Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT06415994
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-29
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected at MRI visits for substances, DNA, RNA and epigenetic analysis.\n\nPlacental sample: A sample of the placenta will be collected during delivery for analysis DNA, RNA and epigenetic analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alterations in fetal brain volume', 'timeFrame': 'Between 20 weeks gestation and delivery', 'description': 'Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls'}, {'measure': 'Differences in placenta signal', 'timeFrame': 'Between 20 weeks gestation and delivery', 'description': 'Comparing differences in placenta signal using MRI between the POE group and controls'}], 'secondaryOutcomes': [{'measure': 'Placental epigenetic changes related to POE', 'timeFrame': 'Between 20 weeks gestation and delivery', 'description': 'Compare placental DNA methylation in POE group and control group'}, {'measure': 'Placental dysfunction biomarkers related to POE', 'timeFrame': 'Between 20 weeks gestation and delivery', 'description': 'Compare concentrations of blood proteins in POE group vs controls'}, {'measure': 'Neonatal Opioid Withdrawal Syndrome (NOWS) severity', 'timeFrame': 'After birth through one year of life', 'description': 'Measuring NOWs severity in the POE group using eat sleep console scores'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'After birth through one year of life', 'description': 'Measuring NOWs severity in the POE group using length of hospital stay'}, {'measure': 'Ages and Stages Questionnaire Scores during infancy', 'timeFrame': 'After birth through one year of life', 'description': "Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track."}, {'measure': 'Neurocognitive and behavioral development assessment (Bayley-4) at one year of age', 'timeFrame': 'After birth through one year of life', 'description': "Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnant with Opioid Use Disorder', 'Opioid Use Disorder', 'Subutex', 'Buprenorphine', 'Pregnant taking buprenorphine/subutex'], 'conditions': ['Opioid Use Disorder', 'Substance-Related Disorders', 'Pregnancy Related', 'Narcotic-Related Disorders', 'Buprenorphine Dependence', 'Methadone Dependence']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:\n\n* Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.\n* To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.\n\nIn this study participants will:\n\n* Receive two placental-fetal MRIs, one during second trimester and one in third trimester.\n* Answer surveys relating to their medical and social history.\n* Have blood drawn during pregnancy and delivery.\n* Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Pregnant women with opioid use disorder\n\nInclusion Criteria:\n\n* Age \\>18 years\n* Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program\n* Singleton Pregnancy\n* Planned delivery at Indiana University or University of Pittsburgh study sites\n\nExclusion Criteria:\n\n* Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures\n* Known or suspected major fetal/ neonatal congenital abnormalities\n* HIV or AIDS\n\nInfants with prenatal opioid exposure:\n\nInclusion:\n\n1. Prenatal buprenorphine or methadone exposure\n2. Born to mother enrolled in Opioid Use Disorder arm of study\n\nExclusion:\n\nMajor congenital anomalies or genetic syndromes affecting neurodevelopment\n\nControl Pregnant Women:\n\nInclusion:\n\n1. Women \\>18 Years of age\n2. Healthy singleton pregnancy\n3. Planned delivery at Indiana University or University of Pittsburgh study sites\n\nExclusion:\n\n1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures\n2. HIV or AIDS\n3. Known or suspected major fetal congenital abnormalities\n4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.\n\nControl infants:\n\nInclusion:\n\nBorn to control pregnant mother enrolled in study\n\nExclusion:\n\nAny major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.'}, 'identificationModule': {'nctId': 'NCT06415994', 'briefTitle': 'Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'RADY-IIR-19751'}, 'secondaryIdInfos': [{'id': 'R01DA059321', 'link': 'https://reporter.nih.gov/quickSearch/R01DA059321', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Mothers with Opioid Use Disorder', 'description': '150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment', 'interventionNames': ['Drug: Buprenorphine or Methadone Treatment', 'Diagnostic Test: Fetal and Placental MRI', 'Behavioral: Child Developmental Assessment', 'Behavioral: Questionnaires', 'Other: Blood and Placental Samples']}, {'label': 'Pregnant Mothers', 'description': '100 pregnant mother who to not have a history of opioid use disorder', 'interventionNames': ['Diagnostic Test: Fetal and Placental MRI', 'Behavioral: Child Developmental Assessment', 'Behavioral: Questionnaires', 'Other: Blood and Placental Samples']}], 'interventions': [{'name': 'Buprenorphine or Methadone Treatment', 'type': 'DRUG', 'description': 'Pregnant mothers must be taking Buprenorphine or Methadone', 'armGroupLabels': ['Pregnant Mothers with Opioid Use Disorder']}, {'name': 'Fetal and Placental MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Two MRIs :\n\n* Second Trimester\n* Third Trimester', 'armGroupLabels': ['Pregnant Mothers', 'Pregnant Mothers with Opioid Use Disorder']}, {'name': 'Child Developmental Assessment', 'type': 'BEHAVIORAL', 'description': 'At 1 year of life child will receive a developmental assessment', 'armGroupLabels': ['Pregnant Mothers', 'Pregnant Mothers with Opioid Use Disorder']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': "Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development", 'armGroupLabels': ['Pregnant Mothers', 'Pregnant Mothers with Opioid Use Disorder']}, {'name': 'Blood and Placental Samples', 'type': 'OTHER', 'description': 'At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.\n\nAt delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.', 'armGroupLabels': ['Pregnant Mothers', 'Pregnant Mothers with Opioid Use Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology & Imaging Sciences', 'investigatorFullName': 'Rupa Radhakrishnan', 'investigatorAffiliation': 'Indiana University'}}}}