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

NCT06415994 | Enrolling By Invitation

• 2 other identifiers: RADY-IIR-19751R01DA059321
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pregnant with Opioid Use Disorder; Opioid Use Disorder; Subutex; Buprenorphine; Pregnant taking buprenorphine/subutex

Outcome Measures

Primary Outcomes (2)

• Alterations in fetal brain volume

  Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls

  Between 20 weeks gestation and delivery

• Differences in placenta signal

  Comparing differences in placenta signal using MRI between the POE group and controls

  Between 20 weeks gestation and delivery

Secondary Outcomes (6)

• Placental epigenetic changes related to POE

  Between 20 weeks gestation and delivery

• Placental dysfunction biomarkers related to POE

  Between 20 weeks gestation and delivery

• Neonatal Opioid Withdrawal Syndrome (NOWS) severity

  After birth through one year of life

• Length of Hospital Stay

  After birth through one year of life

• Ages and Stages Questionnaire Scores during infancy

  After birth through one year of life

Study Arms (2)

Pregnant Mothers with Opioid Use Disorder

150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment

Drug: Buprenorphine or Methadone Treatment; Diagnostic Test: Fetal and Placental MRI; Behavioral: Child Developmental Assessment; Behavioral: Questionnaires; Other: Blood and Placental Samples

Pregnant Mothers

100 pregnant mother who to not have a history of opioid use disorder

Diagnostic Test: Fetal and Placental MRI; Behavioral: Child Developmental Assessment; Behavioral: Questionnaires; Other: Blood and Placental Samples

Interventions

Buprenorphine or Methadone Treatment DRUG

Pregnant mothers must be taking Buprenorphine or Methadone

Pregnant Mothers with Opioid Use Disorder

Fetal and Placental MRI DIAGNOSTIC_TEST

Two MRIs : * Second Trimester * Third Trimester

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Child Developmental Assessment BEHAVIORAL

At 1 year of life child will receive a developmental assessment

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Questionnaires BEHAVIORAL

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

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

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.

Pregnant Mothers; Pregnant Mothers with Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.

You may qualify if:

• 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

You may not qualify if:

• 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:
• Prenatal buprenorphine or methadone exposure
• Born to mother enrolled in Opioid Use Disorder arm of study
• Major congenital anomalies or genetic syndromes affecting neurodevelopment
• Control Pregnant Women:
• Women \>18 Years of age
• Healthy singleton pregnancy
• Planned delivery at Indiana University or University of Pittsburgh study sites
• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15260, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected at MRI visits for substances, DNA, RNA and epigenetic analysis. Placental sample: A sample of the placenta will be collected during delivery for analysis DNA, RNA and epigenetic analysis.

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Narcotic-Related Disorders

Interventions

Buprenorphine; Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology & Imaging Sciences

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: May 16, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (2)