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Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Sponsor: Indiana University
Summary
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: * 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.
Key Details
Gender
FEMALE
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-02-13
Completion Date
2029-12-01
Last Updated
2025-06-29
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (2)
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States