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

Indiana University

Status: Invitation-only

Conditions: Narcotic-Related Disorders; Methadone Dependence; Opioid Use Disorder; Pregnancy Related; Substance-Related Disorders; Buprenorphine Dependence

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06415994

R01DA059321 (U.S. NIH Grant/Contract)

RADY-IIR-19751

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

1. Prenatal buprenorphine or methadone exposure
2. Born to mother enrolled in Opioid Use Disorder arm of study

Exclusion:

Major congenital anomalies or genetic syndromes affecting neurodevelopment

Control Pregnant Women:

Inclusion:

1. Women >18 Years of age
2. Healthy singleton pregnancy
3. Planned delivery at Indiana University or University of Pittsburgh study sites

Exclusion:

1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
2. HIV or AIDS
3. Known or suspected major fetal congenital abnormalities
4. 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.

Trial design

250 participants in 2 patient groups

Pregnant Mothers with Opioid Use Disorder

Description:

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

Treatment:

Other: Blood and Placental Samples

Diagnostic Test: Fetal and Placental MRI

Behavioral: Questionnaires

Drug: Buprenorphine or Methadone Treatment

Behavioral: Child Developmental Assessment

Pregnant Mothers

Description:

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

Treatment:

Other: Blood and Placental Samples

Diagnostic Test: Fetal and Placental MRI

Behavioral: Questionnaires

Behavioral: Child Developmental Assessment