Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT02030106
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2014-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motherhood and Microbiome
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Women will self-collect samples of their cervicovaginal fluid using large cotton swabs.\n\nSubjects who have had a previous preterm birth will also have cervical cells collected in the same manner that cells are collected for a routine pap smear.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervicovaginal Microbiota in Women With and Without Preterm Birth', 'timeFrame': 'Enrollment through delivery', 'description': 'Cervicovaginal Microbiota in Women With and Without Preterm Birth'}], 'secondaryOutcomes': [{'measure': 'Potential Modifiers of the Cervicovaginal Microbiome', 'timeFrame': 'Enrollment through delivery', 'description': 'Potential modifiers of the cervicovaginal microbiome: behavioral factors, stress, nutrition/obesity, vaginal infections, genetic or host immune differences, race and ethnicity, social behaviors, environmental influences'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervicovaginal microbiome', 'Microbiome', 'Preterm Birth', 'Cervical Remodeling', 'Preterm delivery', 'Microbiota'], 'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.', 'detailedDescription': 'Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 20 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pregnant women receiving care in University of Pennsylvania Health System\n\nExclusion Criteria:\n\n* Non-singleton pregnancy (twins, triplets, etc.)\n* Known major fetal anomaly\n* Known HIV positive status\n* History of organ transplant\n* Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)'}, 'identificationModule': {'nctId': 'NCT02030106', 'acronym': 'M&M', 'briefTitle': 'Motherhood and Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth', 'orgStudyIdInfo': {'id': '818914'}, 'secondaryIdInfos': [{'id': 'R01NR014784-01', 'link': 'https://reporter.nih.gov/quickSearch/R01NR014784-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prior Preterm Birth Patients', 'description': 'All obstetrical patients eligible for the study that have had a prior preterm birth.'}, {'label': 'Term Birth Patients', 'description': 'All obstetrical patients eligible for the study that have not had a prior preterm birth.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Michal A Elovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}