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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06415994
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Buprenorphine or Methadone Treatment — DRUG
    Pregnant mothers must be taking Buprenorphine or Methadone
  • Fetal and Placental MRI — DIAGNOSTIC_TEST
    Two MRIs : * Second Trimester * Third Trimester
  • Child Developmental Assessment — BEHAVIORAL
    At 1 year of life child will receive a developmental assessment
  • Questionnaires — BEHAVIORAL
    Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
  • Blood and Placental Samples — OTHER
    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.

Study Details

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 Dates

Start date
Feb 13, 2024
Status verified
Jun 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Pregnant Mothers with Opioid Use Disorder
    150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
  • Arm: Pregnant Mothers
    100 pregnant mother who to not have a history of opioid use disorder

Primary Outcome Measure

Alterations in fetal brain volume [ Time Frame: Between 20 weeks gestation and delivery ]

Locations (2)

FacilityCityStateZIPSite coordinators
Riley Hospital for ChildrenIndianapolisIndiana46202-
University of PittsburgPittsburghPennsylvania15260-

Find similar trials in Indianapolis, IN

By research site
Riley Hospital for Children· Indianapolis, INUniversity of Pittsburg· Pittsburgh, PA

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