Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-27 @ 8:22 AM
Study NCT ID:
NCT03122704
Status:
WITHDRAWN
Last Update Posted:
2017-04-21
First Post:
2015-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of women with GBS infection', 'timeFrame': '7 days after swab taken', 'description': 'Number of women with GBS infection divided by total number of women under screening'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Preterm Labor']}, 'descriptionModule': {'briefSummary': 'This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART.\n\n221 subjects will be involved.', 'detailedDescription': "Pregnant women at 20 0/7 to 36 6/7 weeks of gestation, conceived through ART, with signs and symptoms of preterm labor will be recruited.\n\nAnal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. Digital examination will be performed after that. Only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire.\n\nThe samples will be sent immediately to My Duc hospital laboratory or will be stored in Stuart-Amies medium in \\< 4 hours. All culture results are interpreted based on Clinical and Laboratory Standards Institute (CLSI) in 2012.\n\nStatistical analysis was performed by Statistical Package for the Social Sciences (SPSS) v.20 and chi-square test. A p-value of \\< 0.05 was considered as statistically significant."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '\\* Inclusion Criteria:\n\nTo be eligible for enrolment into this trial, subject must fulfil all of the following criteria, unless specified otherwise\n\n* Being conceived through IVF\n* Moderate uterine contractions (2 contractions per 10 minutes, duration \\< 30 seconds)\n* 20 0/7 to 36 6/7 weeks of gestation\n* Intact membrane\n* Cervical dilation ≤ 3 cm\n* Willing to participate into the study\n\n * Exclusion Criteria:\n\nTo be eligible for enrolment in this study each subject must not meet any of the following criteria:\n\n* Having had intercourse during 24 hours before\n* Being suspected of amniotic leakage\n* Rupture of membrane identified by direct observation through speculum examination of amniotic fluid flow from cervix\n* Vaginal bleeding\n* Being suspected of placenta abruption, placenta previa\n* Having been treated with antibiotics within 1 week before\n* Vaginal douche within 48 hours before\n* Having used vaginal medicines during 48 hours before\n* Having vaginal ultrasound shortly before\n* Urine culture positive with GBS'}, 'identificationModule': {'nctId': 'NCT03122704', 'briefTitle': 'Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam National University'}, 'officialTitle': 'Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.', 'orgStudyIdInfo': {'id': 'NCKH/CGRH_09_2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group B Streptococcus (GBS) screening', 'description': 'Vaginal and anal swab of patients will be screened for GBS screening', 'interventionNames': ['Procedure: GBS screening']}], 'interventions': [{'name': 'GBS screening', 'type': 'PROCEDURE', 'description': 'Vaginal and anal swabs of patients will be screened for GBS screening', 'armGroupLabels': ['Group B Streptococcus (GBS) screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'state': 'Tan Binh District', 'country': 'Vietnam', 'facility': 'My Duc Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Tuong M Ho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Center for Genetics and Reproductive Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manh Tuong Ho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Manh Tuong Ho', 'investigatorAffiliation': 'Vietnam National University'}}}}