Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine or Methadone Treatment, Fetal and Placental MRI, Child Developmental Assessment, Questionnaires.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related, Narcotic-Related Disorders. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Alterations in fetal brain volume [Time frame: Between 20 weeks gestation and delivery]
- Differences in placenta signal [Time frame: Between 20 weeks gestation and delivery]
Secondary outcome measures (6)
- Placental epigenetic changes related to POE [Time frame: Between 20 weeks gestation and delivery]
- Placental dysfunction biomarkers related to POE [Time frame: Between 20 weeks gestation and delivery]
- Neonatal Opioid Withdrawal Syndrome (NOWS) severity [Time frame: After birth through one year of life]
- Length of Hospital Stay [Time frame: After birth through one year of life]
- Ages and Stages Questionnaire Scores during infancy [Time frame: After birth through one year of life]
- Neurocognitive and behavioral development assessment (Bayley-4) at one year of age [Time frame: After birth through one year of life]
Eligibility criteria
Pregnant women with opioid use disorder
Inclusion criteria
- Age >18 years
- Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
- Singleton Pregnancy
- Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion criteria
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- Known or suspected major fetal/ neonatal congenital abnormalities
- HIV or AIDS
Infants with prenatal opioid exposure:
Inclusion:
- Prenatal buprenorphine or methadone exposure
- Born to mother enrolled in Opioid Use Disorder arm of study
Exclusion:
Major congenital anomalies or genetic syndromes affecting neurodevelopment
Control Pregnant Women:
Inclusion:
- Women >18 Years of age
- Healthy singleton pregnancy
- Planned delivery at Indiana University or University of Pittsburgh study sites
Exclusion:
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- HIV or AIDS
- Known or suspected major fetal congenital abnormalities
- Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
Control infants:
Inclusion:
Born to control pregnant mother enrolled in study
Exclusion:
Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Riley Hospital for Children — Indianapolis
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06415994 · STUDY23110104 · R01DA059321 · RADY-IIR-19751