Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-01 @ 11:34 AM
Study NCT ID:
NCT04049032
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perinatal Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of individuals retained in treatment', 'timeFrame': '6-8 weeks postpartum', 'description': 'Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum'}, {'measure': 'Percent of infants born with Neonatal Abstinence Syndrome (NAS)', 'timeFrame': 'At Delivery', 'description': 'Newborn withdrawal, also know as NAS gathered via electronic health record'}], 'secondaryOutcomes': [{'measure': 'Positive urine drug screens', 'timeFrame': 'At delivery and 6-8 weeks postpartum', 'description': 'Number of individuals with a positive urine drug screen'}, {'measure': 'Length of newborn hospital stay and birth weight', 'timeFrame': 'Assessed up to 6 months following delivery', 'description': 'Average number of days infant was in the hospital following delivery; weight of infant at birth'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'prescription opioids'], 'conditions': ['Opioid Use', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '32003816', 'type': 'DERIVED', 'citation': 'Guille C, Simpson AN, Douglas E, Boyars L, Cristaldi K, McElligott J, Johnson D, Brady K. Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920177. doi: 10.1001/jamanetworkopen.2019.20177.'}]}, 'descriptionModule': {'briefSummary': 'To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person.', 'detailedDescription': 'Participants: Pregnant women with OUD.\n\nIntervention: Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine.\n\nDesign: A cohort derived from a prospectively collected database including 98 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables.\n\nSetting: Four outpatient obstetric practices in the southeast.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort derived from a prospectively collected database including 94 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult females, any race or ethnicity, age 18-45 years\n* Currently pregnant\n* Opioid Use Disorder (OUD)\n* received in person or telemedicine treatment for OUD in their obstetrician's office\n\nExclusion Criteria:\n\n* Not currently pregnant or receiving perinatal care\n* Not in agreement with Patient-Physician Agreement"}, 'identificationModule': {'nctId': 'NCT04049032', 'briefTitle': 'Perinatal Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': "MUSC Women's Reproductive Behavioral Health Program for Opioid Use During Pregnancy", 'orgStudyIdInfo': {'id': 'Pro00074655'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In-Person Participants', 'description': 'This group received perinatal OUD treatment in-person.', 'interventionNames': ['Behavioral: In-Person Perinatal OUD Treatment']}, {'label': 'Telemedicine Participants', 'description': 'This group received perinatal OUD treatment via telemedicine.', 'interventionNames': ['Behavioral: Perinatal OUD Treatment via Telemedicine']}], 'interventions': [{'name': 'In-Person Perinatal OUD Treatment', 'type': 'BEHAVIORAL', 'description': 'Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care.', 'armGroupLabels': ['In-Person Participants']}, {'name': 'Perinatal OUD Treatment via Telemedicine', 'type': 'BEHAVIORAL', 'description': 'Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care..', 'armGroupLabels': ['Telemedicine Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}