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Enrolling by Invitation

NCT Number: NCT06415994

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

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.

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Key information

Conditions

Opioid Use Disorder Buprenorphine Dependence Chemically-Induced Disorders Mental Disorders Methadone Dependence Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Related Substance-Related Disorders

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Riley Hospital for Children, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Alterations in fetal brain volume

    Time frame: Between 20 weeks gestation and delivery

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

  2. Differences in placenta signal

    Time frame: Between 20 weeks gestation and delivery

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

Secondary outcomes

  1. Placental epigenetic changes related to POE

    Time frame: Between 20 weeks gestation and delivery

    Compare placental DNA methylation in POE group and control group

  2. Placental dysfunction biomarkers related to POE

    Time frame: Between 20 weeks gestation and delivery

    Compare concentrations of blood proteins in POE group vs controls

  3. Neonatal Opioid Withdrawal Syndrome (NOWS) severity

    Time frame: After birth through one year of life

    Measuring NOWs severity in the POE group using eat sleep console scores

  4. Length of Hospital Stay

    Time frame: After birth through one year of life

    Measuring NOWs severity in the POE group using length of hospital stay

  5. Ages and Stages Questionnaire Scores during infancy

    Time frame: After birth through one year of life

    Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.

  6. Neurocognitive and behavioral development assessment (Bayley-4) at one year of age

    Time frame: After birth through one year of life

    Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.

Sponsors and collaborators

Lead sponsor

Senthil Sadhasivam

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 16, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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