Clinical trial NCT06415994: Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Official title: Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-05-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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:

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.

Primary outcomes:
measure: Alterations in fetal brain volume
timeFrame: Between 20 weeks gestation and delivery
measure: Differences in placenta signal
timeFrame: Between 20 weeks gestation and delivery
Secondary outcomes:
measure: Placental epigenetic changes related to POE
timeFrame: Between 20 weeks gestation and delivery
measure: Placental dysfunction biomarkers related to POE
timeFrame: Between 20 weeks gestation and delivery
measure: Neonatal Opioid Withdrawal Syndrome (NOWS) severity
timeFrame: After birth through one year of life
measure: Length of Hospital Stay
timeFrame: After birth through one year of life
measure: Ages and Stages Questionnaire Scores during infancy
timeFrame: After birth through one year of life
measure: Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
timeFrame: After birth through one year of life
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Pittsburgh
country: United States
facility: University of Pittsburg
state: Pennsylvania
Study officials:
References: