Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
NCT ID: NCT06415994
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
250 participants
OBSERVATIONAL
2024-02-13
2029-12-01
Brief Summary
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* 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.
* 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.
In this study participants will:
* Receive two placental-fetal MRIs, one during second trimester and one in third trimester.
* Answer surveys relating to their medical and social history.
* Have blood drawn during pregnancy and delivery.
* Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
Buprenorphine or Methadone Treatment
Pregnant mothers must be taking Buprenorphine or Methadone
Fetal and Placental MRI
Two MRIs :
* Second Trimester
* Third Trimester
Child Developmental Assessment
At 1 year of life child will receive a developmental assessment
Questionnaires
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
Blood and Placental Samples
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.
At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Pregnant Mothers
100 pregnant mother who to not have a history of opioid use disorder
Fetal and Placental MRI
Two MRIs :
* Second Trimester
* Third Trimester
Child Developmental Assessment
At 1 year of life child will receive a developmental assessment
Questionnaires
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
Blood and Placental Samples
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.
At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Interventions
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Buprenorphine or Methadone Treatment
Pregnant mothers must be taking Buprenorphine or Methadone
Fetal and Placental MRI
Two MRIs :
* Second Trimester
* Third Trimester
Child Developmental Assessment
At 1 year of life child will receive a developmental assessment
Questionnaires
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
Blood and Placental Samples
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.
At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
Eligibility Criteria
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Inclusion Criteria
* Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
* Singleton Pregnancy
* Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion Criteria
* Known or suspected major fetal/ neonatal congenital abnormalities
* HIV or AIDS
Infants with prenatal opioid exposure:
Inclusion:
1. Prenatal buprenorphine or methadone exposure
2. Born to mother enrolled in Opioid Use Disorder arm of study
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
1. Women \>18 Years of age
2. Healthy singleton pregnancy
3. Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion:
1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
2. HIV or AIDS
3. Known or suspected major fetal congenital abnormalities
4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
Control infants:
Inclusion:
Born to control pregnant mother enrolled in study
Exclusion:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
18 Years
100 Years
FEMALE
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Indiana University
OTHER
Responsible Party
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Rupa Radhakrishnan
Associate Professor of Radiology & Imaging Sciences
Locations
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Riley Hospital for Children
Indianapolis, Indiana, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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RADY-IIR-19751
Identifier Type: -
Identifier Source: org_study_id
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