Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT02948192
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2016-10-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Reproductive Microbiome & Perinatal Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sample collection for bacterial microbiome identification and metabolic products'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inability to obtain final specimen routinely', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm Delivery', 'timeFrame': '36 weeks', 'description': 'Onset of preterm labor with subsequent spontaneous preterm birth'}], 'secondaryOutcomes': [{'measure': 'Microbiome profile', 'timeFrame': '36 weeks', 'description': 'Evaluation of characteristics of the vaginal microbiome in cohorts'}, {'measure': 'Metabolomic profile', 'timeFrame': '36 weeks', 'description': 'Evaluation of characteristics of the metabolomic products present in cohort'}, {'measure': 'Medical comorbidities', 'timeFrame': '36 weeks', 'description': 'Evaluation of the comorbidities present in the cohort'}, {'measure': 'Gut Microbiome profile', 'timeFrame': '36 weeks', 'description': 'Evaluation of the characteristics of the gastrointestinal microbiome in cohorts'}, {'measure': 'Term delivery', 'timeFrame': '36 weeks', 'description': 'Delivery at term'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm Delivery', 'Preterm Birth', 'Vaginal Microbiome', 'Microbiome', 'Gut Microbiome', 'African American', 'Metabolomics', 'Pregnancy'], 'conditions': ['Human Microbiota', 'PreTerm Birth', 'Human Gastrointestinal Microbiota', 'Metabolomics']}, 'descriptionModule': {'briefSummary': 'Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African american women between 18 and 45 years of age who are pregnant with a singleton and present for prenatal care at 20 weeks of gestation or less.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age\n\nExclusion Criteria:\n\n* Race other than African American, Advanced gestational age (\\>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.'}, 'identificationModule': {'nctId': 'NCT02948192', 'briefTitle': 'The Reproductive Microbiome & Perinatal Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'The Reproductive Microbiome & Perinatal Health Outcome', 'orgStudyIdInfo': {'id': '016-194'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm Delivery', 'description': 'African american women who present for prenatal care who experience spontaneous preterm birth', 'interventionNames': ['Other: Survey, Sample collection']}, {'label': 'Term delivery', 'description': 'African american women who present for prenatal care who experience term birth', 'interventionNames': ['Other: Survey, Sample collection']}], 'interventions': [{'name': 'Survey, Sample collection', 'type': 'OTHER', 'description': 'Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.', 'armGroupLabels': ['Preterm Delivery', 'Term delivery']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Discovery Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}