NCT06415994

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Use Disorder
• Substance-Related Disorders
• Pregnancy Related
• Narcotic-Related Disorders
• Buprenorphine Dependence
• Methadone Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-13
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2024-05-16
• Last updated: 2025-06-29

Locations

2 sites across 1 country: United States