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

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

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Indiana University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-13

Primary Completion

2028-12-01

Completion

2029-12-01

Countries

• United States

Study Locations