Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-06 @ 2:40 PM
Study NCT ID:
NCT04688866
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation Into the Microorganisms in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002581', 'term': 'Uterine Cervical Incompetence'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000026', 'term': 'Abortion, Habitual'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001483', 'term': 'Base Sequence'}], 'ancestors': [{'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cervical swab samples obtained comprise ample amount of DNA for PCR amplification or sequencing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abundances of microorganisms in the cervix', 'timeFrame': '1 year', 'description': 'Abundances of microorganisms including bacteria and fungi in the cervix are measured by normalized sequencing read counts'}], 'secondaryOutcomes': [{'measure': 'Gestational age at delivery', 'timeFrame': '1 year'}, {'measure': 'Mode of delivery', 'timeFrame': '1 year'}, {'measure': 'Number of participants who received cerclage or ring pessary in the current pregnancy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm birth', 'cervical insufficiency', 'cerclage', 'pessary'], 'conditions': ['Cervical Insufficiency', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Pregnant women with short cervical length (\\<25 mm) in second-trimester ultrasonographic assessment are at high risk for preterm birth, a major cause of perinatal mortality and morbidity worldwide. Some of these short-cervix women proceed to a more advanced stage manifested as a painless prematurely dilated cervix in the second trimester. It is not fully understood why some women have short cervical length or prematurely dilated cervix (cervical insufficiency), although evidence is mounting that there is an association between short cervical length and infection by microorganisms. The investigators hypothesize that the cervical microorganisms in pregnant women with a shortened or dilated cervix are different, compared with those in women with normal cervical length and a closed cervix.', 'detailedDescription': 'Previously, culture-dependent methods were used to detect bacterial or fungal infection, but the sensitivity was low, since not all species grew well in culture. Recently, molecular methods based on PCR amplification of the bacterial 16S ribosomal RNA (rRNA) gene or the fungal internal transcribed spacer (ITS) followed by capillary sequencing has been used to identify bacteria and fungi. However, the resolution of such capillary sequencing-based method (\\<100 sequencing reads/sample) is too low to capture the major collection of microorganisms in a sample. Less abundant but possibly pathogenic microorganisms associated with short cervical length remain undetectable. To address the current gap in this field, we propose to more comprehensively survey microbial communities in the cervix of pregnant women by PCR amplification of the 16S rRNA region, ITS or other genomic regions with taxonomic classification potential. This will be followed by next-generation sequencing (\\>40,000 sequencing reads/sample), which has been proven to capture the majority of microorganisms in a sample.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who attend preterm clinics or receive antenatal care at the participating hospitals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with or without cervical insufficiency (cervical length \\<25 mm or dilated cervix in the second trimester or the late first trimester)\n\nExclusion Criteria:\n\n* multiple pregnancies and pregnancies associated with fetal chromosomal abnormality'}, 'identificationModule': {'nctId': 'NCT04688866', 'briefTitle': 'Investigation Into the Microorganisms in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Investigation Into the Fungal Microbiome (Mycobiome) in the Cervices of Cervical Insufficiency Patients Receiving Cerclage Treatment and Resulting in Term or Preterm Birth', 'orgStudyIdInfo': {'id': '2012.243'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with cervical insufficiency (Cases)', 'description': 'Pregnant women with a shortened (\\<25 mm) or dilated cervix in the second trimester (or late first trimester)', 'interventionNames': ['Other: Sequencing']}, {'label': 'Pregnant women without cervical insufficiency (Controls)', 'description': 'Pregnant women with a normal-length (\\>= 25 mm) and closed cervix in the second trimester (or late first trimester)', 'interventionNames': ['Other: Sequencing']}], 'interventions': [{'name': 'Sequencing', 'type': 'OTHER', 'description': 'This is an observational study, since the assignment of the medical intervention (e.g. cerclage or pessary) is not at the discretion of the investigator. However, cervical samples collected from both groups are subjected to amplicon sequencing for taxonomic classification of microorganisms.', 'armGroupLabels': ['Pregnant women with cervical insufficiency (Cases)', 'Pregnant women without cervical insufficiency (Controls)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Stephen S Chim, PhD', 'role': 'CONTACT', 'email': 'sschim@cuhk.edu.hk', 'phone': '852-35051324'}, {'name': 'Wong K Karen, MPhil', 'role': 'CONTACT', 'email': 'wkwkaren@cuhk.edu.hk', 'phone': '852-23521798'}], 'facility': 'Research Laboratory, Dept of Obstetrics & Gynaecology, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Stephen S Chim, PhD', 'role': 'CONTACT', 'email': 'sschim@cuhk.edu.hk', 'phone': '(852)35051324'}, {'name': 'Karen K Wong, MPhil', 'role': 'CONTACT', 'email': 'wkwkaren@cuhk.edu.hk', 'phone': '(852)'}], 'overallOfficials': [{'name': 'Stephen S Chim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hallym University', 'class': 'OTHER'}, {'name': 'Health and Medical Research Fund', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stephen Chim', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}