID:
NCT03884361
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2019-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Elective Amniocentesis Change Vaginal Microbiome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-03-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal Microbiome', 'timeFrame': '1 year', 'description': 'through blood and vaginal samples we will check if there are a vaginale micobiome - the samples will collected after and before the elective aminocentesis , the samples will sent to the labour of dr. Omer in the university , it will be analaysed there'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Microbiome']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to check if elective amniocentesis change vaginal microbiome'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.\n\nExclusion Criteria:\n\n* infection in the Uterus'}, 'identificationModule': {'nctId': 'NCT03884361', 'briefTitle': 'Does Elective Amniocentesis Change Vaginal Microbiome?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Does Elective Amniocentesis Change Vaginal Microbiome?', 'orgStudyIdInfo': {'id': '0126-18-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal Microbiome as result of aminocentesis', 'description': 'aginal Microbiome as result of aminocentesis by a blood and a vaginal samples that will taken before and after the aminocentesis', 'interventionNames': ['Diagnostic Test: Vaginal Microbiome as result of aminocentesis']}], 'interventions': [{'name': 'Vaginal Microbiome as result of aminocentesis', 'type': 'DIAGNOSTIC_TEST', 'description': 'we will take a blood samples and a vaginale samples after and before the aminicentesis and check if the sample that we took after is different and contain microrganisms , if we find a different o we can say that as result of the Elective Amniocentesis', 'armGroupLabels': ['Vaginal Microbiome as result of aminocentesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3810101', 'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Osnat Palgi, Bsc', 'role': 'CONTACT', 'email': 'osnatp@hymc.gov.il', 'phone': '+972-4-7744602'}], 'facility': 'Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Osnat Palgi, BS.c', 'role': 'CONTACT', 'email': 'osnatp@hymc.gov.il', 'phone': '+972-4-7744602'}, {'name': 'Rinat Gabbay Ben-Ziv, MD', 'role': 'CONTACT', 'email': 'RinatG@hy.health.gov.il'}], 'overallOfficials': [{'name': 'Gabbay Gabbay Ben-Ziv, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe medical center, Hadera, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}