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ENROLLING BY INVITATION
NCT06415994

Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

Sponsor: Indiana University

View on ClinicalTrials.gov

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

Interventions

DRUG

Buprenorphine or Methadone Treatment

Pregnant mothers must be taking Buprenorphine or Methadone

DIAGNOSTIC_TEST

Fetal and Placental MRI

Two MRIs : * Second Trimester * Third Trimester

BEHAVIORAL

Child Developmental Assessment

At 1 year of life child will receive a developmental assessment

BEHAVIORAL

Questionnaires

Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development

OTHER

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